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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 - Salford Lung Study (Asthma); BRIEF: This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period. ; 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 eligible for enrolment in the study must meet all of the following criteria: 1. Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated. 2. Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease. 3. Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2. - Other background asthma medication such as anti-leukotrienes are permitted 4. All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subjects recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines). 5. Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf 6. Gender and Age: Male or female subjects aged ≥18 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of: - Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<147 pmol/L) is confirmatory. OR Child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - Visit 2 to the end of the study). Exclusion Criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1. Recent history of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months. 2. COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease. 3. Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. 4. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta2-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subjects participation will also be excluded. 5. Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening) 6. Chronic user of systemic corticosteroids: A subject who, in the opinion of the GP/Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening) 7. Subjects who are using LABA without an ICS as asthma maintenance therapy. 8. Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area. ; PRIMARY OUTCOME: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.; SECONDARY OUTCOME 1: Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AIR-BX2; BRIEF: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days. ; DRUG USED: Cayston; DRUG CLASS: Non-NME; INDICATION: Bronchiectasis; TARGET: Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Male/Female 18 years or older with non-CF bronchiectasis - Chronic sputum production on most days - Positive sputum culture for gram-negative organisms - Must have met lung function requirements Exclusion Criteria: - History of CF - Hospitalized within 14 days prior to joining the study - Previous exposure to AZLI - Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study - Must have met liver and kidney function requirements - Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed) - Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment - Other serious medical conditions. ; PRIMARY OUTCOME: Change in QOL-B Respiratory Symptoms Score at Day 28; SECONDARY OUTCOME 1: Change in QOL-B Respiratory Symptoms Score at Day 84[/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 - CORAL XT (Ext. Study); BRIEF: The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain. ; DRUG USED: Cebranopadol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cancer Pain; TARGET: Nociceptin/Orphanin FQ Peptide (NOP) Receptor, Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Tris Pharma, Inc.; CRITERIA: Inclusion Criteria: - Informed consent signed indicating that the participant understands the purpose of and procedures required for the trial and is willing to participate in the trial. - Participants must be at least 18 years of age at the Enrollment Visit. - Women of childbearing potential must have a negative pregnancy test at enrollment and must not be lactating at the Enrollment Visit. - Participants must be willing to use medically acceptable and highly effective methods of birth control. - Participants who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids. Exclusion Criteria: - The participant has a clinically significant disease or condition other than cancer which in the investigators opinion may affect efficacy or safety assessments. - Known to or suspected of not being able to comply with the protocol and the use of cebranopadol. - Participants taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment. - History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia). - Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial. - Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Event (TEAEs); SECONDARY OUTCOME 1: Intensity of Treatment Emergent Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AMPLITUDE-O (CVOT); BRIEF: Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters: - 3-point MACE. - Expanded CV outcome. - Composite outcome of new or worsening nephropathy. To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk. ; DRUG USED: Efpeglenatide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - T2DM with glycosylated hemoglobin (HbA1c) greater than (>) 7 percentage. - Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor. - Female participants agreed to follow contraceptive guidance. - Signed written informed consent. Exclusion criteria: - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting. - History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening. - Personal or family history of medullary thyroid cancer. - Hypertension (with a systolic blood pressure >180 millimeters of Mercury [mmHg] and/or diastolic blood pressure >100 mmHg). - Hospitalization for hypertensive emergency within 3 months prior to randomization. - Planned coronary procedure or surgery after randomization. - No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization. - Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study. - Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening. - Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening. - Antihyperglycemic treatment had not been stable within 3 months prior to screening. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis; SECONDARY OUTCOME 1: Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis[/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 - LUNG-NEPA; BRIEF: This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy ; DRUG USED: Akynzeo; DRUG CLASS: Non-NME; INDICATION: Chemotherapy Induced Nausea and Vomiting (CINV); TARGET: Neurokinin Receptor, Serotonin 5-HT3 receptor; THERAPY: Combination; LEAD SPONSOR: Consorzio Oncotech; CRITERIA: Inclusion Criteria: - Patients ≥ 18 years old. - Histologically or cytologically confirmed diagnosis of NSCLC - Patients naїve to cisplatin-containing chemotherapy as well as any prior chemotherapy containing either highly or moderately emetogenic agents given for NSCLC or other malignancy. - Patients scheduled to receive their first cycle of cisplatin-based chemotherapy at a dose ≥70 mg/m2 either alone or in combination with other agents of low or minimal potential of emetogenicity (i.e., pemetrexed, gemcitabine±bevacizumab, vinorelbine) as neo-adjuvant, adjuvant or palliative therapy. Patients with progressive disease on therapy with an EGFR-TKI (Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) and scheduled to receive cisplatin-based chemotherapy will be eligible for the study. - ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1. - Body Mass Index ≥18.5. - Written informed consent before study entry. - If women of childbearing potential age: effective contraceptive measures must be used during all the planned course of chemotherapy and up to 30 days after last NEPA administration. - Normal hepatic function (≤2 times the upper limit of normal for liver transaminases) and renal function (creatinine ≤ 1.5 times the upper limit of normal). - Ability and willingness of the patient to complete the diary and study questionnaires. Exclusion Criteria: - Symptomatic brain metastases. - Patients scheduled to receive radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 following the first cycle of chemotherapy. - Patients scheduled to receive concurrent chemo/radiotherapy for NSCLC. - Treatment with investigational medications within 30 days before the study medication. - Myocardial infarction within the last 6 months. - Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK-1RA (Neurokinin-1 Receptor Antagonist) and excipients (see section 6.1 of Akynzeo SPC). - Uncontrolled diabetes mellitus or active infection. - Nausea and vomiting in the 24 hours before study treatment. - Chronic use of systemic corticosteroids (except for topical and inhaled corticosteroids) or any other agent with anti-emetic potential. Patients receiving dexamethasone on the day before chemotherapy for prevention of the pemetrexed-induced skin rash will be eligible for the study. - Patients inability to take oral medication. - Gastrointestinal obstruction or active peptic ulcer. - Pregnancy or breast feeding. - Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for at least 5 years (see also inclusion criteria if prior chemotherapy treatment). - Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol. ; PRIMARY OUTCOME: Complete Response (CR); SECONDARY OUTCOME 1: CR (acute and delayed).[/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 - HIV/HCV; BRIEF: The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug. ; DRUG USED: Incivek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL) - Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse - Population B: Peg-IFN/RBV prior null or partial responder - Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration - Participant must have positive HIV antibody at Screening - Participant must have a diagnosis of HIV-1 infection >6 months before Screening - Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening: - Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine) - Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components - Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components - Boosted atazanavir plus Epzicom®, or equivalent components - Raltegravir plus Truvada®, or equivalent components - Raltegravir plus Epzicom®, or equivalent components - Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol - Laboratory values within acceptable ranges at Screening as specified in the protocol Exclusion Criteria: - Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1 - Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides - Contraindications to any planned HAART component as per the respective drug labeling information - Contraindications to Peg-IFN or RBV - Evidence of hepatic decompensation - Clinical suspicion of acute hepatitis - Any other cause of liver disease in addition to hepatitis C - History of organ transplantation (except cornea and skin) - Autoimmune-mediated disease - Participated in any investigational drug study within 90 days before Day 1 - Previous treatment with an HCV protease inhibitor ; PRIMARY OUTCOME: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ONTRAC; BRIEF: The question being asked in this study is: Will patients with advanced pancreatic cancer live significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na than if they are treated with Gemcitabine alone? There are two parts to this study. In the first part of the study, patients with metastatic pancreatic cancer who have received no prior chemotherapy for this disease will be assigned by chance either to the group that will be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group) or, to the group that will be treated with Gemcitabine only (about 50 patients will be in this group). How long patients survive in the 2 groups will be compared. If it looks like there is no difference between the groups, the study will stop. If it looks like patients in the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study will continue into a second part where more patients will be treated in order to confirm and better understand the findings of the first part of the study. ; DRUG USED: Estybon (Intravenous); DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: PI3K/AKT pathway, Polo-like kinase 1 (Plk1); THERAPY: Combination; LEAD SPONSOR: Onconova Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Patients at least 18 years old presenting with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas; metastatic disease is defined as disease which has spread beyond the peri-pancreatic lymph nodes. - Patients must have received no prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy. - Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be ≥15 mm in the short axis. - ECOG Performance Status of 0, 1, or 2. - Patients must have adequate renal function and serum creatinine ≤2.0 mg/dL. - Patients must have adequate liver function as defined by total bilirubin ≤2.0 mg/dL and transaminase levels no higher than 3.0 times the institutions upper limit of normal (ULN). Patients with hepatic metastases may have transaminase levels of up to 5.0 times the ULN. - All patients must have a serum albumin ≥3.0 g/dL. - Patients must have adequate bone marrow (BM) function as defined by a granulocyte count ≥1,500/mm3, a platelet count ≥100,000/mm3, and hemoglobin >9 g/dL. - Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] breast disease). - Adequate contraceptive regimen (including prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study for female patients of reproductive potential or female partners of male patients. - Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin (bHCG) pregnancy test at Screening. - Willing to adhere to the prohibitions and restrictions specified in this protocol. - Patient must have signed an informed consent document. Exclusion Criteria: - Patients with unresectable locally advanced disease without evidence of disease elsewhere. - Life expectancy of less than 12 weeks. - Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or seizure disorder. - Active infection not adequately responding to appropriate therapy. - Symptomatic or clinically evident ascites. - Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia. - Female patients who are pregnant or lactating. - Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol. - Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start. - Evidence of brain metastases. - Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of radiotherapy, or immunotherapy. - Psychiatric illness/social situations that would limit the patients ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures (e.g., drug addition, chronic non-compliance, etc.). ; PRIMARY OUTCOME: Survival; SECONDARY OUTCOME 1: Progression-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Autosomal Dominant Polycystic Kidney Disease; BRIEF: The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD). ; DRUG USED: Jynarque; DRUG CLASS: Non-NME; INDICATION: Polycystic Kidney Disease; TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Male and female participants ≥ 18 years with confirmed diagnosis of ADPKD (during participation in prior tolvaptan trials) who have completed and transferred from the double-blind Trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment), or completed Trial 156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial. - eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m^2) within 3 months prior to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m^2 may be enrolled with medical monitor approval. Exclusion Criteria: - Need for chronic diuretic use - Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease - Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP) - Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP. - Participants with contraindications to required trial assessments (contraindications to optional assessments, for example, magnetic resonance imaging [MRI] are not a limitation). - Participants who in the opinion of the investigator or the medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance ; PRIMARY OUTCOME: Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs); 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 IIIb - Previously Treated; BRIEF: To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A. ; DRUG USED: Adynovate; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: INCLUSION CRITERIA Participants Transitioning from Other BAX 855 Studies: Participants transitioning from other BAX 855 studies can be provided with the continuation study informed consent form (ICF) prior to the end of study visit to review and consider participation in this continuation study. These participants will complete any additional screening assessments within 2 weeks of the previous studys end of study visit and will return to the study site within 6 (± 1) weeks of the previous study end of study visit to confirm eligibility for this continuation study. - Participants transitioning from other BAX 855 studies who meet ALL of the following criteria are eligible for this study: 1. Participant has completed a previous BAX 855 study and is willing to immediately transition into this continuation study. 2. Participant is ≤75 years of age at screening of the previous BAX 855 study. 3. Participant continues to have a Karnofsky (for participants aged ≥ 16 years) or Lansky (for participants aged < 16 years) performance score of ≥ 60. 4. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm^3, as confirmed by central laboratory at screening. 5. Participant is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis. 6. If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study. 7. Participant and/or legally authorized representative is willing and able to comply with the requirements of the protocol. - BAX 855 Naïve Participants: BAX 855 naïve participants who are ≥ 12 years of age can only be enrolled in this continuation study after enrollment in the phase 2/3 pivotal study is closed. BAX 855 naïve participants who are < 12 years of age can only be enrolled in this continuation study after enrollment in the pediatric previously treated patient (PTP) study is closed. - Enrolment of BAX 855 naïve participants will only start once the sponsor has notified the study sites accordingly. BAX 855 naïve participants who meet ALL of the following criteria are eligible for this study: 1. Participant is ≤75 years of age at screening. 2. Participant is naïve to BAX 855. 3. Participant has severe hemophilia A (FVIII clotting activity < 1%) as confirmed by central laboratory at screening after at least a 72-hour washout period. 4. Participant aged ≥ 6 years has documented previous treatment with plasma-derived FVIII or rFVIII for ≥ 150 exposure days (EDs). 5. Participant aged < 6 years has documented previous treatment with plasma-derived FVIII concentrates or rFVIII for ≥ 50 EDs. 6. Participant is currently receiving prophylaxis or on-demand therapy with FVIII. 7. Participant has a Karnofsky (for participants aged ≥ 16 years) or Lansky (for participants aged < 16 years) performance score of ≥ 60. 8. Participant is HIV-; or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm^3, as confirmed by central laboratory at screening. 9. Participant is HCV- by antibody or PCR testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis. 10. If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study. 11. Participant and/or legally authorized representative is willing and able to comply with the requirements of the protocol. EXCLUSION CRITERA - Participants Transitioning from Other BAX 855 Studies: Participants transitioning from other BAX 855 studies who meet ANY of the following criteria are not eligible for this study: 1. Participant had detectable factor VIII (FVIII) inhibitory antibodies (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening. 2. Participant has developed FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay as determined at central laboratory in a previous BAX 855 study). 3. Participant has acquired a hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrands disease) in a previous BAX 855 study. 4. Participant has severe chronic hepatic dysfunction (eg, ≥ 5 times upper limit of normal alanine aminotransferase [ALT], as confirmed by central laboratory at screening). 5. Participant has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening. 6. Participant experienced a life-threatening or gastrointestinal bleeding episode within 3 months prior to study entry. 7. Participant is scheduled to use other PEGylated drugs during study participation. 8. Participant is planning to take part in any other clinical study during the course of the continuation study, with the exception of any other parallel BAX 855 study. 9. Participant has medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance. 10. Participant is a family member or employee of the investigator. - BAX 855 Naïve Participants: BAX 855 naïve participants who meet ANY of the following criteria are not eligible for this study: 1. Participant has detectable FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening. 2. Participant has history of FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay or the Bethesda assay) at any time prior to screening. 3. Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrands disease). 4. Participant has known hypersensitivity towards mouse or hamster proteins, polyethylene glycol (PEG), or Tween 80. 5. Participant has severe chronic hepatic dysfunction eg, ≥ 5 times upper limit of normal ALT, as confirmed by central laboratory at screening). 6. Participant has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening. 7. Participant experienced a life-threatening or gastrointestinal bleeding episode within 3 months prior to study entry. 8. Participant has current or recent (< 30 days) use of other PEGylated drugs prior to study participation or scheduled use of such drugs during study participation. 9. Participant has participated in another clinical study involving an IP other than BAX 855 or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device during the course of this study. 10. Participant has medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance. 11. Participant is a family member or employee of the investigator. ; PRIMARY OUTCOME: Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII); SECONDARY OUTCOME 1: Total Annualized Bleed Rate (ABR)[/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 - GREGALE; BRIEF: The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria - Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines - Male and female patients aged 18 to 75 years of age at the time of Visit 1 - Patient or caregiver must be willing and able to self-administer the IP (Investigational product). Caregiver must be age of consent or older at the time of Visit 1, if applicable - Weight of ≥40 kg - Evidence of asthma as documented by either: Airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 2 OR documented in the previous 12 months OR; Airflow variability in FEV1 ≥20% between pulmonary function testing documented in the 12 months prior to V2 OR; Airflow variability shown by >20% diurnal variability in peak flow observed in the patients asthma action plan - Documented history of current treatment with ICS (Inhaled corticosteroids) and LABA (Long-acting β2 agonists). The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, both the mid- and high-strength maintenance doses approved in the local country will meet this ICS criterion. Additional asthma controller medications (e.g., LTRAs (Leukotriene receptor antagonists), tiotropium, theophylline, oral corticosteroids) are allowed - Morning pre-bronchodilator (pre-BD) FEV1 of >50% predicted at Visit 1 or Visit 2 - Not well controlled asthma as documented by either: An ACQ6 (Asthma Control Questionnaire 6) ≥1.5 OR; A peak flow of 60-80% predicted OR; An exacerbation, one or more, that required oral or systemic corticosteroids in the previous year OR; Any one of the following assessed by patient recall over the previous 2-4 weeks: Asthma symptoms >2 days/week; OR / Nighttime awakenings 1 or more/week; OR / Short acting beta2-agonist use for symptom control (not for prevention of exercise induced asthma) >2 days/week Exclusion criteria: - Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD (Chronic obstructive pulmonary disease), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome) - Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: Affect the safety of the patient throughout the study; Influence the findings of the studies or their interpretations; Impede the patients ability to complete the entire duration of study - Known history of allergy or reaction to the IP formulation - History of anaphylaxis to any biologic therapy - History of Guillain-Barré syndrome - A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy - Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening period - Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete entire duration of the study ; PRIMARY OUTCOME: Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home; SECONDARY OUTCOME 1: The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Generation S1 (AD Prevention); BRIEF: The purpose of this study was to test whether two investigational drugs called CAD106 and CNP520, administered separately, could slow down the onset and progression of clinical symptoms associated with Alzheimers disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype. ; DRUG USED: CAD106; DRUG CLASS: Vaccine; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Consented to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype. - Male or female, age 60 to 75 years inclusive. Females were to be post-menopausal. - Mini-Mental State Examination (MMSE) total score ≥ 24 and cognitively unimpaired as evaluated by memory tests - Homozygous APOE4 genotype. - Participant willing to have a study partner. Key Exclusion Criteria: - Any disability that prevented the participant from completing all study requirements. - Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments. - Advanced, severe progressive or unstable disease that may have interfered with the safety, tolerability and study assessments, or put the participant at special risk. - History of malignancy of any organ system, treated or untreated, within 60 months prior to screening. - History of hypersensitivity to any of the investigational drugs or their excipients / adjuvant or to drugs of similar chemical classes. - Indication or on current treatment with ChEIs and/or another AD treatment (e.g. memantine). - Contraindication or intolerance to MRI or PET investigations (with fluorinated radio ligands). - Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator could have been a leading cause to future cognitive decline, pose a risk to the participant, or prevent a satisfactory MRI assessment for safety monitoring. - Suicidal Ideation in the past six months or Suicidal Behavior in the past two years, prior to screening. - A positive drug screen at Screening, if, in the Investigators opinion, this was due to drug abuse. - Significantly abnormal laboratory results at Screening, or infection not as a result of a temporary condition. - Current clinically significant ECG findings. For Cohort - I only: Participants with previous organ transplantation or stem cell transplantation, or indication for treatment with anti-coagulants. For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g. albinism vitiligo) or active / history of chronic urticarial in the past year. ; PRIMARY OUTCOME: Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimers Disease (AD)); SECONDARY OUTCOME 1: Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ICON7; BRIEF: RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Medical Research Council; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer - Newly diagnosed disease - Meets 1 of the following staging criteria: - High-risk stage I or IIA disease (grade 3 disease or clear cell carcinoma only) - Stage IIB-IV disease (all grades and all histological types) - Must have undergone initial surgery (e.g., debulking cytoreductive surgery or a biopsy if the patient has stage IV disease) within the past 6 weeks - Patients with stage IV disease for which initial surgical debulking was not appropriate are eligible provided the following criteria are met: - Stage IV disease diagnosed by histology - No planned surgery prior to disease progression, including interval debulking surgery - Patients with prior early-stage ovarian epithelial or fallopian tube carcinoma treated with surgery alone are eligible at the time of diagnosis of abdominopelvic recurrence provided no further interval cytoreductive therapy is planned prior to disease progression - Synchronous primary endometrial carcinoma or a past history of primary endometrial carcinoma allowed provided the following criteria are met: - Disease ≤ stage IB - No more than superficial myometrial invasion - No lymphovascular invasion - Not poorly differentiated (i.e., no grade 3, papillary serous, or clear cell disease) - Measurable or nonmeasurable disease - No ovarian nonepithelial cancer, including malignant mixed Müllerian tumors - No borderline tumors (e.g., tumors of low malignant potential) - No history or clinical suspicion of brain metastases or spinal cord compression - CT scan or MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases - Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy > 12 weeks - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL (can be post-transfusion) - INR ≤ 1.5 - APTT ≤ 1.5 times upper limit of normal (ULN) - Bilirubin ≤ 1.5 times ULN - ALT and AST ≤ 2.5 times ULN - Creatinine ≤ 2.0 mg/dL - Proteinuria ≤ 1+ by urine dipstick OR ≤ 1 g by 24-hour urine collection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for ≥ 6 weeks after completion of study therapy - No significant traumatic injury within the past 4 weeks - No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months - No other malignancies within the past 5 years except for adequately treated carcinoma in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial carcinoma - No pre-existing sensory or motor neuropathy ≥ grade 2 - No history or evidence of CNS disease (e.g., uncontrolled seizures) by neurological examination unless adequately treated with standard medical therapy - No history or evidence of thrombotic or hemorrhagic disorders - No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite antihypertensive therapy) - No known hypersensitivity to bevacizumab and its excipients, chemotherapy, or Cremophor EL - No nonhealing wound, ulcer, or bone fracture - Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations - No clinically significant cardiovascular disease, including any of the following: - Myocardial infarction or unstable angina within the past 6 months - New York Heart Association class II-IV congestive heart failure - Poorly controlled cardiac arrhythmia despite medication - Rate-controlled atrial fibrillation allowed - Peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision) - No evidence of other disease or condition, metabolic dysfunction, physical examination findings, or laboratory findings that would contraindicate the use of an investigational drug or put the patient at high-risk for treatment-related complications PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 4 weeks since other prior surgery or open biopsy - No prior systemic therapy for ovarian cancer (e.g., chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy) - Prior adjuvant chemotherapy allowed for other malignancies (e.g., breast or colorectal carcinoma) if malignancy was diagnosed over 5 years ago with no evidence of subsequent recurrence - No prior mouse CA 125 antibody - No prior radiotherapy to the abdomen or pelvis - More than 10 days since prior and no concurrent chronic use of acetylsalicylic acid (> 325 mg/day) - Low-dose (< 325 mg/day) acetylsalicylic acid allowed - More than 10 days since prior and no concurrent full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes - Use of therapy for line patency allowed provided INR < 1.5 - More than 30 days since prior and no other concurrent investigational agent or participation in another clinical trial - No other concurrent systemic antitumor agents - No concurrent surgery - No concurrent maintenance chemotherapy or intraperitoneal chemotherapy (including cytotoxic chemotherapy) ; PRIMARY OUTCOME: Progression-free survival; SECONDARY OUTCOME 1: Duration of overall survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/pemetrexed; BRIEF: This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen. ; DRUG USED: Talabostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Fibroblast Activation Protein (FAP); THERAPY: Combination; LEAD SPONSOR: Point Therapeutics; CRITERIA: Inclusion Criteria: - Men or women age ≥18 years - Histologically or cytologically confirmed NSCLC (Recurrent, locally advanced or metastatic, inoperable NSCLC [Stage IIIB/IV]. Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion.) - Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC - Measurable disease on computerized tomography (CT) scan - ECOG Performance Status of 0 or 1 - Expected survival ≥12 weeks - Provide written informed consent Exclusion Criteria: - More than 2 prior chemotherapy regimens - Progression of disease on prior pemetrexed treatment - Brain metastases (exception: patients who had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month) - Serum creatinine ≥2.0mg/dL or creatinine clearance <45mL/min - Absolute neutrophil count <1500/μL or platelets <100,000/μL - Any malignancy within 5 years immediately prior to the first dose of study medication (exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix) - Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol - Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment. - Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception during treatment. ; 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 - vs. Glimepiride; BRIEF: The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). ; DRUG USED: Fasiglifam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GPR40 (FFAR1, free fatty acid receptor 1); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participants legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. The participant is male or female and 18 years of age or older with a historical diagnosis of T2DM. 4. The participant meets one of the following criteria: 1. The participant has an HbA1c level ≥7.0 and <10.0%, and has been on a stable daily dose of ≥1500 mg (or documented MTD) of metformin for at least 2 months prior to Screening. This participant will immediately enter the Placebo Run-in Period, or; 2. The participant has an HbA1c level ≥ 7.5 and <10.5%, and has been on a stable daily dose of <1500 mg of metformin without documented MTD for at least 2 months prior to Screening. After completing the Screening Visit, this participant will have their metformin dose immediately increased to ≥1500 mg (or MTD) for an 8-week Titration Period. Following this 8-week period, the participant must qualify for entry into the Placebo Run-in Period by completing the Week -3 procedures and having an HbA1c concentration ≥7.0 and <10.0%. 5. The participant has had no treatment with antidiabetic agents other than metformin within 2 months prior to Screening (Exception: if a participant has received other antidiabetic therapy for ≤7 days within the 2 months prior to Screening). 6. The participant has a body mass index (BMI) of ≤45 kg/m2 at Screening. 7. Participants regularly using other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator. 8. The participant is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete participant diaries. Additional Inclusion Criteria Prior to Randomization 1. The participant has an HbA1c concentration ≥7.0% and <10.0%, and a FPG ≤270 mg/dL (15.0 mmol/L) at the Week -1 Visit. (If the subject does not qualify for randomization based on these criteria, the assessment may be repeated weekly, for a maximum of 2 additional weeks). 2. The participants compliance with the single-blind study medication during the Placebo Run-in Period is at least 75% and does not exceed 125% based on tablet/capsule counts performed by the study staff. 3. A female participant of childbearing potential must have a negative urine hCG pregnancy test at Baseline (Day 1) prior to Randomization and prior to administration of the first dose of double-blind study medication. Exclusion Criteria: 1. The participant has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening. 2. The participant has been randomized into a previous TAK-875 study 3. The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress. 4. The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study. 5. The participant has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening. 6. The participant has a systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement). 7. The participant has history of cancer that has been in remission for <5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed. 8. The participant has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x upper limit of normal (ULN) at Screening. 9. The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilberts Syndrome the participant will be allowed with an elevated bilirubin level per the investigators discretion. 10. The participant has a serum creatinine ≥1.5 mg/dL(males) and ≥1.4 mg/dL(females) and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at Screening. 11. The participant has uncontrolled thyroid disease. 12. The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening. 13. The participant has had gastric banding, or gastric bypass surgery within one year prior to Screening. 14. The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). 15. The participant had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within 3 months prior to or at Screening. 16. The participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875, metformin, or glimepiride. 17. The participant has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening. 18. The participant received excluded medications prior to Screening or is expected to receive excluded medication. 19. If female, the participant is pregnant (confirmed by laboratory testing, i.e., serum/urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. 20. The participant is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available. 21. The participant has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the participant according to the protocol. Additional Exclusion Criteria Prior to Randomization 1. The participant has received excluded medications listed in the protocol during the Placebo Run-in Period (topical and inhaled corticosteroids are allowed). 2. The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Baseline (Day 1) (If the subject meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement). 3. The participant has a serum creatinine ≥1.5 mg/dL(≥133µmol/L) [males] and ≥1.4 mg/dL (≥124 µmol/L) [females] and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at Visit 3 (Schedule B subjects only). ; PRIMARY OUTCOME: Change From Baseline in HbA1c at Weeks 78 and 104; SECONDARY OUTCOME 1: Percentage of Participants With Hypoglycemia[/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 - MATRIX-1; BRIEF: This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy (tension-free technique). Patients will assess their postoperative pain intensity (PI) using an 11-point numerical rating scale (NRS) from 0 hour through 72 hours postoperatively. The expected maximum study duration for each patient will be up to 60 days, including a maximum 30-day screening period, the day of surgery and implantation, and a 30-day post implantation period including treatment and follow-up. ; DRUG USED: XaraColl; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Innocoll; CRITERIA: Inclusion Criteria: - Has a planned (non-emergent) unilateral inguinal hernioplasty (open laparotomy, tension-free technique) to be performed according to standard surgical technique under general anesthesia. Repair of multiple hernias through a single incision is permitted provided only a single mesh will be used. - If female, is nonpregnant and nonlactating. - If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing 1 of the protocol specified medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study: - Has the ability and willingness to comply with the study procedures and use of the eDiary. - Is willing to use only permitted medications throughout the study. - Is willing to use opioid analgesia. - Must be able to fluently speak and understand either English or Spanish and be able to provide meaningful written informed consent for the study. Exclusion Criteria: - Has a known hypersensitivity to amide local anesthetics, morphine, acetaminophen or bovine products. - Is scheduled for bilateral inguinal hernioplasty or other significant concurrent surgical procedures per investigator discretion. - Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively. - Has used any analgesic other than acetaminophen within 24 hours of surgery. Acetaminophen may be used on the day of surgery but is subject to preoperative restrictions for oral intake. - Has used aspirin or aspirin-containing products within 7 days of surgery. Aspirin at a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days before Screening. - Has used systemic steroids, anticonvulsants, antiepileptics, antidepressants for the management of chronic pain, or monoamine oxidase inhibitors on a regular basis within 10 days of surgery. - Has used any opioid analgesic for an extended daily basis (30 - 60 mg oral morphine equivalent per day for 3 or more days a week) within 4 weeks before surgery. Patients who, in the investigators opinion, may be developing opioid tolerance are also excluded. - Has any chronic painful condition (eg, fibromyalgia) or routinely uses pain medication other than acetaminophen (including nonsteroidal anti-inflammatory drugs [NSAIDs]) that, in the opinion of the investigator, may confound the assessment of pain associated with the hernioplasty. - Has a physical or mental condition that, in the opinion of the investigator, may confound the assessment of postoperative pain after hernioplasty. - Shows evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications. - Has a urine drug screen that tests positive for drugs of abuse or misuse, including cannabinoids. - Has liver function test results greater than 3x the upper limit of normal or a history of cirrhosis. - Has any clinically significant unstable cardiac disease (eg, uncontrolled hypertension, clinically significant arrhythmia at baseline, or an implantable cardioverter-defibrillator [ICD]) - Has any clinically significant unstable neurological, immunological, renal, or hematological disease (eg, uncontrolled diabetes or significantly abnormal laboratory findings), or any other condition that, in the opinion of the investigator, could compromise the patients welfare, ability to communicate with the study staff or otherwise contraindicate study participation. - Has an open workmans compensation claim. - Has participated in a clinical trial (investigational or marketed product) within 30 days of surgery. ; PRIMARY OUTCOME: SPI24; SECONDARY OUTCOME 1: TOpA24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Propofol (EU); BRIEF: A phase III confirmatory trial evaluating the efficacy and safety of remimazolam (CNS7056) compared to propofol for intravenous anesthesia during elective surgery in ASA Class III/IV patients. ; DRUG USED: ByFavo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Paion UK Ltd.; CRITERIA: Inclusion criteria - Male or female ASA III/IV patients at least 18 years old, scheduled for an elective surgical procedure of a minimum duration of approximately 90 minutes under general anesthesia (GA) and planned to be extubated immediately post-operatively. - Total intravenous GA with the requirement for mechanical ventilation via endotracheal tube and necessary invasive blood pressure (BP) monitoring either due to severity of illness, severity of concomitant diseases, type of surgery or decisions of the anesthesia staff. - Patients scheduled to stay in the hospital long enough after the surgical procedure to perform all trial follow-up procedures (~1 day) - For female patients of childbearing potential: Negative result of a pregnancy test taken shortly before the start of the administration of the IMP as well as consent to use highly effective birth control from the last menstrual cycle prior to the start of the IMP until the end of the trial follow-up procedures. Highly effective methods of birth control include: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal and transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable and implantable - Intrauterine device (IUD) - Intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomised partner (provided that the partner is the sole sexual partner of the female patient of childbearing potential and that the vasectomised partner has received medical assessment of the surgical success) - Sexual abstinence (this method is not acceptable in Switzerland) Women who had their last menstruation at least two years ago or who underwent surgical interventions (surgical birth control, bilateral oophorectomy, hysterectomy, etc.) are regarded as having no childbearing potential Exclusion criteria - Patients scheduled for spinal anesthesia, epidural anesthesia (central neuraxial anesthesia) or regional anesthesia. The placement of a peridural catheter with a test dose application of a local anesthetic drug (up to 5 mL) to verify correct positioning to achieve post-operative analgesia and the regional administration of local anesthetic for post-operative analgesia after wound closure is accepted. - Patients undergoing transplant surgery, cardiac surgery, or intracranial neurosurgery, patients which have to be in prone position for surgery, emergency surgery, or any surgical procedure with the need for or scheduled for post-operative ventilator support. - Patients undergoing surgical procedures that require keeping the BP at a high level, e.g. surgical procedures in beach chair position - Patients with severe hypertension, i.e., one baseline result of systolic BP 200 mmHg or more and / or diastolic BP of 120 mmHg or more. Baseline is defined as the time after signature of the informed consent form (ICF) and before arrival in the operating room (OR) suite. - Patients with total bilirubin of ≥3.0 mg/dL or ≥3 times increase in aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) than the institutional reference range in laboratory tests, or any other laboratory results that make the patient unsuitable for the trial. All laboratory tests relevant for subjects enrolment must be performed within 7 days prior to start of IMP* * If the screening samples for the central laboratory were taken earlier than within the last 7 days prior to start of IMP, the lab parameters relevant for subjects enrolment are to be determined in a local laboratory within 7 days prior to start of IMP. If results from samples taken within 7 days prior to the start of the IMP/the surgery from a local laboratory are available, these can be used. If no results from the last 7 days prior to the start of the IMP/the surgery are available, samples need to be taken for the purpose of this trial and to be analysed in a local laboratory. - Patients with end stage renal disease (ESRD) requiring scheduled dialysis - Patients with known anaphylactic reactions to benzodiazepines, propofol, opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), dextran, neuromuscular blocking agents, flumazenil, naloxone, or other anesthetic agents, or a medical condition such that these agents are contraindicated (according to local label) - Presence of acute alcoholic or illicit drug intoxication, shock or coma state - Known current dependency from central nervous system depressant drugs or alcohol - Patients with gastroparesis or delayed gastric emptying, gastric reflux or any other increased risk for gastric aspiration - Patients with an anticipated (small mouth opening, impaired neck movement, goitre, head and neck tumours or any other anatomical reason) or known airway difficulties or with known difficulties in airway maintenance or mask ventilation - Patients in whom Narcotrend (NCT) may not provide reliable results due to organic defect of the brain or forehead, or any neurologic disease interfering with the EEG monitoring - Patients on treatment with valproate - Any pregnant or breast-feeding patient - Patients who participated in any clinical trial within 30 days or 5 times the half-life of the drug under investigation, whichever is longer, prior to the beginning of administration of the IMP. Exception: Non-interventional trials as defined in the European Clinical Trials Directive 2001/20/EC: A trial where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods should be used for the analysis of the collected data. - Any patient judged to lack the ability to give informed consent or perform the trial assessments (e.g., due to dementia) - Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason ; PRIMARY OUTCOME: Percentage (%) of time of Narcotrend Index (NCI) values ≤ 60 during maintenance phase of general anesthesia (defined as time between the first skin incision and the completion of the last skin suture); SECONDARY OUTCOME 1: Number of events of critical decrease(s) in mean arterial blood pressure (MAP)[/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 - ODYSSEY OPTIONS I (Added-on to Atorvastatin); BRIEF: This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH). ; DRUG USED: Praluent; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR 2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin. Exclusion Criteria: 1. LDL-C greater than 250 mg/dL 2. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD 3. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors 4. TG greater than 400 mg/dL 5. Homozygous FH (clinically or previous genotyping) 6. Currently taking a statin that is not atorvastatin 7. Currently taking Ezetimibe (EZE) 8. Not on a stable dose of allowable lipid modifying treatments (LMT) (The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patients potential participation in this clinical trial). ; PRIMARY OUTCOME: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis; SECONDARY OUTCOME 1: Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis[/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 - RESONATE; BRIEF: The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: - ECOG performance status of 0-1. - Diagnosis of CLL or SLL that meets IWCLL 2008 criteria. - Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment. - Must have received at least one prior therapy for CLL/SLL. - Considered not appropriate for treatment or retreatment with purine analog based therapy. - Measurable nodal disease by CT. - Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study. Exclusion Criteria: - Known CNS lymphoma or leukemia. - No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug. - Any history of Richters transformation or prolymphocytic leukemia. - Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP). - Prior exposure to ofatumumab or to ibrutinib. - Prior autologous transplant within 6 months prior to first dose of study drug. - Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug. - History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years. - Serologic status reflecting active hepatitis B or C infection. - Unable to swallow capsules or disease significantly affecting gastrointestinal function. - Uncontrolled active systemic fungal, bacterial, viral, or other infection. - History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug. - Requires anticoagulation with warfarin. ; PRIMARY OUTCOME: PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013; SECONDARY OUTCOME 1: Overall Response Rate (ORR) by Independent Review Committee (IRC)[/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 - TA-7284-05 (Japan); BRIEF: The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration. ; DRUG USED: Invokana; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Men or women age ≥20 years old - Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period - HbA1c of ≥7.0% and ≤10.0% Exclusion Criteria: - Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus - Past or current history of severe diabetic complications - Fasting plasma glucose > 270 mg/dL before treatment start - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Patients requiring insulin therapy ; PRIMARY OUTCOME: Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value); SECONDARY OUTCOME 1: Change in Fasting Plasma Glucose[/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 - Generation S2; BRIEF: The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid. ; DRUG USED: CNP520; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Beta-secretase (BACE); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid. - Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential - Cognitively unimpaired as evaluated by memory tests performed at screening. - Participants willingness to have a study partner. - Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging). Exclusion Criteria: - Any disability that could have prevented the participants from completing all study requirements. - - Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments. - Advanced, severe progressive or unstable disease that could have interfered with the safety, tolerability and study assessments, or put the participant at special risk. - History of malignancy of any organ system, treated or untreated, within the past 60 months. - Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine). - Contraindication or intolerance to MRI. - Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring. - Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years. - A positive drug screen at Screening, if, in the Investigators opinion, was is due to drug abuse. - Significantly abnormal laboratory results at Screening, not as a result of a temporary condition. - Current clinically significant ECG findings. - Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year. ; PRIMARY OUTCOME: Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimers Disease (AD)); SECONDARY OUTCOME 1: Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - SNR-04; BRIEF: The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a multi-center, prospective, randomized, placebo-controlled, in which adult subjects with schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a 4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension part. ; DRUG USED: NaBen; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: D-amino-acid oxidase (DAAO, DAO); THERAPY: Monotherapy; LEAD SPONSOR: SyneuRx International (Taiwan) Corp; CRITERIA: Inclusion Criteria: 1. Male/female subjects between 18 and 45 years of age 2. If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) double-barrier contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL 3. Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements 4. Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subjects history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0) 5. The subject is outpatient with no hospitalization for worsening of schizophrenia within 3 months of the screening.If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study 6. The subjects schizophrenia condition is clinically stable with residual symptoms. Residual symptoms will be defined as a total score of ≤110 and ≥ 60 of PANSS per Visit 1 evaluations 7. An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to screening into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole and Paliperidone; six (6) months for Olanzapine pamoate monohydrate; and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics) 8. In good general physical health and without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above twice the upper limit of normal. 9. BMI between 17 and 35 inclusive 10. Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP) 11. The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker or nurse) as determined by the Investigator and per the local regulations. The identified caregiver should be considered reliable by the Investigator and per the local regulations in providing support to the subject to help ensure compliance with study treatment, study visits and protocol procedures who preferably is also able to provide input helpful for completing study rating scales 12. The subject must not be a danger to self or others per the Investigators judgment Exclusion Criteria: 1. Meets the DSM-IV or V criteria at screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation 2. Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose 3. Subjects who have been previously treated with or are receiving clozapine 4. Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to screening 5. Initiation or dose change of benzodiazepines or sleep medications due to worsening of schizophrenia symptoms or medication side effects, or any other psychotropic medications within 4 weeks prior to screening 6. The subject has previously received NaBen® 7. History of epilepsy, major head trauma, or any neurological illness other than Tourettes syndrome which might impair the subjects cognition or psychiatric functioning per the investigators judgment 8. History of allergic reaction to sodium benzoate 9. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study 10. Any significant gastrointestinal disorders that, in the opinion of the investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate 11. Any movement disorders with a total score higher than 6 on SAS scale, or more than 2 on any items of the AIMS scale 12. Current substance abuse, or history of meeting criteria for moderate or severe substance abuse (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to screening 13. Female subjects who are pregnant (as confirmed by urine pregnancy test performed at Screening Visit) or are breast feeding 14. History of cancer not in remission for the last 3 years except for basal cell carcinoma and squamous cell carcinoma 15. Participation in a clinical trial within 3 months prior to screening or more than two clinical trials within 12 months 16. Electroconvulsive Therapy within 6 months prior to screening 17. The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to screening 18. The subjects anti-EPS medications dose or regimen has changed within 2 weeks prior to screening ; PRIMARY OUTCOME: Positive and Negative Syndrome Scale (PANSS); SECONDARY OUTCOME 1: Positive and Negative Syndrome Scale (PANSS)[/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 - XSGP-304; BRIEF: This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL (3.89 mmol/L) or an increase of > 20 mg/dL (>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug. ; DRUG USED: Gvoke RTU Micro; DRUG CLASS: Non-NME; INDICATION: Hyperinsulinemia/Hypoglycemia; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Xeris Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Males and non-pregnant females diagnosed with type 1 diabetes (T1D) for at least 24 months. 2. Current usage of daily insulin treatment that includes having an assigned correction factor for managing hyperglycemia. 3. Age 18 to 75 years, inclusive. 4. Random serum C-peptide concentration < 0.6 ng/mL. 5. Willingness to follow all study procedures, including attending all clinic visits. 6. Subject has provided informed consent as evidenced by a signed and dated informed consent form (ICF) completed before any trial-related activities occur. Exclusion Criteria: 1. Pregnancy 2. Glycated hemoglobin (HbA1c) > 10% at Screening. 3. Body mass index (BMI) > 40 kg/m2. 4. Renal insufficiency (serum creatinine greater than 3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy. 5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 3 times the upper limit of normal. 6. Hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL. 7. Hematocrit < 30%. 8. Blood pressure (BP) readings at Screening where systolic blood pressure (SBP) < 90 or > 150 mm Hg, and diastolic blood pressure (DBP) < 50 or > 100 mm Hg. 9. Clinically significant electrocardiogram (ECG) abnormalities. 10. Use of total insulin dose per day > 2 U/kg. 11. Inadequate venous access. 12. Congestive heart failure, New York Heart Association (NYHA) class III or IV. 13. History of myocardial infarction, unstable angina, or revascularization within the past 6 months. 14. History of a cerebrovascular accident in the past 6 months or with major neurological deficits. 15. Active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or malignant melanoma will be exclusionary. 16. Major surgical operation within 30 days prior to Screening. 17. Current seizure disorder (other than with suspect or documented hypoglycemia). 18. Current bleeding disorder, treatment with warfarin, or platelet count below 50 × 109 per liter. 19. History of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia type 2 (MEN 2), neurofibromatosis, or Von Hippel-Lindau disease). 20. History of insulinoma. 21. History of allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products or to any of the excipients (DMSO and trehalose) in the investigational formulation. 22. History of glycogen storage disease. 23. Subject tests positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection (hepatitis B surface antigen positive [HBsAg+]) at Screening. 24. Active substance other than tetrahydrocannabinol (THC) or alcohol abuse (more than 21 drinks per week for male subjects or 14 drinks per week for female subject). 25. Administration of glucagon within 7 days of Screening. 26. Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before Screening for the current study and during participation in the current study. 27. Any other reason the Investigator deems exclusionary. ; PRIMARY OUTCOME: Severe Hypoglycemia Rescue; SECONDARY OUTCOME 1: Plasma Glucose Response 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 - B5201003 (Extension Study); BRIEF: This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). ; DRUG USED: Rivipansel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Selectins; THERAPY: Monotherapy; LEAD SPONSOR: GlycoMimetics Incorporated; CRITERIA: Inclusion Criteria: - Completion of Study B5201002. - Documented diagnosis of SCD. - At least 6 years of age. - Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. - Diagnosis of VOC necessitating IV opioids and admission to the hospital. - Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization. Exclusion Criteria: - Non-compliance with study procedures in the double blind study (B5201002). - Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results. - Clinically significant deterioration in renal function in Study B5201002. - Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception. - Active use of illicit drugs and/or alcohol dependence. ; PRIMARY OUTCOME: Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study.; SECONDARY OUTCOME 1: Subject re hospitalization[/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 - SMART-3; BRIEF: The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy. ; DRUG USED: Duavee; DRUG CLASS: Non-NME; INDICATION: Vaginal Atrophy; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Wyeth is now a wholly owned subsidiary of Pfizer; CRITERIA: Inclusion Criteria: - Generally healthy, postmenopausal women, aged 40 to 65 years - Intact uterus - At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome Exclusion Criteria: - Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia - Thrombophlebitis, thrombosis or thromboembolic disorders - Neuro-ocular disease ; PRIMARY OUTCOME: Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.; SECONDARY OUTCOME 1: Vaginal pH at screening, and weeks 4 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 - PHOCUS; BRIEF: This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy. ; DRUG USED: Pexa-Vec; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy, Thymidine Kinase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: SillaJen, Inc.; CRITERIA: Inclusion Criteria: - Histological/cytological diagnosis of primary HCC - Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines) - At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound) - Child-Pugh Class A - Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale - Adequate hematological, hepatic, and renal function: - Additional inclusion criteria exist Exclusion Criteria: - Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma - Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months - Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation - History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening - Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion - Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids - Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment - History of severe eczema (as determined by the Investigator) requiring medical treatment - Additional exclusion criteria exist ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Prior Gilead-Sponsored HCV Treatment (12 weeks); BRIEF: The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens. ; DRUG USED: Vosevi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides), HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUN 1094 - w/Paclitaxel (HER2-); BRIEF: To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer ; DRUG USED: Sutent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Diagnosis of advanced breast cancer. - Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease. - ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. Exclusion Criteria: - No prior treatment with cytotoxics in the advanced disease setting. - HER2/neu positive disease unless trastuzumab was previously received or is contraindicated. - Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment. ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Number of Participants With Objective Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TK008; BRIEF: The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT ; DRUG USED: Zalmoxis; DRUG CLASS: Biologic; INDICATION: Bone Marrow and Stem Cell Transplant - Graft vs. Host Disease (GVHD) Prophylaxis; TARGET: Thymidine Kinase; THERAPY: Monotherapy; LEAD SPONSOR: AGC Biologics S.p.A.; CRITERIA: Inclusion Criteria: - Age ≥ 18 years - Any of the following conditions: 1. AML and ALL in 1st complete remission (CR1) 2. AML and ALL in 2nd or subsequent CR 3. secondary AML in CR 4. AML and ALL in 1st or 2nd relapse or primary refractory - Family donor with patient-donor number of HLA mismatches ≥ 2 (full haploidentical), or family donors sharing one HLA-haplotype with the patient - Stable clinical conditions and life expectancy > 3 months - PS ECOG < 2 - Serum creatinine < 1.5 x ULN - Bilirubin < 1.5 x ULN; transaminases < 3 x ULN - Left ventricular ejection fraction > 45% - QTc interval < 450 ms - DLCO > 50% - Patients, or legal guardians, and donors must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects Exclusion Criteria: - Patients with life-threatening condition or complication other than their basic condition - Contraindication to haploidentical HCT as defined by the Investigator - Patients with active CNS disease - Pregnant or lactation. Exclusion criteria for HSV-Tk infusion: - Infections requiring administration of ganciclovir or valganciclovir at the time of infusion - GvHD requiring systemic immunosuppressive therapy - Ongoing systemic immunosuppressive therapy after haploidentical HCT - Administration of G-CSF after haploidentical HCT HSV-Tk cells can be administered after an adequate patient wash-out period (24 hours) ; PRIMARY OUTCOME: Disease-free Survival (DFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 024 and 025 ext.; BRIEF: This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks. ; DRUG USED: Encenicline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: FORUM Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025 - Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures - Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025 - No clinically significant change in the judgment of the investigator in the subjects medical status during study EVP-6124-024 or EVP-6124-025 - In the judgment of the investigator, extension treatment is in the best interest of the subject - Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method]) - Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible Exclusion Criteria: - Significant risk of suicidal or violent behavior in the judgment of the investigator - Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation - Any condition that would make the subject in the judgment of the investigator unsuitable for the study - Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study ; PRIMARY OUTCOME: Safety of 2 fixed doses of EVP-6124 for up to 52 weeks in subjects with Alzheimers disease who complete study EVP-6124-024 or EVP-6124-025; SECONDARY OUTCOME 1: Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)[/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 - ZS-01-306 (China); BRIEF: The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III. ; DRUG USED: Neucardin; DRUG CLASS: Biologic; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Zensun Sci. & Tech. Co., Ltd.; CRITERIA: Inclusion Criteria: - 1. Age between 18 and 75, gender balance (no more than 960 subjects of either gender in total 1600 subjects). - 2. Left ventricular ejection fraction (LVEF)≤40% (ECHO). - 3. Subjects with chronic heart failure (NYHA class II OR III ). - 4. 600 pg/ml ≤NT-proBNP≤1700 pg/ml ( by Roche assay Kit in central lab). - 5. Diagnosed as chronic systolic heart failure (history, symptoms, signs), and in stable condition in the last one month. - 6. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for one month before randomization. - 7. Capable of signing the informed consent form. Exclusion Criteria: - 1. New chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months. - 2. NYHA functional class I OR IV. - 3. NT-proBNP < 600 pg/ml OR NT-proBNP>1700 pg/ml (by Roche assay Kit in central lab). - 4. Patients with hypertrophic cardiomyopathy, rheumatic heart disease, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension. - 5. Ischemic heart failure without recanalization or with recanalization in recent six months. - 6. Acute MI in the last 3 months. - 7. Unstable angina. - 8. Patients with acute pulmonary edema or acute hemodynamic disorder. - 9. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month (symptoms and signs suggest worsening chronic heart failure and may require intravenous drug therapy). - 10. Patients with right heart failure caused by pulmonary disease. - 11. Patients diagnosed with pericardial effusion (>50 ml) or pleural effusion(>200 ml), or evidenced by Echocardiogram. - 12. Cardiac surgery or cerebrovascular accident within recent six months. - 13. Preparing for heart transplantation or CRT, or has received CRT. - 14. Serious ventricular arrhythmia (sustained ventricular tachycardia or frequent paroxysmal ventricular tachycardia). - 15.Diagnosis of perinatal or chemotherapy-induced cardiomyopathy in last 12 months. - 16. Serious hepatic or renal dysfunction (bilirubin 1.5 times above the normal upper limit, AST or ALT 2 times above the normal upper limit, serum creatinine>2.0mg/dL, HBV or HCV positive). - 17. Serum potassium <3.2 mmol/L or >5.5 mmol/L. - 18. Systolic blood pressure <90mmHg or >160mmHg. - 19. Women of childbearing age who have a pregnancy plan within 2 years (women of childbearing age are defined as women who have a pregnancy physiology). - 20. Pregnant or lactating women. - 21. Patients who participated in any clinical trial in the recent three months. - 22. Subject with a life expectancy less than 6 months as assessed by the investigator. - 23. Serious nervous system diseases (Alzheimers disease, advanced Parkinsonism),lower limb defects, or deaf-mute. - 24. History of any malignancy or suffering from cancer, or biopsy proven pre-malignant condition (e.g., DICS or cervical atypia). - 25. Evidence (physical examination, chest X-ray (CXR), ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm that has an effect on heart function or the endocrine system, e.g., pheochromocytoma or hyperthyroidism (Thyroid nodules with normal thyroid function do not need to be excluded). - 26. As judged by the investigator that the subject cannot complete the study or adhere to the study requirements (due to the management reasons or others). ; PRIMARY OUTCOME: All-cause mortality; SECONDARY OUTCOME 1: Mortality caused by cardiovascular events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INS-13-021; BRIEF: Participants will be selected from patients who have been scheduled at the site for treatment of chronic pain without sedation. They will receive either fentanyl sublingual spray or a matching placebo sublingual spray that delivers no medication. Participants may take pain killers at any time after the procedure for pain relief. They will be given a diary card, which they will take home. They will record the name of the medication taken, the time, and dosage. The study coordinator will call participants about 24 hours after the procedure to collect information from the diary card and follow up information about pain and side effects (adverse events) after they left the site. ; DRUG USED: Subsys; DRUG CLASS: Non-NME; INDICATION: Cancer Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: INSYS Therapeutics Inc; CRITERIA: Inclusion Criteria: - Has scheduled an interventional procedure for treatment of pain without sedation - Has cleared pre-operative assessment - Is able to read or understand informed consent form, and gives consent to participate in the study Exclusion Criteria: - Is taking any form of fentanyl - Has oral pathology that would prevent effective absorption of study medication - Was treated with an investigational drug within protocol-specified parameters - Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff, 2) the safety or well-being of the participants offspring (such as through pregnancy or breast-feeding), 3) the analysis of results ; PRIMARY OUTCOME: Pain scored on a scale from 0 to 10, where 0 = no pain and 10 = the most intense pain imaginable; SECONDARY OUTCOME 1: Sedation scored on a scale from 0 to 4, where 0 = awake/alert and 4 = unarousable[/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 - PROTECT-1; BRIEF: The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients. ; DRUG USED: Ziextenzo; DRUG CLASS: Biosimilar; INDICATION: Neutropenia / Leukopenia; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Sandoz; CRITERIA: Inclusion Criteria: - histologically proven breast cancer - eligible for six cycles of neoadjuvant or adjuvant chemotherapy Exclusion Criteria: - concurrent or prior chemotherapy for breast cancer - concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy - concurrent prophylactic antibiotics - previous therapy with any G-CSF (granulocyte-colony stimulating factor) product Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy; SECONDARY OUTCOME 1: Incidence of Febrile Neutropenia (FN)[/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 - COMPARE (HER2+); BRIEF: The purpose of the study is to to demonstrate equivalence ; DRUG USED: Herzuma; DRUG CLASS: Biosimilar; INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: Celltrion; CRITERIA: Inclusion Criteria: - Are females - Have a Her 2 over-expression - Have ECOG 0 or 1 Exclusion Criteria: - Current clinical or radiographic evidence CNS metastases - Current Known infection - Pregnant or nursing mother ; PRIMARY OUTCOME: To Compare Efficacy; SECONDARY OUTCOME 1: efficacy and safety[/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 - Long-Term Pediatric; BRIEF: The primary purpose of the study is to assess long-term safety and tolerability of Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD). ; DRUG USED: Edivoxetine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: INCLUSION CRITERIA: -Participants must meet Diagnostic and Statistical Manual of Mental Disorders 4th Ed (DSM-IV) diagnostic criteria for ADHD (inattentive, hyperactive/impulsive, or combined subtypes) based on an interview by an experienced clinician and confirmed using the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present (SADS) and Lifetime Version (K-SADS-PL) at Visit 1 for new participants and in the parent trial for rollover participants. -Participants must have an ADHDRS-IV-Parent: Inv total score of at least 1.5 standard deviations above the age/gender norm at both screening/randomization. New participants must have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder- Severity (CGI-ADHD-S) score greater than or equal to 4 at both screening/randomization. - Participants of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Female participants of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test. - Participants must have laboratory results, showing no clinically significant abnormalities. - Parents/participants must have a degree of understanding sufficient to communicate suitably with the investigator/ study coordinator. - Participants must be of normal intelligence. - Participants/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits/all tests, including venipunctures and examinations required by the protocol. - Participants must be able to swallow tablets. EXCLUSION CRITERIA: - Participants who weigh less than 16 kg at screening/randomization. - Female participants who are pregnant/breastfeeding. - Participants who have previously withdrawn/discontinued early from this study or any other study investigating Edivoxetine. - Participants who have a history of Bipolar I/II disorder, psychosis, or pervasive developmental disorder. - Participants with a history of any seizure disorder or known electroencephalographic (EEG) abnormalities in the absence of seizures. - Participants who are at serious suicidal risk. - Participants with a history of severe allergies to more than 1 class of medications, or multiple adverse drug reactions, or known hypersensitivity to Edivoxetine. - Participants with a history of alcohol or drug abuse/dependence within the past 3 months of screening, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse/dependence. - Participants who screen positive for drugs of abuse cannot participate. - Participants who have a medical condition that would increase sympathetic nervous system activity markedly, or who are taking a medication on a daily basis that has sympathomimetic activity are excluded. - Participants with problems that would be exacerbated by increased norepinephrine tone including a history of cardiovascular disease, thyroid dysfunction, glaucoma, or urinary retention. - Participants who at any time during the study are likely to need psychotropic medications apart from the drugs under study. - Participants who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior to randomization. - Participants with current or past history of clinically significant hypertension. - Participants who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. - Participants whose family anticipates a move outside the geographic range of the investigative site during participation in the study or who plan extended travel inconsistent with the recommended visit intervals. - Participants who, in the opinion of the investigator, are unsuitable in any other way to participate in this study. ; PRIMARY OUTCOME: Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study; SECONDARY OUTCOME 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)[/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 - EMERALD; BRIEF: The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter [copies/mL]) HIV-1 infected participants. ; DRUG USED: Symtuza; DRUG CLASS: Non-NME; INDICATION: HIV / AIDS; TARGET: Cytochrome p450, DNA polymerase, HIV-1 protease (HIV PR), Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Janssen R&D Ireland; CRITERIA: Inclusion Criteria: - Currently being treated with a stable antiretroviral (ARV) regimen consisting of a boosted protease inhibitor (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) only, for at least 6 consecutive months preceding the Screening visit - On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) concentrations less than (<) 50 copies per milliliter (copies/mL) or HIV-1 RNA undetectable by a local HIV-1 RNA test between 12 and 2 months prior to the Screening visit and have HIV-1 RNA <50 copies/mL at the Screening visit - A single virologic elevation of greater than or equal to (>=) 50 copies/mL after previously reaching viral suppression between 12 and 2 months prior to Screening is acceptable, provided a subsequent test prior to Screening was <50 copies/mL - Absence of history of failure on DRV treatment and absence of DRV resistance-associated mutations (RAMs), if documented historical genotypes are available - Normal electrocardiogram (ECG) at Screening (or if abnormal, determined by the Investigator to be not clinically significant) Exclusion Criteria: - A new acquired immunodeficiency syndrome (AIDS) - defining condition diagnosed within the 30 days prior to Screening - Proven or suspected acute hepatitis within 30 days prior to study entry - Hepatitis C antibody positive; however, participants previously cured of hepatitis C virus (HCV) infection, with documented sustained virologic response, that is, undetectable HCV RNA 24 weeks after the last dose of HCV treatment, are allowed to participate - Hepatitis B surface antigen (HBsAg) positive - Participants with cirrhosis as diagnosed based on local practices ; PRIMARY OUTCOME: Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48; SECONDARY OUTCOME 1: Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 16830; BRIEF: The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D). ; DRUG USED: Lyumjev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification. - Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily. - Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs). - Participants must have a HbA1c ≥7.0% and ≤11.0%. - Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2). Exclusion Criteria: - Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults. - Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening. - Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. - Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening. ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)[/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 - PIONEER (1); BRIEF: The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus. ; DRUG USED: Pyridorin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: Receptor for Advanced Glycation End Products (RAGE) ; THERAPY: Monotherapy; LEAD SPONSOR: NephroGenex, Inc.; CRITERIA: Inclusion Criteria: Patients meeting all of the following criteria will be eligible to participate in the study: 1. Patients who have given voluntary written informed consent to participate in this study prior to conducting Screening (Visit 1) procedures; 2. Patients 18 years of age or older with a diagnosis of type 2 diabetes; 3. Women of childbearing potential (WOCBP) who agree to use appropriate birth control (double-barrier methods, hormonal contraceptives, or intrauterine device) for the duration of the study (women of childbearing potential is defined as all women who are not surgically sterile or are not at least 1 year post menopausal). All women of childbearing potential must have a negative serum pregnancy test at Visit 1; 4. All men (unless surgically sterile, as defined below) who have sexual intercourse with a WOCBP must agree and commit to use a highly effective method of contraception for the duration of the study (defined as the time of the signing of the informed consent form through the conclusion of patient participation). Highly effective methods of contraception include: i. Male subjects agreeing that they and their female spouse/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential. ii. To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks before Visit 1; 5. At Visit 1, patients must have a history of overt diabetic nephropathy, as defined by the following: - A SCr measurement ≥1.3 (≥1.25)mg/dL (111 µmol/L) for females or ≥1.5 (≥1.45) mg/dL (128 µmol/L) for males; - At Visit 1 or 1.1 24-hour urine collection PCR >1200 mg/g (130 mg/µmol) and, if applicable for PS phase, at Visit 1S or 1.1S a 24-urine collection PCR >600 mg/g (67 mg/µmol) - For eligibility determination, laboratory reported values of PCR will be rounded up to 2 significant digits (e.g. ≥1150 mg/g to 1200 mg/g; ≥595 mg/g to 600 mg/g), 6. Patients must have a SCr measurement <3.0 mg/dL (265 µmol/L); 7. Patients must have an eGFR of ≥20 mL/min/1.73m2, using the 4-variable Modification of Diet in Renal Disease equation in which eGFR = 175 x (SCr(mg/dL))-1.154 x (Age(years))-0.203 x (0.742 if female) x (1.212 if African American); 8. Patient must have a second screening SCr measurement at Visit 1.1 or 1.1S taken 1 week (± 2 days) after screening (Visit 1 or 1S). The value of the second screening SCr measurement must be <3.0 mg/dL (265 µmol/L) for both genders and within 25% of the first screening measurement; 9. Patients must be taking a single ACE-I or ARB at a constant dose for at least 26 weeks prior to Visit 1, where the dose of the ACE-I or the ARB is considered appropriate for that patient (can be zero to max dose approved by the FDA) and it is anticipated that the same dose can and will be maintained throughout the course of the study; 10. Patients taking any blood pressure medications in addition to an ACE-I or ARB, including diuretics, must be on a stable dose for 13 weeks prior to Visit 1 (and Visit 1S if applicable) with a seated blood pressure of ≤ 150/90 mmHg; 11. Patients not taking any blood pressure medications, including diuretics, other than an ACE-I or ARB must have a seated blood pressure ≤ 150/90 mmHg at Visit 1 (and Visit 1S if applicable) and a seated blood pressure considered appropriate for the patient and one that can be sustained throughout the study. Exclusion Criteria: Patients are excluded from participation in the study if any of the following criteria apply 1. Patients with type 1 diabetes or MODY (a monogenic form of diabetes); 2. Patients with a diagnosis of chronic kidney disease other than diabetic renal disease with or without hypertensive renal disease 3. Patients receiving a renin inhibitor or an aldosterone antagonist or a combination of an ACE-I and an ARB within 26 weeks of Visit 1 4. Patients with a history of solid organ transplantation 5. Patients with a history of myocardial infarction, coronary re-vascularization procedures (including percutaneous transluminal coronary angioplasty), stroke, or transient ischemic attack within 30 days prior to Visit 1 6. Patients with a diagnosis of New York Heart Association Class III or IV congestive heart failure at any time 7. Patients with a history of being treated for neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to Visit 1 8. Patients with any history of dialysis within 2 years prior to Visit 1 9. Patients in whom dialysis or renal transplantation is anticipated by their physician within 1 year after Visit 1 10. Patients who used SCr-altering drugs within 30 days prior to Visit 1 11. Patients who require systemic immunosuppression therapy for >2 weeks (except for inhalant steroids) 12. Patients with clinically significant liver disease or transaminase (alanine aminotransferase and aspartate aminotransferase) levels >2.5 × the upper limit of normal (ULN) measured at Visit 1.1 or Visit 1.1S 13. Patients with bilirubin levels >1.5 × ULN measured at Visit 1.1 or Visit 1.1S 14. Patients with a history of allergic or other adverse response to vitamin B preparations 15. Patients who require >50 mg of vitamin B6 daily 16. Patients who have an active history of dysphagia or swallowing disorders 17. Patients with a history of hypersensitivity to Pyridorin or any of the excipients (non-active ingredients) in the Pyridorin formulation 18. Patients who have taken pyridoxamine or any other investigational drug within 30 days prior to Visit 1, or have participated in a previous Pyridorin study or another interventional clinical study within 30 days prior to Visit 1 19. Patients with an active history of drug or alcohol abuse 20. Patients unlikely to comply with the study protocol (eg, an inability and unwillingness to participate in adequate training, an uncooperative attitude, inability to return for follow-up visits, or unlikelihood of completing the study) 21. Women who are lactating, pregnant, or intend to become pregnant during the course of the study 22. Persons employed with the sponsor, CRO, or one of the study investigative sites must be excluded from participation, even if they are not involved directly in the conduct of the study. ; PRIMARY OUTCOME: Time to composite endpoint of >=50% SCr increase from baseline or ESRD; SECONDARY OUTCOME 1: Time to the composite endpoint >=100% SCr increase or ESRD[/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 - Cataplexy; BRIEF: This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258. ; DRUG USED: Xywav; DRUG CLASS: Non-NME; INDICATION: Narcolepsy; TARGET: GABA Receptors, GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female subjects between 18 and 70 years of age, inclusive. 2. Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or DSM-5 criteria, and currently untreated or treated with or without anticataplectics. 3. If applicable, treated with a stimulant or alerting agent at unchanged doses for at least 2 months prior to dosing or not treated with a stimulant or alerting agent. 4. Willing and able to comply with the study design schedule and other requirements. 5. Willing and able to provide written informed consent. Exclusion Criteria: 1. Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion) 2. History or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or history or presence of another neurological disorder or surgical history that might affect the subjects safety and/or interfere with the conduct of the study in the opinion of the Investigator. 3. Treatment with any central nervous system sedating agents, including but not limited to benzodiazepines, nonbenzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, e.g. diclofenac, valproate, ibuprofen, within 2 weeks prior to enrollment (discontinuation for the purpose of study enrollment is permitted only if considered safe by the Investigator and approved by the Medical Monitor). 4. Treatment with an antidepressant for cataplexy, if the withdrawal of the antidepressant during cross-titration with JZP-258 might be unsafe due to prior history of depression. 5. Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the Investigator. ; PRIMARY OUTCOME: Change in Weekly Number of Cataplexy Attacks; SECONDARY OUTCOME 1: Change in the Epworth Sleepiness Scale (ESS) Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMAGINE 4 (26 Weeks); BRIEF: The purpose of this study is: - To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. - To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. - To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment. ; DRUG USED: LY2605541; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria - Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification - Had diabetes ≥1 year - Have a hemoglobin A1c (HbA1c) value ≥7.0% and <12.0% at screening - Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m^2) - Participants on any glucose lowering regimen that contains at least 1 daily insulin injection - This inclusion criterion applies ONLY to women of childbearing potential - Are not breastfeeding - Test negative for pregnancy at screening and randomization - Do not intend to become pregnant during the study - Have practiced a reliable method of birth control for at least 6 weeks prior to screening - Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug) - Have access to a method of communication with the site - Have refrigeration in the home - Capable of, and willing to do the following: adhere to a multiple daily injection regimen, inject insulin with a covered vial and syringe and prefilled pen, attend some appointments in the fasting state, and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above - Have given written informed consent to participate in this study in accordance with local regulations Exclusion Criteria - Continuous subcutaneous insulin infusion therapy prior to screening - Are using twice daily insulin glargine prior to screening - Excessive insulin resistance defined as having received a daily dose of insulin ≥2.0 units per kilogram (units/kg) at the time of pre-randomization - Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening - Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening - Have fasting hypertriglyceridemia (defined as >4.5 millimoles per liter [mmol/L], >400 milligrams per deciliter [mg/dL]) at screening - Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss - Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study - Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening - Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening - Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification) - Are currently receiving renal dialysis or have a serum creatinine ≥2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine - Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD], acute or chronic hepatitis, non-alcoholic steatohepatitis [NASH], or elevated liver enzyme measurements as indicated below: - total bilirubin ≥2X the upper limit of normal (ULN) as defined by the central laboratory, or - alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >2.5X ULN as defined by the central laboratory, or - aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) >2.5X ULN as defined by the central laboratory - Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator - Have known or develop hypersensitivity or allergy to any of the study insulins or their excipients - Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement - Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency - Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator - Have had an organ transplant - Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks; SECONDARY OUTCOME 1: Total Hypoglycemia Rates (Adjusted for 30 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 - BRAF V600E/K ; BRIEF: This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV). Trametinib may be given as monotherapy or in combination since first line metastatic melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they have not progressed under such treatment or if they have presented limited progression as per eligibility criteria. It is estimated that between 250 and 400 subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled. ; DRUG USED: Mekinist; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Provides signed and dated informed consent, with age at the time of consent >=18 years. - Has histologically confirmed cutaneous melanoma BRAF V600E/K positive mutation either unresectable (stage IIIc) or distant metastatic (stage IV). - Is not eligible for enrolment in any other ongoing relevant hypothesis testing clinical study for metastatic melanoma or, if eligible, is so geographically distant from a participating site that attending frequent clinic visits is not feasible. - Has not participated in the following GSK sponsored clinical studies (COMBI-v: MEK116513, COMBI-d: MEK115306, COMBI-AD: BRF115532) for melanoma indication prior to participating in this open label access study. - Is able to swallow and retain oral medication. - For subjects with active brain metastases: the subject does not require or is ineligible for immediate local treatment. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 and in stable clinical condition. NOTE: subject in rapidly deteriorating clinical condition prior to start of therapy should not be considered for this open label access study. ECOG 3 subjects may be included provided the subject is clinically stable on the investigators judgement. - Does not require treatment with another anti-cancer therapy while on this open label access study (except dabrafenib if in combination with trametinib). - Does not require treatment with prohibited concomitant medications. - Does not have any medical conditions or physical examination or clinical laboratory findings which, in the opinion of the investigator and/or GSK Medical Monitor, would put the subject at high risk for an adverse outcome. - Where applicable, female subjects of childbearing potential must agree to use one of the contraceptive methods listed in the study protocol. These subjects must have a negative serum pregnancy test within 7 days prior to the first dose of trametinib, preferably as close to the first dose as possible, agree to use adequate contraception from the time of the pregnancy test, throughout the treatment period and for a total of 4 months following the last dose of treatment. - For subjects enrolled in France: a subject will be eligible for inclusion in this study only if he is, either affiliated to or beneficiary of a social security category. Exclusion Criteria: - Subjects who have received prior therapy with a MEK or BRAF inhibitor. NOTE: However subjects may be eligible in the following cases: Subjects whose tumor has not progressed based on radiographic and clinical assessments. Such subjects may receive therapy with: trametinib in combination with dabrafenib (in case of an adverse event related to a previous BRAF or MEK inhibitor other than trametinib or dabrafenib and without cross-reaction anticipated, or if clinically indicated according to investigator judgement). Prior treatment (except trametinib and dabrafenib) should have been stopped for a period of 5 half lives or 28 days (whichever is shorter) before starting treatment of this study; trametinib monotherapy if the subject has benefited from a treatment with a BRAF-inhibitor without progression but cannot receive it anymore due to tolerability reason. Subjects who have met the criteria for disease progression may receive trametinib in combination with dabrafenib if: the disease progression was confirmed after a period of at least 6 months of clinical benefit (Response or Stable Disease) on monotherapy and if the progression was characterized by a limited radiographic progression in the absence of clinical signs and symptoms of progression. no treatment-related grade 4 AEs or any SAEs occurred during the last 4 weeks of treatment. - Concurrent treatment with other systemic anti-cancer therapies is not allowed (except dabrafenib in combination with trametinib). Subjects who are currently being treated with another systemic anti-cancer therapy (e.g. chemo, immune, biologic, or targeted therapy) must discontinue use prior to initiation of treatment in this open label access study for a period of 5 half lives or 28 days (whichever is shorter). - Presence of malignancy other than melanoma within 1 year of enrolment into this program or any malignancy with confirmed activating RAS mutation. Subject with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility. - Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib or dabrafenib, or excipients or to dimethyl sulfoxide (DMSO). - Current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) - Current evidence of cardiovascular risk including any of the following: Left Ventricular Ejection Fraction (LVEF) < lower limit of normal (LLN); A QT interval corrected for heart rate using the Bazetts formula >=480 millisecond (msec); Clinically significant uncontrolled arrhythmias; Acute coronary syndromes (including myocardial infarction and unstable angina); Congestive heart failure >=Class II as defined by New York Heart Association. ; 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 - Mountain Cedar Pollen; BRIEF: This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen. ; DRUG USED: Setipiprant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Allergic Rhinitis; TARGET: Chemoattractant Receptor-Homologous Molecule (CRTH2); THERAPY: Monotherapy; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria - Males and females aged 12-76 years with documented clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last 2 years. - Evening reflective Total Nasal Symptom Score (p.m.rTNSS) at least 42 out of a maximum potential score of 84 over the 7-day run-in period, or > or = 6 out of a maximum score of 12 on each of the last 4 consecutive days during the run-in period. Exclusion Criteria - Non-allergic rhinitis. - Severe physical nasal obstruction. - Acute or significant chronic sinusitis. - Bacterial or viral infection of the upper or lower respiratory tract, nasal sinuses, or middle ear. - Ongoing chronic respiratory disorders. - Asthma requiring use of short-acting beta2-agonists > 2 times a week or any asthma treatment other than inhaled short-acting beta2-agonists. - Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma. - Nasal biopsy or surgery, sinus surgery, or perforation within the 8 weeks prior to the Screening Visit. - Ocular surgery within the 8 weeks prior to the Screening Visit. - Ocular infections (bacterial or viral) within the 4 weeks before screening. - Use of forbidden medications (prescribed or over-the-counter [OTC]) - Congenital or acquired severe immunodeficiency or known Human immunodeficiency virus (HIV)infection. ; PRIMARY OUTCOME: The mean change in Daytime Nasal Symptom Score; SECONDARY OUTCOME 1: The mean change in other daytime/nighttime symptom scores of allergic rhinitis[/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 - OL006; BRIEF: The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body. ; DRUG USED: Aptocine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Combination; LEAD SPONSOR: Light Sciences Oncology; CRITERIA: Inclusion Criteria: - Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI - Biopsy proven evidence of colorectal cancer - At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed) - ECOG Performance Status 0-2 - Life expectancy of at least 16 weeks - At least 30 days must have elapsed since the completion of any prior antineoplastic therapy and the patient must have recovered from acute side effects before day 0 - Understanding and ability to sign written informed consent - 18 years of age or more - Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2.5 × 10^9/L ; Platelet Count > 100 × 10^9/L ; Hemoglobin > 90 g/L ; Neutrophils >1.5 × 10^9/L ; PT and PTT < 1.5 Control ; SGOT, SGPT < 5 × ULN ; GGT < 5 × ULN ; Alkaline phosphatase < 5 × ULN ; Bilirubin < 3 × ULN ; Creatinine < 1.5 × ULN Exclusion Criteria: - Patients who are candidates for complete surgical resection - Patients who received bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizumab or cetuximab is prohibited while participating in this study - Patients who would require more than a total number of 12 light source applications over three Litx™ experimental treatments (no more than 4 light sources per treatment). - Patients who have a single measurable tumor greater than 7.5 cm in any organ - Target lesions irradiated within 3 months of randomization - Patients with tumor involvement in greater than 50% of parenchyma of the liver - Evidence of major vessel invasion of any organ - Patients with any non-colorectal cancers except for adequately treated basal or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient has been disease-free for ≥ 3 years, or other cancer from which the patient has been disease-free for ≥ 5 years - Known sensitivity to porphyrin-type drugs or known history of porphyria - Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study - Concurrent participation in another clinical trial involving experimental treatment - Any concurrent disease or condition that in the opinion of the investigator impairs the patients ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigators opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trials data. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Ages 4 to 6; BRIEF: The purpose of this study is to support licensure of GSK Biologicals MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Mercks MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age. ; DRUG USED: Priorix; DRUG CLASS: Vaccine; INDICATION: Measles, Mumps and Rubella (MMR) Vaccines; TARGET: Immune System, Measles virus, Mumps virus, Rubella Virus; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol. - Male or female subjects 4 to 6 years of age at the time of vaccination. - Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations). - Subjects in stable health as determined by investigators physical examination and assessment of subjects medical history. - Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life. - For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV: - subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine. - subjects received a first dose of VV in the second year of life. Exclusion Criteria: - Child in care. - Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period. - Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s. - Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2. - Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. - History of measles, mumps, and/or rubella disease. - Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin or gelatin. - Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. - Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever. - Active untreated tuberculosis according to the subjects medical history. - Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study. In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV: - Previous vaccination with a second dose of varicella-containing vaccine. - Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination. - History of varicella/zoster disease. - Known exposure to varicella/zoster during the period starting 30 days prior to enrollment. - History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease. - Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life. - Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids. - Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine. - Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines. ; PRIMARY OUTCOME: Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value; SECONDARY OUTCOME 1: Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value[/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 - 200938 (Pediatric); BRIEF: The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment options are limited in children and adolescents. Albiglutide, approved for the treatment of T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. The study will be conducted in 2 parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a randomized double-blind placebo controlled study to evaluate the safety and efficacy (glycemic control) of albiglutide in the pediatric population. Treatment duration in Part B is 52 weeks (24 weeks double-blind placebo-controlled and 28 weeks open-label during which all subjects will receive albiglutide). Approximately 210 eligible male and female subjects will be included in the study. ; DRUG USED: Tanzeum; DRUG CLASS: Biologic; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Between 10 to less than 18 years of age inclusive at the time of screening. - Diagnosis of T2DM with HbA1c more than or equal to 7.0% [53 millimole per mole (mmol/mol)] and less than 10.0% (85.8 mmol/mol) assessed at screening. Currently treated with regimen of diet and exercise with or without metformin. Subjects on metformin monotherapy should have been treated for a minimum of 8 weeks prior to randomization on a dose above 1000 milligram per day (mg/day) or prior documented maximum tolerated dose (MTD) less than or equal to 1000 mg/day. - FPG less than 240 mg/deciliter (dL) at screening. - Fasting C-peptide more than or equal to 0.8 nanogram per milliliter (ng/mL) at screening. - Negative central laboratory assays for Glutamic Acid Decarboxylase 65 (GAD-65) and Islet Cell Autoantigen 512 (ICA512) autoantibodies at screening. - Body weight more than or equal to 30 kilogram (kg) at screening. - Male subjects will be included. Female subjects who have achieved menarche and are of childbearing potential must be practicing adequate contraception for the duration of participation in the study. - Signed informed consent of parent or legal guardian and assent as appropriate will be obtained from the child. Exclusion Criteria: - Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM) - Female subject is pregnant (confirmed by laboratory testing), planning a pregnancy or lactating. - History of cancer that has not been in full remission for at least 3 years before screening. - History of thyroid cancer. - Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2). - History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones). - Severe gastroparesis within 6 months prior to screening. - History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function. - Have a history of at least one episode of diabetic ketoacidosis (DKA) after receiving anti-diabetic medication. - Fasting triglyceride level more than 750 mg/dL at screening. - Serum calcitonin more than 50 picogram (pg/mL) at screening. - Hemoglobinopathy that may affect determination of HbA1c. - Uncontrolled hypertension at screening. - Estimated Glomerular Filtration Rate (eGFR) less than 90 mL/minute/1.73 meter^2 (calculated using the Schwartz equation) at screening. - ALT more than 2.5x upper limit of normal (ULN) or Bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening. - Current active liver or biliary disease (with the exception of Gilberts syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). - Current or previous insulin therapy used for more than 4 weeks (continuously) in the 3 months prior to screening. - Use of a GLP-1receptor agonist at study entry and during the study. - Any oral diabetic medications, except metformin, at study entry and during the study. - Use of oral or systemically injected glucocorticoids is generally not allowed within the 3 months before randomization; however, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor. - Weight loss medications. - Antiretroviral drugs. - Known allergy or serious hypersensitivity reaction to albiglutide or any product components (including yeast and human albumin), any other GLP 1 analogue, insulin, or other study medications excipients or other contraindications. - Any other reason the investigator deems the subject to be unsuitable for the study or may interfere with trial compliance (e.g. significant medical or psychiatric history). - The subject has participated in a clinical trial and has received an investigational product or device within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). ; PRIMARY OUTCOME: Area under the curve (AUC) of albiglutide: Part A; SECONDARY OUTCOME 1: Change from Baseline in fasting Plasma Glucose (FPG): Part B[/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 - TACTICS-HF; BRIEF: The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone ; DRUG USED: Samsca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Duke University; CRITERIA: Inclusion Criteria: - ≥ 18 years of age - Daily oral dose of furosemide between ≥ 40 mg(or equivalent) - Identified within 24 hours of presentation, defined for purposes of this study as the time of initial dose of intravenous loop diuretic - Prior clinical HF diagnosis that was treated with oral loop diuretics for at least 1 month - Admission for acute decompensated Heart Failure (HF) as determined by - dyspnea at rest or with minimal exertion - Brain Natriuretic Peptide (BNP) > 400 or NTproBNP > 2000 pg/mL AND at least one of the following additional signs and symptoms: - Orthopnea - Peripheral edema - Elevated JVP (Jugular Venous Pressure) - Pulmonary rales - Congestion on Chest X-ray - No plan for revascularization, cardiac transplant, of ventricular assist device implantation, or other cardiac surgery within 60 days of randomization - Signed informed consent Exclusion Criteria: - Serum Na > 140 meq/L - Received IV vasoactive treatment or ultra-filtration therapy for HF since initial presentation - Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for HF - Systolic Blood Pressure (SBP)<90mmHg - Serum-Cr>3.5mg/dl or currently undergoing renal replacement therapy . Known underlying liver disease - Hemodynamically significant arrhythmias - ACS(Acute coronary syndrome) within 4 weeks prior to study entry - Active myocarditis - Hypertrophic obstructive, restrictive, constrictive cardiomyopathy - Severe stenotic valvular disease - Complex congenital heart disease - Constrictive pericarditis - Clinical evidence of digoxin toxicity - Need for mechanical hemodynamic support - Terminal illness (other than heart failure) with expected survival time of less than 1 year - History of adverse reaction to Tolvaptan - Enrollment or planned enrollment in another randomized clinical trial during this hospitalization - Pregnant or breast-feeding - Inability to comply with planned study procedures ; PRIMARY OUTCOME: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours; SECONDARY OUTCOME 1: Renal Function[/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 - GEN411/OFA110634 - TNFa Failures; BRIEF: This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy. ; DRUG USED: Kesimpta; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Age ≥ 18 years; - Active disease at the time of screening as defined by: ≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR); - Inadequate response to previous or current TNF-alpha antagonist treatment; - Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks. Exclusion Criteria: - Patients with a history of a rheumatic autoimmune disease other than RA or with significant systemic involvement secondary to RA; - Previous exposure to biologic anti-rheumatic therapies, including investigational compounds; - Exposure to TNF-alpha antagonist treatment < 12 weeks prior to visit 2; - Chronic or ongoing active infectious disease requiring systemic treatment; - Clinically significant cardiac disease; History of significant cerebrovascular disease; - Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease; - Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for Hepatitis C; Positive plasma / white cell JC Virus PCR; - Serum IgG < lower limit of normal; - Breast feeding women or women with a positive pregnancy test at screening; - Current participation in any other interventional clinical study; - Patients known or suspected of not being able to comply with a study protocol. ; PRIMARY OUTCOME: Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24; SECONDARY OUTCOME 1: Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - US & International; BRIEF: The purpose of this 1-year study is to evaluate the efficacy and safety of a new contraceptive vaginal ring (CVR) delivering low doses of Nestorone (NES), a new, nonandrogenic progestin, and ethinyl estradiol (EE), an estrogen used in oral contraceptives. The CVR, which is made of silicone rubber, is designed to be used for 1 year (13 menstrual cycles) before replacement is required. ; DRUG USED: Annovera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Contraception; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Population Council; CRITERIA: Inclusion Criteria: Healthy women who meet the following criteria: - Aged 18-<40 years who wish to use a combined hormonal contraceptive. - Women not intending to become pregnant for 13 months. - Intact uterus and both ovaries. - Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal contraception; if postpartum or postabortal, history of regular menstrual cycles of 21-35 days in length and at least one cycle (2 menses) with a cycle length consistent with her past cycles. - Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study. - In the opinion of the investigator, able to comply with the protocol, e.g. live within the clinic catchment area or within a reasonable distance from the clinic. - Do not meet any of the exclusion criteria. - Signed informed consent prior to entry into the trial. [For pharmacokinetics study only; 39 subjects already recruited] - Willing to undergo frequent blooding sampling Exclusion Criteria: Contraindications for enrollment will be the same as those for use with combined hormonal contraceptives in addition to contraindications specific to this clinical trial including: - Known hypersensitivity to estrogens or progestins. - Known hypersensitivity to silicone rubber. - Known or suspected pregnancy. - History of infertility of >1.0 year in woman or her male partner. - History of vasectomy or sterility in male partner; tubal ligation (sterilization) in women. - Undiagnosed abnormal genital bleeding. - Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with a chlamydia or gonococcus infection may be included in the trial following treatment; partner treatment is also recommended. Investigators should make a determination if subjects are at high risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included.) - History of pelvic inflammatory disease since last pregnancy episode. - History of toxic shock syndrome. - Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative may participate provided there is follow up for this finding per standard of care). - Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring. - Women planning to undergo major surgery. - Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women < 35yrs who smoke 15 cigarettes or more must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age. - Breastfeeding. - Current or past thrombophlebitis or thromboembolic disorders. - History of venous thrombosis or embolism in a first-degree relative, <55 years of age suggesting a familial defect in the blood coagulation system, which in the opinion of the PI, suggests use of a hormonal contraceptive could pose a significant risk. - Cerebrovascular or cardiovascular disease. - History of retinal vascular lesions, unexplained partial or complete loss of vision. - Known or suspected carcinoma of the breast. - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. - Past history of any other carcinoma unless in remission for more than 5 years. - Current or history of medically diagnosed severe depression, which, in the opinions of the investigator, could be exacerbated by use of a hormonal contraceptive. - Headaches with focal neurological symptoms. - Severe constipation. - History of cholestatic jaundice of pregnancy or jaundice with prior steroid use. - Benign or malignant liver tumors; active liver disease. - Diastolic blood pressure (BP) 85 mm Hg and/or systolic BP 135 mm Hg after 5-10 minutes rest. - Known or suspected alcoholism or drug abuse. - Abnormal serum chemistry values according to the physicians judgment. - Participation in another clinical trial within last 30 days. - Weight >95 kg or >209 lbs. - Use of liver enzyme inducers on a regular basis. - Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months before initiation of treatment. Use of Depo-Provera [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment. - Current use of implanted hormonal contraceptives, including Mirena® [progestin containing intrauterine system (IUS)], Jadelle®, Norplant® or Implanon® (subjects using any of these methods who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation). - Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation. - Known HIV infection. - Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. If women enrolled in the study do use condoms to protect against STIs, they should be instructed that this occasional use should be with non-N-9 containing condoms and they should record condom use in their diaries. Women found to have an STI at screening will be treated prior to inclusion in the study (with the exception of those infected with HIV). ; PRIMARY OUTCOME: Efficacy; 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 - JAVELIN Gastric 300; BRIEF: The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physicians choice (chosen from a pre-specified list of therapeutic options) plus BSC. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects aged greater than or equal to (>=) 18 years - Subjects with histologically confirmed recurrent unresectable, recurrent locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ) - Availability of a formalin-fixed, paraffin-embedded (FFPE) block containing tumor tissue - Subjects must have received 2 prior courses of systemic treatment for unresectable, recurrent, locally advanced or metastatic gastric cancer, and must have progressed after the second line - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at trial entry - Adequate hematological, hepatic and renal functions defined by the protocol - Negative blood pregnancy test at Screening for women of childbearing potential. - Highly effective contraception for both male and female subjects if the risk of conception exists Other protocol defined inclusion criteria could apply Exclusion Criteria: - Prior therapy with any antibody or drug targeting T-cell coregulatory proteins - Concurrent anticancer treatment - Major surgery - Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to less than [<] 10 mg prednisone daily). - All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) - Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder,cervical, colorectal, breast) - Prior organ transplantation, including allogeneic stem-cell transplantation Significant acute or chronic infections - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent - Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) - Persisting toxicity of grade >2 related to prior therapy except neuropathy and alopecia - Neuropathy Grade greater than or equal (>=) 3. - Pregnancy or lactation - Known alcohol or drug abuse - History of uncontrolled intercurrent illness including hypertension, active infection, diabetes - Clinically significant (i.e., active) cardiovascular disease - All other significant diseases might impair the subjects tolerance of trial treatment - Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements - Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines - Legal incapacity or limited legal capacity - Subjects will be excluded from the treatment with irinotecan or paclitaxel monotherapy if administration of their chemotherapy would be inconsistent with the current local labeling (for example, in regard to contraindications, warnings/precautions, or special provisions) for that chemotherapy. Investigators should check updated labeling via relevant websites before randomization - Subjects should start treatment administration within 28 days after signing the informed consent form (ICF). Treatment administration will start within 4 days after the randomization call ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Hallucination and Delusions; BRIEF: The purpose of this study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo for the treatment of patients with hallucinations and delusions associated with Alzheimers disease. ; DRUG USED: Risperdal; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Pharmaceutical K.K.; CRITERIA: Inclusion Criteria: - Diagnosis of Alzheimers disease according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) - Mini-Mental State Examination (MMSE) score of not greater than 23 - Behavioral Pathology in Alzheimers Disease (BEHAVE-AD) psychotic score of >=2 for any item in the psychotic cluster - occurrence of hallucination or delusion after onset of symptoms of dementia at least 28 days before screening. Exclusion Criteria: - Patients with a disease that could significantly diminish cognitive function (e.g., Parkinsonism, Huntingtons disease, Creutzfeldt-Jacob disease, dementia of Levy body type, vitamin B12 or folic acid deficiency) - persistent dementia or amnestic disorders according to DSM-IV criteria - occurrence of hallucination or delusion only while delirium is observed - psychiatric symptoms induced by psychosis (e.g., schizophrenia, schizoaffective disorders, delusional disorders, depression or bipolar disorders) - history of neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness) ; PRIMARY OUTCOME: Change in Behavioral Pathology in Alzheimers Disease (BEHAVE-AD) psychotic symptom cluster score from baseline and intermediate visits to study end (Week 9) compared with placebo.; SECONDARY OUTCOME 1: Changes in BEHAVE-AD total, subscales and items scores, changes in CMAI aggressiveness and non-aggressiveness item scores and changes in CGI-C from baseline and intermediate visits to study end (Week 9) compared with placebo. Safety evaluations.[/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 - ABC (IST); BRIEF: Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups. ; DRUG USED: Botox - Therapeutic; DRUG CLASS: Biologic; INDICATION: Overactive Bladder (OAB); TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: NICHD Pelvic Floor Disorders Network; CRITERIA: Inclusion Criteria: - Subject has signed informed consent. - Females at least 21 years of age - Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type. - Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary. - Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required. - Request for treatment for urge urinary incontinence. The patient may have tried other non-pharmacologic treatments for urge incontinence, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation. - Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment. - Subject is able to complete all study related items and interviews. Exclusion Criteria: - Any previous therapy with trospium chloride, solifenacin, or darifenacin - Failed three or more anticholinergic drugs. - Contraindication to anticholinergic therapy, specifically with solifenacin or trospium. - Current symptomatic urinary tract infection that has not resolved prior to randomization. - Uncontrolled narrow-angle glaucoma - Gastric retention - Baseline need for intermittent self catheterization - PVR >150ml on 2 occasions with void(s) of greater than 150ml - Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s). - Any prior intra-detrusor botulinum toxin A injections - Previous or currently implanted neuromodulation (sacral or tibial). - Surgically altered detrusor muscle, such as augmentation cystoplasty. - Known allergy to botulinum toxin A. - Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease). - Known allergy to lidocaine. - Currently pregnant or lactating patients or patients planning pregnancy within the next year. - Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study. - Cystoscopic findings that preclude injection, in the opinion of the investigator. - Current or prior bladder malignancy. - In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary. - Subjects who are on anticoagulant therapy,excluding aspirin - Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome. - Subjects with hematuria who have not undergone a clinically appropriate evaluation. - Subjects taking aminoglycosides at the time of injection. - Serum creatinine level greater than twice the upper limit of normal within the previous year. - Two or more hospitalizations for medical conditions in the previous year. - Plans to move out of area in the next 6 months. ; PRIMARY OUTCOME: Change in Urge Urinary Incontinence (UUI) Episodes; SECONDARY OUTCOME 1: Change From Baseline in Score on OABq-SF[/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 - INSPIRE; BRIEF: - Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF - Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe - Randomization: 2:1 active-to-placebo ratio - Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria) ; DRUG USED: Actimmune; DRUG CLASS: Biologic; INDICATION: Idiopathic Pulmonary Fibrosis (IPF); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: InterMune; CRITERIA: Inclusion criteria: - Clinical symptoms consistent with IPF of >= 3 months duration - Diagnosis of IPF within 48 months before randomization - Age 40 through 79, inclusive - High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient. - For patients aged < 50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP within 48 months before randomization. In addition, there are no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage (BAL) if performed. - For patients aged < 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months before randomization: - Open or VATS lung biopsy showing definite or probable UIP - Transbronchial biopsy showing no features to support an alternative diagnosis - BAL showing no features to support an alternative diagnosis IPF Disease Severity and Progression - FVC >= 55% of predicted value (post administration of bronchodilator) - Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon monoxide transfer capacity (DLCO/TLCO) >= 35% of predicted value - At least one of either FVC or Hb-corrected DLCO/TLCO <= 90% of predicted value - IPF disease progression evidenced by one or more of the following within the past year and the absence of evidence of improvement in the past year: - Absolute decrease of >= 10% in FVC - Absolute decrease of >= 15% in DLCO/TLCO - Evidence of clinically significant worsening on chest X ray or HRCT - Significant worsening of dyspnea - Distance walked >= 150 meters (492 feet) with O2 saturation >= 83% on <= 6 L/min of O2 during the 6 Minute Walk Test (6MWT) oxygen titration procedure Exclusion criteria: 1. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Principal Investigator (PI) 2. Forced expiratory volume in the first second (FEV1)/FVC ratio < 0.6 (after administration of bronchodilator) 3. Residual volume (RV) > 140% of predicted (before administration of bronchodilator) 4. History of clinically significant environmental exposure known to cause pulmonary fibrosis (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds) 5. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, and cancer 6. Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis 7. Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis 8. On a lung transplantation waiting list at time of randomization Medical Exclusions: 9. Any history of malignancy likely to result in death, significant disability, or likely to require significant medical or surgical intervention within the next 3 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma) 10. Any condition other than IPF which, in the opinion of the PI, is likely to result in the death of the patient within the next 3 years 11. History of unstable or deteriorating cardiac, vascular, or neurologic disease within the previous 6 months, including but not limited to the following: - Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty - Congestive heart failure requiring hospitalization - Uncontrolled arrhythmias - Thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism) - Transient ischemic attacks (TIAs) or cerebral vascular accident 12. Any condition, which, in the opinion of the investigator, might be significantly exacerbated by the known side effects, (e.g., flu-like syndrome) associated with the administration of IFN g 1b 13. History of any of the following medical conditions: - Multiple sclerosis - Seizures within the past 10 years or taking anti seizure medication - Severe or poorly controlled diabetes 14. Pregnancy or lactation. Females of childbearing potential are required to have a negative serum pregnancy test before treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study 15. Inability to tolerate nonsteroidal anti-inflammatory drugs (NSAIDS) or acetaminophen (paracetamol) 16. History of ethanol abuse in the past 2 years 17. Known hypersensitivity to IFN-g or closely related interferons or to any component of the study treatment 18. Presence of human immunodeficiency virus (HIV) or chronic viral hepatitis Laboratory Exclusions: 19. Any of the following liver function test criteria above specified limits: Total bilirubin > 1.5 x upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or ALT/SGPT) > 2 x ULN; alkaline phosphatase > 2 x ULN; or albumin < 3.0 mg/dL 20. Any of the following hematology test criteria outside of specified limits: WBC < 2,500/mm3, hematocrit < 30% or > 59%, platelets < 100,000 /mm3 21. Creatinine > 1.5 x ULN Concomitant Therapy Exclusions: 22. Prednisone therapy (prednisone or equivalent, with dose adjusted for potency) in excess of 0.125 mg/kg ideal body weight (IBW) per day or in excess of 0.25 mg/kg IBW every other day. Patients will also be excluded if they were not on a stable dose of corticosteroid therapy for at least 28 days prior to screening. 23. Prior treatment with IFN g 1b 24. Investigational therapy (i.e., agents that are not approved by local regulatory agencies) for any indication within 28 days prior to screening 25. The following therapies are excluded within 28 days prior to screening: - Investigational therapy for IPF, including pirfenidone - Any cytotoxic/immunosuppressive agent other than corticosteroids (including but not limited to azathioprine, cyclophosphamide, methotrexate, cyclosporine) - Any cytokine modulators (including but not limited to etanercept, infliximab) - Any therapy targeted to treat IPF (including but not limited to d penicillamine, colchicine, bosentan, N-acetyl-cysteine [NAC]) ; PRIMARY OUTCOME: Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status.; SECONDARY OUTCOME 1: Lung transplant-free survival time (ongoing assessment up to 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 III - ENDEAR (Infants); BRIEF: The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA. ; DRUG USED: Spinraza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Spinal Muscular Atrophy; TARGET: Survival of Motor Neuron (SMN) Protein; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Be born (gestational age) between 37 and 42 weeks - Be medically diagnosed with spinal muscular atrophy (SMA) - Have Survival Motor Neuron2 (SMN2) Copy number = 2 - Body weight equal to or greater than 3rd percentile for age using appropriate country-specific guidelines - Be able to follow all study procedures - Reside within approximately 9 hours ground-travel distance from a participating study center, for the duration of the study Key Exclusion Criteria: - Hypoxemia (oxygen [O2] saturation awake less than 96% or O2 saturation asleep less than 96%, without ventilation support) during screening evaluation - Clinically significant abnormalities in hematology or clinical chemistry parameters or Electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit that would render the participant unsuitable for participation in the study - Participants parent or legal guardian is not willing to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Motor Milestones Responders; SECONDARY OUTCOME 1: Percentage of Childrens Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) Responders[/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 - IRONS; BRIEF: This is a multicenter, randomized (2:1; oral treprostinil:placebo), double-blind, placebo-controlled event-driven (time to pulmonary hypertension [PH] clinical worsening) study in subjects with PH associated with sickle cell disease (SCD). Once enrolled, subjects will be evaluated at Weeks 6, 12, 24, and then every 12 weeks for the duration of the study. Subjects will be permitted to enter a 48-week open-label extension period if they experience a PH clinical worsening event. ; DRUG USED: Orenitram; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: 1. The subject must have a diagnosis of SCD confirmed by hemoglobin electrophoresis. 2. The subject has a diagnosis of symptomatic World Health Organization (WHO) Group 5.1 chronic hemolytic anemia PH. 3. The subject must have a Baseline 6MWD greater than 150 meters, in the absence of a concurrent injury, illness, or other confounding factor. 4. The subject has pulmonary function tests conducted within 6 months of Screening or during the Screening period. 5. The subject must be on stable doses of other medical therapy for at least 30 days prior to randomization with no dose adjustments, additions, or discontinuations. 6. The subject must be optimally treated with conventional PH therapy for at least 10 days prior to randomization with no additions, discontinuations, or dose changes. 7. Subjects receiving an endothelin receptor antagonist (ERA) must have been receiving therapy for greater than 90 days, and have reached and maintained a stable dose for a minimum of 30 days prior to randomization. 8. Subjects receiving calcium channel blockers must have been on a stable dose for a minimum of 3 months prior to randomization. Exclusion Criteria: 1. The subject is pregnant or lactating. 2. The subject has previously received oral treprostinil or is receiving a phosphodiesterase type 5 inhibitor (PDE5-I). 3. The subject has received a prostacyclin within 30 days prior to start of the study, or had previous intolerance or significant lack of efficacy to any prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to titrate that therapy effectively. 4. The subject has had any other background conventional therapies for PH added, removed, or doses adjusted within 10 days prior to randomization. 5. The subject has any disease associated with pulmonary arterial hypertension (PAH). 6. The subject has had a vaso-occlusive crisis, acute chest syndrome event, or unscheduled transfusion within 30 days of randomization. 7. The subject has a history of ischemic heart disease, including a previous myocardial infarction or symptomatic coronary artery disease, within 6 months prior to Screening or a left ventricular ejection fraction less than 40% assessed by either multigated angiogram (MUGA), angiography, or echocardiogram. 8. The subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels 3 times or greater than the upper limit of normal, clinically significant liver disease/dysfunction, or known Child-Pugh Class B or C hepatic disease at Screening. 9. The subject has chronic renal insufficiency, as defined by the requirement for dialysis. 10. The subject has a musculoskeletal disorder, any disease that is likely to limit ambulation, or is connected to a machine that is not portable. 11. The subject has an unstable psychiatric condition or is mentally incapable of understanding the objectives, nature, or consequences of the study, or has any condition which in the Investigators opinion would constitute an unacceptable risk to the subjects safety. 12. The subject is receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening. ; PRIMARY OUTCOME: Effect of oral treprostinil compared with placebo on time to first adjudicated PH clinical worsening (morbidity or mortality) event in subjects with PH associated with SCD; SECONDARY OUTCOME 1: Effect of oral treprostinil compared with placebo on exercise capacity as assessed by 6-Minute Walk Distance (6MWD)[/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 - RRMS (Lymphocyte Subsets); BRIEF: The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment. ; DRUG USED: Tecfidera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) , NRF2; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. - Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011] Key Exclusion Criteria: - History of or positive test result at Screening for: - human immunodeficiency virus - hepatitis C virus antibody - hepatitis B infection - Drug or alcohol abuse within 1 year prior to Screening. - Prior treatment with any of the following: - cladribine - mitoxantrone - total lymphoid irradiation - alemtuzumab - T-cell or T-cell receptor vaccination - any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab - Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1): - DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure - cyclosporine - azathioprine - methotrexate - mycophenolate mofetil - intravenous (IV) Ig - plasmapheresis or cytapheresis NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK); SECONDARY OUTCOME 1: Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Liver Mets; BRIEF: RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving melphalan directly into the arteries around the tumor may kill more tumor cells. It is not yet known whether hepatic arterial infusion with melphalan is more effective than standard therapy in treating liver metastases due to melanoma. PURPOSE: This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma. ; DRUG USED: Hepzato; DRUG CLASS: Non-NME; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Delcath Systems Inc.; CRITERIA: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed liver metastases secondary to cutaneous or ocular melanoma - Unresectable disease - Predominantly in the parenchyma of the liver - Measurable disease by CT scan and/or MRI - Limited unresectable extrahepatic disease allowed provided the life-limiting component of progressive disease is in the liver, including, but not limited to, any of the following: - Up to 4 pulmonary nodules, each < 1 cm in diameter - Retroperitoneal lymph nodes < 3 cm in diameter - Less than 10 skin or subcutaneous metastases < 1 cm in diameter - Asymptomatic bone metastases that are eligible for or have undergone palliative external-beam radiotherapy - Solitary metastasis to any site that can be resected PATIENT CHARACTERISTICS: - Life expectancy ≥ 3 months - ECOG performance status 0-2 - Bilirubin < 3.0 mg/dL - PT within 2 seconds of upper limit of normal (ULN) - AST/ALT ≤ 10 times ULN - Platelet count > 75,000/mm^3 - Hematocrit > 27% (may be achieved with a transfusion) - Absolute neutrophil count ≥ 1,300/mm^3 - Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min - Fertile patients must use effective contraception - Not pregnant or nursing - Negative pregnancy test - No history of congestive heart failure - LVEF ≥ 40% - No significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease - FEV_1 ≥ 30% - DLCO ≥ 40% of predicted - Weight ≥ 35 kg - No untreated active bacterial infection with systemic manifestations (e.g., malaise, fever, and leucocytosis) - No severe allergic reactions to iodine contrast unless reaction can be controlled by antihistamines and/or steroids - No known hypersensitivity to melphalan - No positive serology for HIV, hepatitis B surface antigen, or hepatitis C antibody (pharmacokinetics portion of the study only) - No known latex allergy - No Childs B or C cirrhosis - No evidence of portal hypertension by history, endoscopy, or radiological study - No prior history of gastrinoma PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 1 month since prior chemotherapy, radiotherapy, or biologic therapy for this cancer and recovered - No prior regionally delivered melphalan - No prior Whipple procedure - No concurrent immunosuppressive therapy - No concurrent chronic anticoagulation therapy ; PRIMARY OUTCOME: Hepatic progression free survival; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RAP-MD-06 (Long-Term/Adjunctive); BRIEF: This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD). ; DRUG USED: Rapastinel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Receptor - Glycine Site; THERAPY: Monotherapy; LEAD SPONSOR: Naurex, Inc, an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD - Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening - Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant - If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test. Exclusion Criteria: - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening - Lifetime history of meeting DSM-5 criteria for: - Schizophrenia spectrum or other psychotic disorder - Bipolar or related disorder - Major neurocognitive disorder - Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participants ability to consent, follow study directions, or otherwise safely participate in the study - Dissociative disorder - Posttraumatic stress disorder - MDD with psychotic features - Significant suicide risk, as judged by the Investigator. ; PRIMARY OUTCOME: The Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)[/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. Insulin Glargine (Japan); BRIEF: The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM). ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening - Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable - Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening - Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2) Exclusion Criteria: - Participants who have a diagnosis of type 1 diabetes - Participants who have previously been treated with any other glucagon-like peptide 1 (GLP-1) analog - Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening - Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening - Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening - Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC) ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - China Pivotal; BRIEF: The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m. ; DRUG USED: Ilaris; DRUG CLASS: Biologic; INDICATION: Gout; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Meeting diagnosis criteria for acute arthritis of primary gout. - Start of acute gout flare within 5 days prior to study visit 1 - History of ≥ 3 gout flares within the 12 months prior to study start - Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines Exclusion criteria: - Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide - Refractory heart failure (Stage D). - Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia - Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout - Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS); SECONDARY OUTCOME 1: The Number of Patients With at Least 1 New Gout Flare[/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 - COMORBID; BRIEF: Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH. ; DRUG USED: Cialis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Benign Prostatic Hyperplasia (BPH); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have BPH Lower Urinary Tract Symptoms (LUTS) based on the disease diagnostic criteria at 1st screening. - Have a history of ED based on the disease diagnostic criteria at 1st screening. - Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at 2nd screening. - Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greater than or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (from a prevoid total bladder volume as assessed by ultrasound of greater than or equal to 150 to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2nd screening. - Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening as recorded in the Sexual Encounter Profile (SEP) diary. - Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study. - Agree not to use any other approved or experimental BPH, overactive bladder (OAB), or ED treatments as indicated in the protocol at any time during the study. - Have not taken treatments indicated in the protocol prior to the 2nd screening. Exclusion Criteria: - Current treatment with nitrates. - Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening. - PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist. - Clinical evidence of prostate cancer. - Bladder postvoid residual volume (PVR) greater than or equal to 300 mL by ultrasound determination at 1st screening. - History or clinical evidence of certain pelvic, bladder, urinary tract, or urinary retention conditions described in the protocol. - Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1st screening. - Clinical evidence of severe hepatic impairment at 1st screening. - Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinsons disease or multiple sclerosis). - History of significant renal insufficiency as defined by the protocol. - History of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease. - Presence of penile deformity judged by the investigator to be clinically significant. - History of certain cardiac or cardiovascular conditions described in the protocol. - History of resuscitated cardiac arrest. - Current treatment with certain medications described in the protocol. - Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study. - History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of 1st screening. - Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening. - Prior treatment with phosphodiesterase type 5 (PDE5) inhibitors judged by the investigator to be ineffective. However, if the investigator judges that a subjects lack of response to as-needed PDE5 inhibitors is the result of inadequate coordination between dosing and sexual activity with a treatment, the subject may be enrolled. ; PRIMARY OUTCOME: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg); SECONDARY OUTCOME 1: Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Ha03-001; BRIEF: The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home. ; DRUG USED: Xeglyze; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: Metal ions (e.g., Ca2+, Cu2+, Zn2+, and Fe2/3+), MMP (metalloproteinase); THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion Criteria: 1. Male or female, aged six months of age or older. 2. Is in good general health based on medical history. 3. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members. 4. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home. 5. Belongs to a household with an eligible index subject with active head lice infestation. 6. Agrees to an examination for head lice and to all visits and procedures throughout the study. 7. Has signed an informed consent and/or assent form. Exclusion Criteria: 1. Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0. 2. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol. 3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol. 4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit. 5. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment. 6. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data. 7. Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations. 8. Has eczema or atopic dermatitis of skin/scalp. 9. Has had a prior reaction to Nix® or products containing permethrin. 10. Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments. 11. Has received an investigational agent within 30 days prior to Day 0. 12. Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location). ; PRIMARY OUTCOME: Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - T3MPO-3; BRIEF: This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study. ; DRUG USED: Ibsrela; DRUG CLASS: New Molecular Entity (NME); INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Sodium-hydrogen exchanger 3 (NHE3) ; THERAPY: Monotherapy; LEAD SPONSOR: Ardelyx; CRITERIA: Inclusion Criteria: - Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302 - Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies - Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception - Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization Exclusion Criteria: - Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302 - The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake - Pregnant or lactating women ; PRIMARY OUTCOME: Adverse Events in >2% Patients; 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 - 111738 - US/EU ; BRIEF: The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516). ; DRUG USED: GSK2186877A; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine. - Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse. - Written informed consent obtained from the subject. - Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study - If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. Exclusion Criteria: - Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. - Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. - Planned administration of an influenza vaccine other than the study vaccines during the entire study period. - Any vaccination against influenza since January 2008 with any seasonal influenza vaccine. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - History of hypersensitivity to a previous dose of influenza vaccine. - History of allergy or reactions likely to be exacerbated by any component of the vaccines. - Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests. - Acute disease at the time of enrolment. - Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period. - Any medical conditions in which intramuscular injections are contraindicated. - Pregnant or lactating females. - Female planning to become pregnant or planning to discontinue contraceptive precautions. ; PRIMARY OUTCOME: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs); SECONDARY OUTCOME 1: Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179[/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 - TANGO 1 - vs. Piperacillin/Tazobactam; BRIEF: Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP). ; DRUG USED: Vabomere; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Melinta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. A signed informed consent form, the ability to understand the study conduct and tasks that are required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol. 2. Male or female ≥18 years of age. 3. Weight ≤185 kilograms (kg). 4. Expectation, in the judgment of the Investigator, that the participants cUTI or AP requires initial treatment with at least 5 days of IV antibiotics. 5. Documented or suspected cUTI or AP as defined below: cUTI Signs or symptoms evidenced by at least 2 of the following: - Chills, rigors, or fever (fever must be documented within 24 hours of the screening visit with a temperature of ≥38.0 degrees Celsius [°C] [≥100.4 degrees Fahrenheit (°F)] or rectal/core temperature ≥38.3°C [≥100.9°F], observed and documented by a health care provider); - Elevated white blood cell count (>10,000/ cubic millimeters [mm^3]) or left shift (>15% immature polymorphonuclear leukocytes [PMNs]); - Nausea or vomiting; - Dysuria, increased urinary frequency, or urinary urgency; - Lower abdominal pain or pelvic pain Pyuria evidenced by 1 of the following: - Positive leukocyte esterase (LCE) on urinalysis; - White blood cell count ≥10 cells/mm^3 in unspun urine; - White blood cell count ≥10 cells/high-power field (hpf) in urine sediment At least 1 of the following associated risks: - Indwelling urinary catheter; - Neurogenic bladder with presence or history of urine residual volume of ≥100 mL; - Obstructive uropathy (such as, nephrolithiasis, tumor, fibrosis) that is expected to be medically or surgically treated within 48 hours post randomization; - Azotemia due to intrinsic renal disease; - Urinary retention in men due to previously diagnosed benign prostatic hypertrophy AP Signs or symptoms evidenced by at least 2 of the following: - Chills, rigors, or fever (fever must be documented within 24 hours of the screening visit with a temperature of ≥38.0°C [≥100.4°F] or rectal/core temperature ≥38.3°C [≥100.9°F], observed and documented by a health care provider); - Elevated white blood cell count (>10,000/mm^3), or left shift (>15% immature PMNs); - Nausea or vomiting; - Dysuria, increased urinary frequency, or urinary urgency; - Flank pain; - Costo-vertebral angle tenderness on physical examination Pyuria evidenced by 1 of the following: - Positive LCE on urinalysis; - White blood cell count ≥10 cells/mm^3 in unspun urine; - White blood cell count ≥10 cells/hpf in urine sediment 6. Expectation, in the judgment of the Investigator, that any indwelling urinary catheter or instrumentation (including nephrostomy tubes and/or indwelling stents) will be removed or replaced (if removal is not clinically acceptable) before or as soon as possible, but not longer than 12 hours, after randomization. 7. Expectation, in the judgment of the Investigator that the participant will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study. 8. Women of childbearing potential must have a negative pregnancy test before randomization and be willing to use a highly effective method of contraception between randomization and for 7 days after the completion of the study. A highly effective method of contraception includes 2 of the following: hormonal implants/patch, injectable hormones, oral hormonal contraceptives, prior bilateral oophorectomy, prior hysterectomy, prior bilateral tubal ligation, intra-uterine device, approved cervical ring, condom, true abstinence (if approved by the Investigator), or a vasectomized partner. 9. Willingness to comply with all the study procedures, whether in the hospital or after discharge, for the duration of the study. Exclusion Criteria: 1. Presence of any of the following conditions: 1. Perinephric abscess; 2. Renal corticomedullary abscess; 3. Uncomplicated urinary tract infection; 4. Polycystic kidney disease; 5. Chronic vesicoureteral reflux; 6. Previous or planned renal transplantation; 7. Participants receiving hemodialysis; 8. Previous or planned cystectomy or ileal loop surgery; or 9. Known candiduria. 2. Presence of suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination. 3. Gross hematuria requiring intervention other than administration of study drug. 4. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy). 5. Renal function at screening as estimated by creatinine clearance <50 mL/minute (min) using the Cockcroft-Gault formula. 6. Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization. 7. Any of the following signs of severe sepsis: 1. Shock or profound hypotension defined as systolic blood pressure <90 millimeters mercury (mmHg) or a decrease of >40 mmHg from baseline (if known) that is not responsive to fluid challenge; 2. Hypothermia (temperature <35.6°C or <96.1°F); or 3. Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time ≥2 × the upper limit of normal (ULN) or platelets <50% of the lower limit of normal. 8. Pregnant or breastfeeding women. 9. History of epilepsy or known seizure disorder requiring current treatment with anti-seizure medication. 10. Treatment within 30 days prior to enrollment with valproic acid. 11. Treatment within 30 days prior to enrollment with probenecid. 12. Treatment within 30 days prior to enrollment with any cancer chemotherapy, immunosuppressive medications for transplantation, or medications for rejection of transplantation. 13. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy. 14. Aspartate aminotransferase or alanine aminotransferase >5 × ULN or total bilirubin >3 × ULN. 15. Receipt of any potentially therapeutic antibiotic agent within 48 hours before randomization. Participants with a pathogen-causing cUTI or AP that is resistant to the prior therapy may be enrolled in this study (assuming the organism is known to be sensitive to piperacillin/tazobactam). Participants who develop signs and symptoms of cUTI or AP while on antibiotics may also be enrolled. 16. Prior exposure to vaborbactam alone or in combination with another product. 17. Receipt of any potentially therapeutic antibiotic agent within 48 hours before randomization. EXCEPTIONS: - Participants who received a single dose of a short-acting oral or IV antibiotic (an antibiotic that is typically dosed every 4 hours, every 6 hours, or q8h in a participant with normal renal function). No more than 25% of participants will be enrolled who meet this criterion. - Participants who received >48 hours of prior systemic antibiotic therapy for the current episode of cUTI with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms). - Participants who develop signs and symptoms of cUTI or AP while on antibiotics for another indication. 18. Requirement at time of enrollment for any reason for additional systemic antibiotic therapy (other than study drug) or antifungal therapy. Topical antifungal or a single oral dose of any antifungal treatment for vaginal candidiasis will be allowed. 19. Likely to require the use of an antibiotic for cUTI prophylaxis during the participants participation in the study (from enrollment through the last follow up visit). 20. Known history of human immunodeficiency virus infection and known recent cluster of differentiation 4 count <200/mm^3. 21. Presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term (≥2 weeks) use of systemic corticosteroids. 22. Presence of neutropenia (<1,000 PMNs/mm^3). 23. Presence of thrombocytopenia (<60,000 platelets/mm^3). 24. A corrected QT with Fridericias Formula >480 milliseconds. 25. History of significant hypersensitivity or allergic reaction to meropenem/vaborbactam, piperacillin/tazobactam, any of the excipients used in the respective formulations, or any beta-lactam antibiotics (such as, cephalosporins, penicillins, carbapenems, or monobactams). 26. Known hypersensitivity or inability to tolerate all of the following: fluoroquinolones (including levofloxacin), trimethoprim/ sulfamethoxazole, cefdinir, cefixime, or cefpodoxime, based on prescribing information. 27. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol. 28. An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, or a family member of the employee or the Investigator. 29. Acute Physiology and Chronic Health Evaluation II score >30 (if clinically indicated) 30. Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration. 31. Any recent history of trauma to the pelvis or urinary tract. ; PRIMARY OUTCOME: Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit; SECONDARY OUTCOME 1: Proportion Of Participants In The m-MITT Population With Overall Success[/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 - OPH1003 (w/Lucentis); BRIEF: The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). ; DRUG USED: Fovista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Platelet-derived growth factor (PDGF); THERAPY: Combination; LEAD SPONSOR: Ophthotech Corporation; CRITERIA: Inclusion Criteria: - Subjects of either gender aged ≥ 50 years - Active subfoveal choroidal neovascularization (CNV) secondary to AMD - Presence of sub-retinal hyper-reflective material (SD-OCT) Exclusion Criteria: - Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals - Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids) - Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication - Subjects with subfoveal scar or subfoveal atrophy are excluded - Diabetes mellitus ; PRIMARY OUTCOME: Mean Change in Visual Acuity From Baseline to 12 Months; 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 - TRANSPORT; BRIEF: The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene. ; DRUG USED: Orkambi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of CF - Homozygous for the F508del CFTR mutation - Forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent (%) and less than or equal to (=<) 90% of predicted normal for age, sex, and height - Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit Exclusion Criteria: - An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug - History of solid organ or hematological transplantation - History of alcohol or drug abuse in the past year - Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening. - Use of strong inhibitors, moderate inducers, or strong inducers of Cytochrome P450 3A (CYP3A) within 14 days before Day 1 of dosing ; PRIMARY OUTCOME: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24; SECONDARY OUTCOME 1: Relative Change From Baseline in Percent Predicted FEV1 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 - REAL JP (vs. Norditropin); BRIEF: This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency. ; DRUG USED: Sogroya; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subjects medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation ; PRIMARY OUTCOME: Incidence of Adverse Events, Including Injection Site Reactions; SECONDARY OUTCOME 1: Change in Cross-sectional Total Adipose Tissue Compartments[/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 - RECAPTURE-2; BRIEF: The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis ; DRUG USED: Avycaz; DRUG CLASS: Non-NME; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - 18 to 90 years of age inclusive - Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after - Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem) - Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis Exclusion Criteria: - Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem - Patients urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI - Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant - Patient is immunocompromised - Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality ; PRIMARY OUTCOME: Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test; SECONDARY OUTCOME 1: Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IP157-001; BRIEF: To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone. ; DRUG USED: Aveed; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypogonadism; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Endo Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male with primary or secondary hypogonadism at least 18 years of age and for study part C2 weighs ≥143.3 lb (≥65 kg) - Morning screening serum testosterone concentration <300 ng/dL Exclusion Criteria: - American Urological Association (AUA) Symptom Score ≥15 or significant prostatic symptoms - History of carcinoma, tumors or induration of the prostate or the male mammary gland including suspicion thereof - Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the prostate (size >75 cm3 as measured by transrectal ultrasonography) - Past or present liver tumors or acute or chronic hepatic disease with impairment of liver function; liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) exceeding 1.5 times upper limit of normal - History of deep vein thrombosis in the past 5 years or any history of cerebrovascular accident - Severe acne - Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg) or coronary heart disease not stabilized by therapy as assessed by the investigator - Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C) level is >9% - Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7 days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit and throughout the study (exclusive of administered study drug) - Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by any application method within the 28 days prior to first administration of study drug and throughout the study (exclusive of administrated study drug) - Medication with substances which might interfere with testosterone metabolism within 28 days before the first administration of study drug - History of sleep apnea Insulin-dependent diabetes mellitus - Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug) ; PRIMARY OUTCOME: Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C; SECONDARY OUTCOME 1: Serum Total Testosterone Maximum Concentration in Part A[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ReLive; BRIEF: The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and with good liver functions are eligible. Only those who can not benefit from treatment for which efficacy is demonstrated are eligible. These patients are usually proposed either best standard of care (BSC) or participation to clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or DT at 30 mg/m2 or the BSC. ; DRUG USED: Livatag; DRUG CLASS: Non-NME; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: Valerio Therapeutics; CRITERIA: Inclusion Criteria: - Male or non-pregnant, non-breast feeding female; - Aged ≥ 18 years; - Patient with: - advanced HCC (BCLC-C according to BCLC staging classification) having progressed under Sorafenib therapy or intolerant to Sorafenib, or; - intermediate HCC (BCLC-B) non eligible or non responders to transarterial chemoembolization (TACE), and having progressed under or intolerant to Sorafenib therapy - Patients with porta hepatis lymph nodes, extrahepatic metastases, or portal/suprahepatic vein thrombosis without extension in inferior/superior vena cava, are eligible; - HCC diagnosed according to the American Association for Study of Liver Diseases (AASLD) and/or European Association for the Study of the Liver (EASL) criteria: - Radiological Criteria applicable in cirrhotic liver: - Nodule ≥ 10 mm: one imaging technique among MRI and CT-scan showing typical appearances for HCC defined as arterial enhancement and rapid washout in portal venous or delayed phase; - If appearance not typical for HCC on initial imaging: second contrast enhanced study (CT or MRI) showing typical appearances for HCC defined as arterial enhancement and rapid wash-out in portal venous or delayed phase; - And/Or cyto-histology criteria (e.g. in case of atypical lesions for HCC at imaging, absence of cirrhosis); - Without cirrhosis or with a non decompensated cirrhosis (Child-Pugh score from A5 to B7 included); - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1; - Laboratory tests as follows: - Platelets ≥ 50,000 /mm3 - Neutrophil count ≥ 1000/mm3 - Hemoglobin ≥ 10g/dL - Serum transaminases < 5 upper limit normal (ULN) (NCI/common toxicity criteria (CTC) grades 0, 1, or 2) - Alkaline phosphatases < 5 ULN (NCI/CTC grades 0, 1, or 2) - Serum bilirubin < 35 micromolar (µM)/L (or 2.0 mg/dL); - Signed and dated written informed consent form. Exclusion Criteria: - Cirrhosis with a Child-Pugh score B8-C15; - Untreated chronic hepatitis B; - Patients eligible for curative treatments (transplantation, surgical resection, percutaneous treatment); - Patients eligible for palliative treatments with demonstrated efficacy: TACE, Sorafenib; Patients who failed to Sorafenib treatment or intolerant to sorafenib are eligible and can be included if Sorafenib has been stopped at least 2 weeks before randomization; - Prior history of malignancy with the exception of adequately treated basal cell carcinoma or in situ cervical cancer in complete remission since five years at least; - HCC developed on transplanted liver; - HIV infection; - Risk of variceal bleeding; - Oxygen saturation (SaO2) < 95%; - Presence of a significant acute or chronic respiratory disease defined as NCI/CTCAE > grade 2; - Presence of recent (< 6 months) or current cardiac failure (class III or IV New York Heart Association (NYHA) classification), recent (< 6 months) acute coronary syndrome, clinically significant ECG abnormalities or recent (less than 6 months) acute vascular diseases (stroke, myocardial infarction (MI)…); - Prior cumulative dose of 300 mg/m² of doxorubicin or equivalent; - Patients currently treated with immunosuppressive agents that cannot be stopped; - Patients whose medical or surgical conditions are unstable and may not allow the study completion or compliance, and specially patients with uncontrolled diabetes; - Uncontrolled systemic infection; - Patients with a life expectancy of less than 2 months; - Patients who have received an experimental drug in another clinical trial in the last 30 days prior to randomization in the present clinical trial; - Women of child-bearing age who are unwilling or unable to use an effective contraception method during the study treatment period and for 6 months after the last administration of study drug, and their male partner(s) refusing to use a condom (if applicable); - Men who are unwilling or unable to use a condom during the study treatment period and for 6 months after the last administration of study drug, and their female partner(s) refusing to use one of the appropriate effective contraception methods (if applicable); - Patients unwilling or unable to comply with protocol requirements and scheduled visits. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASCENT; BRIEF: The objective of this study is to assess the efficacy of SC411 in reducing the number of sickle cell crisis (SCC) events in sickle cell disease (SCD) subjects receiving SC411 compared to those subjects receiving placebo. ; DRUG USED: Altemia; DRUG CLASS: Non-NME; INDICATION: Sickle Cell Anemia; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Micelle BioPharma Inc; CRITERIA: Inclusion Criteria: Patients who meet all of the following criteria will be eligible to participate in the study: 1. 1. Aged ≥ 5 years and ≤ 17 years at screening; 2. Has been diagnosed with SCD (that includes the genotypes HbSS, HbSC, and HbS/β°-thalassemia, documented by hemoglobin HPLC or electrophoresis); 3. Has had between ≥ 2 to ≤10 episodes of acute SCC (as defined above) within 12 months of the Screening Visit. At least one crisis must have been managed in a hospital, clinic, or emergency room. For at least 2 of the episodes, the site must obtain the documentation created in a medical record at the time of the event. 4. Must not be receiving HU or L-Glutamine, or if receiving HU and/or L-Glutamine must be at a stable weight-based treatment regimen (mg/kg), for at least 3 months prior to the Screening Visit with the intent to continue at a weight-based dose level at the discretion of the treating physician for the duration of the study, other than for safety reasons. If taking HU and/or L-glutamine, subjects must have had at least one SCC event (as previously defined) while on HU and/or L-Glutamine. 5. Has a parent or guardian who is able to give written informed consent, and the potential pediatric subject must be able to provide assent in a manner approved by the Institutional Review Board (IRB) and comply with the requirements of the study; and 6. If post pubertal in the opinion of the Investigator, must agree to use a reliable method of birth control (e.g., barrier, birth control pills, abstinence) during the study and for 1 month following the last dose of study drug. Exclusion Criteria Patients who meet any of the following criteria will be excluded from participation in the study: 1. A known allergy or hypersensitivity to fish or shellfish; 2. A known allergy or hypersensitivity to soy; 3. Inability to swallow capsules; 4. History of treatment with SC411; 5. Confirmed diagnosis of chronic pain or chronic opioid use: Defined as pain experienced ≥3 days per week over a 6-month period or daily opioid use for pain management; 6. Active infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C; 7. Prothrombin time > 1.5 x ULN at screening; 8. Required regular anticoagulation or chronic aspirin therapy; 9. Moderate thrombocytopenia, defined as platelets < 80,000/µL at screening; 10. History of stroke or Moyamoya syndrome; 11. Abnormal results on most recent transcranial Doppler (TCD) evaluation; 12. Received blood transfusion or blood products in the 2 months prior to the Screening Visit or on chronic blood transfusion; 13. Chronic renal insufficiency, defined as a eGFR < 30ml/min at screening as estimated by the Schwartz equation (Appendix H), or requiring peritoneal or hemodialysis; 14. Abnormal liver function tests (ALT > 3.0 x ULN) at screening; 15. Received any organ transplant; 16. Has a recent acute illness or other concomitant chronic medical or psychiatric condition that in the opinion of the Investigator would compromise participation in the study, prevent adherence to the protocol or confound the evaluation of the study outcome; 17. Is pregnant or lactating, or has the intention of becoming pregnant during the study (if a female of child-bearing potential or partner of a female of child-bearing potential and sexually active and not willing to use an effective means of birth control); 18. Is currently taking or has been treated with any form of omega-3 fatty acid or fish oil supplement within 30 days of the Screening Visit, or intends to do so during the course of the study; 19. Has been treated with any investigational product within 30 days of the Screening Visit or intends to receive an investigational product during the course of this study; and 20. There are factors that, in the judgment of the Investigator, would make it difficult for the patient to comply with the requirements of the study ; PRIMARY OUTCOME: Assessment of the efficacy of SC411 in reducing the number of sickle cell crisis (SCC) events in subjects compared to placebo will be measured by counting the number of sickle cell crises that occur after randomization.; SECONDARY OUTCOME 1: Evaluation of the effect of SC411 compared to placebo by measuring the time until the patients first sickle cell event.[/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 - POLARIS-3; BRIEF: The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis. ; DRUG USED: Vosevi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides), HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent - HCV RNA ≥ 10^4 IU/mL at screening - Chronic genotype 3 HCV infection (≥ 6 months) - Presence of cirrhosis - HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen - Use of protocol specified methods of contraception Key Exclusion Criteria: - Current or prior history of clinically significant illness that may interfere with participation in the study - Screening ECG with clinically significant abnormalities - Laboratory parameters outside the acceptable range at screening - Pregnant or nursing female - Chronic liver disease not caused by HCV - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric; BRIEF: The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children. Primary Objective: To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among children aged 6 months to less than 9 years of age Secondary Objective: To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates. Observational Objective: To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2. ; DRUG USED: Fluzone Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: - Subject is 6 months to < 9 years of age on the day of inclusion. - Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. - Subject is in reasonably good health as assessed by the Investigator. - Informed consent is granted by the parent(s) or other legally acceptable representative; assent by subjects 7 to < 9 years of age. - For subjects 6 months to < 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs). Exclusion Criteria: - History of allergy to egg proteins or any constituents of the vaccine. - History of serious adverse reaction to any influenza vaccine. - Any vaccination scheduled between Visit 1 and Visit 2 (or Visit 1 and Visit 3 for those requiring two doses). - Receipt of any vaccine in the 4 weeks preceding the first study vaccination. - Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. - Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine. - Personal history of Guillain-Barré syndrome. - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). - Personal or immediate family history of congenital immune deficiency. - Personal developmental delay, neurologic disorder, or seizure disorder. - Any chronic illness that, in the opinion of the Investigator, is not well controlled and may interfere with trial conduct or completion, or with assessment of adverse events. - Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C. - Receipt of blood or blood-derived products (including immunoglobulin therapy) in the past 3 months, which might interfere with assessment of the immune response. - Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator. ; PRIMARY OUTCOME: Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants; 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 - SP756 (Extension); BRIEF: The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy ; DRUG USED: Vimpat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Collapsin Response Mediator Protein 2 (CRMP-2), Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: UCB BIOSCIENCES, Inc.; CRITERIA: Inclusion Criteria: - Completion of parent clinical trial for treatment of partial seizures Exclusion Criteria: - Receiving any study drug or experimental device other than lacosamide - Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event ; PRIMARY OUTCOME: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years); SECONDARY OUTCOME 1: Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - China/Asia; BRIEF: The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea. ; DRUG USED: Invokana; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c >=7.0% and <=10.5% at Week -2 are eligible for enrollment in the study. Exclusion Criteria: - History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy - Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling - History of a severe hypoglycemic episode within 6 months before screening - History of or current illness considered to be clinically significant by the investigator ; PRIMARY OUTCOME: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18; SECONDARY OUTCOME 1: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18[/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 - Face/Chest; BRIEF: The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment. ; DRUG USED: LEO 43204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Mitochondria, Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: - Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest - Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area Exclusion Criteria: - Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC - Treatment with ingenol mebutate gel in the treatment area within the last 12 months - Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions) - History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum) ; PRIMARY OUTCOME: Percentage of Participants With Complete Clearance of Actinic Keratosis (AK); SECONDARY OUTCOME 1: Percentage of Participants With Partial Clearance (Multiple Imputation)[/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 - PETIT2 (Pediatric); BRIEF: The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag. ; DRUG USED: Promacta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Written informed consent must be obtained from the patients guardian and accompanying informed assent from the patient (for children over 6 years old) - Patients must be between 1 year and <18 years of age at Day 1 - Patients will have a confirmed diagnosis of chronic ITP for at least 1 year, at screening, according to the guidelines published in the International Working Group Report - A peripheral blood smear or bone marrow examination will support the diagnosis of ITP with no evidence of other causes of thrombocytopenia. - Patients must be refractory or have relapsed after at least one prior ITP therapy, or patients must be unable, for a medical reason, to continue other ITP treatments. - Patients must have a Day 1 (or within 48 hours prior) platelet count <30 Gi/L. - Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1, or these therapies must have been completed at least 1 week prior to Day 1 and have been clearly ineffective. - Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1. - Patients treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1. - Patients must have a complete blood count (CBC) not suggestive of another hematological disorder. - Patients must have the following laboratory results: - prothrombin time international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range. - clinical chemistries that do NOT exceed the upper limit of normal reference range by more than 20% for the following: creatinine, ALT, AST, total bilirubin, and alkaline phosphatase. - total albumin that is not below the lower limit of normal by more than 10%. - Female patients of child-bearing potential (after menarche) must: - have a negative pregnancy test within 24 hours of first dose of study treatment, - agree and be able to provide a blood or urine specimen for pregnancy testing during the study, - agree to use effective contraception during the study and for 28 days following the last dose of study treatment, and not be lactating. - Male patients with a female partner of childbearing potential must agree to use effective contraception from 2 weeks prior to administration of the first dose of study treatment until 3 months after the last dose of study treatment. - In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: - Patients with any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the patient unsuitable for participation in the study or suggests another primary diagnosis (e.g. Thrombocytopenia is secondary to another disease). - Patients with concurrent or past malignant disease, including myeloproliferative disorder. - Patients expected not to be suitable for continuation of their current therapy for at least 13 additional weeks. - Patients with a history of platelet agglutination abnormality that prevents reliable measurement of platelet counts. - Patients with a diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis c virus infection, or any evidence of active hepatitis at the time of subject screening. - Patients with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis). - Patients with known inherited thrombocytopenia (e.g. MYH9 disorders). - Patients treated with any medication that affects platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDS) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1. - Patients who have received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1. - Patients who have previously received eltrombopag or any other thrombopoietin receptor agonist. - Any patient considered to be a child in care, defined as one who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. This can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or who has an appointed legal guardian. - Patients who have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or excipients that contraindicates their participation. - Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with the patients safety or compliance to the study procedures. ; PRIMARY OUTCOME: Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1; SECONDARY OUTCOME 1: Percentage of Responders[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LUME-Lung 2 - w/Pemetrexed; BRIEF: The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained. ; DRUG USED: Ofev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , Platelet-derived growth factor receptor (PDGFR), Src Kinase Family, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Male or female patient aged 18 years or older. 2. Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or recurrent non small cell lung cancer (NSCLC) (non squamous histologies) 3. Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy). 4. At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT. 5. Life expectancy of at least three months. 6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 7. Patient has given written informed consent which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation. Exclusion criteria: 1. Previous therapy with other vascular endothelial growth factor (VEGF) inhibitors (other than bevacizumab) or pemetrexed for treatment of NSCLC 2. Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial 3. Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks 4. Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days 5. Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants). Dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation) 6. Radiographic evidence of cavitary or necrotic tumors 7. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels 8. History of clinically significant haemoptysis within the past 3 months 9. Therapeutic anticoagulation 10. History of major thrombotic or clinically relevant major bleeding event in the past 6 months 11. Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, 12. Inadequate kidney, liver, blood clotting function 13. Inadequate blood count 14. Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial 15. Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma 16. Pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall) 17. Major injuries and/or surgery within the past ten days prior to start of study drug 18. Incomplete wound healing 19. Active or chronic hepatitis C and/or B infection Additional exclusion criteria apply ; PRIMARY OUTCOME: Progression Free Survival (PFS) as Assessed by Central Independent Review; SECONDARY OUTCOME 1: Overall Survival (Key Secondary Endpoint)[/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 - SUSTAIN 8 (vs. Canagliflozin); BRIEF: This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening - Any disorder which in the investigators opinion might jeopardise subjects safety or compliance with the protocol - Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis (DKA) - Any of the following: myocardial infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as eGFR below 60 ml/min/1.73 m^2 as defined by Kidney Disease Improving global outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed - Medical history of diabetes-related lower limb amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to screening ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Change in Body Weight (kg)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TAK-491CLD-308; BRIEF: The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in adults with essential hypertension. ; DRUG USED: Edarbyclor; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Na/Cl transporter - Thiazide-sensitive; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on Day, or has not received antihypertensive treatment within 14 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day 1. - Females of childbearing potential who are sexually active agree to routinely use adequate contraception, and can neither be pregnant nor lactating from before study participation to Screening to 30 days after the last study drug dose. - Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant. - Is willing to discontinue current antihypertensive medications up to 3 weeks before enrollment. Exclusion Criteria: - Has a mean clinic diastolic blood pressure (sitting, trough) greater than 119 mm Hg on Day 1. - Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushings syndrome). - Has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack. - Has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome). - Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. - Has severe renal dysfunction or disease. - Has known or suspected unilateral or bilateral renal artery stenosis. - Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. - Has poorly-controlled type 1 or 2 diabetes mellitus at Screening. - Has hypokalemia or hyperkalemia at Screening. - Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening. - Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow according to the protocol. - Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds. - Has been randomized/enrolled in a previous azilsartan or azilsartan medoxomil plus chlorthalidone study. - Currently is participating in another investigational study or has received any investigational compound within 30 days prior to Screening. - Has a history of drug abuse or a history of alcohol abuse within the past 2 years. - Is taking or expected to take any excluded medication, including: - Antihypertensive medications must be discontinued completely by Day -14, except antihypertensive medications used in the open-label treatment period in accordance with the titration-to-target blood pressure titration. - Angiotensin II receptor blockers or thiazide-type diuretics other than study medication. - Over-the-counter products not permitted by investigator. ; PRIMARY OUTCOME: Percentage of Participants With at Least 1 Adverse Event; SECONDARY OUTCOME 1: Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)[/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 - 2500 pts; BRIEF: The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults ; DRUG USED: Otenabant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: Cannabinoid-1 (CB1) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Obese adults with a body mass index > or = 30 kg/m2; > or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia Exclusion Criteria: - Pregnancy - Diabetes - Adults with serious or unstable current or past medical conditions ; PRIMARY OUTCOME: Proportion of subjects with 5% weight loss; SECONDARY OUTCOME 1: Blood pressure, blood lipids and glucose, waist circumference, quality of life[/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 - Chronic Low Back Pain and Osteoarthritis of Hip or Knee; BRIEF: The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip. ; DRUG USED: Fasinumab; DRUG CLASS: Biologic; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Nerve growth factor (NGF)/receptor; THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit) 2. Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening 3. History of inadequate relief of CLBP from non-pharmacologic therapy 4. Willing to undergo joint replacement (JR) surgery, if necessary 5. History of regular analgesic medication use 6. History of inadequate pain relief or intolerance to analgesics used for chronic LBP Key Exclusion Criteria: 1. Patient is not a candidate for MRI 2. History of major trauma or back surgery in the past 6 months prior to the screening visit 3. History or presence of pyriformis syndrome 4. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions 5. History or evidence on joint imaging of conditions that may confound joint safety evaluation 6. Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol 7. Recent use of longer acting pain medications 8. Other medical conditions that may interfere with participation or accurate assessments during the trial Note: Other protocol defined Inclusion/ Exclusion criteria apply. ; PRIMARY OUTCOME: Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score; SECONDARY OUTCOME 1: Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EXPEDITION EXT; BRIEF: This study is an open-label extension study in Alzheimers patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683). ; DRUG USED: Solanezumab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimers Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimers Disease - Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks - Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study - Must have good vein access to administer infusions - Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study ; PRIMARY OUTCOME: Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs); SECONDARY OUTCOME 1: Change From Baseline to 104-week Endpoint in Alzheimers Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)[/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 - PROLONG-9FP; BRIEF: This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. ; DRUG USED: Idelvion; DRUG CLASS: Biologic; INDICATION: Hemophilia B; TARGET: Coagulation Factor IX; THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Male subjects, 12 to 65 years old - Severe hemophilia B (FIX activity of ≤ 2%) - Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for > 150 exposure days (EDs) - No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX - Written informed consent for study participation - On-demand subjects only, who have experienced a minimum average of 2 non-trauma induced bleeding episodes requiring treatment with a FIX product during the previous 6 or 3 months Exclusion Criteria: - Known hypersensitivity to any FIX product or hamster protein - Known congenital or acquired coagulation disorder other than congenital FIX deficiency - HIV positive subjects with a CD4 count < 200/mm3 - Low platelet count, kidney or liver dysfunction - Recent life-threatening bleeding episode ; PRIMARY OUTCOME: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized); SECONDARY OUTCOME 1: The Frequency of Related Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AA-GYN-002; BRIEF: The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries. ; DRUG USED: Adhexil; DRUG CLASS: Biologic; INDICATION: Wound Healing; TARGET: Plasminogen; THERAPY: Monotherapy; LEAD SPONSOR: OMRIX Biopharmaceuticals; CRITERIA: Inclusion Criteria: - Female patients aged 18-45 years at screening. - Patients undergoing elective laparoscopic surgery involving at least one adnexa. Exclusion Criteria: - Pregnant (including ectopic pregnancy) or breastfeeding patient. - Patients with a documented diagnosis of cancer. - Patients with a lymphatic, hematologic or coagulation disorder. - Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™. - Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. - Patients who have participated in another clinical study within 30 days of enrolment. - Investigators opinion that the patient is medically unfit or would be at major risk if enrolled into the study. ; PRIMARY OUTCOME: Adhesions will be assessed according to incidence, extent and severity.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MB102-077 - Hypertensive Pts; BRIEF: The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Written informed consent - Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105 - Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit - Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for at least 4 weeks - C-peptide ≥ 0.8 ng/mL - Body Mass Index ≤ 45.0 kg/m2 - Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women Exclusion Criteria: - Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0*upper limit of normal (ULN) - Serum total bilirubin ≥ 1.5*ULN - Creatinine kinase > 3*ULN - Symptoms of severely uncontrolled diabetes - History of malignant or accelerated hypertension - Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases ; PRIMARY OUTCOME: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants; SECONDARY OUTCOME 1: Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III (China); BRIEF: This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment. ; DRUG USED: Pradefovir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: DNA polymerase, Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Xian Xintong Pharmaceutical Research Co.,Ltd.; CRITERIA: Inclusion Criteria: - Age from 18 to 65 years old, male or female. - Meets the diagnosis and treatment standards of chronic hepatitis B( HBsAg or HBV DNA positive over 6 months, or diagnosed by liver biopsy. - For HBeAg positive, HBV DNA equal or over 20000 IU/ml; for HBeAg negative ,HBV DNA equal or over 2000 IU/ml. - ALT level between 1.2 ULN to 10 UNL. - Treatment naive or experienced when any nucleos(t)ide analogs or interferons stopped over 6 months. - Use of effective contraceptive measures if procreative potential exists. - Written informed consent. Exclusion Criteria: - Allergic to study drug,metabolite product or excipient. - Evidence of hepatic decompensation such as Child-Pugh B or C, with previous gastroesophageal variceal haemorrhage, hepatic encephalopathy, ascites - Suspected or confirmed hepatocellular carcinoma, or AFP>50μg/L. - Other liver diseases (such as Chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease). - Resistant to antiviral drugs (adefovir or tenofovir). - Concommitant disease of severe heart, blood, respiratory and central nervous system diseases. - Chronic kidney diseases, or Ccr<60ml/min at screening. - Abnormal hematological and biochemical parameters at screening: White blood cell count less than 3.0×109/L，or neutrophil count less than 1.5×109/L，or platelet count less than 80×109/L，or total bilirubin more than 2ULN，or the prolong of PT more than 3s. - Positive-HCV or positive-HIV. - Severe bone disease (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, rickets) or multiple fractures. - History of pancreatitis or malignancy within 5 years (excluding cervical epithelial carcinoma, squamous epithelial carcinoma, or basal cell carcinoma of the skin that was clinically cured within 5 years of diagnosis). - Plan to receive or have already had an organ transplant. - Subject with disabilities as prescribed by law (blindness, deafness, deafness, deafness, mental disorders, etc.). - History of alcohol or drug abuse within the last 1 year. - Pregnant or lactating women. - Participated in any clinical trial or taken any IMP (investigational medical product) within 3 months prior to the trial. - Other cases that could not be enrolled in the judgement of the investigators. ; PRIMARY OUTCOME: HBV viral suppression; SECONDARY OUTCOME 1: HBV viral suppression[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Insulin Alone or on Insulin w/Metformin (China); BRIEF: A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination with Metformin ; 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: 1. Provision of informed consent before participating in the study. 2. Diagnosed with type 2 diabetes. 3. Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG<270 mg/dL (15mmol/L). At Day -4 visit, HbA1c ≥7.5% and ≤10.5%. and FPG<270 mg/dL (15mmol/L)). 4. On a stable dose of insulin for 8 weeks or longer prior to screening. 5. If taking metformin, subjects should have been taking the same daily dose for 8 weeks or longer prior to screening. 6. Insulin type should be intermediate-acting or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as one component). 7. Body mass index ≤45 kg/m^2. Exclusion Criteria: 1. Women of childbearing potential unable or unwilling to use acceptable birth control. 2. Women who are pregnant or breastfeeding. 3. Symptoms of poorly controlled diabetes. including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms. 4. Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable clinical significant arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident. 5. Congestive heart failure 6. Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled). 7. History of unstable or rapidly progressing renal disease. 8. History of alcohol or drug abuse within the previous year. 9. Unstable major psychiatric disorders. 10. History of hemoglobinopathies 11. Immunocompromised status 12. Severe liver disease. 13. In subjects treated with insulin alone a calculated creatinine clearance <50 ml/min. In patients treated with insulin in combination with metformin a calculated creatinine clearance <60 ml/min or serum creatinine > 1.5 mg/dL in males or > 1.4mg/dL in females. 14. Anemia ; PRIMARY OUTCOME: Change in HbA1c From Baseline to Week 24; SECONDARY OUTCOME 1: Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test[/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 - C-05-35 - Acute Otitis Media; BRIEF: The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes. ; DRUG USED: Vigadexa; DRUG CLASS: Non-NME; INDICATION: Ear Infections (Antibacterial); TARGET: Glucocorticoid Receptor (GR), Topoisomerase II (DNA gyrase) and IV; THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - 6 months to 12 years old - Ear tubes in one or both ears - Ear drainage visible by the parent / guardian - Ear drainage less than 21 days - Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube - Patient may not have non-tube otorrhea - Patient may not have had otic surgery other than tube placement in the last year - Patient may not be a menarchal female - Diabetic patients are not eligible - Patient may not have any disease or condition that would negatively affect the conduct of the study - Patient may not require any other systemic antimicrobial therapy during the study - Patient must meet certain medication washouts to be eligible - Analgesic use (other than acetaminophen) is not allowed - Patient may not be pre-disposed to neurosensory hearing loss - Other protocol-defined inclusion criteria may apply Exclusion Criteria: - Age related - Other protocol-defined exclusion criteria may apply ; PRIMARY OUTCOME: Clinical cure rate at the test of cure visit as determined by the investigator; SECONDARY OUTCOME 1: Time to cessation of otorrhea[/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 - SGTP-002; BRIEF: Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in patients who will be recipients of a donation after brain death (DBD) donor kidney. ; DRUG USED: SANGUINATE; DRUG CLASS: Biologic; INDICATION: Delayed Graft Function (DGF); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Prolong Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Able to understand and provide written informed consent. 2. Male or female subject at least 18 years of age. 3. Dialysis-dependent renal failure initiated at least 3 months prior to transplantation. 4. Subject is to be the recipient of a first kidney transplant from a deceased donor (brain death criteria). 5. Is able to receive intravenous infusions of study drug. 6. Anticipated donor organ cold ischemia time < 30 hours. 7. A calculated prediction of DGF risk of least 25%. 8. Females of childbearing potential must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period. 9. Male subjects must agree to use condoms or other suitable means of pregnancy prevention. Exclusion Criteria: 1. Has received a blood transfusion of packed red blood cells (PRBC), other than with leukocyte-poor blood, within the 90-day period prior to screening. 2. Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor. 3. Recipient of donor kidney preserved with normothermic machine perfusion. 4. Is scheduled to undergo multi-organ transplantation. 5. Has planned transplant of kidney(s) from a donor < 6 years of age. 6. Has planned transplant of kidneys that are implanted en bloc (dual kidney transplant). 7. Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc. 8. Body Mass Index (BMI) > 38 kg/m2 9. Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another Investigational New Drug) for ischemic/reperfusion injury immediately prior to organ recovery. 10. Is scheduled to receive an blood type-incompatible donor kidney. 11. Has undergone desensitization to remove antibodies prior to transplantation. 12. Total bilirubin > 1.5 mg per dL, transaminase more than twice the upper limit of normal or evidence of hepatic insufficiency 13. Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest. Potential subjects participating in a strictly observational study or a study involving approved treatments should be discussed with the Medical Monitor. 14. Has a history of human immunodeficiency virus (HIV) 15. History or presence of active substance abuse (illicit drugs or alcohol) in the previous 6 months, as believed by the Investigator 16. Presence of ECG-based evidence of acute myocardial infarction, unstable angina, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability 17. History or presence of any disease or psychiatric condition that in the Investigators assessment that would increase the risk to subjects associated with study participation, drug administration or interpretation of results 18. History of biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ skin lesions, carcinoma of the cervix in situ, or early detected prostate cancer. 19. Female subject who is pregnant or breast feeding. ; PRIMARY OUTCOME: Reduction of delayed graft function (DGF); SECONDARY OUTCOME 1: Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant[/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 - STRATOS 1 (Adults/Adolescents); BRIEF: A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist ; DRUG USED: Tralokinumab; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Age 12 -75 2. Documented physician-diagnosed asthma. 3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA 4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV. 5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1 6. ACQ-6 score ≥1.5 Exclusion Criteria: 1. Pulmonary disease other than asthma 2. History of anaphylaxis following any biologic therapy 3. Hepatitis B, C or HIV 4. Pregnant or breastfeeding 5. History of cancer 6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years 7. Previous receipt of tralokinumab ; PRIMARY OUTCOME: Annualised Asthma Exacerbation Rate (AAER) up to Week 52; SECONDARY OUTCOME 1: Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)[/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 - 1222.12; BRIEF: This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD). ; DRUG USED: Striverdi Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - All patients must have a diagnosis of chronic obstructive pulmonary disease - Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 <80% predicted and post-bronchodilator FEV1/FVC <70% Exclusion criteria: - Patients with a significant disease other than COPD - Patients with a history of asthma - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis ; PRIMARY OUTCOME: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks); SECONDARY OUTCOME 1: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TOPICAL (NCI); BRIEF: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer. ; DRUG USED: Tarceva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: University College, London; CRITERIA: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Advanced disease (stage IIIB or IV) - Diagnosis within 62 days prior to randomization - Not suitable for first-line chemotherapy, as defined by the following criteria*: - ECOG performance status 2-3 - ECOG performance status 0-1 AND creatinine clearance < 60 mL/min - NOTE: *These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis - No symptomatic brain metastases PATIENT CHARACTERISTICS: - Estimated life expectancy of at least 8 weeks - Able to take oral medication - Not pregnant or nursing - Fertile patients must use effective contraception - No severe uncontrolled infection - No unstable angina - No myocardial infarction within the past month - No uncontrolled inflammatory bowel disease (e.g., Crohns disease or ulcerative colitis) - No acute renal failure - Bilirubin < 2 times upper limit of normal (ULN) - Transaminases < 2 times ULN (5 times ULN if liver metastases are present) - Creatinine < 5 times ULN - No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications - No other prior or current malignant disease likely to interfere with study treatment or comparisons PRIOR CONCURRENT THERAPY: - No prior chemotherapy - No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab) - No prior palliative radiotherapy - Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks - No concurrent cyclooxygenase-2 inhibitors ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Progression free survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GAIT 1; BRIEF: The purpose of this study is to determine whether Granexin gel is safe and effective in the treatment of diabetic foot ulcers. ; DRUG USED: Granexin Gel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Foot and Other Ulcers; TARGET: Unknown; THERAPY: Combination; LEAD SPONSOR: Xequel Bio, Inc.; CRITERIA: Inclusion Criteria: Both male and female participants may participate in the study. To be eligible for entry into this study, a patient must meet all of the following Inclusion criteria: 1. Age 18 years or older 2. Established diagnosis of diabetes mellitus (type I or II) 3. Glycosylated hemoglobin (HbA1c) value < 12.0% at the screening visit 4. Diagnosis of neuropathic foot ulcer by 10g monofilament test, tuning fork (128 Hz), or cotton wisp 5. Designated foot ulcer meets the following criteria at both the screening and baseline visits: 1. Present for at least 4 weeks 2. Full-thickness cutaneous ulcer below the ankle surface 3. University of Texas grade A1 4. Wound area (after debridement) 1 to 40.0 cm2 5. Viable, granulating wound (investigator discretion) 6. Ankle brachial index ≤ 0.7 at both the screening and baseline visits. If the ABI is >1.30, one of the following confirmatory tests must be performed for the patient to be considered eligible: 1. Does Not have a monophonic or biphasic flow (with the loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, as determined by standard practices of the investigator and the site. 2. Transcutaneous oxygen pressure (TcPO2) at the foot >40 mmHg Additionally, patients must meet all other protocol-defined eligibility criteria. 7. Signed informed consent 8. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence throughout until 2 weeks after the last administration of investigational product. Male patients must also agree to use contraception such as a condom. Exclusion Criteria: Patients will not be eligible for enrollment in the study if they meet any of the exclusion criterial listed below: 1. Change (decrease or increase) in size of the designated target ulcer by ≥ 30% during the 7-day screening period 2. Cannot tolerate the off-loading methods or cannot comply with study related procedures 3. Has an ulcer that meets any of the following criteria: 1. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site 2. Requires surgical debridement 3. Is positive for β-hemolytic streptococci upon culture performed prior to screening debridement procedure 4. Has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure 5. Is highly exuding (i.e., requires daily change of dressing) 4. Requires total contact cast 5. Ankle brachial pressure index < 0.7 6. Has a local or systemic infection or local lymphangitis ≥ 0.5 cm 7. Has any 1 of the following (only 1 of the 2 tests is required): 1. A monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries 2. Transcutaneous oxygen pressure (TcPO2) at the foot <40 mgHg 8. Presence of active malignant or benign tumor of any kind, (with the exception to nonmelanoma skin cancer as per investigators discretion) 9. Congestive heart failure (New York Heart Association class II-IV) 10. Coronary heart disease with ST segment elevation myocardial infarction or coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the last 6 months 11. Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI 12. Active connective tissue disease 13. Acute or chronic Charcots neuro-arthropathy as determined by clinical and/or radiographic examination 14. Active treatment with systemic corticosteroids or topical corticosteroids (for treatment of the target ulcer or any area of the foot). This does not include inhaled corticosteroids used for conditions other than treating the target ulcer or any area of the foot. Wash out period for systemic corticosteroids is 14 days for inclusion in this study. Wash out period for topical corticosteroids (for treatment of the target ulcer or any area of the foot) is 14 days for inclusion in the study) 15. Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for the inclusion in the study) 16. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation 17. Pregnant or nursing mothers 18. Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males) 19. Estimated glomerular filtration rate < 25 mL/min 20. Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl) 21. Significant peripheral edema as per investigators discretion 22. Known inability or unavailability of a patient to complete required study visits during study participation 23. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patients medical history, which, in the opinion of the investigator, may pose a threat to patient compliance 24. Use of a platelet-derived growth factor within 28 days before screening 25. Use of any investigational drug or therapy within 28 days before screening 26. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study ; PRIMARY OUTCOME: Incidence of complete wound closure at Week 12 based on investigator assessment; SECONDARY OUTCOME 1: Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Palliative Chemotherapy; BRIEF: The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy. ; DRUG USED: CV-301; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Carcinoembryonic antigen (CEA), Immune System, Mucin 1 (MUC-1); THERAPY: Monotherapy; LEAD SPONSOR: Therion Biologics Corporation; CRITERIA: Inclusion Criteria: - Patients > 18 years of age who have been vaccinated against smallpox; - Histologically confirmed diagnosis of adenocarcinoma of the pancreas; - Patient has metastatic (Stage IV) disease; - ECOG performance status 0-1; - Failed a gemcitabine-containing chemotherapeutic regimen within 3 months of study entry. Exclusion Criteria: - Prior or concurrent immunotherapy for cancer; - Radiation therapy within 28 days prior to registration; - Systemic corticosteroid therapy (except inhaled or topical steroids) within 28 days of registration; - Significant cardiovascular abnormalities or diseases; - Known positive for HIV, hepatitis B and/or C; - Evidence of immunodeficiency or immune suppression. ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LIN-MD-02 - Safety (FRX); BRIEF: The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C). ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Patients must have - entered study LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimum completed the pre-treatment period or - completed one of the following studies: MCP-103-004 [NCT00306748], MCP-103-005 [NCT00258193], MCP-103-201 [NCT00402337], MCP-103-202 [NCT00460811] - Sexually active patients of childbearing potential agree to use birth control - Females of childbearing potential must have a negative urine pregnancy test prior to dosing - Lactating females must agree not to breastfeed - Patient must meet protocol criteria for CC or IBS-C Exclusion Criteria: - Patient must not use protocol-defined prohibited medicine - Patient is planning to receive an investigational drug at any time during the study - Patient has an unresolved AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test ; PRIMARY OUTCOME: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs); 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 - ZS-01-305 (China); BRIEF: The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure. ; DRUG USED: Neucardin; DRUG CLASS: Biologic; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Zensun Sci. & Tech. Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Age between 18 and 75, both sex. 2. Left ventricular ejection fraction (LVEF)≤40% (ECHO). 3. NYNA functional class II OR III. 4. Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month. 5. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month. 6. Capable of signing the informed consent form. Exclusion Criteria: 1. new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months. 2. NYNA functional class I OR IV. 3. Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension. 4. Ischemic heart failure without recanalization or with recanalization in recent six months. 5. acute MI in the last 3 months. 6. unstable angina. 7. Patients with acute pulmonary edema or acute hemodynamic disorder. 8. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month. 9. Patients with right heart failure caused by pulmonary disease. 10. Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml). 11. Cardiac surgery or cerebrovascular accident within recent six months. 12. Preparing for heart transplantation or CRT, or has received CRT. 13. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate). 14. Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit). 15. Serum potassium <3.2 mmol/L or >5.5 mmol/L. 16. Systolic blood pressure <90mmHg or >160mmHg. 17. Pregnant or plan to pregnant. 18. Patients who participated in any clinical trial in the recent three months. 19. Subject with a life expectancy less than 6 months as assessed by the investigator. 20. Serious nervous system diseases (Alzheimers disease, advanced Parkinsonism),lower limb defects, or deaf-mute. 21. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia). 22. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism. 23. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others). ; PRIMARY OUTCOME: All-cause mortality; SECONDARY OUTCOME 1: sudden death[/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 - GE 067-008 (NPH); BRIEF: This study will determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH). ; DRUG USED: Vizamyl; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease - Imaging; TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: GE Healthcare; CRITERIA: Inclusion Criteria: - The subject is 50 years old or older. - The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid. - Informed consent has been signed and dated by the subject/and/or subjects legally acceptable representative, if applicable, in accordance with local regulations. Exclusion Criteria: - The subject has a contraindication for MRI or PET. - The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol. - The subject has participated in any clinical study using an investigational agent within 30 days of dosing. ; PRIMARY OUTCOME: Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.; SECONDARY OUTCOME 1: Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects[/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 - BEAT OLE; BRIEF: This is a multi-center, open-label study for eligible participants who were actively participating in the BPS-314d-MR-PAH-302 double-blind study (NCT01908699) at the time the study was concluded. This open-label extension (OLE) study will evaluate the safety, tolerability, and efficacy of long-term treatment with esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets). ; DRUG USED: Beraprost 314d; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Lung Biotechnology PBC; CRITERIA: Inclusion Criteria: 1. Participant must have been actively participating in the double-blind study, BPS-314d-MR-PAH-302 (NCT01908699), when the Sponsor concluded that study. 2. In the Investigators opinion, participant must be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent form (ICF) and must sign the form prior to the initiation of any study procedures. 3. Women of child-bearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must be practicing abstinence or using 2 highly-effective methods of contraception (defined as a method of birth control that results in a low failure rate [that is, less than 1% per year, such as approved hormonal contraceptives, barrier methods (such as a condom or diaphragm) used with a spermicide or an intrauterine device]). Participant must have a negative pregnancy test at the BPS-314d-MR-PAH-302 EOS Visit / BPS-314d-MR-PAH-303 Enrollment Visit. 4. Participant must be willing and able to comply with study requirements and restrictions. Exclusion Criteria: 1. Participant is pregnant or lactating. 2. Participant is scheduled to receive another investigational drug, device, or therapy during the course of the study. 3. Participant is taking or intends to take any prostacyclin / prostacyclin (IP) analog or IP receptor agonist (except for treprostinil, inhaled [Tyvaso®]). 4. Participant has any other clinically significant illness or other reason that, in the opinion of the Investigator, might put the participant at risk of harm during the study or might adversely affect the interpretation of the study data. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Area Walked for the 6 Minute Walk Distance (6MWD) Test[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HOVON 150 AML (Intensive Chemo); BRIEF: AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period. ; DRUG USED: Idhifa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Isocitrate Dehydrogenase (IDH); THERAPY: Combination; LEAD SPONSOR: Stichting Hemato-Oncologie voor Volwassenen Nederland; CRITERIA: Inclusion Criteria: - Age ≥18 years - Newly diagnosed AML or MDS-EB2 defined according to WHO criteria, with a documented IDH1 or IDH2 gene mutation (as determined by the clinical trial assay) at a specific site (IDH1 R132, IDH2 R140, IDH2 R172). AML may be secondary to prior hematological disorders, including MDS, and/or therapy-related (in which prior disease should have been documented to have existed for at least 3 months). Patients may have had previous treatment with hypomethylating agents (HMAs) for MDS. HMAs have to be stopped at least four weeks before registration - Patients with dual mutant FLT3 and IDH1 or IDH2 mutations may be enrolled only if, for medical or other reasons, treatment with a FLT3 inhibitor is not considered. - Considered to be eligible for intensive chemotherapy. - ECOG/WHO performance status ≤ 2 - Adequate hepatic function as evidenced by: - Serum total bilirubin ≤ 2.5 × upper limit of normal (ULN) unless considered due to Gilberts disease (e.g. a mutation in UGT1A1) (only for patients in IDH2 cohort), or leukemic involvement of the liver - following written approval by the (Co)Principal Investigator. - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement of the liver, following written approval by the Principal Investigator. - Adequate renal function as evidenced by creatinine clearance > 40 mL/min based on the Cockroft-Gault formula for glomerular filtration rate (GFR). - Able to understand and willing to sign an informed consent form (ICF). - Written informed consent Female patient must either: o Be of nonchildbearing potential: Postmenopausal (defined as at least 1 year without any menses) prior to screening, or Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening) o Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 6 months after the final study drug administration And have a negative urine or serum pregnancy test at screening And, if heterosexually active, agree to consistently use highly effective* contraception per locally accepted standards in addition to a barrier method starting at screening and throughout the study period and for 6 months after the final study drug administration. - Highly effective forms of birth control include: - Consistent and correct usage of established hormonal contraceptives that inhibit ovulation, - Established intrauterine device (IUD) or intrauterine system (IUS), - Bilateral tubal occlusion, - Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.) - Male is sterile due to a bilateral orchiectomy. - Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. - List is not all inclusive. Prior to enrollment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control per the requirements of the CTFG Guidance document Recommendations related to contraception and pregnancy testing in clinical trials, September 2014 (and any updates thereof) during the protocol defined period. - Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration. - Female patient must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration. - Male patient and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and continue throughout the study period and for 4 months and 1 week after the final study drug administration - Male patient must not donate sperm starting at screening and throughout the study period and for 4 months and 1 week after the final study drug administration. - Subject agrees not to participate in another interventional study while on treatment Exclusion Criteria: - Prior chemotherapy for AML or MDS-EB2 (with the exception of HMA). Hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts > 30x109/L). - Dual IDH1 and IDH2 mutations. - Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic variant fusion genes/chromosome translocations. - Blast crisis after chronic myeloid leukemia (CML). - Known allergy or suspected hypersensitivity to Ivosidenib or Enasidenib and/or any exipients. - Taking medications with narrow therapeutic windows with potential interaction with investigational medication (see Appendix I), unless the patient can be transferred to other medications prior to enrolling or unless the medications can be properly monitored during the study. - Taking P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) transporter-sensitive substrate medications (see Appendix J) unless the patient can be transferred to other medications within ≥ 5 half-lives prior to administration of ivosidenib or enasidenib, or unless the medications can be properly monitored during the study. - Breast feeding at the start of study treatment. - Active infection, including hepatitis B or C or HIV infection that is uncontrolled at randomization. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed. - Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed: - Basal or squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast - Incidental histologic finding of prostate cancer - Significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) Class III or IV congestive heart failure (appendix G); myocardial infarction, unstable angina and/or stroke; or left ventricular ejection fraction (LVEF) < 40% by ultrasound or MUGA scan obtained within 28 days prior to the start of study treatment. - QTc interval using Fridericias formula (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure,family history of long QT interval syndrome). Prolonged QTc interval associated with bundle branch block or pacemaking is permitted with written approval of the Principal Investigator. - Taking medications that are known to prolong the QT interval (see Appendix K), unless deemed critical and without a suitable alternative. In those cases, they may be administered, but with proper monitoring (see section 10.2, Table 13). - Dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs. - Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening. - A known medical history of progressive multifocal leukoencephalopathy (PML). - Immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or severe disseminated intravascular coagulation - Any other medical condition deemed by the Investigator to be likely to interfere with a patients ability to give informed consent or participate in the study. - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. ; PRIMARY OUTCOME: Event-free survival (EFS); SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - w/Peginterferon + Ribavirin (Naive, Genotype 1); BRIEF: This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combination treatment, compared with the placebo add-on. ; DRUG USED: TCM-700C; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: ; THERAPY: Combination; LEAD SPONSOR: TCM Biotech International Corp.; CRITERIA: Inclusion Criteria: - Adult subjects who are 20 to 65 years old (inclusive), of either gender and in any ethnical group in Asia. - Chronic hepatitis C, positive with both antibody to hepatitis C virus (anti HCV) and HCV RNA assays. - Confirmed HCV genotype 1. - Subjects who are indicated to have combination treatment of PegIFNα 2a and RBV at the discretion of the investigator. - All fertile males and females receiving RBV must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion. - Subjects must voluntarily give written informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. - Subjects must be able to comply with the assessments during the study. - Subjects must be able to understand study QoL questionnaires. Exclusion Criteria: - Prior treatment with any IFN α or any medicines that contain Cordyceps. - Prior treatment of hepatitis C with any other antiviral or immune modulators. - Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study. - Subjects diagnosed with hepatocellular carcinoma (HCC) by biopsy or α fetoprotein (AFP) serology and radiology (helical computed tomography [CT] and/or magnetic resonance imaging [MRI]) within 5 years of signing the informed consent form. - Evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy). - History or evidence of other liver diseases other than chronic HCV infection. - Subjects with known allergy or hypersensitivity to any ingredient of the study drug or placebo. - Pregnant, planning on becoming pregnant, or breastfeeding female subject or male subject whose partner is pregnant or planning on becoming pregnant. - Subject with any of the following laboratory abnormalities: 1. Platelet count <90,000/mm3; 2. Absolute neutrophil count <1500 cells/mm3; 3. Hemoglobin <12 g/dL for women and <13 g/dL for men; 4. Creatinine >1.5 mg/dL; 5. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN); 6. Total serum bilirubin >1.5 x ULN; 7. Subjects without cirrhosis and AFP >50 ng/mL must have an ultrasound between the screening and baseline visit with no findings suspicious for HCC. - Medical conditions which are contraindications for PegIFNα 2a or RBV therapy: 1. Psychiatric disorders; 2. Organ transplant (other than cornea or hair transplant or skin graft); 3. Severe concurrent medical disease such as severe hypertension, significant coronary heart disease, poorly controlled diabetes mellitus (glycated hemoglobin A1c [HbA1c] >8.5%), not adequately controlled thyroid dysfunction, chronic obstructive pulmonary disease, severe infections (bacterial, viral, fungal, including acute tuberculosis), or hemoglobinopathies (thalassemia major or sickle cell anemia); 4. Autoimmune hepatitis or other autoimmune conditions known to be exacerbated by PegIFNα 2a and RBV. - History of a severe seizure disorder or current anticonvulsant use. - Evidence of severe retinopathy (e.g., cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g., due to diabetes mellitus or hypertension). - Other cases judged by the investigator to be ineligible for participation in the study. ; PRIMARY OUTCOME: sustained virologic response (SVR) rate; SECONDARY OUTCOME 1: Virologic response (VR)[/INST]No</s>