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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 - Chinese Subjects (vs. Botox); BRIEF: The objective of this study is to demonstrate the efficacy of Dysport for the improvement in appearance of moderate to severe glabellar lines and to assess the short term and long term safety of Dysport, used for the improvement in appearance of moderate to severe glabellar lines in Chinese subjects. ; DRUG USED: Dysport; DRUG CLASS: Biologic; INDICATION: Wrinkles; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Ipsen; CRITERIA: Inclusion Criteria: - Provision of written informed consent - Male or female Chinese subjects who are between 18 to 65 years of age inclusive. - Have moderate or severe wrinkles of vertical glabellar lines (Grade 2 or 3) at maximum frown at baseline (Day 1), as assessed by the subject using SSA. - Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at baseline (Day 1), as assessed by the Investigator using ILA. - Be Botulinum Toxin (BTX) naïve or have received their most recent BTX-A treatment more than 1 year prior to screening. - Have a negative pregnancy test - Have an understanding of the study Exclusion Criteria: - Any prior surgery affecting corrugator supercilii, prior blepharoplasty or brow lift, dermal resurfacing, or any prior cosmetic procedures or scars within 36 months. - Any prior treatment with permanent fillers in the upper face. - Any prior treatment with nonpermanent dermal fillers in the upper face within the past 3 years and/or skin abrasions/resurfacing, photorejuvenation or skin/vascular laser intervention within the past 12 months. - Any planned facial cosmetic surgery or procedures during the study period. - Lack of capacity to frown. - Facial conditions that could affect safety or efficacy results. - History of facial nerve palsy. - Marked asymmetry; ptosis; excessive dermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc. - Presence of any condition that could affect the safety, conduct or outcome of the study. - Any subjects who have any psychiatric illness or are taking antidepressant, anxiolytic or antipsychotic medication. - Pregnant and/or lactating female subjects. - Female subjects of childbearing potential not willing to use contraceptive measures throughout the course of the study. - History of drug or alcohol abuse. - Treatment with an experimental drug or device within 30 days prior to screening for this study and during the conduct of this study. - Requirement for BTX injection to site(s) for disorders other than glabellar lines. - Known allergy or hypersensitivity to BTX. - Any medical condition or laboratory finding from central laboratory results. - The subject is unable and/or unwilling to comply fully with the protocol and the study. - Mental incapacity, unwillingness or language barriers. ; PRIMARY OUTCOME: Superiority Analysis of The Percentage of Responders Measured by the Investigators Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).; SECONDARY OUTCOME 1: The Percentage of Responders With Respect to Independent Reviewers Assessment of Photographs of the Subjects Glabellar Lines at Maximum Frown at Cycle 1, Day 29 (DB Period).[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Extension Study to 100185; BRIEF: This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome. ; DRUG USED: Nucala Lyophilized Powder Formulation; DRUG CLASS: Biologic; INDICATION: Hypereosinophilic Syndrome (HES); TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion criteria: - Signed informed consent. - Subjects who have participated in Study MHE100185 and have been administered at least 2 doses of study medication. - Not pregnant or nursing - Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or - Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following:1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; Or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose:Male partner who is sterile prior to the female subjects entry into the study and is the sole sexual partner for the female subjects; Implants of levonorgestrel;Injectable progestogen;Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; Oral contraceptives (either combined or progestogen only) Exclusion criteria: - Has developed life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator - Has any of the following abnormal laboratory values at the Week36/EW Visit of Study MHE100185: • Serum creatinine ≥3 times institutional upper limit normal (ULN); • AST or/ALT ≥5 times institutional ULN; • Platelet count < 50,000/uL - Has developed abnormal cardiac functions, as the following, within past 3 months:• Left ventricular ejection fraction (LVEF) < 20%; • NYHA class IIIb or IV; • Angina or acute myocardial infarction - Has developed allergic reaction to Study MHE100185 investigational product Use of an investigational drug as concurrent medication - Does not complete Week36/EW Visit assessments required in Study MHE100185 - Has completed or been terminated from Study MHE100185 for more than 1 month - Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months - Positive pregnancy test at the Week36/EW Visit of Study MHE100185 ; PRIMARY OUTCOME: Number of Participants With Any Adverse Event (AE) During the Treatment Phase; SECONDARY OUTCOME 1: Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - vs.Vancomycin (AC-061A303, Children); BRIEF: Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile. ; DRUG USED: Cadazolid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Clostridium difficile-Associated Diarrhea/Infection (CDAD/CDI); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Actelion; CRITERIA: Key Inclusion Criteria: - Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure. - Male or female from birth to < 18 years of age, diagnosed with Clostridium Difficile-associated diarrhea (CDAD). - Females of childbearing potential must have a negative pregnancy test at screening and must agree to use an adequate and reliable method of contraception. Key Exclusion Criteria: - Positive Rotavirus test for subjects < 5 years. - Fulminant or life-threatening CDAD. - More than one previous episode of CDAD in the 3 month period prior to enrollment / randomization. - Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF). - Subjects with body weight < 3 kg. - Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology. - Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug to prevent or treat CDAD within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrollment / randomization. - Monoclonal antibodies against C. difficile within 6 months prior to enrollment / randomization. - Previous vaccination against C. difficile. - Known mental disorders. - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subjects full participation in the study, or compliance with the protocol. ; PRIMARY OUTCOME: Clinical Cure Rate During Part B; SECONDARY OUTCOME 1: Clinical Cure Rate During Part A[/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 - ESRD; BRIEF: The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis. ; DRUG USED: Heplisav-B; DRUG CLASS: Vaccine; INDICATION: Hepatitis B Prevention (Vaccines, Antiviral); TARGET: Immune System, Toll-like receptor 9 (TLR9); THERAPY: Monotherapy; LEAD SPONSOR: Dynavax Technologies Corporation; CRITERIA: Inclusion Criteria: - ≥ 18 years of age - Has loss of renal function and is receiving hemodialysis treatments - Is not seroprotected against hepatitis B (has anti-HBs < 10 mIU/mL) - In the opinion of the investigator, is clinically stable - Be serum negative for HBsAg, anti-hepatitis B core antigen (HBc), hepatitis C virus (HCV), and HIV - Is not scheduled to undergo a kidney transplant during the study period - If female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study. Exclusion Criteria: - If female, is pregnant, breastfeeding, or planning a pregnancy; - Has a history of or is at high risk for recent exposure to HBV, HCV, or HIV; - Has known history of autoimmune disease; - Has history of sensitivity to any component of study vaccines; - Has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results; - Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin; - Has uncontrolled diabetes; - Has received a kidney transplant previously that is still functioning and requires anti-rejection medication; - Has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period; - Has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF); any other investigational medicinal agent; - At any time: an injection of deoxyribonucleic acid (DNA) plasmids or oligonucleotides; investigational or intradermal hepatitis B vaccine. ; PRIMARY OUTCOME: Proportion of subjects with seroprotection rate (SPR), defined as the percentage of subjects with anti-HBsAg serum concentration of 10 milli-international unit (mIU)/mL or higher, measured at Week 4; SECONDARY OUTCOME 1: Overall incidence of post-injection reactions and adverse events in each treatment group[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - telos; BRIEF: This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. ; DRUG USED: PT-008; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Pearl Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Give their signed written informed consent to participate 2. Are at least 40 years of age and no older than 80 years 3. COPD patients who are symptomatic 4. Must be receiving one or more inhaled bronchodilators as maintenance therapy Exclusion Criteria: 1. Current diagnosis of asthma, 2. COPD due to α1-Antitrypsin Deficiency 3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months 4. Long-term-oxygen therapy (≥ 12 hours a day). ; PRIMARY OUTCOME: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI); SECONDARY OUTCOME 1: Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).[/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 - REFLECTIONS B538-02; BRIEF: The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home. ; DRUG USED: Abrilada; DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months. - At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline. - Hs-CRP equal or greater than 8 mg/L. - Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose. Exclusion Criteria: - Evidence of untreated or inadequately treated latent or active TB. - Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years. - History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug. - May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy). - Any second DMARD must be washed out prior to the first study dose. ; PRIMARY OUTCOME: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1; SECONDARY OUTCOME 1: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 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 - 911502 ; BRIEF: The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA) ; DRUG USED: Biosimilar Adalimumab (Momenta); DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Momenta Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Participants ≥18 years old at the time of Screening 2. Able to understand and communicate with the Investigator and comply with the requirements of the study, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations. 3. RA diagnosed for at least 6 months before Screening 4. Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria 5. Active disease at Screening and Baseline 6. Participants must have at least 1 documented swollen and/or tender joint in their hand or wrist of the dominant hand as assessed by the Investigator or designated assessor 7. Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s) 8. Male participants and their female partners must be willing to comply with the contraception restrictions for this study from the time of the first administration of investigational product (IP) until 3 months after the last dose. 9. Female participants must have a negative pregnancy test at screening and on admission to the clinic, and must not be lactating and must be using an acceptable method of contraception throughout the study and for 3 months after the last dose, or be of non-childbearing potential. Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception. Exclusion Criteria: 1. Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy. 2. Prior use of rituximab 3. Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening 4. Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted. 5. Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline 6. Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening 7. Current use of more than 1 nonsteroidal anti-inflammatory drug. 8. Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or intravenous [IV]) within 6 weeks prior to Baseline 9. Prior or current use of other self-injected drugs, eg, insulin 10. All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline 11. Meets Class IV Steinbrocker criteria for disability/activities of daily living 12. Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor. 13. Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogrens syndrome is permitted. 14. Joint surgery within the last 8 weeks prior to Screening 15. Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk 16. History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder 17. History or presence of Class III or IV New York Heart Association congestive heart failure 18. History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma 19. Existing malignancy or history of any malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ, with no more than 3 lifetime basal cell or squamous cell carcinomas 20. Chronic infections, recurrent infections (3 or more of the same infection requiring anti-infective treatment in any rolling 12-month period); any recent infection (ie, in the last 30 days) requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidioidomycosis, histoplasmosis, toxoplasmosis) 21. History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus 22. History of active tuberculosis (TB) or untreated or inadequately treated latent TB. 23. Participant has been exposed to an investigational product (IP) within 30 days (or 5 half-lives) prior to enrollment, whichever is longer, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study 24. Participant is a family member or employee of the Investigator or Baxalta or its partners ; PRIMARY OUTCOME: Usability of the Auto-injector (AI) at Week 4; SECONDARY OUTCOME 1: Number of Participants With Successful Injections as Assessed by the Observer at Week 4[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RLM 3071-305-020 (OLE); BRIEF: This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development. ; DRUG USED: Relamorelin; DRUG CLASS: Biologic; INDICATION: Diabetic Gastroparesis; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Successful completion of either Study RLM-MD-03 or Study RLM-MD-04 - Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures - Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator. Exclusion Criteria: - Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020 - Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigators opinion, would limit the participants ability to participate in or complete the study - Any other reason that, in the investigators opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease - Females who are pregnant, nursing, or planning a pregnancy during the study. ; PRIMARY OUTCOME: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LUME-COLON 1; BRIEF: The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents. ; DRUG USED: Ofev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , Platelet-derived growth factor receptor (PDGFR), Src Kinase Family, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Age >= 18 years - Signed informed consent - Histologically or cytologically confirmed colorectal adenocarcinoma - Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy - Eastern Cooperative Oncology Group (ECOG) performance status = 1 - At least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 - Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following: - - fluoropyrimidine - - oxaliplatin: Patients treated with oxaliplatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease - - irinotecan - - bevacizumab or aflibercept - - cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumours - - The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS 102 are allowed and these agents should be administered before study if available to patient according to local standards) - - Life expectancy of at least 12 weeks - - Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Transferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < 2 X ULN and normal AST/ALT are eligible - Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN Exclusion criteria: - Previous treatment with nintedanib - toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1 - History of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results. - Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, - Significant cardiovascular diseases - History of severe haemorrhagic or thromboembolic event in the past 12 months - Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring - Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug - Patient with brain metastases that are symptomatic and/or require therapy. - Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception - Pregnancy or breast-feeding. ; PRIMARY OUTCOME: Progression-Free Survival (PFS) by Central Review Assessment; SECONDARY OUTCOME 1: Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 253 (China); BRIEF: A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin. ; DRUG USED: Januvia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - has T2DM - is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks - has a Visit 1/Screening HbA1C between 7.5% and 11.0% - is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication Exclusion Criteria: - has a history of type 1 diabetes mellitus or a history of ketoacidosis - has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue - has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin - is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months - has undergone a surgical procedure within 4 weeks or has planned major surgery during the study - has a medical history of active liver disease - has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder - has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status - has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg - has human immunodeficiency virus (HIV) - has severe peripheral vascular disease - is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks - has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication - is a user of recreational or illicit drugs or has had a recent history of drug abuse ; PRIMARY OUTCOME: Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin; SECONDARY OUTCOME 1: Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin[/INST]Yes</s>

<s>[INST]<<SYS>>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 - MAB-N007; BRIEF: Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23. ; DRUG USED: Pagibaximab; DRUG CLASS: Biologic; INDICATION: Staphylococcal Vaccines and Other Staphylococcus-Specific Agents (Antibacterial); TARGET: Bacteria-miscellaneous, Staphylococcus, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Biosynexus Incorporated; CRITERIA: Inclusion Criteria: 1. In-patient at a Neonatal Intensive Care Unit (NICU) 2. Informed consent obtained from the legally authorized representative 3. Less than 48 hours old at the time of first infusion 4. Birth weight between 600 grams and 1200 grams 5. Estimated gestation age ≤33 weeks For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group. Exclusion Criteria: 1. Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation. 2. Infants with proven staphylococcal infection prior to randomization. 3. Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk. 4. Immunodeficiency other than due to prematurity. 5. Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study. 6. Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study 7. Uncontrolled seizures ; PRIMARY OUTCOME: The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.; 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 - ENFORCE (Cluster - Long-Term Safety); BRIEF: This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies [ADAs]), and biomarker analyses. Participants will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP. ; DRUG USED: Ajovy; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - The participant completes either the Phase 3 pivotal study for ECH (Study TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to participant safety and participant compliance. - Prior to 15 June 2018, participants from the ECH study and the CCH study were enrolled. After 15 June 2018, only participants who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment. - In addition, participants who do not complete the pivotal efficacy studies, and participants who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating ADAs, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP. - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: - Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation) - Additional criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs); 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 - vs. Doxorubicin (TRS); BRIEF: The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS). ; DRUG USED: Yondelis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sarcoma; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Pathological diagnosis of translocation-related sarcomas (TRS) including the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid/round cell liposarcoma (MRCL) and synovial sarcoma - Participants must have unresectable locally advanced or metastatic progressive disease prior to enrolment - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2 - Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within normal limits according to institutional standards, as shown by echocardiography or scintigraphy multiple-gated acquisition scan [MUGA] - Measurable disease as defined by the radiological (computed tomography [CT] scan and magnetic resonance imaging [MRI]) Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) guidelines Exclusion Criteria: - Known hypersensitivity to any components of the intravenous formulation of trabectedin or the comparators - Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is available - Brain metastases and/or leptomeningeal metastases, even if treated - Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods - History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more ; PRIMARY OUTCOME: Progression - Free Survival (PFS); SECONDARY OUTCOME 1: 6-month Progression - Free Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NURTURE 1 - vs. Placebo and Abatacept; BRIEF: The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or non-pregnant, non-lactating female patients - Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening - At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >= 6 swollen joints out of 66 WITH at least 1 of the following at screening: - Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR - Rheumatoid Factor positive AND WITH at least 1 of the following at screening: - High sensitivity C-Reactive Protein (hsCRP) >= 10 mg/L OR - Erythrocyte Sedimentation Rate (ESR) >= 28 millimeter (mm)/1st hour - Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent - Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated dose) Exclusion Criteria: - Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician - RA patients functional status class IV according to the ACR 1991 revised criteria - Patients who have ever received biologic immunomodulating agents except for those targeting TNFα - Previous treatment with any cell-depleting therapies Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).; SECONDARY OUTCOME 1: Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)[/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 - Insulin Add-on w/ or w/o Metformin; BRIEF: The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks. ; DRUG USED: Onglyza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Type 2 diabetes mellitus - Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening - If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening - Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component). - Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive) - Body mass index of 45 kg/m² or lower - Fasting C-peptide level of 0.8 ng/mL or higher Exclusion Criteria: - Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms - History of diabetic ketoacidosis or hyperosmolar nonketotic coma - Women of childbearing potential unable or unwilling to use acceptable birth control - Women who are pregnant or breastfeeding - Active liver disease - Anemia - Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled) - Use of short- or rapid-acting insulin - Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident - Congestive heart failure - Unstable or rapidly progressing renal disease - History of alcohol or drug abuse within the previous year - History of hemoglobinopathies - Unstable major psychiatric disorders - Immunocompromised status ; PRIMARY OUTCOME: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]); SECONDARY OUTCOME 1: Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EPITOPE; BRIEF: The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT). ; DRUG USED: Viaskin Peanut; DRUG CLASS: Biologic; INDICATION: Food Allergies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: DBV Technologies; CRITERIA: Key Inclusion Criteria: - Male or female from 1-3 years of age; - Physician-diagnosed peanut allergy; - Peanut-specific IgE level > 0.7 kU/L; - Positive peanut SPT with a largest wheal diameter ≥ 6 mm; - Positive DBPCFC at ≤ 300 mg peanut protein; Key Exclusion Criteria: - Uncontrolled asthma; - History of severe anaphylaxis to peanut; - Prior immunotherapy to any food or other immunotherapy; - Generalized severe dermatologic disease; ; PRIMARY OUTCOME: Differences between the percentage of treatment responders in the selected active Viaskin Peanut group compared to the placebo group.; 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 - COMBI-v - w/Dabrafenib vs. Vemurafenib; BRIEF: This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib. ; DRUG USED: Mekinist; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - >= 18 years of age - Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma - Measurable disease according to RECIST 1.1 - Women of childbearing potential with negative serum pregnancy test prior to randomisation - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Adequate baseline organ function Key Exclusion Criteria: - Any prior use of a BRAF or MEK inhibitor - Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed - History of another malignancy (except subjects who have been disease free for 3 years or with a history of completely resected non-melanoma skin cancer) - Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which will be allowed) - Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation - History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by anti-hypertensive therapy) - History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-Free Survival (PFS), as Assessed by the Investigator[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 301; BRIEF: The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris. ; DRUG USED: Altreno; DRUG CLASS: Non-NME; INDICATION: Acne; TARGET: Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: Valeant Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female at least 9 years of age and older - Written and verbal informed consent must be obtained. - Subject must have a score of moderate or severe on the Evaluators Global Severity assessment at the screening and baseline visit - Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits - Subjects must be willing to comply with study instructions and return to the clinic for required visits. Exclusion Criteria: - Any dermatological conditions on the face that could interfere with clinical evaluations - Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive - Subjects with a facial beard or mustache that could interfere with the study assessments - Concomitant use of potentially irritating over-the-counter products ; PRIMARY OUTCOME: Absolute change in inflammatory lesion count from baseline to Week 12; SECONDARY OUTCOME 1: Percent change in inflammatory lesion count from baseline to Week 4, 8, and 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OPAL BALANCE; BRIEF: This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication. This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriatic Arthritis (PA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Previous participation in qualifying PsA study involving tofacitinib Exclusion Criteria: - Time from End of Study visit of qualifying study is >3 months. - Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter. Sub-study Inclusion Criteria: - Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study - Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week) Sub-study Exclusion Criteria: -Subjects who are receiving methotrexate by a route other than oral ; PRIMARY OUTCOME: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Korea Bridging Study; BRIEF: A randomized, double-blind, Multicenter, parallel, placebo-controlled study ; DRUG USED: Simdax; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Phosphodiesterase 3 (PDE3), Potassium channels, Troponin-C; THERAPY: Monotherapy; LEAD SPONSOR: Yooyoung Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Written, signed and dated informed consent by the patient or the patients legally authorized representative. 2. Male and female patients over 18 years of age. 3. Patients with chronic heart failure who were diagnosed with acute decompensated heart failure 4. Hospitalization for with a primary or secondary diagnosis at admission of worsening heart failure within the 48 hours prior to start of study drug infusion. Symptoms of worsening heart failure must have been treated with IV diuretics Patients who have been hospitalized more than 48 hours may be enrolled if they fail to improve clinically to treatments administered during the first 48 hours (1)(following initial improvement) their clinical status deteriorates either spontaneously or following the withdrawal of intravenous medications. (2) Infusion rates for continuous IV diuretics, inotropes and vasodilators must have been unchanged for at least 2 hours prior to baseline. 5.Left ventricular ejection fraction less than or equal to 35% as assessed using echocardiography, radionuclide ventriculography or contrast angiography within the previous 12 months 6.Dyspnea at rest at both screening and baseline, as assessed by the patient. Exclusion Criteria: 1. Severe obstruction of ventricular outflow tracts such as hemodynamically significant uncorrected primary valve disease and restrictive or hypertrophic cardiomyopathy. 2. Patients scheduled to receive angioplasty, cardiac surgery, a LV assist device or a heart transplant within 3months after randomization. 3. Patients who have undergone cardioversion during the 4 hours prior to baseline or are expected to undergo cardioversion in the 5 days after baseline. 4. Patients who have undergone a cardiac resynchronization procedure within the 30 days of screening or are expected to undergo such a procedure within 3 months. 5. Patients who have received an IV diuretics dose (including or change in dose of a continuous diuretic infusion) within 2 hours of the baseline assessments. 6. Patients who are intubated or otherwise not able to comply with the pre-study assessments. 7. Stroke or TIA within 3 months prior to randomization. 8. Systolic blood pressure 90 mmHg or less at screening or baseline. 9. Heart rate 120 bpm or greater, persistent for at least 5 minutes at screening or baseline. 10. Serum potassium less than 3.5mmol/l or greater than 5.4 mmol/l. 11. Angina pectoris during the 6 hours before baseline. 12. Administration of amrinone or milrinone within 24 hours before start of study drug infusion. 13. Hypersensitivity to levosimendan or any of the excipients: Povidone, Citric acid, Ethanol 14. A history of Torsades de Pointes. 15. Severe renal insufficiency (serum creatinine > 450mol/l (5.0 mg/dl)) or on dialysis. 16. Significant hepatic impairment or elevation of liver enzymes to 5 times the upper limit of normal. 17. Acute bleeding or severe anemia (hemoglobin < 10g/dl or blood transfusion during current admission) or acute decompensation due to an active infection 18. Patients with low hemoglobin between 9-10g/dl may be 19. Enrolled provided there is no evidence of bleeding, no intention to transfuse blood, no identified cause for anemia other than renal insufficiency and if the severity of anemia is longstanding (documented hemoglobin +/-1 g/dl of screening value > 30 days prior). 20. History of severe chronic obstructive pulmonary disease or unstable bronchial asthma as evidenced by e.g. CO2 retention or ongoing use of oral, intravenous or intramuscular steroids 21. Patients with pneumonia or pneumothorax 22. Patients with non-cardiac respiratory distress 23. A person with a BNP level of less than 100pg/mL on screening for an organ laboratory test. 24. Active infected patients who need to have symptoms of fever over 38.5℃ or get an intravenous administration of septicemia or antimicrobial agents. 25. Pregnant and lactating women 26. Patients who take Investigational Product including other clinical study within screening 4 weeks. 27. In case of unsuitable patients who are participated in this study because of other reason. ; PRIMARY OUTCOME: Assessment of the Clinical Composite Classification(CCC); SECONDARY OUTCOME 1: BNP[/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 - INFORMS (PPMS); BRIEF: The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population ; DRUG USED: Gilenya; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: General 1. sign written informed consent prior to participating in the study 2. 25 through 65 years of age inclusive 3. females of childbearing potential must: - have a negative pregnancy test at Baseline (prior to randomization) and - use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication Primary Progressive Multiple sclerosis. 1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria): 2. time since first reported symptoms between 2 and 10 years 3. evidence of clinical disability progression in the 2 years prior to Screening 4. disability status at Screening - EDSS score of 3.5-6.0 inclusive - pyramidal functional system score of 2 or more - 25TWT less than 30 seconds Extension study Inclusion criteria - Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to have completed at least 3 years on study drug treatment at the time of extension study initiation. - Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study Exclusion Criteria: PPMS specific: - History of relapses/attacks - Progressive neurological disorder other than PPMS - Pure cerebellar syndrome or pure visual progressive syndrome or pure - cognitive progressive syndrome - Presence of spinal cord compression at screening MRI - Relevant history of vitamin B12 deficit - Evidence of syphilis or borreliosis at Screening Cardiovascular conditions: - Myocardial infarction within the past 6 months or current unstable ischemic heart disease - History of angina pectoris due to coronary spasm or history of Raynauds phenomenon - Severe cardiac failure or cardiac arrest - History of symptomatic bradycardia - Resting pulse <55 bpm pre-dose - History of sick sinus syndrome or sino-atrial heart block - History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms) - Arrythmia requiring treatment with class III antiarrythmic drugs - History of positive tilt test from workout of vasovagal syncope - Hypertension, not controlled with medication Pulmonary: - Severe respiratory disease or pulmonary fibrosis - TB - Abnormal X-ray, suggestive of active pulmonary disease - Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO - Patients receiving chronic (daily) therapies for asthma Hepatic: - Known history of alcohol abuse, chronic liver or biliary disease - Total or conjugated Brb >ULN, unless in context of Gilberts syndrome - AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN Other: - History of chronic disease of the immune system other than MS - Malignancy (other than successfully treated SCC or BCC) - Diabetes Mellitus - Macular Edema present at screening - HIV, Hepatitis C or B, other active infection - History of total lymphoid irradiation or bone marrow transplantation - Serum creatinine >1.7 mg/dl - WBC <3500 cells/mm3 - Lymphocyte count <800 cells/mm3 - History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures - Unable to undergo MRI scans - Participation in any therapeutical clinical research study in the 6 months prior to randomization - Pregnant or lactating women - Drugs requiring wash-out period: 3 months: - Systemic corticosteroids or ACTH - INF-beta 6 months: - Immunosuppressive medication - Immunoglobulins - Monoclonal antibodies - Drugs that exclude participation in the study: - Cladribine - Cyclophosphamide - Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study) Extension study Exclusion criteria -Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition ; PRIMARY OUTCOME: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint; SECONDARY OUTCOME 1: Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)[/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 - Glut1 DS (Movement Disorder); BRIEF: The primary objective of the study was to evaluate the efficacy and safety of UX007 in the treatment of disabling paroxysmal movement disorders associated with Glut1 DS. ; DRUG USED: Dojolvi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Metabolic - General; TARGET: Tricarboxylic Acid (TCA) Cycle/Citric Acid Cycle (CAC); THERAPY: Monotherapy; LEAD SPONSOR: Ultragenyx Pharmaceutical Inc; CRITERIA: Inclusion Criteria: 1. Diagnosis of Glut1 DS confirmed by SLC2A1 mutation 2. Males and females, aged ≥6 years old at the time of informed consent 3. At least 8 disabling paroxysmal movement disorder events in the 12 weeks prior to the Screening, by subject or caregiver report or At least 6 disabling paroxysmal movement disorder events in any 6 consecutive week period, over the last 12 week period prior to the Screening, by subject or caregiver report 4. At least 4 disabling paroxysmal movement disorder events in 6 week Run-in Period, reported in the daily electronic Glut1 DS symptom diary 5. ≥80% compliance with daily electronic Glut1 DS symptom diary completion during the Run in Period 6. Not on ketogenic diet (KD), modified KD, or ketosis-inducing modified-fat diet for at least 3 months prior to Screening 7. Plasma level of beta-hydroxybutyrate (BHB) ≤ 1 mmol/L (non-fasting) at Screening 8. Provide written or verbal assent (if possible) and written informed consent by the patient(if an adult), or by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures 9. Must, in the opinion of the Investigator, be willing and able to complete key aspects of the study and be likely to complete the 22-week, placebo-controlled, treatment period 10. Patient (or caregiver) must, in the opinion of the Investigator, be able to comply with accurate completion of the study daily electronic Glut1 DS symptom diary 11. Females of child-bearing potential must have a negative urine pregnancy test at Screening and Baseline and be willing to have additional pregnancy tests during the study. Females considered not to be of child-bearing potential include those who have not experienced menarche, are post-menopausal (defined as having no menses for at least 12 months without an alternative medical cause) or are permanently sterile due to total hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. 12. Participants of child-bearing potential or fertile males with partners of child-bearing potential who are sexually active must consent to use a highly effective method of contraception as determined by the site Investigator from the period following the signing of the informed consent through 30 days after last dose of study drug Exclusion Criteria: 1. Any known hypersensitivity to triheptanoin or safflower oil that, in the judgment of the Investigator, places the subject at increased risk for adverse effects 2. Prior use of triheptanoin within 30 days prior to Screening 3. History of, or current suicidal ideation, behavior and/or attempts per Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or Baseline 4. Pregnant and/or breastfeeding an infant at Screening or Baseline 5. Participants unwilling or unable to discontinue use of a prohibited medication or other substance that may confound study objectives (medium chain triglyceride [MCT] oil, barbiturates, pancreatic lipase inhibitors, KetoCal or other KD supplements, and/or KD]) 6. Glut1 DS treatment regimen, including antiepileptic drugs (AEDs), should be stable for at least 30 days prior to Screening 7. Use of any investigational product (drug, medical food, or supplement, including MCT oil, including coconut oil) within 30 days prior to Screening 8. Has a concurrent disease or condition, or laboratory abnormality that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or introduces additional safety concerns 9. Feeding or nutrition that, in the opinion of the dietitian, potentially affects consistent administration of study drug ; PRIMARY OUTCOME: Maintenance Phase Movement Disorder Frequency; SECONDARY OUTCOME 1: Change From Period Baseline in 12 Minute Walk Test (12MWT) Distance at Treatment Week 10[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - V59P14 (Infants); BRIEF: This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants. ; DRUG USED: Menveo; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: - Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent. Exclusion Criteria: - Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease ; PRIMARY OUTCOME: Percentage of Subjects With hSBA Titer >=1:8 - US Subjects; SECONDARY OUTCOME 1: Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - M16-156 (Brazil); BRIEF: This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit. - Participant must have been documented as without cirrhosis with METAVIR equivalent fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a liver biopsy, or FibroScan, or FibroTest score. - Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected may have been enrolled if they had a positive test result for anti-HIV antibody at Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline. - Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma (HCC) within 3 months prior to Screening or a negative ultrasound at Screening. Exclusion Criteria: - Current hepatitis B virus (HBV) infection on screening tests. - Any current or past clinical evidence of Child-Pugh B or C classification (score of > 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding. - Receipt of any investigational or commercially available anti-HCV agents. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-treatment HCV Virologic Failure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - TREASURE (Japan); BRIEF: The primary objectives of this study is to evaluate the efficacy of HLCM051 on functional outcome in subjects with acute ischemic stroke and to evaluate the safety of HLCM051 in subjects with acute ischemic stroke. ; DRUG USED: MultiStem; DRUG CLASS: Biologic; INDICATION: Ischemic Stroke; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Healios K.K.; CRITERIA: Inclusion Criteria: - Japanese male or female patients 20 years of age or older; - Clinical diagnosis of cerebral cortical ischemic stroke; - Occurrence of an ischemic stroke with clear motor or speech deficit documented by National Institutes of Health Stroke Scale (NIHSS) score of 8 to 20 (at the baseline assessment) that did not change by ≥4 points from the screening to the baseline assessment; - Onset of ischemic stroke must have occurred within 18 to 36 hours prior to the start of administration of the investigational product; - Confirmation of hemispheric cortical infarct with brain magnetic resonance imaging (MRI) including diffusion-weighted imaging with b-value of 1,000 demonstrating an acute lesion measuring ≥ 2.0 cm of longest diameter; - A modified Rankin Scale (mRS) of 0 or 1, by either self-report or family report, prior to the onset of ischemic stroke; - Female patients who meet either: - Not pregnant, not breastfeeding/ interrupting breastfeeding, and not planning on becoming pregnant during the trial; - Not of childbearing potential, defined as one who has been postmenopausal for at least 1 year, or has been surgically sterilized, or has had a hysterectomy at least 3 months prior to the start of this trial; or - If of childbearing potential, one who has agreed to follow investigators advice and use an effective contraceptive method up to the end of the trial. Effective contraceptive methods include contraceptive methods used consistently and correctly (oral contraceptives, intrauterine devices, diaphragm, or male or female condoms), abstinence, and a sterile sexual partner; - Male patients with female partners of childbearing potential must agree to follow investigators advice and use adequate contraceptive methods (a combination of a condom and another form of contraception) up to the end of the trial if engaging in sexual intercourse; - Patients or legal representatives must freely sign the informed consent form after the nature of the trial and the disclosure of his/her data have been explained; - Willing and able to comply with all aspects of the treatment and testing schedule; and - Willing and able to return to the trial site for the post-treatment evaluations. Exclusion Criteria: - Presence of a lacunar, a lesion of ≤ 2.0 cm of longest diameter, or a brainstem infarct on MRI as the etiology of symptoms of ischemic stroke; - Reduced level of consciousness (score of 3 for item 1a of NIHSS); - Occurrence of a hemorrhagic transformation as evidenced by computerized tomography (CT) or brain MRI scan that is clinically significant in the opinion of the investigator; - Ipsilateral focal neurological deficits from prior lesions in the brain that would complicate evaluation; - Experienced seizures since the onset of ischemic stroke; - History of a neurological event such as stroke or clinically significant head trauma within 6 months prior to the start of screening; - Patients who both received tPA treatment and underwent mechanical reperfusion (patients are eligible for the trial if they had only one of them, tPA treatment or mechanical reperfusion); - Uncontrolled hypertension, defined as persistent systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg, despite antihypertensive therapy; - Blood glucose level <50 mg/dL or >350 mg/dL at baseline; - Patients who have a significant comorbid medical condition(s), including, but not limited to: - Severe kidney disease requiring hemodialysis or peritoneal dialysis; - Advanced liver disease such as hepatitis or liver cirrhosis; - Severe congestive heart failure or history of ejection fraction <30%; - Severe lung disease requiring home oxygen; or - Active unstable angina requiring daily treatment with nitrates or other medications; - Known human immunodeficiency virus infection, ongoing systemic infection, severe local infection or who are immunocompromised; - Alzheimers disease or other dementias, Parkinsons disease, or any other neurological disorder that in the opinion of the trial doctor would affect their ability to participate in the trial or confound study assessments; - History of malignant tumor(s) within 2 years of the onset of ischemic stroke, with the exception of adequately treated basal or squamous cell carcinoma of the skin; - Contraindication for MRI such as implanted pacemakers or other metallic prosthesis incompatible with MRI, body weight, or claustrophobia; - Thrombocytopenia (platelet count <100,000/mm3) or heparin-induced thrombocytopenia; - Known allergy to human tissue or bovine or porcine products, or religious objections to biological products; - Prior participation in another clinical trial involving investigational pharmacological agents or devices within 30 days prior to providing consent to receive the investigational product, or participation in investigational pharmacological agents, devices, or rehabilitation stroke recovery program is planned during the trial; - Other serious medical or psychiatric illness that is not adequately controlled and, in the investigators opinion, would not permit the subject to be managed according to the protocol; - Previous surgical removal of the spleen; - Major fluctuation in neurological status since the onset of ischemic stroke indicating progression or expansion of ischemic stroke, or possible transient ischemic attack; - Plan to have a neurovascular procedure (e.g., carotid endarterectomy, stent placement, etc.) within the first year following ischemic stroke; or - Abnormal laboratory test results which investigators consider clinically significant and inappropriate for the trial. ; PRIMARY OUTCOME: Proportion of subjects with an excellent outcome defined by the functional assessments; SECONDARY OUTCOME 1: Proportion of subjects with an excellent outcome defined by the functional assessments[/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 - 12 weeks (Efficacy & Safety); BRIEF: This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7). ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects must give their signed and dated (written) informed consent to participate. Written informed consent must be obtained if a subjects current medication is changed as a result of study participation - Outpatient >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health. Countries with local restrictions prohibiting enrolment of adolescents will only enroll subjects >=18 years of age - Male or an eligible female. Eligible female is defined as having non-childbearing potential or having childbearing potential and using an acceptable method of birth control consistently and correctly. - Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value. - Demonstrate >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) or have documented reversibility testing within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer device may be used for testing, if required. - If subject have received ICS for at least 12 weeks prior to Visit 1 and their treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e.g., >=FP 250 mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e.g., FP/Salmeterol [SALM] 250/50 mcg twice daily) or an equivalent combination via separate inhalers. - Use of ICS/LABA are not permitted with LABA on the day of Visit 1. - Must be able to replace current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, during the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits Exclusion Criteria: - History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years. - Upper or lower respiratory tract, sinus, or middle ear that is: not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the investigator, expected to affect the subjects asthma status or the subjects ability to participate in the study. - Any asthma exacerbation that required oral corticosteroids within the 12 weeks prior to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1. - A subject must not have current evidence of atelectasis (segmental or larger), bronchopulmonary dysplasia, chronic obstructive pulmonary disease, Or any evidence of concurrent respiratory disease other than asthma - A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study - Chronic stable hepatitis B or C are acceptable provided their screening alanine transaminase (ALT) is <2x upper limit of normal (ULN) and the y otherwise meet the entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not eligible - Clinical visual evidence of candidiasis at Visit 1 - Use of any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½), whichever is longer of the two. - Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or known or suspected sensitivity to the constituents of the NDPI, or history of severe milk protein allergy - Administration of medication that would significantly affect the course of asthma, or interact with study drug - Use of immunosuppressive medications during the study. - Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1. - A subject or his/her parent or legal guardian has any infirmity, disability, disease, or resides in a geographical location which seems likely, in the opinion of the Investigator, to impair compliance with any aspect of this study protocol, including visit schedule, and completion of the daily diaries. - Current smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, or pipe tobacco). - If subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator. - Subject previously randomized to treatment with FF/VI or FF in another Phase III study - Subjects working on night shift a week prior to Visit 1 or during the study period. - Adolescents who are wards of the state or government ; PRIMARY OUTCOME: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period; SECONDARY OUTCOME 1: Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - CFTR Gating Mutation (Age 3-5); BRIEF: To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation ; DRUG USED: Kalydeco; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Male or female with confirmed diagnosis of CF. - Must have 1 of the following CFTR gating mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D. - Hematology, serum chemistry, and coagulation at Screening with no clinically significant abnormalities or concomitant diagnosis that would interfere with the LCI and CT scan study assessments, as judged by the investigator. Exclusion Criteria: - An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1 - Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject (in the opinion of the investigator) - Abnormal liver function, at Screening, defined as ≥3 × upper limit of normal (ULN), of any 3 or more of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT), serum alkaline phosphatase (ALP), and total bilirubin - History of solid organ or hematological transplantation - Any clinically significant non-CF-related illness within 2 weeks before Day 1 - Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks before Day 1 - Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer or as determined by the local requirements) before Screening ; PRIMARY OUTCOME: Absolute Change From Baseline in Lung Clearance Index (LCI2.5) Through 8 Weeks of Treatment (Average of Week 4 and Week 8 LCI2.5); SECONDARY OUTCOME 1: Absolute Change From Baseline in Immunoreactive Trypsinogen Levels at Week 8[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GiACTA; BRIEF: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks. ; DRUG USED: Actemra (Subcutaneous); DRUG CLASS: Biologic; INDICATION: Giant Cell Arteritis; TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Diagnosis of GCA classified according to age >/=50 years; history of ESR >/=50 mm/hr or history of CRP >/=2.45 mg/dL; and at least one of the following: unequivocal cranial symptoms of GCA or symptoms of polymyalgia rheumatica [PMR]; and at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large-vessel vasculitis by angiography or cross-sectional imaging - New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than [>] 6 weeks before baseline and previous treatment with >/= 40 milligrams per day prednisone [or equivalent] for at least 2 consecutive weeks at any time) GCA - Active disease (presence of clinical signs and symptoms [cranial or PMR] and ESR >/=30 mm/hour or CRP >/=1 mg/dL) within 6 weeks of baseline visit Exclusion Criteria: - Major surgery within 8 weeks prior to screening or planned within 12 months after randomization - Transplanted organs (except corneas with transplant performed >3 months prior to screening) - Major ischemic event, unrelated to GCA, within 12 weeks of screening - Prior treatment with any of the following: investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening; cell-depleting therapies including investigational agent; intravenous (IV) gamma globulin or plasmapheresis within 6 months of baseline; alkylating agents or with total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2 weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib; cyclophosphamide within 6 months of baseline; >100 milligrams of daily IV methylprednisolone within 6 weeks of baseline - Participants requiring systemic glucocorticoids for conditions other than GCA, which, in the opinion of the investigator, would interfere with adherence to the fixed glucocorticoid taper regimen and/or to assessment of efficacy in response to the test article - History of severe allergic reactions to monoclonal antibodies or to prednisone - Evidence of serious uncontrolled concomitant disease (for example, cardiovascular, respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or gastrointestinal [GI] disease) - Current liver disease, as determined by the investigator - History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation - Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other infection - Primary or secondary immunodeficiency - Evidence of malignancies diagnosed within previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured) - Inadequate hematologic, renal or liver function - Positive for hepatitis B or hepatitis C infection ; PRIMARY OUTCOME: Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper); SECONDARY OUTCOME 1: Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - AVERT-2; BRIEF: The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis. ; DRUG USED: Orencia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Cluster of Differentiation 80 (CD80), Cluster of Differentiation 86 (CD86); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Rheumatoid arthritis (RA) diagnosis less than 6 months - CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h - At least 3 swollen and 3 tender joints - Anti-citrullinated protein antibodies (ACPA) positive Exclusion Criteria: - At risk for tuberculosis - Have acute infection - Have chronic or recurrent bacterial or serious latent viral infection - History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma - Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD) ; PRIMARY OUTCOME: Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24; SECONDARY OUTCOME 1: Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission 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 - Germany (EU Pediatric Pivotal); BRIEF: The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany. ; DRUG USED: Prevnar 13; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Wyeth is now a wholly owned subsidiary of Pfizer; CRITERIA: Inclusion Criteria: 1. Aged 2 months (56 to 112 days) at time of enrollment. 2. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone. 3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator. 4. Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation. Exclusion criteria: 1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines. 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression. 7. History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b. 8. Major known congenital malformation or serious chronic disorder. 9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy. 10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®). 11. Participation in another investigational trial. Participation in purely observational studies was acceptable. 12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel. ; 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: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RELAX-AHF-EU; BRIEF: This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF). ; DRUG USED: Reasanz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Relaxin Family Peptide Receptors 1-4 (RXFP1-4); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Systolic blood pressure ≥ 125 mmHg - Admitted for Acute Heart Failure (AHF) - Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening - eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m^2 Exclusion Criteria: - Dyspnea (non-cardiac causes) - T > 38.5°C - Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment. - Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis. - AHF due to significant arrhythmias - Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function). ; PRIMARY OUTCOME: Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5; SECONDARY OUTCOME 1: Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AFLAME - w/FOLFIRI (Oxaliplatin-Failure) (China); BRIEF: Primary Objective: To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo in participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment for metastatic disease. Secondary Objectives: To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers. ; DRUG USED: Zaltrap; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Histological or cytological proven adenocarcinoma of the colon or rectum. - Metastatic disease that was not amenable to potentially curative treatment. - One and only one prior chemotherapeutic regimen for metastatic disease. This prior chemotherapy must be an oxaliplatin containing regimen. Participants who were relapsed within 6 months of completion of oxaliplatin based adjuvant chemotherapy were eligible. Exclusion criteria: - Prior therapy with irinotecan. - Eastern Cooperative Oncology Group (ECOG) performance status >1. - Less than 28 days elapsed from prior radiotherapy, from prior surgery and prior chemotherapy to the time of randomization. Less than 42 days elapsed from prior major surgery to the time to randomization. - Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization. - Age <18 years. - History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease. - Other prior malignancy. Adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or any other cancer from which the participants had disease free for > 5 years were allowed. - Participation in another clinical trial with an investigational drug and any concurrent treatment with any investigational drug within 30 days prior to randomization. - Any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association Functional Classification (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack. - Any of the following within 3 months prior to randomization: treatment resistant peptic or duodenal ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/hemorrhage, gastrointestinal perforation/fistula, abdominal abscess, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. - Participants who had given high dose of aspirin or non steroidal anti-inflammatory agents (NSAIDS) or high steroids within 4 weeks prior to randomization. The definition of high dose was to be based on the investigators judgment. - Occurrence of deep vein thrombosis within 4 weeks, prior to randomization. - Inadequate organ or bone marrow function. - Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization. Participants with reproductive (M/F) who were not agree to use accepted and effective method of contraception during the study treatment period and for at least 6 months following completion of study treatment. - Uncontrolled hypertension. - Urine Protein: creatine ratio (UPCR) >1 on morning spot urinalysis or proteinuria > 500mg/24 hours. - Participants on anticoagulant therapy with unstable dose of warfarin and/or having an out-of-therapeutic range international normalized ratio (INR) (>3) within 4 weeks prior to randomization. - Evidence of clinically significant bleeding diathesis or underlying coagulopathy. - Known dihydropyrimidine dehydrogenase deficiency. - Predisposing colonic or small bowel disorder in which the symptoms were uncontrolled as indicated by baseline of > 3 loose stools daily. - Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, unresolved bowel obstruction/sub-obstruction, more than hemicolectomy, extensive small intestine resection with chronic diarrhea. - History of anaphylaxis or known intolerance to atropine sulphate or loperamide or appropriate antiemetics to be administered in conjunction with FOLFIRI. - Treatment with concomitant anticonvulsant agents that were cytochrome P450 3A4 (CYP3A4) inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued > 7 days. - Participants with known Gilberts syndrome. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INSTRIDE 2; BRIEF: To test whether Mylans insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks ; DRUG USED: Semglee; DRUG CLASS: Biosimilar; INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Mylan Inc.; CRITERIA: Inclusion Criteria: - Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following: - Diagnosis established 1 year prior to screening - Insulin-naïve OR - On Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening - Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive). - Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history. - Hemoglobin ≥9.0 g/dL at screening - Glycosylated hemoglobin (HbA1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening. Exclusion Criteria: - History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions. - History of use of animal insulin within the last 3 years, any insulin other than Lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening. - Patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control. - Regular use of immune-modulator therapy in the 1 year prior to screening. - History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I) as judged by the investigator. - History of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening. - Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening. - History of drug or alcohol dependence or abuse during the 1 year prior to screening. - Receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period. ; PRIMARY OUTCOME: Change in HbA1c From Baseline to 24 Weeks; SECONDARY OUTCOME 1: Rate of Hypoglycemic Events Per 30 Days[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TOMMORROW; BRIEF: The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimers Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in cognitively-normal participants who are at high-risk for developing MCI within 5 years. ; DRUG USED: Actos; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. In the opinion of the investigator, participant is capable of understanding and complying with protocol requirements. 2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Is able to physically perform the cognitive tests in the opinion of the investigator and is fluent in the language that tests will be administered. 4. Is cognitively normal at baseline, scoring as indicated for the following tests: - Clinical Dementia Rating (CDR)=0. - At least one memory test above -1.5 standard deviation (SD) of the demographically corrected normative mean. 5. Must score ≥25 on the Mini-Mental State Examination (MMSE) at the screening visit after the education and age adjustment. 6. Is male or postmenopausal female between the ages of 65 and 83 years, inclusive, at time of the Screening visit. 7. Has the ability and intention to participate in regular study visits, in the opinion of the Investigator. 8. Has a project partner who can separately complete an Acknowledgement Form on his/her own behalf and take part in the study (with the intent to do so as long as the participant is enrolled) to provide information on the cognitive, functional, and behavioral status of the participant and to assist with monitoring of study medication, if needed. Exclusion Criteria: 1. Has a current diagnosis or history of any type of cognitive impairment or dementia or has a current diagnosis or history of neurological/psychiatric disorder or any other diagnosis that significantly affects cognitive performance (eg, mental retardation, organic mental disorder). 2. Has a current diagnosis of significant psychiatric illness, per Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) (or DSM-V when published) (including but not limited to major depressive disorder, anxiety disorders) and is in an acute phase/episode, or the participant has a current diagnosis or history of schizophrenia or bipolar disorder. 3. Has a glycosylated hemoglobin (HbA1c) >8.0% at the time of baseline or requires treatment with insulin, triple oral antidiabetic therapy or a peroxisome proliferator-activated receptor-gamma (PPAR-γ) agonist. The participant should be on a stable antidiabetic regimen for at least 3 months prior to enrollment. 4. Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal (including s/p gastric bypass), endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. History of HIV infection is considered exclusionary for this study. 5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse/dependence within 2 years prior to the Screening Visit. 6. Is an immediate family member, testing center employee, or is in a dependent relationship with a testing center employee who is involved in conduct of this study (eg, spouse, parent, child, and sibling) or may consent under duress. 7. Has a history of hypersensitivity or allergies to pioglitazone or related compounds. 8. Is required to take excluded medications as specified in the Excluded Medications Section. 9. Had any of the following values at the Baseline Visit (Visit 2): 1. A serum total bilirubin value >1.5× upper limit of normal (ULN). 2. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2xULN. 3. Unexplained microscopic/macroscopic hematuria on one repeat examinations within 2 weeks of the initial assessment. 10. Is positive for either Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibodies at the Baseline Visit (Visit 2). 11. Has a condition or takes medication that, in the opinion of the Investigator, could interfere with the assessments of safety, tolerability, or efficacy, or prevent the participant from adequately participating in the study or continue for the anticipated duration of the study. 12. Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to Screening or is currently participating in another study which entails the administration of an investigational or marketed drug, supplement or intervention including, but not limited to diet, exercise, lifestyle or invasive procedure. 13. Has a history of any cancer that has been in remission for less than 2 years from the Screening Visit. Participants with basal cell or stage I squamous cell carcinoma of the skin will be eligible. Participants with history of bladder cancer are not eligible irrespective of the remission status. 14. Has a history or current diagnosis of macular edema or macular degeneration. 15. If female, has a history of postmenopausal fractures with no or minimal trauma (eg, wrist, hip, lumbar or thoracic vertebral fracture). 16. Has a history or current diagnosis of congestive heart failure (CHF), New York Heart Association Class III-IV. 17. Has been exposed to the cognitive tests performed in this study within 6 months prior to the Screening Visit, with the exception of the MMSE. 18. Participants Translocase of the Outer Mitochondrial Membrane 40 homolog (TOMM40) rs10524523 or apolipoprotein E (APOE) genotypes or APOE phenotype are known by the participant or the study staff participating in this study. ; PRIMARY OUTCOME: Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimers Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants; SECONDARY OUTCOME 1: Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - INAD; BRIEF: The purpose of this study is to evaluate the efficacy and safety of RT001 in patients with Infantile Neuroaxonal Dystrophy (INAD). ; DRUG USED: RT001 (Retrotope); DRUG CLASS: New Molecular Entity (NME); INDICATION: Neurology - Other; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Retrotope, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female 18 months to 10 years of age 2. Medical history consistent with the symptoms of classic INAD (onset of symptoms between the ages of 6 months and 3 years) 3. Homozygous for PLA2G6 deficiency (variant alleles may be mixed heterozygotes) 4. Must have impairment in at least 2 of the assessed categories at baseline 5. Signed informed consent form (ICF) prior to entry into the study 6. Able to provide the necessary blood samples Exclusion Criteria: 1. Received treatment with other experimental therapies within the last 30 days prior to the first dose 2. Requiring mechanical ventilation, other than positive air pressure support primarily for mitigation of sleep apnea. 3. Have a life expectancy of less than one year 4. Diagnosis of atypical NAD (ANAD) 5. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subjects ability to return for visits as scheduled ; PRIMARY OUTCOME: Modified Ashworth Spasticity Scale; SECONDARY OUTCOME 1: INAD Progression Composite[/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 - DLCL04; BRIEF: The purpose of this study is to define an improvement in patients randomized in four different arms: Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells. ; DRUG USED: Rituxan; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: Fondazione Italiana Linfomi - ETS; CRITERIA: Inclusion Criteria: 1. Age 18-60; 2. Histological confirmed diagnosis of Diffuse Large B-Cell Lymphoma CD20+ (newly diagnosis or shifted from low grade NHL and not previously treated) or of Follicular Lymphoma grade III according to REAL/WHO Classification. 3. Advanced stage II, stage III and stage IV with at least two aa-IPI risk factors. 4. Age-adjusted IPI 2-3. 5. ECOG performance status 0-2. 6. LVEF>45%, measured with echocardiography. 7. Normal hepatic, renal and pulmonary functions. 8. HIV, HCV and HBV negativity. 9. HCV+ admitted only in histologically confirmed absence of replication marks. 10. Positive serology for HBV (occult carriers: AntiHBcAg+, HbsAg-, AntiHBsAg+/-) admitted only upon negativity of weakly positive HBV-DNA test. 11. Life expectancy > 3 months. 12. Negative pregnancy test. 13. Written Informed Consent. Exclusion Criteria: 1. Histological diagnosis of: - Lymphoblastic NHL - Burkitts Lymphoma - CD 20 negative B-cell Lymphoma - grade I-IIIa Follicular Lymphoma - Mantle Cell Lymphoma - Primary mediastinal NHL with exclusively intrathoracic localization. 2. Age > 60 3. Stage I disease 4. Age-adjusted IPI 0-1 5. ECOG-PS>3, if not related to Lymphoma 6. Renal impairment (creatinine>1,2 mg/dl or creatinine clearance < 60ml/min) 7. Hepatic impairment (AST/ALT or bilirubin > 2,5 times normal limit, unless due to Lymphoma) 8. HIV positive patients and/or with HBV or HCV active infection(documented by HBV-DNA and HCV-RNA positive tests) 9. Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension (resting diastolic blood pressure > 115 mmHG), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV 10. LFEV<45% 11. Severe diabetes mellitus difficult to control with adequate insulin therapy 12. Severe chronic obstructive pulmonary disease with hypoxemia 13. Active bacterial, viral of fungal infection requiring systemic therapy 14. Concurrent thrombohemolytic disease 15. HIV positivity 16. HBV positivity 17. Positive serology for HBV (occult carriers: AntiHBc+, HbsAg-, AntiHbs+/-) with positive HBV-DNA test 18. HCV positivity in presence of replication marks (HCV+, CRP+, AST 1,5-2 times normal ranges) 19. CNS localization of disease 20. Prior (during last 3 years) or concurrent malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix or early stage prostate cancer not requiring systemic therapy, or early breast cancer treated with surgery alone. Any other co.existing medical condition that would preclude study therapy administration 21. Pregnancy or breast-feeding women 22. Inability of the patient to give her/his informed consent 23. Known hypersensitivity or anaphylactic reaction to murine antibodies or proteins ; PRIMARY OUTCOME: To evaluate the activity of arms R-MegaCHOP14/R-CHOP14 + R-MAD+BEAM and ASCT and R-MegaCHOP14/R-CHOP14 in terms of 2-years Failure Free Survival (FFS).; SECONDARY OUTCOME 1: To evaluate the activity of arms R-MegaCHOP14/R-CHOP14 + R-MAD+BEAM and ASCT and R-MegaCHOP14/R-CHOP14 in terms of 3-years Overall Survival (OS).[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COMPLEMENT 1 (w/Chlorambucil); BRIEF: The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia. ; DRUG USED: Arzerra; DRUG CLASS: Biologic; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - confirmed CLL diagnosis and active CLL requiring treatment - considered inappropriate for fludarabine-based therapy - not been treated for CLL before - fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours - age 18yrs or older - signed written informed consent Exclusion Criteria: - prior CLL therapy - abnormal/inadequate blood values, liver, and kidney function - certain heart problems, active or chronic infections, serious significant diseases, active autoimmune hemolytic anemia (AIHA) requiring treatment, other current cancer or within last 5 years - CLL transformation - CLL central nervous system involvement - current participation in other clinical study - inability to comply with the protocol activities - lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception ; PRIMARY OUTCOME: Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC); SECONDARY OUTCOME 1: Number of Participants With the Best Overall Response (OR), as Assessed by the IRC[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Saxagliptin or Metformin Alone; BRIEF: The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone ; DRUG USED: Kombiglyze XR; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK), Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Type 2 diabetes - Inadequate blood sugar control - No current treatment with other medications to lower blood sugar Exclusion Criteria: - Major heart, liver or kidney problems - Pregnant or breast feeding ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy; SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Renaissance 5 (Fixed Dose); BRIEF: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant. ; DRUG USED: TC-5214; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Nicotinic Acetylcholine Receptor - a3ß4 subtype , Nicotinic Acetylcholine Receptor - a4ß2 subtype &lt;br&gt;(a4ß2 nAChR); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed and dated informed consent before initiation of any study-related procedures. - The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant. - Outpatient status at enrollment and randomization. Exclusion Criteria: - Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder. - Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide. - History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product. ; PRIMARY OUTCOME: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.; SECONDARY OUTCOME 1: Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ZA-305 (vs. AndroGel); BRIEF: This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%. ; DRUG USED: Enclomiphene; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypogonadism; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Repros Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive - Previously or concurrently diagnosed as having secondary hypogonadism characterized as having at least 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be confirmed at Baseline. - LH < 9.4 mIU/mL (at Visit 1 only) - Sperm concentration ≥ 15 million per milliliter (assessed at V2 and Baseline). V2 and Baseline measurements must be at least 48 hours apart. - Ability to complete the study in compliance with the protocol - Ability to understand and provide written informed consent - Agreement to provide a total of at least 4 semen samples in a sponsor-approved clinic on 4 separate occasions. Exclusion Criteria: - Any prior use of testosterone treatments (injectable, pelleted, transdermal or sublingual) within the last 6 months - Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study - Use of Clomid in the past year - Any clinically significant laboratory abnormality that does not have prior written sponsor approval. If the sponsor approves subject enrollment, this will not be considered to be a protocol deviation. - Uncontrolled hypertension or diabetes mellitus based on the Investigators assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study, if considered clinically stable by the investigator. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study. - A hematocrit >54 - Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication. - Known hypersensitivity to Clomid - Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any evidence of posterior subcapsular cataract) - Abnormal fundoscopy exam such as central retinal vein occlusion - Any condition which in the opinion of the investigator would interfere with the participants ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study - Have received a diagnosis of irreversible infertility or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary), or history of evaluation or treatment for low fertility - Current or history of breast cancer - Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6 - Presence or history of known hyperprolactinemia with or without a tumor (prolactin > 20 ng/mL). - Chronic use of medications such as glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable) - History of drug abuse or chronic narcotic use including methadone - A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week) - Subjects with known history of HIV and/or Hepatitis C - Subjects with end stage renal disease - History of liver disease (including malignancy) or a confirmed AST or ALT >3 times the upper limit of normal - History of clinically relevant myocardial infarction (within the previous year), unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history of QTc interval prolongation - History of clinically relevant cerebrovascular disease - History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism) - History of erythrocytosis or polycythemia - Subjects unable to provide a semen sample in a sponsor-approved clinic - Enrollment in a previous Androxal study - Subjects who have Type I Diabetes ; PRIMARY OUTCOME: Comparison of the proportion of subjects who meet the composite endpoint of normal 24-hour average testosterone and sperm concentration.; SECONDARY OUTCOME 1: Proportion of subjects with mean sperm concentration less than 15 million/mL after 16 weeks of treatment comparing Androxal to placebo in a non-inferiority assessment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RUXCOVID-DEVENT; BRIEF: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Participant or guardian health proxy must provide informed consent before any study assessment is performed. - Male or female participants aged ≥ 12 years. - Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval. - Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization. Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan. Exclusion Criteria: - Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib. - Presence of severely impaired renal function defined by estimated creatinine clearance < 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening. - In the opinion of the investigator, unlikely to survive for > 24 hours from randomization. - Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19). - Currently receiving ECMO. - Participant may not be sharing a ventilator, or co-ventilating, with any other patient. - Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization. - Treatment with a JAK inhibitor within 30 days of randomization. - Participants who are on long-term use of antirejection or immunomodulatory drugs. - Pregnant or nursing (lactating) women. ; PRIMARY OUTCOME: Percentage of Participants Who Have Died Due to Any Cause; SECONDARY OUTCOME 1: Number of Ventilator Free Days[/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 - STRIDE 5 (Safety Study); BRIEF: To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks. ; DRUG USED: Aclerastide; DRUG CLASS: Non-NME; INDICATION: Diabetic Foot and Other Ulcers; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Integra LifeSciences Corporation; CRITERIA: Inclusion Criteria: 1. Male or female ambulatory subjects who are at least 18 years of age at screening 2. Have at least one ulcer: 1. chronic ( present >1month) 2. Wagner Grade 1 or Grade 2 ulcer (i.e. Partial- or full- thickness and not involving bone, tendon or capsule (probing to tendon or capsule) and/or penetrating to tendon or capsule.) 3. with no sign of infection or osteomyelitis, and 4. is located below the malleolus. 3. Have an ABI > 0.7, or have a TcPO2 > 40 mm Hg or great toe systolic pressure > 50 mmHg to ensure healing potential. 4. Have Type I or Type II diabetes under metabolic control as confirmed by glycosylated hemoglobin (HbA1c) of ≤ 14%, obtained at enrollment or within 30 days prior to study enrollment. 5. Female subjects of child-bearing potential must have a negative pregnancy test at the time of enrollment and at the initiation of each study treatment period. 6. Female subjects of child-bearing potential must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device or skin patch), intrauterine device, tubal ligation, double barrier, or abstinence during the treatment periods of study participation. 7. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures Exclusion Criteria: 1. Has a known hypersensitivity to any of the study medication components. 2. Exposure to any investigational product within 30 days of entry into study. 3. Has active malignant disease of any kind (with the exception of basal cell carcinoma). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Disease-free is defined as in remission for at least 5 years. 4. Chronic liver dysfunction evidenced by transaminase levels > 2.5 times higher than the upper level of normal on two occasions. 5. Has a history of additional risk factors for TdP (eg. heart failure, hypokalemia, family history of Long QT Syndrome) or taking medication which are known to prolong QT/QTc (Appendix G) 6. Receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy. 7. Prior radiation therapy of the foot with the ulcer under study. 8. Current use of systemic corticosteroids or immunosuppressants within 8 weeks prior to enrollment into the study 9. Sickle-cell anemia, Raynauds or other peripheral vascular disease. 10. Subjects receiving a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the 7 days prior to exposure to DSC127. 11. Subject who, in the opinion of the investigator, has uncontrolled hypertension 12. Subject has an ulcer which is determined to be clinically infected and requires antimicrobials or agents known to affect wound healing or has been taking systemic antibiotics for more than 7 days for any reason. (Subjects with infection at the initial visit of the Screening Period can be re-screened three weeks later after a single course of antibiotic therapy (occurring concurrently - within three weeks of the initial visit, the antibiotic treatment must have completed and some washout (7 days) must have elapsed); if after that time infection is still present, the subject will be excluded.) 13. Subjects who, in the opinion of the investigator, have clinically significant anemia ; PRIMARY OUTCOME: The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment; 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 - EPIC-2; BRIEF: The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohns Disease who are responding to steroid induction therapy. Patient safety and quality of life will also be monitored throughout the study. ; DRUG USED: Epanova; DRUG CLASS: Non-NME; INDICATION: Crohns Disease; TARGET: Diglycerol Acyltransferase (DGAT), Lipoprotein lipase, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Tillotts Pharma AG; CRITERIA: Key Inclusion Criteria: - symptomatic active Crohns disease (requiring a 16-week course of induction steroid therapy at a starting dose of prednisone 40 mg or budesonide 9 mg daily) - respond to induction therapy (CDAI<150) following 8 weeks of steroid tapering regimen to prednisone 20 mg or budesonide 6 mg daily - Crohns disease of at least 3 months duration - 16 years of age or older Key Exclusion Criteria: - intolerance of omega-3 free fatty acid (FFA) - intolerance of both prednisone and budesonide - ongoing therapy for Crohns disease with: 5-ASA compounds, immune modifiers, systemic antibiotics, tube feeding - received in the past 3 months: systemic steroid therapy (other than study prednisone or budesonide induction therapy), azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, probiotic products, preparations containing omega-3 fatty acids - received in the past 6 months: biologicals e.g. enbrel, infliximab, monoclonal antibody, mycophenolate, tacrolimus, thalidomide, other immune modifiers and/or investigational products - chronic narcotic analgesics for pain control - short bowel syndrome, ostomy or need for bowel surgery for Crohns disease, bowel obstruction or resection in the past 3 months - malignancy, clinically significant impairment or conditions which could interfere with the evaluation of the trial medication - clinically relevant hematology, liver and renal function laboratory tests - known allergy to fish or fish products ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Extension Study (ARIDO); BRIEF: This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies. ; DRUG USED: Qbrexza; DRUG CLASS: Non-NME; INDICATION: Dermatology; TARGET: Muscarinic acetylcholine receptor, Sweat gland activation; THERAPY: Monotherapy; LEAD SPONSOR: Journey Medical Corporation; CRITERIA: Inclusion Criteria: - Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance - Male or females Exclusion Criteria: - Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated - Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy - Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study ; PRIMARY OUTCOME: Long-term Safety Assessed Through Adverse Events and Local Skin Reactions; 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 - TOPIC - EFC6260 (Early MS/CIS); BRIEF: The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives were: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes ; DRUG USED: Aubagio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Dihydroorotate Dehydrogenase (DHODH), DNA synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes) - Onset of MS symptoms occurring within 90 days of randomization - A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS Exclusion Criteria: - Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease - Significantly impaired bone marrow function - Pregnancy or nursing - Alcohol or drug abuse - Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment - Any known condition or circumstance that would prevent in the investigators opinion compliance or completion of the study The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS); SECONDARY OUTCOME 1: Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OCTAVE Induction 2; BRIEF: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Subject must be at least 18 years of age. - Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study. - Subjects with moderately to severely active UC based on Mayo score criteria. - Subjects must have failed or be intolerant of at least one of the following treatments for UC: - Corticosteroids (oral or intravenous). - Azathioprine or 6 mercaptopurine (6 MP). - Anti TNF therapy. Exclusion Criteria: - Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns disease. - Subjects with disease limited to distal 15 cm. - Subjects without previous treatment for UC (ie, treatment naïve). - Subjects displaying clinical signs of fulminant colitis or toxic megacolon. ; PRIMARY OUTCOME: Percentage of Participants With Remission at Week 8; SECONDARY OUTCOME 1: Percentage of Participants Achieving Mucosal Healing at Week 8[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CIRCUS; BRIEF: Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment. ; DRUG USED: CicloMulsion; DRUG CLASS: Non-NME; INDICATION: Acute Coronary Syndrome (ACS); TARGET: Cyclophilin D; THERAPY: Monotherapy; LEAD SPONSOR: Hospices Civils de Lyon; CRITERIA: Inclusion Criteria: Eligibility criteria (for screening before hospital admission): 1. All (male and female) patients, aged over 18, without any legal protection measure, 2. Having a health coverage, 3. Presenting within 12 hours of the onset of chest pain, 4. Who have ST segment elevation ≥0.2 mV in two contiguous leads, 5. For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI). And (further inclusion criteria to be confirmed by the admission coronary-angiography): 6. The culprit coronary artery has to be the LAD 7. The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography. 8. Preliminary oral informed consent followed by signed informed consent as soon as possible. Patients undergoing either primary PCI or rescue PCI are eligible for the study. Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study. Exclusion Criteria: 1. Patients with loss of consciousness or confused 2. Patients with cardiogenic shock 3. Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region 4. Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography 5. Patients with 5.2. known hypersensitivity to cyclosporine 5.3. known hypersensitivity to egg, peanut or Soya-bean proteins 5.4. known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 5.5. known liver insufficiency 5.6. uncontrolled (treated or untreated) hypertension (> 180/110 mmHg) 6. Patients treated with any compound containing Hypericum perforatum (St.-Johns-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine 7. Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis). 8. Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8.2. cancer, lymphoma 8.3. known positive serology for HIV, or hepatitis ; PRIMARY OUTCOME: Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]; SECONDARY OUTCOME 1: Ejection fraction[/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 - AIMM; BRIEF: To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma. ; DRUG USED: Allovectin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Immune System, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Vical; CRITERIA: Inclusion Criteria (Potential study participants must meet the following criteria): - Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2) - At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected - Normal blood chemistries and blood cell counts - At least 18 years old and able and willing to provide informed consent to participate Exclusion Criteria (Potential study participants will not be eligible with the following): - Previous chemotherapy treatment for melanoma - Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed) - If surgical removal of all lesions would be possible and could be curative - Any melanoma tumors greater than 10cm x 10cm in size - Known condition resulting in a suppressed immune system - Female subjects who are pregnant ; PRIMARY OUTCOME: To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.; SECONDARY OUTCOME 1: To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.[/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 - CONCUR (Asia); BRIEF: The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer. ; DRUG USED: Stivarga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Raf kinase, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded. - Subjects with metastatic colorectal cancer(CRC) (Stage IV). - Subjects must have failed at least two lines of prior treatment. - Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan. - Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. - Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible. - Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. - Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT) - Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 1. - Life expectancy of at least 3 months. - Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol. Exclusion Criteria: - Prior treatment with Regorafenib. - Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]. - Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. - Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy. - Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management). - Subjects with phaeochromocytoma. - Pleural effusion or ascites that causes respiratory compromise. - Arterial or venous thrombotic or embolic events. - Any history of or currently known brain metastases. - Interstitial lung disease with ongoing signs and symptoms at the time of informed consent. - Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALSYMPCA; BRIEF: ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases. ; DRUG USED: Xofigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: DNA, Radiopharmaceutical, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Known hormone refractory disease - Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy - No intention to use cytotoxic chemotherapy within the next 6 months - Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain Exclusion Criteria: - Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period - Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available - Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago - Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks - Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) - History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Time to Total Alkaline Phosphatase (ALP) 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 IIb/III - Episodic Migraine Prevention; BRIEF: This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship. ; DRUG USED: Qulipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Has at least a 1-year history of migraine with or without aura - Age of the patient at the time of migraine onset < 50 years - History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigators judgment - Demonstrated compliance with e-diary Exclusion Criteria: - Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine - Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy - Difficulty distinguishing migraine headache from other headaches - Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption - Has a history of hepatitis within previous 6 months - Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 - Pregnant or nursing females ; PRIMARY OUTCOME: Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period; SECONDARY OUTCOME 1: Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HARBOR (High Dose); BRIEF: This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Results are presented for the first 12 months of the study. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study. Ocular Inclusion Criteria (Study Eye) - Best corrected visual acuity (BCVA), using Early Treatment Diabetic Retinopathy Study (ETDRS) charts, of 20/40-20/320 (Snellen equivalent). - Choroidal neovascularization (CNV) lesions with classic CNV component, occult CNV, or with some classic CNV component were permissible. - Total area of lesion < 12 disc area or 30.48 mm^2. Exclusion Criteria: - History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye. - Prior treatment with Visudyne(R), external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye. - Previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation) in the study eye. - Previous treatment or participation in a clinical trial involving anti-angiogenic drugs (Avastin(R), anecortave acetate, protein kinase C inhibitors, etc), in the non-study eye within 3 months of Day 0 (first day of treatment). The patient may not have received Lucentis(R) or Macugen(R) in the non-study eye within 7 days of Day 0. - Treatment with Visudyne(R) in the non-study eye < 7 days preceding Day 0. - Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm^2) in size. - Subfoveal fibrosis or atrophy in the study eye. - CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia. - Retinal pigment epithelial tear involving the macula in the study eye. - Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity (BCVA) over the 24-month study period. - Uncontrolled blood pressure. - Atrial fibrillation not managed by patients primary care physician or cardiologist within 3 months of screening visit. - History of stroke within the last 3 months of screening visit. - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications. - Current treatment for active systemic infection. - Active malignancy. - History of allergy to fluorescein, not amenable to treatment. - Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals). ; PRIMARY OUTCOME: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12; SECONDARY OUTCOME 1: Number of Ranibizumab Injections up to But Not Including Month 12[/INST]Yes</s>