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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 - A3301 (Palmoplantar Pustular Psoriasis); BRIEF: A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Palmoplantar pustular psoriasis for at least 6 months before Randomization - Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by: - ppPASI score of ≥ 12 and - DLQI ≥ 10 - Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by: - Topical treatment, and/or - Phototherapy, and/or - Previous systemic therapy Exclusion Criteria: - Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis) - Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis - Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study - Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to - Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab) - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment - Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy - Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1); SECONDARY OUTCOME 1: ppPASI: Absolute Change From Baseline to Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Arzerra; BRIEF: This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy. ; DRUG USED: Dinaciclib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Aged 18 years or older - Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) - Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody - Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2 - Adequate organ function and laboratory parameters - Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study Exclusion Criteria: - Symptomatic brain metastases or primary central nervous system malignancy - Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization - Known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy - Participants with with clinically active hepatitis B or C defined as disease that requires therapy - Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency - Prior allogeneic bone marrow transplant - Presence of Richters transformation - Indeterminate deletion 17p status - Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors - Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy ; PRIMARY OUTCOME: Participant Progression Free Survival; SECONDARY OUTCOME 1: Participant Overall Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TRIST; BRIEF: The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma. ; DRUG USED: TroVax; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: 5T4 tumor antigen , Immune System; THERAPY: Combination; LEAD SPONSOR: Oxford BioMedica; CRITERIA: Inclusion Criteria: - Signed informed consent. The patient must be competent to give written informed consent and comply with the protocol requirements. - Locally advanced or metastatic, histologically proven clear cell renal carcinoma. - Primary tumour surgically removed (some residual advanced primary tumour may remain). - At least four weeks post surgery or radiotherapy. - First-line. No prior therapy for renal cancer except surgery or radiotherapy. - Measurable disease. - Aged 18 years or more. - Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the investigator there is a >90% probability that the patient will survive >12 weeks if treated with the selected standard of care). - Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Graves disease, Hashimotos thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease). - Total white cell count ≥ 3 x 109/L and lymphocyte count ≥1 x 109/L. - Serum creatinine ≤1.5 times the upper limit of normal. - Bilirubin ≤ 2 times the upper limit of normal and an SGPT of ≤ 4 times the upper limit of normal. - Women must be either post menopausal, or rendered surgically sterile or, if of child bearing potential, must have been practising a reliable form of contraception (oral contraception + a barrier method) for at least three months prior to the first dose of TroVax® and must continue while they are being treated with TroVax®. Men must practise a reliable form of contraception (barrier or vasectomy) while they are being treated with TroVax®. - No acute changes on 12-lead ECG. - Ejection fraction documented as not less than 45% or no clinical suspicion that cardiac ejection fraction is less than 45%.(If clinical suspicion exists the ejection fraction should be measured according to local site procedures). - Karnofsky performance status of ≥ 80%. Exclusion Criteria: - Cerebral metastases. (Known from previous investigations or clinically detectable). - Previous exposure to TroVax®. - Serious infections within the 28 days prior to entry to the trial. - Known to test positive for HIV or hepatitis B or C. - Life threatening illness unrelated to cancer. - History of allergic response to previous vaccinia vaccinations. - Known allergy to egg proteins. - Known hypersensitivity to neomycin. - Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial. - Previous malignancies within the last 10 years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy. - Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patients ability to provide informed consent or to comply with the protocol. - Oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency. - Ongoing use of agents listed in locally approved prescribing information as causing immunosuppression. - Prior history of organ transplantation. - Pregnancy or lactation. ; 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 - Study 006 (Ovarian); BRIEF: This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. ; DRUG USED: Pafolacianine Sodium; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors - Imaging; TARGET: Folate Receptor (FOLR1); THERAPY: Monotherapy; LEAD SPONSOR: On Target Laboratories, LLC; CRITERIA: Inclusion Criteria: - Female patients 18 years of age and older - Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and: - Who are scheduled to undergo laparotomy for the debulking surgery OR - Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy - A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential - Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion - Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments Exclusion Criteria: - Previous exposure to OTL38 - Known FR-negative ovarian cancer - Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy. - Patients with known ovarian cancer miliary disease determined preoperatively to be inoperable. - Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient - History of anaphylactic reactions - History of allergy to any of the components of OTL38, including folic acid - Pregnancy or positive pregnancy test - Clinically significant abnormalities on electrocardiogram (ECG) - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule - Impaired renal function defined as eGFR< 50 mL/min/1.73m2 - Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin. - Known Stage IV ovarian cancer with brain metastases - Received an investigational agent in another clinical trial within 30 days prior to surgery - Known sensitivity to fluorescent light ; PRIMARY OUTCOME: Efficacy Patient Level; SECONDARY OUTCOME 1: Patient False Positive Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Protective-2 (China); BRIEF: The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and cyclophosphamide (TAC) + combination plinabulin/pegfilgrastim Severe neutropenia is an absolute neutrophil count (ANC) <0.5 × 10^9/L. Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this study. ; DRUG USED: Plinabulin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neutropenia / Leukopenia; TARGET: c-Jun N-terminal kinase (JNK), Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: BeyondSpring Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Women who are at least 18 years of age at the time of signing the informed consent form. 2. In the opinion of their treating oncology investigator, are candidates for at least 4 cycles of chemotherapy with TAC (docetaxel, doxorubicin, & cyclophosphamide). 3. Patients who are candidates for adjuvant or neoadjuvant TAC will meet all of the following criteria: - Biopsy-proven, early stage (Stage I and II) and Stage III breast cancer, and - Have had no prior chemotherapy. 4. Pathological confirmation of cancer is required. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Have life expectancy of 3 months or more. 7. Laboratory results provided by the central laboratory within 14 days prior to study drug administration within noted ranges, per study protocol (local laboratories may be accepted on a case by case basis after discussion with the medical monitor; however in this case central laboratories must also be taken within the screening time window) 8. Prothrombin time (PT) and International Normalized Ratio (INR) ≤1.5 × ULN, activated partial thromboplastin time (PTT) ≤1.5 × ULN, based on central laboratory results. 9. Women of childbearing potential have a negative pregnancy test at screening. Exclusion Criteria: 1. History of myelogenous leukemia, myelodysplastic syndrome, or sickle cell disease. 2. Use of strong CYP3A4, CYP2D6 or P-glycoprotein (P-gp) inhibitors and inducers, within 14 days of the first administration of study drug and for the duration of the study. 3. Received an investigational agent or tumor vaccine within 2 weeks before the first dose of study drug; patients must have recovered from toxicity of prior treatment and have no >Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) treatment emergent adverse events (TEAE). 4. Receiving any concurrent anticancer therapies (including concomitant anti-HER2/neu agents such as trastuzumab [Herceptin®], trastuzumab emtansine [TDM 1, Kadcyla®], pertuzumab [Perjeta®], lapatinib [Tykerb®]). 5. Received a prior bone marrow or stem cell transplant. 6. Have a co-existing active infection or received systemic anti-infective treatment within 72 hours before the first dose of study drug. 7. Concurrent or prior radiation therapy within 4 weeks before the first dose of study drug. 8. Chronic use of filgrastim, pegfilgrastim, or any bioequivalent (biosimilar) for severe chronic neutropenia or other chronic neutropenia syndrome. 9. Presence of any serious or uncontrolled illness including, but not limited to: uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirements or any other conditions that would preclude the patient from study treatment as per the discretion of the Investigator. 10. Significant cardiovascular history: - Cardiac ventricular dysfunction inhibiting the patients ability to receive 4 cycles of doxorubicin. - History of myocardial infarction or ischemic heart disease within 1 year (within a window of up to 18 days less than 1 year) before first study drug administration - Uncontrolled arrhythmia - History of congenital QT prolongation - Electrocardiogram (ECG) findings consistent with active ischemic heart disease - New York Heart Association Class III or IV cardiac disease; - Uncontrolled hypertension: blood pressure consistently >150 mm Hg systolic and > 100 mm Hg diastolic in spite of antihypertensive medication 11. History of hemorrhagic diarrhea, inflammatory bowel disease, or active uncontrolled peptic ulcer disease. (Concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable). History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility. 12. Any other active malignancy requiring active therapy. 13. Known human immunodeficiency virus (HIV) seropositivity. 14. Active Hepatitis B virus (HBV) infection which requires antiviral treatment or the patient has detectable Hepatitis B surface Antigen (HBsAg); hepatitis B surface antibody (anti-HBs) without detectable HBsAg does not exclude patients from the study. Hepatitis C infection (Hepatitis C antibody reactive) which requires treatment also excludes patients from the study. 15. Female patient who is pregnant or lactating. 16. Use of prophylactic antibiotics. 17. Unwilling or unable to comply with procedures required in this protocol. 18. History of allergy to any of the study drugs. ; PRIMARY OUTCOME: Percentage of patients with Duration of Severe Neutropenia (DSN) =0; SECONDARY OUTCOME 1: Mean DSN assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BUP-306 - Chronic Low Back Pain; BRIEF: This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain. BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States. ; DRUG USED: Belbuca; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: BioDelivery Sciences International; CRITERIA: Inclusion Criteria: - Male or non-pregnant and non-nursing female aged 18 or older - History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks - Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures - Female subjects of childbearing potential must be using a recognized effective method of birth control - Written informed consent obtained prior to any procedure being performed Exclusion Criteria: - Cancer related pain - Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis - Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit - History of severe emesis with opioids - Clinically significant sleep apnea in the judgment of the investigator ; PRIMARY OUTCOME: Mean change in pain intensity; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - 101; BRIEF: The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury. ; DRUG USED: VX-210; DRUG CLASS: Biologic; INDICATION: Spinal Cord Injury (SCI); TARGET: Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Acute traumatic cervical SCI, motor level of C4, C5, C6, or C7 on each side: - Screening UEMS score must be ≤16 points on each side. - AIS A subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and T1 on at least 1 side. - AIS B subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and C7 on at least 1 side. - American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B. - Scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury. - Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with the subjects neurological deficit. Exclusion Criteria: - Participation in any other clinical study for acute SCI without approval by the sponsor. - Inability to undergo decompression/stabilization surgery that commences within 72 hours after injury. - One or more upper extremity muscle groups untestable during screening ISNCSCI examination. - Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal SCI. - Females who are breastfeeding or have a positive serum pregnancy test. - Body mass index (BMI) of ≥40 kg/m^2 at screening. - History of an adverse reaction to a fibrin sealant or its components. - Unconsciousness or other mental impairment that precludes reliable International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. - Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs. - Any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgment of the investigator. Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Change in Upper Extremity Motor Score (UEMS); SECONDARY OUTCOME 1: Spinal Cord Independence Measure (SCIM) III Self-Care Subscore[/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 301; BRIEF: This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigators Global Assessment [IGA] score of 3 or 4). ; DRUG USED: Bryhali; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Key Inclusion Criteria: - Male or female, of any race, at least 18 years of age (inclusive). - Freely provides both verbal and written informed consent. - Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation. - Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. - Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, if psoriasis is present). Key Exclusion Criteria: - Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator. - Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator. - Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator. - Is pregnant, nursing an infant, or planning a pregnancy during the study period. - Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device. ; PRIMARY OUTCOME: Percentage of Participants With Treatment Success at Week 8; SECONDARY OUTCOME 1: Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - T1DMLIRA (Hvidovre University Hospital); BRIEF: The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Hvidovre University Hospital; CRITERIA: Inclusion Criteria: - Age: 18-70 years - BMI: 18-28 - HbA1c ≥ 8 % - No residual β-cell function (glucagon test with c-peptide < 60 pM) - Caucasian - Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive). - Remission phase must be completed - Female participants must use adequate contraception - Informed consent Exclusion Criteria: - Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria. - Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH). - Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l - Pregnancy or lactation - Epilepsy - Use of antiepileptic medication - Use of beta blockers - Previously apoplexy cerebri. - Any use of benzodiazepine within the last month - Any use of neuroleptic drugs within the last six months - Self-perceived hearing loss - Alcohol or drug abuse - Allergy to the medication or placebo. - Treatment with any medication affecting glucose metabolism. - Any disorder which in the investigators opinion could interfere with the safety and results of the trial ; PRIMARY OUTCOME: Change from baseline in HbA1c (glycosylated haemoglobin); SECONDARY OUTCOME 1: Change from baseline in glycemic control (CGM)[/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 - Bunionectomy (Study 022); BRIEF: This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery. ; DRUG USED: MoxDuo IR; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: QRxPharma Inc.; CRITERIA: Inclusion Criteria: - Patient is male or female and at least 18 years of age. - Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment. - Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery. - To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or 4 or more on the 11 point NPRS scale). - At least 40% of study subjects will be 60 years of age or older. Exclusion Criteria: - In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that would jeopardize the patients well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments. - Used opiates continuously (including tramadol) for more than ten days in the past year. - Hypersensitivity or poor tolerance to acetaminophen. - Currently receiving any medications that are not at a stable dose (the same dose for > 2 months prior to date of surgery). - Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003. - Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia). - Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit). ; PRIMARY OUTCOME: Differences in desaturation events per standardized time unit; SECONDARY OUTCOME 1: Difference in efficacy between Q8003 and its components (morphine and oxycodone)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - IIT (Onset); BRIEF: The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes patients. This two-arm study is designed to evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved therapies among recent onset type 1 diabetes patients. One of the greatest new insights of today in the field of type 1 diabetes, is the understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan 2103). More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some studies have demonstrated as high as a 57% insulin-free remission rate that was not sustained due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988, Eisenbarth 1989, Sobel 2010). Studies among diabetes patients with proton pump inhibitors have shown the potential to increase beta cell mass by 40%, but among type 1 patients without immune protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014). The usage of a beta cell regeneration agent such as omeprazole, in combination with an immune tolerance, like cyclosporine, provides both the potential ability to maintain and regenerate beta cells. This is a new paradigm for the treatment of new onset type 1 diabetes. More than 60 human trials have been conducted among type 1 diabetes with a variety of different therapies aimed at preventing autoimmune attack on insulin-producing beta cells. None have been as effective as cyclosporine in both slowing the decline in beta cell mass and resulting in the potential for insulin-free remissions. (Canadian-European Randomized Control Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010). Because cyclosporine is known for its potential side-effects, most notably in the kidney, all previous studies among type 1 patients have carefully monitored kidney function. Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months did not demonstrate renal or other side effects at the dosages that will be used in this trial (Assan 2002). The most effective initiating dosage for insulin independence in the cyclosporine trials was 7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and will monitor kidney function and cyclosporine levels initially on a weekly basis. This study will use only those dosages of cyclosporine that have not demonstrated toxicity to the kidney or resulted in non-reversible side effects among more than 500 patients with recent onset type 1 diabetes treated with cyclosporine. Omeprazole has been shown to significantly increase gastrin levels which is associated with increased beta cells. Lansoprazole has also been shown to be safe among patients with new onset type 1 diabetes for one year with a trend toward increased beta cell mass among patients with higher gastrin levels. In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those randomized to receive a proton pump inhibitor had significantly increased gastrin levels, higher insulin levels and improved endocrine function by glucose tolerance testing and less pancreatic atrophy as measured by CT scans (Jang 2003). The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta cells was specifically noted to have likely been due to lack of usage of immune therapy to protect beta cells (Griffin 2014, Rigby 2014). Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the control group had a trend towards improved preservation of C-peptide with a suggestion of a decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental data). Glucose levels also trended lower than controls in the intervention arm with gastrin levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006). REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy among type 1 patients (Griffin 2014, Rigby 2014). The combination of cyclosporine with a proton pump inhibitor has the potential to demonstrate maintenance and expansion of residual beta cells. This combination therapy provides the unique ability for patients to become insulin independent. For a request of references, please email info@perlebioscience.com ; DRUG USED: PRL001; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Calcineurin phosphatase , Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Perle Bioscience, Inc.; CRITERIA: Inclusion Criteria Participants included in this study are those who meet all of the following criteria: 1. Male or female participant 10-20 years old. 2. Diagnosis of new onset type 1 diabetes within 12 weeks of symptoms according to the American Diabetes Association (ADA) criteria. 3. History of at least one positive result on testing for any of the following antibodies: Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2), Glutamic Acid Decarboxylase (GAD) autoantibodies, Insulin autoantibodies. 4. Body weight > 30 kg. 5. Signs or symptoms of diabetes within 12 weeks of the first study visit. 6. Requires insulin > 0.2 units/kg body weight/day for T1DM 7. Fasting C-peptide greater than 0.3 ng/mL = 0.1 nmol/L = 100 pmol/L = 0.1 pmol/mL and Glucagon Stimulated C-peptide greater than 0.6 ng/mL = 0.2 nmol/L = 200 pmol/L = 0.2 pmol/mL. 8. Female of child bearing potential must have a negative pregnancy test and practice acceptable contraception [e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine device] or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to first clinic visit)]. Female of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of study drug. 9. Able to swallow capsules. 10. Able to read, understand, and provide signed informed consent for the study (participants under the age of 18, shall provide an assent for the study as per country requirements). Exclusion Criteria Participants must not meet any of the following exclusion criteria to be eligible for the study: 1. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or impact participant safety or evaluability of drug effect. 2. Prior administration of immunosuppressants at any time in the past, including in a clinical trial for type 1 diabetes. 3. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks prior to the first clinic visit. 4. Taking any prescription medications, vitamins or herbal supplements that are contraindicated with cyclosporine within the last 14 days prior to first clinic visit. 5. Pregnant or lactating female. 6. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion. 7. Current treatment with oral antidiabetic agents. 8. Evidence of active or latent tuberculosis. 9. Vaccination with a live virus or organism within the last 8 weeks prior to the first clinic visit. 10. Influenza vaccination with a killed virus, including booster vaccinations, within the last 4 weeks prior to the first clinic visit. 11. Vaccination with other antigens or killed organisms within the last 8 weeks prior to the first clinic visit. 12. Any infectious mononucleosis-like illness within the last 6 months prior to the first clinic visit. 13. History of or known active infection with HIV, HCV, or HBV. 14. Systolic or diastolic blood pressure >150 mmHg and > 90 mmHg, respectively, at the first clinic visit. 15. 95% percentile for weight at the first clinic visit. 16. An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level >2 times the upper limit of normal (ULN) at the first clinic visit. 17. A blood urea nitrogen (BUN) > 50 mg/dL (> 17.85 mmol/L) or a serum creatinine level > 1.3 mg/dL (> 115 µmol/L) at the first clinic visit. 18. A serum amylase level > 1.5 times the ULN or a serum lipase level > 2 times the ULN at the first clinic visit. 19. A history of substance abuse or dependence within the last 12 months prior to the first clinic visit as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria. ; PRIMARY OUTCOME: Insulin Independence and Hemoglobin A1c (A1C) < 6.5%; SECONDARY OUTCOME 1: Safety and tolerability[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/IIIa - BPLG-003; BRIEF: Annualised height velocity after 12/24 months treatment and HV SDS height velocity after 12/24 months treatment expressed as number of standard deviations difference from the mean population height velocity for the appropriate gender and chronological age. ; DRUG USED: Biosimilar Somatropin (LG Life Sciences); DRUG CLASS: Biosimilar; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: BioPartners GmbH; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of GHD as determined by two different GH provocation tests documenting deficient GH secretion, defined as a peak plasma GH level of less than 7 ng/mL and absence of any peak plasma GH level in the spontaneous growth hormone secretion above 7 ng/mL monitored 3 hours before the application of the pharmacological stimuli at least before one stimulation test. - Pre-pubertal children (boys age: 4-10 years or girls: age 4-9 years) with primary (idiopathic) and secondary (organic) insufficiency of growth hormone secretion. - Children with negative signs for intracranial tumour or tumour growth as confirmed with Computer tomography (CT) or magnetic resonance imaging (MRI) scan within 12 months prior to inclusion or within 6 months prior to inclusion of children with GH insufficiency occurred after treatment for any brain tumour. Such patients have to be at least 24 months into full clinical remission. - No prior exposure to rhGH (GH-naïve) - Height (HT) of at least 2.0 standard deviation (SD) (HT SDS ≤2.0) below the mean height for chronological age (CA) and sex according to the Standards of Prader et al15. - Height Velocity (HV) of at least -1 SD (HV SDS ≤1) below the mean HV for CA and sex according to the Standards of Prader et al15. - Baseline IGF-I level standardized for age and sex less than -1.0 SDS - Bone age (BA) ≤9 years for boys and ≤ 8 years for girls, - For children with multiple hormonal deficiencies, stabilized on replacement therapies for other pituitary axes (e.g. thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol and vasopressin) for at least 3 months and 6 months for thyroid replacement therapy prior to enrolment for children with multiple hormonal deficiencies. - Written informed consent of parent or legal guardian of subject. Exclusion Criteria: - The result of the 3 hours spontaneous GH peak is equal to, or above 7 ng/ml. The value of the peak GH level in case of repeated pharmacology test is below 7 ng/ml, whilst the 6 hours spontaneous peak GH is above this value, - Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to chronic diseases like renal insufficiency, diabetes mellitus and malnutrition (BMI must be above -2SD and below +2SD of mean BMI for the chronological age and sex, and albumin must be above lower limit of normal (LLN) of the central laboratory for a patient to be included), Chromosomal abnormalities and medical syndromes, with the exception of holoprosencephaly/septo-optic dysplasia (Turners syndrome, Laron syndrome, Noonan syndrome or absence of growth hormone receptors). - Congenital abnormalities (causing skeletal abnormalities), Russell-Silver Syndrome, Skeletal dysplasias, Closed epiphyses, - Other growth promoting medication such as anabolic steroids, with the exception of pituitary hormone replacement therapy, thyroxine, hydrocortisone and desmopressin (DDAVP) replacement therapies, - Children requiring glucocorticoid therapy (e.g. asthma) that are on the dose of more than 400 micro gram/day of budesonide or equivalents inhaled for longer than 1 month during a year, - Poorly controlled pituitary insufficiencies of other axes (e.g., thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol, vasopressin-deficiency), Major medical conditions and/or presence of contraindication to rhGH treatment. - Known or suspected HIV-positive patient or patient with advanced diseases such as AIDS or tuberculosis, Drug, substance, or alcohol abuse, Known hypersensitivity to the components of study medication, Evidence of tumour growth or malignant disease in remission for less than one year At screening, presence of anti-hGH antibodies - The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct. ; PRIMARY OUTCOME: Annualised HV after 12/24 months treatment and HV SDS height velocity; SECONDARY OUTCOME 1: HVSDS, HTG, HTSD, bone maturation (BM), IGF-I, IGFBP-3[/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 - 3002; BRIEF: The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day). ; DRUG USED: Rectabul; DRUG CLASS: Non-NME; INDICATION: Ulcerative Colitis (UC); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Voluntarily sign written informed consent. - Male or non-pregnant and non-lactating females. - Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge. - Must possess a baseline MMDAI score between 5 and 10. Exclusion Criteria: - History or current diagnosis of Crohns disease and indeterminate colitis. - Prior gastrointestinal surgery except appendectomy and hernia. - Concomitant active gastrointestinal disease or distortion of intestinal anatomy. - History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease. - Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus. - Uncontrolled abnormal thyroid function. - Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease. - Hemoglobin levels less than (<) 7.5 grams /deciliter (g/dL). - History of sclerosing cholangitis, cirrhosis, or hepatic impairment. - Renal disease manifested by greater than (>) 2.0 milligrams/deciliter (mg/dL) serum creatinine. - History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and HIV or hepatitis B or C. - Adrenal insufficiency. - Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess. - History of uncontrolled psychiatric disorders or seizure disorders. - History of asthma requiring ongoing use of inhaled steroids. - Recent history of drug or alcohol abuse. - Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites. - Vaccination within 28 days prior to randomization. - Allergies to budesonide or to any other items used in its preparation. - Participation in another clinical trial in the past 30 days. - Pregnant or at risk of pregnancy. - Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited. ; PRIMARY OUTCOME: Percentage of Participants Who Achieved Remission; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ONU3704; BRIEF: The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy. ; DRUG USED: Targiniq ER; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Purdue Pharma LP; CRITERIA: Inclusion Criteria include: - Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period; - The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation; - Subjects must have a self-reported history of opioid induced constipation (OIC). Exclusion Criteria include: - Subjects with rheumatoid arthritis or other inflammatory arthritis; - Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months; - Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility; - Subjects with chronic constipation not related to opioid use; - Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study; - Subjects with a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated. Other protocol specific inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Overall complete spontaneous bowel movement (CSBM) responder rates; SECONDARY OUTCOME 1: CSBM Responder at least 50% of the weeks in the double-blind period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CENTRIC; BRIEF: CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue. The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment. ; DRUG USED: EspoiR-003; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Integrin Alpha-V Family; THERAPY: Combination; LEAD SPONSOR: EMD Serono; CRITERIA: Inclusion Criteria: 1. Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed, paraffin-embedded block; stereotactic biopsy not allowed) must be available for MGMT status analysis and central pathology review 2. Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV) 3. Proven methylated MGMT gene promoter methylation status 4. Available post-operative gadolinium-enhanced magnetic resonance imaging (Gd-MRI) performed within less than (<) 48 hours after surgery (in case it was not possible to obtain a Gd-MRI within <48 hours post surgery, a Gd-MRI is to be performed prior to randomization) 5. Stable or decreasing dose of steroids for greater than or equal to (>=) 5 days prior to randomization 6. Eastern Cooperative Oncology Group performance score (ECOG PS) of 0-1 7. Meets 1 of the following recursive partitioning analysis (RPA) classifications: Class III (Age < 50 years and ECOG PS 0). Class IV (meeting one of the following criteria: a) Age < 50 years and ECOG PS 1 or b) Age >= 50 years, underwent prior partial or total tumor resection, mini mental state examination [MMSE] >= 27). Class V (meeting one of the following criteria: a) Age >= 50 years and underwent prior partial or total tumor resection, MMSE < 27 or b) Age >= 50 years and underwent prior tumor biopsy only) 8. Other protocol defined inclusion criteria could apply Exclusion Criteria: 1. Prior chemotherapy within the last 5 years 2. Prior RTX of the head 3. Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide 4. Prior systemic antiangiogenic therapy 5. Placement of Gliadel® wafer at surgery 6. Inability to undergo Gd-MRI. 7. Planned surgery for other diseases 8. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment 9. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for >= 5 years are eligible for this study 10. History of coagulation disorder associated with bleeding or recurrent thrombotic events 11. Clinically manifest myocardial insufficiency (New York Heart Association [NYHA] III, IV) or history of myocardial infarction during the past 6 months; uncontrolled arterial hypertension 12. Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Overall Survival (OS) Time; SECONDARY OUTCOME 1: Progression Free Survival (PFS) Time - Investigator and Independent Read[/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 - TRANXITION; BRIEF: The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy. ; DRUG USED: Viramune XR; DRUG CLASS: Non-NME; INDICATION: HIV / AIDS; TARGET: Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: HIV infected subjects treated with a Viramune based regimen. A subject that meets the following inclusion criteria will be eligible for participation in this study: 1. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation. 2. HIV-1 infected males or females of at least 18 years. 3. Treatment with Viramune regimen for at least the preceding 18 weeks. 4. Background therapy with lamivudine/ abacavir(3TC/ABC) (Kivexa® in EU; Epzicom in US), emtricitabine/tenofovir( FTC/TDF) (Truvada) or lamivudine/zidovudine 3TC/AZT (Combivir®). 5. An HIV viral load < 50 copies/mL in preceding 3 months. 6. An HIV viral load of < 50 copies/mL at screening (Visit 1). 7. Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions: alanine aminotrnasferase (ALT) and asparatate aminotransferase (AST) < 2.5 × upper limit of normal (ULN) Division of Acquired Immunodeficiency Syndrome (DAIDS Grade 1). 8. Willingness to abstain from ingesting medications that are listed as contraindicated in the Summary of Product Characteristics (SPC) or package insert (or PI) or Investigators Brochure during the study. 9. Karnofsky performance score of < 70 Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded from the study: 1. Current treatment with an HIV protease inhibitor 2. Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study 3. Female patients of child-bearing potential who: 1. Have a positive serum pregnancy test at screening. 2. Are breast feeding. 3. Are planning to become pregnant 4. Are not willing to use a double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception, or require ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.. 4. Laboratory parameters > DAIDS grade 2 Coagulation prothrombin time (PT), partial thromboplastin time (PTT), International Normalized ratio (INR) Hematology (absolute platelets, white blood cells (WBC), absolute neutrophil count, hemoglobin) Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase) 5. Laboratory parameters > DAIDS grade 3 Total triglycerides (total cholesterol no restriction) 6. Hypersensitivity to any ingredients of the test products 7. Active drug abuse or chronic alcoholism. 8. Hepatic cirrhosis stage Child-Pugh B or C 9. History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial 10. Inability to comply with protocol requirements ; PRIMARY OUTCOME: Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population; SECONDARY OUTCOME 1: Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EYEGUARD-C; BRIEF: The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment. ; DRUG USED: Gevokizumab; DRUG CLASS: Biologic; INDICATION: Uveitis (Ophthalmology); TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: XOMA (US) LLC; CRITERIA: Inclusion Criteria: - Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye - Controlled uveitic disease in both eyes - Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy - Effective contraceptive measures Exclusion Criteria: - Infectious uveitis and masquerade syndromes - Isolated anterior uveitis - Contraindication to mydriatics - Active tuberculosis disease - History of allergic or anaphylactic reactions to monoclonal antibodies - History of recurrent infection or predisposition to infection; active ocular infection - Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Proportion of subjects with an occurrence of uveitic disease through Day 168; SECONDARY OUTCOME 1: Time to first occurrence of uveitic disease[/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 - NK-104-CR-3.01; BRIEF: The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia ; DRUG USED: Livalo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: HMG CoA Reductase (HMGR); THERAPY: Monotherapy; LEAD SPONSOR: Kowa Research Institute, Inc.; CRITERIA: Inclusion Criteria: - Male and female patients with primary hyperlipidemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent; - Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL - Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 weeks before randomization and throughout study participation Exclusion Criteria: - Homozygous familial hypercholesterolemia; - Any conditions which may cause secondary dyslipidemia. - Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >8% ; PRIMARY OUTCOME: Percent change in LDL-C from baseline; SECONDARY OUTCOME 1: The percent change from baseline in fasting serum total cholesterol (TC )[/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 - P04230; BRIEF: This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued and will have their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1. ; DRUG USED: Dulera; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion Criteria: - Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC) ratio of <=70%. - At Screening & Baseline, postbronchodilator FEV1 must be >= 60% predicted normal & >=25% predicted normal. - COPD symptoms for >=24 months. - >=2 COPD exacerbations requiring course of oral corticosteroid &/or antibiotics within 2-12 months before screening. - Ex- or current smoker with smoking history >=10 pack years. - Only albuterol/salbutamol for relief for at least 2 weeks prior to randomization. - Withdraw from parenteral & oral steroids, anticholinergics, & antibiotics 4 weeks prior to Screening. - No harm in changing current COPD therapy, willing to discontinue his/her anticholinergics, inhaled corticosteroids (ICS) or ICS/long-acting beta agonists (LABA) at Screening, & transferred to albuterol/salbutamol for relief for 2 weeks prior to Randomization. - Lab tests conducted at Screening must be acceptable to investigator. Electrocardiogram (ECG) performed at Screening or within 30 days prior to Screening must be acceptable to investigator. Chest X-ray or computerized tomography (CT) scan is acceptable within 12 months prior to Screening must be acceptable to investigator. - Female of childbearing potential must use birth control. Includes: hormonal contraceptives, intra-uterine device (IUD), condom in combination with spermicide, monogamous relationship with male partner who had vasectomy. Started birth control at least 3 months prior to Screening (exception condom), & must agree to continue. Female who is not currently sexually active must agree/consent to using a method should she become sexually active. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. Female must have negative serum pregnancy test at Screening. Exclusion Criteria: - Evidence (upon visual inspection) of oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence at Screening, may be treated as appropriate & visit can be scheduled upon resolution. If there is evidence at Baseline, may be treated as appropriate & visit can be rescheduled upon resolution. - History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmological, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere with study. Examples include (but are not limited to) hypertension treated with beta-blockers), active hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF or QTcB [Fridericia or Bazett corrections, respectively >500 milliseconds (msecs)]) stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as asthma, bronchiectasis, cystic fibrosis. Others which are well-controlled & stable (eg hypertension not requiring beta-blockers) will not prohibit participation if appropriate to investigator. - Allergy/sensitivity to glucocorticosteroids, beta-2 agonists, study drug/excipients. - Female who is breast-feeding, pregnant, or intends to become pregnant. - Illicit drug user. - Human immunodeficiency virus (HIV) positive (testing not conducted). - Unable to correctly use oral MDI. - Taking any restricted medications prior to Screening without meeting washout. - Cannot adhere to permitted concomitant & prohibited medications. - May not participate in this same study at another investigational site. Cannot participate in different investigational study at any site, during same time. - Not be randomized into study more than once. - No person directly associated with administration of study may participate. - Previously participated in MF/F trial. - Increase in absolute volume of >=400 milliliters (mL) at Screening or prior to Baseline within 30 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg), or nebulized 2.5 mg albuterol/salbutamol. - Asthma. - Lobectomy, pneumonectomy or lung volume reduction surgery. - Lung cancer. - Requires long-term administration of oxygen (>15 hours/day). - Alpha-1-antitrypsin deficiency. - A history and/or presence of intraocular pressure in either eye >=22 millimeters of mercury (mm Hg), glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following Lens Opacities Classification System (LOCS) III grades at screening: - nuclear opalescence (NO): >=3.0, - nuclear color (NC): >=3.0, - cortical cataract (C): >=2.0, - posterior subcapsular (P): >=0.5. ; PRIMARY OUTCOME: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1); SECONDARY OUTCOME 1: Change From Baseline to Endpoint in St Georges Respiratory Questionaire (SGRQ) 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 - EVOLVE; BRIEF: The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia. ; DRUG USED: Epanova; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Diglycerol Acyltransferase (DGAT), Lipoprotein lipase, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Men or women, >=18 years of age. - Very high serum TG values in the range >=500 mg/dL and <2000 mg/dL (>=5.65 mmol/L and <22.60 mmol/L) Exclusion Criteria: - Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish. - Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia. - Unable to discontinue use of omega-3 drugs/supplements. - Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins <200 mg), or any supplement used to alter lipid metabolism. - Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods. - Use of tamoxifen, estrogens or progestins that has not been stable for >4 weeks prior to Visit 1. - Use of oral or injected corticosteroids or anabolic steroids. - History of pancreatitis. - History of symptomatic gallstone disease, unless treated with cholecystectomy. - Uncontrolled diabetes. - Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH). - History of cancer (other than basal cell carcinoma) in the past 2 years. - Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to Visit 1. - Use of anticoagulants (e.g. warfarin [Coumadin®], coumarin, heparin, enoxaparin, clopidogrel). - Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1. - Recent history (within six months prior to Visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease. - Poorly controlled hypertension. - Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), glucose, glomerular filtration rate (GFR), platelet count,or hemoglobin outside of study range. - Recent history (past 12 months) of drug abuse or alcohol abuse. - Exposure to any investigational product, within 4 weeks prior to Visit 1. - Presence of any other condition the Investigator believes would interfere with the subjects ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk ; PRIMARY OUTCOME: Fasting Serum Triglycerides; 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 - HEC1 (Oral); BRIEF: This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles. ; DRUG USED: Varubi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chemotherapy Induced Nausea and Vomiting (CINV); TARGET: Neurokinin Receptor; THERAPY: Combination; LEAD SPONSOR: Tesaro, Inc.; CRITERIA: Inclusion Criteria: - 18 years of age or older, of either gender, and of any race - has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2) - Karnofsky performance score of ≥60 - Predicted life expectancy of ≥4 months - Adequate bone marrow, kidney, and liver function Exclusion Criteria: - Contraindication to cisplatin, granisetron, or dexamethasone - Is pregnant or breast feeding - Has previously received cisplatin or subject is planning to receive multiple days of cisplatin in a single cycle - Has taken the following agents within the last 48 hours 5-HT3 antagonists,Phenothiazines,Benzamides,Domperidone,Cannabinoids,NK1 antagonist, Benzodiazepines - Scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 4 or above (Hesketh Scale) from Day 2 through Day 6, except on Day 1. - Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6 - Has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes, pemetrexed) - symptomatic primary or metastatic CNS disease. - Has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting. - Has vomited and/or has had dry heaves/retching within 24 hours prior to the start of cisplatin-based chemotherapy on Day 1 in Cycle 1. ; PRIMARY OUTCOME: No Emetic Episodes and No Rescue Medication; SECONDARY OUTCOME 1: Acute Phase Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACT-303 (Ext.); BRIEF: The purpose of this long term extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreichs Ataxia (FA). ; DRUG USED: Actimmune; DRUG CLASS: Biologic; INDICATION: Friedreichs Ataxia; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Horizon Pharma Ireland, Ltd., Dublin Ireland; CRITERIA: Inclusion Criteria: - Written informed consent and child assent, if applicable. - Completed 26 weeks of treatment and the Week 28 Follow-Up visit in Study HZNP-ACT-302 (NCT02593773). - If female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. Female subjects of child-bearing potential must have a negative urine pregnancy test result at Week 26 of Study HZNP-ACT-302 (NCT02593773) and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug. Exclusion Criteria: - If in the opinion of the Investigator, patients have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk, the subject will be excluded from the study. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Dapa-CKD; BRIEF: The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease. ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed informed consent prior to any study specific procedures - Female or male aged ≥18 years at the time of consent - eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 - Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1 - Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated, Exclusion Criteria: - Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis - Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment - History of organ transplantation - Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment ; PRIMARY OUTCOME: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.; SECONDARY OUTCOME 1: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.[/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 - BR1-141; BRIEF: The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (CE-DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography. ; DRUG USED: Lumason; DRUG CLASS: New Molecular Entity (NME); INDICATION: Coronary Artery Disease – Imaging; TARGET: Blood plasma; THERAPY: Monotherapy; LEAD SPONSOR: Bracco Diagnostics, Inc; CRITERIA: Inclusion Criteria: - Provided written Informed Consent and was willing to comply with protocol requirements; - Was at least 18 years of age; - Had suspected or known CAD and was scheduled to undergo coronary angiography within 6 months after the LUMASON DSE. - Had undergone a previous echocardiography prior to enrollment; resulting in suboptimal unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical view. Exclusion Criteria: - Was a pregnant or lactating female. Excluded the possibility of pregnancy by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of LUMASON administration(s), by surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses; - Had any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON); - Had any known hypersensitivity to dobutamine; - Had an ongoing or recent (within the last 30 days) acute myocardial infarction; - Had known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON); - Had electrolyte (especially potassium and magnesium) abnormalities; - Had unstable pulmonary and/or systemic hemodynamic conditions e.g.: - decompensated or inadequately controlled congestive heart failure (NYHA Class IV); - hypovolemia; - uncontrolled hypertension, i.e. resting systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg; - unstable angina; - acute coronary syndrome; - aortic dissection; - acute pericarditis, - myocarditis, or endocarditis; - stenosis of the main left coronary artery; - hemodynamically significant outflow obstruction of the left ventricle, including hypertrophic obstructive cardiomyopathy; - hemodynamically significant cardiac valvular defect; - acute pulmonary embolism; - Had uncontrolled cardiac arrhythmias; - Had significant disturbance in conduction; - Had hypertrophic subaortic stenosis; - Had an acute illness (e.g., infections, hyperthyroidism, or severe anemia); - Was previously entered into this study or received an investigational compound within 30 days before admission into this study; - Had been treated with any other contrast agent either intravascularly or orally within 48 hours of the first LUMASON administration; - Had any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations; In addition, due to the use of Atropine in subjects who had not reached targeted heart rate with peak dobutamine infusion, subjects with the following were excluded: - Glaucoma; - Pyloric stenosis; - Prostatic hypertrophy. ; PRIMARY OUTCOME: Sensitivity and Specificity for Detection or Exclusion of Coronary Artery Disease (CAD); SECONDARY OUTCOME 1: Change in Total LV EBD[/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 - COR 1.1 (Canada); BRIEF: The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection. ; DRUG USED: Hydros; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Hyaluronic acid; THERAPY: Monotherapy; LEAD SPONSOR: Carbylan Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA. - Symptoms in the index knee for at least 12 months. - Fully ambulatory Subject (ability to perform a 15 meters walk test). - Male and female Subjects 40 through 85 years of age. Exclusion Criteria: - BMI >40 kg - Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease. - Intra articular steroid therapy in last 3 months - Intra articular viscosupplementation in last 6 months ; PRIMARY OUTCOME: Change from baseline in the WOMAC A subscale score for the treatment knee.; SECONDARY OUTCOME 1: Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee[/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 - CNVA237B2301; BRIEF: The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in patients with poorly controlled asthma over 52 weeks of treatment. ; DRUG USED: Seebri Neohaler; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Written informed consent must be obtained before any assessment is performed; Male and female adult patients aged 18 to <75 years; Patients with a diagnosis of asthma (according to GINA 2012) for a period of at least 5 years prior screening; The diagnosis of asthma must have been made before the patient was 40; Increase in forced expiratory volume in 1 second (FEV1) of ≥ 12% and ≥ 200 mLs within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose); Pre-bronchodilator FEV1 of ≥ 50 and ≤ 80% of the predicted normal value for the patient; Patients who qualify for treatment (according to GINA 2012) and have been treated with a stable dose of a fixed dose inhaled corticosteriod (ICS) and long-acting β2 agonist (LABA) combination for at least 4 weeks prior to screening. Patient must be using a total daily dose of ICS of ≥800 μg/day of budesonide of equivalent; All patients must be symptomatic with a mean ACQ-5 score ≥ 1.5 at Visit 101 and Visit 102; A documented history of one or more asthma exacerbations in the previous 12 months that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation Exclusion Criteria: Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof: Muscarinic antagonist agents, sympathomimetic amines, lactose or any of the other excipients of the study drug, long and short acting beta-2 agonists, corticosteroids; Women of child-bearing potential; Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Visit 101 (assessed by central reader) and at Visit 102 (assessed by investigator at the site); Patients with a body mass index (BMI) of more than 40 kg/m2; Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction, arrhythmia, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment; Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention (BPH patients who are stable on treatment can be considered); Patients who have had an asthma exacerbation that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation in the 6 weeks prior to screening; Patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note:10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.); Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging); Patients on Maintenance Immunotherapy (desensitization) for allergies must have been so for at least 3 months prior to run-in, and must be expected to remain unchanged throughout the course of the study; ; PRIMARY OUTCOME: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26; SECONDARY OUTCOME 1: Time to First Moderate or Severe Asthma Exacerbation Over 52 Weeks of Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Cyst-HD; BRIEF: The purpose of this study is to evaluate the effect of cysteamine in patients with symptomatic Huntingtons disease by comparing two groups of patients (cysteamine vs placebo) on the results of the Unified Huntingtons Disease Rating Scale (UHDRS, Huntington study group 1996). ; DRUG USED: Procysbi; DRUG CLASS: Non-NME; INDICATION: Huntingtons Disease; TARGET: Lysosomal Cysteine Transporter; THERAPY: Monotherapy; LEAD SPONSOR: University Hospital, Angers; CRITERIA: Inclusion Criteria: - Clinically disease-registered for at least one year, leading to consult (abnormal movements, neuropsychiatric disorders, neuropsychological impairment). - Unified Huntingtons Disease Rating Scale motor ≥ 5 - Total Functional Capacity > 10 (≥ 11) - Huntington Disease diagnosed with abnormal number of CAG repeats: 38 < nucleotide expansion (CAG) - Age between 18 and 65 - Voluntarily Patient Consent - Patients willing and able to take oral medications, and comply with the specific procedures of the study Exclusion Criteria: - Severe cognitive impairment or neuropsychiatric troubles. - No drug compliance to previous treatment. - Patients with contra indication to the realization of imaging studies (including claustrophobia ) . - Patients who have not given their written and informed consent signed . - No national health insurance affiliation - Private patients of their liberty by judicial or administrative decision, or patients under supervision. - Pregnant women ( pregnancy test will be carried out systematically for women at risk) or lactating . - Women who could become pregnant during the study period and with no contraception. - Patients who have developed hypersensitivity to cysteamine or penicillamine ( against indication of cysteamine ) . - Brain Damage intercurrent MRI. Brain morphological abnormalities , other than those characteristic of the disease . - Disease - associated with neurological repercussions. - Affection - visceral serious , scalable , involving life-threatening. - Mental - disorder may disrupt accession to the Protocol , including a history of spontaneous and / or drug-induced hallucinations history of severe depression that required repeated hospitalizations , history of repeated suicide attempts . - Participation in progress, or interrupted for less than three months, a therapeutic protocol of Huntingtons disease . - Patients with a history of surgical interventions to improve the symptoms of Huntington s disease such as graft neuron, deep brain stimulation, infusion of neurotrophic agent ; PRIMARY OUTCOME: Unified Huntingtons Disease Rating Scale motor; 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 - FLEX-V (SC) - TNF Failures; BRIEF: The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors. This study is comprised of 2 periods: Period 1: 24-week blinded treatment Period 2: 48-week post-treatment follow-up ; DRUG USED: Tabalumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: B-cell activating factor (BAFF); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Diagnosis of RA of more than 6 months and less than 15 years - At least 8 tender and swollen joints - An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR) - Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody - Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance - Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start - Woman must not be pregnant, breastfeeding, or become pregnant during the study Exclusion Criteria: - Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks - Steroid injection or intravenous (IV) infusion in the last 6 weeks - Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks - History of a serious reaction to other biological DMARDs - Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks - Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study - Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA - Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years - Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines) - Hepatitis or human immunodeficiency virus (HIV) - A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months - Symptoms of herpes zoster or herpes simplex within the last month - Active or latent tuberculosis (TB) - Current symptoms of a serious disorder or illness - Use of an investigational drug within the last month ; PRIMARY OUTCOME: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response; SECONDARY OUTCOME 1: Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) 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 - Trial 14377 (Japan); BRIEF: The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia. ; DRUG USED: Cymbalta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibromyalgia; TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia - Participants with pain rated severity 4 or over by Brief Pain Inventory (BPI) - average pain severity item (Question 3) Exclusion Criteria: - Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators - Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 international units per liter (IU/L) or total bilirubin of not less than 1.6 milligrams per deciliter (mg/dL) - Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis - Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment - Participants with treatment-refractory fibromyalgia - Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by 3-month or longer drug therapy - Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency - Participants with an axis I condition according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV), currently or within the past year, except for major depressive disorders - Participants with a lifetime diagnosis of bipolar disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator - Participants with personality disorder or mental retardation - Participants with uncontrolled angle closure glaucoma - Participants with present or past history of uncontrolled seizures or convulsion disorders - Participants with suicidal ideation within past 6 months, with suicidal attempt within past 1 year - Participants answering yes to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section) - Participants with past history of multiple episodes of drug allergy - Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant - Females of child-bearing potential who cant agree to utilize medically. acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study - Participants with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year - Participants who have a positive urine drug screen for any substance of abuse (phencyclidine, cocaine, antihypnotic agent, or cannabis) - Participants previously treated with duloxetine ; PRIMARY OUTCOME: Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM); SECONDARY OUTCOME 1: Patients Global Impression of Improvement (PGI-I) at Endpoint[/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 - Protocol S (DRCR); BRIEF: The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy. Secondary objectives include: - Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP. - Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP. - Comparing safety outcomes between treatment groups. - Comparing associated treatment and follow-up exam costs between treatment groups. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Diabetic Retinopathy (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Jaeb Center for Health Research; CRITERIA: Inclusion Criteria: Age >= 18 years -Individuals < 18 years old are not being included because proliferative diabetic retinopathy (PDR) is so rare in this age group that the diagnosis of PDR may be questionable. Diagnosis of diabetes mellitus (type 1 or type 2) Any one of the following will be considered to be sufficient evidence that diabetes is present: - Current regular use of insulin for the treatment of diabetes - Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes - Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria (see Procedures Manual for definitions) Able and willing to provide informed consent. Meets at least all of the following ocular criteria criteria: - Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal ranibizumab, in the investigators judgment. - Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score > 24 (approximate Snellen equivalent 20/320) on the day of randomization. - Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and optical coherence tomography (OCT). - Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). - Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied. - Study participants cannot receive another investigational drug while participating in the study. Known allergy to any component of the study drug. Blood pressure > 180/110 (systolic above 180 or diastolic above 110). - If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. - These drugs should not be used during the study. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years. - Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed. Individual is expecting to move out of the area of the clinical center to an area not covered by another Diabetic Retinopathy Clinical Research Network (DRCR.net) certified clinical center during the 3 years of the study. Individual has any of the following ocular characteristics: - History of prior panretinal photocoagulation (prior PRP is defined as ≥ 100 burns outside of the posterior pole) - Tractional retinal detachment involving the macula. -- A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula) and in the investigators judgment, is not a contraindication to intravitreal ranibizumab treatment and also does not preclude deferring PRP for at least 4 weeks in the setting of intravitreal ranibizumab - Exam evidence of neovascularization of the angle (neovascularization of the iris alone is not an exclusion if it does not preclude deferring PRP for at least 4 weeks in the investigators judgment). - If macular edema is present, it is considered to be primarily due to a cause other than diabetic macular edema. -- An eye should not be considered eligible if: - macular edema is present that is considered to be related to ocular surgery such as cataract extraction or - clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of any macular edema. - An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.). -- A vitreous or preretinal hemorrhage is not an exclusion if it is out of the visual axis and in the investigators judgment is not having any affect on visual acuity. - Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye were otherwise normal). - History of intravitreal anti-VEGF treatment at any time in the past 2 months. - History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months. --If the investigator believes that there may still be a substantial effect 4 months after prior treatment (e.g., dose of intravitreal triamcinolone higher than 4 mg), the eye should not be included. - History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. - History of (yttrium-aluminum-garnet) YAG capsulotomy performed within 2 months prior to randomization. - Aphakia. - Uncontrolled glaucoma (in investigators judgment). - Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis ; PRIMARY OUTCOME: Mean Change in Visual Acuity From Baseline; SECONDARY OUTCOME 1: Mean Visual Acuity[/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 - 16160A (Adjunctive Therapy); BRIEF: The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Main Inclusion Criteria: - • The patient is a man or woman aged ≥65 yrs - The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). - The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE). - The patient has had the current MDE for ≥8 weeks - The patient is currently treated with a protocol specified ADT for at least 6 weeks - The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator. - Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at screening and baseline - Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and baseline Main Exclusion Criteria: - • The patient has a clinically significant unstable illness - The patient has newly diagnosed or unstable diabetes - The patient has a Mini Mental State Exam (MMSE) score <24 - The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening. - The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide Other protocol defined inclusion and exclusion criteria may apply ; PRIMARY OUTCOME: Number of Patients With Treatment-Emergent Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 06-003-15; BRIEF: The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis ; DRUG USED: Ketotifen Contact Lens; DRUG CLASS: Non-NME; INDICATION: Allergic Conjunctivitis (Ophthalmology); TARGET: Histamine H1 Receptor (HRH1), Mast Cell; THERAPY: Monotherapy; LEAD SPONSOR: Vistakon Pharmaceuticals; CRITERIA: Inclusion Criteria: - history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more Exclusion Criteria: - active ocular infection; clinically significant blepharitis; follicular conjunctivitis; pterygium; narrow angle glaucoma; dry eye syndrome; ocular surgery within past 6 months; pregnancy or lactation ; PRIMARY OUTCOME: Ocular itching; SECONDARY OUTCOME 1: Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling[/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 - RGH-MD-11 (Long-Term); BRIEF: The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia. ; DRUG USED: Vraylar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures. - Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID). - Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG). Exclusion Criteria: - Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia. ; PRIMARY OUTCOME: Change From Baseline to Week 48 in the PANSS Total Score; SECONDARY OUTCOME 1: Change From Baseline to Week 48 in the CGI-S 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 - ARIA; BRIEF: This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen. ; 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: 1. Provision of informed consent prior to any study specific procedures 2. Female or male aged 18 to 65 years, inclusively, at the time of enrolment. 3. General good health 4. Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta 2 agonists (not more than twice weekly) 5. Positive skin-prick test to at least one common aeroallergen Exclusion Criteria: 1. Current lung disease other than mild allergic asthma 2. Any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic 3. Any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period 4. History of anaphylaxis to any biologic therapy or vaccine ; PRIMARY OUTCOME: Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge; 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 - 002; BRIEF: This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV. ; DRUG USED: GDC-229; DRUG CLASS: Non-NME; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Microbial DNA, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Balmoral Medical company; CRITERIA: Inclusion Criteria: 1. Non-pregnant female aged ≥ 18 years who is in good general health 2. Diagnosis of BV 3. Willing to refrain from using any intravaginal product (e.g., spermicide, tampon, douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom with spermicide or insertion into the vagina of any drug or non-drug product during treatment), other than study treatment for the duration of the trial 4. Subjects of childbearing potential who have a negative urine pregnancy test at the Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout the study 5. Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol Exclusion Criteria: 1. History of alcohol or substance abuse 2. Experienced a clinically significant medical event within 90 days 3. Abnormal pap or high risk human papillomavirus (HPV) 4. History or presence of clinically significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease 5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study period 6. Primary or secondary immunodeficiency 7. Evidence of any vulvovaginitis at screening other than BV 8. History of hypersensitivity or allergy to metronidazole, parabens, other nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75% vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle gel 9. Participating in another clinical trial ; PRIMARY OUTCOME: Clinical Cure; 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 - w/Buprenorphine; BRIEF: This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL. ; DRUG USED: ALKS 6428; DRUG CLASS: Non-NME; INDICATION: Substance Use Disorder; TARGET: Opioid receptors; THERAPY: Combination; LEAD SPONSOR: Alkermes, Inc.; CRITERIA: Inclusion Criteria: - Willing and able to provide informed consent - Willing and able to provide government-issued identification - Has a BMI of 18.0-40.0 kg/m^2 - Has a physiologic dependence on opioids - Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy - Wiling to abide by the contraception requirements for the duration of the study - Additional criteria may apply Exclusion Criteria: - Is pregnant, planning to become pregnant or breastfeeding during the study - Has used Buprenorphine within 7 days prior to randomization - Has used Methadone within 14 days prior to randomization - Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization - Has a history of seizures or has received anticonvulsant therapy within the past 5 years - Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments - Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder - Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification - Has a history of hypersensitivity or adverse reaction to Buprenorphine, Naltrexone, or Naloxone - Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime - Has significant suicidal ideation or behavior within the past year - Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening - Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received - Is court mandated to receive treatment for opioid use disorder - Additional criteria may apply ; PRIMARY OUTCOME: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection; SECONDARY OUTCOME 1: Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection[/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 - IM-UNITI (Maintenance; SC); BRIEF: The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohns disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo. ; DRUG USED: Stelara; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Patients who received study agent at the start of study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria: - Patients who underwent a Crohns disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002 - Patients who started a protocol prohibited medication since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002 - Patients with protocol-specified changes to their concomitant medications due to Crohns disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002 ; PRIMARY OUTCOME: Number of Participants With Clinical Remission at Week 44; SECONDARY OUTCOME 1: Number of Participants With Clinical Response at Week 44[/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 - BEGONIA (Premenopausal) - 511.147; BRIEF: The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women. ; DRUG USED: Addyi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Female Sexual Arousal Disorder; TARGET: Dopamine 4 (D4) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sprout Pharmaceuticals, Inc; CRITERIA: Inclusion criteria: 1. Premenopausal women who are 18 years old and older 2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration. 3. Stable, monogamous heterosexual relationship for at least one year. 4. Willing to discuss sexual issues. 5. Willing to engage in sexual activity at least once a month 6. Normal pap smear 7. Must use medically acceptable method of contraception 8. Able to comply with daily use of a handheld entry device Exclusion criteria: 1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit. 2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition. 3. Partner with inadequately treated organic or psychosexual dysfunction 4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior. 5. Sexual function impaired by psychiatric disorder 6. Sexual function impaired by gynecological disorder 7. Major life stress that could impair sexual function 8. Substance abuse ; PRIMARY OUTCOME: The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.; 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 - C-05-36 - Acute Otitis Media; BRIEF: The purpose of this study is to determine if a topical 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 - Other protocol-defined exclusion criteria may apply ; PRIMARY OUTCOME: Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary; SECONDARY OUTCOME 1: Clinical cure rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Extension (CB-01-02/06); BRIEF: Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study [NCT00679432]). ; DRUG USED: Uceris; DRUG CLASS: Non-NME; INDICATION: Ulcerative Colitis (UC); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Male and female patients 18 to 74 years of age, who are able to understand and voluntarily provide written informed consent - Completed all Final Visit assessments for study CB-01-02/01 (NCT00679432) and are not in clinical remission - Diagnosis of ulcerative colitis of mild to moderate severity with an Ulcerative Colitis Disease Activity Index (UCDAI) <or= 10 according to Sutherland - Females of child-bearing potential must have had a serum pregnancy test performed at the Final Visit of the parent study, and must use an acceptable contraceptive method throughout the treatment period. Female subjects must also not be actively breast-feeding through the entire study period. - Ability to comprehend the full nature and purpose of the study, including possible risks and side effects - Ability to co-operate with the investigator and to comply with the requirements of the entire study Exclusion Criteria: - Did not complete study CB-01-02/01 - Achieved clinical remission in study CB-01-02/01 - Patients with severe ulcerative colitis (UCDAI >10) - Patients with infectious colitis - Evidence or history of toxic megacolon - Severe anemia, leucopenia, or granulocytopenia - Use of immunosuppressive agents in the last 8 weeks before the study - use of anti-tumor necrosis factor alpha agents in the last three months - Concomitant use of any rectal preparation for the treatment of ulcerative colitis - Concomitant use of antibiotics - Concurrent use of cytochrome P-450 3A4 (CYP3A4) inducers and CYP3A4 inhibitors. - Patients with verified, presumed of expected pregnancy or ongoing lactation - Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency and/or severe impairment of the bio-humoral parameters (i.e., 2x upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or creatinine) - Patients with severe disease(s) in other organs of systems - Patients with local of systemic complications of other pathological states requiring a therapy with corticosteroids and/or immunosuppressive agents - Patients diagnosed with Type 1 diabetes - Patients diagnosed with or with a family history of glaucoma - Patients with known hepatitis B, hepatitis C, or with human immunodeficiency virus (HIV), according to the local privacy policy - Any other medical condition that in the principal investigators opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events ; PRIMARY OUTCOME: The Percentage of Patients Achieving Clinical Remission; SECONDARY OUTCOME 1: The Secondary Efficacy Endpoint is Clinical Improvement[/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 - ACES 257 (Extension); BRIEF: This is a multicenter, 52-week, open-label study designed to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with major depressive disorder (MDD). Enrollment into the study will be from eligible participants who have completed participation in Protocol 31-08-255 [NCT01111539], 31-08-256 [NCT01111552], or 31-08-263 [NCT01111565] (rollover participants). ; DRUG USED: Aripiprazole/Escitalopram; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Participants who participated in Protocol 31-08-255, 31-08-256, or 31-08-263. Exclusion Criteria: - Participants with a current need for involuntary commitment or who have been hospitalized ≤ 28 days of the Baseline Visit for the current major depressive episode. - Participants with a diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder. - Participants with a diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder. - Participants experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode. - Participants who have met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for substance abuse in the past 6 months (prior to the Baseline Visit) and/or dependence up to and including the past 12 months (prior to the Baseline Visit), including alcohol and benzodiazepines, but excluding caffeine and nicotine. Participants with two positive drug results for cocaine should be excluded from the study. - Participants with hypothyroidism or hyperthyroidism. - Participants with a significant risk of committing suicide based on history, investigators judgment, and/or evaluation based on the Columbia-Suicide Severity Rating Scale (C-SSRS). - Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders. - Participants with insulin-dependent diabetes mellitus (IDDM). - Participants with epilepsy or significant history of seizure disorders, except for a single childhood febrile seizure, post-traumatic, etc. ; PRIMARY OUTCOME: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs; SECONDARY OUTCOME 1: Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) 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 - w/Faldaprevir+RBV (PegIFN ineligible pts) (HCVerso 2); BRIEF: The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis. ; DRUG USED: Deleobuvir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening 2. HCV infection of sub-GT1b confirmed by genotypic testing at screening. 3. HCV viral load =1,000 IU/mL at randomisation. 4. Patients who have never been previously treated with any other HCV treatment regimen. Exclusion criteria: 1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1. 3. Liver disease due to causes other than chronic HCV infection. 4. HIV infection. 5. Hepatitis B virus infection based on presence of HBs-Ag. 6. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening. 7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation. 8. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis). 9. Decompensated liver disease, or history of decompensated liver disease. 10. Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia. 11. Red blood cell disorders. 12. Body weight <40 kg or >125 kg. ; PRIMARY OUTCOME: SVR12 Rates With Historical Control; SECONDARY OUTCOME 1: SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ION-1 (+/- RBV, GT1, Treatment-naive); BRIEF: The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection. ; DRUG USED: Harvoni; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Age ≥ 18, with chronic genotype 1 HCV infection - HCV treatment-naive - HCV RNA > 10,000 IU/mL at screening - Cirrhosis determination; a liver biopsy may be required - Screening laboratory values within defined thresholds - Use of two effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: - Pregnant or nursing female or male with pregnant female partner - Co-infection with HIV or hepatitis B virus (HBV) - Current or prior history of clinical hepatic decompensation - Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) - Chronic use of systemic immunosuppressive agents - History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug[/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 - X052172 (I); BRIEF: The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG). ; DRUG USED: Gevokizumab; DRUG CLASS: Biologic; INDICATION: Neutrophilic Dermatoses; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: XOMA (US) LLC; CRITERIA: Inclusion Criteria: - A clinical diagnosis of classic pyoderma gangrenosum - An active pyoderma gangrenosum ulcer - Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: - Clinical evidence of acutely infected pyoderma gangrenosum - History of allergic or anaphylactic reactions to monoclonal antibodies - History of recurrent or chronic systemic infections - Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment; SECONDARY OUTCOME 1: The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SIRROUND-T; BRIEF: The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have a diagnosis of rheumatoid arthritis (RA) for at least 3 months before screening - Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline - Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents - If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent - If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent - If using non-biologic disease modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD - C-reactive protein (CRP) 8.00 mg/L or more or erythrocyte sedimentation rate (ESR) 28 mm/hr or more at screening Exclusion Criteria: - Has received infliximab, infliximab biosimilar, or golimumab intravenous (IV) within 8 weeks of the first study agent administration - Has received subcutaneously (SC) golimumab, adalimumab, or certolizumab pegol within 6 weeks of the first study agent administration - Has received etanercept or yisaipu within 4 weeks of the first study agent administration - Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy. Has used tocilizumab within 8 weeks of the first study agent administration - Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy - Has used anakinra within 1 week of first study agent administration - Has used abatacept or any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration - Has received intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration - Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable - Has a history of cyclophosphamide or cytotoxic agent use - Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration - Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before the first study agent administration ; PRIMARY OUTCOME: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16; SECONDARY OUTCOME 1: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 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 - vs. Ferrous Sulfate; BRIEF: The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron. ; DRUG USED: Injectafer; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: American Regent, Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects ≥ to 18 years of age and able to give informed consent. - Diagnosis of Iron Deficiency Anemia (IDA). - Hemoglobin (Hgb) ≤ to 11 g/dL. - Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%. - Must demonstrate an unsatisfactory response or intolerance to oral iron. Exclusion Criteria: - Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate. - Previously randomized in a clinical study of Ferric Carboxymaltose (FCM). - Requires dialysis for treatment of chronic kidney disease. - No evidence of iron deficiency. - Any non-viral infection. - AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal. - Known positive hepatitis with evidence of active disease. - Received an investigational drug within 30 days of screening. - Alcohol or drug abuse within the past 6 months. - Hemochromatosis or other iron storage disorders. - Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1. - Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subjects disease management at risk or may result in the subject being unable to comply with study requirements. - Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception. ; PRIMARY OUTCOME: Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.; 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 - Study 015; BRIEF: The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic therapy. ; DRUG USED: Encenicline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Combination; LEAD SPONSOR: FORUM Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Age 18 to 50 years of age, inclusive - Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any study specific procedures. Subjects who are unable to provide informed consent will not be included in the study. - Resides in a stable living situation, according to the investigators judgment, and must have an identified informant who should be consistent throughout the study. If possible, the informant should accompany the subject or be available for in person ratings at the screening, baseline (Day 1), and final study visits. In person informant ratings on all relevant study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview throughout the study at all visits. As long as both the informant visit and subject visit are within the study visit windows, it is not necessary that they occur on the same day. The informant must interact with the subject at least 2 times a week. - Diagnosis of Schizophrenia of at least 3 years duration. This diagnosis can be established utilizing the SCID-I, direct clinical assessments, family, informants, and confirmation of diagnosis from clinical sources. These may include medical records, confirmation of diagnosis by treating clinician through telephone contact, or written confirmation from treating clinic. If the listed sources are not available, other sources of diagnostic confirmation may also be acceptable after discussion with the medical monitor. - Treated with atypical antipsychotic drug (in any approved dosage form) other than Clozapine at a stable dose for at least 8 weeks prior to screening and be clinically stable; the subject must remain clinically stable (in the opinion of the principal investigator) through randomization. The use of up to 2 atypical antipsychotic drugs is permitted, as long as in the opinion of the investigator, the second medication is not required to control treatment-resistant or intractable psychotic symptoms. No subject will be washed off antipsychotic therapy to become eligible for this study. - Schizophrenia clinical symptom burden severity defined by the following: a Brief Psychiatric Rating Scale (BPRS) Conceptual Disorganization item score ≤ 4; and a BPRS Hallucinatory Behavior item score ≤ 5, or an Unusual Thought Content item score ≤ 5. Either Hallucinatory Behavior or Unusual Thought Content, but not both, may have a score of 6 (but not > 6). - Simpson-Angus Scale (SAS) total score ≤ 6 - Calgary Depression Scale for Schizophrenia (CDSS) total score ≤ 10 - General health status acceptable for participation in a 26-week clinical study - Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study - Fluency (oral and written) in the language in which the standardized tests will be administered - The ability to refrain from using any tobacco or other nicotine-containing products for at least 30 minutes before any cognitive testing Exclusion Criteria: - Hospitalization within 12 weeks before screening or during the screening period, or change of antipsychotic medication or dose within 8 weeks before screening or during the screening period. - Participation in another therapeutic (medication administration) clinical study within the past 2 months. - Psychiatric hospitalization or incarcerations due to breakthrough symptoms or acute exacerbations for a period of 3 months before screening. Subjects with a recent social hospitalization or incarceration may be entered into screening after consultation with the medical monitor - Likelihood, in the opinion of the investigator, that either the subject or informant will be unable to complete a 26-week study - Treatment with prohibited antipsychotic drug, and/or treatment with more than 2 permitted antipsychotic drugs. Treatment with a first-generation antipsychotic drug (typical antipsychotic) is prohibited unless it is administered at a low dose after discussion with the medical monitor - Current treatment with any anticholinergic agent - Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria met for alcohol abuse within the past 3 months or substance abuse (other than nicotine) within the last 6 months before screening - Significant suicide risk as defined by 1) suicidal ideation as endorsed on items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past year; 2) suicidal behavior detected by the C-SSRS during the past 2 years, or 3) psychiatric interview and examination - Stroke within 6 months before screening, history of brain tumor, subdural hematoma, or other clinically significant neurological condition, head trauma with loss of consciousness within 12 months before screening - Monoamine oxidase inhibitor antidepressants or tricyclic medications used in antidepressant doses are excluded. Other antidepressant medications are allowed if the subject has been treated with a stable dose for at least 3 months before screening - Immunosuppressants, mood stabilizers, chronic use of a sedative hypnotic drug, chronic intake of clinically significant doses of opioid containing analgesics or any current methadone treatment all in the judgment of the investigator may be permitted depending on the circumstance - Use of Central Nervous System(CNS) stimulants - Nicotine therapy (including patches), varenicline (Chantix), or similar therapeutic agent within the last six months before screening - Use of a benzodiazepine medication is allowed if the subject has not had a change in medication or dose for at least 3 months. For subjects prescribed benzodiazepines, short-acting benzodiazepines are to be used whenever possible. Use of longer-acting benzodiazepines may be acceptable if prior authorization is obtained from the medical monitor. When possible, benzodiazepines should not be administered within 3 hours before cognitive testing. The use of more than one sedative-hypnotic medication is not allowed. ; PRIMARY OUTCOME: Change from Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) to Day 182; SECONDARY OUTCOME 1: Change from Baseline in the Positive and Negative Symptom Scale (PANSS) to Day 182[/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 - IGNITE 1; BRIEF: This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI). ; DRUG USED: Xerava; DRUG CLASS: New Molecular Entity (NME); INDICATION: Intra-Abdominal Infections (Antibacterial); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Tetraphase Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female participant hospitalized for cIAI 2. At least 18 years of age (and not over 65 years of age for participant in India) 3. Evidence of a systemic inflammatory response 4. Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by cIAI that is referred to another anatomic area 5. Able to provide informed consent 6. If male: must agree to use an effective barrier method of contraception during the study and for 90 days following the last dose if sexually active with a female of childbearing potential 7. If female, not pregnant or nursing or, if of childbearing potential: either will commit to use at least two medically accepted, effective methods of birth control (for example, condom, oral contraceptive, indwelling intrauterine device, hormonal implant /patch, injections, approved cervical ring) during study drug dosing and for 90 days following last study drug dose or practicing sexual abstinence Exclusion Criteria: 1. Unlikely to survive the 6-8 week study period 2. Renal failure 3. Presence or possible signs of hepatic disease 4. Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity (requiring anti-retroviral therapy or with CD4 count <300), acquired immune deficiency syndrome (AIDS), organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (for example, >40 mg prednisone or equivalent per day for greater than 2 weeks) 5. History of hypersensitivity reactions to tetracyclines, carbapenems, β-lactam antibiotics or to excipients contained in the study drug formulations 6. Participation in any investigational drug or device study within 30 days prior to study entry 7. Known or suspected current Central Nervous System disorder that may predispose to seizures or lower seizure threshold 8. Previously received eravacycline in a clinical trial 9. Antibiotic-related exclusions: 1. Receipt of effective antibacterial drug therapy for cIAI for a continuous duration of >24 hours during the 72-hour preceding enrollment (however, participants with documented cIAI [that is, known baseline pathogen] who have received at least 72 hours of antibiotic therapy and are considered treatment failures may be enrolled. Treatment failure is defined as persistent fever and/or clinical symptoms; or the development of a new intra-abdominal abscess after ≥72 hours of antibiotic therapy), or 2. Receipt of ertapenem or any other carbapenem, or tigecycline for the current infection or 3. Need for concomitant systemic antimicrobial agents other than study drug 10. Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any other resuscitative measures and drug/fluid therapy at time of consent 11. Known or suspected inflammatory bowel disease or associated visceral abscess 12. The anticipated need for systemic antibiotics for a duration of more than 14 days 13. Systemic malignancy that required chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the previous 3 months or that is anticipated to begin prior to the Test-of-Cure (TOC) visit ; PRIMARY OUTCOME: Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population; SECONDARY OUTCOME 1: Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - REPROVE; BRIEF: The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia ; DRUG USED: Avycaz; DRUG CLASS: Non-NME; INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - 18 to 90 years of age inclusive - Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after - Onset of symptoms ≥ 48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility - New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization - At least 1 of the following systemic signs:Fever (temperature >38 C) or hypothermia (rectal/core temperature <35 C); White blood cell count >10,000 cells/mm3, or White blood cell count <4500 cells/mm3, or >15% band forms. Exclusion Criteria: - Pulmonary disease that, in the investigators judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism). - Patients with lung abscess, pleural empyema or post obstructive pneumonia. - Patients with an estimated creatinine clearance <16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy. - Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure. - Patients receiving hemodialysis or peritoneal dialysis. ; PRIMARY OUTCOME: The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses); SECONDARY OUTCOME 1: The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat 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 - w/Underlying Inflammatory Bowel Disease; BRIEF: The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying inflammatory bowel disease (IBD). ; DRUG USED: Entyvio; DRUG CLASS: Biologic; INDICATION: Primary Sclerosing Cholangitis (PSC); TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has chronic cholestatic liver disease, of at least 6 months duration, with a subsequent diagnosis of primary sclerosing cholangitis (PSC), based on cholangiographic findings of intrahepatic and/or extrahepatic bile duct irregularities consistent with PSC. 2. Has a diagnosis of inflammatory bowel disease (IBD) (either ulcerative colitis [UC], Crohns disease [CD], or IBD unclassified [IBDU]), established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. 3. Has a liver stiffness transient elastography (TE) score of ≤14.3 kPa, as assessed by FibroScan. 4. Has had a colorectal cancer screen within 12 months of the Screening Visit with no signs of malignancy, dysplasia, or neoplasia. Exclusion Criteria: Hepatic and Gastrointestinal Exclusion Criteria 1. Has received any fibrates within 8 weeks of Screening. 2. Has high suspicion of cholangiocarcinoma, as indicated by an elevated Ca 19-9 value (>129 U/mL) at screening. 3. Has evidence of overlap syndrome with autoimmune hepatitis or primary or secondary biliary cirrhosis or autoimmune cholangitis, as judged by the investigator. 4. Has evidence of alcoholic liver disease including history of alcoholic hepatitis. 5. Has a diagnosis of small duct PSC. 6. Has a Model for End-Stage Liver Disease (MELD) score >12 at screening. 7. Has a Child-Pugh score >7 (following adjustment for PSC diagnosis) at screening. 8. Has received a liver transplant. 9. Has evidence of autoimmune immunoglobin (Ig) IgG4-associated cholangitis, as defined by elevated serum IgG4 at least 2 x ULN (at screening), or IgG4/IgG1 ratio above 0.24. 10. Has undergone prior biliary surgery (laparoscopic or open surgery). Participants who have undergone cholecystectomy without surgical complications will be allowed provided the surgery was not done within 6 weeks prior to screening. 11. Has had 2 or more interventional treatments for dominant stricture (including stent placement/replacement) within 12 months prior to the Screening Visit. 12. Has evidence of cholangitis, requiring antibiotics, within 3 months prior to the Screening Visit [short courses of antibiotics for no more than 5 days are allowed for stent placement or endoscopic retrograde cholangiopancreatography (ERCP) prophylaxis]. Infectious Disease Exclusion Criteria 13. Has chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 14. Has positive hepatitis B core antibody (anti-HBc) at screening. 15. Has evidence of an active infection during the Screening Period. 16. Has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation). 17. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following: 1. History of TB. 2. A positive diagnostic TB test within 30 days of enrollment defined as: 1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests (or, a positive T-SPOT TB test [Japan only]), OR 3. Chest X-ray within 3 months of enrollment in which active or latent pulmonary TB cannot be excluded General Exclusion Criteria 18. Has had previous exposure to natalizumab, efalizumab, rituximab, or any other integrin antagonist. 19. Has received any of the following for the treatment of underlying disease within 30 days of screening: - Nonbiologic therapies (eg, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in the protocol for the treatment of IBD. - An approved nonbiologic therapy in an investigational protocol. 20. Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at the Screening Visit. 21. Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to randomization. Participant with remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to randomization. 22. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease. 23. Has a positive response on the progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of study drug. 24. Has received any of the following for the treatment of underlying disease within 30 days of screening: - Nonbiologic therapies (eg, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in the protocol for the treatment of IBD. - An approved nonbiologic therapy in an investigational protocol. 25. Has had any surgical procedure requiring general anesthesia within 30 days prior to screening or is planning to undergo major surgery during the study. 26. Is required to take excluded medications. 27. Has received any live vaccinations within 30 days prior to screening. 28. Has evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to the Screening Visit or other known infectious, immunologic, or ischemic liver or intestinal disease that, in the investigators opinion, may interfere with the study procedures or study results. 29. Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at the Screening Visit. 30. Has previous history of colectomy. 31. In the opinion of the investigator, the participant has a life expectancy or anticipated need for liver transplantation within <24 months. 32. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to screening. 33. For the magnetic resonance elastography (MRE) substudy, participants are excluded if they have contraindications to magnetic resonance (MR) scanning. Contraindications include ferromagnetic foreign bodies (eg, shrapnel, ferromagnetic fragments in the orbital area, certain tattoos), certain implanted medical devices (eg, aneurysm clips, cardiac pacemakers) or claustrophobia. ; PRIMARY OUTCOME: Percentage of Participants with No Worsening in Ishak Fibrosis Staging Score from Baseline to Week 106 Visit; SECONDARY OUTCOME 1: Percentage of Participants with a ≥35% Reduction in Serum Alkaline Phosphatase (ALP) from Baseline to Week 106 Visit[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Post-OTL; BRIEF: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with disease progression after liver transplant. ; DRUG USED: Onpattro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hereditary Transthyretin (hATTR) Amyloidosis With Polyneuropathy (Familial Amyloid Polyneuropathy); TARGET: Transthyretin (TTR); THERAPY: Monotherapy; LEAD SPONSOR: Alnylam Pharmaceuticals; CRITERIA: Inclusion Criteria: - Received liver transplant for treatment of hATTR amyloidosis ≥12 months before study start - Has increase in polyneuropathy disability (PND) score after liver transplant - Has received stable immunosuppressive regimen with ≤10 mg/day of prednisone for at least 3 months before study start - Has Karnofsky Performance Status (KPS) of ≥70% - Has vitamin A level greater than or equal to lower limit of normal Exclusion Criteria: - Has previously received inotersen or patisiran - Has clinically significant liver function test abnormalities - Has known portal hypertension with ascites - Has estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m^2 - Has known leptomeningeal amyloidosis - Has infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) - Has New York Heart Association heart failure classification of >2 - Is wheelchair bound or bedridden - Has received organ transplants other than liver transplant - Will be using another tetramer stabilizer during the study ; PRIMARY OUTCOME: Average of Month 6 and Month 12 Percentage Reduction From Baseline in Serum Transthyretin (TTR); SECONDARY OUTCOME 1: Change From Baseline in the Neuropathy Impairment Score (NIS) at Month 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INS005-15-062; BRIEF: The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy. ; DRUG USED: Buprenorphine Spray; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: INSYS Therapeutics Inc; CRITERIA: Inclusion Criteria: - Meets protocol-specified criteria for qualification and contraception - Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications - Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Exclusion Criteria: - History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters - 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: Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48); SECONDARY OUTCOME 1: NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0[/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 - Femoral Nerve Block; BRIEF: The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2. Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline). ; DRUG USED: Exparel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Male or female, >=18 years of age. 2. Scheduled to undergo primary unilateral TKA under general or spinal anesthesia. 3. American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3. 4. Able to demonstrate motor function by performing a 20-meter walk, unassisted with the optional use of a 4-legged walker, and sensory function by exhibiting sensitivity to cold. 5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: 1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before surgery. 2. Planned concurrent surgical procedure (e.g., bilateral TKA). 3. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, NSAIDs, aspirin (except for low-dose aspirin used for cardioprotection) or acetaminophen within 3 days, or and any opioid medication within 24 hours. 4. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the surgical site administered study treatment, and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, prior contralateral TKA, concurrent foot surgery). 5. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinepherine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). 6. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study. 7. Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 40 kg/m2. 8. Contraindication to hydromorphone, oxycodone, or bupivacaine. 9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subjects participation in this study. 10. Previous participation in a liposome bupivacaine study. 11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 12. Failure to pass the urine drug screen. 13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance. 14. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. 15. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subjects postsurgical course. 16. Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures. 17. Subjects who are planned to receive Entereg® (alvimopan). 18. Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics given without regard to the subjects emesis needs. 19. Use of dexmedetomidine HCl (Precedex®) within 3 days of surgery. ; PRIMARY OUTCOME: Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours; SECONDARY OUTCOME 1: Total Postsurgical Opioid Consumption Through 72 Hours[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Long-Term Extension - OCT-011 (Japan) ; BRIEF: The purpose of this study is to assess the safety and efficacy of Lu AA21004 in participants with major depressive disorder after completion of an 8-week double-blind treatment period in a preceding study (Lu AA21004/CCT-003; NCT01355081). ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has completed the double-blind treatment period of the preceding study (CCT-003) 2. Signs and dates a written, informed consent form for this study, different from that for the preceding study (CCT-003). 3. Has CGI-S score improved at least one point at completion of the 8-week double-blind treatment period compared to the Baseline Visit in the preceding study (CCT-003). 4. In the opinion of the investigator, the subject appears to benefit from long-term treatment of Lu AA21004. Exclusion Criteria: 1. Diagnosed with the following disorder or symptom in the preceding study (CCT-003): - Any current psychiatric disorder other than MDD as defined in a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR). - Any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. - Clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder (Alzheimers disease, Parkinsons disease, multiple sclerosis, Huntingtons disease, etc.). - Any DSM-IV-TR axis II disorder that might compromise this study. 2. Is at significant risk of suicide, or had a score ≥5 on Item 10 (suicidal thoughts) of the MADRS or attempted suicides during the preceding study (CCT-003) ; PRIMARY OUTCOME: Number of Participants Reporting One or More Treatment-emergent Adverse Events; SECONDARY OUTCOME 1: Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at each time point[/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/Glimepiride; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when added to glimepiride on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise. ; DRUG USED: Ranexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Late Sodium Current; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Written informed consent - Males and females, 18 to 75 years old, inclusive - Documented history of T2DM - Receiving one of the following sulfonylurea or metformin therapies in addition to diet and exercise for at least 90 days prior to Screening: 1. glimepiride at a daily dose of ≥ 2 mg and ≤ 4 mg 2. glipizide, glyburide, or glibenclamide (or equivalent) at a daily dose of ≥ 7.5 mg 3. gliclazide at a daily dose of > 160 mg (or ≥ 60 mg for the modified release [MR] formulation) 4. metformin at a daily dose of ≥ 1500 mg - Body mass index (BMI) 25 kg/m2 to 45 kg/m2, inclusive, at Screening - HbA1c 7% to 10%, inclusive, at Screening and the end of the Qualifying Period (Day 14) - Fasting Serum C-peptide ≥ 0.8 ng/mL at Screening - Fasting serum glucose (FSG) ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period (Day 14): A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 120 mg/dL (6.7 mmol/L) and < 130 mg/dL (7.2 mmol/L) who are otherwise eligible as determined by the investigator. - Able and willing to comply with all study procedures during the course of the study - Females of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug. - At least 80% compliant in dosing during the Qualifying Period Exclusion Criteria: - History of or current diagnosis of type 1 diabetes mellitus - History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma - History of a severe episode of hypoglycemia (≥ 1 episode within 3 months prior to Screening or ≥ 2 episodes within 6 months prior to Screening), defined as hypoglycemia requiring 3rd party assistance to actively administer carbohydrate, glucagon, or other resuscitative actions due to severe impairment in consciousness or behavior - Clinically significant complications of diabetes that in the judgment of the investigator would make the subject unsuitable to participate in this study - History of any clinically significant cardiovascular (CV) or cerebrovascular event (eg, myocardial infarction [MI], acute coronary syndrome [ACS], recent revascularization [including coronary artery bypass graft procedures or percutaneous coronary intervention], transient ischemic attack, or ischemic stroke) ≤ 3 months prior to Screening - Inadequately controlled or unstable hypertension as defined by a systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and at Randomization - Prolonged QT interval corrected for heart rate (QTc) interval > 500 msec by electrocardiogram (ECG) at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone) - History of bariatric surgery at any time in the past or or any other surgery < 2 months before Screening; or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the medical monitor. - Any other hospitalization in the 14 days prior to Screening or planned hospitalization at any time during the study - Significant weight change (± 5%) < 2 months prior to Screening or enrollment in a weight-loss program other than a maintenance phase at Screening. - Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation < 30 mL/min/1.73 m2 at Screening or undergoing any type of dialysis at Screening or planning to undergo any type of dialysis during the course of the study - History of liver cirrhosis (Child-Pugh Class A, B or C) - Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL - History of cancer (except nonmelanomic skin cancers or cervical in situ) within 5 years prior to Screening - History of alcohol or other drug abuse < 12 months prior to Screening - Any other clinically significant existing medical or psychiatric condition, including clinically significant laboratory abnormalities, or one requiring further evaluation that in the opinion of the investigator could interfere with conduct of the study or interpretation of the data - Use of antihyperglycemic agents other than sulfonylurea agents or metformin, including but not limited to dipeptidyl peptidase-4 inhibitors (eg, saxagliptin and sitagliptin), glucagon-like peptide-mimetics (eg, exenatide), or insulin < 3 months prior to Screening; use of thiazolidinediones (TZDs) (eg, rosiglitazone or pioglitazone) < 24 weeks prior to Screening - Previous history of intolerance of glimepiride (as a single-agent therapy) - Prior treatment with open-label ranolazine, or known hypersensitivity or intolerance to ranolazine or any of its excipients - Treatment with strong or moderate cytochrome P (CYP)3A inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization - Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization - Treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, or sirolimus) within 14 days prior to Randomization - Treatment with simvastatin at a dose of > 20 mg daily or lovastatin at a dose of > 40 mg daily within 14 days prior to Randomization - Weight loss medication or anti-obesity medication (prescription or non-prescription) < 3 months prior to Screening - Treatment with niacin > 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 3 months prior to Screening - Expected or current treatment with systemic corticosteroids (oral or injectable) for > 14 days from Screening through the end of the Treatment Period. Topical or inhaled corticosteroid formulations are permitted at any time during the study. - If receiving thyroid replacement therapy, should be on stable doses for at least 6 weeks prior to randomization - Hemoglobin < 12 g/dL for males or < 11 g/dL for females at Screening - Participation in another clinical study involving an investigational drug or device < 30 days prior to Screening; participation in another clinical study involving an oral antihyperglycemic agent (OHA) < 90 days prior to Screening - Donation of blood < 2 months prior to Screening or plans to donate blood while participating in the study - Females who are pregnant or are breastfeeding - Other condition(s) that, in the opinion of the investigator, would compromise the safety of the individual, prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or compromise the quality of the clinical study ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 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 - READY - w/Docetaxel/Prednisone; BRIEF: The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone. ; DRUG USED: Sprycel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: BCR-ABL Fusion Protein, Src Kinase Family, Tyrosine Kinases; THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - History of histologically diagnosed prostate cancer - Evidence of metastatic disease by any 1 of the following: computed tomography scan, magnetic resonance imaging, bone scan, or skeletal survey - Evidence of progression, as defined by 1 of the following: rising prostate specific antigen levels at least 1 week apart with the final value being >=2 ng/mL; progression of measurable nodal or visceral disease, with nodal lesions >=20 mm and visceral lesions measurable per response evaluation criteria for solid tumors (Response Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan compared with previous scan; or local recurrence in the prostate or prostate bed - Maintaining castrate status: Participants who have not undergone surgical orchiectomy should have received and continue on medical therapies, such as gonadotropin releasing hormone analogs, to maintain castrate levels of serum testosterone <=50 ng/dL - Eastern Cooperative Oncology Group Performance Status of 0 to 2 - At least 4 weeks since an investigational agent prior to starting study therapy - At least 8 weeks since radioisotope therapy prior to starting study therapy - Recovery from any local therapy including surgery or radiation/radiotherapy for a minimum of 7 days prior to starting study therapy - Required initial laboratory values: white blood cell count >=3,000/mm^3; absolute neutrophil count >=1,500/mm^3; platelet count >=100,000/mm^3; creatinine level <=1.5*upper limit of normal (ULN); bilirubin <=ULN; aspartate aminotransferase <=2.5*ULN; alanine aminotransferase <=2.5*ULN. Exclusion Criteria: - Symptomatic brain metastases or leptomeningeal metastases - Clinically significant cardiovascular disease, including myocardial infarction; ventricular tachyarrhythmia within 6 months; prolonged QTc >450 msec; ejection fraction <40%; or major conduction abnormality, unless a cardiac pacemaker is present - Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade - Peripheral neuropathy CTC Grade >=2 - Currently active second malignancy other than nonmelanoma skin cancers. Participants are not considered to have a currently active malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse - Uncontrolled intercurrent illness including ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - HIV infection-positive patients receiving combination antiretroviral therapy - History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents - Receipt of any other investigational agents for the treatment of prostate cancer - Prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine - Patients may continue on a daily multivitamin but must discontinue all other herbal, alternative, and food supplements before enrollment - Ketoconazole must be discontinued 4 weeks prior to starting study therapy - Antiandrogens must be discontinued prior to starting study therapy. Patients with a history of response to an antiandrogen and subsequent progression while on that antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks. Observation for antiandrogen withdrawal response is not necessary for those who have never responded to antiandrogens - Bisphosphonates must not be initiated within 28 days prior to starting study therapy - QT prolonging agents strongly associated with torsade de pointes. ; PRIMARY OUTCOME: Overall Survival: Time From Randomization to Date of Death; SECONDARY OUTCOME 1: Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)[/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-2; BRIEF: The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal impairment. ; DRUG USED: KW-3902 - intravenous; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Adenosine A1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: 1. History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed 2. Hospitalized for acute heart failure syndrome requiring IV diuretic therapy. 3. Impaired renal function Exclusion Criteria: 1. Acute contrast induced nephropathy 2. Ongoing or planned IV therapy for heart failure with positive inotropic agents, vasopressors, vasodilators, or mechanical support with the exception of IV nitrates 3. BNP <500 pg/mL or NT-pro-BNP <2000 pg/mL 4. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis 5. Severe pulmonary disease 6. Significant stenotic valvular disease 7. Heart transplant recipient or admitted for cardiac transplantation 8. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening 9. Heart failure due to significant arrhythmias 10. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. 11. Known hepatic impairment 12. Non-cardiac pulmonary edema, including suspected sepsis 13. Allergy to soybean oil or eggs 14. History of seizure 15. Stroke within 2 years 16. History of or current brain tumor of any etiology 17. Brain surgery within 2 years 18. Encephalitis/meningitis within 2 years 19. History of penetrating head trauma 20. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years 21. History of, or at risk for, alcohol withdrawal seizures 22. Advanced Alzheimers disease 23. Advanced multiple sclerosis 24. Hgb <8 g/dL, Hct <25%, or the need for a blood transfusion 25. Previous exposure to KW-3902 ; PRIMARY OUTCOME: effect on heart failure signs and symptoms; SECONDARY OUTCOME 1: 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 III/IV - FLAMINGO - vs. Darunavir/Ritonavir, each with 2 nucleotide background; BRIEF: This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study. ; DRUG USED: Tivicay; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - HIV-1 infected adults greater than or equal to 18 years of age. Females are eligible to enter and participate in the study if she is (1) non-childbearing potential, (2) child bearing potential with negative pregnancy test at screening and Day 1 and agrees to use protocol-specified methods of birth control while on study. - HIV-1 infection with a screening plasma HIV-1 RNA greater than or equal to 1000copies/mL - Antiretroviral-naïve (less than or equal to 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) - Signed and dated written informed consent is obtained from the subject or the subjects legal representative prior to screening Exclusion Criteria: - Women who are pregnant or breastfeeding - Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease [CDC, 1993], except cutaneous Kaposis sarcoma not requiring systemic therapy - Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification - Anticipated need for Hepatitis C virus (HCV) therapy during the study - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class - History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposis sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening - Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators - Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product - Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation [IAS-USA, 2010] in the Screening result or, if known, any historical resistance test result - Any verified Grade 4 laboratory abnormality. Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subjects participation in the study of an investigational compound is exclusionary - Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal - ALT greater than 3 times the upper limit of normal and bilirubin greater than or equal to 1.5 times the upper limit of normal (with greater than 35% direct bilirubin) - Subject has creatinine clearance of less than 50 mL/min via Cockroft-Gault method - Recent history (less than or equal to 3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding ; PRIMARY OUTCOME: Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48; SECONDARY OUTCOME 1: Time to Virologic Suppression (<50 Copies/mL) Through Week 48[/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 - CONQUER; BRIEF: The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine. ; DRUG USED: Emgality; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have a diagnosis of migraine or chronic migraine. - History of migraine headaches at least 1 year prior to screening, with onset prior to age 50. - History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months. - Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years. Exclusion Criteria: - Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. - Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody. - History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine). - Pregnant or nursing. ; PRIMARY OUTCOME: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days; SECONDARY OUTCOME 1: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine[/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 - ZOSTER-048 (Previous Zostavax); BRIEF: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier. ; DRUG USED: Shingrix; DRUG CLASS: Vaccine; INDICATION: Chickenpox and Shingles - Vaccines and Treatments; TARGET: Immune System, Varicella Zoster Virus (VSV); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - A male or female ≥ 65 years of age at the time of the first vaccination. - Written informed consent obtained from the subject prior to performing any study specific procedure. For the No prev-Zvax group only: • No previous vaccination with Zostavax. For the Prev-Zvax group only: • Previous vaccination with Zostavax ≥ 5 calendar years earlier. - Documentation indicating the date of previous Zostavax vaccination will be required. Exclusion Criteria: - Previous vaccination with Zostavax < 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax. - Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group). - Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed.) Inhaled, topical and intra-articular corticosteroids are allowed. - Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period. - Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine in the period starting 8 days prior to and ending 14 days after either dose of study vaccine. - Current participation in or planned concurrent participation 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. - Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study. - History of HZ or any suspected HZ between the screening visit and Visit 1. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product. - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral. - Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. - Administration of immunoglobulins and/or any blood products in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period. - Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study. - Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. - Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe. ; PRIMARY OUTCOME: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations; SECONDARY OUTCOME 1: Anti-gE Ab Concentrations[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - 003 (Lactose Intolerance); BRIEF: RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products). ; DRUG USED: RP-G28; DRUG CLASS: New Molecular Entity (NME); INDICATION: Food Allergies; TARGET: Bacteria-miscellaneous; THERAPY: Monotherapy; LEAD SPONSOR: Ritter Pharmaceuticals, Inc.; CRITERIA: Inclusion/Exclusion Criteria: - Female subjects must be non pregnant, and non lactating. Females of childbearing potential must use adequate birth control during study participation - Medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance. - Must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohns disease (CD), Celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (SIBO), active gastric or duodenal ulcers, or history of severe ulcers. - Must be nicotine free. ; PRIMARY OUTCOME: Change from baseline in abdominal pain; 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 - 113361 - FEV1 (125/25); BRIEF: This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only). ; DRUG USED: Anoro Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Diagnosis of COPD - 10 pack-year or greater history of cigarette smoking - Post-bronchodilator FEV1/FVC of <0.7 - Predicted FEV1 of 70% of normal or less - Modified Medical Research Council (mMRC) dyspnea score of 2 or greater Exclusion Criteria: - Women who are pregnant, lactating, or planning to become pregnant - Respiratory disorders other than COPD, including a current diagnosis of asthma - Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled - Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device - Hospitalization for COPD or pneumonia within 12 weeks prior to screening - Lung volume reduction surgery within 12 weeks prior to screening - Abnormal and clinically significant ECG findings at screening - Clinically significant laboratory findings at screening - Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit - Use of long-term oxygen therapy (12 hours or greater per day) - Regular use of nebulized treatment with short-acting bronchodilators - Participation in the acute phase of a pulmonary rehabilitation program - A know or suspected history of alcohol or drug abuse - Affiliation with the investigational site - Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW642444 ; PRIMARY OUTCOME: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24); SECONDARY OUTCOME 1: Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (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 - Flexible Dose (LNBR); BRIEF: The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18 mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who are partial responders to their selective serotonin reuptake inhibitor (SSRI) treatment. ; DRUG USED: Edivoxetine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control - Are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, or fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose - Drug and dosage should be within the labeling guidelines for the specific country - Meet criteria for major depressive disorder (MDD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR) criteria - Meet criteria for partial response, as defined by investigators opinion that the participant has experienced a minimal clinically meaningful improvement with SSRI - Have a GRID 17-Item Hamilton Depression Rating Scale (GRID-HAMD17) total score greater than or equal to 16 at screening - Have less than or equal to 75% improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) Exclusion Criteria: - Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than major depression within 1 year of screening - Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder [OCD], post-traumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias) - Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder - Have a history of substance abuse and/or dependence within the past year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine - Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol - Unstable medical conditions that contraindicate the use of LY2216684 - Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, history of urinary hesitancy or retention - Use of excluded concomitant or psychotropic medication other than SSRI - Have initiated or discontinued hormone therapy within the 3 months prior to enrollment - History of treatment-resistant depression as shown by lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks or, in the judgment of the investigator, the participant has treatment-resistant depression - Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery - Have received electroconvulsive therapy (ECT) in the past year ; PRIMARY OUTCOME: Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score; SECONDARY OUTCOME 1: Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment 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 - RoZetta; BRIEF: The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma. ; DRUG USED: Zevalin; DRUG CLASS: Biologic; INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 20 (CD20), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - 18 to 75 years of age. - Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe dEtude de Lymphomes Folliculaires) treatment criteria prior to induction. - Achieved a response to induction treatment with either rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14), rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or rituximab-bendamustine (R-B) (4 to 6 cycles). - Must have completed all doses of the induction treatment, except for the modifications allowed in the protocol. Exclusion Criteria: - Transformation to high grade lymphoma (secondary to low grade follicular lymphoma [FL]). - Grade 3b follicular lymphoma. - Primary follicular lymphoma of the skin or gastrointestinal tract. - Previous treatment of follicular lymphoma. - Altered renal and hepatic function. - Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection - Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). - Life expectancy < 6. - Must have: - Platelet count ≥ 100x10^9/L. - Bone marrow infiltration <25%. ; PRIMARY OUTCOME: Progression Free Survival; SECONDARY OUTCOME 1: Complete Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. ActHIB Vaccine (Immunogenicity); BRIEF: This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age. ; DRUG USED: MenHibrix; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Haemophilus influenzae, Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol - A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. - Written informed consent obtained from the parent or guardian of the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Born after 36 weeks gestation. - Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment. - Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. - Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed. - Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. - History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). - History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. - Major congenital defects or serious chronic illness. - History of any neurologic disorders or seizures. - Acute disease at time of enrollment. - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. - Concurrent participation 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 (pharmaceutical product or device). Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply: - History of measles, mumps, rubella or varicella. - Previous vaccination against measles, mumps, rubella or varicella. - Hypersensitivity to any component of the vaccines, including gelatin or neomycin. - Patients receiving immunosuppressive therapy. - Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. - Individuals with primary and acquired immunodeficiency states. - Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. - Individuals with active tuberculosis. - Acute disease at time of booster vaccination. ; PRIMARY OUTCOME: Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations; SECONDARY OUTCOME 1: Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)[/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: The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function. ; 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: - Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses. - Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization. - Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive. - Have a Multiple Sclerosis (MS) Severity Score of 4 or higher. Key Exclusion Criteria: - Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS as defined by the revised McDonald criteria. - Had a recent clinical relapse (within 3 months) prior to randomization. - Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements. Note: Other protocol-defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Time to Disability Progression Independent of Relapse; SECONDARY OUTCOME 1: Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-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 - REASSURE - vs. Placebo; BRIEF: The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Male or non-pregnant, non-lactating female patients - Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening - At Baseline: Disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6 swollen joints out of 66 with at least 1 of the following at screening: - Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following at screening: - High sensitivity C-reactive protein (hsCRP) ≥ 10 mg/L OR Erythrocyte sedimentation rate (ESR) ≥ 28 mm/1st hr - Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent - Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan only: 6 to 25 mg/week) Exclusion criteria: - Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria - Patients who have ever received biologic immunomodulating agents except for those targeting TNFα - Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19) - Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24; SECONDARY OUTCOME 1: Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)[/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 - E15 (Paediatric; w/CKD stage 5 on dialysis or stages 3b-5 no dialysis); BRIEF: The Primary Objectives of this study are to assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of treatment with colestilan (MCI-196) (including combination therapy). ; DRUG USED: BindRen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Bile Acids, Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - The subject and/or parent(s)/guardian(s) must be capable of providing informed consent, and assent when applicable, in agreement with regional requirements. - The subject has completed either of the short-term studies, MCI-196-E14 or MCI-196-E16 or - The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14: - Hyperphosphataemia: Subjects who experienced hyperphosphataemia, defined as any increase in serum phosphorus [P] levels above the age-related upper limit of normal(ULN) on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one obtained at Week 3 and one obtained at Week 6). After Week 6, subjects meeting the above criteria may enter this study at any time (the two consecutive out-of-range P values having been obtained any time after Week 6 from a scheduled or unscheduled visit). - Hypercalcaemia: Subjects treated with CBPB and experiencing hypercalcaemia may be withdrawn from the short-term study at the discretion of the Investigator in order to proceed to this study at any time, where flexible dosing with colestilan (MCI-196) is available. Exclusion Criteria: - The subject has current clinically significant medical co-morbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery). - The subject is expected to receive immunosuppressant treatment during the course of the study. - The subject is considered unstable on his/her current treatment for CKD within one month prior to enrolment (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e., serum P and calcium (Ca) levels]). - The subject is considered to be non-compliant with study procedures in the opinion of the Investigator. ; PRIMARY OUTCOME: Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value); SECONDARY OUTCOME 1: Mean absolute change in efficacy laboratory parameters (i.e.,P, Ca, Ca P ion product [CaxP], intact parathyroid hormone [iPTH], serum glucose, glycosylated haemoglobin [HbA1c], and uric acid)[/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 - w/Low-Dose Cytarabine; BRIEF: The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia. ; DRUG USED: Trisenox; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: PML/RARalpha ; THERAPY: Combination; LEAD SPONSOR: Cephalon; CRITERIA: Inclusion Criteria: - The patient has confirmed acute myeloid leukemia (AML). - The patient is unwilling or unable to tolerate conventional induction chemotherapy. - The patient has no comorbid conditions that would limit life expectancy to less than 3 months. - Patient must meet specific laboratory parameters for study inclusion. Exclusion Criteria: - The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Previous treatment with low-dose cytarabine is not permitted. - The patient has a QT interval outside of the protocol-specified range. - The patient has laboratory values outside of protocol-specified ranges. - The patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents. - The patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition. - The patient has known central nervous system involvement with AML. ; PRIMARY OUTCOME: Percentage of Participants in Complete Remission (CR); SECONDARY OUTCOME 1: Number of Participants Who Died or Were Censored by 24 Months[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TOZ-CL05; BRIEF: Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B). ; DRUG USED: Tozadenant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Adenosine A2a Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biotie Therapies Inc.; CRITERIA: Inclusion Criteria: - Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form. - Parkinsons disease diagnosis consistent with UK Parkinsons Disease Society Brain Bank Diagnostic criteria - Minimum of 3 years since diagnosis. - Meet Hoehn and Yahr PD stage - Good response to levodopa - Stable regimen of anti-PD medications - Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months - Patient has documented a minimum amount of Off time. - If of childbearing potential (male and female) must use an acceptable method of contraception Exclusion Criteria: - Previous tozadenant study participation - Current or recent participation in another study. - Secondary or atypical parkinsonism - Neurosurgical intervention for PD - Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa® - Treatment with excluded medications - Untreated or uncontrolled hyperthyroidism or hypothyroidism - Clinically significant out-of-range laboratory - MMSE out of range - Current episode of major depression (stable treatment for depression is permitted). - Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) - Women lactating or pregnant - Hypersensitivity to any components of tozadenant or excipients - Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study - History of hepatitis or cholangitis ; PRIMARY OUTCOME: Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time; SECONDARY OUTCOME 1: Change in Good ON Time From Baseline to Week 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 - P05692 - 26wk Extension; BRIEF: Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion criteria: - Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment - Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691 Exclusion criteria: - A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subjects continuation into this long-term extension trial - A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691 - A participant must not be at imminent risk of self-harm or harm to others ; PRIMARY OUTCOME: Number of participants experiencing clinical and laboratory adverse events (AEs); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUSTAIN; BRIEF: The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab. ; DRUG USED: Zinbryta; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 25 (CD25), IL-2 Receptor (IL-2R) ; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria - Must have documented diagnosis of RRMS (McDonald 2010 Criteria) at screening [Polman 2011]. - Must have been treated with natalizumab for at least the 12 months prior to screening and have not missed 2 or more consecutive scheduled doses. - Must be naïve to daclizumab and other forms of daclizumab such as Zenapax® prior to enrollment. - Must have a confirmed Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive, at screening. - Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for duration of the study. Key Exclusion Criteria - Current participation in another investigational study. - Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) [Lublin 2014]. - Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening. - History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to screening. - History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to the active ingredient or any of the excipients. - History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator. - Discontinued natalizumab due to suspicion of PML. - Known active malignancies (participants with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible). - The participant is using another MS therapy concomitantly. - Known history of human immunodeficiency virus (HIV). - Positive test result for Hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). - The participant has been treated with immunosuppressive or immunomodulating treatments including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants Relapse-free at Month 6; SECONDARY OUTCOME 1: Percentage of Participants Relapse-free at Month 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 - SAVE-ONCO; BRIEF: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population. ; DRUG USED: Visamerin/Mulsevo; DRUG CLASS: Non-NME; INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X, Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy Exclusion Criteria: - Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic; - High risk of bleeding; - Severe renal impairment (estimated creatinine clearance <30 mL/min); - ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4; - Major surgery within 4 weeks before randomization; - Known hypersensitivity to unfractionated heparin [UFH] or low molecular weight heparin [LMWH]. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial ; PRIMARY OUTCOME: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death; SECONDARY OUTCOME 1: Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CVOT (The Light Study); BRIEF: The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors. ; DRUG USED: Contrave; DRUG CLASS: Non-NME; INDICATION: Obesity; TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Orexigen Therapeutics, Inc; CRITERIA: Inclusion Criteria: 1. ≥50 years of age (women) or ≥45 years of age (men) 2. Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2 3. Waist circumference ≥88 cm (women) or ≥102 cm (men) 4. At increased risk of adverse cardiovascular outcomes: - Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following: - History of documented myocardial infarction >3 months prior to screening - History of coronary revascularization - History of carotid or peripheral revascularization - Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study - Ankle brachial index <0.9 (by simple palpation) within prior 2 years - ≥50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years AND/OR - Type 2 diabetes mellitus with at least 2 of the following: - Hypertension (controlled with or without pharmacotherapy at <145/95 mm Hg) - Dyslipidemia requiring pharmacotherapy - Documented low HDL cholesterol (<50 mg/dL in women or <40 mg/dL in men) within prior 12 months - Current tobacco smoker Exclusion Criteria: 1. Myocardial infarction within 3 months prior to screening 2. Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme 3. Clinical history of cerebrovascular disease (stroke) 4. History of tachyarrhythmia other than sinus tachycardia 5. Planned bariatric surgery, cardiac surgery, or coronary angioplasty 6. History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures 7. History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary) 8. Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4) ; PRIMARY OUTCOME: Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE); SECONDARY OUTCOME 1: Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring 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 - 06-OM-8301; BRIEF: The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in retardation of increase of serum creatinine(SCr) in IgA Nephropathy ; DRUG USED: Lovaza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immunoglobulin A (IgA) Nephropathy (Bergers Disease); TARGET: Diglycerol Acyltransferase (DGAT), Lipoprotein lipase, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Kuhnil Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Patient of both sexes age 18 or above - Biopsy-proven IgA nephropathy - Baseline serum creatinine ≥ 1.2mg/dl(Female),≥ 1.4mg/dl(Male) - Able to give written informed consent Exclusion Criteria: - Hypertension SBP>160mmHg and/or DBP>100mmHg - Subject, who in the investigators opinion, has a systemic disease that would contraindicate participation in this study - Use of omega-3 fatty acids or analog supplement - Pregnancy or breast feeding at time of entry or unwillingness to comply with measures for contraception - Current or recent (within 30 days) exposure to any investigational drug - Subject who has hypersensitivity to this agent as a previous illness - Low platelet(<100,000/㎕) or the subject who has a high risk of bleeding - Use of corticosteroid during the treatment period or less than 3 months prior to the screening - Use of anticoagulant during the treatment period or within 1 month or 6 half lives prior to screening - Subject who in the investigators opinion, would be confronted with a difficulty ; PRIMARY OUTCOME: The rate of number of patients that 50% or more increase in SCr after 42 months; SECONDARY OUTCOME 1: The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Long Term Study; BRIEF: This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome. ; DRUG USED: Requip IR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Restless Leg Syndrome (RLS); TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Male and female subjects, between the ages of 18 and 79, inclusive A female is eligible to enter and participate in the study if she is of: 1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or, 2. Childbearing potential, has a negative result on all required pregnancy tests prior to randomisation, and agrees to an acceptable contraceptive method. - Subjects with a diagnosis of idiopathic RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria during the Screening Visit. - Subjects have had RLS symptoms with a history of a minimum of 15 RLS episodes during the previous month. If this is not possible due to the subject being on previous medication to treat RLS the investigator should ensure that the subject should have experienced 4-5 episodes of RLS symptoms during the last 7 days of the wash-out phase (see below). The subject must discontinue and wash-out any previous medication for the treatment of RLS or sleep prior to the Baseline Visit (Day 0). The minimum discontinuation period for wash-out is generally 5 half-lives of the medication or 7 consecutive evenings/nights medication-free prior to baseline, whichever is the longer period. - During the Wash-out and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 nights immediately prior to the Baseline Visit (e.g., any combination of evenings and /or nights for = 4 days). - Subjects with a total score = 24 on the IRLS Rating Scale at baseline (Day 0). - Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to Question 4 of the IRLS Rating Scale (e.g., ordinarily this will include a response of (3) severe or (4) very severe sleep disturbance) at the Baseline Visit OR RLS symptoms that cause severe/very severe discomfort in the limbs based on clinical judgment and guided by subject response to Question 1 of the IRLS Rating Scale (e.g., this will include a response of (3) severe or (4) very severe discomfort in limbs) at the Baseline Visit (Day 0). - Subjects must be experiencing RLS symptoms requiring treatment at night-time. - Subjects must have given written informed consent prior to any specific study procedures. Exclusion criteria: - Subjects suffering from augmentation and/ or end of treatment rebound RLS symptoms at baseline (Day 0). Augmentation is defined as RLS symptoms that occurred while on treatment and occur earlier in the afternoon/evening than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk. End of treatment rebound describes worsening of symptoms from baseline that occur after pharmacological treatment is stopped. - Subjects with a previous history of augmentation. - Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist. - Subjects requiring treatment of daytime RLS symptoms (daytime defined as 10:00 hours until 17:00 hours). - Signs of secondary RLS (e.g., end stage renal disease, iron deficient anaemia or pregnancy at Baseline Visit). - Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) at Screening Visit. - Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder). - Subjects diagnosed with movement disorders (e.g., Parkinsons Disease, dyskinesias, and dystonias). - Subjects who have medical conditions which could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to, the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis, major psychotic illness. - Subjects having a clinically significant abnormal laboratory value, ECG, or physical examination findings not resolved by the time of the baseline examinations (Day 0). Abnormal 12-lead ECG findings include, but are not limited to, the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias. - Subjects with a diastolic blood pressure = 110mmHg or = 50mmHg or systolic blood pressure = 180mmHg or = 90mmHg at the Screening or Baseline Visit. - Subjects with a history of alcohol or substance abuse within the past year. - Subjects taking any medication known to induce drowsiness, affect RLS or sleep and which have not been discontinued prior to the Baseline Visit. These medications include the following: Atypical and typical antipsychotics, anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroleptics, stimulants (including methylphenidate), dopamine agonists (including ropinirole), dopamine antagonists (e.g., typical neuroleptics, metoclopramide), levodopa/carbidopa, clonidine, and sedating antihistamines (e.g., chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines. The minimum discontinuation period is generally 5 half lives or 7 consecutive evenings/nights medication free, prior to baseline, whichever is the longer period. Exceptions to this general rule are: fluoxetine, monoamine oxidase inhibitors: 4 weeks. For subjects entering the 40-week, open-label treatment phase, the GSK Medical Monitor can be contacted to discuss individual cases where adherence to the above may not have occurred. - Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to enrolment through to the follow-up visit at the end of the study. - Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study. - Participation in any clinical drug or device trial in the one month prior to the Baseline Visit. - Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedules or other study procedures. - Women who have a positive pregnancy test or who are lactating. ; PRIMARY OUTCOME: Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26; SECONDARY OUTCOME 1: Mean Change From Baseline in the International RLS (IRLS) Rating Scale Total Score at Weeks 1, 4, 8, 16, and 20[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AiME - 13; BRIEF: The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis. ; DRUG USED: Retacrit; DRUG CLASS: Biosimilar; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Erythropoietin Receptor (EPOR); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities 2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) dose administered IV or SC, 1 to 3 times per week for whom the following apply: - A change in Epogen dosing of no more than 10% from the mean - Mean hemoglobin between 9.0 and 11.0 g/dL - No more than one hemoglobin result outside of range from 9.0-11.0 g/dL - No hemoglobin result more than ±1 g/dL from the mean hemoglobin level 3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer 4. Patients with adequate iron stores, defined as plasma ferritin > 100 μg/L and TSAT >20%, prior to randomization 5. Male or female patients aged 18 to 80 years (both inclusive) 6. If female, patient must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control: - hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to randomization - intrauterine device (IUD) - double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream) If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to randomization. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patients last dose Exclusion Criteria: 1. Maintenance epoetin dosage >600 U/kg per week (1-3 times per week) 2. Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior to randomization 3. Any of the following within 3 months prior to randomization: - Myocardial infarction - Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction - Severe/unstable angina - Coronary angioplasty, bypass surgery, or peripheral artery bypass graft - Decompensated congestive heart failure (New York Heart Association [NYHA] class IV) - Pulmonary embolism - Deep vein thrombosis or other thromboembolic event - Received live or attenuated vaccination (except flu vaccination) 4. Uncontrolled hypertension within the 4 weeks prior to randomization defined as more than 10% of post-dialysis blood pressures >170 mmHg systolic and/or >110 mmHg diastolic, based on blood pressure readings obtained when the patients post-dialysis body weight was not more than 0.5 kg above their listed dry weight 5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not) 6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease that in the Investigators opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral or fungal infection or mental disease 7. Contraindication for the test drug or have been previously treated with Epoetin Hospira 8. Relative or absolute iron deficiency prior to randomization into the Maintenance Period 9. Platelet count below 100 x 10^9/L 10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks 11. Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for the study participation 12. History of any of the following: - Detectable anti-rhEPO antibodies - Clinically relevant malnutrition - Confirmed aluminum intoxication - Myelodysplastic syndrome - Known bone marrow fibrosis (osteitis fibrosa cystica) - Known seizure disorder - Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites) 13. A female patient who is pregnant, lactating or planning a pregnancy during the study 14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator 15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization 16. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study 17. Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization 18. A patient who in the Investigators opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit 19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) ; PRIMARY OUTCOME: Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period; SECONDARY OUTCOME 1: Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - OSPREY; BRIEF: This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B). Cohort B is complete and no longer recruiting subjects. ; DRUG USED: Pylarify; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer - Imaging; TARGET: Prostate-specific Membrane Antigen (PSMA), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Progenics Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. 2. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. Cohort A Only: - At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA >20 ng/mL or Gleason score ≥8). - Scheduled or planned radical prostatectomy with PLND. Cohort B Only: [Enrollment is complete; No longer recruiting subjects] - Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment. - If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed. - Scheduled or planned percutaneous biopsy of at least one amenable lesion. Exclusion Criteria: 1. Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection. 2. Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. Cohort A Only: - Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention Cohort B Only: [Enrollment is Complete; No longer recruiting subjects] - Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed - Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression. ; PRIMARY OUTCOME: Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A); SECONDARY OUTCOME 1: Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)[/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 - METRIC (V600); BRIEF: This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212. ; DRUG USED: Mekinist; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - ≥18 years of age - Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory - Received no prior treatment or up to one prior regimen of chemotherapy for advanced or metastatic melanoma. Prior treatment with immunotherapy (with the exception of prior ipilimumab, which is only allowed if given in the adjuvant setting), cytokine therapy, biological or vaccine regimen is permitted. Prior use of sorafenib is allowed - Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) - Women of childbearing potential and men with reproductive potential must agree to use effective contraception during the study. Additionally women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Adequate screening organ function Exclusion Criteria: - Any prior use of BRAF inhibitors or MEK inhibitors. - Subjects who have received dacarbazine or paclitaxel prior to randomization will not be eligible to receive the same chemotherapy as study medication (i.e. a subject who received prior dacarbazine cannot receive dacarbazine on this trial and would thus receive paclitaxel if randomized to the control arm) - History of another malignancy. Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above - Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed) - Brain metastases with the following exceptions that are ALL confirmed by the GSK Medical Monitor: All known lesions must be previously treated with surgery or stereotactic radiosurgery, and Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for ≥90 days prior to randomization (must be documented with two consecutive MRI or CT scans using contrast), and asymptomatic with no corticosteroids requirement for ≥ 30 days prior to randomization, and no enzyme-inducing anticonvulsants for ≥ 30 days prior to randomization - History or evidence of cardiovascular risk including any of the following: - QTcB ≥ 480 msec. - History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible - History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization. - History or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association - History of interstitial lung disease or pneumonitis - History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): - History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes). - Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as: - Evidence of new optic disc cupping. - Intraocular pressure > 21 mm Hg as measured by tonography ; PRIMARY OUTCOME: Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review; SECONDARY OUTCOME 1: Progression-free Survival in All Participants[/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 - Orthopedic Surgery; BRIEF: The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery. ; DRUG USED: Zalviso; DRUG CLASS: Non-NME; INDICATION: Moderate to Severe Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: AcelRx Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female patients who are 18 years of age or older - Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid - Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery Exclusion Criteria: - Patients who have undergone a replacement of the same knee or hip - Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet) - Patients with an allergy or hypersensitivity to opioids ; PRIMARY OUTCOME: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASCLEPIOS I; BRIEF: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis ; DRUG USED: Kesimpta; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - 18 to 55 years of age - Diagnosis of multiple sclerosis (MS) - Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) - At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year - Expanded disability status scale (EDSS) score of 0 to 5.5 Exclusion Criteria: - Primary progressive MS - Disease duration of more than 10 years in patients with an EDSS score of 2 or less - Patients with an active chronic disease of the immune system other than MS - Patients at risk of developing or having reactivation of hepatitis - Patients with active systemic infections or with neurological findings consistent with PML ; PRIMARY OUTCOME: Annualized Relapse Rate (ARR); SECONDARY OUTCOME 1: 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 7791-005 (Japan); BRIEF: To evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders. ; DRUG USED: Ibsrela; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Sodium-hydrogen exchanger 3 (NHE3) ; THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Kirin Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Has voluntarily provided written informed consent to participate in the study. 2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent. 3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination. 4. Dialysis conditions, excluding dry weight, should have been unchanged during the last 2 weeks before screening examination. 5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination. 6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination. 7. If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination. 8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination. Exclusion Criteria: 1. Peritoneal dialysis was performed within 12 weeks before screening examination. 2. iPTH >600 pg/mL (should be based on the most recent value from the patients medical records, etc. before pre-enrollment) 3. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome 4. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination. 5. Subjects who used anti RANKL preparations within 6 weeks before screening examination. 6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination. 7. Having concurrent severe heart disease or hepatic impairment. 8. Developed cerebrovascular disease requiring hospitalization within 6 months before screening examination. 9. Uncontrollable hypertension or diabetes. 10. Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period. 11. Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix). ; PRIMARY OUTCOME: Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.; SECONDARY OUTCOME 1: Changes in serum phosphorous levels from baseline values at each time point.[/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 - MATISSE; BRIEF: This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial. ; DRUG USED: Zymafos; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: DNA; THERAPY: Combination; LEAD SPONSOR: Alaunos Therapeutics; CRITERIA: Inclusion Criteria: - Documented extensive-stage small cell lung cancer. - Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer. - ECOG Performance Status of 0, 1 or 2. - Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests. - Male and female patients must agree to use a highly reliable method of birth control during study participation. - Able to provide informed consent Exclusion Criteria: - Previously untreated (non-irradiated), symptomatic brain metastases. - Known allergy to any of the study drugs or their excipients. - Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol). - Any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (Exception: Subjects with a history of malignancy other than small cell lung cancer may be enrolled after consultation with the medical monitor provided the patients prognosis is best defined by the extensive-stage small cell lung cancer). - Currently pregnant or nursing. ; 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 - RVO in Japan (Branch/Central RVO); BRIEF: The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1 - Best-corrected visual acuity (BCVA): - CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2 - BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2 Exclusion Criteria: - Pregnant or nursing women - History of stroke - Uncontrolled blood pressure - Active ocular infection or intraocular inflammation in either eye - Uncontrolled glaucoma in either eye - Neovascularization of the iris or neovascular glaucoma in either eye - Prior episode of RVO more than 12 months prior to Visit 1 in the study eye - Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2 - Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye - Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye - Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye - Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye - Use of any intra-ocular corticosteroid implants in the study eye Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline; SECONDARY OUTCOME 1: Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Limbal Stem Cell Deficiency (Germany); BRIEF: This clinical study is a scientific study on patients who do not have any limbal stem cells. In this clinical study tissue is taken from the inside of the mouth, and cells from that tissue (epithelial cells) will be grown to form a multilayered cell-sheet, called CAOMECS, which is then transplanted onto the cornea. This transplantation method should repair the damage of the cornea. The aim of this study is to see if the transplantation of CAOMECS renews the surface of the eye, by preventing the growth of the conjunctiva over the cornea and stopping new small blood vessels forming. ; DRUG USED: CAOMECS; DRUG CLASS: Biologic; INDICATION: Corneal Neovascularization (Ophthalmology); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: CellSeed France S.A.R.L.; CRITERIA: Inclusion Criteria: 1. Age ≥2 years to 74 years 2. Males or females with bilateral or unilateral total LSCD due to one of the following causes: 1. Chemical burns 2. Thermal burns 3. Contact lens wear 4. Surgery of the ocular surface 5. Stevens-Johnson syndrome and other inflammatory disease under stable condition 6. Aniridia 3. Documented conjunctivalization of the corneal surface, measured by fluorescein staining 4. Stable disease, i.e. history of LSCD for at least 6 months 5. Clinical signs indicative of conjunctivalisation: 1. Superficial blood vessels on the corneal surface 2. Loss of epithelial transparency or persistent epithelial defect 6. Healthy oral mucosa 7. Absence from tobacco and alcohol (7 days before the biopsy) 8. Regular tooth brushing (at least twice daily) 9. Ability to comply with the protocol 10. Covered by a social security system 11. Signed informed consent form, ability to understand the study procedures, and contractual capability. Applicable to patient or legal carer (including parent) Special inclusion criteria for patients between 18 and 74 years of age (adults): 12. Multiple surgeries in the limbal region Exclusion Criteria: 1. Acute systemic infection 2. Acute ocular inflammation in the previous 6 months 3. Previous neoplastic/cancer disease 4. Severe dry eye confirmed by a Schirmer test 5. Lyell-Syndrome, epidermolysis bullosa 6. Total symblepharon 7. Medical history of hypersensitivity or allergy to bovine or murine derived materials 8. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential 9. Any systemic infectious disease as diagnosed by serology tests such as syphilis, HIV-1, HIV-2, hepatitis B or C, or HTLV-1 infection at screening and at the day of the biopsy 10. Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study 11. Previous participation of the patient in this study 12. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk of treatment-related complications 13. Employees of the sponsor or patients who are employees or relatives of the investigator 14. Genetic conditions such as ectodermal dysplasia or multiple endocrine neoplasia Special exclusion criteria for patients ≥2 and <18 years of age (children): 15. Multiple surgeries in the limbal region ; PRIMARY OUTCOME: Presence of a stable epithelium on cornea and absence of conjunctivalization in the visual axis; SECONDARY OUTCOME 1: Presence of a stable epithelium on cornea and absence of conjunctivalization in the visual axis[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - AB06012; BRIEF: The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs. ; DRUG USED: Masitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: AB Science; CRITERIA: Inclusion Criteria: 1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months 2. Patient with ACR functional class I-III 3. Patient who have active RA 4. Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs 5. Patient with a disease onset at > 16 years of age Exclusion Criteria: 1. Patient for whom the use of methotrexate is contraindicated as per its SPC 2. Patient with documented fibromyalgia 3. Patient with lactose intolerance 4. Patient presenting with cardiac disorders ; PRIMARY OUTCOME: ACR50; SECONDARY OUTCOME 1: ACR[/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 - SCALE (Maintenance); BRIEF: This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood). Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68). ; DRUG USED: Saxenda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Body Mass Index (BMI) of either 30 kg/m^2 or more or BMI of less than 30 kg/m^2 to 27 kg/m^2 with presence of co-morbidities - Stable body weight during the previous 3 months (less than 5 kg self-reported weight change) - Previously undergone dietary weight loss and was not able to maintain reduced weight Exclusion Criteria: - Diagnosis of type 1 or type 2 diabetes - Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months - Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L - History of chronic pancreatitis or idiopathic acute pancreatitis - Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome) - Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial - Current participation in an organized diet reduction program (or within the last 3 months) - Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin - Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry) - History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder - Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial ; PRIMARY OUTCOME: Mean Percentage Change in Fasting Body Weight From Baseline; SECONDARY OUTCOME 1: Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0[/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 - FHA101; BRIEF: This is an open-label study to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide guidance to investigators with respect to identification of appropriate subjects for metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy data following metreleptin treatment in this population ; DRUG USED: Myalept; DRUG CLASS: Biologic; INDICATION: Lipodystrophy; TARGET: Leptin Receptor (LepR); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Is male or female ≥5 years old - If female of childbearing potential (including perimenopausal women who have had a menstrual period within one year): 1. Not breastfeeding 2. Negative pregnancy test result 3. Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (Double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.) - Has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation - Has been diagnosed with at least one of the following 2 metabolic disorders: 1. Diabetes Mellitus 2. Hypertriglyceridemia as defined by fasting triglyceride concentrations >200 mg/dL - If ≥18 years of age, is able to read, understand, and sign the Informed Consent Form (ICF) and an Authorization to Use and Disclose Protected Health Information form, communicate with the investigator, and understand and comply with protocol requirements - If <18 years of age, has a parent or legal guardian to read and understand the ICF and Child Assent Form, communicate with the investigator, and understand and comply with protocol requirements. Adolescent subjects must also read and understand the Child Assent Form; if the child is too young or unable to read, then the Child Assent Form must be explained to the child. Exclusion Criteria: - Has been diagnosed with HIV infection - Has known infectious liver disease - Has known allergies to E. coli-derived proteins or hypersensitivity to any component of study treatment ; PRIMARY OUTCOME: To provide metreleptin, an investigational medication, under a treatment protocol to subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia; SECONDARY OUTCOME 1: To monitor the safety and tolerability of metreleptin in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia[/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 - Relapse-Prevention (Maintenance); BRIEF: The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Generalized Anxiety Disorder (GAD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: The patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02). - The patient has a HAM-A total score >=20 at screening and baseline visits - The patient has a HAM-A score >=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits - The patient has a MADRS total score <=16 at screening and baseline visits Exclusion Criteria: - Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI) - Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR - Women of childbearing potential not using effective contraception Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Time to relapse; SECONDARY OUTCOME 1: Relapse rates, Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), MOS SF-36, Sheehan Disability Scale (SDS), Adverse events, Clinical laboratory tests, Vital signs, ECG[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric (279); BRIEF: The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured by durable platelet response. ; DRUG USED: Nplate; DRUG CLASS: Biologic; INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Diagnosis of primary ITP according to the American Society of Hematology (ASH) guidelines at least 6 months prior to screening, regardless of splenectomy status - Subject must be refractory to a prior ITP therapy, having relapsed after at least 1 prior ITP therapy, or ineligible for other ITP therapies; prior therapy includes first-line therapies - Age ≥ 1 year and < 18 years at the time of providing informed consent - The mean of 2 platelet counts taken during the screening period must be ≤ 30 x 10^9/L with neither count > 35 x 10^9/L - A serum creatinine concentration ≤ 1.5 times the laboratory normal range (for each age category) during the screening period - Adequate liver function; serum bilirubin ≤ 1.5 times the laboratory normal range during the screening period; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times the laboratory normal range during the screening period - Hemoglobin > 10.0 g/dL during the screening period - Subject and/or subjects legally acceptable representative has provided informed consent prior to any study-specific procedure; subject has provided assent, where required Exclusion Criteria: - Known history of a bone marrow stem cell disorder; any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study - Known active or prior malignancy except adequately treated basal cell carcinoma - Known history of congenital thrombocytopenia - Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) - Known history of H. pylori by urea breath test or stool antigen test within 6 months of enrollment or successfully treated with no evidence of infection - Known history of systemic lupus erythematosus, evans syndrome, or autoimmune neutropenia - Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant - Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura - Previous history of venous thromboembolism or thrombotic events - Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent - Rituximab (for any indication) or 6-mercaptopurine (6-MP) within 14 weeks before the screening visit, or anticipated use during the time of the proposed study - Splenectomy within 4 weeks of the screening visit - All hematopoietic growth factors including interleukin-11 (IL-11) (oprelvekin) within 4 weeks before the screening visit - Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study - Vaccinations known to decrease platelet counts within 8 weeks before the screening visit - Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune) - Other criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With a Durable Platelet Response; SECONDARY OUTCOME 1: Percentage of Participants With an Overall Platelet Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FIXTURE 2; BRIEF: This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Chronic plaque-type psoriasis, moderate to severe - Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy Exclusion Criteria: - Forms of psoriasis other than chronic plaque-type - Ongoing use of treatments not allowed for psoriasis Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: PASI (psoriasis area and severity index) and IGA (investigators global assessment); SECONDARY OUTCOME 1: PASI (psoriasis area and severity index) and IGA (investigators global assessment)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 52 weeks (Japan); BRIEF: This study is a multicenter trial performed in Japan, consisting of a comparative study period and a continuous administration period. Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study in patients with retinitis pigmentosa. The safety of same eye drops will also be examined in 52 weeks continuous administration period, in all the patients who completed the comparative study period. ; DRUG USED: Rescula; DRUG CLASS: New Molecular Entity (NME); INDICATION: Retinitis Pigmentosa (RP) (Ophthalmology); TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: R-Tech Ueno, Ltd.; CRITERIA: Inclusion Criteria: 1. Age: 20 years or more, 70 years or less (at obtaining informed consent) 2. Medical examination classification: Outpatients 3. Observation, examination, and surveillance in accordance with the study protocol are judged to be feasible. 4. ETDRS visual acuity test is judged to be feasible at a distance of 4 meters. 5. HFA (10-2) test is judged to be feasible by investigator. 6. Goldmann perimetry shows concentric central visual field loss (including a ring scotoma) with the central 30 degrees or less. 7. The difference in the mean retinal sensitivity at four central points must be less than 3 dB between two reliable measurements with HFA (10-2) (SITA-Standard) conducted within 31 days and both values are worse than 30 dB.(When this criterion is not met after two tests, a 3rd measurement will be implemented within 31 days from the 2nd test. The difference between the 3rd reliable measurement value and the 1st or 2nd measurements must be less than 3 dB, and both values are worse than 30 dB; the most recent data will be regarded as the data acquired before instillation.) Exclusion Criteria: 1. Judged to have difficulty by investigator for visiting the hospital and returning home safely over the study period. 2. Planning to undergo an ophthalmic operation for eye for efficacy evaluation during study period. 3. Current treatment for glaucoma or ocular hypertension. 4. Prior ophthalmectomy or evisceration of an eye 5. Intraocular surgery within the past five months. 6. History of allergy to drugs (instillation narcotics, fluorescein, etc.) that will be used during the clinical study, and to drugs similar to the investigational product 7. Complications of diabetic retinopathy. 8. Complications of external eye inflammation, infectious diseases, or severe dry eye. 9. Use of isopropyl unoprostone in the past or present. 10. Use of the following drugs within 31 days before obtaining informed consent. Calcium antagonists, Dark adaptation improvement drug (helenien) 11. Participation in UF-021 phase Ⅱ trial (including subjects assigned to the placebo group). 12. Participation in other clinical studies within the past 6 months (However, any subject who has not been administered an investigational product will be accepted) 13. Pregnancy or the possibility of becoming pregnant. Currently breastfeeding. Childbearing patients who wish to become pregnant during the clinical study period and are not using appropriate contraceptive measures. 14. Cone-rod dystrophy where cone function was primarily impaired 15. History of optic nerve disease in the eye for efficacy evaluation 16. Complications of a moderate or more severe (grade 3 of the Emery classification) central cataract, an anterior subcapsular cataract, a posterior subcapsular cataract, and posterior capsule opacification that may exert a major influence on visual acuity in the eye for efficacy evaluation ; PRIMARY OUTCOME: Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2); SECONDARY OUTCOME 1: - Changes in the value of the retinal sensitivity through HFA (10-2) (MD value, mean retinal sensitivity at 12 central points /24 central points /68 central points)[/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 - HR-NBL-1 (1.5) (EU); BRIEF: This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified > 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®). In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned. Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted. Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles. After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour. Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour. The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed. The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval. ; DRUG USED: Qarziba; DRUG CLASS: Biologic; INDICATION: Neuroendocrine Tumors (NET); TARGET: Ganglioside GD2; THERAPY: Monotherapy; LEAD SPONSOR: St. Anna Kinderkrebsforschung; CRITERIA: Inclusion Criteria: - • Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS). - Age below 21 years. - High risk neuroblastoma defined as either: 1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or 2. INSS stage 4 without MYCN amplification aged > 12 months at diagnosis - Patients who have received no previous chemotherapy except for one cycle of etoposide and carboplatin (VP16/Carbo). In this situation patients will receive Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the first cycle VP16/Carbo (etoposide / carboplatin). - Written informed consent, including agreement of parents or legal guardian for minors, to enter a randomised study if the criteria for randomisation are met. - Tumour cell material available for determination of biological prognostic factors. - Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding. - Registration of all eligibility criteria with the data centre within 6 weeks from diagnosis. - Provisional follow up of 5 years. - National and local ethical committee approval. Exclusion Criteria: Any negative answer concerning the inclusion criteria of the study - ; PRIMARY OUTCOME: Event Free Survival (R1: MAT therapy); 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 - TRINOVA-1 (w/Paclitaxel); BRIEF: The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow. ; DRUG USED: Trebananib; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Angiopoietins; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Female 18 years of age or older at the time the written informed consent is obtained - Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 - Life expectancy >= 3 months (per investigator opinion) - Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded) - Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy - Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications - Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment. - Adequate organ and hematological function - Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted - Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer Exclusion Criteria: - Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers - Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded - Subjects with primary platinum-refractory disease - Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy - Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities - Previous abdominal or pelvic radiotherapy - History of arterial or venous thromboembolism within 12 months prior to randomization - History of clinically significant bleeding within 6 months prior to randomization - History of central nervous system metastasis - Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab) - Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments - Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia - Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization - Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor - Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide - Clinically significant cardiovascular disease within 12 months prior to randomization - Major surgery within 28 days prior to randomization or still recovering from prior surgery - Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure. ; PRIMARY OUTCOME: Progression-Free Survival; SECONDARY OUTCOME 1: Overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASPIRE - 31-07-247 (Maintenance); BRIEF: The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks. ; DRUG USED: Abilify Maintena; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by Institutional Review Board/Independent Ethics Committee [IRB/IEC]), prior to the initiation of any protocol-required procedures. - Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent. - Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, version 4, Text Revision (DSM-IV-TR) criteria and a history of the illness for at least 3 years prior to screening. - Subjects who, in the investigators judgment, require chronic treatment with an anti-psychotic medication. - Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcome measures, and who can be reliably rated on assessment scales. Exclusion Criteria: - Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. - Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine. - Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigators judgment. - Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or 2 positive drug screens for cocaine. - Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones, or hypersensitivity to anti-psychotic agents, including aripiprazole. - Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening. - Subjects with uncontrolled thyroid function abnormalities. - Subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose the subject to undue risk or interfere with study assessments. - Subjects who are involuntarily incarcerated. - Subjects who have undergone electroconvulsive therapy within 180 days of entry into Phase 2. - Subjects who have used an investigational agent within 30 days of screening; and prior participation in a clinical study with aripiprazole IM depot. - Subjects with clinically significant abnormalities in laboratory test results, vital signs, or ECG results. - Subjects hospitalized for more than 30 days in the 90 days prior to Phase 1 (or Phase 2 for subjects bypassing Phase 1). - Subjects requiring more than 1 benzodiazepine beyond screening (eg, lorazepam and oxazepam). - Subjects who fail to wash-out from prohibited concomitant medications, including the use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors [MAOI]), and mood stabilizers, during screening and Phase 1. ; PRIMARY OUTCOME: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26; SECONDARY OUTCOME 1: Time to Exacerbation of Psychotic Symptoms/Impending Relapse[/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 - VLZ-MD-22 (Pediatric); BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder. ; DRUG USED: Viibryd; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Male or Female outpatients between 7-17 years of age - Primary diagnosis of Major Depressive Disorder (MDD) - Childrens Depression Rating Scale-Revised (CDRS-R) score of 40 or greater - Clinical Global Impressions-Severity (CGI-S) score of 4 or greater Exclusion Criteria: - Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment. - History of suicidal behavior, or requires precaution against suicide - Not generally healthy medical condition - Seizure disorder ; PRIMARY OUTCOME: Change in Childrens Depression Rating Scale-Revised (CDRS-R) Total Score; SECONDARY OUTCOME 1: Change in Clinical Global Impressions-Severity (CGI-S) 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 - vs. Prepopik; BRIEF: The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy. ; DRUG USED: Clenpiq; DRUG CLASS: Non-NME; INDICATION: Colon Cleansing/Laxatives; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy - Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation. - An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy Exclusion Criteria: - Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention - Acute intestinal or gastric ulceration - Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon - Undergoing colonoscopy for foreign body removal or decompression - Reduced level of consciousness or inability to swallow without aspiration - Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures - Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass) - Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites - Severely reduced renal function (<30 mL/min/1.73 m2) - Pregnant or lactating women - Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1 - Rhabdomyolysis - Chronic nausea and vomiting - Hypermagnesemia - Undergoing treatment with Lithium ; PRIMARY OUTCOME: Percentage of Subjects Classified as a Responder Defined by Excellent or Good; SECONDARY OUTCOME 1: Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IV-ATG-SCT-01; BRIEF: The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival. ; DRUG USED: Grafalon; DRUG CLASS: Biologic; INDICATION: Bone Marrow and Stem Cell Transplant - Graft vs. Host Disease (GVHD) Prophylaxis; TARGET: T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Neovii Biotech; CRITERIA: Key Inclusion Criteria: - Patients designated to undergo allogeneic peripheral blood or bone marrow stem cell transplantation following the diagnosis of one of the primary diseases in early or intermediate disease status (i.e., acute myeloid leukemia, acute lymphoid leukemia, and myelodysplastic syndrome) - Patients with an unrelated HLA-A,-B, -C and -DRBI matched donor - Patients with a Karnofsky Performance Score ≥ 70% Key Exclusion Criteria: - Clinically significant concomitant diseases (i.e., cardiac, pulmonary, renal and CNS) - Bacterial, viral, or fungal infections - Known positive for Hepatitis B surfaces antigen, or Hepatitis C antibody, or who have been tested positive for HIV - Patients with any concurrent malignancy. Cancer treated with curative intent < 5 years previously will not be allowed except for patients with resected basal cell carcinoma or treated cervical carcinoma in situ - Known contraindications to the administration of rabbit immunoglobulin antibodies - Hypersensitivity to methylprednisolone, tacrolimus, methotrexate or any excipients contains in these products ; PRIMARY OUTCOME: Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD According to 2005 NIH Criteria as Determined by the Independent Endpoint Committee or Death From Any Cause After Allogeneic Stem Cell Transplantation; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GOLDEN-5 (Safety); BRIEF: This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® [tiotropium] given as 18 mcg once a day). ; DRUG USED: Lonhala Magnair; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sunovion Respiratory Development Inc.; CRITERIA: Inclusion Criteria: 1. Male or female patients age ≥ 40 years, inclusive. 2. A clinical diagnosis of COPD according to the GOLD 2014 guidelines. 3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent). 4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1). 5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1). 6. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005). 7. Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, e.g., condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence.. 8. Willing and able to provide written informed consent. 9. Willing and able to attend all study visits and adhere to all study assessments and procedures. Exclusion Criteria: 1. Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject. 2. Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease). 3. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1). 4. Use of daily oxygen therapy > 12 hours per day. 5. Respiratory tract infection within 6 weeks prior to Screening (Visit 1). 6. Use of systemic steroids within 3 months prior to Screening (Visit 1). 7. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin. 8. Prolonged QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome. 9. History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months. 10. History of narrow angle glaucoma. 11. History of hypersensitivity or intolerance to aerosol medications. 12. Recent documented history (within the previous 3 months) of substance abuse. 13. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator. 14. Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study. 15. Previously received SUN-101 (active treatment; formerly known as EP-101). 16. Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines. ; PRIMARY OUTCOME: Number of Subjects With Treatment-emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke[/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 - Long-Term Safety Study; BRIEF: The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters. ; DRUG USED: Nayzilam; DRUG CLASS: Non-NME; INDICATION: Seizure Disorders (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma S.P.R.L.; CRITERIA: Inclusion Criteria: 1. Has a competent, adult caregiver(s) who is able to recognize and observe the subjects seizure cluster episodes 2. Has an established diagnosis of partial or generalized epilepsy that includes all the following: - A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subjects other non-cluster seizure activity (if any) - A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition - A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures - A seizure cluster pattern established >3 months before Visit 1 - A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1 - At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1 3. Currently on a stable regimen of AED(s) that includes a benzodiazepine 4. Weight is 40 kg to 125 kg, inclusive Exclusion Criteria: 1. Has a neurological disorder that is likely to progress in the next year 2. Has a severe chronic cardio-respiratory disease 3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1 4. Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1 5. Has a history of acute narrow-angle glaucoma 6. Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years ; PRIMARY OUTCOME: Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation; SECONDARY OUTCOME 1: Treatment Success[/INST]No</s>