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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ATLAS; BRIEF: The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival. ; DRUG USED: Erleada; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors; THERAPY: Combination; LEAD SPONSOR: Aragon Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Age >= 18 years - Indicated and planned to receive primary radiation therapy for prostate cancer - Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c - Charlson index (CCI) <=3 - An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1 - Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<) 1.5 milligram/deciliter (mg/dL) (<133 micromoles/Liter [mcmol/L]), (3) platelets greater than or equal to (>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 12.0 gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth factors within 3 months prior to randomization - Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial - Signed, written, informed consent - Be able to swallow whole study drug tablets Exclusion Criteria: - - Presence of distant metastasis, (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0. - Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization - Bilateral orchiectomy - History of pelvic radiation - Prior systemic (example [e.g.], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer - History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect) - Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer - Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer - Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study - Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior to randomization - Use of any investigational agent <=4 weeks prior to randomization - Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations - Major surgery <=4 weeks prior to randomization - Current or prior treatment with anti-epileptic medications for the treatment of seizures - Gastrointestinal conditions affecting absorption - Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject ; PRIMARY OUTCOME: Metastasis-free survival; SECONDARY OUTCOME 1: Event-free Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ANNEXA-A (w/Eliquis); BRIEF: The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban. ; DRUG USED: Andexxa; DRUG CLASS: Biologic; INDICATION: Drug Toxicity; TARGET: Factor X Inhibitors; THERAPY: Combination; LEAD SPONSOR: Portola Pharmaceuticals; CRITERIA: Inclusion Criteria: - Reasonably healthy men and women aged 50 to 75 Exclusion Criteria: - History of abnormal bleeding, active bleeding or risk factors for bleeding - History of thrombosis or risk factors for thrombosis - History of adult asthma or use of inhaled medications ; PRIMARY OUTCOME: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II); SECONDARY OUTCOME 1: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Part II)[/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 - P05688 (vs. Zyprexa); BRIEF: The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion Criteria: - Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype - Minimum PANSS total score of 70 at Screening and Baseline - Score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS - Confirmed to be experiencing an acute exacerbation of schizophrenia - CGI-S scale score of at least 4 (moderately ill) at Baseline - Has responded positively to an antipsychotic medication other than clozapine (Clozaril®) in a prior episode Exclusion Criteria: - Body mass index (BMI) <18.5 or >40.0 kg/m^2 - Laboratory and/or clinical evidence of clinically significant hepatic conditions - Known history of, or undergoing treatment for, narrow angle glaucoma - Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile seizures - Known serological evidence of human immunodeficiency virus (HIV) antibody - History of neuroleptic malignant syndrome or tardive dyskinesias - Past or current diagnosis of schizoaffective disorder, schizophrenia of residual subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission, or borderline personality disorder ; PRIMARY OUTCOME: Change From Baseline in PANSS Total Score at Day 42; SECONDARY OUTCOME 1: Change From Baseline in CGI-S Score at Day 42[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 3000 - Rest of World (IV); BRIEF: This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patients participation will last approximately 1.5 years. ; DRUG USED: Bapineuzumab (IV and SQ); DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD - Concurrent use of cholinesterase inhibitor or memantine allowed, if stable - Caregiver will participate and be able to attend clinic visits with patient Exclusion Criteria: - Significant neurological disease other than AD - Major psychiatric disorder - Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body] - Women of childbearing potential ; PRIMARY OUTCOME: The Change From Baseline in the Alzheimers Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78; SECONDARY OUTCOME 1: The Change From Baseline in Brain Amyloid Burden at Week 71.[/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 - SIMPLE-2 (Moderate); BRIEF: The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11. ; DRUG USED: Veklury; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: RNA polymerase, SARS-CoV-2; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age) prior to performing study procedures. For participants ≥ 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization - Currently hospitalized and requiring medical care for COVID-19 - Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening - Radiographic evidence of pulmonary infiltrates Key Exclusion Criteria: - Participation in any other clinical trial of an experimental treatment for COVID-19 - Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 - Requiring mechanical ventilation at screening - Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) - Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11; SECONDARY OUTCOME 1: Part A: Percentage 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 IIa - BRONC01.01; BRIEF: Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa Bronchiolitis is defined as an infection of the small airways. It is also the most common manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the leading cause of global child mortality. NO has been shown to play a critical role in various biological functions, including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and immune responses to infection such as microbicidal action directed toward various organisms. NO in the airways is considered to play a key role in the innate immune system in which the first-line of host defense against microbes is built. It has shown the beneficial effect of NO in different diseases with several options of doses and regimens - from newborn with primary pulmonary hypertension which showed improvement in oxygenation after 30 minutes of NO treatment at 10-20 ppm, to a subject with adult respiratory distress syndrome, who demonstrated clinical improvement during NO treatment at 18 and 36 ppm. In vitro studies utilizing a variety of nitric oxide (NO) donors suggested that NO, in part per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a wide variety of phyla including bacteria, viruses, helminthes and parasites. Primary Objectives: Assess the safety of NO intermittent inhalation treatment in 2-12 month old bronchiolitis subjects. Assess the tolerability of NO intermittent inhalation treatment in 2-12 month old bronchiolitis subjects Secondary Objective: Assess the efficacy of NO intermittent inhalation treatment compared to standard treatment in 2-12 months old bronchiolitis subjects. Prospective, double blind, randomized single-Center study of 44 hospitalized subjects aged 2 -12 months old, diagnosed with bronchiolitis will be enrolled into the study and randomized into 2 groups. Group 1 -Treatment group - Will receive nitric oxide inhalation in addition to standard treatment for up to 5 days, Group 2 - will receive ongoing inhalation of the standard treatment for 5 days. Treatment administration: Treatment blindness will be kept by separating between unblinded team members (giving the actual treatment) and blinded team members, and by hiding the NO container and all study related equipment behind a curtain. Between study inhalations the subject will continue to receive the standard inhalation treatment. Oxygen (O2), NO , nitrogen dioxide(NO2)and fraction of inspired oxygen (FiO2) delivered to the patient will be continuously monitored. All subjects will come for follow up visits on day 7(+5), 14 (+5) days and will be contacted on day 30 (+5) from day of admission to the department. End of study treatment (both groups) will be assessed by a blinded study physician base on clinical assessment. Subject improvement that will lead to end study treatment = clinical score < 6 and/or (Oxygen saturation)SaO2 above 92% and/or decision of subject discharge from the hospital. ; DRUG USED: Nitric Oxide (AIT); DRUG CLASS: Non-NME; INDICATION: Bronchiectasis; TARGET: Immune System, Nitric Oxide/ Nitrogen Monoxide; THERAPY: Monotherapy; LEAD SPONSOR: Beyond Air Inc.; CRITERIA: Inclusion Criteria: - Subjects (Male or female) 2-12 months old - Diagnosed as bronchiolitis - Parents/ legal guardian signed informed consent. Exclusion Criteria: - Subjects diagnosed with concomitant diseases such as pneumonia,urine tract infection (UTI) or otitis media - Prematurity <36 weeks gestational age. - Received (Respiratory syncytial virus) RSV immunoglobulin prophylaxis - Subjects diagnosed with, methemoglobinemia, chronic lung disease, immune deficiency, heart disease - Use of an investigational drug within 30 days before enrollment and not expected to participate in a new study within 30 days - History of frequent epistaxis (>1 episode/month) - Significant hemoptysis within 30 days (≥ 5 mL of blood in one coughing episode or > 30 mL of blood in a 24 hour period) - Methemoglobin >3% at screening - Subjects cannot fulfill the study design - Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data. - Underlying diseases such as genetic disorders (Cystic fibrosis, Down Syndrome) or chronic lung diseases (Bronchopulmonary dysplasia,Primary ciliary dyskinesia, Bronchiolitis Obliterans), hypotonia, Congenital heart disease) ; PRIMARY OUTCOME: Met-Hemoglobin percentage (MetHb) associated with inhaled NO; SECONDARY OUTCOME 1: Proportion of subjects (%) who prematurely discontinued the study due to adverse events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - A3921116 (Topical); BRIEF: The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months; - A target plaque of at least 9 sq. cm. Exclusion Criteria: - Demonstrates rebound or flare of chronic plaque psoriasis; - Non plaque form of psoriasis; - Currently have or history of psoriatic arthritis; - Current drug induced psoriasis; - Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months; - Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months ; PRIMARY OUTCOME: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4; SECONDARY OUTCOME 1: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ET/PV; BRIEF: This is a phase II open-label study of single agent imetelstat in patients with essential thrombocytopenia or with polycythemia vera who have failed or are intolerant to at least one prior therapy, or who refuse standard therapy. ; DRUG USED: Imetelstat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Essential Thrombocythemia (ET); TARGET: Telomerase; THERAPY: Monotherapy; LEAD SPONSOR: Geron Corporation; CRITERIA: Inclusion Criteria: ET-Specific Criteria - Confirmed diagnosis of ET by WHO criteria - Patients with ET requiring cytoreduction who have failed or are intolerant to at least one prior therapy, or who refuse standard therapy - Laboratory criteria (within 14 days of first study drug administration): - Platelets > 600,000/μL - ANC ≥ 1500/μL - Hemoglobin ≥ 10 g/dL PV-Specific Criteria - Confirmed diagnosis of PV by WHO criteria - Patients with PV requiring cytoreduction with phlebotomy and/or myelosuppressive agents - Patients may have failed or are intolerant to at least one prior therapy, or refuse standard therapy - For those patients receiving phlebotomy only, the frequency over the past year must be at least one phlebotomy every 3 months. - Undergone phlebotomy and attained a Hct < 47% (men) or < 45% (women) (or pre-specified Hct count that is tolerable) within 14 days prior to the start of study treatment - Cessation of myelosuppressive agents prior to initiation of study treatment (unless approved by Geron Medical Monitor for unusual circumstances) - Hydroxyurea or anagrelide: Cessation 1 day prior to initiation of study treatment. Consideration to the timing of cessation of this therapy prior to the start of study treatment should take into account the requirement for phlebotomy. - INF-α or pegylated- INF-α: Cessation 4 weeks prior to initiation of study treatment - Laboratory criteria (within 14 days of first study drug administration): - Platelets > the lower limit of normal (LLN) - ANC ≥ 1500/μL General Criteria (All Patients) - Willing and able to sign an informed consent - Male or female, aged 18 years or older - ECOG performance status 0-2 - Laboratory criteria (within 14 days of first study drug administration): - INR (or PT) and aPTT < 1.5 x the upper limit of normal (ULN) - Serum creatinine ≤ 2 mg/dL - Serum bilirubin < 2.0 mg/dL (patients with Gilberts syndrome: serum bilirubin < 3 x ULN) - AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN - Alkaline phosphatase < 2.5 x ULN - Any clinically significant toxicity from previous cancer treatments and/or major surgery must have recovered to Grade 0-1 prior to initiation of study treatment - Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and for at least 12 weeks after the last study treatment with imetelstat - Male patients must agree to use effective birth control for themselves or their partner during and for 12 weeks after the last study treatment with imetelstat. Exclusion Criteria Patients who meet any of the following criteria will be excluded from screening and study entry: - Women who are pregnant or breast feeding - Prior stem cell transplantation - Investigational therapy within 4 weeks prior to first study drug administration - Clinically significant cardiovascular disease or condition including: - Uncontrolled congestive heart failure (CHF) - Need for anti-arrhythmic therapy for a ventricular arrhythmia - Clinically significant severe conduction disturbance per the Investigators discretion - Ongoing angina pectoris requiring therapy - New York Heart Association (NYHA) Class II, III, or IV cardiovascular disease (see Appendix E) - Known positive serology for human immunodeficiency virus (HIV) - Serious co-morbid medical conditions, including active or chronically recurrent bleeding, clinically relevant active infection, cirrhosis, and chronic obstructive or chronic restrictive pulmonary disease per the Investigators discretion - Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study. ; PRIMARY OUTCOME: Hematologic Response; SECONDARY OUTCOME 1: Safety and tolerability: Number of Patients with Hematological Toxicities, Non-Heme Grade 3 and 4 AEs, and Hemorrhagic 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 III - 013 (Healthy); BRIEF: A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects. ; DRUG USED: Jynneos; DRUG CLASS: Vaccine; INDICATION: Smallpox; TARGET: Immune System, Smallpox virus; THERAPY: Monotherapy; LEAD SPONSOR: Bavarian Nordic; CRITERIA: Inclusion Criteria: - Male and female subjects, 18 to 40 years of age - The subject has read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedures - BMI ≥ 18.5 and < 35 - Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or with a history of hysterectomy (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products) - WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each vaccination - White blood cells ≥ 2,500/mm3 < ULN - Absolute neutrophil count (ANC) within normal limits - Hemoglobin within normal limits - Platelets within normal limits - Adequate renal function defined as a calculated Creatinine Clearance (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation: - For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl x 72) = CrCl (ml/min) - For women: multiply the result by 0.85 = CrCl (ml/min). - Adequate hepatic function defined as: - a. Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant liver disease - b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 1.5 x ULN - Troponin I < 2 x ULN - Electrocardiogram (ECG) without clinically significant findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia) Exclusion criteria - Typical vaccinia scar - Known or suspected history of smallpox vaccination - History of vaccination with any poxvirus-based vaccine - US Military service prior to 1991 or after January 2003 - Pregnant or breast-feeding women - Uncontrolled serious infection, i.e. not responding to antimicrobial therapy - History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subjects ability to complete the trial - History of or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid replacement are not excluded - Known or suspected impairment of immunologic function including, but not limited to, HIV Infection, clinically significant liver disease (including chronic active HBV or HCV), diabetes mellitus, moderate to severe kidney impairment - History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site - History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders - Clinically significant mental disorder not adequately controlled by medical treatment - History of coronary heart disease, myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor - Known history of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years - Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Programs risk assessment tool (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to subjects 20 years of age and older - Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months) - Known allergy to IMVAMUNE® vaccine and its constituents, e.g. tris (hydroxymethyl)-amino methane, including know allergy to egg or aminoglycosides - History of anaphylaxis or severe allergic reaction to any vaccine - Acute disease (illness with or without a fever) at the time enrollment - Body temperature ≥100.4°F (≥38.0°C) at the time of enrollment - Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination - Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after trial vaccination - Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5) - Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy - Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5) - Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine, or planned administration of such a drug during the trial period - Trial personnel ; PRIMARY OUTCOME: PRNT GMT; SECONDARY OUTCOME 1: ELISA GMT[/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 - C202; BRIEF: This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) ; DRUG USED: Monjuvi; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cluster of Differentiation 19 (CD19); THERAPY: Monotherapy; LEAD SPONSOR: MorphoSys AG; CRITERIA: Inclusion Criteria: - Patients with previously treated Philadelphia-chromosome-negative B-ALL, with progression after at least one prior therapy. Patients with Philadelphia-chromosome-positive B-ALL can only be included if they are refractory or intolerant to at least one tyrosine-kinase-inhibitor. - Male or female patients at least 16 years of age; if the patient is less than 18 years of age, the patient must have the ability to understand and give written assent in addition to the parents/guardians written informed consent. - Patients with histologically confirmed diagnosis of B-ALL - Mixed phenotype acute leukemia patients who have B cell immunophenotype. - Patients with an Eastern Cooperative Oncology Group performance status of less than or equal to 2 - Patients with a total bilirubin of less than or equal to 2.0 mg/dL - Patients with alanine aminotransferase or aspartate aminotransferase less than or equal to 2.5 times the upper limit of normal - Patients with a creatinine level of less than or equal to 2.0 mg/dL - If a female of childbearing potential, confirmation of a negative pregnancy test before enrollment and use of double-barrier contraception, confirmation of a negative pregnancy test before enrollment and use of oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy, oophorectomy, or tubal ligation - If a male, use of an effective barrier method of contraception during the study and for 3 months after the last dose if sexually active with a female of childbearing potential - Patients with the ability to understand and give written informed consent and to comply with the study protocol Exclusion Criteria: - Patients who received previous treatment with an anti-CD19 antibody or fragments - Receipt of anti-CD20 therapy no greater than 4 weeks before the first study dose - Patients having undergone prior allogeneic stem cell transplantation within 3 months or having active graft versus host disease - Patients with known hypersensitivity to any excipient contained in the drug formulation - Patients with a New York Heart Association Class III or IV - History of stroke or myocardial infarction within the last 6 months - Patients with a history of positive human immunodeficiency virus test result (ELISA or western blot) - Patients with positive hepatitis serology. Hepatitis B (HBV): Patients with positive serology for hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg) or total anti-hepatitis B core antibody (anti-Hbc). Patients positive for anti- Hbc may be included if hepatitis B viral DNA is not detectable. Hepatitis C (HCV): Patients with positive hepatitis C serology (defined as positive for anti-hepatitis C virus antibody (anti-HCV) unless HCV-RNA is confirmed negative. - Patients with active viral, bacterial, or systemic fungal infection requiring active parenteral treatment - Patients who are receiving active treatment/chemotherapy for another primary malignancy or have received any treatment, including surgery, radiation, or chemotherapy, within the past 5 years (except ductal breast cancer in situ, for nonmelanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) - Patients who are pregnant or breastfeeding - Patients with major surgery or radiation therapy within 4 weeks prior to first study dose ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT[/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 - TIVO-1; BRIEF: This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib. ; DRUG USED: Fotivda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: AVEO Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. ≥ 18-years of age. 2. Subjects with recurrent or metastatic RCC. 3. Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor. 4. Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, mixed tumor containing predominantly sarcomatoid cells, and unclassified RCC are excluded). 5. Measurable disease per the RECIST criteria Version 1.0. 6. Treatment naïve subjects or subjects who have received no more than one prior systemic treatment (immunotherapy, including interferon-alfa or interleukin-2 based therapy, chemotherapy, hormonal therapy or an investigational agent) for metastatic RCC. Postoperative or adjuvant systemic therapy will not be counted as a prior therapy unless recurrence is detected within 6 months of completion of treatment, in which case it will be counted as a prior therapy for metastatic disease. 7. ECOG performance status of 0 or 1, and life expectancy ≥ 3 months. 8. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment. 9. Ability to give written informed consent and comply with protocol requirements. Exclusion Criteria: 1. Any prior VEGF-directed therapy including VEGF antibody (eg, bevacizumab), VEGF receptor tyrosine kinase inhibitor (eg, sunitinib, sorafenib, axitinib, pazopanib, etc.), VEGF trap (eg, aflibercept), or any other agent or investigational agent targeting the VEGF pathway. 2. Any prior therapy with an agent targeting the mTOR pathway (eg, temsirolimus, everolimus, etc) 3. Primary CNS malignancies or CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery). 4. Any hematologic abnormalities (as noted in the protocol). 5. Any serum chemistry abnormalities (as noted in the protocol). 6. Significant cardiovascular disease. 7. Non-healing wound, bone fracture, or skin ulcer. 8. Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug. 9. Serious/active infection or infection requiring parenteral antibiotics. 10. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug. 11. Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug. 12. Significant bleeding disorders within 6 months prior to administration of first dose of study drug. 13. Currently active second primary malignancy, including hematologic malignancies (leukemia, lymphoma, multiple myeloma, etc.), other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular carcinoma in situ of the breast. Subjects are not considered to have a currently active malignancy if they have completed anti-cancer therapy and have been disease free for >2 years. 14. Pregnant or lactating females. 15. History of genetic or acquired immune suppression disease such as HIV; subjects on immune suppressive therapy for organ transplant. 16. Life-threatening illness or organ system dysfunction compromising safety evaluation. 17. Requirement for hemodialysis or peritoneal dialysis. 18. Inability to swallow pills, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of tivozanib or sorafenib, major resection of the stomach or small bowel, or gastric bypass procedure. 19. Psychiatric disorder or altered mental status precluding informed consent or necessary testing. 20. Sexually active pre-menopausal female subjects (and female partners of male subjects) must use adequate contraceptive measures, while on study and for 50 days after the last dose of study drug. Sexually active male subjects must use adequate contraceptive measures, while on study for at least 90 days after the last dose of drug. All fertile male and female subjects and their partners must agree to use a highly effective method of contraception (including their partner). Effective birth control includes (a) IUD plus one barrier method; or (b) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). (Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.) ; PRIMARY OUTCOME: Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib; SECONDARY OUTCOME 1: Overall Survival (OS) of Subjects Randomized to Treatment With Tivozanib or Sorafenib[/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 - ZEBRA - vs. Everolimus; BRIEF: When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 2 years of the diagnosis. Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for untreated patients with metastatic kidney cancer. They target a growth factor known as VEGF which is important in treating kidney cancer. Although the results with this drug are impressive, patients develop resistance to the drug and stop therapy. It is currently standard practice is to give everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the average time to cancer regrowth with everolimus is only 5 months. It is thought this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2). Therefore further improvement in treating patients is required. AZD2014 is a promising new drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in renal cancer as it theoretically could may have advantages over everolimus. Therefore study compares AZD2014 to everolimus in the setting where everolimus is used as standard of care. (e.g. in patients who have failed drug like sunitinib). The study is a randomised trial allowing us to quantify the benefit and potential for further development of AZD2014. Repeat Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will be closely followed up in clinic to ensure safety. A maximum of 122 patients will be recruited into this multi centre national trial. The primary goal of the study is to investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to everolimus. ; DRUG USED: Vistusertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Queen Mary University of London; CRITERIA: Inclusion Criteria: 1. Histopathologically confirmed renal cell carcinoma with measurable metastases on CT/MRI imaging. Only a component of clear cell is required. 2. Radiological progressive disease on VEGF targeted therapy (RECIST v1.1). Exposure to more than one line of VEGF targeted therapy is acceptable. Previous treatment with initial interferon or IL-2 or other experimental agent is acceptable (with the exception of drugs specifically targeting mTOR). 3. Evidence of measurable disease (ie, ≥1 malignant tumour mass that can be accurately measured in at least 1 dimension ≥ 20 mm with conventional computerized tomography [CT] scan or Magnetic Resonance Imaging [MRI], or ≥10 mm (except lymph nodes which must have short axis ≥ 15 mm) with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm). Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable. 4. Adequate organ function as defined by the following criteria: 1. Total serum bilirubin ≤1.5 x ULN (patients with Gilberts disease exempt), 2. Serum transaminases ≤3.0 x ULN (x5 in the presence of liver metastasis). 3. Serum creatinine ≤ 2 x ULN or Cockcroft and Gault >30ml/min 4. Absolute neutrophil count (ANC) ≥1.5 x 109/L without growth factor support, 5. Platelets ≥ 100 x 109/L 5. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment. 6. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures 7. ECOG performance status of 0, 1 or 2. 8. Life expectance >12 weeks 9. At least 14 days since the end of prior systemic treatment (sunitinib, pazopanib, sorafenib), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 or back to baseline except for alopecia or hypothyroidism. A 21 day gap between bevacizumab and interferon therapy should exist. 10. Fasting blood sugar ≤8mmol/l and HbA1C ≤7% 11. Age ≥18 years Exclusion Criteria: 1. Previous exposure to mTOR inhibitors for metastatic renal cancer. 2. Females of child-bearing potential. The definition of child-bearing potential: women between menarche and menopause who have not been permanently or surgically sterilised and capable of procreation. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception. 3. Pregnant and Breast feeding women. 4. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormally that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study. Specifically the following indications are contraindicated: Hereditary galacto-intolerance, glucose/galactose malabsorption and lactose deficiency 5. Untreated clinically symptomatic brain or meningeal metastases. Patients with evidence of clinically stable brain metastases are eligible providing that they do not require corticosteroids. 6. Any evidence of severe or uncontrolled diseases e.g., unstable or uncompensated respiratory, hepatic or renal disease. 7. Evidence of interstitial fibrotic lung disease (bilateral, diffuse, parenchymal lung disease). 8. Unresolved toxicity ≥ CTCAE v.4.0 grade 2 (except alopecia and hypothyroidism) from previous anti-cancer therapy. 9. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ or localised controlled prostate cancer) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion. 10. Uncontrolled diabetes mellitus or hyperlipidaemia (> grade 1) 11. Treatment with an investigational drug (not including VEGF TKIs such as pazopanib/ tivozanib) within 21 days prior to the first dose of therapy. If investigational drug is a VEGF TKI then with 14 days prior to the first dose of therapy 12. Patients who have experienced any of the following procedures or conditions currently or in the preceding 12 months: 1. Coronary artery bypass graft 2. Angioplasty 3. Vascular stent 4. Myocardial infarction 5. Angina pectoris 6. Congestive heart failure new york heart association grade ≥2 7. Ventricular arrhythmias requiring continuous therapy 8. Supraventricular arrhythmias including atrial fibrillation, which are uncontrolled 9. Haemorrhagic or thrombotic stroke, including transient ischaemic attacks or 10. Any other central nervous system bleeding 13. Mean resting QTcF ≥470 msec as per local reading 14. Abnormal ECHO at baseline (left ventricular ejection fraction [LVEF] <50% 15. Known inherited or acquired immunodeficiency 16. Known active hepatitis B or C infection or Known HIV. 17. Other concomitant anti-cancer therapy (including LHRH agonists) except steroids 18. Previous bone marrow transplant 19. Age <18 years 20. Any haemopoietic growth factors (eg, G-CSF, GM-CSF) within 2 weeks prior to receiving study drug ; PRIMARY OUTCOME: To investigate if single agent AZD2014 delays progression free survival compared to everolimus using RESIST v1.1; SECONDARY OUTCOME 1: To evaluate tumour response rate after at least 8 weeks of treatment with the study drugs.[/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 - SPAN-PD; BRIEF: This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study. ; DRUG USED: Inbrija; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: Acorda Therapeutics; CRITERIA: Inclusion Criteria: - Idiopathic Parkinsons Disease (PD) diagnosed between the ages of 30 and 85 years; - Hoehn and Yahr Stage 1-3 in an on state; - Require levodopa-containing medication regimen at least 3 times during the waking day; - Experience motor fluctuations with a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) and demonstrate levodopa responsiveness; - Are on stable PD medication regimen; - Total daily LD dose <1600 mg/day; - Able to perform a spirometry maneuver in the ON and OFF states; - Normal cognition confirmed by MMSE score ≥25 Exclusion Criteria: - Pregnant or lactating females; - Previous surgery for PD or plan to have stereotactic surgery during the study period; - History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year; - Known contraindication to the use of levodopa; - Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety; - Any contraindication to performing routine spirometry. ; PRIMARY OUTCOME: Unified Parkinsons Disease Rating Scale (UPDRS) Part III; SECONDARY OUTCOME 1: Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.[/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 purpose this research study is to determine if the combination of nivolumab and CMP-001 improves the likelihood of eradicating (destroying) disease in the lymph node (pathologic response rate). ; DRUG USED: Vidutolimod; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, Toll-Like Receptor (TLR) Family, Toll-like receptor 9 (TLR9); THERAPY: Combination; LEAD SPONSOR: Diwakar Davar; CRITERIA: Inclusion Criteria: 1. Be willing and able to provide written informed consent for the study. 2. Be ≥ 18 years of age on day of signing informed consent. 3. Diagnosis of histologically or cytologically confirmed diagnosis of cutaneous melanoma belonging to one of the following AJCC TNM stages: 1. Tx or T1-4 and 2. N1b, or N1c, or N2b, or N2c, or N3b, or N3c and 3. M0 Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal and/or in-transit metastasis; or at the time of clinical detected nodal and/or in-transit recurrence; and may belong to any of the following groups: - Primary cutaneous melanoma with clinically apparent regional lymph node metastases. - Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin. - Clinically detected primary cutaneous melanoma involving multiple regional nodal groups. - Clinical detected nodal melanoma (if single site) arising from an unknown primary. - In-transit and/or satellite metastases with or without regional lymph node involved permitted if considered potentially surgically resectable at baseline. - NOTE: Determination of potential resectability must be made at baseline to be eligible for this neoadjuvant study. - NOTE: Patients with mucosal and/or uveal melanoma are not permitted to enroll. Patients with melanomas of unknown primary may be enrolled at the discretion of the treating investigator in discussion with Principal Investigator. 4. Presence of injectable and measureable disease based on RECIST 1.1. 5. Willing to undergo tumor biopsy (core, punch, incisional or excisional). Patients must undergo biopsy (core, punch) or open biopsy (incisional, excisional) within 4 weeks of registration on the study. 6. Performance status of 0 or 1 on the ECOG Performance Scale. 7. Demonstrate adequate organ function as defined below performed on screening labs obtained within 4 weeks of registration. - Absolute neutrophil count (ANC) ≥1,500 /mcL - Hemoglobin ≥9 g/dL or ≥5.6 mmol/L - Platelets ≥100,000 / mcL - Serum creatinine or Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN. - Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. - AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN. - International Normalized Ratio (INR) or 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. 8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days 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. 9. 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 26 weeks 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. 10. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 26 weeks after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Exclusion Criteria: 1. History of uveal or mucosal melanoma. 2. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment. 3. 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. 4. 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: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. - Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. - Note: Subjects with autoimmune disorders of Grade 4 while on prior immunotherapy will be excluded. Subjects who developed autoimmune disorders of Grade ≤ 3 may enroll if the disorder has resolved to Grade ≤1 and the subject has been off systemic steroids at doses >10 mg/d for at least 2 weeks. 5. Active (i.e., symptomatic or growing) central nervous system (CNS) metastases. 6. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 7. Has a systemic disease that requires systemic pharmacologic doses of corticosteroids greater than 10mg daily prednisone (or equivalent). Subjects who are currently receiving steroids at a dose of ≤10mg daily do not need to discontinue steroids prior to enrollment Subjects that require topical, ophthalmologic and inhalational steroids would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogrens syndrome will not be excluded from the study. Subjects who require active immunosuppression (greater than steroid dose discussed above) for any reason are excluded. 8. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 9. Has an active infection requiring systemic therapy. 10. 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. 11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. 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 26 weeks after the last dose of trial treatment. 13. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137. Prior treatment with ipilimumab or interferon alfa is allowed. Patients with history of allergic or hypersensitivity reaction to interferon alfa or ipilimumab are also excluded. 14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 15. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected. Patients with treated Hepatitis B/C with no evidence of active infection may be enrolled. ; PRIMARY OUTCOME: Major Pathologic Response Rate (MPR); SECONDARY OUTCOME 1: Radiographic 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 - 1276.1 - w/Metformin (Treatment Naive); BRIEF: This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment. ; DRUG USED: Jardiance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization 3. HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol) 4. Body Mass Index (BMI) <= 45 kg/m2 at screening Exclusion criteria: 1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day) 2. Any antidiabetic drug within 12 weeks prior to randomization 3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period 4. Contraindications to metformin according to the local label ; PRIMARY OUTCOME: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24; SECONDARY OUTCOME 1: FPG (Fasting Plasma Glucose) Change From Baseline at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - KEYNOTE-427; BRIEF: The purpose of this study is to assess the safety and efficacy of monotherapy pembrolizumab (MK-3475) in participants with renal cell carcinoma (RCC). There will be two cohorts in this study: Cohort A will consist of participants with clear cell (cc) RCC and Cohort B will consist of participants with non-clear cell (ncc) RCC. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); 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: - Cohort A (clear cell RCC cohort) participant must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features). - Cohort B (non-clear cell RCC cohort) participant must have histologically confirmed diagnosis of non-clear cell RCC (with or without sarcomatoid features). Participants with tumors that have a component of clear cell histology are not eligible for inclusion in Cohort B. - Has locally advanced/metastatic disease, i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer (AJCC) or have recurrent disease. - Has measurable disease per RECIST 1.1 as assessed by BICR. - Has received no prior systemic therapy for advanced RCC. Prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed >12 months prior to allocation. - Must provide adequate tissue for biomarker analysis for Cohorts A and B from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. - Participants receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to treatment allocation. - Has Karnofsky Performance Status (KPS) ≥70%, as assessed within 10 days prior to treatment allocation. - Demonstrates adequate organ function. - Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. - Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug. Exclusion Criteria: - Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to allocation, has had major surgery within 4 weeks or radiation therapy within 2 weeks prior to allocation, or who has not recovered (i.e., ≤ Grade 1 or to Baseline) from AEs due to prior treatment. - Had prior treatment with any anti-programmed cell death 1 (anti-PD-1), or anti-programmed cell death ligand 1 (PD-L1), or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include antibodies against indoleamine-2,3-dioxygenase (IDO), PD-L1, interleukin 2 receptors (IL-2R), glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR). - Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding 10 mg daily dose of prednisone or equivalent or any other form of immunosuppressive therapy within 7 days prior to allocation, except in the case of central nervous system (CNS) metastases (see below). - Has an active autoimmune disease requiring systemic treatment within the past 2 years OR a documented history of clinically severe autoimmune disease. - Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, such as breast cancer in situ, that has undergone potentially curative therapy are acceptable. - Has known active CNS metastases and/or carcinomatous meningitis. - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. - Has an active infection requiring systemic therapy. - Has a known history of Human Immunodeficiency Virus (HIV) infection. - Has known history of Hepatitis B or known active Hepatitis C. - Has received a live virus vaccine within 30 days of allocation. - Has had a prior solid organ transplant. - Is pregnant or breastfeeding, 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 drug. ; 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 - ACT 1; BRIEF: This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm. ; DRUG USED: Brinavess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atrial Fibrillation/Flutter; TARGET: Potassium channels, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Advanz Pharma; CRITERIA: Inclusion Criteria: - 18 years of age or older; - Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days. - Have adequate anticoagulant therapy. Exclusion Criteria: - Have a QRS > 0.14 seconds unless patient has pacemaker or uncorrected QT > 0.440 seconds as measured on a 12-lead ECG. - Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety. - Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing. ; PRIMARY OUTCOME: To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.; SECONDARY OUTCOME 1: To assess the safety of RSD1235 in this patient population.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - T2D Patients; BRIEF: The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The study will also include a 3 week, posttreatment follow-up period. ; DRUG USED: MK-0736; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: 11ß-HSD1 (11 beta-hydroxysteroid dehydrogenase); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Must be 18 to 75 years of age - Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%) - Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg) - LDL-C < 140 mg/dL - On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) Exclusion Criteria: - History of Type I Diabetes mellitus or ketoacidosis - Patients taking 3 or more blood pressure lowering medications - Have severe chronic heart failure - History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease - History of cancer within the last 5 years - Human immunodeficiency virus (HIV) Positive - Have received treatment with any investigational drugs within the past 30 days - History of alcohol or drug abuse within the past 3 years - Body Mass Index ( BMI) >= 41 kg/m2 ; PRIMARY OUTCOME: Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12; SECONDARY OUTCOME 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) 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 II - Proof of Concept Study; BRIEF: Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. - Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. - Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability. ; DRUG USED: REGN3500; DRUG CLASS: Biologic; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: IL-33 (Interleukin-33)IL-33 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Participants with a diagnosis of chronic obstructive pulmonary disease (COPD) for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition). - Participants with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] less than [<] 70 percent (%) and post-bronchodilator FEV1% predicted <80%, but greater than equal to [>=] 30%). - Participants with COPD assessment test (CAT) score >=10 at Screening. - Participants with reported history of signs and symptoms of chronic bronchitis (chronic productive cough for 3 months in the year up to screening in a participant in whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis] had been excluded). - Participants with a documented history (e.g., medical record verification) of >=2 moderate exacerbations or >=1 severe exacerbation within the year prior to screening. A moderate exacerbation was defined as an acute exacerbation of COPD (AECOPD) requiring systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with antibiotics (however, use of antibiotics alone does not qualify as a moderate exacerbation unless documentation was available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation was defined as an AECOPD that required a hospitalization. - Participants with standard of care background therapy, for 3 months and at a stable dose for at least 1 month, including either: - Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist (LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA. or - Triple therapy: LABA + LAMA + ICS. - Current or former smokers with a smoking history of >=10 packs/year. Exclusion criteria: - Concomitant severe diseases or diseases for which the use of ICS (e.g., active pulmonary tuberculosis, etc.) or LABA were contraindicated (e.g., diagnosis of a history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis, pheochromocytoma, hypokalemia). - Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within previous 1 month or more than 4 courses of intravenous glucocorticosteroids within the previous 6 months. - Participants with bronchial thermoplasty procedure (up to 3 years prior to Visit 1). - A current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines. - Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway Pressure, etc.) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. - Diagnosis of α-1 anti-trypsin deficiency. - Advanced COPD with need for chronic (greater than [>] 15 hours/day) oxygen support. - Participant with a moderate or severe acute exacerbation of COPD event within previous 4 weeks. - A participant who has experienced an upper or lower respiratory tract infection within previous 4 weeks. - Prior history of or planned pneumonectomy or lung volume reduction surgery. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Annualized Rate of Moderate to Severe Acute Exacerbation Events in Chronic Obstructive Pulmonary Disease (AECOPD) Participants; SECONDARY OUTCOME 1: Average Change in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 16 Through Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SERENE; BRIEF: The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy. ; DRUG USED: Orgovyx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Contraception; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Combination; LEAD SPONSOR: Myovant Sciences GmbH; CRITERIA: Key Inclusion Criteria: 1. Is a premenopausal woman, 18 to 50 years of age. 2. Is at risk of pregnancy (that is, having heterosexual intercourse at least once per month) and is seeking contraception. 3. Has normal, regular menstrual cycles that are between 21 and 35 days in duration. 4. Has a diagnosis of uterine fibroids or endometriosis meeting either of the following criteria: 1. Diagnosis of uterine fibroids by confirmation of ultrasound performed in the last 2 years and patient report of heavy menstrual bleeding affecting quality of life. 2. Diagnosis of endometriosis and has had surgical or direct visualization (laparoscopy or laparotomy) and/or histopathologic confirmation of endometriosis, and the patient reports moderate, severe, or very severe pain during the most recent menses and/or during nonmenstrual portion of the cycle in the prior month 5. Is willing to use the study intervention as the sole method of contraception for 13 consecutive 28-day treatment cycles and does not intend to use any other form of contraception (for example, condoms). Key Exclusion Criteria: 1. Is pregnant, or breastfeeding, or has breastfed in the last year. 2. Has a known history of infertility or sub-fertility. 3. Has presence or history of a venous thromboembolic event (for example, deep vein thrombosis, pulmonary embolism), an arterial thrombotic or thromboembolic event (for example, myocardial infarction, stroke, or peripheral arterial), or a transient ischemic attack, angina pectoris, or claudication. 4. Has a higher risk of arterial, venous thrombotic, or thromboembolic disorders. 5. Has a history of migraine with aura or focal neurological symptoms. 6. Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors. 7. Has a history of clinically significant ventricular arrhythmias. 8. Has clinically significant liver disease, including active viral hepatitis or cirrhosis. 9. Has a history of pancreatitis associated with severe hypertriglyceridemia. 10. Has known human immunodeficiency virus (HIV) infection or high risk of contracting HIV. 11. Has a hepatic hemangioma or has a history of cholestasis with prior estrogen use or during pregnancy. 12. Has a serious contraindication to pregnancy (for example, a medical condition or use of chronic medication such as isotretinoin or thalidomide). 13. History of suicidal ideation or behavior, or confirmed yes to any question (with exception of non-suicidal self-injurious behavior, unless deemed as an unacceptable risk by the investigator) on the C-SSRS. 14. Has a bone mineral density Z-score ≤ -2.0 at lumbar spine, femoral neck, or total hip during the screening period. 15. Has a history of or currently has osteoporosis, or other metabolic bone disease, collagen vascular disease, chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperparathyroidism, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, abnormal bone mineral metabolism (eg, hypophosphatemia), or low traumatic (fragility) fracture. 16. Has used chronic glucocorticoids that are oral, parenteral, inhaled (prednisone equivalents of ≥ 2.5 mg daily for ≥ 3 months) in 12 months prior to the study. 17. Has known BRCA mutation or other mutation associated with increased risk of breast cancer. ; PRIMARY OUTCOME: Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI); SECONDARY OUTCOME 1: Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Modified At-Risk PI[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III; BRIEF: At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period. ; DRUG USED: Xeomin; DRUG CLASS: Biologic; INDICATION: Cervical Dystonia; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Merz Pharmaceuticals GmbH; CRITERIA: Main Inclusion Criteria: - Male or female outpatients between ages 18 and 75 years inclusive) - A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) with predominantly rotational form and a need for injection (determined by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score) - TWSTRS-Total score >= 20 - TWSTRS-Severity score >= 10 - TWSTRS-Disability score >= 3 - TWSTRS-Pain score >= 1 - On a stable dose of medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period - For pre-treated patients only: Source documentation of the last two consecutive injection sessions with Botulinum Toxin and stable therapeutic response directly prior to trial entry - For pre-treated patients only: At least 10 weeks must have been passed between the last injection with Botulinum Toxin for cervical dystonia and baseline - For pre-treated patients only: The most recent injection with Botulinum Toxin must have been maximal 300 Units of type A or 12,000 Units of type B Main Exclusion Criteria: - Traumatic torticollis or tardive torticollis - TWSTRS-Severity score for anterocollis >= 2 points (pure anterocollis) - TWSTRS-Severity score for retrocollis >= 2 points (pure retrocollis) - Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation) - Hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin Type A - Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial - Current swallowing disorder of any origin (dysphagia scale >= 3, i.e. severe, with swallowing difficulties and requiring a change in diet) - Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spine syndrome - Treatment with Botulinum Toxins for any indication other than cervical dystonia within 4 months prior to baseline and during the trial ; PRIMARY OUTCOME: Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo; SECONDARY OUTCOME 1: Change From Baseline in the TWSTRS-Total 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 - Entecavir-Treated Patients; BRIEF: This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection. ; DRUG USED: RG7795; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Toll-like receptor 7 (TLR7); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Chronic hepatitis B infection - Positive test for HBsAg for more than 6 months prior to randomization - HBsAg titer greater than or equal to (>/=) 250 international units per milliliter (IU/mL) at Screening - Treatment with any nucleoside/nucleotide analogue for >/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization - HBV DNA less than (<) 90 IU/mL for at least the preceding 6 months - HBeAg positive at randomization and for at least 6 months prior to randomization Exclusion Criteria: - Pregnant or lactating women - Documented history of HBV genotype D - History or other evidence of bleeding from esophageal varices - History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease - Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) - Documented history of hepatitis D infection - History of or suspicion of hepatocellular carcinoma - History of immunologically mediated disease - History of organ transplantation - History of thyroid disease - Significant acute infection ; PRIMARY OUTCOME: Safety: Percentage of Participants with Adverse Events; SECONDARY OUTCOME 1: Pharmacodynamics: Peripheral Blood Levels of Interferon (IFN)-Alpha in QOD Dosing Cohorts[/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 - VOLTAIRE-RA (vs. Adalimumab); BRIEF: Primary Objective: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®. Secondary Objectives: The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks. ; DRUG USED: Cyltezo; DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, which include medication washout and restrictions) and be willing to follow the protocol. - Male or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active Rheumatoid arthritis for at least 6 months as defined by at least six swollen joints (66 joint count) and at least six tender joints (68 joint count) at Screening and Baseline (Day 1), and either an Erythrocyte sedimentation rate of >28 mm/hour OR a C-reactive protein (CRP) level >1.0 mg/dL (normal: <0.4 mg/dL) at Screening. Patients must currently be receiving methotrexate (MTX) therapy. - Current treatment for Rheumatoid arthritis on an outpatient basis: 1. Must be receiving and tolerating oral or parenteral MTX therapy at a dose of 15 to 25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose) for at least 12 weeks immediately prior to Day 1. The dose and administration route should remain stable for at least 4 weeks prior to Day 1 until Week 24. After Week 24 the administration route can be changed at the investigators discretion. Patients receiving a lower dose of MTX (10 to 14 mg/week) should be doing so as a result of a documented history of intolerance to higher doses of MTX. 2. Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or folinic acid (at least 1 mg/week or as per local practice) or equivalent during the entire trial (mandatory comedication for MTX treatment). 3. Disease modifying antirheumatic drug (DMARD) use will be restricted according to guidelines listed in the trial protocol. 4. If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent. During the 4 weeks prior to Baseline (Day 1) the dose must remain stable. 5. Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable for at least 2 weeks prior to Day 1. 6. Patients may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day or chloroquine provided that the dose is not greater than 250 mg/day. These doses must have been stable for a minimum of 12 weeks prior to Day 1. The hydroxychloroquine or chloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the trial. - For participants of reproductive potential (males and females), a reliable means of contraception has to be used throughout trial participation(acceptable methods of birth control include for example birth control pills, intrauterine devices [IUDs], surgical sterilization, vasectomized partner and double barrier method.. All patients (males and females of child-bearing potential) must also agree to use an acceptable method of contraception for 6 months following completion or discontinuation from the trial medication. Exclusion criteria: - ACR functional Class IV or wheelchair/bed bound. - Primary or secondary immunodeficiency, including known history of HIV infection, or a positive test at Screening. - History of Tuberculosis, latent Tuberculosis, or positive purified protein derivative test or interferon gamma-releasing assay . - Known clinically significant coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure, or interstitial lung disease. - Previous treatment with >=2 biologic agents. - Previous treatment with adalimumab or adalimumab biosimilar. - Current treatment or previous treatment with leflunomide within 8 weeks. - History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to adalimumab or any component of the trial drug. - History of cancer including solid tumors, hematologic malignancies, and carcinoma in situ. - Has evidence of positive serology for Hepatitis B virus or Hepatitis C virus - Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit. Patients who are expecting to receive any live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug. - Any treatment that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial. - Patients with a significant disease other than Rheumatoid arthritis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders). A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patients ability to participate in the trial. - Premenopausal, sexually active women who are pregnant or nursing, or are of child-bearing potential and not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial. - History of, or current, inflammatory joint disease other than Rheumatoid arthritis or other systemic autoimmune disorder. - Diagnosis of juvenile idiopathic arthritis, and/or Rheumatoid arthritis before age 16. - Any planned surgical procedure within 12 weeks prior to the Screening Visit or for the duration of the trial. - Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous anti infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit. - History of deep space/tissue infection within 52 weeks of the Screening Visit. - History of serious infection or opportunistic infection in the last 2 years. - Any neurological, vascular or systemic disorder that might affect any of the efficacy assessments. - Currently active alcohol or drug abuse or history of alcohol or drug abuse within 2 years of the Screening Visit. - Treatment with intravenous Gamma Globulin or the Prosorba® Column within 6 months of the Screening Visit. - Treatment with intravenous, intramuscular, intra-articular and parenteral corticosteroids within 6 weeks prior to Day 1 or throughout the trial. - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times upper limit of normal. - Hemoglobin <8.0 g/dL. - Platelets <100,000/µL. - Leukocyte count <4000/µL. - Creatinine clearance <60 mL/min. - Patients who are currently participating in another clinical trial or who have been participating in another clinical trial with another investigational drug within a minimum of 12 weeks or five half-lives (whichever is longer) of the drug prior to Day 1. - Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins. ; PRIMARY OUTCOME: The Proportion of Patients Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 and Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMvigor010 (WO29636; Adjuvant); BRIEF: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group. ; DRUG USED: Tecentriq; 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: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters) - For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0 - For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0 - Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor programmed death-ligand 1 (PD-L1) expression prior to study enrollment - Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization - Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery - Eastern Cooperative Oncology Group performance status of less than or equal to (</=) 2 - Life expectancy greater than or equal to (>/=) 12 weeks - Adequate hematologic and end-organ function - For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab Exclusion Criteria: - Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment - Adjuvant chemotherapy or radiation therapy for UC following surgical resection - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment - Malignancies other than UC within 5 years prior to Cycle 1, Day 1 - Pregnancy or breastfeeding - Significant cardiovascular disease - Severe infections within 4 weeks prior to Cycle 1, Day 1 - Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation - History of autoimmune disease - Prior allogeneic stem cell or solid organ transplant - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan - Positive test for human immunodeficiency virus and/or active hepatitis B or hepatitis C or tuberculosis - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 - Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-CD40, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies ; PRIMARY OUTCOME: Disease-Free Survival (DFS), as Assessed by Investigator; SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LCP-AtorFen-2001; BRIEF: The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate. ; DRUG USED: AtorFen; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: HMG CoA Reductase (HMGR), PPAR alpha; THERAPY: Monotherapy; LEAD SPONSOR: Veloxis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL). 2. Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or >1000 mg of fish oil per day. 3. Other inclusion criteria might apply Exclusion Criteria: 1. TGs > 500 mg/dL. 2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior. 3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months. 4. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy. 5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia. 6. History of pancreatitis. 7. Known allergy or sensitivity to statins or fibrates. 8. Poorly controlled hypertension. 9. Other exclusion criteria might apply. ; PRIMARY OUTCOME: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy; SECONDARY OUTCOME 1: Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy[/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 - Peripheral Nerve Injury; BRIEF: This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily (BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 142 evaluable subjects. This is a double-blind, randomized, placebo-controlled, parallel group study. Subjects will undertake a screening period which may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over 28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg BID. ; DRUG USED: Losmapimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuropathic Pain; TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Male or female subjects aged 18 - 80 years inclusive, at the time of signing the informed consent. - Female of non-child bearing potential or child bearing potential who agrees to use appropriate contraception methods. - A diagnosis of peripheral neuropathic pain - Focal neuropathic pain related to nerve injury caused by trauma or surgery not associated with an acute medical condition or injury by avulsion (examples include but are not limited to neuropathic pain secondary to surgical procedures such as thoracotomy, mastectomy, inguinal herniorrhaphy and radical neck dissection, traumatic mononeuropathies and brachial plexus or lumbosacral injuries due to bullet wounds, lacerations, road traffic accidents etc). - Location of pain consistent with the area innervated by the affected nerve(s), with or without other sensory symptoms in the affected area. - Duration of pain should be at least 12 weeks since the initial insult. - Subjects on medications for neuropathic pain (including tricyclic antidepressants, anticonvulsants, opioids, tramadol, bupropion, venlafaxine, mexiletine, muscle relaxants, N-methyl-D-aspartate (NMDA) antagonists) but excluding but excluding non-steroidal anti-inflammatory drugs (NSAIDs), cycloxygenase-2 inhibitors (COX-2) , topical lidocaine, topical capsaicin, nerve blocks and steroid injections may only be included in the study if they have been on stable doses of such medications for at least 4 weeks prior to baseline period (Day -7). - Participants who have been on NSAIDs, COX-2 inhibitors and topical lidocaine may only be included in the study if they have stopped these medications for at least 5 half-lives prior to the baseline period (Day -7). In the case of topical capsaicin, subjects should have stopped this for at least 8 weeks prior to the baseline period. - Participants who have received nerve blocks or steroid injections for neuropathic pain may be included if their most recent treatment was at least 4 weeks prior to the baseline period (Day -7). - Subjects baseline average daily pain score on the PI-NRS, calculated as the average of their daily PI-NRS scores over the 7 days prior to Day 1, is greater than or equal to 4 on the PI-NRS, after wash-out of prohibited medications. Subjects will need to have recorded their daily PI-NRS for a minimum of 4 days during the 7 days prior to Day 1. Subjects will not be told prior to the completion of the baseline period that the entry requirement of the average PI-NRS is at least 4, in order not to bias their pain intensity score during the baseline period. - Male subjects must agree to use appropriate contraception methods. - Body weight >=50 kg for men and >=45 kg for women. - Participants has provided full written informed consent prior to the performance of any protocol-specified procedure, which includes compliance with the requirements and restrictions. - Single QT duration corrected for heart rate by Bazetts formula (QTcB) or QT duration corrected for heart rate by Fridericias formula (QTcF) < 450 msec; or QTc < 480 milliseconds (msec) in subjects with Bundle Branch Block. If the first QTc exceeds the above limits, repeat the ECG twice at least 5 min apart and take the mean of the three QTc values to determine that the mean QTc satisfies the above limits. - A subject with a clinical abnormality or other laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Exclusion Criteria: - Subjects with other causes for their neuropathic pain [e.g. trigeminal neuralgia, painful diabetic neuropathy, mononeuritis multiplex, central post-stroke pain, failed back surgery, phantom limb pain, peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus (HIV), syphilis, drug abuse, cobalamin (vitamin B12) deficiency, hypothyroidism, liver disease, toxic exposure], substantial somatic pain component or more than one cause or potential cause for pain symptoms or nerve entrapment or chronic neck or back pain of more than mild degree or any concurrent rheumatic disease such as but not limited to fibromyalgia or rheumatoid arthritis. - Subjects with intractable pain of unknown origin or active infection/inflammation in the area of nerve injury. - Subjects who have had extensive soft tissue injury associated with extensive surgery in the treatment of their nerve injury. Any question regarding the definition of extensive surgery should be discussed with the GSK medical monitor. - A positive pre-study drug/alcohol screen. However, a positive drug screen will not automatically exclude a subject if there is a medical explanation for the positive result other than drug abuse e.g. a subject who is taking opioids for their neuropathic pain. - A positive test for HIV antibody. - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening - History of any liver disease within the last 6 months. - History of excessive regular alcohol consumption within 6 months of the study. - History or presence of significant cardiovascular, gastro-intestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety. - History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests, or have any medical or psychiatric condition, which, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety. - Subject has clinical evidence of recent major depression (by medical history) except those subjects already controlled by anti-depressants at screening. - Subjects who, in the clinical judgement of the investigator, may be malingering or be motivated by secondary gain from participation in the study, will be excluded. Examples for consideration of exclusion include subjects who have compensation or social security claims pending in relation to their peripheral nerve injury or who are appealing against refusal of such claims, but subjects whose claims have been settled need not be excluded. - Changes to medications permitted for the treatment of neuropathic pain within 4 weeks of the baseline period (Day -7), including dose adjustment, withdrawal of medications or initiation of new medications. - Subjects who are unable to maintain the same medications for the treatment of neuropathic pain at the same stable dose as at baseline during the study. - Unable to refrain from excessive use of sedative medications (e.g. benzodiazepines prescribed as hypnotics) that in the opinion of the Investigator may interfere with efficacy or safety assessments. - Use of other prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication or during the study, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety or introduce a risk of drug-drug interactions. - Unable to stop and remain abstain from non-pharmacological treatments for their neuropathic pain during the study. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the baseline period (Day -7) in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - History of hypersensitivity to GW856553 or its components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. - Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56 day period. - Pregnant females as determined by positive urine or serum human chorionic gonadotropin (hCG) test at screening or prior to dosing. - Lactating females. - Unwillingness or inability to follow the study procedures - Subject is mentally or legally incapacitated. - Subjects with conditions requiring immunosuppressive therapy, or otherwise considered immunosuppressed. ; PRIMARY OUTCOME: Change in average daily pain score from baseline to Week 4 of treatment based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS); SECONDARY OUTCOME 1: Change in average daily pain score from baseline to Weeks 1, 2 and 3 of treatment and the week before the follow-up 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 II - AGTC-AAT-002; BRIEF: Assessment of the safety and efficacy of intramuscular (IM) administration of a recombinant adenoassociated virus (rAAV) alpha-1 antitrypsin (AAT) vector (rAAV1-CB-hAAT) in AAT-deficient adults at three dosage levels [6.0 × 10e11, 1.9 × 10e12 and 6.0 × 10e12 vector genome particles (vg) per kg body weight]. Funding Sources - The FDA Office of Orphan Products Development and NIH National Heart, Lung, and Blood Institute ; DRUG USED: rAAV1-CB-hAAT; DRUG CLASS: Biologic; INDICATION: Alpha-1 Antitrypsin Deficiency (A1AD or AATD); TARGET: Alpha-1-antitrypsin (A1AT); THERAPY: Monotherapy; LEAD SPONSOR: Applied Genetic Technologies Corp; CRITERIA: Inclusion Criteria: 1. Have a diagnosis of AAT-deficiency, as defined by a serum AAT level of less than 11 µM and a phenotype or genotype either homozygous for PI*Z or compound heterozygous consisting of PI*Z and another allele known to be associated with disease 2. Be at least 18 and not more than 75 years of age 3. Have a forced expiratory volume at one second (FEV1) >25% of predicted value (post bronchodilator) 4. Weigh ≤ 90 kg 5. Not receiving AAT augmentation therapy currently or with the past 3 months, and not planning to begin such therapy for at least 12 months after administration of rAAV1-CB-hAAT 6. Be willing to discontinue aspirin, aspirin-containing products, and other drugs that may alter platelet function, 7 days prior to dosing, resuming no earlier than 24 hours after the dose has been administered 7. Have acceptable laboratory parameters: - Hemoglobin ≥ 11.2 g/dL for females, ≥ 12.8 g/dL for males, - White blood cell count 3,300 - 12,000 cells/mm3, - Platelet count 125,000 - 550,000/mm3, - Serum creatine kinase (CK) ≤ 3 times upper normal range for study laboratory, - Alanine aminotransferase (ALT) ≤ 2 times upper normal range for study laboratory, - Serum bilirubin ≤ 1.5 times upper normal range for study laboratory, - Serum creatinine within normal range for study laboratory, - Prothrombin time (PT) ≤ 14.5 seconds and partial thromboplastin time (PTT) ≤ 36 seconds, - Normal urine dipstick (negative glucose, negative hemoglobin, and negative or trace protein), 8. For females of childbearing potential: - A negative pregnancy test (urine or serum) at screening and at baseline (within 2 days before administration of study agent) - Agreement to consistently use barrier contraception (condoms, diaphragm or cervical cap with spermicide) or another form of contraception (e.g. intrauterine device or hormonal contraception) from the screening visit until 12 months after administration of rAAV1-CB-hAAT, for sexual activity that could lead to pregnancy 9. For males of reproductive potential, agreement to consistently use barrier contraception (condoms with spermicide) for 12 months after administration of rAAV1-CB-hAAT, for sexual activity that could lead to pregnancy, 10. Provide signed informed consent before screening Exclusion Criteria: 1. Prior receipt of any AAV gene therapy product 2. Use of anticoagulants or anti-platelet agents within 7 days prior to study agent administration 3. History of immune response to human AAT augmentation therapy as indicated by clinical history of an adverse immune response to infusion and/or decreased therapeutic effect in combination with documentation of serum anti-AAT antibodies 4. Use of acute oral or intravenous antibiotic therapy for a respiratory infection within 28 days prior to study agent administration (long-term maintenance or chronic suppressive oral antibiotics, and antibiotics for a non-respiratory indication, are allowed) 5. Use of oral or systemic corticosteroids within 28 days prior to study agent administration 6. Use of any investigational agent, or any immunosuppressive drug(s), within 3 months prior to enrollment 7. For females of childbearing potential, a positive pregnancy test at screening or baseline (within 2 days before rAAV1-CB-hAAT administration) Note: At the Cincinnati Childrens Hospital Medical Center site, women of childbearing potential were not permitted to enroll in the study. 8. Females who are breast feeding 9. Have a significant abnormal EKG finding at screening and/or cardiac disease (e.g. recent myocardial infarction or CHF) within past 6 months 10. Have had pulmonary edema or a pulmonary embolism within the past 6 months 11. Have a history of immunodeficiency or other medical condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation ; PRIMARY OUTCOME: Frequency of Grade 3 or 4 Adverse Events; SECONDARY OUTCOME 1: Changes in Serum M-specific Alpha-1 Antitrypsin Concentration[/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 - BLOOM (Study 009); BRIEF: The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104) ; DRUG USED: Belviq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: - Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea) - Ability to complete a 2 year study Exclusion Criteria: - Diabetes - Pregnancy - History of heart valve disease - Serious or unstable current or past medical conditions ; PRIMARY OUTCOME: Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52; SECONDARY OUTCOME 1: Year 1: Percent Change in Body Weight From Baseline to 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 II - ENACT; BRIEF: This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures Days 2-4 and end-of study procedures on Day 30. Standard safety criteria will be analysed. Efficacy endpoints include the ability of NA-1 to: 1) reduce the volume of ischemic embolic strokes, 2) reduce the number of ischemic embolic strokes, 3) reduce vascular cognitive impairment, and 4) reduce the frequency of large strokes induced by the endovascular procedure. The plasma concentrations of NA-1 will also be analyzed. ; DRUG USED: NA-1; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ischemic Stroke; TARGET: PSD-95 (postsynaptic density protein 95)/SAP-90 (synapse-associated protein 90); THERAPY: Monotherapy; LEAD SPONSOR: NoNO Inc.; CRITERIA: Inclusion Criteria - A diagnosis of a ruptured or unruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, stent-assisted coiling, pipeline stent, balloon-assisted coiling, covered stent only, neck-bridge device, re-coiling, or re-treatment of a previously coiled/treated aneurysm. There are no restrictions on adjunctive devices. For patients with a ruptured aneurysm, endovascular repair must take place within 72 hours of the ictal haemorrhage. - If the aneurysm has ruptured, patient should be Grade I-III on the World Federation of Neurological Surgeons (WFNS) grading scale for subarachnoid hemorrhage. If the patient is intubated but alert and able to follow commands (at least a 2-step command), and is not kept intubated for neurological status (i.e., WFNS Grade IV or V), the patient is considered WFNS Grade III and is eligible for the trial. - Absence of ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, stroke-in-evolution, or clinical evidence of cerebral vasospasm within 2 weeks prior to randomization. (If a CT scan, cerebral angiogram, or other imaging performed during the 2 weeks prior to randomization shows radiological vasospasm deemed by the treating physician to be potentially clinically significant, the subject is excluded.) - Brain MRI imaging (DWI and FLAIR sequences) within 2 weeks prior to the endovascular aneurysm repair procedure as detailed in Section 8.2. Imaging must not demonstrate any focal ischemic stroke defined as a new region of restricted diffusion and/or a focal area of reduced perfusion on a relative mean transit time (rMTT) or relative time to peak (rTTP) map - Male or female with a minimum age of 18 years on the day of enrolment. - Female subjects of childbearing potential: Negative pregnancy test. After enrolment, blood will be drawn from women of childbearing potential for a confirmatory test of pregnancy as evaluated by a serum B-hCG test. The definition of non-childbearing potential includes the following: - Surgically sterile (e.g., hysterectomy with or without oophorectomy; fallopian tube ligation; endometrial ablation), at least 30 days prior to signature of the Informed Consent form - At least 5 years post-menopause (i.e., 6 years post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing. Non-surgically sterile females or females with undocumented post-menopausal status must be willing to use a medically approved method of birth control for 3 months after completion of dosing. - Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing. - Body weight less than or equal to 180 kg. - Normal or abnormal but not clinically significant findings in the - non-neurological physical examination - 12-lead ECG - PQ or PR interval less than or equal to 210 msec; - In unruptured aneurysm cases, QTc interval less than 450 msec for males or 470 msec for females. For ruptured aneurysm cases, QTc interval is not restricted. - vital signs - blood pressure between 80-180/50-100 mm Hg, - body temperature less than or equal to 38.5oC - Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed Informed Consent Form. Exclusion Criteria - Dissecting or mycotic brain aneurysm. Fusiform or atherosclerotic intracerebral aneurysms may be eligible for the trial if endovascular treatment is planned with a goal of exclusion of the aneurysm from the circulation. - Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment. - Known history of life-threatening allergic reaction to any medication. - Chronic renal disease defined as a baseline serum creatinine > 150 umol/L. - Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test. - Women who are breastfeeding. - Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol. - Pre-morbid (estimated) modified Rankin scale score of greater than 2. - Previous serious traumatic brain injury that would preclude the patient from completing the protocol or preclude MRI analysis of small strokes. - Patients with known HIV infection. - Patients who are unable to have an MRI scan for any reason. - Participation in a clinical trial with an investigational drug within 30 days preceding this study. Previous participation in the ENACT trial (e.g,, to treat a prior aneurysm), participation in another trial involving NA-1 or prior receipt of NA-1. - Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 30 days. ; PRIMARY OUTCOME: Volume of New FLAIR Lesions(MRI); SECONDARY OUTCOME 1: Number of New DWI Lesions (MRI)[/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 - Total Knee Arthroplasty; BRIEF: The purpose of this study is: - To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty. - To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin. ; DRUG USED: IONIS-FXI-Rx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor XI; THERAPY: Monotherapy; LEAD SPONSOR: Ionis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Give written informed consent - Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile, abstinent, or if engaged in sexual relations of child-bearing potential, must use contraception - Undergoing elective, primary unilateral total knee arthroplasty Exclusion Criteria: - Body weight <50 kg - Patients at increased risk of bleeding. History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year. - History of excessive intra- or direct post operative bleeding or a traumatic spinal or epidural anesthesia - Brain, spinal, or ophthalmologic surgery within the past 3 months - History of clinically significant liver disease in the past year - Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values - aPTT or PT or INR >ULN - Factor IX activity <LLN - Factor VIII activity, vWF antigen or Ristocetin cofactor activity <0.5 U/mL - FXI activity <0.3 U/mL - Urine protein or blood persistently positive by dipstick. In the event of positive test results, eligibility may be confirmed with urine microscopy or 24 hour urine protein measurement as applicable - ALT or AST >1.5 x ULN - Total bilirubin >ULN - Platelet count <150,000 (or history of thrombocytopenia) - Hypersensitivity to enoxaparin - Anticipated concomitant use of anticoagulants/antiplatelet agents or the NSAID nimesulide that may affect study outcome or any other drug influencing coagulation (except low dose aspirin and short acting NSAIDs with a half-life <20 hours) at least 7 days before surgery or during treatment with ISIS Rx. - Anticipated use of indwelling intrathecal or epidural catheters - Anemia at Screening - Have any other conditions which could interfere with the patient participating in or completing the study ; PRIMARY OUTCOME: Primary efficacy outcome; SECONDARY OUTCOME 1: Secondary efficacy outcome[/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 - Pediatric; BRIEF: This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in approximately 12 pediatric female and male subjects (14 to 17 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH). ; DRUG USED: NBI-74788; DRUG CLASS: New Molecular Entity (NME); INDICATION: Congenital Adrenal Hyperplasia (CAH); TARGET: Corticotropin Releasing Factor -Receptor1 (CRF-R1), Corticotropin Releasing Factor -Receptor2 (CRF-R2); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: 1. Be in good general health. 2. Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH. 3. Be on a stable regimen of steroidal treatment for CAH that is expected to remain stable throughout the study. 4. Subjects of childbearing potential must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently from screening until the final study visit or a prespecified window after the last dose of study drug, whichever is longer. 5. Subjects of childbearing potential must have a negative pregnancy test at screening and negative urine pregnancy test at baseline. 6. Have a negative urine drug (for illegal drugs) and alcohol breath test at screening and baseline. 7. Be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent form, including all requirements at the study center and return for the follow-up visit. Exclusion Criteria: 1. Have a clinically significant unstable medical condition or chronic disease, or malignancy. 2. Had a medically significant illness within 30 days of screening. 3. Have a known or suspected differential diagnosis of any of the other known forms of classic CAH. 4. Have a history that includes bilateral adrenalectomy, hypopituitarism, or other condition requiring daily therapy with orally administered glucocorticoids. 5. Are pregnant or lactating females. 6. Have a history of epilepsy or serious head injury. 7. Have a known history of long QT syndrome or cardiac tachy-arrhythmia. 8. Have hypersensitivity to any corticotropin releasing hormone antagonists. 9. Test positive at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or have a history of a positive result. 10. Have a recent history (≤1 year) of alcohol or drug abuse, or current evidence of substance dependence or abuse criteria. 11. Used any anticoagulants or antiplatelet therapies within 30 days before screening. 12. Have an active bleeding disorder. 13. Used any other investigational drug within 30 days before initial screening, or plans to use an investigational drug (other than the study drug) during the study. 14. Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days before baseline. ; PRIMARY OUTCOME: Number of participants with adverse events following dosing of NBI-74788; SECONDARY OUTCOME 1: Area under the plasma concentration versus time curve (AUC) of NBI-74788 and its metabolites following dosing of NBI-74788[/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 - Bunionectomy Surgery; BRIEF: The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy. ; DRUG USED: Dexmedetomidine (Intranasal); DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Baudax Bio; CRITERIA: Inclusion Criteria: - Voluntarily provide written informed consent. - Male or female between 18 and 70 years of age, inclusive. - Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair - Be American Society of Anesthesiology (ASA) physical class 1 or 2. - Female subject are eligible only if all the following apply: - Not pregnant; - Not lactating; - Not planning to become pregnant during the study; - Be surgically sterile; or at least two year post menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive. - Male subjects must be surgically sterile or commit to the use of a reliable method of birth control - Have a body mass index ≤35 kg/m2 - Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program. Exclusion Criteria: - Have a known allergy to dexmedetomidine or any excipient DEX-IN/placebo or to any peri- or postoperative medications used in this study. - Have a clinically significant abnormal clinical laboratory tests value. - Have history of or positive test results for HIV, or hepatitis B or C. - Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study. - Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants. - Have another painful physical condition that may confound the assessments of post operative pain. - Have a history of syncope or other syncopal attacks. - Have evidence of a clinically significant 12 lead ECG abnormality. - Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse.. - Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse. - Have a history or evidence of orthostatic hypotension. - Have a resting heart rate of <50 beats per minutes or systolic blood pressure <100mmHg. - Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months. - Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigators opinion may exert significant analgesic properties or act synergistically with DEX-IN. - Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half lives of the specific prior medication (or, if half life is not known, within 48 hours) before dosing. - Have utilized any intranasal medications within the preceding 10 days. - Have signs or a history of significant rhinitis or rhinorrhea (constant or chronic), nasal polyps, mucosal lesions of the nostril, postnasal drip of any etiology (constant or chronic), nasal ulcers, septal perforation or deviation, any nasal surgery, anosmia, nasal piercings, or frequent nosebleeds or other nasal pathology, that is sufficient to interfere with IN drug delivery. - Have had an upper respiratory tract infection within 14 days of screening. - Have utilized corticosteroids, either systemically, inhalational either intranasally or oral, or by intra-articular injection, within 14 days prior to the study. - Have received any investigational product within 30 days before dosing with study medication. - Have previously received DEX-IN in clinical trials, or had bunionectomy in the last 3 months. ; PRIMARY OUTCOME: Summed Pain Intensity Difference Over the First 48 Hours (SPID48).; 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 - VALOR (PGTC Seizures); BRIEF: Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion. ; DRUG USED: Vimpat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Collapsin Response Mediator Protein 2 (CRMP-2), Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: UCB BIOSCIENCES, Inc.; CRITERIA: Inclusion Criteria: - Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981) - Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline) - If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures - Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS) - Subjects are required to have had an electroencephalogram (EEG) report consistent with idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer Exclusion Criteria: - Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM) - Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE) - Subject has an active suicidal ideation as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Since Last Visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) - Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilberts syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilberts syndrome (ie, direct bilirubin <35%) For randomized subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic case report form (eCRF). If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening. ; PRIMARY OUTCOME: Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24); SECONDARY OUTCOME 1: Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - w/Paclitaxel; BRIEF: Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC) ; DRUG USED: Vistusertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically proven squamous non-small cell lung cancer (NSCLC) where treatment with weekly paclitaxel is an appropriate treatment option. 2. Relapsed or refractory disease after at least one line of prior therapy. Subjects must have previously received appropriate line(s) of standard of care (SOC) treatment. 3. Measurable disease by RECIST v1.1 criteria 4. Life expectancy of at least 12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal products and 6 weeks for nitrosoureas and Mitomycin-C) before treatment. 2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade 1 toxicities which, in the opinion of the Investigator, should not exclude the patient. 3. Known leptomeningeal involvement, brain metastases or spinal cord compression. 4. History of hypersensitivity (> Grade 2) to active or inactive excipients of AZD2014, drugs containing Cremophor, taxanes or structurally/chemically similar drugs 5. Current refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014 6. Patients with Diabetes Type I or uncontrolled Type II (HbA1c > 59 mmol/mol assessed locally) as judged by the Investigator 7. Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study and from which the patient has not yet recovered 8. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as: - Absolute neutrophil count 1500 cells/mm3 (1.5 x 109/L) - Platelet count 100.000 cells/mm3 (100 x 109/L) - Haemoglobin 9.0 g/dL 9. Adequate hepatic and renal function defined as: - Serum aspartate transaminase (AST) or alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or 5 x ULN in the presence of liver metastases - Alkaline phosphatase (ALP) < 5 x ULN - Serum bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilberts syndrome or of non-hepatic origin) - Estimated Creatinine Clearance 50 ml/min (Cockcroft-Gault) or serum creatinine 1.5 x ULN ; PRIMARY OUTCOME: Percentage of Patients Who Have a Partial Response or Complete Response Through Measurement of Tumour Lesion Sizes; SECONDARY OUTCOME 1: Number of Patients Who Experienced at Least One Adverse Event (AE) or Serious Adverse Event (SAE)[/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 - DiViD (Oslo University); BRIEF: The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D). ; DRUG USED: Diamyd; DRUG CLASS: Vaccine; INDICATION: Diabetes Mellitus, Type I; TARGET: Glutamic Acid Decarboxylase (GAD), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Oslo University Hospital; CRITERIA: Inclusion Criteria: - Newly diagnosed classical type-1 diabetes - Positive GAD antibodies - Fasting C-peptide >0.1 mmol/l - Insulin dosage >0.1 U/kg Bodyweight/day Exclusion Criteria: - Pregnancy - Weaning - Other chronic diseases than diabetes - Any regular medication except oral contraceptives - Psychiatric disturbances ; PRIMARY OUTCOME: Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies; SECONDARY OUTCOME 1: Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - PC CE101/06 (CIN 1/2/3); BRIEF: The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery). ; DRUG USED: Cevira; DRUG CLASS: Non-NME; INDICATION: Cervical Dysplasia; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Photocure; CRITERIA: Inclusion Criteria: - Positive histology of CIN 1-3 Exclusion Criteria: - Patients with endocervical lesions - Patients with AGUS - Patients with invasive disease - Patients with porphyria - Patients sensitive to MAL and HAL ; PRIMARY OUTCOME: Lesion eradication; SECONDARY OUTCOME 1: Eradication of lesion and HPV[/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 - P05692 - 26wk Extension; BRIEF: Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion criteria: - Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment - Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691 Exclusion criteria: - A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subjects continuation into this long-term extension trial - A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691 - A participant must not be at imminent risk of self-harm or harm to others ; PRIMARY OUTCOME: Number of participants experiencing clinical and laboratory adverse events (AEs); 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 IIa - 02; BRIEF: A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure. ; DRUG USED: Cimlanod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Guanylate Cyclase (sGC), Ryanodine Receptor (RyRs), Sarcoplasmic reticulum Ca2+-ATPase (SERCA); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Inclusion Criteria -In order to be eligible for study participation, a patient MUST: - Be ≥ 18 and ≤ 85 years of age; - Have a left ventricular ejection fraction (LVEF) ≤40%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) within 3 months prior to or during the current hospitalization; - Be hospitalized with a primary heart failure or heart failure-related reason, e.g., acute decompensation of heart failure, transplant evaluation, hemodynamic optimization prior to ambulatory inotropes or left ventricular assist device placement; - Have an indwelling pulmonary artery (PA) catheter in place for assessment of central hemodynamic parameters; [Note: The indwelling catheter may already be in place for medically-indicated reasons, OR be placed for the primary purpose of monitoring the hemodynamic effects of the study drug. If the pulmonary artery catheter is to be placed for the sole purpose of monitoring the hemodynamic effect of the study drug, the patient must have a cardiac index (CI) ≤ 2.2L/min•m2 as measured by a non-invasive cardiac output monitor (NICaS device) ≤6 hours prior to placement of the catheter. In this setting, Exclusion Criteria 3 below also applies.] - Have a Fick and/or thermodilution determination of cardiac index ≤2.5L/min•m2 at screening, i.e., ≤4 hours before the intended start of the study drug infusion; [Note: For determinations of CI using the thermodilution method, a mean of three consecutive values measured approximately 5 minutes apart, none of which differs from the mean value by more than 15%, should be used.] - Have a screening and baseline PCWP (or PAD, if a PCWP waveform cannot be reliably obtained) of ≥20 mmHg if systolic blood pressure is ≥100mmHg OR ≥22mmHg if systolic blood pressure is between 95-99mmHg (inclusive); - Be considered sufficiently stable to be expected not to require administration of any IV or oral vasoactive medications, including diuretics, for at least ~10 hours, i.e., from 4 hours before performing baseline hemodynamic assessments until after the completion of the 6-hour study drug infusion; - Have a body weight of at least 50kg (110 pounds), but not more than 125kg (275 pounds), and have a body mass index (BMI) <40kg/m2; - Have adequate peripheral forearm vein access or an available central line port for administration of study drug; - Be capable of understanding the nature of the trial; be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study (screening period, treatment period, and 30-day post-infusion follow-up period); and be willing to participate in the study, as documented by written informed consent. Exclusion Criteria- - In order to be eligible for study participation, a patient MUST NOT: - Have a heart rate <50 or >110 beats per minute (bpm) at baseline; - Have a screening OR baseline systolic blood pressure (SBP) of >150mmHg or <100mmHg, if PCWP ≥ 20mmHg, but <22mmHg OR <95mmHg, if PCWP ≥ 22mmHg; - Have tricuspid or pulmonary valve prosthesis or endocarditis, right heart mass, a history of pneumothorax or hemothorax, a bleeding diathesis that would preclude placement of a PAL, or a history of complications from previous pulmonary artery catheter placement, when a pulmonary artery catheter is to be placed solely for the purposes of monitoring the hemodynamic effects of the study drug; In this setting, patients with multiple intracardiac leads and/or left bundle branch block should have such elective pulmonary artery catheter placement performed under radiologic guidance by experienced personnel, e.g. in the cardiac catheterization laboratory. [Note: Other pertinent history, such as trauma, vascular injury or previous surgery should guide selection of the vessel for PAL placement.] - Have a primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8cm) or uncorrected severe valvular disease as defined by AHA/ACC/ESC criteria; - Have been treated with dopamine, dobutamine, enoximone, nesiritide, nitroglycerine or nitroprusside within 4 hours, or with levosimendan, amrinone or milrinone within 8 hours, prior to performing baseline hemodynamic assessments, or have an anticipated need to be treated with any of these agents before the completion of the 6-hour study drug infusion; - Be receiving concomitant parenteral therapy with any antiarrhythmic drugs (oral therapy is allowed); - Be in atrial fibrillation/flutter with an uncontrolled rate (≥100bpm) at the time of randomization; [Note: Patients with a history of A-fib/flutter are eligible, if heart rate is controlled with a ventricular rate not exceeding 100bpm.] - Have non-sustained ventricular tachycardia (NSVT) of 10 beats or more during any bedside monitoring within 2 hours prior to randomization, or have excessive premature ventricular contractions (PVCs) or complex multifocal ventricular ectopy exceeding 10 beats per minute on a 2-minute rhythm strip taken within 2 hours prior to randomization; - Require, or be expected to require, any alteration of settings to an implantable cardioverter-defibrillator (ICD), single chamber or biventricular pacemaker, if applicable, from 2 hours before the intended start of the study drug infusion, until after the completion of the study drug infusion; - Have a history of sudden cardiac death/resuscitation or other appropriate ICD firing within the past 1 year. (Inappropriate ICD firings are not exclusionary); - Be hospitalized with acute coronary syndrome or acute myocardial infarction during the previous 90 days prior to randomization; - Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) within 6 months prior to randomization; - Have a digoxin level above 1ng/ml (1.281nmol/L) within 8 hours before initiation of the study drug infusion; - Have persistent abnormal serum electrolytes at baseline, as defined by: a Na+ concentration <130 or >145 mEq/L, or a K+ or Mg2+ concentration outside the normal range (according to the local laboratory); [Note: Any observed electrolyte abnormalities during screening or earlier should be corrected by electrolyte supplementation and within normal acceptable concentrations should be confirmed prior to dosing. Any serum electrolyte abnormalities with associated clinical instability within 8 hours before initiation of the study drug infusion is exclusionary.] - Have an ALT or AST >3 times the upper normal limit or a hemoglobin <10g/dl (100g/L) within 8 hours before initiation of the study drug infusion; - Have a serum creatinine >2.5mg/dl (221µmol/L) or severe renal insufficiency [based on any standard limit and equation employed by the local lab, such as a GFR < 30mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) equation] within 8 hours before initiation of the study drug infusion; - Have taken an oral phosphodiesterase type 5 inhibitor (PDE5) inhibitor within 96 hours before initiation of the study drug infusion; - If female, be pregnant or of child-bearing potential (i.e., female patients must be post-menopausal or surgically sterilized); - Be receiving a drug which is expected to possess a potential for a clinically significant pharmacokinetic interaction with CXL-1427, as defined in the CXL-1427 Investigators Brochure; - Be the recipient of a myocardial restraint device or flap; - Have an anticipated survival of less than 90 days, for any reason; - Have received an investigational drug, device or biologic product within 30 days (or if longer, 5 half-lives for a drug or biologic agent) prior to randomization, or be planning to receive an investigational agent at any time throughout the full duration of the study until at least 30 days after discontinuation of study drug; - Have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigators opinion, makes it inappropriate for the patient to participate in this clinical trial. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events; SECONDARY OUTCOME 1: Mean Time-Averaged Change From Baseline in Adjudicated Pulmonary Artery Systolic Pressure (PAS) During the Infusion[/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 - PT017; BRIEF: The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care. ; DRUG USED: Bermekimab; DRUG CLASS: Biologic; INDICATION: Percutaneous Coronary Intervention Restenosis; TARGET: IL-1 (Interleukin-1); THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have suspected superficial femoro-popliteal artery occlusion due to lower extremity pain with exercise or at rest and are undergoing a planned arteriogram. - Subjects will be randomized after angiographic evidence of qualifying lesion Exclusion Criteria: - Acute critical limb ischemia - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - 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. ; PRIMARY OUTCOME: Safety and tolerability of CV-18C3; SECONDARY OUTCOME 1: Time to restenosis and restenosis rates compared between CV-18C3 and controls[/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 - Adolescents; BRIEF: This is a prospective, randomized, double-blinded, multicenter, pivotal study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control will be administered as single immunization on Day 1. Overall, approximately 750 male and female subjects aged 12 years to <18 years will be enrolled into the study. ; DRUG USED: VLA1553; DRUG CLASS: Vaccine; INDICATION: Antiviral - Miscellaneous Vaccines; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Butantan Institute; CRITERIA: Inclusion Criteria: 1. From the 12th birthday to the last day before the 18th birthday on the Day of screening; 2. able to provide informed consent as well as written informed consent by the subjects legal representative ; 3. generally healthy as determined by the Investigators clinical judgement based on medical history, physical examination and screening laboratory tests; 4. seropositive for previous CHIKV exposure (i.e. IgM+/IgG+ or IgM-/IgG+) or seronegative (i.e. IgM-/IgG-) as screened by CHIKV-specific ELISA. 5. for women of childbearing potential: 1. negative serum or urine pregnancy test at screening. 2. practiced an adequate method of contraception during 30 days before screening 3. agrees to employ adequate birth control measures for the first three months post-vaccination (i.e. until Day 85). Exclusion Criteria: 1. CHIKV infection in the past, including suspected CHIKV infection; is taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or has participated in a clinical study involving an investigational CHIKV vaccine; 2. acute or recent infection; 3. tests positive for human immunodeficiency virus (HIV) human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); 4. live virus vaccine within 28 days or inactivated vaccine within 14 days prior to vaccination in this study or plans to receive a vaccine within 28 days or 14 days after vaccination, respectively; 5. abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the study; 6. medical history of or currently has acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation in the study; 7. history of immune-mediated or clinically relevant arthritis / arthralgia; 8. history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the subject may be enrolled; 9. known or suspected defect of the immune system, such as subjects with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to vaccination; 10. history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications); 11. with clinical conditions representing a contraindication to intramuscular vaccination and blood draws; 12. pregnant or lactating at the time of enrollment; 13. donation of blood, blood fractions or plasma within 30 days or received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or plans to donate blood or use blood products until Day 180 of the study; 14. rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating; 15. known or suspected problem with alcohol or drug abuse as determined by the Investigator; 16. any condition that, in the opinion of the Investigator, may compromise the subjects well-being, might interfere with evaluation of study endpoints, or would limit the subjects ability to complete the study; 17. committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities); 18. participation in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study; 19. member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study. ; PRIMARY OUTCOME: Seroprotection; SECONDARY OUTCOME 1: Immunogenicity[/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 - RAPID-C (China); BRIEF: This study will evaluate the safety & efficacy of Certolizumab Pegol (CZP) as additional medication to Methotrexate (MTX) in Chinese subjects with Rheumatoid Arthritis. 400 patients will be randomized to receive either CZP + MTX or placebo + MTX. Anticipated time in the study is about 32 weeks. ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Combination; LEAD SPONSOR: UCB Pharma SA, Belgium; CRITERIA: Inclusion Criteria: - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or by the legal representative - Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgment of the Investigator - Subject is male or female, and at least 18 years of age at the Screening Visit - Subjects must have a diagnosis of adult onset Rheumatoid Arthritis RA of at least 6 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988). - Subjects must have active RA disease as defined by: - ≥6 tender joints at Screening and Baseline - ≥6 swollen joints at Screening and Baseline - Fulfilling 1 of the following 2 criteria during the Screening Period: - European League Against Rheumatism (ESR) (Westergren) ≥30 mm/hour, or - C-reactive protein (CRP) >15 mg/L - Subjects must have a normal chest x ray within 3 months prior to the Baseline Visit - Female subjects with childbearing potential should have a negative pregnancy test at Screening and at Baseline and should have a medically accepted method of contraception used during the entire duration of the study and for 10 weeks after the last dose of Certolizumab Pegol (CZP). - Male subjects must agree to ensure they use adequate contraception during the study and for at least 10 weeks after the subject receives their last dose of study medication - Subjects must have received treatment with Methotrexate (MTX) (with or without folic acid) for at least 3 months prior to the Baseline Visit. The dose and route of administration of MTX must have been stable for at least 2 months prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10 mg weekly Exclusion Criteria: Rheumatoid Arthritis disease-related exclusions: - Subjects have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis) - Subjects have a secondary, noninflammatory type of arthritis (eg, Osteoarthritis or Fibromyalgia) that in the Investigators opinion is symptomatic enough to interfere with evaluation of the effect of study medication on the subjects primary diagnosis of Rheumatoid Arthritis (RA) - Subjects have a history of an infected joint prosthesis at any time with that prosthesis still in situ - Subjects have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity Concomitant medication exclusions: - Subjects must be free of prohibited medication, Analgesics (including Paracetamol and Acetominophen), NSAIDs /COX-2 Inhibitors, Oral corticosteroids, DMARDs, etc. as detailed in protocol Previous clinical studies and previous biological therapy exclusions - Subjects have previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study - Subjects have participated in another study of an investigational medicinal product (or a medical device) within the previous 3 months or are currently participating in another study of an investigational medicinal product (or a medical device) - Subjects have received any experimental nonbiological therapy, within or outside a clinical study in the 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit - Subjects have received any biological therapy for RA within 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit, except for Etanercept and Anakinra where only a 1 month washout prior to the Baseline Visit is necessary - Subjects have received Rituximab or Tocilizumab - Subjects have received Yunke (technetium-99 conjugated with methylene diphosphonate) other than for diagnostic purpose within 5 years prior to Baseline - Subjects have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction - Subjects who failed to respond to previous treatment with a Tumor Necrosis Factor (TNF) blocking drug are excluded. Subjects who initially responded to a maximum of 2 TNF blocking agents but who later discontinued the agent(s) due to loss of efficacy or other reasons may be included Medical history exclusions: - Female subjects who are breast feeding, pregnant, or plan to become pregnant during the study or for 3 months following last dose of study medication - Subjects with a history of chronic infection, recent serious or life threatening infection (within 6 months, including herpes zoster), or a current sign or symptom that may indicate an infection (eg, fever, cough) - Subjects with a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens including but not limited to histoplasmosis, coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus, and nontuberculous mycobacteria (NTMB) - Radiographic evidence suggestive of any of these infections is sufficient grounds for exclusion - Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB infection, or Latent Tuberculosis (LTB) infection are excluded - Subjects at a high risk of infection (eg, leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and subjects that are permanently bedridden or wheelchair bound) - Subjects with a positive Hepatitis B surface antigen (HBsAg) test and/or Hepatitis C virus antibody (anti HCV) test result - Subjects with positive human immunodeficiency virus (HIV) test - Subjects receiving any live (includes attenuated) vaccination within 56 days prior to Baseline (eg, injectable influenza and pneumococcal vaccines are allowed, but nasal influenza vaccine is not) - Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time - Subjects with an active malignancy of any type or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to Screening) - Subjects with a history of blood dyscrasias, eg, leukemia or hemophilia where the blood constituents are abnormal or are present in abnormal quantity - Subjects with class III or IV congestive heart failure New York Heart Association (NYHA) 1994 - Subjects with a history of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis) - Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, GI, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subjects participation in the study. Abnormal laboratory parameters as detailed in protocol that require exclusion of a subject - Subjects with a history of an adverse reaction to Polyethylene Glycol (PEG) or a protein based medicinal product or known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol ; PRIMARY OUTCOME: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 24; SECONDARY OUTCOME 1: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Proof-of-Concept (Children); BRIEF: This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose infusion rates in children < 1 year of age with congenital hyperinsulinism. ; DRUG USED: Gvoke RTU Micro; DRUG CLASS: Non-NME; INDICATION: Hyperinsulinemia/Hypoglycemia; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Xeris Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Diagnosed with hyperinsulinism: a. Biochemical; detectable insulin (i.e., ≥1 µIU/L) at time of hypoglycemia (i.e, blood glucose <50 mg/dl), and/or suppressed free fatty acids (FFA), and/or suppressed beta-hydroxybutyrate (BOHB) and/or glycemic response to glucagon at time of hypoglycemia. 2. Absolute necessity of intravenous glucose to prevent hypoglycemia: 1. Having failed diazoxide therapy as defined by inadequacy of 5 days maximum dose of diazoxide to eliminate the need for IV glucose, not necessarily that diazoxide has no effect. 2. May be on diazoxide and/or octreotide, but these drugs will be weaned off prior to randomization. 3. May be on dextrose feeds. 3. Patient may be a participant in other study protocols such as observational studies, as long as no investigational intervention has taken place within 24 hrs. prior to screening. 4. Less than 12 months of age at screening. Exclusion Criteria: 1. History of allergy to glucagon or excipients in the CSI-Glucagon formulation. 2. Currently receiving, or less than 12 hours removed from IV glucagon treatment that resulted in a best achievable GIR > 8 mg/(kg*min), prior to the start of study drug. 3. Diazoxide naïve or within five days of starting diazoxide. 4. Receiving steroids at doses larger than 20 mg/m2/day (hydrocortisone equivalent). 5. Patients with sepsis. 6. Receiving alpha or beta agonists for blood pressure support. 7. Received an investigational or other study drug within 5 half-lives of drug. 8. Body weight less than or equal to 2.3 kg/5.0 lbs. 9. History of pancreatectomy and GIR < 8 mg/(kg*min) after weaning of all concomitant therapies. ; PRIMARY OUTCOME: Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Double-Blind); SECONDARY OUTCOME 1: Percent Change in GIR (Double-Blind)[/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 - AURORA2; BRIEF: The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN). ; DRUG USED: Lupkynis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Lupus Nephritis; TARGET: Calcineurin phosphatase ; THERAPY: Monotherapy; LEAD SPONSOR: Aurinia Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval. 2. Written informed consent before any study-specific procedures were performed. 3. In the opinion of the investigator, subject required continued immunosuppressive therapy. 4. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12. 5. Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study. Exclusion Criteria: 1. Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study. 2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. 3. A planned kidney transplant within study treatment period. 4. Subjects with any medical condition which, in the Investigators judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes. 5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 6. Vaccines using live organisms, virus or bacterial, while taking the study treatment. ; PRIMARY OUTCOME: Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.; SECONDARY OUTCOME 1: Number (and Percent) of Subjects in Renal 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 - STRIDE-1 (TRD); BRIEF: To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD. Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period. ; DRUG USED: AXS-05; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine Reuptake, Nicotinic Acetylcholine Receptors (nAChR) , NMDA Glutamate Receptor, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Receptors - Unspecified, Sigma-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Axsome Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Currently meets DSM-V criteria for MDD - History of inadequate response to 1 or 2 adequate antidepressant treatments - Body mass index (BMI) between 18 and 40 kg/m2, inclusive - Agree to use adequate method of contraception for the duration of the study - Additional criteria may apply Key Exclusion Criteria: - Suicide risk - Treatment with any investigational drug within 6 months - History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study - Additional criteria may apply ; PRIMARY OUTCOME: Montgomery-Åsberg Depression Rating Scale (MADRS) total score; SECONDARY OUTCOME 1: Clinical Global Impressions-Severity (CGI-S)[/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 - AWARD-4 (vs. Insulin Glargine); BRIEF: The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Type 2 diabetes - Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications - Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11% - Willing to inject subcutaneous medication - Willing to monitor blood glucose levels and adjust insulin dose - Willing to maintain a study diary - Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2) - Stable weight for 3 months prior to screening - Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug Exclusion Criteria: - Type 1 Diabetes - Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening - 1 or more episodes of ketoacidosis within 6 months prior to screening - Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening - Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening - Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled - History of heart failure, New York Heart Classification III or IV within 2 months prior to screening - Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility - Acute or chronic hepatitis or pancreatitis - Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia - Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening - Organ transplant except cornea - Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis - History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years - Known drug or alcohol abuse - Have enrolled in another clinical trial within the last 30 days - Have previously signed an informed consent or participated in a LY2189265 study ; PRIMARY OUTCOME: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c); SECONDARY OUTCOME 1: Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)[/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 - LUMINOS-103; BRIEF: This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which will be referred to throughout this protocol as anti-PD-1/L1 therapy) therapy in adult patients with solid tumor cancers. Non-muscle invasive Bladder Cancer has been selected as the tumor specific cancer of interest for enrollment. ; DRUG USED: PVSRIPO; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: Istari Oncology, Inc.; CRITERIA: Master Protocol Inclusion Criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Age ≥ 18 years of age at the time of signing the informed consent. 3. Prior CDC-recommended vaccination series against PV and has received a boost immunization with trivalent Poliovirus Vaccine Inactivated (IPOL®) (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to Cycle 1 Day 1. * Note: Patients who are unsure of their vaccination status must provide evidence of anti-PV immunity prior to enrollment, as applicable. 4. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 5. A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting the histology of the tumor type of interest must be confirmed to be available to send to the Sponsor. * Note: additional details can be found in the tumor specific appendix. 6. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. 7. Adequate bone marrow and liver function as assessed by the following: - Hemoglobin ≥9.0 g/dl (patients may be transfused) - Lymphocyte count ≥ 0.5 x 109/L (500/µL) - Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL) - Platelet count ≥100 x 109/L (100,000/µL) without transfusion - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) - Subjects with documented liver metastases: AST and ALT ≤5 x ULN - Serum total bilirubin ≤1.5 x ULN OR direct bilirubin <ULN for patients with total bilirubin > 1.5 x ULN - For patients not receiving therapeutic anticoagulation: international normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT) (or activated partial thromboplastin time [aPTT]) ≤ 1.5 x ULN 8. Resolution of nonhematologic toxicities from prior therapy or surgical procedures to ≤ Grade 1 or baseline (except alopecia). 9. Contraceptive use by men or women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Master Protocol Exclusion Criteria: 1. Any radiotherapy, chemotherapy, immunotherapy, biological, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or prostate-specific antigen persistence/recurrence without metastatic disease) within 21 days of Cycle 1 Day 1. 2. Patients requiring anticoagulation with warfarin are excluded. Additional eligibility criteria for anticoagulation requirements for each solid tumor cancer of interest will be provided in the tumor specific appendix. 3. Presence of central nervous system (CNS) metastases requiring immediate treatment with radiation therapy or steroids (ie, patient must be off steroids administered for brain metastases for ≥ 14 days prior to Cycle Day 1). Leptomeningeal disease is excluded regardless of clinical stability or treatment status. 4. Clinically significant (ie, active) cardiovascular disease at the time of signing the informed consent; for example, cerebrovascular accidents (≤ 6 months before the first dose of lerapolturev, myocardial infarction (≤ 6 months before the first dose of lerapolturev), unstable angina, serious cardiac arrythmia requiring medication, or uncontrolled symptomatic congestive heart failure [Class II or higher as defined by the New York Heart Association [NYHA] functional classification system; see Appendix 4]). 5. QTcF interval > 450 msec (males) or > 470 msec (females) at Screening (confirmed in triplicate). For patients with ventricular pacemakers or bundle branch block, QTcF >500 msec. 6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle Day 1, or anticipation of the need for major surgical procedure during the course of the study. 7. Active or history of autoimmune disease or immune deficiency within previous 2 years, with the following exceptions: - History of autoimmune-related hypothyroidism that is managed by thyroid replacement hormone - Type 1 diabetes mellitus that is well-controlled (as determined by the Investigator) by an established insulin regimen - Eczema, psoriasis, or lichen simplex chronicus with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded), provided all of the following conditions are met: - Rash must cover < 10% of body surface area - Disease is well-controlled (as determined by the Investigator) at baseline and requires only low-potency topical corticosteroids - No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within 12 months of Cycle 1 Day 1 8. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. - History of radiation pneumonitis in the radiation field (fibrosis) is allowed. 9. Uncontrolled pleural effusion, pericardial effusion, or ascites; patients with indwelling catheters (eg, PleurX®) are allowed. 10. Known serious active infection (eg, human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.). - Participants with a negative hepatitis B surface antigen (HBsAg) test and a positive total hepatitis B core antibody (HBcAb) test are allowed. - History of positive hepatitis C virus (HCV) antibody test, but negative HCV RNA test is allowed. - Participants with a historical positive HIV test are not allowed. 11. Treatment with systemic immunosuppressive medication within 28 days of Cycle 1 Day 1, with the following exceptions: - Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (eg, 48 hours of corticosteroids for a contrast allergy) are eligible. - Patients receiving mineralocorticoids (eg, fludrocortisone), or systemic prednisone equivalent corticosteroid doses of < 10 mg per day are eligible for the study. 12. Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation. 13. Receipt of any live, attenuated vaccines within 28 days of Cycle 1 Day 1. Vaccination to prevent symptomatic SARS-CoV-2 infection is allowed as long as the vaccine is NOT a live attenuated vaccine (e.g. adenovirus-based constructs); however, the vaccine should be administered ≥ 1 week before or after a lerapolturev injection. 14. Known hypersensitivity to any of the drugs used in this study. 15. Pregnant or lactating women. 16. History of human serum albumin allergy. 17. History of neurological complications due to PV infection. 18. History of agammaglobulinemia. 19. Legal incapacity or limited legal capacity. 20. Other uncontrolled serious chronic disease or psychiatric condition that in the Investigators opinion could affect the patients safety, compliance, or follow-up in the protocol. Non-Muscle Invasive Bladder Cancer Specific Inclusion Criteria: 1. Prior history of stage Ta, T1, or Tis urothelial carcinoma of the bladder 1. Tumors with up to 50% squamous or glandular differentiation are eligible 2. History of variant bladder histologies are excluded (eg, sarcomatoid, plasmacytoid, small cell or neuroendocrine, pure pure squamous cell carcinoma, pureadenocarcinoma, micropapillary, nested, lymphepithelioma-like, clear cell) 2. Documented tumor recurrence at cystoscopy where the tumor is amenable to TURBT or cystectomy. 3. Measured or calculated (per institutional standard) creatinine clearance ≥ 45 ml/min (glomerular filtration rate [GFR] can also be used in place of creatinine clearance). 4. If the patient has an available formalin-fixed paraffin-embedded (FFPE) tumor specimen with an associated pathology report documenting NMIBC, the specimen must be confirmed to be available to send to the Sponsor. Patients without an available FFPE specimen are still eligible to enroll. 5. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is NOT required. This is an exception to the inclusion criterion outlined in the master protocol. Non-Muscle Invasive Bladder Cancer Specific Exclusion Criteria: 1. Patients with exposure to intravesical agents (e.g. BCG, mitomycin C, epirubicin, oncolytic viruses, anti-PD-1/L1 inhibitors, investigational therapies, etc.) within 3 months prior to the administration of lerapolturev. 2. Patients whose anticoagulation or antiplatelet medications cannot be managed by local institutional guidelines to accommodate the safe intravesical instillation of lerapolturev followed by TURBT, as determined by the treating physician. 3. Received prior radiation to the pelvis. 4. Received prior systemic therapy for bladder cancer, including PD-1/L1 inhibitors. 5. History of vesicoureteric reflux or an indwelling urinary stent. 6. History of stage T2 or higher bladder cancer 7. Medical conditions (as determined by the investigator) that would interfere with the ability of the patient to retain urine for 2 hours. Examples include urinary incontinence, overactive bladder, or low bladder compliance. ; PRIMARY OUTCOME: Proportion of patients who undergo TURBT or cystectomy as scheduled; 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 - C-SWIFT (w/Sofosbuvir, GT1-3); BRIEF: This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12). ; DRUG USED: Zepatier; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening - has documented chronic HCV GT1 or GT3 infection - has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®) - is treatment naïve to all anti-HCV treatment Exclusion Criteria: - has evidence of decompensated liver disease - is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus - has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy - has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC - has clinically-relevant drug or alcohol abuse within 12 months of screening - has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial - has a history of chronic hepatitis not caused by HCV ; PRIMARY OUTCOME: Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Subcutaneous CSII (02); BRIEF: Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study ; DRUG USED: HDV-L; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Diasome Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. T1DM ≥12 months 2. C-peptide <0.6 ng/mL (a single re-test is allowable) 3. Treatment with rapid analog insulin by CSII for the previous 6 months 4. Familiarity with continuous glucose monitoring (CGM) technology; subjects nee d not be currently using CGM but should have used it in the past. Personal (unblinded) CGM will NOT be allowed during the study 5. Willingness to use insulin lispro as the analog insulin during the study period 6. Use of MiniMed Paradigm® pump for the previous 6 months. Pumps that employ low glucose suspend technology will NOT be allowed during the study 7. BMI ≥18.0 kg/m2 and ≤35.0 kg/m2 8. A1C≤9.0% (a single re-test is allowable) Exclusion Criteria: 1. Known or suspected allergy to any component of any of the study drugs in this trial. 2. A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator. 3. Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.) 4. Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months 5. As judged by the investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG), hepatic, neurological, renal, genitourinary, or hematological systems, or uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position). 6. History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the patient. ; PRIMARY OUTCOME: Glucose area under the curve; SECONDARY OUTCOME 1: total units Insulin[/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 - TRAVERSE; BRIEF: This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib. ; DRUG USED: Pexa-Vec; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy, Thymidine Kinase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Jennerex Biotherapeutics; CRITERIA: KEY Inclusion Criteria: - Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis - Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC - ECOG performance status 0, 1 or 2 - Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites - Hematocrit ≥30% or Hemoglobin ≥10 g/dL - Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited >25% growth in viable tumor size since prior local-regional treatment. KEY Exclusion Criteria: - Received sorafenib within 14 days prior to randomization - Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization - Prior treatment with JX-594 - Platelet count < 50,000 PLT/ mm3 - Total white blood cell count < 2,000 cells/mm3 - Prior or planned organ transplant - Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication - Severe or unstable cardiac disease - Viable CNS malignancy associated with clinical symptoms - Pregnant or nursing an infant - History of inflammatory skin condition (e.g., eczema requiring previous treatment, atopic dermatitis) ; PRIMARY OUTCOME: Survival; SECONDARY OUTCOME 1: Time to Tumor 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 III - NETTER-2; BRIEF: The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression. ; DRUG USED: Lutathera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET); TARGET: Radiopharmaceutical, Somatostatin Receptors; THERAPY: Combination; LEAD SPONSOR: Advanced Accelerator Applications; CRITERIA: Inclusion Criteria: - Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, well differentiated Grade 2 or Grade 3 gastroenteropancreatic neuroendocrine (GEP-NET) tumor diagnosed within 6 months prior to screening. - Ki67 index ≥10 and ≤ 55% - Patients ≥ 15 years of age and a body weight of > 40 kg at screening - Expression of somatostatin receptors on all target lesions documented by CT/MRI scans, assessed by any of the following somatostatin receptor imaging (SRI) modalities within 3 months prior to randomization: [68Ga]-DOTA-TOC (e.g. Somakit-TOC®) PET/CT (or MRI when applicable based on target lesions) imaging, [68Ga]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging (e.g. NETSPOT®), Somatostatin Receptor scintigraphy (SRS) with [111In]-pentetreotide (Octreoscan® SPECT/CT), SRS with [99mTc]-Tektrotyd, [64Cu]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging. - The tumor uptake observed in the target lesions must be > normal liver uptake. - Karnofsky Performance Score (KPS) ≥ 60 - Presence of at least 1 measurable site of disease - Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities Exclusion Criteria: - Creatinine clearance < 40 mL/min calculated by the Cockroft Gault method - Hb concentration < 5.0 mmol/L (<8.0 g/dL); WBC < 2x10E9/L (2000/mm3); platelets < 75x10E9/L (75x10E3/mm3) - Total bilirubin > 3 x ULN - Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range - Pregnancy or lactation - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study treatment period (including cross-over and re-treatment, if applicable) and for 6 months after study drug discontinuation - Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study. - Documented RECIST progression to previous treatments for the current GEP-NET at any time prior to randomization - Patients for whom in the opinion of the investigator other therapeutic options (eg chemo-, targeted therapy) are considered more appropriate than therapy offered in the study, based on patient and disease characteristics - Any previous therapy with Interferons, Everolimus (mTOR-inhibitors), chemotherapy or other systemic therapies for GEP-NET administered for more than 1 month or within 12 weeks prior to randomization in the study. - Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET - Any surgery within 12 weeks prior to randomization in the study - Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to screening in the study. Patients with a history of brain metastases must have a head CT or MRI with contrast to document stable disease prior to randomization in the study. - Uncontrolled congestive heart failure (NYHA II, III, IV). Patients with history of congestive heart failure who do not violate this exclusion criterion will undergo an evaluation of their cardiac ejection fraction prior to randomization via echocardiography. The results from an earlier assessment (not exceeding 30 days prior to randomization) may substitute the evaluation at the discretion of the Investigator, if no clinical worsening is noted. The patients measured cardiac ejection fraction in these patients must be ≥40% before randomization. - QTcF > 470 msec for females and QTcF > 450 msec for males or congenital long QT syndrome - Uncontrolled diabetes mellitus as defined by hemoglobin A1c value > 7.5% - Hyperkaleamia > 6.0 mmol/L (CTCAE Grade 3) which is not corrected prior to study enrolment - Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of Lutathera, or any patient receiving treatment with SSAs (e.g. octreotide long-acting), which cannot be interrupted for at least 6 weeks before the administration of Lutathera. - Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study. - Prior external beam radiation therapy to more than 25% of the bone marrow. - Current spontaneous urinary incontinence - Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years - Patient with known incompatibility to CT Scans with IV contrast due to allergic reaction or renal insufficiency. If such a patient can be imaged with MRI, then the patient would not be excluded. - Hypersensitivity to any somatostatin analogues, the IMPs active substance or to any of the excipients. - Patients who have participated in any therapeutic clinical study/received any investigational agent within the last 30 days ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Objective 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 II - w/Paclitaxel; BRIEF: The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer. ; DRUG USED: AZD8931; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Male or female aged 18 years or older (20 years or older in Japan) - Patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database) - Suitable for paclitaxel therapy. - At least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeat assessment. - Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and +2 Exclusion Criteria: - Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted). - Any prior taxane therapy (at any time from diagnosis of gastric cancer) - Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib) - Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 ) - Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy ; PRIMARY OUTCOME: Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone; SECONDARY OUTCOME 1: Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone[/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/Avelumab; BRIEF: This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics. ; DRUG USED: eFT508; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: MNK1/MNK2; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Effector Therapeutics; CRITERIA: Inclusion Criteria: - ECOG performance status of 0, 1, or 2 - Pathologically documented diagnosis of colorectal adenocarcinoma. - Progressed on or intolerant of at least 2 prior cancer therapy regimens administered for metastatic disease. - Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥3 weeks before the start of study therapy. - Part 2 only: Presence of radiographically measurable disease (defined as the presence of ≥1 lesion that measures ≥10 mm [≥15 mm for lymph nodes]). Measurable disease that was previously radiated is only permitted if progressing. - Agrees to undergo a pretreatment and a post-treatment biopsy. - Microsatellite stable disease determined by IHC and/or polymerase chain reaction (PCR). - Adequate bone marrow function - Adequate hepatic function - Adequate renal function - Normal coagulation profile - Negative antiviral serology - Female subjects of childbearing potential must not be pregnant or breastfeeding - Willingness to use protocol-recommended methods of contraception or to abstain from heterosexual intercourse from start of therapy until at lest 30 days after the last dose of study therapy - Life expectancy of ≥3 months. Exclusion Criteria: - History of another malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical or breast carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ≥2 years. - Known symptomatic brain metastases requiring ≥10 mg/day of prednisolone (or its equivalent). - Significant cardiovascular disease. - Significant screening ECG abnormalities. - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. - Known history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis. - Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis. - Evidence of an ongoing systemic bacterial, fungal, or viral infection. - Any condition that may impact the subjects ability to swallow oral medications. - Major surgery within 4 weeks before the start of study therapy. - Prior solid organ or bone marrow progenitor cell transplantation. - Prior therapy with any known inhibitor of MNK-1 or MNK-2. - Prior therapy with any of the following: PD-1, PD-L1, CTLA4 antibody, or any other drug targeting T cell checkpoint pathways. - Prior high dose chemotherapy requiring stem cell rescue. - Intolerance to or prior severe (≥Grade 3) allergic or anaphylactic reaction to infused antibodies or infused therapeutic proteins. - Vaccination within 4 weeks of the first dose of avelumab and while on study. - Ongoing immunosuppressive therapy. - Use of a strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to the start of study therapy or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study therapy. - Previously received investigational product in a clinical trial within 30 days or within 5 elimination half lives (whichever is longer) prior to the start of study therapy, or is planning to take part in another clinical trial while participating in this study. - Has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subjects ability to sign informed consent, adversely affect the subjects ability to cooperate and participate in the study, or compromise the interpretation of study results ; PRIMARY OUTCOME: Part 1: Proportion of subjects with a dose limiting toxicity (DLT) during the first treatment cycle; 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 - Study 001 (LID); BRIEF: The study is designed to answer the question: will nicotine at doses that do not cause serious side effects, show feasibility in treatment of levodopa-induced dyskinesia in patients with Parkinsons disease? ; DRUG USED: NP002; DRUG CLASS: New Molecular Entity (NME); INDICATION: Levodopa-Induced Dyskinesia; TARGET: Nicotinic Acetylcholine Receptors (nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Neuraltus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - clinical diagnosis of probable idiopathic Parkinsons disease - in stable health - male and female aged 30-83 yrs - Hoehn and Yahr stage II through IV inclusive - levodopa-induced dyskinesias present greater than 25% of waking day; rating equal or greater than 2 on item 32 of UPDRS - dyskinesias moderately or severely disabling as determined by a rating of equal or greater than 2 on item 33 of UPDRS - Mini-Mental state (MMSE) score of equal or greater than 26 - on a stable dose of levodopa for at least 30 days - if subjects are taking dopamine antagonists, amantadine, MAO-B inhibitors (rasagiline only) or COMT inhibitors, doses must have been stable for at least 30 days Exclusion Criteria: - Secondary or non-idiopathic Parkinsons disease - Subjects with parkinsonian symptoms who do not respond to levodopa therapy - history of schizophrenia, or other DSM-IV TR axis 1 diagnosis sufficient to interfere with or affect study conduct or interpretation of results - any history (past 5 years) of suicide or suicide attempt or thoughts or urges of suicide on direct questioning - subjects who score 2 or higher on a single module of the Jay MIDI scale - moderate or severe hallucinations, psychoses or delusions - any medical condition or lab abnormality presenting an unwarranted risk in the opinion of the Investigator - history of HIV positivity, AIDS, or active hepatitis determined by subject report - female who is pregnant or breastfeeding - female of childbearing potential not using double barrier method of birth control throughout the duration of the study - receipt of a neurosurgical intervention (e.g. brain surgery)related to Parkinsons disease or any neurosurgical procedure sufficient to interfere with study conduct or interpretation of results - must not have systolic blood pressure ≥150; diastolic ≥95. - must not have ECG at screening judged clinically significantly abnormal by investigator - must not have QTc > 450 msec at ECG screen - must not have current angina pectoris, history of ventricular arrhythmias, uncontrolled hyperthyroidism, known or suspected pheochromocytoma, symptomatic vasospastic disease, or active peptic ulcer - must not have a history of stroke, transient ischemic attack (TIA) or myocardial infarction within the last 2 years - must not have current drug or alcohol abuse within the last two years. Acceptable alcohol use is no more than 3 ounces of alcohol, 3 beers or 2 glasses of wine per day. - must not be participating in another drug trial or have participated in another drug study in the last 30 days. Observational trials with no intervention are acceptable provided permission is obtained from the other study sponsor in writing. - must not be unwilling or unable to swallow capsules - must not have a positive urine test for cotinine at screening - must not be a smoker, previous (less than 5 years since cessation) smoker or have regular exposure to second hand smoke - must not be allergic to capsule excipients - must not be allergic to ondansetron. If allergic, they may participate provided they understand there is no rescue medication for potential nausea or vomiting during the study - must not have known sensitivity to nicotine or nicotine-containing products - must not be taking any of the following medications or substances within a minimum of 30 days: nicotine, any form; CYP2A6 inducers or inhibitors during the course of the study or within 30 days of the planned initial dose (your investigator will have a full list of these drugs); Monoamine oxidase inhibitors (with the exception of rasagiline, which is allowed)(your investigator will have a full list of these drugs); apokyn (apomorphine), due to its contraindication with ondansetron); warfarin. ; PRIMARY OUTCOME: frequency and severity of adverse events, active vs placebo; SECONDARY OUTCOME 1: measure of frequency and severity of dyskinesia (USDysRS), active vs placebo[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ION-4 - +/- RBV (GT1/4, HIV-1 Co-Infection); BRIEF: This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1. Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks. ; DRUG USED: Harvoni; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - HCV RNA ≥ 10,000 IU/mL at screening - HCV genotype 1 or 4 - HIV-1 infection - Cirrhosis determination, a fibroscan or liver biopsy may be required - Screening laboratory values within defined thresholds - Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male Exclusion Criteria: - Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol - Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers) - Hepatitis B virus (HBV) infection - Pregnant or nursing female - Chronic use of systemically administered immunosuppressive agents ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Humalog; BRIEF: The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes. ; DRUG USED: BIOD-123; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biodel; CRITERIA: Inclusion Criteria: - Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year. - Age: 18 years old, or older. - Body Mass Index: between 18 and 35 kg/m2, inclusive. - Willing to use insulin glargine as the only basal insulin throughout the duration of the trial. - Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial. Exclusion Criteria: - History of known hypersensitivity to any of the components in the study medication - Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study. - Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed. - Consistent recent hypoglycemic unawareness within the last six months - History of more than two severe hypoglycemic events within six months prior to screening ; PRIMARY OUTCOME: Change in HbA1C; SECONDARY OUTCOME 1: Hypoglycemic event rates[/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 - TACTI-002 (w/Pembrolizumab); BRIEF: Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients. ; DRUG USED: Eftilagimod Alpha; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, LAG3 (Lymphocyte-Activation Gene)/CD223; THERAPY: Combination; LEAD SPONSOR: Immutep S.A.S.; CRITERIA: Main Inclusion Criteria: 1. Part A (1st line, PD-X naïve NSCLC): histologically- or cytologically-confirmed diagnosis of non-small cell lung carcinoma stage IIIB not amenable to curative treatment or stage IV not amenable to EGFR/ALK based therapy, treatment naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable) Part B (2nd line, PD-X refractory NSCLC): histologically- or cytologically-confirmed diagnosis of NSCLC after failure of first-line treatment (for metastatic disease) with at least 2 cycles of any PD-1/PD-L1 containing based therapy (e.g. nivolumab, pembrolizumab, avelumab, durvalumab, etc.) alone, or in combination with any other immunotherapeutic or chemotherapy given as part of first-line treatment. Part C (2nd line PD-X naive HNSCC): Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies after failure of prior platinum-based therapy. 2. Submission of formalin-fixed diagnostic tumor tissue 3. ECOG performance status 0-1. 4. Expected survival > 3 months. Main Exclusion Criteria: 1. For part A (1st line, PD-X naïve NSCLC): - The NSCLC can be treated with curative intent with either surgical resection and/or chemoradiation and/or radiation. - Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. - EGFR-sensitizing mutation and/or is EML4 gene/ ALK gene fusion positive (ALK translocation). - Lung radiation therapy that is >30Gy within 6 months of the first dose of trial treatment. For Part B (2nd line, PD-X refractory NSCLC): - Symptomatic ascites or pleural effusion. - > 1 line of chemotherapy for metastatic disease. - Lung radiation therapy that is >30Gy within 6 months of the first dose of trial treatment. For Part C (2nd line PD-X naive HNSCC): - Disease is suitable for local therapy administered with curative intent. - Previously treated with > 1 systemic regimens for recurrent and/or metastatic disease. 2. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) (Part A and C only) 3. 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 irAE (Part B only) 4. Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery, another systemic cancer therapy or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to cycle 1 day 1. Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy, alopecia and elevated transaminases in case of liver metastases may be eligible. If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. 5. Known active central nervous system metastasis and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable: i.e. without evidence of progression documented by repeat imaging performed after therapy completed for CNS metastasis and with at least 4 weeks difference, clinically stable and without requirement for steroid treatment for at least 14 days prior to cycle 1 day 1. 6. Receives continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease. ; PRIMARY OUTCOME: Evaluation of objective response rate (ORR) according to iRECIST; SECONDARY OUTCOME 1: Duration of (serious) 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 - ARO-009; BRIEF: This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3 mutations who have achieved complete remission (CR) after allogeneic stem cell transplantation. Oral crenolanib will be administered daily post-transplant for up to two years. ; DRUG USED: Crenolanib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); 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. History of AML according to World Health Organization (WHO) classification 2. First allogeneic hematopoietic stem cell transplantation (HSCT) using myeloablative conditioning (MAC), non-myeloablative (NMA), or reduced-intensity conditioning (RIC) preparative regimens. 3. FLT3-ITD or FLT3-D835 positive disease at any time during disease course. 4. Hematopoietic stem cell source is either with peripheral blood, bone marrow or cord blood. 5. Donor source is matched related, unrelated, haploidentical donor or cord blood. 6. At the time of allogeneic HSCT: 1. No more than 1 antigen mismatch at HLA-A, -B, -C, -DRB1 or -DQB1 locus for unrelated donor with peripheral blood and bone marrow as the hematopoietic stem cell source; and 2. Bone marrow blast ≤ 10% 7. No sooner than 42 days but no later than 90 days after allogeneic HSCT. 8. Post-transplant bone marrow blast count ≤ 5% confirmed within 21 days (+4 days) prior to starting study therapy 9. Evidence of donor engraftment as defined by institutional standard T cell chimerism > 50%. 10. Adequate engraftment within 7 days prior to starting study therapy: ANC ≥ 1.0 x 10^9/L without daily use of myeloid growth factor; and platelet ≥ 25 x 10^9/L without platelet transfusion within 1 week 11. Non-hematological toxicities ≤ Grade 2 12. Serum creatinine ≤ 1.5 × ULN OR creatinine clearance ≥ 50mL/min/1.73 m2 for subjects with creatinine levels above institutional normal 13. Adequate liver function with serum AST, ALT and bilirubin within the normal range at the time of crenolanib commencement 14. Acute graft-versus-host disease (GVHD) ≤ Grade 1, either no signs of chronic GVHD or mild chronic GVHD graded as limited disease 15. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 16. Age ≥ 18 years with the capacity to give written informed consent 17. Non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test (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) 18. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 90 days following completion of therapy Exclusion Criteria: 1. Bone marrow blast >5% within 21 days (+4 days) of start of study drug 2. Active GVHD grade ≥ 2 3. Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg 4. Active and/or untreated central nervous system (CNS) leukemia 5. Concomitant therapies for treatment or control of leukemia. 6. Use of any of the following after transplantation and prior to starting study therapy: 1. Chemotherapeutic agents for therapy of AML (note that prophylactic use of these agents is allowed in this study, e.g., methotrexate for GVHD) 2. Investigational agents/therapies 3. Azacitidine, decitabine or other demethylating agents 4. Lenalidomide, thalidomide and pomalidomide 7. Uncontrolled infection 8. Known positive for human immunodeficiency virus (HIV); active hepatitis B (HBV) or hepatitis C (HCV) infection 9. Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication 10. Pregnant or breast-feeding 11. Major surgery within 4 weeks of starting study drug 12. Receipt of investigational agents within 5 half-lives of last dose of investigational agent 13. Prior treatment with crenolanib with progression on treatment ; PRIMARY OUTCOME: Number of Patients Who Relapsed; 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 - P07063 - Asia Pacific; BRIEF: This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population. ; DRUG USED: Victrelis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible. - Liver biopsy with histology consistent with CHC and no other etiology. - Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma - Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV - Weight between 40 kg and 125 kg, inclusive - Of local ancestral descent - Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception Exclusion Criteria: - Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus. - Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon. - Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening. - Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity. - Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit. - Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. - Diabetes and/or hypertension with clinically significant ocular examination findings. - Any condition the could interfere with participation in and completion of the trial. - Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin). - Pregnant or breast-feeding. ; PRIMARY OUTCOME: Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population; SECONDARY OUTCOME 1: Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OSTRO; BRIEF: The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Nasal Polyposis; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol. 2. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines. 3. Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis. 4. Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF. 5. Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: - A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1, and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab; - Ongoing symptoms for at least 12 weeks prior to V1; - Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe). 6. SNOT-22 total score ≥ 30 at enrolment. Patient must meet the following criteria (points 7-10) at the randomization visit: 7. At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0). 8. At randomization, a bi-weekly mean NBS ≥ 1.5. 9. SNOT-22 total score ≥ 30 at randomization. 10. At least 70% compliance with INCS during the run-in period based on daily diary. 11. Patients with a minimum weight of 40kg. 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential. 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP). 15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements Exclusion Criteria: 1. Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1. 2. Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: - Unilateral antrochoanal polyps; - Nasal septal deviation that occludes at least one nostril; - Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening; - Current rhinitis medicamentosa; - Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS); - Nasal cavity tumors. 3. Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegeners granulomatosis), Youngs syndrome, etc. 4. Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: - Affect the safety of the patient throughout the study; - Influence the findings of the studies or their interpretations; - Impede the patients ability to complete the entire duration of study. 5. Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1. 6. History of anaphylaxis to any biologic therapy or vaccine. 7. Known history of allergy or reaction to any component of the Investigational Product (IP) formulation. 8. History of Guillain-Barré syndrome. 9. A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy. 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to V1; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to V1. NOTE: Hormonal therapy is allowed. As long as the cancer is in remission for 5 years, the patient is eligible. 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments. 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enroll). 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test. 14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1. 16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, prior to V1 and during the study period. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo. 17. Previous receipt of benralizumab. 18. Receipt of immunoglobulin or blood products within 30 days prior to V1. 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization. 20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization. 21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period. NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1. 22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for ≥30 days prior to V1. 23. Concurrent enrolment in another clinical drug interventional trial. 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 times the upper limit of normal (ULN) confirmed during screening period. 25. Previous randomization in the present study. 26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization. 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period. 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating. ; PRIMARY OUTCOME: Change From Baseline in Total NPS at Week 40; SECONDARY OUTCOME 1: Change From Baseline in SNOT-22 at Week 40[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Ha02-003 (<u>></u>2 yrs old); BRIEF: Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice ; DRUG USED: Xeglyze; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: Metal ions (e.g., Ca2+, Cu2+, Zn2+, and Fe2/3+), MMP (metalloproteinase); THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion Criteria: - 2 years of age or older - Body weight of at least 33 pounds - Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members - Belong to a household of no more than 6 members, except where additional household members are < 2 years of age - Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation - Female subjects must be: - of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or, post-menopausal for at least 2 years) OR, - if of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit. Exclusion Criteria: - Had treatment for head lice within 14 days prior to Day 0 - Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment - Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results - Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment - Has been using hormonal contraception for less than 3 months or is pregnant or lactating - Has received systemic corticosteroids within 7 days prior to Day 0 or planned while on study - Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results - Has received an investigational agent within 30 days prior to Day 0 ; PRIMARY OUTCOME: Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit; SECONDARY OUTCOME 1: Safety and Tolerability of Ha44 Gel[/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 - 1222.37; BRIEF: To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease ; DRUG USED: Striverdi Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Signed informed consent prior to participation. 2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1. 3. Male or female between 40 and 75 years of age. 4. Current or ex-smokers with smoking history of more than 10-pack years. 5. Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records. 6. Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler. Exclusion criteria: 1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN. 2. Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3. 3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute). 4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise. 5. Patients who have undergone thoracotomy with pulmonary resection. 6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 7. Patients who regularly use daytime oxygen for more than one hour per day. 8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program. 9. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea. 10. Pregnant or nursing women. 11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier). ; PRIMARY OUTCOME: Adjusted Mean Endurance Time After 6 Weeks; SECONDARY OUTCOME 1: Adjusted Mean Inspiratory Capacity at Isotime After 6 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 II - BALTIC (Platinum Refractory); BRIEF: Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy. ; DRUG USED: AZD1775; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Tyrosine Kinases, Wee1 Inhibitor ; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria (applicable to all arms) - Adults with histologically or cytologically documented ED SCLC who have demonstrated progressive disease either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum based-chemotherapy (platinum resistant) and have not received further treatment. - Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. - At least 1 lesion, not previously irradiated, that can be accurately measured at baseline (per RECIST v 1.1 guidelines) - Life expectancy of at least 8 weeks. - WHO/ ECOG PS of 0-1 at enrollment. Inclusion criteria (Arm A specific) - Body weight >30 kg. - No prior exposure to immune mediated therapy, excluding therapeutic anticancer vaccines. Inclusion criteria (Arm B specific) • Able and willing to swallow oral medication. Inclusion criteria (Arm C specific) • Able and willing to swallow oral medication. Exclusion criteria (applicable to all arms): - Participation in another clinical study, major surgery, radiation therapy within 28 days. - Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results. - Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. - History of another primary malignancy, leptomeningeal carcinomatosis or spinal cord compression. Exclusion criteria (Arm A specific) - Active autoimmune disease, including a paraneoplastic syndrome. - Active or prior documented autoimmune or inflammatory disorders. - Any unresolved toxicity (CTCAE Grade >2) from previous anticancer therapy. - Active infection including tuberculosis, HIV, Hepatitis B or C. Exclusion criteria (Arm B specific) - Prior exposure to any WEE1 inhibitors. - Products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4. Co-administration of rosuvastatin, atorvastatin, simvastatin and lovastatin, aprepitant or fosaprepitant or any herbal preparations. Grapefruit and Seville oranges should be avoided while taking AZD1775. - Any known hypersensitivity or contraindication to IP or CBDP. - QTcF > 470 msec or congenital long QT syndrome. - Any current or within 6 months cardiac diseases NYHA ≥ Class 2: unstable angina pectoris, congestive heart failure, acute MI, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias. - A recent history of Torsades de pointes. Exclusion criteria (Arm C specific) - Cytotoxic chemotherapy within 21 days of Cycle 1 Day 1 is not permitted - Previous treatment with a PARP inhibitor (including olaparib) or ATR inhibitor - Concomitant use of known strong CYP3A inhibitors and moderate CYP3A inhibitors - Concomitant use of known strong and moderate CYP3A inducers - Persisting (> 4 weeks) severe pancytopenia due to previous therapy - Cardiac dysfunction - Refractory nausea and vomitting, chronic gastrointenstinal diseases or previous significant bowel resection - Patients with uncontrolled seizures - Intenstinal obstruction or CTCAE grade 3 or grade 4 GI bleeding within 4 weeks before dosing ; PRIMARY OUTCOME: Number of Participants With Overall Response; 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 IIa -w/Keytruda; BRIEF: This is an open, single arm, multicenter phase 2 trial in which BO-112 will be administered intratumorally in combination with intravenous pembrolizumab in patients with liver metastasis from colorectal, gastric or gastroesophageal junction cancers. The objective is to reverse the primary resistance that a subgroup of patients from these tumors having microsatellite stability present to the PD-1 inhibitors. Treatment will be administered every 3 weeks, with the exception of the first cycle, in which BO-112 will be also administered on D8, for up to 2 years. The primary objective is overall response rate based on RECIST 1.1 and safety, specifically referred to treatment emergent adverse events (TEAEs) with severity ≥ Grade 3 related to the study treatment (NCI-CTCAE v 5.0). The secondary endpoints include other efficacy endpoints (duration of response, disease control rate, progression-free survival, overall survival at 6 months, all based on RECIST 1.1, and overall response rate based on a specific tumor assessment criteria to evaluate the response to immunotherapies, IRECIST) and safety, in this case considering the number and proportion of subjects with treatment TEAEs (any grade) . In addition, the changes in the tumor microenvironment induced by the injection of BO-112 will be also evaluated as exploratory endpoints. ; DRUG USED: BO-112; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Immune System, Melanoma Differentiation-Associated Protein 5/MDA5, RIG-I-like Receptors (RLR): RIG-I, MDA5, and LGP2, RNA, Toll-like receptor 3 (TLR3); THERAPY: Combination; LEAD SPONSOR: Highlight Therapeutics; CRITERIA: Inclusion Criteria: - Nonresectable liver metastasis(es) of colorectal or gastric/gastro-oesophageal junction cancer (GC/GEJ). History of resection for liver metastasis is allowed. - Histological or cytological proof of colorectal (Cohort A) or GC/GEJ cancer (Cohort B). - Progression during or after, or have not tolerated therapy for advanced/metastatic disease as follows: 1. Cohort A (CRC): at least 2 lines of fluoropyrimidine, irinotecan and/or oxaliplatin containing therapy with or without bevacizumab; if epidermal growth factor receptor (EGFR) positive/RAS wild type, prior anti-EGFR treatment is required. Incase of prior resection of hepatic metastasis with hepatic recurrence, only 1 prior line of fluoropyrimidine, irinotecan and/or oxaliplatin containing therapy is required. 2. Cohort B (GC/GEJ): fluoropyrimidine and platinum containing treatment; if Human epidermal growth factor receptor 2 (HER-2) positive, also prior anti-HER-2 treatment is required. - At least 1 liver metastasis of minimum 20 mm in diameter that is suitable for percutaneous, IT injection . - Presence of at least 1 measurable lesion according to RECIST v1.1. Note: this may be the liver metastasis selected for injection if it is the only measurable lesion present. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate haematologic and end-organ function EXCLUSION CRITERIA - Prior treatment with an anti-PD1, anti-PDL1 or anti-PDL2 agent, an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) or any Toll-like receptor (TLR) agonist. - Liver metastasis(es) with macroscopic tumour infiltration into the main portal vein, hepatic vein or vena cava. - Contraindications to tumour biopsy and injections of the hepatic metastasis(es). - Chemotherapy, definitive (curative) radiation, or biological cancer therapy within 4 weeks prior to the first dose of study treatment. - Palliative radiotherapy (≤ 2 weeks of radiotherapy) within 1 week of start of study treatment. - Clinically active central nervous system (CNS) metastases and/or carcinomatosis meningitis. ; PRIMARY OUTCOME: Anti-tumour efficacy:overall response rate; SECONDARY OUTCOME 1: Disease control 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 II - HER2+; BRIEF: This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases. ; DRUG USED: ANG1005; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Secondary; Metastases); TARGET: Cluster of Differentiation 91 (CD91) / Low density lipoprotein receptor-related protein 1 (LRP1), Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Angiochem Inc; CRITERIA: Inclusion Criteria: 1. ≥ 18 years old 2. Breast cancer 3. Recurrent brain metastases from breast cancer 4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm) 5. Neurologically stable 6. Karnofsky Performance Status (KPS) score ≥ 70 7. Adequate hematology and serum chemistry laboratory test results 8. Expected survival of ≥ 3 months Exclusion Criteria: 1. Prior treatment with ANG1005/GRN1005 2. Evidence of symptomatic intracranial hemorrhage 3. Pregnancy or lactation 4. Inadequate bone marrow reserve 5. Any evidence of severe or uncontrolled diseases 6. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV 7. History of interstitial lung disease or evidence of clinically significant interstitial lung disease 8. Severe cardiac conduction disturbance 9. Central nervous system (CNS) disease requiring immediate neurosurgery intervention 10. Known severe hypersensitivity or allergy to paclitaxel or any of its components ; PRIMARY OUTCOME: Intracranial objective response rate (iORR); SECONDARY OUTCOME 1: Duration of intracranial objective response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - IGLOO (Dry Powder); BRIEF: This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection. ; DRUG USED: Laninamivir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Influenza Viral Neuraminidase; THERAPY: Monotherapy; LEAD SPONSOR: Biota Scientific Management Pty Ltd; CRITERIA: Main Inclusion Criteria: 1. Provide written informed consent 2. Males or females aged 18-64 years, inclusive 3. Symptomatic presumptive influenza A or B infection defined as the presence of: 1. a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND 2. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND 3. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion) 4. Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred: 1. time when the subjects temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR 2. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR 3. time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) Main Exclusion Criteria: 1. Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening 2. Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks. 3. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma 4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months 5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants 6. Presence of clinically significant signs of acute respiratory distress during screening 7. Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study. 8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min 9. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subjects ability to participate in the study or the study results ; PRIMARY OUTCOME: Time to Alleviation of Influenza Symptoms; 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 - Total Knee Arthroplasty (004); BRIEF: The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty. ; DRUG USED: Brivoligide; DRUG CLASS: Biologic; INDICATION: Postsurgical Pain; TARGET: Early growth response gene 1 (EgR-1); THERAPY: Monotherapy; LEAD SPONSOR: Adynxx, Inc.; CRITERIA: Inclusion Criteria: - Scheduled to undergo primary unilateral TKA with spinal anesthesia for painful osteoarthritis without congenital knee pathology - American Society of Anesthesiologists Physical Status Classification System ≤ 3 - Medically stable as determined by the Investigator based on pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings - Body Mass Index of 18-45 kg/m2 - Stable medical regimen for at least 1 week before randomization - Able to read and understand study instructions in English, and willing and able to comply with all study procedures Exclusion Criteria: - More than 2 other current focal areas of pain, any pain areas greater in intensity than the target knee, or any other active chronic pain conditions that would compromise operative knee pain evaluation - Inflammatory arthridities (e.g., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis), with the exception of clinically stable/non-active gout that does not affect the knee and does not interfere with walking - Surgery in either knee within 3 months prior to randomization, or surgery in either knee greater than 3 months prior to randomization with residual symptoms that would interfere with post-TKA study assessments; use of cryoneurolysis (including Iovera) on the current operative knee region within the 6 months prior to randomization and/or at any time through the duration of the study - Planned use of general anesthesia or potent inhalational agents, peripheral nerve block (e.g., femoral nerve block), neuroaxial (intrathecal or epidural) opioids, preoperative extended release/long acting opioids, or any use of ketamine preoperatively and/or at any time through the duration of the study - Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization - Use of gabapentin or pregabalin within 1 week prior to randomization or planned use post-operatively through Day 28 - Use of systemic corticosteroids (IV or oral) within 3 months prior to randomization through Day 28; planned use of intra-articular steroid injections in the operative knee from the time of randomization through Day 28 - Current neurologic disorder, which could confound the assessment of pain (e.g., Parkinsons, Multiple Sclerosis) - Untreated or inadequately treated (in the opinion of the Investigator) active depression - Mini Mental State Exam score < 24 at screening - History of alcohol-related complications within 1 year of randomization including, but not limited to, alcoholic withdrawal seizures, hallucinations, delirium tremens or detoxification treatment - Known or suspected history of illicit drug use within 1 year before randomization, or current or planned use of marijuana (including medical approved use) within 1 month before randomization and/or through the duration of the study - Any confirmed malignancy within the past year, with the exception of basal cell carcinoma or uncomplicated or stable skin cancers documented to not require further or immediate treatment - Women who are pregnant or nursing - Previous participation in any study involving AYX1 Injection ; PRIMARY OUTCOME: Mean pain with walking during the 15 meter walk test Day 7 to Day 28; SECONDARY OUTCOME 1: Percentage of subjects with NRS pain score ≥ 4 during the 15 meter walk at Day 90[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - C3J17-206-00; BRIEF: An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and tolerability of multiple C16G2 Varnish and Strip applications in male and female dental subjects 12-75 years of age. The study will compare multiple study drug administrations of C16G2 Varnish and/or C16G2 Strip in three study arms. In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip and will be followed for microbiology for up to 2 months after the last study drug administration. Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days, followed by 3 additional weekly varnish administrations. Subjects will be followed for microbiology for up to 2 months after the last study drug administration.The treatment allocation will be 1:1 (6 subjects receiving C16G2 Varnish, 6 subjects receiving Placebo). Study Arm 3 will be initiated based on the Sponsors review of all microbiology data up to two week post last study drug administration from Study Arm 2. If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses and will be followed for microbiology for up to 2 months after the last study drug administration. ; DRUG USED: C16G2; DRUG CLASS: New Molecular Entity (NME); INDICATION: Periodontitis; TARGET: Streptococcus mutans; THERAPY: Monotherapy; LEAD SPONSOR: Armata Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Males and females, 12-75 years of age 2. Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent 3. Female subjects of childbearing potential must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with a same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit 4. Negative urine pregnancy test in all females of childbearing potential (past menarche) 5. Male subjects of sexual activity age: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination 6. Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (general, extraoral, head and neck) during Screening. Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the medical monitor on a case-by-case basis. 7. Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns or sealants 8. Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes 9. Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating 10. Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study 11. Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination) 12. Willing and able to comply with oral hygiene and diet instructions 13. Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times Exclusion Criteria: 1. Advanced periodontal disease 2. Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs). Subjects presenting with insipient, non-cavitated lesion(s) are not excluded. Note: If radiographs are deemed appropriate for the study and taken within 6 months prior to the Screening visit, these may be used for determining eligibility and are not required to be repeated at Screening 3. Partially erupted teeth where the entire crown is not erupted or an operculum is present 4. Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures 5. Pathologic lesions of the oral cavity (suspicious or confirmed) 6. Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual brackets. Note: Partial dentures, removable retainers and night guards are not excluded, provided that they are cleaned regularly throughout the duration of the study 7. Use of systemic antibiotics, topical oral antibiotics, any immunosuppressant therapy, and steroids, beginning 30 days prior to Screening until the end of study participation 8. Medical history indicating the woman is pregnant, breastfeeding/lactating or has a positive urine pregnancy test 9. Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration (depending on the specifics, participation in an observational study is not necessarily excluded) 10. Participation in a previous C16G2 clinical trial having received either C16G2 Strip, C16G2 Varnish or Placebo Varnish 11. Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results ; PRIMARY OUTCOME: Antimicrobial Activity of C16G2; SECONDARY OUTCOME 1: To Evaluate the Safety of Multiple C16G2[/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 - PROSPECT; BRIEF: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer. ; DRUG USED: Prostvac; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Immune System, Prostate-Specific Antigen (PSA); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bavarian Nordic; CRITERIA: Inclusion Criteria: Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression). 1. Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer. OR 2. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria). Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated). Exclusion Criteria: Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed). Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F. History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Number of Subjects Alive Without Event at 6 Months[/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 - Shingles Prevention Study (Aged 60 or older); BRIEF: The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patients ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN. This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older. ; DRUG USED: Zostavax; DRUG CLASS: Vaccine; INDICATION: Chickenpox and Shingles - Vaccines and Treatments; TARGET: Immune System, Varicella Zoster Virus (VSV); THERAPY: Monotherapy; LEAD SPONSOR: US Department of Veterans Affairs; CRITERIA: Inclusion Criteria: - Adults 60 years of age and older. - History of Chickenpox. - Have given written informed consent prior to enrollment. - History of varicella or long-term (greater than or equal to 30 years) residence in the continental USA. Exclusion Criteria: - No history of shingles, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy). - No immunosuppression resulting from disease (e.g., malignancy; HIV infection), corticosteroids (except intermittent topical or inhaled corticosteroid [greater than 800 mcg/day beclomethasone dipropionate or equivalent]), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation). - No active neoplastic disease (except local skin cancer or other malignancies [e.g., prostate cancer] that are stable in the absence of immunosuppressive/cytotoxic therapy). - No prior Herpes Zoster. - No prior receipt of varicella vaccine. - No allergic sensitivity to neomycin. - No history of anaphylactoid reaction to gelatin. - No significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 5 years). - Not ambulatory (must not be bed-ridden or homebound). - No receipt of immune globulin or any other blood product within 3 months before or planned during the 3-5 year study period. - No receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., dT, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 6 weeks after study vaccination. - Not currently receiving antiviral therapy. - No other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study. - No intercurrent illness (e.g., urinary tract infection, influenza) that might interfere with the interpretation of the study. - No females who are pre-menopausal. - No subjects unlikely to adhere to protocol follow-up. - No subjects involved in a conflicting (vaccine or investigational drug) clinical trial. ; PRIMARY OUTCOME: Reduce burden of illness due to herpes zoster (HZ); 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 - N-ABLE; BRIEF: The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine regimen when it is given before and after bladder cancer surgery. The study will also provide information about the safety of the vaccine regimen when given in combination with chemotherapy, and how it affects the immune systems. ; DRUG USED: CDX-1307; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Human chorionic gonadotropin (hCG) , Immune System; THERAPY: Combination; LEAD SPONSOR: Celldex Therapeutics; CRITERIA: Inclusion Criteria: Among other criteria, patients must meet all of the following conditions to be eligible to be in the study: 1. 18 years of age or older. 2. Newly diagnosed muscle-invasive transitional cell (urothelial) bladder cancer where neoadjuvant chemotherapy and radical cystectomy with curative intent are indicated (i.e., American Joint Committee on Cancer (AJCC) stage T2-4a, Nany, M0). Patients must be entered into the study within eight weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy or transurethral resection of bladder tumor (TURBT) procedure. 3. Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible. 4. Tumor tissue (obtained during a prior procedure) confirmed to express hCG-β by a central laboratory. 5. Candidate for therapy with neoadjuvant chemotherapy. Exclusion Criteria: Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study: 1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable. 2. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions to imiquimod, resiquimod, or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs. 3. Concurrent chronic treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). 4. Known infection with HIV, HBV or HCV. 5. Any underlying medical condition that, in the Investigators opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or would contraindicate receipt of neoadjuvant chemotherapy or surgical resection. ; PRIMARY OUTCOME: 2 year Recurrence-Free Survival Rate; SECONDARY OUTCOME 1: Tumor response to neoadjuvant chemotherapy[/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 - Cadence-1; BRIEF: This is an open-label study designed to evaluate the safety, tolerability and efficacy of CAD-1883, a positive allosteric modulator of the SK channel, administered twice daily orally to adult patients with ET. Patients with the diagnosis of ET based on the Movement Disorder Society (MDS) criteria with a documented severity of tremor based on the clinician-administered TETRAS Performance Subscale are eligible to be enrolled in the study. ; DRUG USED: CAD-1883; DRUG CLASS: New Molecular Entity (NME); INDICATION: Essential Tremor; TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: Cadent Therapeutics; CRITERIA: Inclusion Criteria: 1. Adult subjects aged between 18 and 75 years old, inclusive, with history of tremor that fulfills the diagnostic criteria of ET according to Movement Disorder Society (MDS) Consensus Statement on the classification of tremors from the task force on tremor of the International Parkinson and Movement Disorder Society (Bhatia, 2018). 2. Duration of ET illness since the first symptoms were noticeable of at least 3 years or more prior to screening, based on the subjects self-report, with onset prior to age 65 years old, per the Principal Investigators assessment during screening. 3. Except for ET, subjects must be otherwise healthy as determined by the Investigator, based upon a medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG. 4. Subjects are able to understand study activities required, can give written informed consent, and are willing to comply with the requirements and restrictions of the study. 5. Women of childbearing potential must undertake a pregnancy test with documented negative serum pregnancy test at Screening and negative urine pregnancy test result at Pre-dose, Days 7 and 14 before administration of the study drug, and then at the Follow-up visit (Day 21). 6. Postmenopausal women must have had ≥365 days of spontaneous amenorrhea, with documented follicle-stimulating hormone (FSH) ≥38 IU/mL, prior to screening. If needed, per Investigators judgment, FSH level can be performed at Screening. 7. Surgically sterile women must have documentation of a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. 8. Female subjects with reproductive potential and male subjects with reproductive potential or who have female partners of reproductive potential, must agree to use two effective methods of contraception from signing informed consent until 90 days after the last dose of study drug. Acceptable forms of contraception include double barrier (ie, condom with spermicide); surgically sterilized partner (180-day minimum); or abstinence. Exclusion Criteria: 1. Prior or ongoing medical condition or any abnormal finding on the Screening visit physical exam, ECG, laboratory testing that, in the Investigators opinion, could adversely affect the safety of the subject or the conduct of the study assessments. 2. Any neurological abnormality other than ET upon neurological exam, including dystonia, ataxia, or any other neurodegenerative disease, including multiple sclerosis or Parkinsons disease. 3. Significant cognitive impairment or dementia that, in the opinion of the Investigator, would interfere with participation in the study. 4. An unstable thyroid condition that, per the Investigators judgment, has not stabilized over the past 90 days prior to screening. This includes current clinical history of hypo- or hyperthyroidism, thyrotoxicosis or significant abnormality of thyroid function testing at Screening. 5. History of, or evidence of psychogenic tremor at Screening. 6. History of anaphylaxis, hypersensitivity reactions (including to any of CAD-1883 excipients), or clinically significant drug allergies. 7. Alkaline phosphatase, aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) level >2.0 x upper limit of normal (ULN) at Screening and/or at Pre-dose. 8. Serum creatinine >120 μmol/L and/or creatinine clearance <60 mL/min (according to Cockcroft-Gault formula) at Screening and/or at Pre-dose. 9. Total bilirubin >2.0 x ULN at Screening and/or at Pre-dose. Note: isolated bilirubin >2.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%. 10. History of Long QT syndrome and/or QTcF (Fridericias correction) interval >450 msec (males) or >470 msec (females) per 12-lead ECG done at Screening. 11. History of Alcohol Use Disorder per Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria. 12. History of human immunodeficiency virus (HIV) infection or positive screening result for: HIV 1 or 2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCVAb). 13. Has a diagnosis of epilepsy or any history of seizure as an adult, head trauma, stroke, transient ischemic attack within 1 year prior to Screening, unexplained loss of consciousness within 1 year prior to Screening, or any lifetime history of asymptomatic or symptomatic orthostatic hypotension (eg, postural syncope). 14. History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class 3 or 4), or clinically significant conduction abnormalities (eg, unstable atrial fibrillation) within 1 year prior to screening. 15. Any major psychiatric disorder that is uncontrolled (for the past 90 days) that, per the Investigators judgment, can interfere with any of the study procedures. 16. Subject has cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin; cervical carcinoma in situ; prostatic carcinoma in situ; or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years. 17. Subjects with scheduled surgeries during the study period. ; PRIMARY OUTCOME: Evaluate the Occurrence and Severity of Treatment Emergent AEs.; 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 - OLE; BRIEF: This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment. ; DRUG USED: ANAVEX 2-73; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Muscarinic acetylcholine receptor, NMDA Glutamate Receptor, Sigma-1 Receptor, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Anavex Life Sciences Corp.; CRITERIA: Inclusion Criteria: - Previous completion of participation in the ANAVEX2-73-PDD-001 study. - Caregivers and subjects (or legal representative) must understand and have signed approved informed consent. - Caregivers and subjects (or legal representative) must be able to understand study requirements and be willing to follow instructions. - Stable regimen of anti-Parkinsons disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline. - Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to joining this study. - Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for ≥8 weeks before Baseline. - Contraception: Women of childbearing potential must use an acceptable method of contraception starting 4 weeks prior to study drug administration and for a minimum of 4 weeks after study completion. Otherwise, women must be postmenopausal (at least one year absence of vaginal bleeding or spotting) as confirmed by FSH greater than or equal to 40 mIU/mL or 40 IU/L or be surgically sterile. - Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation. Exclusion Criteria: - History of any significant neurologic or psychiatric disorder other than PD that can contribute to cognitive impairment. - Any other condition or clinically significant abnormal findings on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the Investigator, would make the subject unsuitable for the study. - Potential symptomatic causes of cognitive impairment including but not limited to - abnormal thyroid function test at screening (TSH) - abnormal B12 level at screening - MRI findings (by history) pointing to a potential symptomatic cause of cognitive dysfunction, including significant vascular changes, or communicating hydrocephalus. - Treatment with memantine or amantadine. If appropriate the drugs can be discontinued for a minimum of 4 weeks prior to enrollment. - History of depression as measured by Beck Depression Inventory score >17 at screening. - Treatment with any other investigational drug or device within 4 weeks prior to screening. - Smoking > 1 pack of cigarettes per day (as assessed for the 4 weeks prior to screening). - Women who are pregnant or lactating. - Known allergy or sensitivity to ANAVEX2-73 or any of its components. - Suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or type 5, or any suicidal behavior, in the past 6 months. Type 4 indicates active suicidal ideation with some intent to act, without a specific plan. Type 5 indicates active suicidal ideation with a specific plan and intent. - Use of centrally acting anticholinergic drugs during the 4 weeks before enrollment. - Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to enrollment. - Treatment with any dopamine receptor blocking medications with the exception of low dose quetiapine (≤50 mg/day). Pimavanserin (≤34 mg/day) will be allowed. - History of neurosurgical intervention (e.g., deep brain stimulation) for PD. - Unpredictable motor fluctuations that would interfere with administering cognitive assessments in the ON state. ; PRIMARY OUTCOME: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03; SECONDARY OUTCOME 1: RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Metformin IR (CV181-168); BRIEF: The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied. ; DRUG USED: Qtern; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4), SGLT; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria 1. Signed Written Informed Consent a) Subjects must be willing and able to give signed and dated written informed consent. 2. Target Population 1. Subjects with T2DM with inadequate glycemic control, defined as central laboratory HbA1c ≥ 8.0 and ≤ 11.5% obtained at the screening visit (ie Week -18 visit) 2. Stable metformin therapy for at least 8 weeks prior to screening visit at a dose ≥ 1500 mg per day. 3. C-peptide ≥ 1.0 ng/mL (0.34 nmol/L) at screening visit. 4. BMI ≤ 45.0 kg/m2 at the screening visit. 3. Age and Reproductive Status 1. Men and women, aged ≥ 18 years old at time of screening visit. 2. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP. 3. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product. 4. Women must not be breastfeeding 5. Sexually active fertile men must use effective birth control if their partners are WOCBP. Exclusion Criteria 1. Target Disease Exceptions 1. History of diabetes insipidus 2. Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the three months prior to screening, or other signs and symptoms. 3. History of diabetic ketoacidosis or hyperosmolar nonketotic coma. 2. Medical History and Concurrent Diseases 1. History of bariatric surgery or lap-band procedure within 12 months prior to screening. 2. Any unstable endocrine, psychiatric or rheumatic disorders as judged by the Investigator. 3. Subject who, in the judgment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data and concomitant use of loop diuretics in countries where this is not recommended as per the Dapagliflozin label. 4. Subject is currently abusing alcohol or other drugs or has done so within the last 6 months. Acute Vascular Event: 5. Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg. Note: Subjects with SBP ≥ 160mmHg and < 180mmHg or a DBP ≥ 100 mmHg and < 110mmHg will be able to enter the lead-in period, provided their hypertension treatment is adjusted as deemed appropriate by the investigator. These subjects cannot be randomized if their blood pressure remains with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg measured at Day 1. 6. Cardiovascular Disease within 3 months of the screening visit [ie myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, stroke or transient ischemic attack (TIA)]. 7. Congestive heart failure as New York Association (NYHA) class IV (see Appendix 1), unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volumes status throughout the study. Renal Diseases: 8. Moderate or severe impairment of renal function [defined as eGFR < 60 mL/min/1.73 m2 (estimated by MDRD) or serum creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females.] 9. Conditions of congenital renal glucosuria Hepatic Diseases: 10. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency, including subjects with ALT and/or AST > 3x ULN and or Total Bilirubin > 2.5 x ULN. Hematological and Oncological Disease/Conditions 11. History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis. 12. Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma) 13. Known immunocompromised status, including but not limited to, individuals who have undergone organ transplantation or who are positive for the human immunodeficiency virus. 14. Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 6 months prior to the screening visit. Prohibited treatment and therapies 15. Administration of any antihyperglycemic therapy, other than metformin, for more than 14 days (consecutive or not) during the 12 weeks prior to screening, as well as previous participation in any DPP-4 or SGLT-2 inhibitor trial is an exclusion criterion. 16. Current treatment with potent cytochrome P450 3A4/5 inhibitors (in countries where dose adjustment would be required by the saxagliptin label). 17. Administration of any other investigational drug or participation in any interventional clinical studies within 30 days of planned screening to this study. Subjects who failed to satisfy all eligibility criteria at screening and did not enter the lead-in or open-label period in CV181-169 or MB102-129 studies specifically, do not need to wait 30 days. 3. Physical and Laboratory Test Findings 1. Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women 2. Male subjects with microscopic hematuria present at Week -18 or Week -16 AND no common cause that can be confirmed. Male subjects with a confirmed common cause can be entered into the open-label phase with a documented negative result for hematuria microscopic urinalysis performed by the central laboratory. NOTE: Female subjects with hematuria can be entered into the open-label phase and be randomized, but should be investigated according to local standards and best clinical practices. (See Appendix 3) 3. Other central laboratory test findings: - Abnormal free T4 values. Abnormal thyroid stimulating hormone (TSH) value at screening will be further evaluated by free T4. Subjects with abnormal free T4 values will be excluded. - Positive for hepatitis B surface antigen - Positive for anti-hepatitis C virus antibody 4. Allergies and Adverse Drug Reaction a) Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure, the local saxagliptin or dapagliflozin package insert or the local metformin package insert, including current treatment with potent cytochrome P450 3A4/5 inhibitors (in countries where dose adjustment would be required by the local saxagliptin label). 5. Sex and Reproductive Status a) Women who are pregnant 6. Other Exclusion Criteria 1. Prisoners or subjects who are involuntarily incarcerated. 2. Subject who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. ; PRIMARY OUTCOME: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24; SECONDARY OUTCOME 1: Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Onset 9 (vs. NovoRapid); BRIEF: The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks). ; DRUG USED: FIAsp; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). ; PRIMARY OUTCOME: Change in Glycosylated Haemoglobin (HbA1c); SECONDARY OUTCOME 1: Change From Baseline in 1-hour PPG Increment[/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 - PERSEPT 1 (Adolescents/Adults); BRIEF: The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX ; DRUG USED: SEVENFACT; DRUG CLASS: Biologic; INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Coagulation Factor IX, Coagulation Factor VII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: rEVO Biologics; CRITERIA: Inclusion Criteria: - be male with a diagnosis of congenital hemophilia A and/or B of any severity - have one of the following: - a positive inhibitor test Bethesda Unit (BU) ≥ 5 (as confirmed at screening by the institutional lab), OR - a BU<5 but expected to have a high anamnestic response to FVIII or FIX, as demonstrated from the subjects medical history, precluding the use of Factor VIII or IX products to treat bleedings, OR - a BU<5 but expected to be refractory to increased dosing of FVIII or FIX, as demonstrated from the subjects medical history, precluding the use of Factor VIII or IX products to treat bleedings - be 12 years or older, up to and including 75 years of age (NOTE: different age restrictions may apply per local regulation and/or ethical considerations) - have at least 3 bleeding episodes of any severity in the past 6 months be capable of understanding and willing to comply with the conditions of the protocol - have read, understood and provided written informed consent (patient and/or parent(s)/legal guardian(s) if <18 years of age) Exclusion Criteria: - have any coagulation disorder other than hemophilia A or B - be immuno-suppressed (i.e., the patient should not be receiving systemic immunosuppressive medication, cluster of differentiation 4 (CD4) counts at screening should be >200/µl) - have a known allergy or hypersensitivity to rabbits - have platelet count <100,000/mL - have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal) - have received an investigational drug within 30 days of the first study drug administration, or is expected to receive such drug during participation in this study - have a clinically relevant hepatic (AST and/or alanine aminotransferase (ALT) >3 times the upper limit of normal) and/or renal impairment (creatinine >2 times the upper limit of normal) - have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or pulmonary embolism) within 2 years prior to first dose of study drug, or current New York Heart Association (NYHA) functional classification score of stage II -IV - have an active malignancy (those with non-melanoma skin cancer are allowed) - have any life-threatening disease or other disease or condition which, according to the investigators judgment, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome (e.g., a history of non-responsiveness to bypassing products). ; PRIMARY OUTCOME: Proportion of Successfully Treated Mild/Moderate Bleeding Episodes; SECONDARY OUTCOME 1: Proportion of Mild/Moderate Bleeding Episodes With Patient (Pt)-Reported Good or Excellent Responses at 12 Hours[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ECHELON-2; BRIEF: This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas. ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Patients with newly diagnosed, CD30-positive mature T-cell lymphomas - Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria: - History of another primary invasive malignancy that has not been in remission for at least 3 years - Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides - History of progressive multifocal leukoencephalopathy (PML) - Cerebral/meningeal disease related to the underlying malignancy ; PRIMARY OUTCOME: Progression-free Survival Per Independent Review Facility (IRF); SECONDARY OUTCOME 1: Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AMR in Deceased-Donor Recipients; BRIEF: Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants. ; DRUG USED: Soliris; DRUG CLASS: Biologic; INDICATION: Antibody Mediated Rejection (AMR); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female participants ≥18 years old. 2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized. 3. History of prior exposure to HLA (human leukocyte antigen): - Prior solid organ or tissue allograft - Pregnancy - Blood transfusion - Prior exposure to specific donors HLA Exclusion Criteria: 1. Has received treatment with eculizumab at any time prior to enrolling in this study. 2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor. 3. History of severe cardiac disease. 4. Prior splenectomy. ; PRIMARY OUTCOME: Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation; 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 IIb - Severe Allergic Asthma; BRIEF: The purpose of this study is to assess the therapeutic potential and safety/tolerability of study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard controller therapy. Altogether 360 patients randomized to 4 treatment groups will be included. The study compares three dose strength with placebo. Each patient receives 7 injections of study drug or undistinguishable placebo. Key outcome measures are patient reported parameters on their asthma. ; DRUG USED: Vidutolimod; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: Immune System, Toll-Like Receptor (TLR) Family, Toll-like receptor 9 (TLR9); THERAPY: Monotherapy; LEAD SPONSOR: Cytos Biotechnology AG; CRITERIA: Inclusion Criteria: - Able and willing to provide written informed consent - Able and willing to complete all protocol requirements - Between 18 to 65 years of age - Presence of persistent asthma for at least 6 months according to GINA 2011 guidelines at step 3 or 4 of treatment who has been on stable controller therapy for at least 4 weeks, and symptoms are not sufficiently controlled with medium to high doses of inhaled corticosteroid (ICS) (>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without long acting beta agonist (LABA), insufficient control will be based on asthma control questionnaire (ACQ) score ≥1.5 points. Use of stable doses of other controller therapies according to GINA steps 3 and 4 (leukotriene modifiers, sustained release theophylline) are also acceptable, but NOT treatment with anti immunoglobulin E (IgE) antibodies within the past 6 months - Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at the screening and the baseline visits. - Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1 aero-allergen during the screening period - Forced expiratory volume in one second (FEV1)≥40 to ≤90% of predicted value - Reversibility of airway obstruction as demonstrated by: - FEV1 improvement by >12% , and - By ≥200 mL after inhaled β2-agonist (400 µg salbutamol or equivalent). If a subject does not meet reversibility criteria at the screening visit, reversibility may be retested once prior to run-in as long as the test is performed at least 5 days prior to the beginning of the run-in phase Exclusion Criteria: - Failure to meet at least 80% compliance with completion of asthma symptoms and medication diaries at the baseline visit, after initial instruction at the screening visit and where necessary additional training at the 2-weeks run-in visit. . An additional maximum 2-weeks training period may be added in such patients. - Treatment or hospitalization for asthma exacerbation within past 2 months. - Current use or use of systemic corticosteroids within past 2 months. - Current smokers. - Ex-smokers with a smoking history of >10 pack years (1 package per day for 10 years). - Pregnancy or female planning to become pregnant during the study period. - Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years. - Treatment with IgE antibodies (Xolair®) within past 6 months. - Use of investigational unapproved drugs within 30 days or within 5 half-lives of the investigational drug, whichever is longer, or planned use during the whole study period. - Use of investigational biologics within the last 6 months. - Previous participation in a clinical study with a virus like particle (VLP) Qb-based vaccine. - Possible dependency of the patient on sponsor and/or investigator. - Women of child bearing potential ; PRIMARY OUTCOME: Asthma Control Questionnaire; 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 IIa - CR108410; BRIEF: The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels. ; DRUG USED: JNJ-6379; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Sciences Ireland UC; CRITERIA: Inclusion Criteria: - Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m^2), extremes included - Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum hepatitis B surface antigen (HBsAg)-positive at screening and serum HBsAg- or hepatitis B virus (HBV) deoxyribonucleic acid (DNA)-positive at least 6 months prior to screening; Serum immunoglobulin M (IgM) anti- hepatitis B core-related (HBc) antibody negative at screening - In participants currently not being treated (Treatment Arms 1-2-3 and 6-7-8): Participants must not be receiving any CHB treatment at screening, that is, Have never received treatment with HBV antiviral medicines, including NAs or interferon (IFN) products, OR Have not been on treatment with HBV antiviral medicines, including nucleos(t)ide analog (NA)s or IFN products within 6 months prior to baseline (first intake of study drugs), and participants must be HBeAg-positive and have HBV DNA greater than or equal to (>=) 20,000 International Units Per Milliliter (IU/mL), OR be hepatitis B e antigen (HBeAg)-negative and have HBV DNA >=2,000 IU /mL at screening, and participants must have HBsAg greater than (>) 250 IU/mL at screening, and participants must have alanine aminotransferase (ALT) > upper limit of normal (ULN) and less than or equal to (<=) 5 * ULN at screening, determined in the central laboratory - In virologically suppressed participants (Treatment Arms 4-5 and 9-10): Participants must be virologically suppressed by current NA treatment (entecavir (ETV) or tenofovir disoproxil fumarate (TDF)) as defined by HBV DNA less than (<) 60 IU/mL at screening and at least 6 months prior to screening, and participants must be on the same NA treatment (ETV or TDF) and the same dose for >=12 months prior to screening, and participants must have HBsAg > 250 IU/mL at screening, and participants must have ALT <=2*ULN at screening - Participants must have: A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR FibroScan liver stiffness measurement <8.0 kilopascal (kPa) within 6 months prior to screening or at the time of screening Exclusion Criteria: Main Study: - Participants who test positive for anti-hepatitis B surface (HBs) antibodies - Participants with current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), hepatitis D virus (HDV) infection (confirmed by HDV antibody), hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening; participants with a history of or current HCV infection (confirmed by HCV antibody). Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion - Participants with any evidence of hepatic decompensation at any time point prior to or at the time of screening: Direct bilirubin >1.2* ULN, or International normalized ratio (INR) >1.5* ULN, or Serum albumin < lower limit of normal (LLN), or documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy - Participants with a history of cardiac arrhythmia (example, extrasystoli, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant 12 lead electrocardiograms (ECGs) abnormalities), moderate to severe valvular disease, or uncontrolled hypertension at screening - Participants with contraindications to the use of ETV or TDF per local prescribing information Substudy: - Presence of coagulopathy or hemoglobinopathy (including sickle cell disease, thalassemia) - Use of any anti-coagulant, anti-platelet, or non-steroidal anti-inflammatory drug medications from 10 days before until 5 days after each liver biopsy - Presence of ascites, focal liver lesions, and other findings that would be contraindications for liver biopsies ; PRIMARY OUTCOME: Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24; SECONDARY OUTCOME 1: Number of Participants With Treatment- Emergent Adverse Events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Adults (1st Recurrence); BRIEF: The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment for recurrent glioblastoma multiform (GBM). ; DRUG USED: SL-701; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Ephrin Receptor EphA2 , IL-13 (Interleukin-13), Immune System, Stem Cells/Other Cell Therapies, Survivin; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Stemline Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - 18 years of age or older. - Histologically confirmed GBM or World Health Organization (WHO) Grade IV variants (gliosarcoma, glioblastoma with oligodendroglial features, or giant cell glioblastoma). - Unequivocal evidence of a first tumor recurrence or progression on the initial treatment regimen (prior to enrollment on this study), consisting of surgical intervention (biopsy and/or resection), radiation, and temozolomide chemotherapy, as assessed by MRI or CT scan of the brain with or without contrast within 14 days prior to the start of SL-701. If receiving corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan. Patients unable to undergo MRI because of non-compatible devices can be enrolled, provided CT scans are obtained and are of sufficient quality. For each patient, the same imaging technique should be performed throughout the study, for purposes of assessing tumor response or PD. - For patients who have undergone resection of recurrent or progressive tumor prior to study enrollment, the following conditions must apply: - Recovery from the effects of surgery. - Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, an MRI should be performed: - No later than 96 hours (h) in the immediate post-operative period; or - At least 4 weeks post-craniotomy (7 days for stereotactic biopsy), within 14 days prior to the start of SL-701, and on a corticosteroid dosage that has been stable or decreasing for at least 5 days. - Patients who have not had resection of recurrent or progressive disease must have measurable disease. - At least 56 of the approximately 76 patients treated must have measurable disease, defined as at least one, contrast-enhancing lesion measuring at least 1 cm in 2 planes (axial, coronal, or sagittal). - No evidence of hemorrhage on the baseline MRI or CT scan other than those that are Grade ≤ 1 and either post-operative or stable on at least two consecutive scans. - Recovery from prior therapy toxicity, defined as resolution of all treatment-related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia and lymphopenia). - At least 12 weeks from prior radiotherapy to the start of SL-701 unless there is new enhancement outside of the radiation field or unequivocal histopathologic evidence of recurrent tumor subsequent to radiotherapy. - No chemotherapy or investigational agent for at least 3 weeks prior to the start of SL-701. - Human leukocyte antigen (HLA)-A2 positive. - A tumor tissue sample is provided for immunohistochemical analysis of relevant antigens, immune markers and potential prognostic factors. Preferably a paraffin block or 10-12 unstained slides will be submitted prior to study entry. Patients for whom tumor samples are unavailable or inadequate are permitted to participate in the study; however, the absence of available/adequate tumor specimen must be documented. - Karnofsky performance status (KPS) score ≥ 70%. - Adequate organ function, including the following: - Absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 100,000/μL. - Serum creatinine < 1.5 × the upper limit of normal (ULN). - Bilirubin < 1.5 × ULN. - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN. - Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the start of SL-701 treatment. - Female patients of childbearing potential and sexually active male patients must agree to use an acceptable form of contraception for heterosexual activity (ie, oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 40 days before Screening, during the study, and for 60 days after the last dose of study drug. Men should not donate semen during the study and for 60 days after the last dose of study drug. - Female patients without childbearing potential (spontaneous amenorrhea for > 12 months or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy > 6 months before Screening) are eligible for inclusion without contraceptive use restriction. - Able and willing to comply with protocol requirements, in the opinion of the investigator. - A written and voluntarily signed informed consent must be obtained from the patient or legally authorized representative, in accordance with local regulations, before the initiation of any study related procedures. The patient or legally authorized representative must be able to read and understand the informed consent form (ICF). Exclusion Criteria: - Prior cancer chemotherapy, bevacizumab (or other vascular endothelial growth factor [VEGF]/VEGF receptor [VEGFR]-directed agent), or an investigational agent for recurrent/progressive GBM or prior bevacizumab as part of initial therapy (prior chemotherapy or investigational agents are permitted as part of initial therapy; VEGF/VEGFR-directed agents are not permitted). - Contrast-enhancing tumor that is any of the following: - Multi-focal (defined as two separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid-attenuated inversion recovery (FLAIR) or T2 sequences); - Associated with either diffuse subependymal or leptomeningeal dissemination; or - ≥ 4 cm in any dimension. - Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of SL-701 treatment. - Surgical resection or major surgical procedure within 4 weeks prior to the start of SL-701, or stereotactic biopsy within 7 days prior to the start of SL-701. - Radiation therapy, local therapy (except for surgical re-resection), or systemic therapy following first recurrence/progressive disease. Excluded local therapies include stereotactic radiation boost, implantation of carmustine biodegradable wafers (Gliadel), intratumoral or convection-enhanced delivery administered agents, etc. - Active infection requiring intravenous antibiotics. - History of cancer (other than GBM) within the past 2 years that has metastatic or local recurrence potential and could negatively impact survival and/or potentially confound tumor response assessments within this study. - Clinically significant cardiovascular disease (eg, uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication). - Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus infection, Hepatitis B, or Hepatitis C, or has taken an immunosuppressive agent within 4 weeks prior to the start of SL-701 treatment. Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. - Any condition which in the investigators opinion makes the patient unsuitable for study participation. - Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed. - Has history of known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of start of study drug. - Has evidence of intratumoral or peritumoral hemorrhage on baseline MRI scan other than those that are ≤Grade 1 and either post-operative or stable on at least 2 consecutive MRI scans - Has gastrointestinal bleeding or any other hemorrhage/bleeding event National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) >Grade 3 within 6 months of start of study drug. ; PRIMARY OUTCOME: Overall Survival at 12 Months (OS-12); SECONDARY OUTCOME 1: Complete Response (CR) or Partial Response (PR)[/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. Ceftriaxone + Azithromycin (Gonorrhoea); BRIEF: This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea. ; DRUG USED: Zoliflodacin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Gram-Negative Bacteria, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: Global Antibiotics Research and Development Partnership; CRITERIA: Inclusion Criteria: 1. Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and thics guidance) 2. Weight ≥ 35 kg 3. Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture) 4. For females of child-bearing potential, a negative urine pregnancy test at screening 5. For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study. 6. For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment 7. Willingness to comply with trial protocol 8. Willingness to undergo HIV testing 9. Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit 10. Willingness and ability to give written informed consent or be consented by a legal representative or provide assent and parental consent (for minors, as appropriate). Exclusion Criteria: 11. Confirmed or suspected complicated or disseminated gonorrhoea 12. Pregnant or breastfeeding women 13. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection) 14. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening 15. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening 16. Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is greater, prior to screening 17. Cytotoxic or radiation therapy within 30 days prior to screening 18. Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug based on medical history and physical examination 19. History of urogenital sex-reassignment surgery 20. Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count <200 cells/μL 21. Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation 22. Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics 23. Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments) 24. Receipt or planned receipt of an investigational product in a clinical trial within 30 days or five half-lives of the drug, whichever is greater, prior to screening until end of participation to this clinical trial 25. History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator 26. Severe medical or psychiatric condition which, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of trial results or affect the individuals ability to provide informed consent 27. Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol 28. Previous randomisation in this clinical trial. 29. Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening ; PRIMARY OUTCOME: Efficacy of a single dose of zoliflodacin will be assessed compared to a combination of a single dose of ceftriaxone and azithromycin.; SECONDARY OUTCOME 1: Safety of a single dose of zoliflodacin will be assessed compared to a combination a single dose of ceftriaxone and azithromycin.[/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 - US (Pediatric Pivotal); BRIEF: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC. ; DRUG USED: Prevnar 13; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy 2-month-old infants. - Available for the entire study period. Exclusion criteria: - Previous vaccination with any vaccine before the start of the study. - Known contraindication to vaccination. ; PRIMARY OUTCOME: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series; SECONDARY OUTCOME 1: Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)[/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 - 202 (China); BRIEF: This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death. ; DRUG USED: KN026; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Jiangsu Alphamab Biopharmaceuticals Co., Ltd; CRITERIA: Inclusion Criteria: - Signed inform consent form(ICF) - Age ≥ 18 years and ≤ 75 years, male or female - Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ & ISH+ HER2 expressing: IHC2+ & ISH- or IHC 1+ & ISH+ - Received at least one prior standard therapy - At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate organ function - LVEF≥ 50% (ECHO) - Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed. - Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures Exclusion Criteria: - Accepted any other anti-tumor drug therapies within 4 weeks before fist dose - Accepted radiotherapy within 4 weeks before enrollment - An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines - Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible - Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study - History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation - Severe chronic and active infection, need to system antibiosis/antiviral treatment - Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage - Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication ; PRIMARY OUTCOME: ORR; 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 - PolarisDMD (Ages 4-7); BRIEF: The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD. ; DRUG USED: Edasalonexent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Diglycerol Acyltransferase (DGAT), IkappaB kinase (IKK), NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) ; THERAPY: Monotherapy; LEAD SPONSOR: Catabasis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements - Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase (CK) and documentation of mutation(s) in the dystrophin gene known to be associated with a DMD phenotype - Able to perform stand from supine without assistance in ≤ 10 seconds - Able to perform the 10MWT and 4-stair climb - Followed by a doctor or medical professional who coordinates Duchenne care on a regular basis and willingness to disclose patients study participation with medical professionals Exclusion Criteria: - Use of corticosteroids within 24 weeks prior to Day 1; use of inhaled, intranasal, and topical corticosteroids is permitted - Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4 weeks. Exception: Patients who have received at least 24 weeks of a stable dose of eteplirsen prior to Day 1, and expected to continue treatment, will be eligible - Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy, warfarin, phenytoin, S mephenytoin, cyclosporine, dihydroergotamine, ergotamine, fentanyl, alfentanil, pimozide, quinidine, sirolimus, tacrolimus, or paclitaxel - Use of human growth hormone within 3 months prior to Day 1 - Other prior or ongoing significant medical conditions ; PRIMARY OUTCOME: Change From Baseline in North Star Ambulatory Assessment (NSAA); SECONDARY OUTCOME 1: Change From Baseline in 10-meter Walk/Run Test[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PLATforM; BRIEF: The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma ; DRUG USED: LAG525; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, LAG3 (Lymphocyte-Activation Gene)/CD223; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key inclusion criteria for Arm 1,2,3,4: - Histologically confirmed unresectable or metastatic stage IIIB/C/D or IV melanoma using AJCC edition 8 - Previously treated for unresectable or metastatic melanoma: - Subjects with V600BRAF wild-type disease must have received prior systemic therapy for unresectable or metastatic melanoma with anti-PD-1/PD-L1. Additionally, subjects may have received anti-CTLA-4 as a single agent or in combination with anti-PD-1/PD-L1, irrespective of the sequence. No additional systemic treatment is allowed for advanced or metastatic melanoma. A maximum of two prior lines of systemic therapies for unresectable or metastatic melanoma are allowed. The last dose of prior therapy (anti-PD-1, anti-PD-L1 or anti-CTLA-4) must have been received more than four weeks before randomization. - Subjects with V600BRAF mutant disease must have received prior systemic therapy for unresectable or metastatic melanoma with anti-PD-1/PD-L1, and V600BRAF inhibitor. Additionally, subjects may have received anti-CTLA-4 as a single agent or in combination with anti-PD-1/PD-L1, or MEK inhibitor (in combination with V600BRAF inhibitor or as a single agent), irrespective of the sequence. No additional systemic treatment is allowed for advanced or metastatic melanoma . A maximum of three prior lines of systemic therapies for unresectable or metastatic melanoma are allowed. The last dose of prior therapy must have been received more than 4 weeks (for anti-PD-1, anti-PD-L1 or anti-CTLA-4) or more than 2 weeks (for V600BRAF or MEK inhibitor) prior to randomization. - All subjects (with V600BRAF wild-type disease and with V600BRAF mutant disease) must have documented disease progression as per RECIST v1.1 while on/after the last therapy received prior to study entry and while on/after treatment with anti-PD1/PD-L1. The last progression must have occured within 12 weeks prior to randomization in the study. - ECOG performance status 0-2 - At least one measurable lesion per RECIST v1.1 - At least one lesion, suitable for sequential mandatory tumor biopsies (screening and on-treatment) in accordance with the biopsy guidelines specified in protocol. The same lesion must be biopsied sequentially. - Screening tumor biopsy must fulfill the tissue quality criteria outlined in the protocol, as assessed by a local pathologist Key inclusion criteria for Arm 1A: - Histologically confirmed unresectable or metastatic stage IIIB/C/D or IV melanoma according to AJCC Edition 8 - Previously treated for unresectable or metastatic melanoma: - All subjects must have received anti-PD-1 checkpoint inhibitor therapy (ie. pembrolizumab or nivolumab) either as monotherapy or in combination with ipilimumab as the last systemic therapy prior to enrollment and must have confirmed disease progression as per RECIST v1.1 (confirmed on a subsequent scan, which can be the scan performed during screening) while on or after this therapy prior to enrollment. - Subjects with V600BRAF wild-type disease must have received no more than 2 prior systemic therapies including prior anti-PD-1/PD-L1 (as monotherapy or in combination with ipilimumab) - Subjects with V600BRAF mutant disease must have received no more than 3 prior systemic therapies including anti-PD-1/PD-L1 (as monotherapy or in combination with ipilimumab), and V600BRAF inhibitor (as monotherapy or in combination with a MEK inhibitor) - The last dose of anti-PD-1 based therapy must have been received more than four weeks prior to first dose of study treatment. - The last documented disease progression must have occurred within 12 weeks prior to first dose of study treatment - No additional systemic treatment is allowed for advanced or metastatic melanoma (this includes for example tumor infiltrating lymphocyte therapy) - ECOG performance status 0-1 - At least one measurable lesion per RECIST v1.1 - Subjects must have baseline tumor sample that is positive for LAG-3 per central assessment Key exclusion criteria common to all combination arms: - Subjects with uveal or mucosal melanoma - Presence of clinically active or unstable brain metastasis at time of screening. - Use of any live vaccines against infectious diseases within 3 months before randomization/enrolment. - Active infection requiring systemic antibiotic therapy at time of randomization/enrolment. - Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization/enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. - Active, known or suspected autoimmune disease or a documented history of autoimmune disease. - Prior allogenic bone marrow or solid organ transplant - History of known hypersensitivity to any of the investigational drugs used in this study - Prior systemic therapy for unresectable or metastatic melanoma with any investigational agent, or with any other agent except anti-PD-1/PD-L1 and anti-CTLA-4 (and V600BRAF and MEK inhibitors if subject has V600BRAF mutant disease). Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months before the start of the study treatment - Medical history or current diagnosis of myocarditis - Cardiac Troponin T (or Troponin I) level > 2 x ULN at screening ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Duration of 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 - AMPLIFY; BRIEF: This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD). ; DRUG USED: Duaklir Pressair; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Adult male or non-pregnant, non-lactating female patients aged ≥40. - Patients with diagnosis of moderate to very severe stable COPD: post-bronchodilator FEV1 < 80% of the predicted normal and post-bronchodilator FEV1/FVC < 70% at Screening Visit. - Symptomatic patients with a CAT score ≥10 at Screening and Randomization visit (Visits 1 and 2). - Current or former-smokers, with a smoking history of ≥ 10 pack-years. - Patients able to perform acceptable and repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1. - Patients eligible and able to participate in the study and who had signed an Informed Consent Form prior to initiation of any study-related procedures. Exclusion Criteria: - Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff), or patients employed by or relatives of the employees of the site or sponsor. - Previous randomization in the present study D6571C00001. - Patients with predominant asthma. - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run-in period. - Patients hospitalized for a COPD exacerbation (an emergency room visit for longer than 24 hours is considered a hospitalization) within 3 months prior to Screening Visit. - Clinically significant respiratory conditions other than COPD. - Patients who in the Investigators opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening. - Use of long-term oxygen therapy (≥ 15 hours/day). - Patients who do not maintain regular day/night, waking/sleeping cycles including night shift workers. - Clinically significant cardiovascular conditions. - Patients with uncontrolled Type I or Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled hypertension. - Patients with history of long QT syndrome or whose QTc (calculated according to Fridericias Formula QTc=QT/RR1/3) > 470 ms as indicated in the centralised reading report assessed at Screening. - Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Screening Visit that might comprise patient safety. - Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis. - Patient with a history of hypersensitivity reaction to inhaled medication or any component thereof, including paradoxical bronchospasm. - Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic non-stable prostate hypertrophy. - History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer. - Patients with any other serious or uncontrolled physical or mental dysfunction. - Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment. - Patients unlikely to be cooperative or that cannot comply with the study procedures. - Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening. - Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication. - Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients. Patients who demonstrate < 80% compliance with the electronic diary during the run-in period. ; PRIMARY OUTCOME: Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Normalized Area Under Curve 3hours Post-dose (nAUC0-3/3h) FEV1 of AB/FF 400/12 μg Compared to AB 400 μg and and FF 12 μg at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PT019; BRIEF: This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the end of the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events. ; DRUG USED: Bermekimab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: 1. Subjects 18 years of age or older 2. Diagnosis of plaque psoriasis for ≥ 6 months; INCLUDING subjects with chronic guttate lesions. 3. Psoriasis area-and-severity index (PASI) score of ≥ 12 4. Involvement of ≥ 5% of body-surface area 5. For female subjects of childbearing age, a negative urine pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize adequate, double barrier contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion. 6. Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed Exclusion Criteria: 1. Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer). 2. Treatment with conventional systemic psoriasis therapy within last 4 weeks 3. Treatment with phototherapy within the last 4 weeks 4. Topical psoriasis treatment with the last 2 weeks 5. History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. 6. Hemoglobin <10.0 g/dL, WBC <3.0 x 103/mm3, platelet count <125 x 103/mm3, creatinine > 1.5mg/dL, AST/ALT >2 x ULN, alkaline phosphatase >2 x ULN 7. Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody. 8. History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin. 9. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA) 11. Infectious disease: CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening 12. Immunodeficiency 13. History of treatment with Tysabri or Raptiva 14. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding 15. Receipt of a live (attenuated) vaccine within 3 months prior to Screening 16. Major surgery within 28 days prior to Day 0 17. Participation in an investigational drug or device trial within 30 days prior to Screening ; PRIMARY OUTCOME: Safety and Tolerability; SECONDARY OUTCOME 1: RA-18C3 Pharmacokinetics[/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/Apatinib; BRIEF: In this one-arm study, histologically or cytologically confirmed advanced NSCLC, uterine malignancies, and soft tissue sarcoma will be enrolled to investigate the efficacy and safety of PD-1 monoclonal antibody SHR-1210 and apatinib, at the same time, peripheral circulating blood tumor cells (CTC) detection and CTC-based PD-L1 antibody immunofluorescence detection will be performed. ; DRUG USED: Camrelizumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Hunan Cancer Hospital; CRITERIA: Inclusion Criteria: 1. Age 18-70 years, both men and women (Uterine cancer limited to women); 2. NSCLC: Pathologically confirmed advanced (IIIB, stage IV) NSCLC with at least 1 measurable lesion that meets the RECIST v1.1 standard without local treatment, of which stage IIIb patients are incapable, unsuitable for surgery or radical radiotherapy, NSCLC patients have failed at least the first-line standard treatment or refused to receive standard treatment, or chemotherapy intolerance, Among them, patients with sensitive gene mutations must fail after TKI treatment (patients who have failed first-line or second-line treatment may participate in this study), Patients with EGFR and ALK mutations must undergo EGFR and ALK inhibitor treatment failure and EGFR T790M mutation negative, for EGFR T790M-positive patients, third-generation EGFR TKI treatment fails. 3. Soft tissue sarcoma: Patients with distant metastasis or locally advanced disease who have previously failed chemotherapy or sensitive recurrence or metastasis to soft tissue sarcoma. Subjects who have judged by the investigator to be unsuitable for surgical treatment (including amputation) of soft tissue sarcomas (diagnosed pathologically or cytologically, but excluding gastrointestinal stromal tumors, chondrocyte-bone tumors, embryonic/acinar rhabdomyosarcoma, Juventus Sarcoma, extensive distant metastatic soft tissue tumors such as keloid cutaneous fibrosarcoma and inflammatory myofibroblastic sarcoma, malignant peripheral nerve sheath tumor, keloid cutaneous fibrosarcoma, inflammatory myofibroblastic sarcoma, malignant interstitial Dermatoma) (priority consideration: synovial sarcoma, undifferentiated multiline sarcoma, dedifferentiated liposarcoma), and measurable lesions that meet the RECIST 1.1 standard. 4. Uterine cancer: Pathologically confirmed uterine cancer, including cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), endometrial cancer, and uterine sarcoma, at least one measurable lesion that meets RECIST 1.1 criteria, recurrence/Persons with persistent cervical cancer, endometrial cancer, and uterine sarcoma cannot be cured by surgery and/or radiotherapy, have received at least a first-line treatment for advanced (stage IVB), recurrent/persistent cervical cancer, endometrial cancer, uterine sarcoma Systemic chemotherapy patients (qualified to participate in this study after the progress of first-line chemotherapy). 5. All acute toxicity caused by previous antitumor treatments were alleviated to level 0-1 (according to NCI CTCAE version 4.03) or to the level specified by the enrollment/ exclusion criteria 1 day before the first dose except for subjects whose toxicity does not pose a safety risk); 6. Able to provide tumor samples (at least 20 unstained tumor samples or fresh tissue specimens embedded in formalin-fixed paraffin within six months, 4ml of peripheral blood samples before treatment and each effect evaluation); 7. ECOG score: 0-1, patients with soft tissue sarcoma amputation can be relaxed to 2 points; 8. Expected survival ≥ 12 weeks; 9. The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening); 1. Absolute neutrophil count ≥1.5 × 109 / L; 2. platelets ≥100 × 109/L; 3. Hemoglobin ≥9g/dL; 4. serum albumin ≥3g/dL; 5. total bilirubin ≤ 1.5ULN; 6. ALT and AST ≤1.5ULN; 7. AKP ≤ 2.5ULN; 8. Serum creatinine ≤ 1.5ULN or creatinine clearance ≥ 60mL/min; 10. Non-surgical sterilization female patients; 11. Participants volunteered to participate in the study, signed informed consent, good compliance, and cooperated with the follow-up. Exclusion Criteria: 1. Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function; subjects with vitiligo or childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not be included in asthma; 2. Participants who were treated with immunosuppressive agents, or systemic or absorbable local hormones for immunosuppressive purposes (dose>10mg/day, prednisone or other curative hormones), and continued to use it within 2 weeks before enrollment; 3. Excessive allergic reactions to other monoclonal antibodies; 4. Participants who had clinical symptoms of central nervous system metastases (such as brain edema, require hormonal intervention, or progress of brain metastases). Participants who had previously received brain or meningeal metastasis treatment, such as clinical stability (MRI) that has been maintained for at least 1 month, and have stopped systemic hormonal therapy (dose> 10 mg / day prednisone or other therapeutic hormone) can be included; 5. Imaging (CT or MRI) showed that the tumor invades or demarcates large blood vessels. 6. Imaging (CT or MRI) showed obvious hollow or necrotic tumors in the lungs; those with marginal adenocarcinoma with cavities can be considered after discussion with the clinician. 7. Participants who had high blood pressure and cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90 mmHg). 8. Participants who had poorly controlled clinical symptoms or diseases of the heart, such as: (1) heart failure above NYHA 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular Sexual arrhythmias require treatment or intervention. 9. Participants who had abnormal blood coagulation (PT> 16s, APTT> 43s, TT> 21s, Fbg <2g / L), bleeding tendency or receiving thrombolytic or anticoagulation； 10. Urine routine indicates urinary protein ≥ ++, or confirms that 24-hour urine protein is ≥1.0 g； 11. Participants who previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy. After treatment is completed (last dose), subjects less than 4 weeks before study medication (or 5 drug half-life, whichever is longer) Patients who did not recover from adverse events (excluding hair loss) from previous treatment to ≤CTCAE 1 degree； 12. Clinically ascites or pleural effusion requiring therapeutic puncture or drainage； 13. Participants who had obvious cough blood in the first 2 months of randomization, or a day with hemoptysis of half teaspoon (2.5ml) or more； 14. Participants who had clinically significant bleeding symptoms or have a clear bleeding tendency within the first 3 months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood at baseline and above, or have vasculitis； 15. Participants who had arterial/venous thrombotic events such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism occurred within the first 6 months； 16. Participants who had known hereditary or acquired bleeding and thrombotic tendency (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.)； 17. Participants who had an active infection or an unexplained fever during the screening period before the first dose> 38.5 degrees; 18. Patients with past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc; 19. Participants who had congenital or acquired immune deficiency (such as HIV-infected persons), or positive for syphilis spiral antibodies, or active hepatitis (HBV reference: HBsAg positive, and HBV DNA detection exceeds the upper limit of normal values; (And the HCV virus titer detection value exceeds the upper limit of normal value); 20. Participants who have used other drugs in clinical trials within 4 weeks before the first use; 21. Participants has previous or concurrent other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ); 22. Participants may receive other systemic anti-tumor treatments during the study; 23. Participants with bone metastases who had received palliative radiation therapy within 4 weeks before participating in the study; 24. Participants who have previously received other PD-1 antibody treatments or other immunotherapy against PD-1/PD-L1 or VEGFR single-target/multi-target inhibitors, such as Sunitinib, Sorafeni, Bevacizumab, Anlotinib, Famitinib, Apatinib, and Reginafinib (in advanced NSCLC, there is no need to exclude previous VEGFR single / multitarget inhibitor Patients treated, but need to be discontinued for more than 4 weeks); 25. Live vaccine may be given less than 4 weeks before study medication or possibly during the study; 26. According to the researchers judgment, Participants has other factors that may lead to the termination of the study. Serious diseases (including mental illness) require combined treatment. There are serious laboratory abnormalities, accompanied by family or social factors. To the safety of the subject, or the collection of information and samples; ; PRIMARY OUTCOME: Objective remission rate (ORR); SECONDARY OUTCOME 1: Duration of response(DOR)[/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 - APPRAISE; BRIEF: A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC). ; DRUG USED: Seliciclib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Monotherapy; LEAD SPONSOR: Cyclacel Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens - Must have measurable disease according to RECIST - Eastern Cooperative Oncology Group performance status 0-1 - Adequate bone marrow, hepatic and renal function - Ability to swallow capsules - At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, at least 7 days from prior radiation therapy and have recovered from prior toxicities - At least 3 weeks from major surgery Exclusion Criteria: - Non-small cell cancer histology contains a component of small cell lung cancer - Previously untreated CNS metastasis or progressive CNS metastasis - Prior treatment with a CDK inhibitor - Currently receiving radiotherapy, biological therapy, or any other investigational therapy - Uncontrolled intercurrent illness - Having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer - Pregnant or lactating women - Known to be HIV-positive - Active hepatitis B and/or hepatitis C infection ; PRIMARY OUTCOME: Progression-free survival; 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 IIb/III - DAZZLE (vs. Eylea); BRIEF: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD). ; DRUG USED: KSI-301; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Kodiak Sciences Inc; CRITERIA: Inclusion Criteria: - Signed informed consent prior to participation in the study. - Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD. - BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive. - Other protocol-specified inclusion criteria may apply Exclusion Criteria: - CNV secondary to other causes in the Study Eye. - Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid. - Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss. - Active ocular or periocular infection or inflammation. - Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye. - Uncontrolled glaucoma in the Study Eye. - Women who are pregnant or lactating or intending to become pregnant during the study. - Stroke or myocardial infarction in the 6-month period prior to Day 1. - Uncontrolled blood pressure defined as a systolic value > 180 mmHg or diastolic value ≥100 mmHg while at rest. - History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. - Other protocol-specified exclusion criteria may apply. ; PRIMARY OUTCOME: Mean change in Best Corrected Visual Acuity (BCVA) from Day 1.; SECONDARY OUTCOME 1: Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RESOLVE 2; BRIEF: Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. Subject is 18 to 75 years of age, inclusive. Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]). Subject is currently experiencing a major depressive episode (diagnosed by DSM-IV-TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050305): - Elevated, expansive mood - Inflated self-esteem or grandiosity - More talkative than usual or pressure to keep talking - Flight of ideas or subjective experience that thoughts are racing - Increase in energy or goal-directed activity (either socially, at work or school, or sexually) - Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) - Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline. Exclusion Criteria: Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening Subject answers yes to Suicidal Ideation Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit. Subject has attempted suicide within the past 3 months. Subject has a lifetime history of any bipolar I manic or mixed manic episode. Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator. ; PRIMARY OUTCOME: MADRS; SECONDARY OUTCOME 1: CGI-S[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VIBRANT (BRVO); BRIEF: This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO. ; 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: The following inclusion criteria include, but are not limited to: 1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit 2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1 3. Provide signed informed consent Exclusion Criteria: The following exclusion criteria include, but are not limited to: 1. Current bilateral manifestation of BRVO 2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye 3. Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves) 4. Uncontrolled diabetes mellitus (DM) 5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye 6. Use of periocular corticosteroids in the study eye within 3 months before day 1 7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1 8. Previous administration of systemic anti-angiogenic medications 9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye ; PRIMARY OUTCOME: Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF; SECONDARY OUTCOME 1: Change From Baseline to Week 24 in BCVA Score - 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 I/II - D11-11002; BRIEF: The purpose of this study is to determine the safety and efficacy of DFP-10917 given via continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL). ; DRUG USED: DFP-10917; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Delta-Fly Pharma, Inc.; CRITERIA: Inclusion Criteria: 1. Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available Phase II Only: Patient must have histologically or pathologically confirmed diagnosis of AML based on WHO classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. Patients aged 60 years or older with newly diagnosed AML who are not eligible for, or who refuse, standard care are also eligible. 2. Aged ≥ 18 years. 3. ECOG Performance Status of 0, 1 or 2. 4. Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution, bilirubin <=1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 x ULN). 5. Absence of CNS involvement by leukemia. 6. Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions. 7. Signed informed consent prior to the start of any study specific procedures. 8. Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration. Exclusion Criteria: 1. The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle. 2. Any >grade 1 persistent clinically significant toxicities from prior chemotherapy. 3. Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation. 4. Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patients compliance. 5. A pregnant or lactating woman. 6. Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more. 7. Patient has acute promyelocytic leukemia (APL). 8. Patients with known HIV, HBV or HCV infection (note: testing for these infections is not required). 9. Documented or known clinically significant bleeding disorder. ; PRIMARY OUTCOME: Number of patients with adverse events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CL-0101-WS01 (US); BRIEF: A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients. ; DRUG USED: JBPOS0101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Infantile Spasms (West Syndrome; Epilepsy); TARGET: Metabotropic Glutamate Receptor subtype 4 (mGluR4), Metabotropic Glutamate Receptor subtype 7 (mGluR7); THERAPY: Monotherapy; LEAD SPONSOR: Bio-Pharm Solutions Co., Ltd.; CRITERIA: Inclusion Criteria: - Male or female between 6 months through 36 months of age at the time of informed consent - Had clinical diagnosis of Infantile spasms (IS), confirmed by video-electroencephalogram (EEG) analysis, and hypsarrhythmia on EEG at screening according to the Burden of Amplitudes and Epileptiform Discharges (BASED) scale score. - As assessed by the investigator had no or partial response to at least 2 out of the 3 therapies of adrenocorticotrophic hormone (ACTH), vigabatrin, and glucocorticoids (i.e. prednisolone), or had no or partial response to at least 1 out of the 3 therapies of ACTH, vigabatrin, and glucocorticoids and was contraindicated to and/or refused by the patients legal representative(s) for treatment with one or both other 2 therapies. - Patient had general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on physical and neurological examinations, medical history, normal renal function and electrocardiogram (ECG), and clinical laboratory values completed during the Screening Period visit (Visit 1). - Parent(s)/caregiver(s) were willing and able to comply with the study procedures and visit schedules in the opinion of the investigator. - Parent(s)/caregiver(s) fully comprehend and sign the ICF in accordance with applicable laws, regulations, and local requirements, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator. Exclusion Criteria: - Patient considered by the investigator, for any reason (including, but not limited to, the risks described as precautions and warnings in the current version of the investigators brochure for investigational product) to be an unsuitable candidate to receive the investigational product. - Patient had known or suspected allergy to the investigational product or apple juice. - Patient had clinically significant renal impairment, defined as creatinine >1.5 mg/dL or blood urea nitrogen >2 × upper limit of normal (ULN); - Clinically significant liver dysfunction, defined as total bilirubin ≥2 × ULN, or aspartate aminotransferase or alanine aminotransferase ≥3 × ULN; - Patient had clinically significant abnormal laboratory values; the investigator may deem the patient eligible if he/she judges the laboratory values to be not clinically significant. - Patient had an ongoing or known history of human immunodeficiency virus infection, or chronic hepatitis B or C. - Patient had a clinically significant abnormality on ECG that, in the opinion of the investigator, increases the safety risks of participating in the study. - Patient had a neurodegenerative disorder as the underlying cause of IS. - Patient had a known history of aspiration pneumonia within the past year. - Patient had previously participated in another clinical study of the investigational product or received any investigational drug or device or investigational therapy within 30 days of study entry. - Patient had received therapy with felbamate, cannabinoids, ketogenic diet or vagus nerve stimulation within 14 days of screening. - Patient had received therapy with a medication known to be a CYP3A4 substrate and whose PK had been shown to be impacted in the presence of a CYP3A4 inhibitor within 14 days of screening. - Patient had not remained at stables doses of all drugs used for treating epileptic seizures for at least 14 days prior to screening (except for rescue medications used for acute treatment of breakthrough seizures which were not known to be CYP3A4 substrates and whose PK had not been shown to be impacted in the presence of a CYP3A4 inhibitor. - Patient had a lethal or potentially lethal condition other than infantile spasms, with a significant risk of death before 18 months of age such as non-ketotic hyperglycinemia. - Patient had a body weight below 5 kg. - Patient had an underlying metabolic disease associated with glucose intolerance (e.g., glucose transporter deficiencies). ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: JBPOS0101 Plasma Concentration 0.5 - 1.5 Hours Post Morning Dose, Day 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 - 03.01.020; BRIEF: A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies. ; DRUG USED: Omidubicel; DRUG CLASS: Biologic; INDICATION: Bone Marrow Transplant and Stem Cell Transplant; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Gamida Cell ltd; CRITERIA: Inclusion Criteria: - Applicable disease and eligible for myeloablative SCT - Patients must have two partially HLA-matched CBUs - Back-up stem cell source - Adequate Karnofsky Performance score or Lansky Play-Performance scale - Sufficient physiological reserves - Signed written informed consent Exclusion Criteria: - HLA-matched donor able to donate - Prior allogeneic HSCT - Other active malignancy - Active or uncontrolled infection - Active/symptoms of central nervous system (CNS) disease - Pregnancy or lactation ; PRIMARY OUTCOME: Engraftment; 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 - 205.420; BRIEF: Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma. Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily. ; DRUG USED: Spiriva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice ( ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1). 2. Male or female patients aged at least 18 years but not more than 75 years. 3. All patients must have at least a 3 months history of asthma at the time of enrolment into the trial. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility resulting in a Forced Expiratory Volume in 1 Second (FEV1) increase of equal above 12% and equal above 200mL. 4. The initial diagnosis of asthma must have been made before the patients age of 40. 5. All patients must have a diagnosis of moderate persistent asthma and must be symptomatic despite their current maintenance treatment with medium doses of inhaled corticosteroids. 6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (alone or in a fixed combination with a Long Acting Betaadrenergic (LABA) or Short Acting Betaadrenergic (SABA)) for at least 4 weeks prior to Visit 1. 7. All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an Asthma Control Questionnaire (ACQ) Score 8. All patients must have a pre-bronchodilator FEV1 above equal 60% predicted and below equal 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to the European Coal and Steel Community Guidelines (ECSC). 9. All patients must have an increase in FEV1 of equal above 12% and equal above 200 mL 15 minutes after 400 µg salbutamol at Visit 1. 10. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30% . 11. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years. 12. Patients must be able to use the Respimat® inhaler correctly. 13. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the e-Diary/peak flow meter. 14. Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study (exception: times of acute disease deterioration). Exclusion criteria: 1. Patients with a significant disease other than asthma.A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patients ability to participate in the trial. 2. Patients with a clinically relevant abnormal screening hematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no. 1. 3. Patients with a recent history (i.e. six months or less) of myocardial infarction. 4. Patients who have been hospitalised for cardiac failure during the past year. 5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. 6. Patients with lung diseases other than asthma (e.g. Chronic Obstructive Lung Disease (COPD)). 7. Patients with known active tuberculosis. 8. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 9. Patients who have undergone thoracotomy with pulmonary resection. 10. Patients with significant alcohol or drug abuse within the past two years. 11. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to V 1. 12. Patients with known hypersensitivity to anticholinergic drugs, Benzalconiumchloride (BAC), Ethylenediaminetetraacetate (EDTA) or any other components of the study medication delivery systems. 13. Pregnant or nursing women. 14. Women of childbearing potential not using a highly effective method of birth control. 15. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 or during the screening period. Topical cardio-selective beta-blocker eye medications for non-arrow angle glaucoma are allowed. 16. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 or during the screening period. 17. Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 or during the screening period. 18. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 or during the screening period. 19. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 or during the screening period.20. Patients who have been treated with cromolyn sodium or nedocromil sodium within two weeks prior to Visit 1 or during the screening period. 21. Patients who have been treated with methylxanthines within two weeks prior to Visit 1 or during the screening period. 22. Patients who have taken an investigational drug within four weeks prior to Visit 1. 23. Patients who have been treated with other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy (e.g. TNFalpha blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 or during the screening period. 24. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period. Visit 1 and/or Visit 2 should be postponed in case of an asthma exacerbation or respiratory tract infection. 25. Patients who have previously been randomised in this trial or are currently participating in another trial. 26.Patients who have been treated with depot corticosteroids within six months prior to Visit 1 or during the screening period. 27.Patients who have been treated with leukotriene modifiers within two weeks prior to Visit 1 or during the screening period. ; PRIMARY OUTCOME: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response; SECONDARY OUTCOME 1: Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on 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 - TRANSFORM; BRIEF: The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B). All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physicians choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT). Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event. Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion. ; DRUG USED: Breyanzi; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: 1. Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 3. Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed indolent NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma [DHL/THL]), primary mediastinal (thymic) large B-cell lymphoma (PMBCL), T cell/histiocyte-rich large B-cell lymphoma (THRBCL) or follicular lymphoma grade 3B. Enough tumor material must be available for confirmation by central pathology. 4. Refractory or relapsed within 12 months from CD20 antibody and anthracycline containing first line therapy. 5. [18F] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion at screening. (Deauville score 4 or 5) 6. Adequate organ function 7. Participants must agree to use effective contraception Exclusion Criteria: 1. Subjects not eligible for hematopoietic stem cell transplantation (HSCT). 2. Subjects planned to undergo allogeneic stem cell transplantation. 3. Subjects with, primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus) positive DLBCL, Burkitt lymphoma or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter transformation). 4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following noninvasive malignancies: - Basal cell carcinoma of the skin - Squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast - Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative. - Other completely resected stage 1 solid tumor with low risk for recurrence 5. Treatment with any prior gene therapy product. 6. Subjects who have received previous CD19-targeted therapy. 7. Subjects with active hepatitis B, or active hepatitis C are excluded. Subjects with negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy. Subjects with a history of or active human immunodeficiency virus (HIV) are excluded. 8. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment. 9. Active autoimmune disease requiring immunosuppressive therapy. 10. History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF: 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. 11. History or presence of clinically relevant central nervous system (CNS) pathology 12. Pregnant or nursing (lactating) women. ; PRIMARY OUTCOME: Event-free survival (EFS); SECONDARY OUTCOME 1: Complete response rate (CRR)[/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 - MDS/AML; BRIEF: Phase 1-2 dose escalation randomized study in patients with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110 with two dosing schedules in MDS and AML patients while the Dose Expansion Segment will further evaluate safety and efficacy at the biological effective dose (BED) or maximum tolerated dose (MTD)as defined in the Dose Escalation Segment. ; DRUG USED: Guadecitabine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: DNA Methyltransferase (DNMT); THERAPY: Monotherapy; LEAD SPONSOR: Astex Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Men or women, 18 years of age or older, with a confirmed diagnosis of international prognostic scoring system (IPSS) intermediate-1, intermediate-2 or high-risk MDS including Chronic Myelomonocytic Leukemia (CMML) or AML. - In the Dose Escalation Segment, patients who are refractory, relapsed, or unresponsive to standard treatment. - In the Dose Expansion Segment, hypomethylating agent (HMA) treatment-naïve MDS subjects (including CMML), and intermediate-2 or high-risk MDS subjects (including CMML) relapsed or refractory to prior HMA treatment are allowed, and treatment-naïve AML subjects who are at least 65 years of age will be allowed if they also have at least one of the following criteria - AML secondary to MDS, chemotherapy, or radiation therapy - poor cytogenetics - pre-existing clinically significant dysfunction of the heart or Chronic Obstructive Pulmonary Disease (COPD) - poor performance status, Eastern Cooperative Oncology Group (ECOG), of 2 2. Eastern ECOG performance status of 0 to 2. 3. Adequate organ function. 4. Prior allogeneic stem cell transplant, no evidence of active graft-versus host disease (GVHD) and must be ≥ 2 weeks off immunosuppressive therapy. 5. No major surgery within 4 weeks of first dose of SGI-110. 6. No chemotherapy within 2 weeks of first dose of SGI-110 (minimum of 6 weeks for nitrosoureas and 8 weeks for bone marrow transplantation) with the exception of hydroxyurea which will be allowed during course 1 of treatment. 7. Sign an approved informed consent form for this study. Exclusion Criteria: 1. In the Dose Expansion Segment, which includes the 10-day regimen, subjects who have received 2 complete full dose cycles or more of a hypomethylating agent (HMA) decitabine or azacitidine (except for intermediate-2 or high-risk MDS subjects (including CMML) relapsed or refractory to prior HMA treatment). 2. Acute promyelocytic leukemia (M3 classification). 3. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease free for at least 3 years. 4. Life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigators opinion, could compromise the patients safety, or put the study outcomes at risk. 5. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). 6. Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients. 7. With the exception of treatment-naïve elderly AML patients, patients with uncontrolled congestive heart failure (CHF), coronary heart disease (CAD), chronic obstructive pulmonary disease (COPD), or left ventricular ejection fraction (LVEF) of ≤ 50% are excluded, symptomatic or uncontrolled arrhythmias or on continuous corticosteroids. ; PRIMARY OUTCOME: Dose Escalation Segment (Safety Lead-in): Determine the optimal BED or MTD and the frequency of drug administration.; SECONDARY OUTCOME 1: Determine the pharmacokinetic profile of SGI-110 and decitabine.[/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 - 2nd Line vs. Sutent (Gleevec-Resistant); BRIEF: The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib. ; DRUG USED: Masitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastrointestinal Stromal Tumor (GIST); TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: AB Science; CRITERIA: Main inclusion criteria include: - Patient with histological proven metastatic GIST or non-operable locally advanced GIST - Patient with c-Kit (CD117) positive tumor detected immuno-histochemically - Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment. Main exclusion criteria include: - Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ - Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis - Pregnant, or nursing female patient ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Survival 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 - SLIT10-01; BRIEF: The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season. ; DRUG USED: Greer SAIL - Ragweed; DRUG CLASS: Biologic; INDICATION: Allergic Rhinitis; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Greer Laboratories; CRITERIA: Inclusion Criteria: - allergic to ragweed Exclusion Criteria: - not allergic to ragweed - history of anaphylaxis - subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease - Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted - Subjects who have received experimental drug within 30 days prior to study admission - Subjects who have received anit-IgE medications in the last 12 months - Subjects who have received ragweed immunotherapy in the last 3 years - Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors - Subjects refusing to sign epi-pen training form - Females who are pregnant or breast feeding ; PRIMARY OUTCOME: Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]; SECONDARY OUTCOME 1: Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)[/INST]No</s>