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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 II - C34004; BRIEF: The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL. ; DRUG USED: TAK-659; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: Calithera Biosciences, Inc; CRITERIA: Inclusion Criteria: 1. Must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL. a. High-grade B-cell lymphoma (BCL) with MYC and BCL-2 and/or BCL-6 translocations (double-hit DLBCL under DLBCL, not otherwise specified [NOS], based on the 2008 World Health Organization [WHO] classification criteria) is not eligible for this study. 2. Local pathology review for histological confirmation; A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required. 3. Relapsed or refractory to greater than or equal to (>=) 2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy. 4. Documented investigator-assessed relapse or progression after the last treatment is required if the participant responded and then progressed on the prior treatment. 5. Measurable disease per IWG 2007 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status less than (<) 2. 7. Life expectancy of greater than (>) 3 months. 8. Adequate organ function, including the following: 1. Bone marrow reserve: absolute neutrophil count (ANC) >=1000/microliter (μL), platelet count >=75,000/μL (>=50,000/μL for participants with bone marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL). 2. Hepatic: total bilirubin less than or equal to (<=) 1.5 times the upper limit of the normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5*ULN. 3. Renal: creatinine clearance >=60 milliliter per minute (mL/min). 4. Others: - Lipase <=1.5*ULN and amylase <=1.5*ULN with no clinical symptoms suggestive of pancreatitis or cholecystitis. - Blood pressure <=Grade 1 (hypertensive participants are permitted if their blood pressure is controlled to <=Grade 1 by hypertensive medications. - Glycosylated hemoglobin is <=6.5% hyperglycemic participants permitted if glucose is well controlled by antihyperglycemic medication). Exclusion Criteria: 1. Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases. 2. Known human immunodeficiency virus (HIV)-related malignancy. 3. Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or anti-tumor vaccine). 4. Radiotherapy less than 3 weeks before the first dose of study treatment. If prior radiotherapy occurred <4 to 6 weeks before study start, as radiated lesions cannot be reliably assessed by fluorodeoxyglucose-positron emission tomography (FDG-PET), nonradiated target lesions are required for eligibility, and prior radiotherapy information must be submitted to the IRC. 5. Known HIV positive, hepatitis B surface antigen positive or known or suspected active hepatitis C infection. 6. Prior autologous stem cell transplant (ASCT) within 6 months or prior ASCT at any time without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell transplant any time. 7. Participants with certain cardiovascular conditions are excluded. 8. Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery. 9. Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug. 10. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659. 11. Participants with another malignancy within 2 years of study start. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry. 12. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659. 13. Received medications, supplements, or food/beverages that are P-glycoprotein (P-gp) inhibitors or inducers or strong cytochrome P450 (CYP) 3A inhibitors or inducers within a certain timeframe prior to the first dose of study drug. Depending on the substance, the washout period for P-gp inhibitors or inducers or strong CYP3A inhibitors or inducers will be either 7 days or 5 times the half-life (half-life is related to the time required for elimination from the body). The washout period for grapefruit containing food or beverages is 5 days. ; PRIMARY OUTCOME: Stage 2: ORR as Assessed by Independent Radiologic Review Committee (IRRC) Based on Modified 2007 International Working Group (IWG) Criteria; SECONDARY OUTCOME 1: Stage 2: CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria[/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 Ib/II - w/Gemcitabine; BRIEF: Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients. Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients. ; DRUG USED: PEGPH20; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Hyaluronic acid; THERAPY: Monotherapy; LEAD SPONSOR: Halozyme Therapeutics; CRITERIA: Key Inclusion Criteria: - Patients with histologically confirmed Stage IV adenocarcinoma of the pancrease previously untreated for metastatic disease - One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria - Life expectancy of at least 3 months - Signed, written IRB/EC-approved informed consent - A negative serum pregnancy test, if female Key Exclusion Criteria: - Known brain metastasis - New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 12 months - Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy - Known allergy to hyaluronidase - Women currently pregnant or breast feeding ; PRIMARY OUTCOME: Number of Participants With a Dose-limiting Toxicity (DLT); SECONDARY OUTCOME 1: Observed Maximum Plasma Concentration (Cmax) Following Single PEGPH20 Doses[/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 - PRX100.FDAIIb; BRIEF: To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in the treatment of early to moderate presbyopia. ; DRUG USED: PRX-100; DRUG CLASS: Non-NME; INDICATION: Refractive Errors (Ophthalmology); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: LENZ Therapeutics, Inc; CRITERIA: Inclusion Criteria: 1. Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed; 2. Be able and willing to follow all instructions and attend study visits; 3. Be 48-64 years of age of either sex and any race or ethnicity at visit 1; 4. Be an early to moderate presbyope determined by screening monocular best-corrected distance visual acuity (VA) at 45 cm 5. Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study without significant risk to the subject. Exclusion Criteria: 1. Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy; 2. Have known contraindications or sensitivity to the use of any of the study medications(s) or their components; 3. Have an active ocular infection at visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (eg, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye; 4. Have moderate or severe dry eye; 5. Have clinically significant abnormal lens findings (eg cataract) including early lens changes and/or any evidence of a media opacity in either eye; 6. Have dark-adapted pupillometry measurements of < 4.0 mm in either eye; 7. Have intraocular pressure (IOP) that is less than 5 millimeters of mercury (mmHg) or greater than 22 mmHg in either eye documented at visit 1, or have a prior diagnosis of ocular hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication at visit 1; 8. Have abnormal findings on dilated fundus exam in either eye documented within 3 months of visit 1 or a known history of retinal detachment or clinically significant retinal disease in either eye; 9. Have a known history or diagnosis in the past of: iritis, scleritis or uveitis, whether active or inactive; 10. Have had surgical intervention (ocular or systemic) within 6 months prior to visit 1, or planned surgical intervention within 30 days after visit 4; 11. Have undergone refractive eye surgery (incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub-epithelial keratectomy [LASEK]), corneal inlay procedures, cataract extraction, or intraocular lens placement; 12. Use artificial tears or lubricant eye ointment on a daily basis; 13. Have an inability or refuse to discontinue soft contact lens wear 7 days prior to study visit 1 and rigid gas permeable (RGP) contact lens wear 14 days prior to visit 1 and during the study; 14. Use any of the following disallowed medications during the 2 weeks (14 days) prior to visit 1 and during the study: 1. narcotic (opiate class) pain medication (eg, codeine, OxyContin®, Vicodin®, Tramadol®) 2. bladder medication (eg Urecholine®, bethanechol) 3. antipsychotics 4. antidepressants 5. attention -deficit/hyperactivity disorder (ADHD) medications 6. alpha-blockers (eg, tamsulosin, Flomax®, Jayln®, Uroxatral®, Rapaflo®) 7. anticholinergics (eg, atropine, belladonna, benztropine, dicyclomine, donepezil, hyoscyamine, propantheline, scopolamine, trihexphenidyl) 8. muscarinic receptor agonists or cholinergic agonists (eg, Salagen®, Evoxac®) 9. over-the-counter (OTC) or prescription antihistamines or decongestants 10. any prescribed topical ophthalmic medications 11. recreational drug use (eg, marijuana, methadone, heroin, cocaine); 15. Have a diagnosis of diabetes mellitus or a history of elevated blood sugar; 16. Have a condition or a situation, which in the Investigators opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subjects study participation, including but not limited to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. ; PRIMARY OUTCOME: Proportion of Subjects With at Least a 3 Line (15 Letter) Improvement in Near Visual Acuity in the Study Eye; 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 II - CN-006 (China); BRIEF: In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy. For colorectal cancer participants, who are required to have been previously treated with standard therapies or refuse standard therapy, other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy. ; DRUG USED: Envafolimab; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: 3D Medicines (Sichuan) Co., Ltd.; CRITERIA: Inclusion Criteria: - Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors. - Confirmed MMR deficient or MSI-H status. - At least one measureable lesion. - Eastern Cooperative Oncology Group performance status of 0 or 1 . - Life expectancy of greater than 12 weeks. - Adequate hematologic and organ function. Exclusion Criteria: - Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the first dose of medication in this study. Patients who have had specific anti-tumor treatment within 2 weeks prior to the first dose of study. - Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy. - Has received prior therapy with an immune check point agonist/inhibitor. - Patients who have undergone major surgery within 4 weeks of dosing of investigational agent. - Has a known additional malignancy that is progressing or requires active treatment within the past 5 years. - Known active central nervous system metastases and/or carcinomatous meningitis. - Active autoimmune disease that has required systemic treatment. - Patients who have known history of infection with HIV. - Patients with evidence of interstitial lung disease. - Patients who have known history of any major cardiac abnormalities. - Patient who is not willing to apply highly effective contraception during the study. - Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigators judgment, contraindicate patient participation in the clinical study. ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: ORR[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Lantus (003); BRIEF: The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantus™. ; DRUG USED: Lusduna Nexvue; DRUG CLASS: Biosimilar; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - T1DM For at least 1 year - is currently using or has been using prandial insulin for at least 4 weeks. Participants taking any type of basal insulin should require a total daily dose of >=10 units/day. For participants currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of >=10 units/day. - is male, or is female who is not of reproductive potential or if of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication Exclusion Criteria: - has had 1 or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months - history of ketoacidosis in the last 6 months - participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L]. - history of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients - used a formulation of insulin glargine other than Lantus™ - has received injectable incretin-based therapy within the past 8 weeks - on a weight loss program and not in the maintenance phase, or has started a weight loss medication within the past 8 weeks - has undergone bariatric surgery within the past 12 months - is likely to require treatment for 2 or more consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal, and topical corticosteroids are permitted) - has undergone a surgical procedure within the past 4 weeks or has planned major surgery during the study - has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder - has severe peripheral vascular disease - has high blood pressure - has chronic myopathy, or a progressive neurological or neuromuscular disorder - has active nephropathy - history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - has human immunodeficiency virus (HIV) - has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - history of malignancy in the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - history of melanoma, leukemia, lymphoma, or renal cell carcinoma - is currently being treated for hyperthyroidism or has been on a stable dose of thyroid hormone replacement therapy for <6 weeks - is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence - is pregnant or breast-feeding, or is expecting to conceive or donate eggs - has donated blood products or has had phlebotomy of >300 mL within the past 8 weeks or intends to donate blood products during the study - has poor mental function or works the night shift ; PRIMARY OUTCOME: Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in A1C at Week 52[/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 - INVIGORATE 2; BRIEF: The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Patients eligible for inclusion in this study had to fulfill all of the following criteria: - Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each) - Rheumatoid factor and anti-CCP antibodies negative at screening - Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis - Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs - Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 16 - Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52. Patients fulfilling any of the following criteria are not eligible for inclusion in this study: - Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician - Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) - Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash-out periods need to be observed: - Oral or topical retinoids- 4 weeks - Photochemotherapy (e.g. PUVA)- 4 weeks - Phototherapy (UVA or UVB)- 2 weeks - Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks - Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization. - Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization. - Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved). - Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα. - Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19) ; PRIMARY OUTCOME: Proportion of subjects achieving American College of Rheumatology 50 (ACR50) response criteria; SECONDARY OUTCOME 1: Proportion of subjects achieving American College of Rheumatology 20 (ACR20) 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 II - TONIC; BRIEF: This is a single center non-blinded randomized non-comparative phase II trial. The first stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1 with no induction treatment before nivolumab). For the second stage, the number of arms will be reduced based on the results obtained in the first stage. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: The Netherlands Cancer Institute; CRITERIA: Inclusion Criteria: - Metastatic triple negative breast cancer with confirmation of Estrogen Receptor (ER) and HER2 negativity on a histological biopsy of a metastatic lesion - 18 years or older - Metastatic lesion accessible for histological biopsy (Mandatory biopsies: pre-induction treatment, post-induction treatment, 6-weeks. Optional biopsies: 12-weeks, at progression, of irradiated site). The pre-induction treatment biopsy has to contain sufficient tumor content (≥100 tumor cells); subjects with samples that have insufficient tumor content will require re-biopsy prior to induction treatment. Interval between last treatment and pre-induction biopsy has to be at least 14 days - One, two or three line(s) of chemotherapy for metastatic disease and with progression of disease on last treatment regimen - Evaluable disease according to RECIST 1.1 - Metastatic lesion accessible for radiation with 1x20 Gray or 3x8 Gray - Subjects with brain metastases are eligible if these are not symptomatic. Subjects who received prior treatment for brain metastases should be free of progression on magnetic resonance imaging (MRI) for at least 4 weeks after treatment is completed and prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. - WHO performance status of 0 or 1 - Adequate bone marrow function - Adequate hepatic function - Adequate renal function - Signed written informed consent Exclusion Criteria: - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris. - known history of leptomeningeal disease localization - history of having received other anticancer therapies within 2 weeks of start of the study drug - history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections. - prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody - live vaccine within 30 days of planned start of study therapy. - active other cancer - positive test for hepatitis B surface virus surface antigen (HBsAg) or hepatitis - history of uncontrolled serious medical or psychiatric illness - any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule - current pregnancy or breastfeeding. ; 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 - COMET; BRIEF: Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12). ; DRUG USED: Nexviazyme; DRUG CLASS: Biologic; INDICATION: Pompe Disease; TARGET: Glycogen; THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion criteria : - The participant has confirmed acid alpha-glucosidase (GAA) enzyme deficiency from any tissue source and/or 2 confirmed GAA gene mutations. - The participant must provide signed, informed consent prior to performing any study related procedures. Consent of a legally authorized guardian(s) is (are) required for legally minor participant as defined by local regulation. If the participant is legally minor, signed written consent shall be obtained from parent(s)/legal guardian and assent obtained from participants, if applicable. Exclusion criteria: - The participant is <3 years of age. - The participant has known Pompe specific cardiac hypertrophy. - The participant is wheelchair dependent. - The participant is not able to ambulate 40 meters (approximately 130 feet) without stopping and without an assistive device. - The participant requires invasive-ventilation (non-invasive ventilation is allowed). - The participant is not able to successfully perform repeated forced vital capacity (FVC) measurements in upright position of greater than or equal to 30% predicted and less than or equal to 85% predicted. - The participant (and participants legal guardian if participant is legally minor as defined by local regulation) is (are) not able to comply with the clinical protocol. - The participant has had previous treatment with alglucosidase alfa or any investigational therapy for Pompe disease. - The participant has prior or current use of immune tolerance induction therapy. - The participant, if female and of childbearing potential, has a positive pregnancy test (beta-human chorionic gonadotropin) at baseline. The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: PAP: Change From Baseline in Percent Predicted Forced Vital Capacity in Upright Position at Week 49; SECONDARY OUTCOME 1: PAP: Change From Baseline in Total Distance Walked During Six-minute Walk Test (6MWT) at Week 49[/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 - OPTIMISMM (w/Bortezomib/Dexamethasone); BRIEF: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone. ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Must be ≥ 18 years at the time of signing informed consent. - Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis. - Must have had at least 1 but no greater than 3 prior anti-myeloma regimens. - Must have documented disease progression during or after their last anti-myeloma therapy. - All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles. Exclusion Criteria: - Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule. - Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization. - Non-secretory multiple myeloma. - Subjects with severe renal impairment requiring dialysis. - Previous therapy with pomalidomide. ; PRIMARY OUTCOME: Progression Free Survival by Independent Response Adjudication Committee (IRAC); SECONDARY OUTCOME 1: Overall Survival (OS)[/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 - POD1UM-203; BRIEF: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established. ; DRUG USED: Retifanlimab; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy. - Measurable disease per RECIST v1.1. - Eastern Cooperative Oncology Group performance status 0 to 1. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug. - Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor). - Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is > 30 Gy. - Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor. - Has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug. - Laboratory values outside the protocol-defined range at screening. - Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry. - Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent). - Evidence of interstitial lung disease or active noninfectious pneumonitis. - Known active central nervous system metastases and/or carcinomatous meningitis. - Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection. - Active infections requiring systemic therapy. - Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥ 300/μL, undetectable viral load, receiving antiretroviral therapy. - Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids). - Impaired cardiac function or clinically significant cardiac disease. - Is pregnant or breastfeeding. - Has received a live vaccine within 28 days of the planned start of study drug. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Duration of Response (DOR)[/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 - SYGMA2; BRIEF: The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used as needed in patients with milder asthma. The efficacy of Symbicort as needed will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler as needed ; DRUG USED: Symbicort; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patients parent/legal guardian is required 2. Male or Female, ≥12 years of age 3. Documented diagnosis of asthma for at least 6 months prior to Visit 1 4. Patients who are in need of GINA step 2 treatment 5. Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN 6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN 7. Patients should have reversible airway obstruction 8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period Exclusion Criteria: 1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission 2. Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization 3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 4. Current or previous smoker with a smoking history of ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study ; PRIMARY OUTCOME: Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis; SECONDARY OUTCOME 1: Number of Participants Experiencing at Least One Severe Asthma 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 - PARADIGMS (Pediatric); BRIEF: To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS) ; DRUG USED: Gilenya; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria Core Phase: - diagnosis of multiple sclerosis - at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive Key Exclusion Criteria Core Phase: - patients with progressive MS - patients with an active, chronic disease of the immune system other than MS - patients meeting the definition of ADEM - patients with severe cardiac disease or significant findings on the screening ECG. - patients with severe renal insufficiency Key Inclusion Criteria Extension Phase: Applies to all patients participating in the Core Phase and then entering the Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug. Applies to patients newly recruited to participate in the Extension Phase. - All newly recruited patients that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria. - Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients. Key Exclusion Criteria Extension Phase: Applies to patients who completed the Core Phase, but prematurely discontinued study drug. 1. Premature discontinuation of the study drug during the Core Phase due to: - an adverse event, - serious adverse event, - laboratory abnormality - other conditions leading to permanent study drug discontinuation due to safety reasons 2. Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required. Applies to patients newly recruited in the younger cohort to participate in the Extension Phase. 1. All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase. ; PRIMARY OUTCOME: Frequency of Relapses in Patients Treated for up to 24 Months; SECONDARY OUTCOME 1: New/Newly Enlarged T2 Lesions[/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 - ALPINE2; BRIEF: The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization. ; DRUG USED: Cayston; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Diagnosis of cystic fibrosis (CF) as determined by the 2008 CF Consensus Conference criteria: Sweat chloride level ≥ 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more clinical features consistent with CF - Documented new onset of positive respiratory tract culture for PA within 30 days of screening defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year) - Forced expiratory volume in one second (FEV1) ≥ 80% predicted (for subjects ≥ 6 years of age who can reliably perform spirometry assessments) - Clinically stable with no evidence of acute significant respiratory symptoms that would require administration of intravenous (IV) antipseudomonal antibiotics, oxygen supplementation, or hospitalization Key Exclusion Criteria: - Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening - Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of study entry (screening visit) - History of intolerance to inhaled short acting β2 agonists - History of lung transplantation - Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night - Hospitalization for a respiratory event within 30 days prior to screening - Changes in bronchodilator, corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to screening. - Significant changes (per investigators discretion) in physiotherapy technique or schedule within 7 days prior to screening - Abnormal renal or hepatic function results at most recent test within the previous 12 months, defined as Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN), or Serum creatinine > 2 times ULN for age - Presence of a condition or abnormality that would compromise the subjects safety or the quality of the study data, in the opinion of the Investigator - Known hypersensitivity to aztreonam, its metabolites, or formulation excipients in AZLI - Respiratory cultures performed within 24 months prior to screening that are positive for ANY Burkholderia spp. or Non-tuberculous mycobacteria (NTM) Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With Pseudomonas Aeruginosa (PA)-Negative Cultures Through 28 Days Post-Treatment in the 14-Day Treatment Group vs 28-Day Treatment Group; SECONDARY OUTCOME 1: Time From Primary Eradication to PA Recurrence Over a 108-Week Post-Treatment Follow-up 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 II - 30-36 Weeks Pregnant; BRIEF: Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study. ; DRUG USED: Retosiban; DRUG CLASS: New Molecular Entity (NME); INDICATION: Preterm Labor; TARGET: Oxytocin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion criteria: - Healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes - 18-45 inclusive - Symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour, each of which at least 30 sec in duration, with cervical dilatation of less than or equal to 4 cm, (measured by tocodynamometry). Exclusion criteria: - Any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the patient (mother and/or fetus) unsuitable for participation in the study - Any clinically relevant pre-existing or pregnancy-related co-morbid condition that may affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes mellitus, bleeding/clotting diathesis) ; PRIMARY OUTCOME: Number of Participants With Vital Sign Values of Potential Clinical Concern; SECONDARY OUTCOME 1: Number of Participants With Preterm Births in Part C[/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 - EP0083 (Asian Subjects); BRIEF: The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age. ; DRUG USED: Briviact; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: SV2A synaptic vesicle protein; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma SRL; CRITERIA: Inclusion Criteria: - Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive - Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method - Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period - Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1 - Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED Exclusion Criteria: - Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline - Subject is currently treated with levetiracetam - Subject has taken levetiracetam within 90 days prior to Visit 1 ; PRIMARY OUTCOME: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: 50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to 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 II (Healthy Volunteers); BRIEF: This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV). ; DRUG USED: Fludase; DRUG CLASS: Biologic; INDICATION: Influenza (excluding vaccines); TARGET: Glycosaminoglycans (GAGs); THERAPY: Monotherapy; LEAD SPONSOR: Ansun Biopharma, Inc.; CRITERIA: Inclusion Criteria: 1. Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a targeted physical exam based on medical history. 2. Subjects must be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures. 3. Be 18 to 70 years of age (inclusive). 4. Subjects must weigh at least 55 kg and must have a Body Mass Index (BMI) of no greater than 35.99 5. Febrile, oral temperature >100°F (37.8°C) and one or more of the following: - Respiratory symptom (cough, sore throat, nasal symptoms) - Constitutional symptom (headache, myalgia, sweat/chills, prostration) 6. Positive rapid antigen test (RAT) for influenza performed using FDA-Cleared and CLIA-Waived commercially available rapid antigen test. A subject may be enrolled following a positive RAT of any manufacturer. Test may be conducted by a primary care physician prior to study enrollment if documentation of a positive RAT can be provided (documentation may consist of subjects medical records and must be included in subject documentation). A subject with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community. Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute. 7. Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute. 8. Onset of illness no more than 48 hours prior to diagnosis. Note: Time of onset of illness is defined as either (1) the time when the temperature was first measured as elevated (at least one degree (°C) of elevation temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom or the presence of at least one constitutional symptom. 9. Female subjects must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, practicing abstinence or practicing two effective methods of birth control. Acceptable methods may include intrauterine device, spermicide, barrier and hormonal contraception. A female subject must agree to practice an acceptable method of birth control during study period and for 12 weeks after study terminates. All female subjects regardless of menopausal status or surgical history must have had a negative urine pregnancy test (urine betahuman chorionic gonadotropin [hCG]) during the screening visit. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG. 10. Male subjects must agree to use a medically accepted form of contraception from time of enrollment to 12 weeks after study termination. Exclusion: 1. Have received any investigational drug or vaccine within 8 weeks prior to study drug dosing. 2. Have had a serious adverse reaction or hypersensitivity to any drug. 3. Have received blood products within 6 months of study enrollment. 4. Have concurrent cystic fibrosis, emphysema or previous episodes of anaphylaxis. 5. Have sickle-cell disease. 6. Allergy or history of allergy to milk or lactose. 7. Any history of congenital or acquired bleeding abnormalities. 8. Existence of any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug. 9. Use of antiviral influenza medications within 10 days prior to screening (subjects will be prohibited from taking antiviral influenza medications during the course of the trial). 10. Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening. 11. Known hypersensitivity to DAS181. 12. Women who are pregnant (urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding. 13. Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study participation. 14. Any significant findings in the subjects medical history or physical examination that, in the opinion of the investigator, would affect subject safety or compliance with the dosing schedule. 15. Documented infection other than IFV in past 2 weeks. 16. Subjects with previous or current history of asthma or COPD requiring acute or chronic medication. 17. Subjects with acute diagnosis of a chronic medical condition within the last 3 months. 18. Subjects with a chronic medical condition that have initiated or changed dosing or regimen of prescription medications for their chronic medical condition within the last 3 months (any changes in chronic medications during the 28 day enrollment period will be captured in the source documentation under concomitant medications). 19. Subjects with previous or current history of the following systemic disorders: immunological disorders, HBV, HCV or cirrhosis, transplant recipients, HIV infection, or other immunosuppressive illness. 20. Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic diseases excluding noninvasive basal cell carcinoma. 21. Subjects who have had or are scheduled to have surgery within 30 days of initiation of the study. 22. Subjects who have donated or lost more than 500 mL of blood in the two months prior to screening. 23. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance. ; PRIMARY OUTCOME: Level of influenza viral load as Area Under the Curve at Day 5 (AUC0 d5) as measured by a) quantitative polymerase chain reaction (quantitative PCR) and b) 50% tissue culture infectious dose (TCID50) in cell culture; 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 IIb - ReDUX4 OLE; BRIEF: This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study. ; DRUG USED: Losmapimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Muscular Dystrophy; TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: Fulcrum Therapeutics; CRITERIA: Inclusion Criteria: - The patient must have consented to participate and must have provided signed, dated and witnessed an IRB-approved informed consent form that conforms to federal and institutional guidelines. - Male or female subjects - Patients must be between 18 and 65 years of age, inclusive - Must be will and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines and other study procedures. - Will practice an approved method of birth control Exclusion Criteria: - Has a history of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; neuromuscular diseases except FSHD (eg, myopathy, neuropathy, neuromuscular junction disorders); or clinically significant history of mental disease. - For subjects who are on drug(s) or supplements that may affect muscle function, as determined by the treating physician, or that are included in the list of drugs presented in the protocol, subjects must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study. Changes to the dose or treatment discontinuation during the study can only be done for strict medical reasons by the treating physician with clear documentation and notification to the sponsor. ; PRIMARY OUTCOME: Safety and Tolerability of Losmapimod; 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 II - 002; BRIEF: Phase II study designed to investigate antitumor activity in terms of objective response rate (ORR) of tipifarnib subjects with advanced Peripheral T-Cell Lymphoma (PTCL). Tipifarnib will be administered orally until disease progression. ; DRUG USED: Tipifarnib (Oncology); DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: Farnesyl transferase; THERAPY: Monotherapy; LEAD SPONSOR: Kura Oncology, Inc.; CRITERIA: Inclusion Criteria: 1. Diagnosis of PTCL according to the most recent edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues, as follows: 1. Anaplastic large cell lymphoma (ALCL), ALK positive 2. ALCL, ALK negative 3. Angioimmunoblastic T-cell lymphoma (AITL) 4. Enteropathy-associated T-cell lymphoma 5. Extranodal natural killer (NK) T-cell lymphoma, nasal type 6. Hepatosplenic T-cell lymphoma 7. Peripheral T-cell lymphoma, not otherwise specified (NOS) 8. Subcutaneous panniculitis-like T-cell lymphoma 2. For enrollment into the AITL expansion cohort, subjects must have the diagnosis of AITL, nodal PTCL with T-follicular helper phenotype or follicular PTC. 3. For enrollment into the CXCL12+ PTCL expansion cohort, subjects must have the diagnosis of PTCL (a - h subtypes listed above, except AITL), consent to provide buccal swabs for CXCL12 SNP testing, and be found to be CXCL12+ based on testing by a Sponsor approved methodology. 4. Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -Subjects must have received conventional therapy as a prior therapy. 5. Subject has consented to provide at least 6 unstained tumor slides (10 preferred) or an FFPE block for biomarker testing. 6. Subject has measurable disease as determined by the Lugano Classification and/or mSWAT. 7. At least 2 weeks since the last systemic therapy regimen prior to enrollment. 8. At least 2 weeks since last radiotherapy if radiation was localized to the only site of measurable disease, unless there is documentation of disease progression of the irradiated site. Subjects must have recovered from all acute toxicities from radiotherapy. 9. ECOG performance status of 0-2 10. Acceptable liver and renal function 11. Acceptable hematologic status 12. Female subjects must be either: 1. Of non-child-bearing potential (surgically sterilized or at least 2 years post- menopausal); or 2. If of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child- bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication. 3. Not breast feeding at any time during the study. 13. Written and voluntary informed consent. Exclusion Criteria: 1. Diagnosis of any of the following: 1. Precursor T-cell lymphoma or leukemia 2. Adult T-cell lymphoma/leukemia (ATLL) 3. T-cell prolymphocytic leukemia 4. T-cell large granular lymphocytic leukemia 5. Primary cutaneous type anaplastic large cell lymphoma 6. Mycosis fungoide/Sezary syndrome 2. Ongoing treatment with an anticancer agent not contemplated in this protocol. 3. Prior treatment (at least 1 full treatment cycle) with an FTase inhibitor. 4. Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years. 5. Known central nervous system lymphoma. 6. Stem cell transplant less than 3 months prior to enrolment. 7. Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. 8. Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery. 9. Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy. 10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C. 11. Subjects who have exhibited allergic reactions to tipifarnib, or structural compounds similar to tipifarnib or to its excipients. This includes hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class. 12. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. 13. The subject has legal incapacity or limited legal capacity. 14. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 15. Unwillingness or inability to comply with the study protocol for any reason. ; PRIMARY OUTCOME: Objective response rate (ORR); SECONDARY OUTCOME 1: Progression Free Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ARO-015; BRIEF: This is a proof of concept, single-arm study to investigate crenolanib monotherapy in patients with recurrent/refractory glioblastoma with PDGFRA gene amplification by assessing the progression-free survival (PFS) at 6 months. Crenolanib will be given orally starting at 100 mg TID continuously until disease progression, unacceptable toxicity, or consent withdrawal. ; DRUG USED: Crenolanib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Arog Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Patients (male or female) ≥ 18 years of age. 2. Histopathologically confirmed glioblastoma or gliosarcoma (WHO Grade IV) confirmed by local pathology tissue screening. 3. Radiologic evidence of first recurrence after initial treatment (including surgery, radiation, and temozolomide) or tumor refractory to initial treatment without subsequent treatment in glioblastoma or gliosarcoma (WHO Grade IV). Transformation from a lower grade glioma previously treated with radiation and/or temozolomide to glioblastoma will be considered first recurrence for the purpose of this trial 4. Tumor tissue available from original diagnosis and/or recurrence; a minimum of 1 FFPE archival tumor tissue block (preferred) or a minimum of 20 FFPE unstained slides from initial and/or most recent pre-registration biopsy or resection. It is recommended that at least 1 cm^2 of tissue composed primarily (defined as greater than 85%) of tumor is present. 5. Confirmed PDGFRA amplification in the tumor tissue at the time of diagnosis or time of recurrence. Central confirmation of PDGFRA amplification will be performed by FISH in CLIA certified lab (ProPath). Signal quantitation will be used to generate a PDGFRA/centromere 4 ratio. PDGFRA to Centromere 4 ratios will be interpreted as follows: 1.8 to 2.2, borderline for amplification; 2.2 to 5.0, low-level amplification; and greater than 5.0 or clustered signals that are too numerous to count would be considered highly amplified. Tumor samples with PDGFRA to Centromere 4 ratios of 2.2 or higher will be considered amplified and therefore eligible for this trial. For patients with local CLIA testing demonstrating PDGFRA amplification by Next Generation Sequencing (Foundation Medicine, CMS400), central testing will not be required. 6. Patients must have adequate organ function at baseline as defined below: • Adequate liver function (within 7 days of crenolanib commencement), as determined by: - Serum ALT, AST ≤ 2 × ULN - Normal serum total bilirubin (lower and upper limits of local Laboratory) - Adequate renal function assessed by: serum creatinine ≤ 1.5 × ULN 7. KPS ≥ 60 8. Recovered (returned to ≤ grade 1 as per CTCAE v4.03) from prior treatment-related toxicity. 9. A minimum of 3 weeks must have elapsed from last intake of prior standard chemotherapy treatment. 10. A minimum of 6 weeks must have elapsed from the last dose of nitrosoureas. 11. A minimum of 5 half-lives of last dose of investigational agent must have elapsed prior to C1D1. 12. More than 12 weeks from completion of chemoradiation, unless RANO criteria for early progression within 12 weeks of chemoradiation are met (See 18.1) 13. Non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test within 3 days of crenolanib commencement (Women of childbearing potential is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months). 14. Women of childbearing potential and men must agree to use adequate contraception (simultaneous use of 2 methods of birth control) prior to study entry, for the duration of study participation and for 90 days following completion of therapy. 15. Patient able and willing to provide informed consent. 16. Ability to understand and willingness for follow-up visits. Exclusion Criteria: 1. Pre-existing liver diseases (i.e., cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, and sclerosing cholangitis, etc.) 2. Known positive for HIV 3. Patients previously treated with bevacizumab. 4. NYHA Class III-IV heart failure, myocardial infarction <6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy 5. Patients receiving concurrent anti-cancer treatment (chemotherapy, investigational agents, immunotherapy, endocrine therapy, or Optune®…) 6. Patients with any other severe and/or uncontrolled concurrent disease affecting the cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patients participation in this trial or would likely interfere with study procedures/results or compromise compliance with the protocol. 7. Pregnant or breast-feeding women. 8. Patients unable to swallow pills. 9. Patients who are allergic to MRI contrast medium or unable to undergo MRI for any other reason. 10. Patients unable to provide informed consent. 11. Patients on EIADs are not eligible, unless the antiepileptic drug can be safely tapered and discontinued before C1D1. ; PRIMARY OUTCOME: Progression-free survival at 6 months; SECONDARY OUTCOME 1: Overall response rate by RANO criteria[/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 - CSPA100A1302 (Japan); BRIEF: The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan. ; DRUG USED: Tekamlo; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Calcium Channel, Renin; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients that complete CSPA100A1301 study - Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled Exclusion Criteria: - Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study - Presence of major protocol violation in CSPA100A1301 study Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Long-term safety of the fixed-dose combination of aliskiren/ amlodipine; SECONDARY OUTCOME 1: Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.[/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 - Prior to ASCT (NCI); BRIEF: This phase II trial studies how well brentuximab vedotin before autologous (taken from an individuals own cells) stem cell transplant works in treating patients with Hodgkin lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Hodgkins Lymphoma; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: City of Hope Medical Center; CRITERIA: Inclusion Criteria: - Patients must have histologically documented or cytologically confirmed Hodgkin lymphoma with CD 30 expression - Patients must have absolute neutrophil count (ANC) >= 1000/uL; neupogen (filgrastim) can be given prior to start of SGN-35 (brentuximab vedotin) and during SGN-35 treatment to achieve target ANC >= 1000/uL - Patients must have platelets (Plts) >= 50,000/uL; platelet transfusion can be given prior to the start of SGN-35 and during SGN-35 treatment to achieve a target plt >= 50,000/uL - Patients must have measurable disease > 1.5 cm evidenced by computed tomography (CT) scan of the neck/chest/abdomen(abd)/pelvis or CT/positron emission tomography (PET) scans - Patient must be either primary refractory to one frontline induction therapy or relapsed after one frontline induction therapy; patients who do not achieve complete remission after induction therapy are also eligible - Patients cannot have had a second line salvage treatment (chemotherapy, biologic agents, investigational drugs, or radiation) or have had an autologous or allogeneic hematopoietic stem cell transplantation; patients can have had mixed frontline therapy such as 2-4 cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) followed by 2-4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) as long as the induction chemotherapy is not more than 8 cycles in total length - Radiation use as part of induction regimen or consolidation (within 90 days after completion of induction chemotherapy) is allowed - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care - Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study - Male subject agrees to use an acceptable method of contraception for the duration of the study - Life expectancy of greater than 3 months - Karnofsky performance status of > 60% - ANC >= 1000/uL - Plts >= 50,000/uL - Total bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilberts disease, are eligible - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 X institutional ULN (unless demonstrated Hodgkin lymphoma involvement of the liver) - Calculated creatinine clearance >30 ml/min (unless demonstrated Hodgkin lymphoma involvement of the kidney) ELIGIBILITY FOR 2.4 MG/KG DOSING IN THE NEW COHORT: - In addition to the inclusion/exclusion criteria outlined, to be eligible for treatment with the higher 2.4 mg/kg dose of brentuximab vedotin in the new cohort of 20 additional patients, best response after 2 cycles of brentuximab vedotin administered at the 1.8 mg/kg dose, must be partial remission (PR) or stable disease (SD) as determined by radiographic imaging Exclusion Criteria: - Patient has > 1.5 x ULN total bilirubin, unless history of Gilberts syndrome - Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant - Patient has hypersensitivity to brentuximab vedotin - Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women - Patient has received other investigational drugs within 14 days before treatment of treatment with brentuximab vedotin - Serious medical or psychiatric illness likely to interfere with participation in this clinical study - Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy - Patients with other active malignancies (no evidence of other cancer or life expectancy greater than 5 years) are ineligible for this study - Patients with active central nervous system (CNS) disease or history of brain metastases (mets) are excluded from study - Patients may be on steroids prior to initiation of treatment as long as by cycle 1 day 1 steroids use was tapered down less than or equal to 20 mg of prednisone. ; PRIMARY OUTCOME: Overall Response Rate Among Patients With Salvage Brentuximab Vedotin (BV); SECONDARY OUTCOME 1: Total CD34+ Cell Dose Among Patients Receiving Brentuximab Vedotin Followed by Autologous Hematopoietic Stem Cell Transplantation[/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 - Indigo301 (w/Pembrolizumab or Nivolumab); BRIEF: This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial. The phase 3 study will not proceed per Sponsor decision. ; DRUG USED: Indoximod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: IDO (Indoleamine 2,3-dioxygenase), Immune System; THERAPY: Combination; LEAD SPONSOR: NewLink Genetics Corporation; CRITERIA: Inclusion Criteria: - Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy - At least one radiologically measurable lesion as per RECIST 1.1 - Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period. - ECOG performance status 0 or 1 - Ability to ingest oral medications Exclusion Criteria: - Has Ocular Melanoma - Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy). - Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting. - Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) - Has received prior radiotherapy within 2 weeks of therapy. - Is pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded. ; PRIMARY OUTCOME: Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab; 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 I/II - 1st Line - w/Len/Dex (Univ. of Michigan); BRIEF: This study is designed to evaluate the safety and to determine the maximum tolerated dose of carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple Myeloma patients who have not received treatment. ; DRUG USED: Kyprolis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: University of Michigan Rogel Cancer Center; CRITERIA: Inclusion Criteria 1. Newly diagnosed, histologically confirmed, previously untreated Stage I, II, or III multiple myeloma requiring systemic chemotherapy 2. Diagnosis of symptomatic multiple myeloma per IMWG uniform criteria within the past 90 days 3. Measurable disease, per IMWG (International Myeloma Working Group) criteria (>= one of the following) within the past 4 weeks: - Monoclonal protein >= 0.5 g/dL by serum protein electrophoresis - Monoclonal light chain >= 200 mg by 24-hour urine protein electrophoresis - If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable 4. Life expectancy > 3 months 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 6. Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST (Aspartate Aminotransferase) and ALT (Alanine Transaminase) < 2.5 x ULN 7. Absolute neutrophil count (ANC) >=1.0 x 109/L, hemoglobin >= 8 g/dL, platelet count >= 75 x 109/L 8. Calculated creatinine clearance (by Cockroft-Gault) >= 60 ml/min 9. Written informed consent in accordance with federal, local, and institutional guidelines. 10. Subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring. 11. Must be able to take either 81 mg or 325 mg aspirin daily as prophylactic anticoagulation. Exclusion Criteria 1. Non-secretory or hyposecretory multiple myeloma, defined as <0.5 g/dL M-protein in serum, <200 mg/24 hr urine M-protein, or disease only measured by serum free light chain 2. POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Gammopathy, and Skin Changes) syndrome 3. Plasma cell leukemia 4. Waldenströms macroglobulinemia or IgM myeloma 5. Radiotherapy to multiple sites or immunotherapy within 2 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible) 6. Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma - Prior treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period) - Bisphosphonates are permitted 7. Participation in an investigational therapeutic study within 3 weeks or within 5 drug halflives (t1/2) prior to first dose, whichever time is greater 8. Pregnant or lactating females 9. History of allergy to mannitol 10. Major surgery within 3 weeks prior to first dose 11. Myocardial infarction within 3 months prior to enrollment, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 12. Uncontrolled hypertension or diabetes 13. Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose 14. Known or suspected HIV infection, known HIV seropositivity 15. Active hepatitis infection 16. Non-hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone 17. Any clinically significant medical disease or condition that, in the Investigators opinion, may interfere with protocol adherence or a subjects ability to give informed consent 18. Significant neuropathy (Grade >2) at the time of the first dose and/or within 14 days before enrollment 19. Contraindication to any of the required concomitant drugs 20. Subjects in whom the required program of PO and IV fluid hydration is contraindicated 21. Subjects with known or suspected amyloidosis of any organ 22. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis ; PRIMARY OUTCOME: The Maximum Tolerated Dose (MTD) of Carfilzomib; SECONDARY OUTCOME 1: The Percentage of Patients Alive Without Progression[/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 - ABC/3TC Switch; BRIEF: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC. ; DRUG USED: Descovy; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Reverse Transcriptase; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - The ability to understand and sign a written informed consent form - On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for ≥ 6 consecutive months prior to screening - Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and without experiencing two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year - Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit - Normal ECG - Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance - Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ≤ 5 × ULN - Females of childbearing potential and males must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug Key Exclusion Criteria: - A new AIDS-defining condition diagnosed within the 30 days prior to screening - Hepatitis B surface antigen (HBsAg) positive - Individuals experiencing decompensated cirrhosis - Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis) - Pregnant or lactating females - Have an implanted defibrillator or pacemaker - Current alcohol or substance use judged by the investigator to potentially interfere with study compliance - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposis sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit - Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements - Participation in any other clinical trial (including observational trials) without prior approval - Medications excluded due to the potential for interaction with emtricitabine (FTC), TAF, ABC or 3TC Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - IV Infusion; BRIEF: This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis. ; DRUG USED: Neihulizumab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: P-selectin glycoprotein ligand-1 (PSGL-1), Selectins; THERAPY: Monotherapy; LEAD SPONSOR: AbGenomics B.V Taiwan Branch; CRITERIA: Inclusion Criteria: 1. Age 18 to 75 (inclusive), males or females 2. Body weight < 140 kg 3. Patients with stable moderate to severe plaque-type psoriasis, no significant changes within the past 6 months, involving ≥ 10% body surface area, with disease severity PASI ≥ 10 at screening visit and visit 2, with at least 1 lesion for target lesion assessment. 4. Psoriasis disease duration of at least 6 months prior to screening 5. Patients must be candidates for systemic psoriasis treatment or phototherapy 6. Patient must give informed consent and sign an approved consent form prior to any study procedures 7. Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year). Exclusion Criteria: 1. Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis 2. Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion) 3. HIV infection or a known HIV-related Malignancy. 4. Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded. 5. Tuberculosis, or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA). 6. History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ of the cervix uteri. 7. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients 8. Use of biologic agents or investigational drug within 12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment 9. Intake of restricted medications (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study 10. History of alcohol abuse 11. History of drug abuse or positive drug screen at screening visit. Subjects with legitimate medically supervised uses of the drugs which are not excluded for other reasons (section 4.2.2 of the protocol) can be enrolled. 12. Any blood donation or significant blood loss within 4 weeks prior to Visit 2 13. Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial) 14. Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators: - Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range) - ALT, AST and/or total bilirubin > 2.5xULN - Serum creatinine > 1.5x ULN ; PRIMARY OUTCOME: PASI75; SECONDARY OUTCOME 1: safety and tolerability[/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 - Memorial Sloan Kettering Cancer Center (w/Trastuzumab + Fluoropyrimidine + Chemo); BRIEF: The purpose of this study is to find out what effects, good and/or bad, pembrolizumab in combination with trastuzumab and chemotherapy, has on the patients esophagogastric cancer. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Memorial Sloan Kettering Cancer Center; CRITERIA: Inclusion Criteria: - Patient must have pathologically or cytologically MSKCC confirmed esophageal, gastric or gastroesophageal junction (GEJ) adenocarcinoma by the enrolling institution. - Patients must have esophageal, gastric or gastroesophageal adenocarcinoma with HER2 overexpression and/or amplification as determined by next generation sequencing assay, immunohistochemistry (IHC 3+) or fluorescent in situ hybridization (FISH+ is defined as HER2:CEP17 ratio ≥ 2.0). MSKCC or enrolling institution confirmation of HER2 status is not mandatory prior to enrollment and treatment on study. For patients with outside HER2 testing, if sufficient tissue is available HER2 testing will be repeated at MSKCC or enrolling institution for purpose of analysis and will not impact the patients eligibility. - Additional available archival tumor tissue in the form of 15-20 unstained slides should be submitted to MSKCC for future correlative analysis, but will not be required prior registration. Note: if tissue is depleted, patient will still be eligible after discussion with the MSK PI. - Patients may have received no prior chemotherapy for Stage IV disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration - Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease per RECIST 1.1. - Patient must have a normal LVEF (>/= 53%). If a patient has a borderline LVEF (40-52%) they may be considered after consultation with cardiology and study PI and treated per the guidelines in section 11.2.2. - Age 18 years or older. - ECOG performance status 0-2. - Demonstrate adequate organ function as defined below. All screening labs should be performed within 10 days of treatment initiation. Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (measured via 24-hour urine collection) ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl) Hepatic Serum total bilirubin ≤ 1.5 X ULN (1.5 mg/dL or 25.65 μmol/L) OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. Except patients with Gilberts disease (≤3x ULN) AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR AST (SGOT) and ALT (SGPT) ≤ 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dL Coagulation Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants - Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. - Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. - Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. - Peripheral neuropathy ≤grade 1 Exclusion Criteria: - Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. - Has a known history of active TB (Bacillus tuberculosis) - Hypersensitivity to pembrolizumab or any of its excipients. - Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. (Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.) - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Has known history of, or any evidence of active, non-infectious pneumonitis. - Has an active infection requiring systemic therapy. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjects participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. - Active or prior documented autoimmune or inflammatory disorder (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterin: - Subjects with vitiligo or alopecia - Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment. - Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). - Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). - Has received a live vaccine within 30 days of planned start of study therapy. (Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.) - Is unwilling to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study. - Has active or clinically significant cardiac disease including: Congestive heart failure - New York Heart Association (NYHA) > Class II. Active coronary artery disease. Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin. Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before initiation, or myocardial infarction within 6 months before initiation. ; PRIMARY OUTCOME: Percentage of Participants With Progression Free Survival; 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 - HALLMARK-Dual - w/Asunaprevir (GT 1b); BRIEF: The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive. ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and females, ≥ 18 years of age - HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive - HCV RNA ≥ 10,000 IU/mL - Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg) - Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population) Exclusion Criteria: - Prior treatment of HCV with HCV direct acting antiviral (DAA) - Evidence of a medical condition contributing to chronic liver disease other than HCV - Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy - Diagnosed or suspected hepatocellular carcinoma or other malignancies - Uncontrolled diabetes or hypertension ; PRIMARY OUTCOME: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive; SECONDARY OUTCOME 1: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R[/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 - UX001-CL203; BRIEF: The primary objective of this Phase 2 study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM participants with severe ambulatory impairment. ; DRUG USED: Ace-ER; DRUG CLASS: New Molecular Entity (NME); INDICATION: GNE-Related Myopathy (Inclusion Body Myopathy 2); TARGET: Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Ultragenyx Pharmaceutical Inc; CRITERIA: Inclusion Criteria: - Male or female, aged ≥ 18 years old - Willing and able to provide written, signed informed consent after the nature of the study has been explained, and before any research-related procedures are conducted - Have a documented diagnosis of GNEM, HIBM, distal myopathy with rimmed vacuoles (DMRV), or Nonaka disease due to previously demonstrated mutations in the gene encoding the GNE/N-acetylmannosamine kinase (MNK) enzyme (genotyping will not be conducted in this study). - Should meet the criteria for severe ambulatory impairment defined below: - Unable to rise from a seated position to standing without help from another person, assistive device(s), stationary object, or other support AND - Unable to walk without the assistance of another person OR if able to walk (use of assistive device(s) permitted), requires at least 2 minutes to walk 40 meters (one full lap of the 6-minute walk test [6MWT] course) AND - Use of wheelchair or scooter for activities outside of the home or unable to leave the home independently - Willing and able to comply with all study procedures - Participants of child-bearing potential or with partners of child-bearing potential who have not undergone a bilateral salpingo-oophorectomy and are sexually active must consent to use highly effective method of contraception as determined by the site investigator (i.e. oral hormonal contraceptives, patch hormonal contraceptives, vaginal ring, intrauterine device, physical double-barrier methods, surgical hysterectomy, vasectomy, tubal ligation or true abstinence (when this is in line with the preferred and usual lifestyle of the subject) which means not having sex because the subject chooses not to), from the period following the signing of the informed consent through 30 days after last dose of study drug - Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause for at least two years, have had tubal ligation at least one year prior to Screening, or who have had a total hysterectomy or bilateral salpingo-oophorectomy Exclusion Criteria: - Ingestion of N-acetyl-D-mannosamine (ManNAc), SA, or related metabolites; intravenous immunoglobulin (IVIG); or anything that can be metabolized to produce SA in the body within 60 days prior to the Screening Visit - Prior participation in a clinical trial involving treatment with Ace-ER/placebo and/or Sialic Acid immediate release (SA-IR) in the past year - Has had any hypersensitivity to aceneuramic acid or its excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects - Has serum transaminase (i.e. aspartate aminotransferase [AST] or gamma-glutamyl transpeptidase [GGT]) levels greater than 3X the upper limit of normal (ULN) for age/gender, or serum creatinine of greater than 2X ULN at Screening - Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study - Use of any investigational product or investigational medical device within 30 days prior to Screening, or anticipated requirement for any investigational agent prior to completion of all scheduled study assessments - Has a condition of such severity and acuity, in the opinion of the investigator, that it warrants immediate surgical intervention or other treatment or may not allow safe participation in the study - Has a concurrent disease, active suicidal ideation, or other condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or would affect safety ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation; SECONDARY OUTCOME 1: Number of Participants Taking Prior and Concomitant Medications[/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 - CF111/303; BRIEF: To demonstrate the contraceptive efficacy of LF111 . To demonstrate the safety and tolerability of LF111 and assessment of pharmacokinetics of LF111. ; DRUG USED: Slynd; DRUG CLASS: Non-NME; INDICATION: Contraception; TARGET: Mineralocorticoid Receptor, Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Laboratories Leon Farma, S.A.; CRITERIA: Inclusion Criteria: 1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women with no upper age limit. 2. Female subjects at risk of pregnancy, between the ages of 15 and 17 (inclusive) provided that - Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and - All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. 3. Regular cycles during the last six months before consent/assent when not using hormonal contraception. 4. At least three complete menstrual cycles after delivery (only applicable for women who were pregnant within the last six months and for non-breastfeeding women). Breastfeeding women can be included six weeks after delivery irrespective of menstrual cycles post-delivery. 5. At screening, maximum systolic blood pressure (median value of three values) ≤ 159 mm Hg and diastolic blood pressure (median value of three values) ≤ 99 mm Hg. 6. Be able and willing to provide written informed consent or assent if the subject is adolescent, prior to undergoing any trial-related procedure. 7. Willing to use trial contraception for thirteen 28-day cycles. 8. Be willing to have intercourse each cycle of trial without the need to use back-up contraceptive. 9. Be willing to state that, to her best knowledge, her male sexual partner(s): - Has not had a vasectomy or been previously diagnosed as infertile. - Has not been previously diagnosed or suspected of human immunodeficiency virus (HIV) unless he has subsequently had a negative HIV test. - Has not been known to have engaged in homosexual intercourse in the past five years unless he has had negative HIV test results since then. - Has not shared injection drug needles in the past unless he has had a negative HIV test at least six weeks since last use. 10. Agree not to participate in any other clinical trials during the course of this trial. Exclusion Criteria: 1. Pregnant. 2. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary. 3. History of infertility. 4. Abnormal finding on pelvic, breast or ultrasound examination that in the investigators opinion contraindicates participation in the trial. 5. Unexplained amenorrhea. 6. Known polycystic ovary syndrome. 7. Women ≥21 years of age with a Papanicolaou (pap) smear reading LGSIL or higher at screening (or six months prior to screening date). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASC-US) can be used as an adjunctive test. - Subjects with ASC-US can be included if they are negative for high-risk HPV strains. - Subjects <21 years of age do not require a pap smear. 8. Known contraindication or hypersensitivity to ingredients or excipients of the IMP (Investigational Medicinal Product), including: 1. Renal insufficiency 2. Hepatic dysfunction 3. Adrenal insufficiency 4. Current or history of venous thrombophlebitis or thromboembolic disorders (venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism) 5. Current or history of cerebral-vascular or coronary-artery disease 6. Valvular heart disease with thrombogenic complications 7. Diabetes with vascular involvement 8. Headaches with focal neurological symptoms 9. Major surgery with prolonged immobilization 10. Known or suspected carcinoma of the breast 11. Known or suspected sex-steroid sensitive malignancies 12. Undiagnosed abnormal genital bleeding 13. Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use 14. Liver tumor (benign or malignant) or active clinically significant liver disease. 9. Uncontrolled thyroid disorder (i.e., on stable dose of thyroid replacement for less than two months). 10. Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months). 11. Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent/assent). 12. Known inherited or acquired predisposition to venous thromboembolism or arterial thromboembolism (e.g., factor V Leiden, Prothrombin mutation, Antiphospholipid antibodies) or bruising within the last 12 months prior to consent/assent. 13. Known or suspected HIV and/or hepatitis infection at screening. 14. Received a dose of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) during the 10 months prior to consent/assent, or received any combined injectable contraceptive (e.g., Cyclofem®) during the six months prior to consent/assent, or no spontaneous menses since last injection. 15. Long-term treatment (longer than seven consecutive days within a month prior to V1b) of any medication that might interfere with the efficacy of hormonal contraceptives. Prohibited medication include: 1. Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone) 2. Barbiturates 3. Rifampin 4. Bosentan 5. Griseofulvin 6. St. Johns wort (hypericum perforatum) 16. Administration of human chorionic gonadotropin (hCG) or intake of co-medication containing hCG within a month prior to V1b). 17. Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last two months prior to consent/assent. 18. Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures (excepting occasional use for safety reasons, e.g., to reduce risk of infection). 19. Evidence or history of clinically significant psychiatric illness or suicide risk. 20. Participation in another trial of an investigational drug or device parallel to the current trial or less than 90 days before consent/assent, or previous participation in the current trial and dispensed trial medication. 21. Subject is a member of the investigators or Sponsors staff or a relative or family member thereof. 22. Any condition that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial. ; PRIMARY OUTCOME: Number of Pregnancies (Evaluable Cycles); SECONDARY OUTCOME 1: Number of Pregnancies (All)[/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 - Extension Study (OMASPECT); BRIEF: This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study. ; DRUG USED: Lampalizumab; DRUG CLASS: Biologic; INDICATION: Dry Age-Related Macular Degeneration (Dry AMD)/Geographic Atrophy (Ophthalmology); TARGET: Factor D (alternate complement pathway); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit - Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential Exclusion Criteria: - Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications - Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications - Increased risk of infection - Pregnancy or lactation ; PRIMARY OUTCOME: Percentage of Participants With Ocular Adverse Events (AEs) by Severity; 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 - COPERNICUS; BRIEF: This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion. ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT - ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye Exclusion Criteria: - Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.) - Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye - CRVO disease duration > 9 months from date of diagnosis - Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1 - Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye ; PRIMARY OUTCOME: Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score; SECONDARY OUTCOME 1: Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)[/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 - APC400-03; BRIEF: An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection. ; DRUG USED: MBM-02; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Adamis Pharmaceuticals Corporation; CRITERIA: Inclusion Criteria: - Subjects 18 years of age and above with at least one risk factor for disease progression (i.e., age≥ 65, hypertension, diabetes, obesity (BMI ≥30 as defined by CDC), cancer, immunodeficiency and in the opinion of the investigator the risk factor is not acutely life-threatening). - Laboratory confirmed infection of SARS-CoV-2 within 5 days of Baseline/day 1. - Subjects must meet the severity score of Moderate or greater for two of the first ten symptoms listed in the Patient Reported Outcomes (PRO) at screening. - Ability to travel to clinic. - Ability to understand and sign an informed consent form. - Female subjects of child-bearing potential who are capable of conception must be: post- menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ≥18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period. - Ability to swallow a capsule. - Ability to complete an electronic diary via smartphone or web. Exclusion Criteria: - Need for hospitalization based on severe or critical symptoms based on CDC guidance. - Subject in long-term care facility. - Known hypersensitivity or contra-indication to Tempol. - Subjects taking STRONG CYP inhibitors (e.g. fluoxetine, itraconazole, quinidine, clarithromycin). - In the opinion of the investigator, any reason that would make the follow up of the subject impossible during the study treatment and follow up period. Any reason the subject cannot comply with study and study procedures. - Subjects receiving any other investigational agent within 4 weeks of Baseline/Day 1. - Use of non-FDA approved (EUA or full approval)/off label treatments for COVID-19. - Lactating females. - History of any known chronic liver or kidney disease. - Subjects taking drugs with a Narrow Therapeutic Index such as Cyclosporine Digoxin Flecainide Lithium Phenytoin Sirolimus Theophylline, and Warfarin. ; PRIMARY OUTCOME: Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19; SECONDARY OUTCOME 1: Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality[/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 - CLOVER-1; BRIEF: Part A of this study evaluates iopofosine I 131 (CLR 131) in patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and central nervous system lymphoma (CNSL) who have been previously treated with standard therapy for their underlying malignancy. Part B (CLOVER-WaM) is a pivotal efficacy study evaluating IV administration of iopofosine I 131 in patients with WM that have received at least two prior lines of therapy. ; DRUG USED: CLR 131; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Lipid Rafts, PI3K/AKT pathway, Radiopharmaceutical; THERAPY: Combination; LEAD SPONSOR: Cellectar Biosciences, Inc.; CRITERIA: [CLOVER-1] Inclusion Criteria: All Patients - Histologically or cytologically confirmed MM; Patients with primary or secondary CNSL may be enrolled. - ECOG performance status of 0 to 2 - 18 years of age or older - Life expectancy of at least 6 months - Platelets ≥ 75,000/µL (if full-dose anticoagulation therapy is used, platelets ≥ 100,000/µL are required) - WBC count ≥ 3000/µL - Absolute neutrophil count ≥ 1500/µL - Hemoglobin ≥ 9 g/dL (last transfusion, if any, must be at least 1 week prior to study registration, and no transfusions are allowed between registration and dosing) - Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 - Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) - Bilirubin < 1.5 × ULN - International normalized ratio (INR) < 2.5 - If patient is on full-dose anticoagulation therapy, the anticoagulation therapy must be reversible and reversal of the anticoagulation therapy must not be life-threatening, as judged by the Investigator - Patients who have undergone stem cell transplant must be at least 100 days from transplant Patients with Multiple Myeloma - At least 5 prior regimens, which must include at least 1 approved proteasome inhibitor (bortezomib, carfilzomib, or ixazomib), at least 1 approved immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide), and at least 1 approved monoclonal antibody (e.g., daratumumab or elotuzumab) with or without maintenance therapy, unless patients are intolerable to such agents or ineligible to receive such agents. - At least triple-class refractory (refractory to a proteasome inhibitor, immunomodulatory agent, and a monoclonal antibody) - Progressive disease defined by any of the following: - 25% increase in serum M-protein from the lowest response value during (or after) last therapy and/or absolute increase in serum M-protein of ≥ 0.5 g/dL - 25% increase in urine M-protein from the lowest response value during (or after) last therapy and/or absolute increase in urine M-protein of ≥ 200 mg/24 h - 25% increase in bone marrow plasma cell percentage from the lowest response value during (or after) last therapy. Absolute bone marrow plasma cell percentage must be ≥ 10% unless prior CR when absolute bone marrow plasma cell percentage must be ≥ 5%. - 25% increase in serum FLC level from the lowest response value during (or after) last therapy; the absolute increase must be > 10 mg/dL - New onset hypercalcemia > 11.5 mg/dL - Failure to obtain a partial response or better to current treatment, or cannot further improve their response to current treatment - Appearance of new extramedullary disease - Measurable disease defined by any of the following: - Serum M-protein > 0.5 g/dL - Urine M-protein > 200 mg/24 h - Serum FLC assay: Involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal. [CLOSED] Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma/Waldenstom Macroglobulinemia, or Marginal Zone Lymphoma - Prior treatment with at least 2 prior regimens, which may include chemotherapy, an approved anti-CD20 antibody with or without maintenance therapy, and an approved targeted agent, unless patients are ineligible to receive such agents - Patients with Helicobacter pylori+ mucosa-associated lymphoid tissue lymphoma must have received 1 prior antibiotic regimen for H pylori - At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable extranodal lesion (eg, hepatic nodule) with longest diameter > 10 mm. Additional parameters (e.g., measurable IgM for patients with Lymphoplasmacytic Lymphoma) may be allowed if they meet current NCCN guidelines for symptomatic disease. Patients with uptake by FDG-PET scan may be allowed with prior approval of Sponsor. [CLOSED] Patients with Mantle Cell Lymphoma - Prior treatment with at least 1 prior regimen - At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable extranodal lesion (eg, hepatic nodule) with longest diameter > 10 mm. Patients with uptake by FDG-PET scan may be allowed with prior approval of Sponsor. [CLOSED] Patients with Diffuse Large B-Cell Lymphoma - Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline; or is intolerable to such agents. Relapsed disease is defined as either recurrence of disease after a CR or PD after achieving a partial response (PR) or SD. Refractory disease is defined as failure to achieve at least SD with any 1 line of therapy or with PD ≤ 3 months of the most recent chemotherapy regimen. - At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable extranodal lesion (eg, hepatic nodule) with longest diameter > 10 mm. Patients with uptake by FDG-PET scan may be allowed with prior approval of Sponsor. Patients with CNS Lymphoma - Must have biopsy-proven disease and must have received at least one prior intervention for their disease. - Must be at least two weeks from CNS biopsy before administration of iopofosine I 131. - Must have at least one lesion with enhancement on brain imaging. - Stable (or decreasing) dose of corticosteroids or anti-convulsant medication for at least 7 days prior to dosing [CLOVER-1] Exclusion Criteria: - Ongoing Grade 2 or greater toxicities due to previous therapies. Stable, tolerable Grade 2 AEs (eg, neuropathy) may be allowed. - Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. - Prior total body or hemi-body irradiation. Patients who have received prior low-dose total body or hemi-body irradiation may be allowed on a case-by-case basis after discussion with Sponsor (considerations may include factors such as time since irradiation, total lifetime accumulated dose, etc.) - Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon the spinal cord - For patients with CLL/SLL, LPL, or MZL, transformation to a more aggressive form of NHL - Ongoing chronic immunosuppressive therapy - Clinically significant bleeding event within prior 6 months - Ongoing anti-platelet therapy (except low-dose aspirin [eg, 81 mg daily] for cardioprotection) - Anti-cancer therapy within two weeks of initial iopofosine I 131 infusion. Low dose dexamethasone for symptom management is allowed - Radiation therapy, chemotherapy, immunotherapy, or investigational therapy within 2 weeks of eligibility-defining bone marrow biopsy. - For patients with primary or secondary CNSL, active bleeding in the tumor bed and/or uncontrolled seizure activity [CLOVER-WaM] Inclusion Criteria - Histologically or cytologically confirmed WM. Patients with a diagnosis of LPL may be enrolled with prior Sponsor approval. - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (Appendix C) - Patient is 18 years of age or older - Life expectancy of at least 6 months - Received at least two prior lines of therapy for WM - Measurable IgM (above upper limit of normal) OR at least one measurable nodal lesion with longest diameter > 15 mm or one measurable extranodal lesion (e.g., hepatic nodule) with longest diameter > 10 mm [CLOVER-WaM] Exclusion Criteria - Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia. - Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. - Prior total body or hemi-body irradiation. Patients who have received prior low-dose total body or hemi-body irradiation may be allowed on a case-by-case basis after discussion with Sponsor (considerations may include factors such as time since irradiation, total lifetime accumulated dose, etc.) - Patients with second malignancies in addition to WM, if the second malignancy has required therapy in the last 2 years or is not in remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy - Anti-cancer therapy within two weeks of initial iopofosine I 131 infusion. - Need for acute treatment of WM (e.g., those with hyperviscosity) ; PRIMARY OUTCOME: Part A [CLOVER-1] Clinical benefit rate; SECONDARY OUTCOME 1: Part A [CLOVER-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 - TRILOGY (w/Atezolizumab & Vemurafenib); BRIEF: This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma. ; DRUG USED: Cotellic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to (</=)1% per year is required during treatment and for 6 months post treatment. Males should not expose pregnant partners to sperm and refrain from donating sperm for 6 months post treatment. Women must refrain from donating eggs during this same period - Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma - Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies) except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies - Documentation of BRAFv600 mutation-positive status in melanoma tumor tissue (archival or newly obtained) through use of a clinical mutation test approved by the local health authority - Eastern Cooperative Oncology Group Performance (ECOG) Status of 0 or 1 - Measurable disease according to RECIST v1.1 (must be outside central nervous system (CNS)) - Life expectancy >/=18 weeks - For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to (</=) 1.5*upper limit of normal (ULN) within 28 days prior to initiation of study treatment - For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment Exclusion Criteria: Cancer-Related Exclusion Criteria: - Major surgical procedure within 4 weeks prior study treatment initiation - Traumatic injury or palliative radiotherapy within 2 weeks prior study treatment initiation - Active malignancy (other than BRAFv600 mutation-positive melanoma) or malignancy within 3 years prior to screening are excluded, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or any other curatively treated malignancies from which the participant has been disease-free for at least 3 years Ocular Exclusion Criteria: - History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration Cardiac Exclusion Criteria: - History of clinically significant cardiac dysfunction - Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50% Central Nervous System (CNS) Exclusion Criteria: - Untreated or actively progressing CNS lesions (carcinomatous meningitis) - History of metastases to brain stem, midbrain, pons, or medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm); or leptomeningeal metastatic disease; or intracranial hemorrhage Additional Exclusion Criteria: - Uncontrolled diabetes or symptomatic hyperglycemia - Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) other than cancer - History of malabsorption or other clinically significant metabolic dysfunction - Pregnant or breastfeeding, or intending to become pregnant during the study - Prior allogeneic stem cell or solid organ transplantation - History of idiopathic pulmonary fibrosis, organizing pneumonia (example: bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - Active or history of autoimmune disease or immune deficiency - Known clinically significant liver disease, inherited liver disease and active viral disease - Active tuberculosis - Treatment with therapeutic oral or intravenous (IV) antibiotics; or with a live, attenuated vaccine; or systemic immunosuppressive medication - Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab, cobimetinib, or vemurafenib formulations - Any grade >/=3 hemorrhage or bleeding event within 4 weeks prior to initiation of study treatment - History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to initiation of study treatment ; PRIMARY OUTCOME: Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; SECONDARY OUTCOME 1: Progression-Free Survival (PFS), as Determined by Independent Review Committee Using RECIST v1.1[/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 IIb - Negative/CIAS; BRIEF: Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on the function, employment, and social interactions of patients with schizophrenia. Medications used to treat schizophrenia (e.g. atypical antipsychotics) do not improve negative symptoms or CDS. TC-5619 is being developed for use as an add-on therapy in combination with atypical antipsychotics to treat patients with negative symptoms and CDS. ; DRUG USED: Bradanicline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Targacept Inc.; CRITERIA: Inclusion Criteria: 1. Diagnosis of schizophrenia, per DSM-IV-TR criteria, as aided by the MINI International Neuropsychiatric Interview 2. Controlled schizophrenia, on stable dose of an approved atypical antipsychotic for at least 2 months prior to screening. Approved refers to regulatory approval in the country of use. 3. Stable schizophrenia as documented by lack of psychiatric hospitalization for 2 months prior to Screening (social admissions for the convenience of the subject allowed) 4. Clinical history of stable psychotic symptoms for 1 month prior to Screening. 5. Stable positive symptoms of schizophrenia for 4 weeks prior to Day 1, as shown by score ≤ 4 on PANSS for items related to delusion, hallucination, conceptual disorganization, and unusual thought content, at Screening and at Day 1. 6. Sum > 20 for the 7 items in the Negative Symptoms subscale of the PANSS. 7. Calgary Depression Schizophrenia Scale (CDSS) score < 6. 8. Simpson Angus Scale score < 12. 9. Outpatient with stable housing, and significant presence of an informant who is not a group home resident. Exclusion Criteria: 1. Diagnosis of schizoaffective or schizophreniform disorders within 1 year prior to Screening. 2. Significant risk of suicide or attempted suicide in the 12 months before screening, or of danger to themselves or others. 3. Change in dosing of atypical antipsychotic within 2 months of Screening. 4. Treatment with electroconvulsive therapy (ECT) within 12 months of Screening. 5. Treatment with mood stabilizers, antidepressants, anxiolytics (short-acting hypnotics permitted), anticholinergics, or more than 1 antipsychotic within 1 month prior to Screening. 6. Treatment within 1 month prior to Screening with cognition-affecting agents other than the above (e.g. CNS stimulants). 7. History within past 6 months of screening of alcohol or illicit drug abuse. 8. Use of smoking cessation therapy within 1 month prior to Screening. 9. Positive urine drug screen except when related to prescribed short-acting benzodiazepines and opiates recently prescribed for an episode of acute pain (e.g., dental extraction). 10. History of significant other major or unstable neurological, neurosurgical (e.g. head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder. 11. History of myocardial infarction based on medical history or electrocardiogram (ECG) findings at screening. 12. History of seizure disorder. 13. Type 1 diabetes mellitus. 14. Type 2 diabetes mellitus that requires medication (diet-controlled allowed, with HbA1C < 7.3). 15. Body Mass Index (BMI) > 35. 16. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency. 17. Current TB or known systemic infection (e.g., HBV, HCV, HIV). 18. Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450 for males and >470 for females. 19. Men, or women of child-bearing potential, who are unwilling or unable to use accepted methods of birth control as specified in Section 4.4.4 20. Women with a positive pregnancy test, or who are lactating. 21. Participated in another clinical trial within 3 months prior to Screening. ; PRIMARY OUTCOME: Change from baseline in the Scale for Assessment of Negative Symptoms (SANS); SECONDARY OUTCOME 1: Change from baseline in the Cogstate Schizophrenia Battery (CSB)[/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 - vs. TCA in Military Veterans; BRIEF: This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee. ; DRUG USED: Zilretta; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions - Male or female ≥20 and ≤50 years of age - Diagnosis of post-traumatic OA of the knee - Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening - Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) - Body mass index (BMI) ≤ 40 kg/m2 - Willingness to abstain from use of restricted medications and therapies during the study Exclusion Criteria: - Prior osteotomy of the index knee - Any condition that could possibly confound the patients assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain) - Fibromyalgia, Reiters syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease - History of, or clinical signs and symptoms of active infection of the index knee - Crystal disease of the index knee within one month of Screening - Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery - IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening - IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening - Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening - Any other IA investigational drug/biologic within 6 months of Screening - Prior use of FX006 - Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period - Type 1 or Type 2 diabetes requiring insulin - Women of child-bearing potential not using effective contraception or who are pregnant or nursing ; PRIMARY OUTCOME: Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10; SECONDARY OUTCOME 1: Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PPL GLAU 12; BRIEF: The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels. ; DRUG USED: L-PPDS; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Mati Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Male or female at least 18 years old - Diagnosis of bilateral open angle glaucoma or ocular hypertension - Unmedicated IOP must be ≥22mm Hg Exclusion Criteria: - Any significant vision loss in the last year - No contact lens use for the length of the study - Abnormal eye lids, eye infection, or diseases to the eye - Recent eye surgery - Uncontrolled medication conditions ; PRIMARY OUTCOME: IOP change from baseline; 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 II - Marker Lesion; BRIEF: A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients with high-risk superficial bladder tumors, and the response and duration of response in patients with carcinoma in situ of the bladder. ; DRUG USED: Qapzola; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Patients with high risk superficial bladder cancer according to EAU criteria defined as: - pT1 and/or Grade 2b-3, or multiple and highly recurrent - histologically confirmed carcinoma in situ 2. All visible lesions must be completely removed by transurethral resection (TUR) at entry to the study 3. Normal bimanual examination under anesthesia (no palpable masses) 4. Absence of upper urinary tract tumor confirmed by intravenous pyelography (IVP) or CT scan or retrograde urogram within 6 months from the beginning of treatment 5. Patient with ZUBROD-ECOG-WHO performance status of 0-2 (see Appendix 2) 6. Over 18 years of age 7. Patients must be fully informed of the investigational nature of the study and signed written informed consent must be obtained prior to any study specific investigations. Exclusion Criteria: 1. Patients having muscle-invasive disease (T2 or greater) 2. Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months 3. Patients with existing urinary tract infection or recurrent severe bacterial cystitis 4. Patients with urogenital tumors with histology other than transitional cell carcinoma (i.e., squamous cell or adenocarcinoma) or with transitional carcinoma involving the upper tract or the prostatic urethra 5. Patients with history of other primary malignancy (other than squamous or basal cell skin cancers or cone biopsied Cis of the uterine cervix or prostate carcinoma treated curatively with normal PSA values at inclusion) in the last five years 6. Patients with active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose to the development of complications from the administration of intravesical therapy and or general anesthesia 7. Patients who, in the opinion of the investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders) 8. Women who are pregnant or lactating. Individuals of reproductive potential may not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partner ; PRIMARY OUTCOME: Time to progression / Duration of remission following transurethral resection of superficial bladder cancer; SECONDARY OUTCOME 1: Additional safety data[/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 - GLD-1875; BRIEF: The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL). The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461. ; DRUG USED: REGN4461; DRUG CLASS: Biologic; INDICATION: Lipodystrophy; TARGET: Leptin Receptor (LepR); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol - Presence of one or both of the following metabolic abnormalities at screening: 1. HbA1c ≥ 7% OR 2. Fasting TG ≥250 mg/dL - Generally stable diet (based on patients recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit Key Exclusion Criteria: - Treatment with metreleptin within 1 month of the screening visit - Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit - Treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day during the study period - History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit - Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening - Participation in any clinical research study evaluating an Investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit. - Pregnant or breast-feeding women NOTE: Other protocol defined inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Absolute change from baseline hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Absolute change in composite endpoint comprising absolute change in either HbA1c or percent change in fasting TG[/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 - IG402; BRIEF: The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery. ; DRUG USED: Fibrin Sealant; DRUG CLASS: Biologic; INDICATION: Hemostasis; TARGET: Fibrinogen (Coagulation Factor I), Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Instituto Grifols, S.A.; CRITERIA: Inclusion Criteria: - Are male or female - Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom) - Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure - Have hemoglobin ≥ 9.0 g/dL - Have platelet count > 70 x 10^3/mm^3 - Required one peripheral vascular procedure involving either an arterial patch angioplasty or an arterial anastomosis utilizing polytetrafluoroethylene or Dacron grafts, according to the Investigators (the surgeons) selection: 1. Carotid endarterectomy requiring patch angioplasty 2. Carotid-subclavian bypass grafting 3. Axillo-femoral bypass grafting 4. Abdominal aortic aneurysm resection and graft replacement 5. Aorto-mesenteric bypass grafting 6. Aorto-celiac bypass grafting 7. Aorto-uni-iliac bypass grafting 8. Aorto-bi-iliac bypass grafting 9. Aorto-uni-femoral bypass grafting 10. Aorto-bi-femoral bypass grafting 11. Iliac aneurysm resection and graft replacement 12. Femoral aneurysm resection and graft replacement 13. Femoral-femoral bypass grafting 14. Femoral-popliteal bypass grafting 15. Renal arterial revascularization (bypass grafting) 16. Renal arterial revascularization (endarterectomy with patch angioplasty) 17. Popliteal artery revascularization (bypass grafting) 18. Popliteal artery revascularization (endarterectomy with patch angioplasty) 19. Femoral endarterectomy with patch angioplasty 20. Ilio-femoral bypass grafting - Intra-operative inclusion criterion: - A Target bleeding site (TBS)can be identified according to the Investigators judgment, and the TBS has a mild or moderate arterial bleeding according to the Investigators judgment Exclusion Criteria: - Weighed < 20 kg - Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0 - Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5 - Have a pre-operative (at Baseline Assessments) serum creatinine > 2 times the upper limit of the normal range - Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis - Have an infection in the anatomical surgical area - Have a history of severe (e.g., anaphylactic) reactions to blood or any blood derived product - Unwilling to receive blood products - Have positive bleeding history - Female who was pregnant or nursing - Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit. - Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit. - Were previously included in this clinical trial (protocol number IG402) ; PRIMARY OUTCOME: The Primary Efficacy Endpoint is Time to Hemostasis.; SECONDARY OUTCOME 1: Proportions of Subjects Achieving Hemostasis[/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 - Young Adult Healthy Subjects; BRIEF: The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations. ; DRUG USED: Quadrivalent Seasonal Flu Vaccine; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria: 1. Healthy adult male or female, 18-49 years of age 2. Willing and able to give informed consent prior to study enrollment 3. Able to comply with study requirements 4. Women of child-bearing potential must have a negative urine pregnancy test at vaccination, will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility are exempt from urine pregnancy testing. Exclusion Criteria: 1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. - Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the investigator. - Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. - Acute or chronic illnesses reasonably expected to be associated with increased risks associated with influenza (e.g., cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. - Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see exclusion criteria 2,5,8,9). 2. Participation in research involving investigational product (drug/ biologic/ device) within 45 days before planned date of first vaccination 3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed TIV (e.g., egg proteins) or polysorbate-80. 4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine. 5. Received any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within six months preceding the study vaccination. 6. History of receipt of any avian influenza vaccine containing an H5 antigen, or known exposure to birds infected with an H5 virus. 7. Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 8. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose greater or equal to 10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. 9. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study. 10. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration. 11. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 12. Known disturbance of coagulation. 13. Women who are breastfeeding or plan to become pregnant during the study. 14. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse. ; PRIMARY OUTCOME: Immunogenicity of the quadrivalent VLP vaccine using HAI responses.; SECONDARY OUTCOME 1: Immunogenicity of each quadrivalent VLP vaccine formulation measured by neuraminidase inhibition (NAI)[/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 I/II - 001; BRIEF: This is a phase l/ll multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. The trial consists of 2 parts: Part I and Part II. In total approximately 48 patients will be included in Part I of the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3). ; DRUG USED: MB-CART19.1; DRUG CLASS: ; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Miltenyi Biomedicine GmbH; CRITERIA: Inclusion Criteria: - Male or female patients must have r/r CD19-expressing ALL or NHL/CLL - CD19 expression must be detected on the malignant cells by flow cytometry (leukemia, malignant effusion in NHL) or immunohistochemistry (NHL); - Age ≥ 1 year (if deemed fit by treating investigator); - Absolute CD3+ T cell count ≥100/μl; - ECOG performance score of 0-2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening; - No active Hepatitis B, Hepatitis C, HIV1/2; - No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential; - Signed and dated informed consent/assent by patients - and meet the following disease-specific criteria: ALL: - patients with >5% blasts in BM (M2 or M3) after at least one standard chemotherapy and one salvage regimen who are ineligible for allogeneic stem cell transplant (alloSCT) or have refractory disease activity precluding alloSCT at this time, or - patients who have relapsed post alloSCT at least 100 days posttransplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment. - patients with Ph+ ALL if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have r/r disease after treatment with at least 2 different TKIs. - ALL patients with combined bone marrow and CNS and/or testicular relapse are eligible only if the extramedullary disease has been successfully cleared by conventional therapy at the time of inclusion (e.g. intrathecal chemotherapy, orchiectomy). Pediatric aggressive NHL (1-17 years): - patients after at least one salvage chemotherapy as bridge to alloSCT or - patients ineligible for alloSCT or - patients who have relapsed post alloSCT at least 100 days posttransplant, with not evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment. - patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion. Adult NHL: - patients after at least one standard chemotherapy and one salvage regimen as bridge to alloSCT or - patients who are ineligible for alloSCT or - patients who have relapsed post alloSCT at least 100 days posttransplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment. - patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion. CLL: - patients with r/r disease after established and approved treatment options have failed. - patients not eligible or appropriate for conventional alloSCT. Exclusion Criteria: - Isolated CNS or testicular relapse in ALL; - Isolated CNS lymphomas; - Active solid brain metastases or history of solid brain metastases - Current autoimmune disease, or history of autoimmune disease with potential CNS involvement; - Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis); - History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years; - Pulmonary function: Patients with pre-existing severe lung disease or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on chest X-ray; - Cardiac function: Fractional shortening <28% or left ventricular ejection fraction <50% by echocardiography; - Renal function: GFR ≤29 mL/min/1.73 m2 by CKD-EPI for patients 18 yrs (Levey et al. 2009) or creatinine clearance ≤29 mL/min/1.73 m2 by Schwartz formula (Schwartz et al. 1976) for patients <18 yrs of age; - Liver function: Patients with a serum bilirubin >3 times upper limit of normal or an AST or ALT > 5 times upper limit of normal, unless due to leukemic liver infiltration in the estimation of the investigator; - Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy; - Pregnant or breast-feeding females; - Medications: - Systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, - Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, calcineurin inhibitors, blinatumomab) or investigational drugs or donor lymphocyte transfusions or radiation therapy within 30 days prior to apheresis, - Alemtuzumab within 3 months prior to leukapheresis, - Exception: Intrathecal chemotherapy is allowed prior to treatment, but should be discontinued in ALL and BL 10 days prior to MB-CART19.1 infusion to limit risk of neurotoxicities; - Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication/salvage therapies for treatment related toxicities; - Intake of concomitant medication contraindicated for other reasons than hypersensitivity, e.g. live vaccines and fludarabine; - Contraindication of trial related procedures as judged by the investigator, e.g. lumbar punctures for CSF sampling; - Female patients of child-bearing potential not willing to practice a highly effective form of birth control from the time of enrollment and for 12 months after dosing the IMP; - Male patients of fathering potential not willing to practice a highly effective form of birth control from the time of enrollment and for 12 months after dosing the IMP; - Concurrent participation in another interventional trial that could interact with this trial, e.g. CAR T trials; - Cerebral dysfunction, legal incapacity of adult patients; - Committal to an institution on judicial or official order. ; PRIMARY OUTCOME: Phase I - Determination of the recommended dose of MB-CART19.1; SECONDARY OUTCOME 1: Phase I - Overall incidence 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 I/II - TACTIC-2; BRIEF: TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them via the endogenous T cell receptor. This is an open-label, multicenter Phase 1/2 study that aims to establish safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma. ; DRUG USED: TAC01-HER2; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), HER2/neu or ErbB-2, Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Triumvira Immunologics, Inc.; CRITERIA: Inclusion Criteria: 1. Written informed consent. 2. Age ≥ 18 years at the time of informed consent. 3. For Phase 1 and Phase 2: - Phase 1 monotherapy (completed): HER2 1+, 2+, 3+ by IHC by central laboratory confirmation - Phase 1 combination therapy and Phase 2: HER2 2+, 3+ by IHC and FISH by central laboratory confirmation 4. Histologically confirmed advanced, metastatic, unresectable solid tumors (regardless of PD-L1 expression levels; Phase 1 monotherapy) and histologically confirmed advanced, metastatic, unresectable gastric or esophageal adenocarcinoma (regardless of PD-L1 expression levels for Phase 1 combination therapy and Phase 2) after at least 2 prior lines of therapy (Phase 1) or after at least 2 and no more than 4 prior lines of therapy (Phase 2). 1. HER2+ incurable malignancies for which no standard-of-care HER2 targeted therapy exists may be enrolled regardless of the number of prior treatment lines, as long as in the opinion of the investigator the subject would be unlikely to tolerate or derive clinically meaningful benefit from other available treatment options. 2. For breast cancer subjects, both prior lines of therapy must have included HER2-targeted agents per current standard-of-care. 3. Subjects with solid tumors with genetic alterations and mutations (such as BRAF, BRCA, EGFR mutations, and ALK translocation) where approved targeted therapies were available to their specific cancers must have been previously treated with such approved therapies or refused such approved targeted therapy for their cancers prior to enrollment, or in the opinion of the investigator would be unlikely to tolerate or derive clinically meaningful benefit from these standard-of-care therapies. 5. Measurable disease per RECIST 1.1 at time of enrollment. 6. ECOG performance status of 0 or 1 at Screening. 7. Life expectancy of at least 12 weeks. 8. Adequate organ and bone marrow reserve function. 9. Recovery to Grade ≤1 or Baseline for any toxicities due to previous therapy. 10. Adequate vascular access for leukapheresis. 11. Negative pregnancy test and use of highly effective contraception. 12. Undetectable HBV viral load. 13. HCV viral load is undetectable. Exclusion Criteria: 1. Intolerant to any component of TAC01-HER2. 2. Prior treatment with any of the following: 1. Adoptive cell transfer of any kind, including CAR T cells 2. Gene therapy 3. Investigational medicinal product within 5 half-lives or 21 days prior to leukapheresis, whichever is shorter. 4. Receipt of a live or live-attenuated vaccine within 30 days prior to study treatment. 5. Monoclonal antibody (mAb), including PD-1 and PD-L1, therapies within 21 days prior to leukapheresis. 6. Radiation within 28 days prior to enrollment. Palliative radiation is allowed up to 14 days prior to enrollment if non-irradiated lesions are present. 7. Chemotherapy or targeted small molecule therapy within 14 days prior to leukapheresis, or within 7 days prior to leukapheresis for erlotinib, gefitinib, afatinib, or crizotinib. 8. Colony stimulating factors, including granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, and other hematopoietic cytokines, within 14 days prior to leukapheresis. 9. Immunosuppressive medication within 14 days or corticosteroid treatment < 72 hours prior to enrollment. 10. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, or psychosis. (Brain metastasis - non-progressive or previously treated and currently stable - are permitted.) 11. Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis). 12. Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogrens syndrome) requiring systemic disease modifying agents in the past 2 years. 13. Active or uncontrolled hepatitis B or C (HCV ribonucleic acid [RNA] positive) infection or any history of or active human immunodeficiency virus (HIV) infection. 14. Uncontrolled, acute, or life-threatening bacterial, viral, or fungal infection. Subjects with ongoing use of prophylactic antibiotics, antifungals, or antivirals are eligible if no evidence of active infection. 15. Class III or IV heart failure (as defined by the New York Heart Association - NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease within 6 months prior to Screening. 16. Cardiac arrhythmia not controlled by medical management. 17. Clinically significant thrombotic events within 6 months prior to leukapheresis and/or inability to stop anti-coagulation for at least 2 weeks prior to TAC01-HER2 infusion. 18. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 19. Pregnant or lactating. 20. As determined by the Investigator, any uncontrolled medical, psychological, familial, sociological, or geographical condition(s) that do(es) not permit compliance with the protocol. 21. Participation in or has participated in a study using an investigational device within 4 weeks prior to study treatment.. 22. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subjects participation for the full duration of the study, such that it is not in the best interest of the subject to participate, in the opinion of the treating investigator. 23. Has a known psychiatric or substance abuse disorder that would interfere with the participants ability to cooperate with the requirements of the study. Combination Arm Only Specific Exclusions: 24. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 25. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE). 26. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 27. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment. 28. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 29. Has history of an allogeneic stem cell transplant or a solid organ transplant. 30. Has a history of radiation pneumonitis. (Note: Cannot receive prior radiotherapy within 2 weeks of start of pembrolizumab. Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation [≤2 weeks of radiotherapy] to non-CNS disease). ; PRIMARY OUTCOME: Phase 1: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; SECONDARY OUTCOME 1: Phase 1: Determine MTD or RP2D for TAC01-HER2 monotherapy and pembrolizumab combination therapy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PK Study; BRIEF: Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration. ; DRUG USED: XaraColl; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Innocoll; CRITERIA: Inclusion Criteria: 1. Man or woman who is ≥ 18 years of age 2. Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique) 3. If female, is nonpregnant Exclusion Criteria: 1. Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures 2. Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively 3. Has any clinically significant unstable cardiac, neurological, immunological, renal, hepatic or hematological disease or any other condition that, in the opinion of the investigator, could compromise the patients welfare, ability to communicate with the study staff or otherwise contraindicate study participation ; PRIMARY OUTCOME: Cmax; 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 I/II - w/Pembrolizumab; BRIEF: To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to checkpoint inhibitor therapy in locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients. ; DRUG USED: SNS-301; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Aspartate ß-hydroxylase (ASPH), Immune System, Notch Receptors; THERAPY: Combination; LEAD SPONSOR: Sensei Biotherapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Signed informed consent. 2. Be 18 years of age or older. 3. Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent SCCHN and meet the criteria of either Cohort A or B. Cohort A: Patients with Ongoing CPI Therapy 1. Patients currently receiving a checkpoint inhibitor (CPI: anti-PD-1 and anti-PD-L1 agents). 2. Patients currently receiving a CPI must be considered by Investigator to have the potential to derive clinical benefit from continued treatment with pembrolizumab. 3. Based on RECIST 1.1/iRECIST criteria on current CPI treatment (prior to initiation of this study), patients must have a best response of stable disease (SD) or first evidence of progressive disease (PD) after a minimum of 12 weeks of a CPI. 4. Patients on other CPI therapy than pembrolizumab must be willing to switch over to pembrolizumab therapy. Cohort B: Patients without Previous CPI Therapy 1. Patients must be checkpoint inhibitor naïve (anti-PD-1 and anti-PD-L1 agents) 2. Patients should receive study treatment as first line (PD-L1 positive) or as second line (PD-L1 negative) systemic therapy in the advanced/metastatic setting. 4. Have measurable disease by RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1. 6. Have a life expectancy of ≥ 3 months. 7. Be willing to provide a pre-treatment tissue sample (archived or fresh). 8. Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters. 9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment. For male patients: Agree that during the period specified above, men will not father a child. Male patients must remain abstinent, must be surgically sterile during the treatment period and for at least 180 days after the last dose of study treatment. Exclusion Criteria: 1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0. 2. Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0. 3. Uncontrolled tumor-related pain. 4. Malignancies other than indications open for enrollment within 3 years prior to Day 0. 5. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 6. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation. 7. Active autoimmune disease that has required systemic treatment in the past 2 years 8. History or any evidence of interstitial lung disease. 9. History of HIV. HIV antibody testing recommended per investigators clinical suspicion. 10. Active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (HCV qualitative RNA detected); testing recommended per investigators clinical suspicion. 11. Severe infections within 4 weeks prior to enrollment. 12. Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0. 13. History or current evidence of any condition, therapy or laboratory abnormality that in the opinion of the treating investigator might confound the results of the trial. 14. Prior allogeneic stem cell or solid organ transplant. 15. Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with the requirements of the trial. 16. Treatment with systemic immunomodulating agents (including but not limited to IFNs, IL-2, ipilimumab) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to first dose. 17. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study. ; PRIMARY OUTCOME: Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab; SECONDARY OUTCOME 1: Antigen-specific Response[/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 - ACORN; BRIEF: Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris ; DRUG USED: Imsidolimab; DRUG CLASS: Biologic; INDICATION: Acne; TARGET: IL-36/IL-36R (Interleukin-36/receptor); THERAPY: Monotherapy; LEAD SPONSOR: AnaptysBio, Inc.; CRITERIA: Key Inclusion Criteria: - Diagnosis of moderate to severe facial AV - Facial IGA) score of 3 (moderate) or 4 (severe) - At least 20 and no more than 100 inflammatory lesions on the face - No more than 100 non-inflammatory lesions on the face. - No more than 5 nodules (≥5 millimeter [mm]) on the face Key Exclusion Criteria: - A participant with acne fulminans or conglobate or secondary acne will be excluded. ; PRIMARY OUTCOME: Change From Baseline in Facial Inflammatory Lesion Counts at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20[/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 - BK-MD-202 (U.S./Korea); BRIEF: This Phase 2, multi-center, double-blind, randomized, placebo-controlled, parallel group, add-on study of MLR 1023 in adults with uncontrolled T2DM on metformin anti diabetic monotherapy is designed to evaluate the efficacy and safety of MLR 1023 in combination with metformin in subjects with uncontrolled T2DM. ; DRUG USED: MLR-1023; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Lyn kinase; THERAPY: Monotherapy; LEAD SPONSOR: Melior Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female, age 18 to 75 years, inclusive. 2. Diagnosis of T2DM. 3. Body mass index (BMI) between 20 and 40 kg/m2. 4. HbA1C between 7.0% and 10.0%. 5. Treated with metformin as the only anti-diabetic therapy. 6. Metformin dosage must have been stable and unchanged for at least 3 months prior to Screening and at a dose of at least 1,500 mg/day or the maximum tolerated dose if less than 1,500 mg/day. 7. Able and willing to comply with the study protocol for the duration of the study including scheduled clinic appointments. 8. Able and willing to provide written informed consent for study participation prior to performance of any study-related assessments. Exclusion Criteria: 1. Subject has signs of or is diagnosed with Type 1 diabetes mellitus or latent autoimmune diabetes in adults. 2. History of hospitalizations or emergency room visits that would impact subject safety or data interpretation, including: - Poor glucose control in the 6 months prior to Screening (per investigator discretion) or - Any bariatric surgical procedures for weight loss. 3. History of significant change of body weight (> 10%) in the 3 months prior to Screening. 4. History of or active proliferative retinopathy or maculopathy within the 6 months before Screening or requiring acute treatment, or severe neuropathy. 5. History of previous gastrointestinal bleeding or ulceration within 3 months prior to Screening. 6. History of acute or chronic pancreatitis. 7. History of significant cardiovascular events defined as: - Myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within 6 months prior to Screening. - Congestive heart failure defined as New York Heart Association (NYHA) Stages III and IV. - Uncontrolled hypertension defined as a systolic blood pressure > 160 mmHg and/or a diastolic blood pressure > 100 mmHg. - Symptomatic postural hypotension - The difference between supine blood pressure and standing blood pressure is 20 mmHg in systolic or 10 mmHg in diastolic with any symptom. 8. Evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined at Screening; subjects receiving dose-stable thyroid replacement therapy for at least 3 months prior to Screening will be allowed to participate in the study. 9. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder that would impact subject safety or data interpretation. 10. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening ( subjects with a history of treated cervical intraepithelial neoplasia will be allowed to participate in the study). 11. Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN) and/or alanine aminotransferase (ALT) > 2.5 × ULN and/or total bilirubin > 2.0 mg/dL. 12. Positive blood screen for anti-hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), and human immunodeficiency (HIV) antibody. 13. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, ECG, or clinical laboratory assessments. 14. Long QT syndrome or prolongation of QTc interval (defined as QTc interval > 460 ms for males and > 480 ms for females). 15. The following medication exclusions apply: - Use of weight control treatment 3 months prior to Screening, including any medication with a labeled reference to weight loss or gain, herbal preparations, and over the counter medications. - Use of other anti-diabetic agents (except metformin) within 3 months prior to Screening (if the subject was previously treated with thiazolidinedione, he/she must have stopped this treatment at least 6 months before Screening). - Use of insulin within 12 months prior to Screening (the following cases can be included in this study: Insulin treatment during hospitalization, insulin treatment for a medical condition that did not require hospitalization [< 2 weeks treatment period], or insulin treatment for gestational diabetes). 16. Treatment with an investigational agent within the longest time frame of either 5 half lives or 30 days of initiating study drug. 17. Use of prohibited concomitant medications (further details about prohibited medication are provided in Section 5.8.1): - Current use of hyperglycemia-causing agents, hypoglycemia-causing agents, Class II and III antiarrhythmic agents (these agents will be allowed if they have been used for hypertension treatment), agents that reduce gastrointestinal motility, central nervous system stimulants (with the exception of caffeinated beverages), and niacin ≥ 1 g/day. - Current use of drugs with a narrow therapeutic index (eg, digoxin, lithium, phenytoin, theophylline, and warfarin). - Current use of drugs that are known to prolong the QT interval. 18. Known recreational substance use or psychiatric illness that, in the opinion of the Investigator, may impact the safety of the subject or the study objectives (eg, cannot comply with scheduled study visits). 19. History of drug abuse. 20. Women who are pregnant (confirmed by laboratory testing), nursing or are planning to become pregnant. 21. Subject is not willing to use an effective method of contraception during the course of the study. Sexually active male subjects are required to use a condom, abstain from intercourse, or previously undergone male sterilization. Male subjects should refrain from sperm donation for the purposes of conception for at least 90 days after their last dose of study drug. Females subjects must be surgically sterile (ie, hysterectomy or bilateral tubal ligation), postmenopausal, or for women of childbearing potential using a medically acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide or abstinence). Female subjects of childbearing potential taking stable oral, implantable, or injectable contraceptives must additionally use a double-barrier method of contraception. 22. Subject has an FPG ≥ 270 mg/dL at the Screening visit. 23. Has a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country. 24. Known allergy or hypersensitivity to MLR-1023 or components of the formulation. ; PRIMARY OUTCOME: Changes in HbA1c between active treatment groups and placebo at Week 12; SECONDARY OUTCOME 1: HbA1c of < 7.0% at Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa; BRIEF: This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. During the run-in period patients with infected wounds will receive oral antibiotic and not be included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SOC treatment for diabetic ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change. ; DRUG USED: NanoDOX Hydrogel; DRUG CLASS: Non-NME; INDICATION: Diabetic Foot and Other Ulcers; TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: NanoSHIFT LLC; CRITERIA: Inclusion Criteria: - Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association - Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and: • Agree to use a double-barrier method of contraception during their participation in this study; - condoms (with spermicide) and hormonal contraceptives OR - condoms (with spermicide) and intrauterine device OR - intrauterine device and hormonal contraceptives OR - Abstains from sexual intercourse during their participation in this study OR - Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant - Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening - Be able to apply study drug to their ulcer, or have a caregiver do it - Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg - Target ulcer is Grade I according to the Wagner Grading Scale - Quantitative bacterial count of of < 1.0 x 1.0E5 per gram of tissue for non-infected ulcers - Quantitative bacterial count of ≥ 1.0 x 1.0E5 per gram of tissue for infected ulcers Exclusion Criteria: - Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control. - Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative - Have more than three chronic ulcers present at baseline - Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months - Have connective tissue disease - Currently be going through kidney dialysis for renal failure - Have undergone treatment with doxycycline, Procuren®, or Regranex® within the last 30 days - Have participated in another clinical research trial within the last 30 days - Have a known history of osteomyelitis affecting to the area where the target ulcer is present - Have any other concomitant condition which, in the opinion of the investigator, would make the subject unsuitable for the study. - Subject has ulcers resulting from any cause other than diabetes (electrical burn, arterial insufficiency, chemical or radiation insult) ; PRIMARY OUTCOME: Number of Participants Without Adverse Events; SECONDARY OUTCOME 1: Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)[/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 - KEYNOTE147 (w/Pembrolizumab); BRIEF: Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma. ; DRUG USED: Calquence; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Combination; LEAD SPONSOR: Acerta Pharma BV; CRITERIA: Inclusion Criteria: - Men and women ≥ 18 years of age - Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy - Presence of radiographically measurable disease as defined by RECIST 1.1 - ECOG performance status of 0 or 1 Exclusion Criteria: - Prior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years - Known central nervous system metastases and/or carcinomatous meningitis - A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigators opinion, could compromise the subjects safety - Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug ; PRIMARY OUTCOME: Number of Participants With Overall 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 - HARMONY I (vs. Modafinil); BRIEF: The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS) ; DRUG USED: Wakix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Narcolepsy; TARGET: Histamine H3 Receptor (HRH3); THERAPY: Monotherapy; LEAD SPONSOR: Bioprojet; CRITERIA: Inclusion Criteria: - diagnosis of narcolepsy with or without cataplexy - patients need to free of or discontinue psychostimulant medications for at least 14 days, - patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses - patients must have adequate support to comply with the entire study requirements Exclusion Criteria: - Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness - Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances - Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigators opinion would preclude the patients participation - Current or recent history of a substance abuse or dependence disorder including alcohol abuse ; PRIMARY OUTCOME: Epworth Sleepiness Scale (ESS); SECONDARY OUTCOME 1: Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks[/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. FluLaval - Adult Safety; BRIEF: This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines. This study will also evaluate the lot-to-lot consistency of three vaccine lots. ; DRUG USED: FluLaval; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes can and will comply with the requirements of the protocol - A male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study. - Written informed consent obtained from the subject. - Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device. - Female subjects of non-childbearing potential may be enrolled in the study. - Female subjects of childbearing potential may be enrolled in the study, if the subject: - - has practiced adequate contraception for 30 days prior to vaccination, and - - has a negative pregnancy test on the day of vaccination, and - - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: - Use of an investigational / non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. - Planned administration or administration of a licensed vaccine within 30 days before study vaccination. - Prior receipt of 2010/2011 influenza vaccine. - Receipt of any investigational or approved influenza vaccine within six months of the first study visit. - Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. - History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. - Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable / unlikely to provide accurate safety reports. - Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination. - Presence of significant uncontrolled chronic medical or neuropsychiatric illness, based on history and physical examination - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin - Chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine/product dose. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. - Pregnant or lactating female. - Fever at the time of enrolment. - Acute disease at the time of enrolment - Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study. ; PRIMARY OUTCOME: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease; SECONDARY OUTCOME 1: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ANNEXA-S; BRIEF: Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors. ; DRUG USED: Andexxa; DRUG CLASS: Biologic; INDICATION: Drug Toxicity; TARGET: Factor X Inhibitors; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: All of the following criteria must be met for the patient to be eligible: - Either the patient or their medical proxy (or legal designee) has given written informed consent. - Age ≥ 18 and < 85 years old. - Requires urgent surgical intervention that must occur within 12 hours of consent, for which reversal of anti-fXa activity is judged necessary. - Treatment with an oral FXa inhibitor (apixaban [last dose 2.5 mg or greater], rivaroxaban [last dose 10 mg or greater], edoxaban [last dose 30 mg or greater] or enoxaparin [≥ 1 mg/kg/d]): - ≤ 15 hours prior to start of surgery. - > 15 hours prior to start of surgery or unknown time from the last dose, if documented anti fXa activity is > 100 ng/mL (> 0.5 IU/mL for enoxaparin, or over the equivalent IU/mL threshold on a low molecular weight heparin assay; see Laboratory Manual) within 2 hours prior to consent. Note: Patients enrolled in this manner should receive a high-andexanet dosing regimen. - Have a negative pregnancy test documented prior to enrollment (for women of childbearing potential). - Willingness to use highly effective methods of contraception through 30 days following study drug dose (for female and male patients who are fertile). Exclusion Criteria: If a patient meets any of the following criteria, he or she is not eligible: - Surgery for which the risk of clinically meaningful uncontrolled or unmanageable bleeding is low. - Acute life-threatening bleeding (ISTH criteria) at the time of Screening: 1. The patient has acute-overt bleeding that is potentially life-threatening, e.g., with signs or symptoms of hemodynamic compromise, such as severe hypotension, poor skin perfusion, mental confusion, low urine output that cannot be otherwise explained. 2. The patient has overt bleeding associated with a fall in hemoglobin level by ≥2g/dL, OR, a hemoglobin ≤8 g/dL if no baseline hemoglobin is available. 3. The patient has acute bleeding in a critical area or organ, such as pericardial, intracranial, or intraspinal. - Any surgical procedure that involves the intraoperative use of systemic, intravascular, unfractionated heparin. - Primary procedure for efficacy assessment is a non-surgical interventional procedure (e.g, lumbar puncture, skin biopsy, cardiac catheterization, endoscopic retrograde cholangio-pancreatography). - Expected survival of < 1 month due to comorbidity. - Known Do Not Resuscitate order or similar advanced directive. - The patient has a recent history (within 30 days prior to screening) of a diagnosed TE as follows: venous thromboembolism (including deep vein thrombosis, pulmonary embolism, intracardiac thrombus), myocardial infarction (including asymptomatic troponin elevations), disseminated intravascular coagulation, acute traumatic coagulopathy, cerebrovascular accident, transient ischemic attack, unstable angina pectoris hospitalization, or severe peripheral vascular disease. - Acute decompensated heart failure or cardiogenic shock at the time of screening. - The patient has sepsis or septic or severe hemorrhagic shock at the time of Screening. - The patient has heparin-induced thrombocytopenia (with or without thrombosis). - Inherited coagulopathy (e.g., anti-phospholipid antibody syndrome, protein C/S deficiency, Factor V Leiden) at time of Screening. - Platelet count < 80,000/µL at the time of Screening. - Last dose of apixaban < 2.5 mg, rivaroxaban < 10 mg, edoxaban < 30 mg, or enoxaparin 40 mg. - The patient is pregnant or a lactating female. - The patient has received any of the following drugs or blood products within 7 days of enrollment: - Vitamin K antagonists (e.g., warfarin). - Dabigatran. - Prothrombin complex concentrate products (e.g., Kcentra®) or recombinant factor VIIa (e.g., NovoSeven®). - Whole blood, plasma fractions. Note: Administration of tranexamic acid, platelets or packed red blood cells is not an exclusion criterion. - The patient was treated with an investigational drug < 30 days prior to Screening. - Prior treatment with andexanet. - Known hypersensitivity to any component of andexanet. - Known allergic reaction to hamster proteins. - Known or suspected (i.e., presumed positive) COVID-19-related illness at the time of Screening. ; PRIMARY OUTCOME: Number of Participants Achieving Effective Hemostasis; SECONDARY OUTCOME 1: Percent Change From Baseline In Anti-fXa Activity To Treatment Nadir[/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 - Premature Birth; BRIEF: The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol. ; DRUG USED: NTRA-2112; DRUG CLASS: Non-NME; INDICATION: Gastroenterologic Disorders; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Elgan Pharma Ltd.; CRITERIA: Inclusion Criteria: 1. Pre-term infants 26-33 weeks gestation. ; PRIMARY OUTCOME: Number of days to achieve complete enteral feeding; SECONDARY OUTCOME 1: Number of gastric residual > 2 ml/kg[/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 - KINECT3/4 Rollover; BRIEF: This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study. ; DRUG USED: Ingrezza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tardive Dyskinesia; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: - Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study. - Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine. - If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses. - Be in general good health. - Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol. Exclusion Criteria: - Have an active, clinically significant unstable medical condition within 1 month prior to screening. - Have a known history of substance dependence, substance (drug) or alcohol abuse. - Have a significant risk of suicidal or violent behavior. - Have a known history of neuroleptic malignant syndrome. - Have a known history of long QT syndrome or cardiac arrhythmia. - Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed). - Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than valbenazine) during the study. - Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline. - Have an allergy, hypersensitivity, or intolerance to tetrabenazine. - Are currently pregnant or breastfeeding. ; PRIMARY OUTCOME: Number of Participants Monitored for Long-term Safety of Valbenazine; SECONDARY OUTCOME 1: Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale[/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 Ib/II - Study 203 w/Capecitabine (EU); BRIEF: This is a Phase 1b/2, multi-center, open-label, dose escalation (in 2 different dosing schedules [1 and 2]) and dose-confirmation study of eribulin administered in combination with capecitabine. ; DRUG USED: Halaven; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Eisai Limited; CRITERIA: Inclusion Criteria Subjects who meet all of the following criteria will be included in the study: Dose-escalation cohorts (Phase 1b): 1. Histologically or cytologically confirmed cancer that is advanced and/or metastatic 2. Resistant/refractory to approved therapies (defined as progressive disease during or within 6 months after the last anti-cancer therapy) or for whom single agent capecitabine at this dose level and schedule would be a reasonable treatment option in the opinion of the investigator 3. For subjects that previously received capecitabine, all capecitabine related toxicities must have completely resolved 4. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L 5. Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP. 6. Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement. 7. Females of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin (hCG) at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. 8. Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly affective method of contraception (e.g. condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) 9. Life expectancy of greater than 3 months 10. Willing and able to comply with all aspects of the protocol 11. Provide written informed consent 12. Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2 13. Males and females, age greater than or equal to18 years Dose-confirmation cohorts (Phase 2): 1. Histologically or cytologically confirmed carcinoma of the breast that is advanced and/or metastatic 2. Received up to three prior chemotherapy regimens in any setting (sequential neoadjuvant/ adjuvant treatment counting as one regimen) 3. Chemotherapy regimens must have included an anthracycline (unless anthracycline containing chemotherapy is inappropriate) and a taxane, either in combination or in separate regimens 4. No prior treatment with capecitabine in any setting 5. At least one lesion of greater than or equal to 1.5cm in longest diameter for non-lymph nodes and greater than or equal to 1.5cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 7 6. Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L 7. Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP. 8. Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement. 9. Females of childbearing potential must have a negative urine or serum beta hCG at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD, or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential 10. Life expectancy of greater than 3 months 11. Willing and able to comply with all aspects of the protocol 12. ECOG-PS 0 or 1 13. Females, age greater than or equal to 18 years Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the study: 1. Radiotherapy, chemotherapy, biological therapy or investigational agents within 4 weeks prior to the start of study treatment; subjects must have recovered from any previous therapy related toxicity to less than Grade 1 at study entry (except for stable sensory neuropathy less than or equal to Grade 2 and alopecia) 2. Treatment with mitomycin C or nitrosourea within 6 weeks prior to commencing on study treatment 3. Hormonal treatment within 2 weeks prior to start of study treatment (continued use of antiandrogens and/or gonadorelin analogues for treatment of prostate cancer permitted) 4. Prior participation in an eribulin clinical study, even if not assigned to eribulin treatment 5. Subject with hypersensitivity to halochondrin B and /or halochondrin B chemical derivates or capecitabine or any of the excipients 6. Suspected dihydropyrimidine dehydrogenase (DPD) deficiency 7. Previous radiotherapy encompassing greater than 30% of marrow 8. Previous organ allograft requiring immunosuppression 9. Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed at least 4 weeks earlier 10. Meningeal carcinomatosis 11. Significant cardiovascular impairment (history of congestive heart failure greater than New York Heart Association [NYHA] grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia) 12. Electrocardiogram (ECG) with QT interval corrected for heart rate (QTc) interval greater than 470 msec (as measured either by Bazetts or Fredericias formula) 13. Pre-existing neuropathy greater than Grade 2 14. Anti-coagulant therapy with warfarin or related compounds, other than for line patency, that cannot be changed to heparin-based therapy for the duration of the study 15. Subjects with known positive serology for Human Immunodeficiency Virus (HIV), or Hepatitis B or C 16. Subjects with other significant disease or disorder that, in the Investigators opinion, would exclude the subject from the study 17. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study 18. Unable to swallow tablets ; PRIMARY OUTCOME: Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0); SECONDARY OUTCOME 1: Phase 2: Time to 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 Ib/II - E7050-703; BRIEF: The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and capecitabine is more effective in patients with previously untreated gastric cancer versus cisplatin and capecitabine alone. ; DRUG USED: Golvatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: Hepatocyte growth factor receptor (c-Met, HGFR), VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria - Histologically confirmed, unresectable, locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (Phase II). For the Phase Ib portion, any unresectable, locally advanced or metastatic solid tumor; - ECOG PS of 0-1; - Blood pressure must be well-controlled. Patients must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function Exclusion Criteria - Gastric cancer patients who have had a complete gastrectomy; - Patients with known HER2 over-expressing advanced or metastatic gastric cancer; - Previously received E7050, its chemical derivatives, anti-cMet, anti-angiogenic therapy, (prior anti-angiogenic therapy is permitted in Phase Ib only). - For Phase Ib prior systemic therapy is allowed as long as PS and end organ function meet entry criteria; - For Phase II no prior palliative chemotherapy is permitted. Adjuvant/neoadjuvant chemotherapy is permitted if less than 12 months have elapsed between the end of adjuvant/neoadjuvant therapy and first recurrence; - Known central nervous system lesions, except for asymptomatic non-progressing, treated brain metastases. Treatment for brain mets, but have been completed at least 4 weeks prior to Day 1 - Palliative radiotherapy is not permitted throughout the study period. Prior palliative radiotherapy within 30 days prior to commencing study treatment; - Clinically significant hemoptysis; - Patients with known dihydropyrimidine dehydrogenase deficiency; - Patients with clinically significant hearing loss that may be further diminished by treatment with cisplatin plus capecitabine (significance of hearing loss to be determined by the Investigator; - Serious non-healing wound, ulcer, or active bone fracture; - Major surgical procedure, open biopsy, or significant traumatic injury within the 21 days prior to commencing study treatment; - Clinically significant gastrointestinal bleeding within 6 months prior to first dose. ; PRIMARY OUTCOME: Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib; SECONDARY OUTCOME 1: Overall Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PEP005-016 - REGION IIa; BRIEF: This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp. ; DRUG USED: Picato Gel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Mitochondria, Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: Peplin; CRITERIA: Inclusion Criteria: - Patient is male or female and at least 18 years of age - Female patients must be of either: - Non-childbearing potential, post-menopausal - Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy Exclusion Criteria: - Cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area - Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks - Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area ; PRIMARY OUTCOME: Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.; SECONDARY OUTCOME 1: Patients With Partial Clearance of Actinic Keratosis (AK)[/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 - FUNDAMENTAL - w/Peg-IFN/RBV (GT1, Treatment Experienced); BRIEF: The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV. ; DRUG USED: Debio 025; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Cyclophilin; THERAPY: Combination; LEAD SPONSOR: Debiopharm International SA; CRITERIA: Inclusion criteria: - Chronic HCV genotype 1 viral infection - HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening - Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks Exclusion criteria: - Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening - Women of child-bearing potential unless using highly effective - Any other cause of relevant liver disease other than HCV - Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ); SECONDARY OUTCOME 1: Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)[/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 - SIGN IgA Nephropathy; BRIEF: The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy ; DRUG USED: Tavalisse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immunoglobulin A (IgA) Nephropathy (Bergers Disease); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: Rigel Pharmaceuticals; CRITERIA: Inclusion Criteria: - Renal biopsy findings consistent with IgA nephropathy - Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose - Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day at the second Screening Visit - Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents Exclusion Criteria: - Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab. - Use of > 15 mg/day prednisone (or other corticosteroid equivalent). ; PRIMARY OUTCOME: Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24; SECONDARY OUTCOME 1: Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies.[/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 - OPTiHAN; BRIEF: This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. This study may provide information on the usefulness of talimogene laherparepvec combined with chemoradiation as a future treatment for head and neck cancer. ; DRUG USED: Imlygic; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy; THERAPY: Combination; LEAD SPONSOR: BioVex Limited; CRITERIA: Inclusion Criteria: 1. Male or female ≥ 18 years 2. Eastern Co-Operative Oncology Group (ECOG) Performance Status ≤ 1 3. Histological evidence (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx 4. Stage III or IV disease (T2N2-3M0, T3-4N1-3M0) 5. No evidence of distant metastases by computed tomography (CT) or positron emission tomography (PET)/CT scan 6. Life expectancy > 4 months 7. Neutrophil count ≥ 2,000/mm^3 8. Platelet count ≥ 100,000/mm^3 9. Hemoglobin ≥ 10 g/dL 10. Bilirubin ≤ 1.5 times upper limit of normal (ULN) 11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN 12. Alkaline phosphatase ≤ 2.5 times ULN 13. Creatinine clearance ≥ 60 mL/min 14. Female patients of child-bearing potential (i.e. not surgically sterile, or not having spontaneous amenorrhea for at least 12 months) must agree to use an effective form of contraception during the treatment phase of the study. 15. Male patients must agree to use a condom with spermicide or their female partner must use an effective method of birth control. 16. Provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable of understanding the investigational nature, potential risks and benefits of the study. Exclusion Criteria: 1. Prior treatment for locally advanced SCCHN (No prior surgery for SCCHN except nodal sampling or biopsy for study disease). 2. Patients with T1-2N1 or T1N2-3. 3. Pre-existing peripheral neuropathy ≥ Grade 2 (motor or sensory). 4. Weight loss > 20% of body weight within 3 months of screening (unless purposeful). 5. Surgery ≤ 28 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling. 6. Cancer of the nasopharynx, sinus, salivary gland or skin. 7. Previous radical radiation therapy (RT) to the head and neck region, excluding superficial RT for a non-melanomatous skin cancer. 8. Prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix. 9. Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as human immunodeficiency (HIV) infection, cardiac failure, pulmonary compromise (chronic obstructive pulmonary disease, pneumonia or respiratory decompensation) resulting in hospitalization within 12 months of screening, or active infection. 10. Any significant cardiac disease (e.g., New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias.. 11. High risk for poor compliance with therapy or follow up as assessed by the investigator. 12. Active herpes labialis, other lesions due to herpes simplex virus type I (HSV1) or dermatoses involving or within 50 cm of the lesions to be injected; active HSV1 lesions must have resolved before talimogene laherparepvec is injected. 13. Prior systemic chemotherapy for any type of cancer. 14. Patients for whom radiation therapy is contraindicated. 15. Pregnant or breast-feeding female. Confirmation that women of child-bearing potential are not pregnant. A negative serum β- human chorionic gonadotropin (β-hCG) pregnancy test result must be obtained during the screening period. 16. Currently enrolled and receiving an investigational agent in a clinical research study or received an investigational agent for any reason within 4 weeks prior to screening. 17. Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use. ; PRIMARY OUTCOME: 2-year Event-free Survival; SECONDARY OUTCOME 1: Clinical Objective Response (cOR)[/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 - ARCTIC-AF; BRIEF: To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration >3 days and <6 months). ; DRUG USED: K201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atrial Fibrillation/Flutter; TARGET: Alpha Adrenergic Receptors, Calcium Channel, Potassium channels, Ryanodine Receptor (RyRs), Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Sequel Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Symptomatic AF (sustained >3 days and <6 months) and clinically indicated for cardioversion; - Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice; - Hemodynamically stable (90 mmHg < systolic blood pressure < 190 mmHg)at screening and on Day 1; Exclusion Criteria: - Known prolonged QT syndrome or QTc interval of >0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT); - QRS >0.130 sec; - Previous episodes of second- or third-degree atrioventricular block; - Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF; - Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD); - Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; - NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months; - Known concurrent temporary secondary causes of AF; - Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks; - Received treatment with other drugs known to prolong the QT interval within 5 half-lives. ; PRIMARY OUTCOME: time to first documented recurrence of symptomatic AF; 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 - PATH (CIDP) (3003); BRIEF: This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP. Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations. ; DRUG USED: Hizentra; DRUG CLASS: Biologic; INDICATION: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010. - An IVIG treatment during the last 8 weeks prior to enrollment. - Age ≥18 years. - Written informed consent for study participation obtained before undergoing any study-specific procedures. Exclusion Criteria: - Any polyneuropathy of other causes - Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments - Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study - History of thrombotic episodes within the 2 years prior to enrolment - Known allergic or other severe reactions to blood products including intolerability to previous IVIG ; PRIMARY OUTCOME: Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period; SECONDARY OUTCOME 1: Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC 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 - 1218.89 (MARLINA); BRIEF: Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment. ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Diagnosis of type 2 diabetes mellitus - Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive) - Current therapy with ACEi or ARB at stable dose for 10 weeks - Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening. - Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min. - Age between 18 and 80 years. Exclusion criteria: - Dual or triple blockade of the Renin Angiotensin System (RAS) - Uncontrolled hyperglycaemia - Mean arterial blood pressure > 110 mmHg - Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos). - Treatment with a glitazone within 6 months prior to informed consent. - Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1 (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, a dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or premixed insulin within 10 weeks prior to informed consent. - Treatment with anti-obesity drugs 10 weeks prior to informed consent. - Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator. - Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. - Participation in another trial with an investigational drug within 2 months prior to informed consent. ; PRIMARY OUTCOME: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment; SECONDARY OUTCOME 1: The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ECHO-306 w/Pembrolizumab; BRIEF: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC). ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation - Measurable disease based on RECIST 1.1 - Life expectancy of at least 3 months. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function per protocol-defined criteria. - Provide tumor tissue sample. Exclusion Criteria: - Known untreated central nervous system metastases and/or carcinomatous meningitis - History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. - Symptomatic ascites or pleural effusion. - Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. - Active autoimmune disease that has required systemic treatment in past 2 years. - Has had an allogeneic tissue/solid organ transplant. - Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority. - Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility. - History or presence of an abnormal electrocardiogram (ECG) that, in the Investigators opinion, is clinically meaningful. - Use of protocol-defined prior/concomitant therapy. ; PRIMARY OUTCOME: Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo; SECONDARY OUTCOME 1: Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo[/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 - PROCEED; BRIEF: The purpose of this study is to compare progression-free survival (PFS) (based upon investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with that in participants who receive PLD and placebo. ; DRUG USED: Vintafolide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Folate Receptor (FOLR1), Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Endocyte; CRITERIA: Inclusion Criteria: - Participants must sign an approved informed consent form (ICF). - Participants must be ≥ 18 years of age. - Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. - Participants must have primary or secondary platinum-resistant ovarian cancer. - Participants must have at least a single (RECIST v1.1-defined) measurable lesion. - For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy (PLD). NOTE: For participants with a history of CNS metastasis, baseline radiological imaging must include an evaluation of the head. - Participants must have had prior debulking surgery. - Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 2 prior systemic cytotoxic regimens. - Participants are allowed to have received, but are not required to have received, one additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the management of ovarian cancer. - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Participants must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities. - Participants must have adequate organ function including: 1. Bone Marrow Reserve: 1. Absolute neutrophil count (ANC) ≥ 1.5x10^9/L prior to treatment. Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible. 2. Platelets ≥ 100x10^9/L 3. Hemoglobin ≥ 9 g/dL 4. Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, epoetin) should follow the ASCO guidelines as listed at www.asco.org. Participants should receive full supportive care, including transfusion of blood as mandated by clinical need; however, transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of EC145/placebo/PLD is administered are not allowed. 2. Hepatic: Total bilirubin level < 1.5 x ULN and ALT, AST, GGT, and alkaline phosphatase levels < 2.5 x ULN. 3. Renal: Serum creatinine level ≤ 1.5 x ULN or for participants with serum creatinine levels above 1.5 x ULN, creatinine clearance ≥ 50 mL/min/1.73m^2 4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal. Exclusion Criteria: - Patients refractory to primary platinum therapy where refactory is defined as disease progression within 6 months of first dose of initial platinum-based therapy. - Diagnosis of tumor of low-malignant potential. - Prior exposure to PLD or anthracycline therapy. - Prior exposure to FR-targeted therapy (eg, EC145, EC0225, EC0489, farletuzumab). - Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds. - Prior abdominal or pelvic radiation therapy or radiation therapy to > 10% of the bone marrow at any time in the past or prior radiation therapy within the past 3 years to the breast/sternum, dermal lesions, head or neck. - Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis - Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure or recent myocardial infarction. Patients who require antifolate therapy for the management of comorbid conditions (e.g., rheumatoid arthritis) will be excluded from the trial. - Pregnant or nursing. - Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ). - Symptomatic central nervous system (CNS) metastasis. - Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Use of low dose corticosteroid therapy (e.g., for nausea prophylaxis) is acceptable; however, concomitant tamoxifen therapy is not. Supportive care measures are allowed. ; PRIMARY OUTCOME: Progression-free survival based on investigator assessment using RECIST v1.1.; SECONDARY OUTCOME 1: Compare overall survival of participants between treatment arms.[/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 - SHINY (China); BRIEF: This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia. ; DRUG USED: Conbercept; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Chengdu Kanghong Biotech Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Patients give fully informed consent and are willing and able to comply with all study procedures. 2. In the study eye: - Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm. - Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia. - Visual impairment due to CNV secondary to high myopia. - BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40~ 20/320 Snellen equivalent). - Ocular media of sufficient quality to obtain fundus and OCT images. 3. The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent) Exclusion Criteria: 1. Current vitreous hemorrhage in either eye. 2. Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye. 3. Active infectious ocular inflammation in either eye. 4. Fibrosis or atrophy involving the center of foveal in the study eye. 5. Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition. 6. The lesion size ≥30 mm2 in the study eye. 7. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results. 8. Uncontrolled glaucoma or cup/disk ratio > 0.8 in the study eye. 9. Aphakia (excluding artificial lens) in the study eye. 10. Serious amblyopia and amaurosis in the fellow eye. ; PRIMARY OUTCOME: mean change from baseline of visual acuity; SECONDARY OUTCOME 1: mean change from baseline of anatomical features[/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 - CheckMate 627; BRIEF: The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: 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: Inclusion Criteria: - Diagnosed with advanced or metastatic malignancy - Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways. - Subjects previously treated with investigational anticancer therapies less than 6 weeks prior to the first dose of Nivolumab - Subjects with an active, known, or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Duration of Response (DOR)[/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 - HIBISCUS I (vs. Adalimumab; TNF Naive; Induction); BRIEF: This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted. ; DRUG USED: Etrolizumab; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Diagnosis of ulcerative colitis (UC) established at least 3 months prior to randomization (Day 1) - Moderately to severely active UC as determined by the MCS - Naive to treatment with TNF inhibitor therapy - An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment - Background UC therapy may include oral 5-aminosalisylate (5-ASA), budesonide, oral corticosteroids, probiotics, azathioprine (AZA), 6-mercaptopurine (6MP), or methotrexate (MTX) if doses have been stable for: - AZA, 6-MP, MTX: 8 weeks immediately prior to randomization - 5-ASA: 4 weeks immediately prior to randomization - Corticosteroids: 4 weeks immediately prior to randomization; if corticosteroids are being tapered, dose has to be stable for at least 2 weeks prior to randomization - Use of highly effective contraception method as defined by the protocol - Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening Exclusion Criteria: Exclusion Criteria Related to Inflammatory Bowel Disease: - Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC - Past or present ileostomy or colostomy - Diagnosis of indeterminate colitis - Suspicion of ischemic colitis, radiation colitis, or microscopic colitis - Diagnosis of toxic megacolon within 12 months of initial screening visit - Any diagnosis of Crohns disease - Past or present fistula or abdominal abscess - A history or current evidence of colonic mucosal dysplasia - Patients with any stricture (stenosis) of the colon - Patients with history or evidence of adenomatous colonic polyps that have not been removed Exclusion Criteria Related to Prior or Concomitant Therapy: - Prior treatment with TNF-alpha antagonists - Any prior treatment with etrolizumab or other anti-integrin agents - Any prior treatment with rituximab - Any treatment with tofacitinib during screening - Any prior treatment with anti-adhesion molecules - Use of intravenous (IV) steroids within 30 days prior to screening with the exception of a single administration of IV steroid - Use of agents that deplete B or T cells - Use of anakinra, abatacept, cyclosporine, sirolimus, or mycophenolate mofetil (MMF) within 4 weeks prior to randomization - Chronic nonsteroidal anti-inflammatory drug (NSAID) use - Patients who are currently using anticoagulants including, but not limited to, warfarin, heparin, enoxaparin, dabigatran, apixaban, rivaroxaban - Patients who have received treatment with corticosteroid enemas/suppositories and/or topical (rectal) 5-ASA preparations within 2 weeks prior to randomization - Apheresis (i.e., Adacolumn apheresis) within 2 weeks prior to randomization - Received any investigational treatment including investigational vaccines within 5 half lives of the investigational product or 28 days after the last dose, whichever is greater, prior to randomization - History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies, fusion proteins, or murine proteins or hypersensitivity to etrolizumab (active drug substance) or any of the excipients (L histidine, L-arginine, succinic acid, polysorbate 20) - Patients administered tube feeding, defined formula diets, or parenteral alimentation/nutrition who have not discontinued these treatments within 3 weeks prior to randomization Exclusion Criteria Related to General Safety: - Pregnant or lactating - Lack of peripheral venous access - Hospitalization (other than for elective reasons) during the screening period - Significant uncontrolled comorbidity, such as cardiac (e.g., moderate to severe heart failure New York Heart Association Class III/IV), pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders - Neurological conditions or diseases that may interfere with monitoring for PML - History of demyelinating disease - Clinically significant abnormalities on screening neurologic examination (PML Objective Checklist) - Clinically significant abnormalities on the screening PML Subjective Checklist - History of alcohol, drug, or chemical abuse less than 6 months prior to screening - Conditions other than UC that could require treatment with >10 mg/day of prednisone (or equivalent) during the course of the study - History of cancer, including hematologic malignancy, solid tumors, and carcinoma in situ, within 5 years before screening Exclusion Criteria Related to Infection Risk - Congenital or acquired immune deficiency - Patients must undergo screening for HIV and test positive for preliminary and confirmatory tests - Positive hepatitis C virus (HCV) antibody test result - Positive hepatitis B virus (HBV) antibody test result - Evidence of or treatment for Clostridium difficile (as assessed by C. difficile toxin testing) within 60 days prior to randomization or other intestinal pathogens (as assessed by stool culture and ova and parasite evaluation) within 30 days prior to randomization - Evidence of or treatment for clinically significant cytomegalovirus (CMV) colitis (based on the investigators judgment) within 60 days prior to randomization - History of active or latent TB - History of recurrent opportunistic infections and/or history of severe disseminated viral infections - Any serious opportunistic infection within the last 6 months prior to screening - Any current or recent signs or symptoms (within 4 weeks before screening and during screening) of infection - Any major episode of infection requiring treatment with IV antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening - Received a live attenuated vaccine within 4 weeks prior to randomization - History of organ transplant Exclusion Criteria Related to Laboratory Abnormalities (at Screening) - Serum creatinine >2 x upper limit of normal (ULN) - ALT or AST >3 x ULN or alkaline phosphatase >3 x ULN or total bilirubin >2.5 x ULN - Platelet count <100,000/uL - Hemoglobin <8 g/dL - Absolute neutrophil count <1500/uL - Absolute lymphocyte count <500/uL ; PRIMARY OUTCOME: Percentage of Participants in Remission at Week 10 With Etrolizumab as Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28948 Population; SECONDARY OUTCOME 1: Percentage of Participants in Remission at Week 10 With Etrolizumab as Compared With Adalimumab, as Determined by the MCS, GA28948 Population[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VIVID (Japan); BRIEF: This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year. ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Adults ≥ 18 years with type 1 or 2 diabetes mellitus - Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye - BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye Exclusion Criteria: - Active proliferative diabetic retinopathy (PDR) in the study eye - Uncontrolled diabetes mellitus, as defined by HbA1c >12% - Only 1 functional eye even if that eye is otherwise eligible for the study ; PRIMARY OUTCOME: Adverse Event collection; SECONDARY OUTCOME 1: Change from baseline in BCVA (best corrected visual acuity) letter 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 - MP-101-01; BRIEF: A ten-week study to assess MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression ; DRUG USED: MP-101 (Mediti); DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Metabotropic Glutamate Receptor subtype 2 (mGluR2); THERAPY: Monotherapy; LEAD SPONSOR: Mediti Pharma Inc.; CRITERIA: Inclusion Criteria: - Females must be of non-childbearing potential, defined as women greater than or equal to (≥) 60 years of age, postmenopausal women ≥50 and less than (<) 60 years of age who have had a cessation of menses for at least 12 months, or women who are congenitally or surgically sterile - Males must agree to use 2 forms of highly effective birth control with female partners of childbearing potential while enrolled in the study, and for at least 28 days following the last dose - Ambulatory (with or without walking device) with a stable gait - Have a Mini-Mental State Examination (MMSE) score of 10 to 24 - Meet clinical criteria for one of the following disorders: dementia associated with Parkinsons disease, dementia with Lewy bodies, possible or probable Alzheimers disease, frontotemporal degeneration spectrum disorders, vascular dementia - Able to communicate verbally - Have an NPI score of ≥4 on either individual item (delusions or hallucinations) or ≥6 on the Psychosis Subscale (combined delusions and hallucinations), or an NPI score of ≥4 on agitation/aggression domain - Have a reliable caregiver who provides written informed consent to participate and who is in frequent contact with the patient (defined as spending at least 4 hours/day at least 4 days/week with the patient and who is knowledgeable about the patients daytime and nighttime behaviors). The caregiver must be able to communicate with site personnel, and opinion of the investigator, must understand the written protocol-specified questionnaires. If a caregiver cannot continue, one replacement caregiver will be allowed if the above criterion is met - Must be on a stable dose of cholinesterase inhibitor and/or memantine, if applicable - If taking antipsychotic drugs or any drug intended to treat psychosis, must be on a stable treatment regimen for ≥1 month prior to the study - Have venous access sufficient to allow for blood sampling per the protocol - Have clinical laboratory test results within normal reference range for the population or investigative site - Are capable of participating in all study assessments - Are able and willing to provide consent (patients and caregivers) Exclusion Criteria: - Have a history of significant psychotic disorders (including, schizophrenia, delusional disorder, substance abuse psychosis that lasted over 6 months, major depressive disorder or bipolar disorder with psychotic episodes) - Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke - Have renal impairment as defined by Estimated Glomerular Filtration Rate (eGFR) <45 milliliters per minute per 1.73 square meters (ml/min/1.73m2) - Have significant cardiovascular, respiratory, gastrointestinal, renal, hematologic, or oncologic comorbidities that could impact patient safety and study participation over 10 weeks - Have a history of seizures or other condition that would place the patient at increased risk of seizures. - Are, in the investigators judgment, at risk for suicide, or as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) - Have a Fridericias corrected QT interval (QTcF) greater than (>) 450 milliseconds (ms) for males or 470 ms for females - Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study - Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, at least 3 months (or more) must have passed - In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study ; PRIMARY OUTCOME: Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score; SECONDARY OUTCOME 1: Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10[/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 IIb - SUSTAIN; BRIEF: This study is designed to provide an assessment of the change in baseline lipid parameters with RVX000222 after 12 weeks and 24 weeks of treatment when given in addition to optimized statin background therapy in subjects with low baseline HDL-C. ; DRUG USED: Apabetalone; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiovascular Disease; TARGET: Apolipoprotein A-I, BET Proteins/Bromodomains, BRD4 (Bromodomain Containing 4); THERAPY: Monotherapy; LEAD SPONSOR: Resverlogix Corp; CRITERIA: Inclusion Criteria: 1. Male and female patients ≥ 18 years of age with or without documented coronary artery disease 2. Women of child-bearing potential, that is, women not surgically sterilized and between menarche and 1 year post menopause, must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel); or a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for one month following the last dose of study drug. 3. HDL-C requirements. Current (Local lab within 60 days or central lab results prior to Visit 1): HDL-C of ≤45 mg/dL (1.17 mmol/L) for females, and HDL-C of ≤40 mg/dL (1.04 mmol/L) for males 4. Taking statin therapy for at least 30 days prior to screening (Visit 1), and in the investigators opinion, an unlikely need for statin dose adjustment during the course of the study. 5. In the opinion of the investigator patients currently on statin therapy other than atorvastatin (10mg, 20mg or 40mg) or rosuvastatin (5mg, 10mg or 20 mg) can be switched to rosuvastatin (5mg, 10mg or 20mg) at Visit 1. Exclusion Criteria: 1. Clinically significant heart disease which will require coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study. 2. Coronary artery bypass graft (CABG) procedure within the past 90 days. 3. Previous or current diagnosis of severe heart failure (NYHA Class III-IV) or a documented left ventricular ejection fraction (LVEF) of <25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography the absence of an LVEF measurement in a patient without a previous or current diagnosis of heart failure does not prohibit entry into the study. 4. Patients with evidence of cardiac electrophysiologic instability including a history of uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response heart rate of >100 beats per minute at rest within 4 weeks prior to Visit 1. 5. Evidence of renal impairment as determined by any one of the following: 1. serum creatinine >1.5 mg/dL (>133 micromol/L) at screening Visit 1 2. a history of dialysis 3. a history of nephritic syndrome 6. Have hypertension that is uncontrolled defined as 2 consecutive measurements of sitting blood pressure of systolic >160 mm Hg or diastolic >95 mm Hg at Visit 1. 7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta-hCG laboratory test (≥5 mIU/mL). 8. Current or recent (within 12 month prior to Visit 1) treatment with immunosuppressants (eg, Cyclosporine). 9. Triglycerides >400 mg/dL at screening Visit 1. 10. Atorvastatin >40 mg daily 11. Rosuvastatin >20 mg daily 12. Use of fibrates any dose or niacin/nicotinic acid 250 mg or more within 90 days prior to Visit 1. 13. Any medical or surgical condition which might significantly alter the absorption, distribution, metabolism or excretion of medication including, but not limited to any of the following: cholecystitis, Crohns disease, ulcerative colitis, or any gastric bypass alteration. 14. Evidence of hepatic disease as determined by any one of the following: - ALT, AST or GGT values >ULN by central lab at screening, Visit 1 - a history of hepatic encephalopathy, - history of Hepatitis B, C or E, - a history of esophageal varices, or - a history of portocaval shunt. 15. A total bilirubin that is >ULN by central lab at screening, Visit 1. 16. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 17. History or evidence of drug or alcohol abuse within the last 12 months. 18. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. 19. Use of other investigational drugs and devices at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. 20. History of noncompliance to medical regimens or unwillingness to comply with the study protocol. 21. Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data. 22. Persons directly involved in the execution of this protocol ; PRIMARY OUTCOME: The percent change in HDL-C from baseline to 24 weeks for RVX000222 200 mg daily compared to placebo; SECONDARY OUTCOME 1: Within treatment group percent change in HDL-C from baseline to 24 weeks for RVX000222 and placebo groups.[/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 - REsCue; BRIEF: This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2 via nasopharynx swab and subsequent reverse transcription polymerase chain reaction (RT-PCR). ; DRUG USED: Rayaldee; DRUG CLASS: Non-NME; INDICATION: COVID-19 Treatment; TARGET: Vitamin D; THERAPY: Monotherapy; LEAD SPONSOR: OPKO Health, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female ≥18 years of age 2. Confirmed within the past 3 days to have SARS-CoV-2 infection as evidenced by a positive nasopharyngeal swab test using RT-PCR 3. Confirmed to have only mild or moderate COVID-19 based on a FLU-PRO© score of ≥ 1.5 for each of the chest/respiratory and body/systemic domains, and the absence of clinical signs indicative of more severe disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm) 4. Represents on self-assessment that the current COVID-19 symptoms are not consistent with usual health and that they are the same or worse than on the previous day 5. Willing to limit the use of vitamin D therapies or supplements except for normally fortified food products (eg, milk) during the course of the 6-week study 6. Must demonstrate the ability to comply with all study requirements 7. Must be without any disease state or physical condition that might impair evaluation of safety or which, in the investigators opinion, would interfere with study participation. Exclusion Criteria: 1. Clinical signs indicative of severe or critical COVID-19 disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm) 2. Pregnant or lactating women who are breastfeeding 3. Use of systemic glucocorticoid medications in the last six months 4. Recent history (previous 12 months) of primary hyperparathyroidism, kidney stones, hypercalciuria and/or hypercalcemia 5. History of a chronic granuloma-forming disease (eg, sarcoidosis) 6. History of tuberculosis or histoplasmosis 7. History of chronic liver disease 8. History (previous 12 months) of cardiac event indicative of chronic cardiovascular diseases including congestive heart failure, poorly controlled hypertension and arrhythmias 9. History in the past five years of multiple myeloma or carcinoma of the breast, lung or prostate 10. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of vitamin D or 25-hydroxyvitamin D (eg, small bowel resection, history of Crohns disease or ulcerative colitis) 11. Ongoing treatment with thiazide diuretics 12. History of hyperphosphatemia, hyperuricemia and gout 13. Renal impairment measured as eGFR< 15 mL/min/1.73m² on serum creatinine in the last three months 14. Serum calcium ≥9.8 mg/dL in the last three months 15. Evidence of existing or impending dehydration 16. Known or suspected to have hypersensitivity to any of the constituents of the study drug 17. Currently participating in, or have participated in, an interventional/investigational study within 30 days prior to study screening. ; PRIMARY OUTCOME: Severity and duration of disease as evidenced by COVID-19 symptoms using the FLU-PRO© questionnaire.; 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 II - Moderate to Severe (205050); BRIEF: Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils; thereby reducing the production and survival of eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study will investigate the efficacy and safety of mepolizumab (100 milligram [mg] subcutaneous [SC] administered every 4 weeks) compared with placebo in adult subjects with moderate to severe atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or mepolizumab SC. The study will comprise of a pre-screening period of up to approximately 4 weeks, a screening period of up to 2 weeks, followed by a 16-Week study treatment period (16 weeks with the last dose of study treatment at Week 12) and follow-up period of up to 4-week. The total duration of subject participation will be approximately 26 weeks. (Note: For subjects, who may need to stop treatment with a biologic, the total Pre-Screening and Screening period may last up to 20 weeks and total duration of participation in the study may be up to 40 weeks). ; DRUG USED: Nucala Lyophilized Powder Formulation; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria - Age between 18 and 70 years of age inclusive, at the time of signing the informed consent. - AD diagnosed by the Eichenfield revised criteria of Hanifin and Rajka. - Diagnosis of AD >=2 years prior to the Screening visit. - An IGA score >=3 at the Screening and Baseline visits. - AD involvement of >=10% body surface area at the Screening and Baseline visits. - EASI score >=16 at the Screening and Baseline visits. - Absolute blood eosinophil count >=350 cells/microliter at the Screening visit. - Applied the same non-prescription, non-medicated (without an active ingredient) emollient twice daily for at least 7 days immediately before the Baseline visit. - Recent history (<=6 months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication or for whom prescription topical medications are not tolerated or where there is a concern for potential side effects, such as skin thinning or increased risk of hypothalamic-pituitary-adrenal [HPA] suppression; as well as, inadequate response to optimization of non-pharmacological measures such as moisturizers. Inadequate response to a stable regimen of prescription topical medication (such as medium to high potency topical corticosteroids or topical calcineurin inhibitors) is defined as failure to achieve and maintain remission or low disease activity state (equivalent to an IGA score =0 [clear] to 2 [mild]) despite treatment for the recommended duration as per label or for the maximum duration recommended for the subject treatment, whichever is shorter. - Male or female: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions: Non-reproductive potential- Pre-menopausal females with documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral oophorectomy; and postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until 16 weeks after the last dose of study medication. - The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Subject is able to give signed informed consent that includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Exclusion Criteria - Other types of eczema. - Any other concomitant skin disorder (e.g., generalized erythroderma such as Nethertons Syndrome, or psoriasis), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise subject safety. - Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich Syndrome) or has a history of malignant disease within 5 years before the Baseline visit. Note: Subjects with successfully treated basal cell carcinoma (no more than 3 lesions), squamous cell carcinoma of the skin, or cervical carcinoma in situ, with no evidence of recurrence within the 3 years prior to the Baseline visit may participate in the study. - A positive history for human immunodeficiency virus (HIV) antibody. - Chronic or acute infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, anti-protozoals, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits. - Superficial skin infections within 1 week before the Screening visit. - Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit. - Other known or suspected conditions that could lead to elevated eosinophils, for example, hypereosinophilic syndromes including eosinophilic granulomatosis with polyangiitis (EGPA, also known as Churg-Strauss Syndrome), eosinophilic esophagitis, or severe asthma. - A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigators opinion, may interfere with the subjects completion of the study. - ALT >2x upper limit of normal (ULN) - Bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - QT Interval Corrected by Fridericia Correction Formula (QTcF) >450 milliseconds (msec) or QTcF >480 msec in subjects with Bundle Branch Block. - Clinically significant abnormality in the hematological or biochemical screen, as judged by the investigator. - Previously treated with mepolizumab or participated in a previous mepolizumab clinical study. - Prior treatment with any of the medications or treatments listed in Table 1 within the indicated periods before the Screening visit. - Prolonged exposure to natural (e.g, sunlight) ultraviolet (UV) radiation within 4 weeks prior to the Baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subjects AD. - More than 2 visits per week to a tanning booth or parlor in the 4 weeks prior to the Baseline visit. - Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks before randomization, or unwilling to maintain current level of physical activity throughout the length of participation in this study. - History of alcohol or other substance abuse within the last 2 years. - Hypersensitivity to mepolizumab or any of its excipients. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - Exposure to more than 4 investigational medicinal products within 12 months prior to the Baseline visit. - Subject is a member of the investigational team or his/her immediate family. ; PRIMARY OUTCOME: Number of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and at Least a 2- Grade Improvement at Week 16; SECONDARY OUTCOME 1: Mean Percentage Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Study Visit[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EQUIRA; BRIEF: Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX). ; DRUG USED: Erelzi; DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Sandoz; CRITERIA: Inclusion Criteria: - Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria >/= 6 months at the time of baseline visit - Patient must have active disease defined as DAS28-CRP>/=3.2 - Patients must have CRP level above ULN >5mg/l) or erythrocyte sedimentation rate (ESR) >/=28mm/h - Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards Exclusion Criteria: - Previous exposure to etanercept in the past - Patients with functional status class IV according to the ACR 1991 revised criteria - History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening ; PRIMARY OUTCOME: Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel; SECONDARY OUTCOME 1: Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel[/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 - RAPIDe-1; BRIEF: This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo. ; DRUG USED: PHVS416; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hereditary Angioedema (HAE); TARGET: Bradykinin B2 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pharvaris Netherlands B.V.; CRITERIA: Key Inclusion Criteria: 1. Signed and dated informed consent form 2. Diagnosis of HAE type I or II 3. Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening 4. Reliable access and experience to use standard of care acute attack medications Key Exclusion Criteria: 1. Pregnancy or breast-feeding 2. Clinically significant abnormal electrocardiogram 3. Any other systemic disease or significant disease or disorder that would interfere with the patients safety or ability to participate in the study 4. Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment 5. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus 6. Abnormal hepatic function 7. Abnormal renal function 8. History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse 9. History of documented severe hypersensitivity to any medicinal product 10. Participation in any other investigational drug study within defined period ; PRIMARY OUTCOME: Change of the 3-symptom composite visual analogue scale (VAS-3) score from pre-treatment to 4 hours post-treatment; SECONDARY OUTCOME 1: Time to onset of symptom relief by visual analogue scale (VAS-3) 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 - 1204 Study; BRIEF: This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. ; DRUG USED: BTX-1204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Botanix Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Subject is of either gender between 12 and 70 years of age, inclusive. 2. Subject (or parent/legal guardian) has the ability and willingness to sign a written informed consent. 3. Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD) 4. Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the scalp and groin. 5. Subject has an Investigators Global Assessment (IGA) score of moderate (3) atopic dermatitis on the 5-point IGA (0-4) scale. 6. For selected photography sites, subject has a target lesion of 25 to 200 cm2 in surface area on the trunk, upper extremities or lower extremities with a Baseline Signs of AD score of ≥ 6 and ≤ 12. 7. Subject is in good general health without clinically significant hematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator. 8. Subject has suitable venous access for blood sampling. 9. Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits. 10. Male subjects and their partners must agree and commit to use a barrier method of contraception throughout the study and for 90 days after last study drug application. 11. A negative urine pregnancy test result for all Women of child bearing potential (WOCBP) at the Screening Visit and Baseline Visit. 12. Sexually active women must agree to use the following throughout the study and for 30 days after last study drug application. WOCBP who are not sexually active at Baseline and become sexually active must identify a plan for contraception. 1. One of these highly effective contraception methods Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation; partner vasectomy, OR 2. Oral contraceptives WITH a barrier method (listed below), OR 3. Two barrier forms of contraception (listed below) Male or female condom; diaphragm; cervical cap; contraceptive sponge. 13. Males subjects must refrain from sperm donation during the study treatment period and until 90 days after last study drug application. Exclusion Criteria: 1. Female subject who is breast feeding, pregnant, or planning to become pregnant. 2. Subject who has an IGA score of 2 (mild) or 4 (severe). 3. Subject with history of known or suspected intolerance to the drug product excipients. 4. Subject has any clinically significant active infection in the investigators opinion. This includes active impetigo at any AD lesion. 5. Subject has known Hepatitis-B, Hepatitis-C, or HIV infection. 6. Subject has excessive body or facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of AD. 7. Subject has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to evaluate the AD lesions. 8. Subject has clinically significant or severe allergies that in the investigators opinion would interfere with participation in the study. 9. Subject has known intolerability to topical treatments e.g., reports excessive burning/stinging or pain with use of topical treatments. 10. Subject has an active or potentially recurring skin conditions(s) other than AD that in the investigators opinion would interfere with participation in the study. 11. Subject has unstable AD consistent with a requirement for high-potency corticosteroids. 12. Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit. 13. Subject has used any biologic therapy, other than dupilumab, within 28 days prior to the Baseline Visit. 14. Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the Baseline Visit. Intra-articular injection for arthroses allowed. 15. Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior to the Baseline Visit. 16. If subject is taking oral antihistamines, subject has not been on a stable dose of oral antihistamines within 28 days prior to the Baseline visit. 17. Subject has used phototherapy, tanning beds, or any other artificial light device within 28 days prior to the Baseline Visit. 18. Subject has used topical corticosteroids within 14 days prior to the Baseline Visit. 19. Subject has used topical calcineurin inhibitors within 14 days prior to the Baseline Visit. 20. Subjects has used barrier creams (e.g., Mimyx, Atopiclair), within 7 days prior to the Baseline Visit. 21. Subject has an underlying disease that requires the use of interfering topical or systemic therapy. 22. Subject has other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, acne or rosacea. 23. Subject has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk or interfere with the subjects participation in the study. Subjects with other dermatologic conditions, including genetic syndromes that have an eczematous dermatitis as a component of the disease (e.g., Nethertons) are excluded. 24. Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drugs. 25. Subject is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. 26. Subject has participated in another investigational drug or device research study within 30 days of the Screening Visit or five half-lives of the drug, whichever is longer. 27. Any other reason that would make the subject, in the opinion of the Investigator or sponsor, unsuitable for the study. ; PRIMARY OUTCOME: Investigators Global Assessment (IGA); 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 II - NB-402 - Depression; BRIEF: The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects. ; DRUG USED: Contrave; DRUG CLASS: Non-NME; INDICATION: Obesity; TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Orexigen Therapeutics, Inc; CRITERIA: Inclusion Criteria: - Female and male subjects must be 18 to 65 years of age; - Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2; - Meet criteria for major depression - Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug; - Able to comply with all required study procedures and schedule; - Able to speak and read English; - Willing and able to give written informed consent Exclusion Criteria: - Obesity of known endocrine origin - Serious medical condition - History of drug or alcohol abuse or dependence - Use of excluded concomitant medications - History of surgical or device (e.g. gastric banding) intervention for obesity; - History or predisposition to seizures - Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug; - Planned surgical procedure that can impact the conduct of the study; - Use of investigational drug, device or procedure within 30 days prior to Screening; - Participation in any previous clinical trial conducted by Orexigen Therapeutics; - Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study. ; PRIMARY OUTCOME: To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks; SECONDARY OUTCOME 1: To assess the percentage change from baseline in total body weight at 12 and 24 weeks.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - PIER (every 3 mo); BRIEF: This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Signed informed consent - Age >=50 years - Active primary or recurrent subfoveal CNV lesions secondary to AMD in the study eye - Total area of CNV (including both classic and occult components) encompassed within the lesion >= 50% of the total lesion area - Total lesion area <=12 disc areas in size - Best corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: - Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye - Treatment with verteporfin in the nonstudy eye <7 days preceding Day 0 - Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.) - Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye - Previous subfoveal focal laser photocoagulation in the study eye - Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 - History of vitrectomy surgery in the study eye - History of submacular surgery or other surgical intervention for AMD in the study eye - Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) - Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >= 50% of the total lesion area or >=1 disc area in size - Fibrosis or atrophy involving the center of the fovea in the study eye - CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia - Retinal pigment epithelial tear involving the macula in the study eye - Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 24-month study period - Active intraocular inflammation (grade trace or above) in the study eye - Current vitreous hemorrhage in the study eye - History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye - History of idiopathic or autoimmune-associated uveitis in either eye - Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye - Aphakia or absence of the posterior capsule in the study eye - Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia - Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0 - Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with antiglaucoma medication) - History of glaucoma filtering surgery in the study eye - History of corneal transplant in the study eye - Premenopausal women not using adequate contraception - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications - Current treatment for active systemic infection - History of allergy to fluorescein, not amenable to treatment - Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center - Inability to comply with study or follow up procedures ; PRIMARY OUTCOME: ; 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 I/II - vs. Fluzone HD; BRIEF: This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age ; DRUG USED: NanoFlu; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria: 1. Healthy older adults, male or female, 2. Willing and able to give informed consent prior to trial enrollment, and 3. Able to attend trial visits, comply with trial requirements, and provide reliable and complete reports of adverse events. Exclusion Criteria: 1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. - Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this trial) in the opinion of the investigator. - Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. - Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. - Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see exclusion criteria 2, 5, 8, 9). 2. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection. 3. History of a serious reaction to prior influenza vaccination, or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80. 4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine. 5. Receipt of any vaccine in the 4 weeks preceding the trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination. 6. Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 7. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. 8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine or during the trial. 9. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°C, on the planned day of vaccine administration). 10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 11. Known disturbance of coagulation. 12. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse. ; PRIMARY OUTCOME: Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).; SECONDARY OUTCOME 1: Geometric Mean Titers (GMT) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay[/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 Ib/II - KRYSTAL (KRAS G12C Mutation); BRIEF: This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. ; DRUG USED: Adagrasib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: KRas; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Mirati Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation - Unresectable or metastatic disease - Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts - Adequate organ function Exclusion Criteria: - History of intestinal disease or major gastric surgery or inability to swallow oral medications - Other active cancer ; PRIMARY OUTCOME: Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation; SECONDARY OUTCOME 1: Establish maximum tolerated dose[/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 IIa - w/Cimzia; BRIEF: The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group. ; DRUG USED: Bimekizumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: UCB Celltech; CRITERIA: Inclusion Criteria To be eligible to participate in this study, all of the following criteria must be met: - Subject is informed and given approved written Informed Consent Form (ICF). - Subject is considered reliable and capable of adhering to the protocol. - Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months duration as defined by ACR/EULAR 2010 classification criteria. - Subject must have: - ≥6 tender joints (out of 68) - ≥6 swollen joints (out of 66) - CRP≥10.0mg/L . - Subject must have had inadequate response to at least 1 synthetic DMARD. - Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening). - Female subjects must either be: - postmenopausal - permanently sterilized or, - if of childbearing potential, must be willing to use at least 2 effective methods of contraception, - Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug. Exclusion Criteria Subjects are not permitted to enroll in the study if any of the following criteria is met: - Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP). - Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens. - Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded. - Subject is at high risk of infection. - Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0. - Subject has renal or liver impairment. - Subject has a current or past history of gastrointestinal ulceration. - Subject has active neoplastic disease or history of neoplastic disease. - Subject has a concomitant diagnosis of any other inflammatory condition. - Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia. ; PRIMARY OUTCOME: Incidence of Adverse Events; SECONDARY OUTCOME 1: Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2[/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 - Roll-Over - C213 (Europe, Canada); BRIEF: The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time. ; DRUG USED: Olysio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Janssen R&D Ireland; CRITERIA: Inclusion Criteria: - Patients who participated in the placebo arm of a TMC435 study who did not achieve undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after end of treatment OR Patients who received short-term direct-acting antiviral therapy in a Tibotec-sponsored study. - Liver disease stage documented by liver biopsy is required within 3 years prior to screening unless contraindicated. Exclusion Criteria: - Infection with human immunodeficiency virus. - Liver disease not related to hepatitic C infection. - Significant laboratory abnormalities or other active diseases. - Pregnant or planning to become pregnant. - Prematurely stopped medication in previous TMC435 study for non-compliance or for safety reasons. ; PRIMARY OUTCOME: The proportion of participants with sustained viral response; SECONDARY OUTCOME 1: The proportion of participants with sustained viral 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 - INNO2VATE-Conversion; BRIEF: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD) ; DRUG USED: Vadadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Akebia Therapeutics; CRITERIA: Inclusion Criteria: - ≥18 years of age - Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening - Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening - Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US - Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening Exclusion Criteria: - Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss - Uncontrolled hypertension - Red blood cell transfusion within 8 weeks prior to randomization - Anticipated to recover adequate kidney function to no longer require dialysis - Severe heart failure at Screening (New York Heart Association Class IV) - Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening - Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36); SECONDARY OUTCOME 1: Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)[/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 - CHI SQUARE; BRIEF: Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS). ; DRUG USED: CER-001; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Reverse Cholesterol Transport (RCT); THERAPY: Monotherapy; LEAD SPONSOR: Cerenis Therapeutics, SA; CRITERIA: Inclusion Criteria: - Male or female less than 75 years of age - Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina) - Angiographic evidence of coronary artery disease with suitable target coronary artery for IVUS evaluation Exclusion Criteria: - Females of child-bearing potential - Weight >120 kg - Angiographic evidence of >50% stenosis of the left main artery - Uncontrolled diabetes (HbA1C>10%) - Hypertriglyceridemia (>500 mg/dL) - Congestive heart failure (NYHA class III or IV) - Ejection fraction <35% - Uncontrolled hypertension (SBP >180 mm Hg) - Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction ; PRIMARY OUTCOME: Change in Total Plaque Volume; SECONDARY OUTCOME 1: Percent Change in Plaque Volume[/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 - HopES (JAF); BRIEF: The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts: - Clinically advanced Ewings Sarcoma patients who have not progressed at the conclusion of systemic treatment - Clinically advanced sarcoma patients in the salvage treatment setting Up to 24 efficacy evaluable patients (up to 12 per cohort) will be enrolled. Study patients will receive oral SM-88, with scheduled safety and efficacy evaluations. ; DRUG USED: SM-88; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sarcoma; TARGET: Cytochrome p450, Mammalian Target of Rapamycin (mTOR)/mTORC, OX40/CD134 and OX40L, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Sarcoma Oncology Research Center, LLC; CRITERIA: Key Inclusion Criteria: 1. Ability to understand and willingness to provide written informed consent to participate in this study 2. ≥12 years of age 3. Diagnosis: 1. Maintenance treatment cohort: Histologic or cytologic diagnosis of Ewings sarcoma, including non-resected, locally advanced or metastatic disease 2. Salvage treatment cohort: Non-resected, locally advanced or metastatic sarcoma (including Ewings sarcoma) for which there is no standard of care treatment and no curative other option 4. Radiographic disease assessment within 35 days prior to enrollment and planned treatment start with study drug 5. Prior treatment: 1. Maintenance treatment cohort : 1-3 prior lines of systemic treatment (including current treatment) 2. Salvage cohort: Any number of prior treatments 6. Maintenance treatment cohort only: Patient completed current line of treatment (systemic, surgery, radiation) prior to enrollment, without disease progression as compared to baseline AND has achieved at least one of the following 1. CR in response to current second or third line treatment 2. PR in response to current line of treatment (after at least 4 cycles, if treatment included systemic therapy) 3. SD in response to current line of treatment (after at least 4 cycles, if treatment included systemic therapy) 7. Measurable disease, except for patients in Cohort A who have achieved CR at the conclusion of current 2nd or 3rd line of treatment 8. ECOG performance status 0-2 9. Adequate organ function defined as all laboratory parameters ≤ Grade 2 NCI CTCAE criteria 10. Patients must be able to swallow and retain whole capsules Key Exclusion Criteria: 1. Systemic anticancer agents within 14 days prior to treatment on study 2. Major surgery within 30 days 3. Prior treatment with SM-88 4. Any screening laboratory, electrocardiogram (ECG), other clinical finding, comorbidity or clinical history that, in the opinion of the investigator, indicates an unacceptable risk for patient to participate in the study or would limit patients ability to comply with study requirements 5. History of any drug allergies or significant adverse reactions to any of the components of SM-88 6. History of light sensitive diseases for which methoxsalen would be contraindicated 7. Current or anticipated treatment with a contraindicated medication 8. Evidence of viral infections including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C ; PRIMARY OUTCOME: Overall Response Rate; SECONDARY OUTCOME 1: Duration of Response[/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 - Orthopedic Surgery; BRIEF: The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery. ; DRUG USED: Zalviso; DRUG CLASS: Non-NME; INDICATION: Moderate to Severe Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: AcelRx Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female patients who are 18 years of age or older - Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid - Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery Exclusion Criteria: - Patients who have undergone a replacement of the same knee or hip - Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet) - Patients with an allergy or hypersensitivity to opioids ; PRIMARY OUTCOME: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).; 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 II - w/Temozolomide (G-100); BRIEF: This phase II trial studies the side effects and how well HSPPC-96 (vitespen) and temozolomide work in treating patients with newly diagnosed glioblastoma multiforme. Vaccines made from a persons tumor cells and heat shock protein peptide may help the body to build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving HSPPC-96 (vitespen) together with temozolomide may kill more tumor cells. ; DRUG USED: Prophage; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Immune System; THERAPY: Combination; LEAD SPONSOR: University of California, San Francisco; CRITERIA: Inclusion Criteria: Pre-surgery tissue acquisition Inclusion criteria 1. Age > or equal to 18 years old 2. Life expectancy of greater than 12 weeks. 3. Able to read and understand the informed consent document; must sign the informed consent 4. Must have suspected diagnosis of Glioblastoma Multiforme with a surgical intent to resect at least 90% of enhancing disease 5. Must be eligible for post-surgical treatment with radiotherapy and temozolomide Post-radiation therapy/pre-vaccine eligibility Inclusion criteria 1. Agree to use contraception or abstain from sexual activity from the time of consent through 1 month after the end of study drug administration 2. Negative serum pregnancy test for female patients of childbearing potential 3. Patients with histologically proven, non-progressive glioblastoma multiforme (GBM) 4. Patient must have received standard of care radiation and temozolomide therapy 5. Must have undergone a at least a 90% resection (determined by the principal investigator (PI)) measured by postoperative magnetic resonance imaging (MRI) scan, T1-weighted contrast scan, or CT scan if clinically indicated, performed within 72 hours after surgery 6. All radiotherapy must be discontinued at least 2 weeks and no more than 5 weeks prior to the first planned vaccine administration 7. Availability of at least 4 doses of vaccine (at least 4 vials for clinical administration produced from the tumor provided) 8. Karnofsky functional status rating > or equal to 70 9. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; absolute lymphocyte count (ALC) > 500/mm3 ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase (AST), alanine amino transferase (ALT), and alkaline phosphatase <2.5 times institutional upper limit of normals [IULNs] and bilirubin (total) <1.5 mg*IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs Exclusion Criteria: Pre-surgery tissue acquisition 1. Current diagnosis of Human Immunodeficiency Virus (HIV testing is not required per protocol) 2. Any prior diagnosis of any other cancer or other concurrent malignancy, with the exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all therapy for that disease for a minimum of 5 years 3. Any systemic autoimmune disease (e.g., Hashimotos thyroiditis) and/or any history of primary or secondary immunodeficiency 4. Any prior therapy for glioma 5. Planned use or current use of other investigational therapy for the treatment of glioma Post-radiation therapy/pre-vaccine Exclusion 1. Inability to comply with study-related procedures 2. Prior diagnosis of any other cancer or other concurrent malignancy, with the exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all therapy for that disease for a minimum of 5 years 3. Current or active use of chemotherapy (except temozolomide) or immune therapy 4. Contrast MRI findings (or CT scan if MRI is clinically contraindicated) consistent with progression per protocol defined modified Response assessment in neuro-oncology criteria (RANO) criteria. Progression prior to vaccination as determined by the Principal Investigator 5. Patients with active uncontrolled infection 6. Evidence of bleeding diathesis 7. Unstable or severe intercurrent medical conditions 8. Female patients who are pregnant or breastfeeding ; PRIMARY OUTCOME: Number of Participants With Treatment-Related Adverse Events of Any Grade; SECONDARY OUTCOME 1: Median Progression Free Survival (PFS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Nivolumab; BRIEF: The study will evaluate the clinical activity of sitravatinib in combination with nivolumab in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant setting prior to nephrectomy. ; DRUG USED: Sitravatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: EPH receptor B4 (EPHB4), Hepatocyte growth factor receptor (c-Met, HGFR), RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Mirati Therapeutics Inc.; CRITERIA: Inclusion Criteria: 1. Imaging results consistent with locally-advanced RCC 2. Candidate for partial or complete nephrectomy as part of treatment plan. 3. Measurable disease per RECIST version 1.1. 4. ECOG performance status 0 or 1. 5. Adequate bone marrow and organ function. Exclusion Criteria: 1. Prior systemic anti-tumor treatment for RCC. 2. Patients who are receiving any other investigational agents. 3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted regardless of whether neoadjuvant therapy is to be administered, as assessed by the treating surgeon. 4. Inability to undergo baseline tumor biopsy. 5. Active or prior documented autoimmune or immunocompromising conditions. 6. Uncontrolled hypertension. ; PRIMARY OUTCOME: Percentage of Participants Who Achieved a Point in Time Objective Response (Either Complete or Partial Response [CR or PR]) Prior to Surgery; SECONDARY OUTCOME 1: Number of Participants Who Experienced 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 II - CD-005; BRIEF: This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery. patients will be randomized to active or placebo gel in a double-blind manner. The gel will be applied a single time in the incision during closure at the end of surgery. A cohort of patients will also be randomized to standard of care, saline irrigation at prior to skin closure, in an open manner. The efficacy, safety and tolerability of the active gel will be assessed compared to the control group (combined placebo gel and standard of care groups). Patients will be randomized to DFA-02 active gel: placebo gel: standard of care in a 4:1:1 ratio. ; DRUG USED: DFA-02; DRUG CLASS: Non-NME; INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Bacterial ribosome, Cell wall synthesis, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion Criteria: 1. Males and females 18 years of age or older; 2. If female, the subject must be postmenopausal, surgically sterilized or, if of child-bearing potential, she must have a negative serum or urine pregnancy test within 48 hours of surgery and agree to use adequate birth control during the study and for 30 days after the administration of study agent; 3. Body mass index (BMI) ≥ 20; 4. Scheduled to undergo non-emergent abdominal surgery involving a planned incision of 7 cm or greater; 5. Willing and able to give informed consent; 6. Available for evaluation from Baseline until final evaluation at 30 days post-surgery. Exclusion Criteria: 1. Known hypersensitivity to gentamicin, vancomycin, other aminoglycoside antibiotics or the excipients of the study products; 2. Emergency surgery; 3. Significant concomitant surgical procedure; 4. Prior laparotomy within the last 60 days of the planned procedure; 5. Planned second laparotomy or abdominal surgical procedure within 30 days of the planned first procedure; 6. Expectation that a surgical drain will be placed in the incision; 7. Preoperative sepsis, severe sepsis, or septic shock; 8. Abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason; 9. Active systemic infection or systemic (oral or intravenous) antibiotic therapy within the 1 week prior to the date of surgery other than specified preoperative antimicrobial prophylaxis; 10. Requirement for gentamicin or vancomycin preoperative antimicrobial prophylaxis; 11. Concurrent systemic use of other potentially neurotoxic, nephrotoxic, and/or ototoxic drugs; 12. Preoperative evaluation suggesting an intra-abdominal process that might preclude full closure of the skin; 13. Ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer; 14. History of significant drug or alcohol abuse; 15. Serum Creatinine > 1.8 mg/dL; 16. Serum Bilirubin > 2.5 times upper limit of normal; 17. Subjects who are immunocompromised including but not limited to systemic corticosteroid use or chemotherapy/radiation during the 30 days prior to surgery, organ transplantation, or HIV infection; 18. Known history of HIV; 19. Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability; 20. Refusal to accept medically indicated blood products; 21. Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated; 22. Unable to participate in the study for any reason in the opinion of the Principal Investigator; 23. Postsurgical life expectancy of less than 30 days; 24. Expected discharge from the hospital less than 3 days after surgery. ; PRIMARY OUTCOME: Number of Patients With Surgical Site Infections; SECONDARY OUTCOME 1: Number of Patients With 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 II - IFN-Free w/ABT-267/ABT-450/Ribavirin (On Methadone or Buprenorphine); BRIEF: The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone. ; DRUG USED: Exviera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile. - Chronic HCV infection prior to study enrollment. - Screening laboratory result indicating HCV genotype 1-infection. - Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced. - Subjects must be on a stable opioid replacement therapy of methadone or buprenorphine ± naloxone for at least 6 months prior to screening. Exclusion Criteria: - Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening. - Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir. - Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug. - Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of >3 or Ishak score of > 4. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment; SECONDARY OUTCOME 1: Percentage of Participants With Virologic Failure During Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 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 II - Moderate/Severe Knee OA; BRIEF: This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee. ; DRUG USED: XT-150; DRUG CLASS: Biologic; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: IL-10 (Interleukin-10) and IL-10 Receptor (IL-10R); THERAPY: Monotherapy; LEAD SPONSOR: Xalud Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Symptomatic disease due to osteoarthritis, defined as a WOMAC Pain score ≥ 8 (worst possible = 20) 2. Focused Analgesia Selection Test will be used to determine whether patients can report pain with sufficient consistency to enter the clinical trial 3. Males and females between 45 and 85 years of age, inclusive 4. Kellgren-Lawrence grading of 2 or 3 within the last 6 months 5. Stable analgesic regimen during the 4 weeks prior to enrollment 6. In the judgment of the Investigator, acceptable general medical condition 7. Life expectancy >6 months 8. Male and female participants who are heterosexually active and not surgically sterile must agree to use effective contraception, including abstinence, for the duration of the study 9. Have suitable knee joint anatomy for intra-articular injection 10. Willing and able to return for the follow-up (FU) visits 11. Able to read and understand study instructions, and willing and able to comply with all study procedures Exclusion Criteria: 1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose 2. Previously received XT-150 injection(s) 3. Scheduled partial or complete knee replacement within 6 months; participant agrees not to schedule a knee replacement during Stage A of the study 4. History of knee arthroplasty on the Index Knee, i.e., selected for study injection(s) 5. History of rheumatoid arthritis or other inflammatory disease 6. History of immunosuppressive therapy; systemic steroids in the last 3 months 7. Received knee injection with hyaluronic acid or stem-cells in the last 6 months 8. Knee injection of glucocorticoid in the last 3 months 9. Current treatment with systemic immunosuppressive (systemic corticosteroid therapy or other strong immunosuppressant) 10. Currently receiving systemic chemotherapy or radiation therapy for malignancy 11. Clinically significant hepatic disease as indicated by clinical laboratory results ≥3 times the upper limit of normal for any liver function test (e.g., aspartate aminotransferase, alanine aminotransferase) 12. Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion indicated), Grade 1 white cell counts (lymphocytes <LLN - 800/mm^3; <LLN - 0.8 x 109 /L, neutrophils <LLN - 1500/mm^3; <LLN - 1.5 x 109 /L), LLN=Lower Limit Normal Range 13. Positive serology for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus 14. Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation 15. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments) 16. Current anticoagulant or anti-platelet treatment (e.g., warfarin, heparins, factor X inhibitors, clopidogrel, prasugrel, ticagrelor, or dipyridamole). Low-dose (≤ 325 mg/day) aspirin is permitted 17. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit 18. Use of any investigational drug or device within 3 months before enrollment or current participation in a trial that included intervention with a drug or device; or currently participating in an investigational drug or device study 19. Any condition that, in the opinion of the Investigator, could compromise the safety of the participant, the participants ability to communicate with the study staff, or the quality of the data ; PRIMARY OUTCOME: Stage A: Number of participants achieving 30% improvement from Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) pain score; SECONDARY OUTCOME 1: Stage B: Change from Baseline in WOMAC Pain Score at Day 360[/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 I/II - NEPHSTROM; BRIEF: The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and progressive diabetic kidney disease (DKD). ; DRUG USED: Orbcel; DRUG CLASS: Biologic; INDICATION: Diabetic Nephropathy; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Mario Negri Institute for Pharmacological Research; CRITERIA: Inclusion Criteria: - Male and female ≥ 40 years and <85 years old. ; - T2D for 3 or more years under a clinician with mandated responsibility for management of the patients to national guidelines; - Urinary albumin excretion (UAE) ≥ 60 µg/min (in a 24 hour urine collection) and urine albumin-to-creatinine ratio (UACR) ≥ 88 mg/g (≥ 10 mg/mmol) (in a spot morning urine collection); - Estimated GFR (eGFR) 30-50 ml/min/1.73 m^2 by the CKD-EPI equation on 2 or more consecutive measurements at least 30 days apart within the past 6 months; - A documented decline of eGFR of ≥ -10ml/min/1.73 m^2 over the past 3 years or documented rate of eGFR decline of ≥ -5 ml/min/1.73 m^2 year based on 3 or more consecutive readings at least 90 days apart in the past 18 months; - Lack of suspicion of renal diagnosis other than DKD; - Willing and able to provide written informed consent. Exclusion Criteria: 1. Current resting systolic BP ≥ 150 mmHg and current resting diastolic BP ≥ 90 mmHg in a clinical setting, despite treatment with 3 hypertensive agents of different classes (including one diuretic), measured in a quiet environment with morning medications already taken; 2. Initiation of a new anti-hypertensive agent within the past 6 months 3. Increase the dose of an anti-hypertensive agent by ≥ 100% of the previous dose within the past 3 months Exclusion criteria related to glycaemic control: 4. Current HbA1c > 75 mmol/mol (> 9%) 5. Initiation of a new hypoglycaemic agent within the past 6 months 6. Increase the dose of a hypoglycaemic agent by ≥ 100% of the previous dose within the past 3 months Exclusion criteria related to dyslipidaemia: 7. Current fasting total cholesterol > 7 mmol/l 8. Current fasting total triglycerides > 3.5 mmol/l 9. Initiation of a new lipid lowering agent within the past 6 months Other exclusion criteria: 10. Chronic lung or liver disease; 11. Cardiovascular events (myocardial infarction, stroke or acute limb ischemia) within 6 months prior to enrolment; 12. Current or history within 6 months prior to enrolment of NYHA class III or IV heart failure; 13. Other concomitant disease or conditions in the opinion of the investigator that are likely to pose risk to the patient and that would render the patient unsuitable for participation or that could impair patient safety or ability to participate in the study, such as active malignancy; 14. Irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%; 15. Positive screening test for clinically significant anti-HLA antibodies. An initial antibody screening with Luminex® multi-antigen beads to detect class I and class II MHC antibodies followed by a Luminex single antigen bead assay to determine the specificity of any antibody detected. Potential study subjects with positive screening for any clinically significant anti-HLA antibody will be excluded and will not be eligible to participate in the NEPHSTROM clinical study (MFI>1500); 16. History or presence of any medical condition or disease which, in the opinion of the Investigator may place the participant at unacceptable risk for study participation; 17. Childbearing potential without use of effective acceptable methods of contraception. Women of childbearing potential can only be included in the study if a pregnancy test is negative at the screening visit (V1) and at baseline visit (V2) if they agree to use adequate contraception. Adequate contraception is defined as any combination of at least two effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate) or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical treatment such as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. 18. Pregnancy or lactating; 19. Participation in other investigational medicinal product (IMP) trials within 30 days before the inclusion or concurrent to this study (18 month follow-up); 20. Inability to understand the potential risks and benefits of the study; 21. Legal incapacity. ; PRIMARY OUTCOME: Number and severity of all pre-specified infusion-associated events and the overall number and frequency of adverse events.; SECONDARY OUTCOME 1: Glomerular filtration rate (GFR)[/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 - Bile Acid Malabsorption/Diarrhea; BRIEF: The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD). ; DRUG USED: A3384; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroenterologic Disorders; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Albireo; CRITERIA: Inclusion Criteria: - Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea - Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable Exclusion Criteria: - Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study - Patient needs medications prohibited as specified in the protocol ; PRIMARY OUTCOME: The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs).; SECONDARY OUTCOME 1: Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms[/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 - w/Pegasys + Copegus; BRIEF: Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects. ; DRUG USED: BMS-824393; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Treatment-naive subjects with genotype 1 chronic HCV - HCV RNA ≥ 100,000 IU/mL at screening - Seronegative for HIV and HBsAg - Liver biopsy within prior 2 years demonstrating no cirrhosis Exclusion Criteria: - Any evidence of liver disease other than hepatitis C - Diagnosed or suspected hepatocellular carcinoma - Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men - Cirrhosis ; PRIMARY OUTCOME: Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs); SECONDARY OUTCOME 1: Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA[/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 I/II - PK/PD; BRIEF: The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects. ; DRUG USED: Haegarda; DRUG CLASS: Biologic; INDICATION: Hereditary Angioedema (HAE); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Males or females aged 18 years or older. - Laboratory-confirmed hereditary angioedema type I or II. - Less than two hereditary angioedema attacks per month in the last three months. - Body weight of 50.0 kg to 110.0 kg. Exclusion Criteria: - Receiving prophylactic C1-esterase inhibitor therapy. - Received C1-esterase inhibitor, ecallantide, icatibant or any blood products for the prevention or treatment of hereditary angioedema within 7 days before the screening visit. - Intends to use recombinant C1-esterase inhibitor or fresh frozen plasma for the acute treatment of hereditary angioedema during the study. - Received androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 30 days before the screening visit. - Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit. - Known or suspected hypersensitivity to the study product, or to any excipients of the study product. - Pregnancy or lactation. ; PRIMARY OUTCOME: Modeled C1-esterase Inhibitor Functional Activity Trough Level; SECONDARY OUTCOME 1: As-observed C1-esterase Inhibitor Functional Activity Trough Level[/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 - LiFT (Biopsy-Confirmed NASH); BRIEF: This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH. ; DRUG USED: LPCN 1144; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Lipocine Inc.; CRITERIA: Inclusion Criteria: 1. Male between 18 and 80 years of age, inclusive. 2. Subject with histologic evidence of NASH upon central read of a liver biopsy. i. A historical biopsy no more than 4 months before Screening may be considered for use with medical monitor approval if the following criteria are met: - Stable weights between the time of the biopsy and Screening. Stable weight is defined as no more than a 5% change. - Is either not taking or is on a stable dose of Thiazolidinedione(TZDs)/glitazones for 3 months before Day 1. 3. Background therapy for other ongoing chronic conditions, and weight should be stable for at least 3 months before trial enrollment. Stable weight is defined as no more than a 5% change. 4. Judged to be in good general health as determined by the investigator at screening. Exclusion Criteria: 1. Significant alcohol consumption more than 30 g/day on average, either currently or for a period of more than 3 consecutive months in the 5 years prior to screening. 2. Inability to reliably quantify alcohol intake. 3. Biochemical, clinical or histologic evidence of cirrhosis on liver biopsy (stage 4 fibrosis). 4. Evidence of other causes of chronic liver disease including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilsons disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, etc. 5. Suspected or proven liver cancer. 6. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to: - Hematocrit > upper limits of normal (ULN) - Hemoglobin > ULN - Prostate-specific antigen (PSA) > 4 ng/mL - Serum aspartate aminotransferase (AST) or alanine transaminase (ALT) > 200 IU/L - Serum alkaline phosphatase (ALP) > 2 x ULN - Serum creatinine of 2.0 mg/dL or greater - Total bilirubin > ULN - International normalized ratio (INR) ≥ 1.3. - Prolactin > ULN 7. Subjects with evidence of worsening liver function based on the two initial laboratory values used to establish the screening / baseline values. 8. Model for End-Stage Liver Disease (MELD) score greater than 12 9. Subjects with a documented history of Gilberts syndrome 10. Evidence of portal hypertension (e.g., low platelet counts, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly). 11. Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to randomization. 12. Subjects who are not on a stable dose of lipid-lowering drugs, diabetic and / or hypertensive medication in the 3 months prior to biopsy or the 3 months prior to randomization 13. Any over-the-counter medication or herbal remedy that is being taken with an intent to improve hyperlipidemia must be stable for at least 3 months prior to randomization and through the end of the study. 14. Vitamin E supplementation of greater than 100 IU/day, unless completed adequate washout for at least 4 weeks prior to Day 1 or biopsy if one is required. 15. Inability to safely obtain a liver biopsy. 16. History of total parenteral nutrition in the year prior to screening. 17. History of bariatric surgery or currently undergoing evaluation for bariatric surgery. 18. History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption. 19. History of biliary diversion. 20. Known positivity for antibody to Human Immunodeficiency Virus (HIV). 21. Known heart failure of New York Heart Association class 3 or 4. 22. Active, serious medical disease with likely life-expectancy less than 5 years. 23. History of current or suspected prostate or breast cancer. 24. History of diagnosed, severe, untreated, obstructive sleep apnea. 25. Active substance abuse in the year prior to screening. 26. History of significant sensitivity or allergy to any androgens, including testosterone, or product excipients 27. History of seizures or convulsions, including alcohol or drug withdrawal seizures. Childhood seizures are not exclusionary. 28. Use of known strong inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study. 29. Subjects who are currently receiving any androgens (testosterone or other androgens or androgen supplements). Subjects who are on testosterone may be eligible for the study following an adequate washout (12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal androgens; 3 weeks following oral androgens). 30. Use of any investigational drug within 5 half-lives of the last dose or in the past 6 months prior to Study Day -2 without PI and/or Sponsor approval. 31. Receipt of any drug by injection within 30 days or 10 half-lives (whichever is longer) prior to study drug administration without PI and/or Sponsor approval. Insulin, allergy shots, and vaccines are allowed. 32. Subject who is not willing to use adequate contraception for the duration of the study. 33. Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study. 34. Failure to give informed consent. ; PRIMARY OUTCOME: Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.; SECONDARY OUTCOME 1: Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.[/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 - Compensated Cirrhosis From NASH; BRIEF: The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH). ; DRUG USED: BMS-986263; DRUG CLASS: ; INDICATION: Liver Failure / Cirrhosis; TARGET: Heat Shock Protein 47 (HSP47); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months - Men and women must agree to follow methods of contraception Exclusion Criteria: - Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator - Known immunocompromised status or any disease or condition which might compromise participant safety - Prior exposure to BMS-986263 - Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests - Hepatic decompensation Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score); SECONDARY OUTCOME 1: Proportion of participants with ≥ 1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by ≥ 1 point[/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 - Study 201; BRIEF: A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD). ; DRUG USED: Dasotraline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: - Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined subtype) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria. Diagnosis is confirmed by Conners Adult ADHD Diagnostic Interview (CAADID) Part 2. - Subject currently taking medication (stimulant or nonstimulant) for the control of ADHD symptoms has an ADHD RS-IV score of ≥ 22 at screening. - Subject currently not taking any medication for the purpose of controlling ADHD symptoms has an ADHD RS-IV score of ≥ 26 at screening. - Subject has a CGI-S score of ≥ 4 at screening. - Subject has a lifetime history of treatment with at least one medication for ADHD (stimulant or nonstimulant). Subjects may be either medicated or unmedicated for ADHD at the time of screening (all ADHD medications must be washed out during screening). - Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug at screening, unless a false positive is suspected, in which case the UDS will be repeated. If the subject has a positive drug screen for ADHD medications (ie, methylphenidate or amphetamine) at screening; the subject must have a negative UDS after a washout period at least 3 days prior to baseline. - Subject is male or a non-pregnant, non-lactating female. - Female subjects must have a negative serum pregnancy test at screening; women who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test. - Female subjects of childbearing potential and male subjects with female partners of child-bearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period and for one month (30 days) after study completion. Medically acceptable and effective contraceptives include abstinence, prescription hormonal contraceptives (oral, patch, vaginal ring, implant, or injection), diaphragm with spermicide, intrauterine device (IUD), condom with spermicide, surgical sterilization, or vasectomy. For male subjects adequate contraception is defined as abstinence or continuous use of 2 barrier methods of contraception (eg, spermicidal condom). - Subject is 18 to 55 years old, inclusive, at the time of informed consent. 11. Subject can read well enough to understand the informed consent form and other subject materials. Exclusion Criteria: - Subject has a DSM-IV-TR diagnosis of ADHD not otherwise specified. - Subject is receiving adequate benefit from current ADHD medication in the opinion of the investigator. - Subject has an Axis I disorder other than ADHD that has been the primary focus of treatment at any time during the 12 months prior to screening. - Subject has a past history of, or current presentation consistent with, bipolar disorder (including bipolar I, bipolar II, and bipolar not otherwise specified [NOS]), schizophrenia, schizoaffective disorder, or any other psychotic disorder. - Subject has a history of drug dependence or substance abuse (excluding nicotine and caffeine) within the 12 months prior to screening, as defined by the DSM-IV-TR criteria. - Subject has a current Axis II disorder per DSM-IV-TR criteria. - Subject has a history of epilepsy, seizures (except childhood febrile seizures), unexplained syncope or other unexplained blackouts (except single incident), or head trauma with loss of consciousness lasting more than 5 minutes. - Subject has a currently active medical condition (other than ADHD) that, in the opinion of the investigator, could interfere with the ability of the subject to participate in the study. - Subject is currently taking an antidepressant medication (eg, bupropion, selective serotonin reuptake inhibitor [SSRI]/ serotonin norepinephrine reuptake inhibitor [SNRI], monoamine oxidase [MAO] blocker, tricyclic, etc) or St. Johns Wort. - Subject is currently taking or has taken within the previous 6 months an anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid, etc); antipsychotic medication; or lithium (any lithium preparation or formulation). - Subject is currently taking an alpha-2 adrenergic receptor agonist (including clonidine and guanfacine). - Subject has a Body Mass Index (BMI) less than 18 or greater than 35 kg/m2 (refer to Appendix V) - Subject answers yes to Suicidal Ideation item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (in the past month). Subjects who answer yes to this question must be referred to the Investigator for follow-up evaluation. - Subject has attempted suicide within 2 years prior to the screening period. - Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C antibody. Note: Subjects with a history of a positive test for Hepatitis B surface antigen or Hepatitis C antibody may be enrolled in the study if they have liver function test results at screening within the normal range. - Subject is known to have tested positive for human immunodeficiency virus (HIV). - Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study. - The subjects screening ECG shows a corrected QT interval using Fridericias formula (QTcF) of ≥ 450 msec for male subjects or ≥ 470 msec for female subjects. - The subjects screening hematology results show an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥ 2 times the upper limit of normal (ULN), or a blood urea nitrogen (BUN) value ≥ 1.5 times the ULN for the reference lab. - Subject who is currently participating or has participated in a clinical trial within the last 180 days or who participated in more than 2 clinical trials within the past year. This includes studies using marketed compounds or devices. - Subject is at high risk of non-compliance in the investigators opinion. ; PRIMARY OUTCOME: Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV); SECONDARY OUTCOME 1: Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - KEYNOTE-052 (First-Line); BRIEF: This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants and by programmed cell death ligand 1 (PD-L1) status. With Amendment 4, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. ; DRUG USED: Keytruda; 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: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Histologically- or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies) - Ineligible for cisplatin therapy - No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed) - Available tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated - Measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Adequate organ function - Female participants of childbearing potential have a negative urine or serum pregnancy test; surgically sterile, or willing to use 2 acceptable methods of birth control, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment - Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment Exclusion Criteria: - Disease that is suitable for local therapy administered with curative intent - Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment - Prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier - Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs due to a previously administered agent - Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease that has required systemic treatment in past 2 years - Evidence of interstitial lung disease or active non-infectious pneumonitis - Active infection requiring systemic therapy - Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment - Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor - Known human immunodeficiency virus (HIV) - Known active Hepatitis B or C - Received a live virus vaccine within 30 days of planned start of study treatment ; PRIMARY OUTCOME: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants; SECONDARY OUTCOME 1: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants[/INST]Yes</s>