Datasets:

mi-rei

/

CT_II-III_efficent_5k

like 0

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - WT1-Expressing; BRIEF: This phase I/II trial studies the side effects and best dose of genetically modified T cells in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma. Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell from patients, called T cells, and modifies their genes in the laboratory so that they are programmed to find cells with WT1 and kill them. The T cells are then given back to the patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may help the body build an immune response to kill tumor cells. ; DRUG USED: JTCR016; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Stem Cells/Other Cell Therapies, T-Cell Receptor (TCR), Wilms Tumor Protein 1 (WT1); THERAPY: Combination; LEAD SPONSOR: Fred Hutchinson Cancer Center; CRITERIA: Inclusion Criteria: - ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS 1 AND 2): Histopathological documentation of NSCLC or mesothelioma - ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS 1 AND 2): Patients must be able to give informed consent - ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS 1 AND 2): Patients must be able to provide blood and tumor samples and undergo the procedures required for this protocol - Arm 2 ONLY: Surgically operable NSCLC or mesothelioma - ELIGIBILITY FOR TREATMENT ON ARM 1: Patients must express human leukocyte antigen (HLA)-A*0201 - ELIGIBILITY FOR TREATMENT ON ARM 1: Evidence of WT1 tumor expression - ELIGIBILITY FOR TREATMENT ON ARM 1: Patients must have received at least one line of therapy for NSCLC or mesothelioma or previously documented to have declined therapy - ELIGIBILITY FOR TREATMENT ON ARM 1: NSCLC patients with a mutation in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) must have demonstrated progression or intolerance to at least one of the corresponding targeted therapies (for example erlotinib or crizotinib) - ELIGIBILITY FOR TREATMENT ON ARM 1: Bi-dimensionally measurable disease by palpation, clinical exam, or radiographic imaging (X-ray, computed tomography [CT] scan, positron emission tomography [PET] scan, magnetic resonance imaging [MRI], or ultrasound) - ELIGIBILITY FOR TREATMENT ON ARM 1: Ninety days must have passed since the last doses of radiation or chemoradiation treatment involving lung tissue or thorax prior to T cell infusion (to avoid confounding pneumonitis) - ELIGIBILITY FOR TREATMENT ON ARM 1: Patients treated with prior immunotherapy including and not limited to vaccines, cytokines, T cell stimulating agents, cytotoxic T lymphocyte antigen 4 (CTLA4) inhibitors and programmed death (PD)-1 check point inhibitors are allowed on therapy provided they did not have any severe grade 4 toxicities due to prior therapy and any toxicities due to prior therapy should have resolved, if resolvable to less than or equal to grade 1 - ELIGIBILITY FOR TREATMENT ON ARM 2: Patients must express HLA-A*0201 - ELIGIBILITY FOR TREATMENT ON ARM 2: Evidence of WT1 tumor expression - ELIGIBILITY FOR TREATMENT ON ARM 2: Ninety days must have passed since the last definitive doses of radiation or chemoradiation treatment prior to T cell infusion (to avoid confounding pneumonitis) Exclusion Criteria: - EXCLUSION FOR ENROLLMENT/SCREENING (ARMS 1 AND 2) - Eastern Cooperative Oncology Group (ECOG) performance status >= 2 - Active autoimmune disease (e.g., systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) in which possible progression during treatment would be considered unacceptable by the investigators - Any condition or organ toxicity deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocol - Men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative urine pregnancy test within 2 weeks prior to first infusion - Pregnant women and nursing mothers will be eligible for screening only to test HLA type by saliva or buccal swab and WT1 expression from previously collected tissue sample - Clinically significant and ongoing immune suppression including, but not limited to, systemic immunosuppressive agents such as cyclosporine or corticosteroids, chronic lymphocytic leukemia (CLL), uncontrolled human immunodeficiency virus (HIV) infection, or solid organ transplantation - EXCLUSION FOR TREATMENT (ARMS 1 AND 2) - Exclusions for the leukapheresis procedure (this can be performed at a later time of symptoms resolve): - Infection, with or without antibiotic treatment - Recent hepatitis exposure (hepatitis B or C antigenemia) - Pregnancy or nursing - HIV or human T-lymphotropic virus (HTLV) infection - Positive result on standard test for syphilis (STS) - Unable to generate antigen-specific WT1-specific CD8+ T cells for infusions; however, the patient will have the option to receive WT1-specific T-cells if a lower than planned number of cells is available - Documented infections or known oral temperature > 38.2 degrees Celsius (C) fewer than 72 hours prior to receiving study treatment or systemic infection requiring chronic maintenance; the start of treatment may be delayed - Systemic steroids should be stopped 2 weeks before the start of treatment; topical and inhaled steroids are allowed - Untreated central nervous system (CNS) metastasis that are > 1 cm or symptomatic are not allowed; (patients with CNS metastases > 1 cm or symptomatic that have been treated and demonstrated to be radiologically and clinically stable for at least 4 weeks are allowed) - White blood cells (WBC) < 2,000/ul - Hemoglobin (Hb) < 8 g/dL - Absolute neutrophil count (ANC) < 1,000/ul - Platelets < 50,000/ul - New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, stable or unstable angina, symptoms of coronary artery disease (CAD), congestive heart failure, clinically significant hypotension or history of an ejection fraction of =< 30% (echocardiogram or multi-gated acquisition scan [MUGA]) - Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in 1 second (FEV1) < 2.0 L or diffusion capacity of the lungs for carbon monoxide (DLCO) (corrected for Hb) < 50% will be excluded - Creatinine > 1.5 x the upper limit of normal - Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 5 x upper limits of normal (ULN) - Bilirubin > 3 x ULN that cannot be attributed to NSCLC metastasis - HIV or HTLV infection ; PRIMARY OUTCOME: Number of Participants With Adverse Events; 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 - GS-US-380-1961; BRIEF: The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women. ; DRUG USED: Biktarvy; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria Medically stable HIV-1 infected women who meet the following criteria: - Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111. - Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit - Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 12 weeks preceding the Screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA ≥ 50 copies/mL followed by re-suppression to < 50 copies/mL is allowed - HIV-1 RNA <50 copies/mL at screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Prior Failure; BRIEF: The purpose of this study is to evaluate the efficacy and safety of ponatinib in participants with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure of prior tyrosine kinase inhibitor (TKI) therapy. ; DRUG USED: Iclusig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastrointestinal Stromal Tumor (GIST); TARGET: BCR-ABL Fusion Protein, Fibroblast Growth Factor Receptor (FGFR) , FMS-like tyrosine kinase 3 (FLT-3) , RET, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Ariad Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female participants >=18 years old. 2. GIST with failure of prior TKI therapy defined as: 1. Histologically confirmed metastatic and/or unresectable GIST after experiencing failure of prior treatment with imatinib, sunitinib, and regorafenib. If prior TKI treatment was neoadjuvant therapy, then relapse must have occurred during the neoadjuvant therapy in order to consider it failed therapy. 2. Participants in Cohort A must have evidence of activation mutations in exon 11 of KIT in their tumors. Demonstration of an exon 11 mutation may be based on prior assessment or on evaluation of a tumor sample after enrollment in this study. Participants in Cohort B must have GIST that lacks activating mutations in KIT exon 11, but may have evidence of another activating mutation such as in KIT exon 9 or in PDGFR-α. Participants may be enrolled in the study prior to determination of the appropriate cohort (as long as both cohorts are open for enrollment). 3. Measurable disease per modified RECIST 1.1. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5. Adequate hepatic function as defined by the following criteria: 1. Total serum bilirubin less than or equal to (<=) 1.5*Upper Limit of Normal (ULN), unless due to Gilberts syndrome. 2. ALT <=2.5*ULN or <=5.0*ULN if liver metastases are present. 3. AST <=2.5*ULN or <=5.0*ULN if liver metastases are present. 6. Adequate renal function as defined by the following criterion: a. Serum creatinine <1.5*ULN. 7. Adequate pancreatic function as defined by the following criterion: a. Serum lipase and amylase <=1.5*ULN. 8. For participants of childbearing potential, a negative pregnancy test must be documented prior to enrollment. 9. Female and male participants who are fertile must agree to use an effective form of contraception with their sexual partners from signing of the informed consent form for this study through 4 months after the end of treatment. 10. Provision of written informed consent. 11. Willingness and ability to comply with scheduled visits and study procedures 12. Fully recovered (<= Grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug. Exclusion Criteria: 1. Major surgery within 28 days prior to initiating therapy 2. History of bleeding disorder 3. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis 4. History of alcohol abuse 5. Uncontrolled hypertriglyceridemia (triglycerides >450 milligram per deciliter [mg/dL]) 6. Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: 1. Any history of myocardial infarction (MI). 2. Any history of unstable angina. 3. Congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards within 6 months prior to enrollment. 4. History of clinically significant (as determined by the treating physician) atrial arrhythmia. 5. Any history of ventricular arrhythmia. 6. Any history of cerebrovascular accident or transient ischemic attack (TIA). 7. Any history of peripheral vascular infarction, including visceral infarction; or any revascularization procedure of any vasculature, including the placement of a stent. 8. Venous thromboembolism including deep venous thrombosis (DVT) or pulmonary embolism within 6 months prior to enrollment. 7. Uncontrolled hypertension (diastolic blood pressure greater than (>) 90 millimeter of mercury [mmHg]; systolic >150 mmHg). Participants with hypertension should be under treatment on study entry to effect blood pressure control. 8. Taking medications with a known risk of Torsades de Pointes. 9. Taking any medications or herbal supplements that are known to be strong inhibitors of cytochrome P3A4 (CYP3A4) within at least 14 days before the first dose of ponatinib. 10. Ongoing or active infection. This includes but is not limited to the requirement for intravenous antibiotics. 11. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of prior documentation or known history. 12. Pregnant or breastfeeding. 13. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs. 14. Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR if the other primary malignancy is neither currently clinically significant nor requiring active intervention. 15. Use of any approved TKIs or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is longer, prior to receiving study drug. 16. Any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with the evaluation of the drug. ; PRIMARY OUTCOME: Clinical Benefit Rate (CBR) in Cohort A; SECONDARY OUTCOME 1: Clinical Benefit Rate (CBR) in Cohort B[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Mirena; BRIEF: The primary objective of this study was to compare the efficacy of Test Product (Levosert) vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia. The secondary objectives includes physical and gynaecological examinations, vital signs, clinical laboratory tests including hemoglobin and ferritin measurements, body weight and spontaneously reported adverse events were analysed and compared between Levosert and Mirena® treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various periods of time. The residual amounts of LNG in the devices were finally measured after withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were compared between the two treatment groups. Contraceptive effect of Levosert was estimated by Pearl Index. ; DRUG USED: Liletta; DRUG CLASS: Non-NME; INDICATION: Contraception; TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Uteron Pharma S.A.; CRITERIA: Inclusion Criteria: - Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18 years of age. - Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months. - Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them. Exclusion Criteria: - History of endometrial ablation or dilatation and/or curettage within the 3 months prior to screening - Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to screening - Abnormal liver function or jaundice - Renal insufficiency - Other hormonal treatment (sexual steroids), - Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous myomas of any size, or myometrial myomas > than 3 cm, adenomyosis, atypical hyperplasia, carcinoma) - Abnormal uterine morphology - Presence of ovarian cyst > 3 cm - Lower genital tract infection - Current or recurrent PID (present or recurrent pelvis infection (including history of postpartum endometritis, infected miscarriage) during the past 3 months - Uncontrolled hypertension - Congenital or acquired valvular disease (including corrections with prosthetic valves) - Known or suspected pregnancy - Known or suspected hormone-dependent tumor - BMI > 30 - Abnormal Pap smear test or other evidence of cervical/endometrial mancy - Unexplained amenorrhea - Known hypersensitivity to device material and/or Levonorgestrel ; PRIMARY OUTCOME: Mean change from baseline to Year 1 in the mean menstrual blood loss volume measured using the modified Wyatt pictogram in the two treatment groups; SECONDARY OUTCOME 1: Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Study 0099; BRIEF: Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure. ; DRUG USED: Velusetrag; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroparesis Therapy; TARGET: Serotonin 5-HT4 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Theravance Biopharma; CRITERIA: Inclusion Criteria: - Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening - Composite score ≥2and <5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening - Delayed gastric emptying by either GES (gastric emptying scintigraphy) or GEBT(gastric emptying breath test) - Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms - Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during Screening, if applicable; 24 hours prior to start of the Baseline period; and during the Baseline Period - GCSI-24H 7-day mean composite score ≥2.5 and <5 at Day 1 Exclusion Criteria: - If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >11% - Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach - History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator - History of alcohol or drug abuse or dependence within the last year prior to Screening ; PRIMARY OUTCOME: 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score; SECONDARY OUTCOME 1: Gastric emptying half-time[/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 - GALAXI 1; BRIEF: The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohns disease. ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have Crohns disease (CD) or fistulizing Crohns disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy - Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohns Disease (SES-CD) - Have screening laboratory test results within the protocol specified parameters - A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Has complications of Crohns disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation - Unstable doses of concomitant Crohns disease therapy - Receipt of Crohns disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol - Any medical contraindications preventing study participation ; PRIMARY OUTCOME: Phase 2: Change from Baseline in the Crohns Disease Activity Index (CDAI) Score at Week 12; SECONDARY OUTCOME 1: Phase 2: Clinical Remission at Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - AB12008; BRIEF: The objective is to evaluate the efficacy and safety of masitinib in combination with gemcitabine in refractory ovarian cancer patients. ; DRUG USED: Masitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Combination; LEAD SPONSOR: AB Science; CRITERIA: Main inclusion criteria: 1. Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer), which is either: - First line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy) - First line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy); - Candidate to third line of treatment (refractory, resistant, or sensitive to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line). 2. Patient with adequate organ function per laboratory tests evaluations Main exclusion criteria: 1. Patient intolerant to gemcitabine 2. Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2) 3. Pregnant or nursing female patient ; PRIMARY OUTCOME: Overall survival (OS); SECONDARY OUTCOME 1: Overall 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 II - w/Vitamin K1; BRIEF: This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma. ; DRUG USED: BPM31510-IV; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Berg, LLC; CRITERIA: Inclusion Criteria: 1. Subjects with newly diagnosed pathologically verified GB. 2. No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated. 3. Age ≥18 y. 4. Life expectancy ≥3 months. 5. Karnofsky performance score ≥60. 6. Adequate organ and marrow function as per protocol. 7. Ability for subject to understand and the willingness to sign a written ICF. 8. Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study. 9. Be at least 14 d out from surgery. Exclusion Criteria: 1. No evidence of residual tumor. 2. History of clinically significant tumor-related cerebral hemorrhage. 3. Any serious cardiac history as per protocol. 4. Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months. 5. Known predisposition for bleeding such as von Willebrands disease or other such condition(s). 6. Uncontrolled concurrent illness. 7. Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 y prior to first dose of study drug. 8. Receiving any of the following medications: 1. Therapeutic doses of any anticoagulant, including low-molecular weight heparin. Concomitant use of warfarin, even at prophylactic doses, is prohibited. 2. Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids. 3. Antiangiogenic drugs (ie, Avastin) either in the past 2 wk or if anticipated within the next 2 wk of informed consent. 4. Theophylline 9. Known allergy to CoQ10. 10. Known allergy or adverse reaction to oral, subcutaneous, or IV Vitamin K1. 11. Pregnant or lactating. 12. Known to be positive for the human immunodeficiency virus (HIV). Note: HIV testing is not required for eligibility, but if performed previously and was positive, the subject is ineligible. ; PRIMARY OUTCOME: Efficacy will be assessed by subject progression free survival; SECONDARY OUTCOME 1: Efficacy will be assessed by subject 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 I/II - Mayo Clinic; BRIEF: The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica. ; DRUG USED: Soliris; DRUG CLASS: Biologic; INDICATION: Neuromyelitis Optica (Devics Syndrome, NMO); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Mayo Clinic; CRITERIA: Inclusion Criteria: 1. Diagnosis of NMO, as defined by 2006 criteria OR NMO seropositive spectrum disorder (Recurrent ON or longitudinally extensive transverse myelitis (LETM)). All patients must be NMO-IgG seropositive. 2. Clinical evidence of at least 2 relapses in last 6 months or 3 relapses in the last 12 months (with at least 1 relapse occurring in the preceding 6 months). 3. Age ≥18 years 4. Corrected visual acuity 20/100 or better in at least one eye. If fails item # 4 then entry allowed but only if last attack was myelitis and only attacks of myelitis are considered as outcome measurement. 5. Ambulatory (with or without walker). If fails item # 5 then entry allowed but only if last attack was ON and only attacks of ON are considered as outcome measurement. 6. Provision of written informed consent (see attached) to participate in the study. 7. N. meningitidis vaccination at least 14 days prior to receiving the first eculizumab infusion. If patient in midst of an acute relapse, then relapse will be treated with standard therapy and vaccination given only after a minimum of 4 weeks post attack onset. Exclusion Criteria: Candidates will be excluded from study entry if any of the following criteria are met at the time of randomization: 1. Progressive neurological deterioration unrelated to relapses of ON or myelitis. 2. Pregnant, breastfeeding, or intending to conceive during the course of the study 3. Patients will not participate in any other clinical therapeutic study or will not have participated in any other experimental treatment study within 30 days of screening 4. Patients with a history of splenectomy, because of a potential increased risk of developing meningococcal infection. ; PRIMARY OUTCOME: Median Number of Neuromyelitis Optica (NMO) Attacks Per Year; SECONDARY OUTCOME 1: Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Cat Allergen (w/Asthma); BRIEF: The primary objective is to evaluate the prophylactic efficacy of REGN1908-1909 (anti-Fel d 1) administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the prevention of a Controlled Cat Allergen Challenge-induced early asthmatic response (EAR) assessed by measures of lung function (FEV1) compared to placebo-treated patients. Secondary Efficacy Objectives: - To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat, in the prevention of a Controlled Cat Allergen Challenge-induced: Allergic rhinitis and Ocular symptoms - To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat to increase the exposure to cat allergen, measured as a product of minute ventilation and time, required to induce EAR in a Controlled Cat Allergen Challenge as compared to placebo patients Secondary Safety Objective: - To evaluate the safety and tolerability of REGN1908-1909 vs. placebo in patients with cat allergen-triggered asthma ; DRUG USED: REGN1908-1909; DRUG CLASS: Biologic; INDICATION: Allergy; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Documented or patient reported history (for at least 2 years) of symptomatic cat allergen-triggered asthma with rhinitis with or without conjunctivitis - No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure outside of the home shall be avoided for at least one week prior to any Cat Allergen Challenge and during the defined follow-up period - Less than 10 pack-years of smoking history Key Exclusion Criteria: - Positive human immunodeficiency virus (HIV) test - Positive hepatitis test (HBsAg and hepatitis C antibody) - History of significant multiple and/or severe allergies (including latex gloves) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food - Participation in a prior REGN1908-1909 clinical trial - History of severe anaphylactic or severe asthmatic reactions to cat exposure - Active lung disease other than asthma - Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening - Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening - History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures - Treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within 12 months or once within 3 months prior to screening or has been hospitalized or has attended the ER/Urgent Care facility for asthma more than twice in prior 12 months before screening. - History of hypersensitivity to corticosteroids or antihistamines, or drug treatment excipient Note: Other protocol defined Inclusion/Exclusion Criteria Apply ; PRIMARY OUTCOME: Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8; SECONDARY OUTCOME 1: Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85[/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 - 13-HMedIdeS-03 (Sweden); BRIEF: This study will assess the safety and efficacy of IdeS in the transplantation setting. Each patient will receive one dose of IdeS. If the crossmatch test is negative at the time of transplantation, the patient will be transplanted with a kidney from a deceased or living donor. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior to surgery. ; DRUG USED: IdeS; DRUG CLASS: Biologic; INDICATION: Kidney Transplant Rejection; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Hansa Biopharma AB; CRITERIA: Inclusion Criteria: - Patients diagnosed with CKD and in dialysis with preformed anti-HLA antibodies (non-DSA, DSA or both), negative T-CDC CXM and at least one antibody MFI > 3000 Exclusion Criteria: - Prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer Gleason <6 and prostate-specific antigen (PSA) <10 ng/mL. - Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV - Clinical signs of ongoing infectious disease. - Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > New York Heart Association (NYHA) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (COPD) - History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patients ability to participate in the study - Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L - History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g streptokinase and/or staphylokinase) - Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study. - Patients consented and screened but not dosed in previous studies are not excluded ; PRIMARY OUTCOME: safety; SECONDARY OUTCOME 1: Efficacy (mean fluorescent intensity (MFI) of less than 1100 as measured in an single antigen bead (SAB) assay)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - B1701019; BRIEF: The purpose of this study is to determine whether PF-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects ; DRUG USED: BIIB104; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: AMPA-type glutamate receptor - allosteric site; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the M.I.N.I 7.0 for Psychotic Disorders - Evidence of stable schizophrenia symptomatology >=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia). - Subjects must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for >=2 months prior to Baseline/Day 1, including concomitant psychotropic treatments. Subjects should be on no more than 2 background antipsychotics. - Subject must have an identified informant - Subject must reside in a stable living situation for at least 12 weeks prior to Screening. Key Exclusion Criteria: - Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of the investigator. - Subjects with a current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator. - Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator. - Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I 7.0 for Psychotic Disorders interview and as determined by the investigator. - Subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12; SECONDARY OUTCOME 1: Scale for the Assessment and Rating of Ataxia (SARA)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Centre René Gauducheau; BRIEF: Lung cancer is currently the leading cause of cancer death in both men and women in Europe, with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients indicates that the current recommended regimens are falling short. In addition, many of the commonly used chemotherapy agents are associated with severe nonhematologic toxicities that are often cumulative and nonreversible and impair quality of life in this essentially palliative setting. Therefore, agents with novel mechanisms of action and superior safety profiles need to be investigated. More than 50% of lung cancer shows carcinoembryonic antigen (CEA) expression and anti-CEA radioimmunotherapy (RAIT) could be used. The investigators group showed that pretargeted RAIT (PRAIT) using bispecific antibody (bsMAb) can deliver a higher radiation dose to a tumor than a directly radiolabeled anti-CEA antibody, and shows improved anti-tumor efficacy. This clinical trial is designed to assess PRAIT using an entirely new recombinant anti-CEA bsMAb and a 177Lu-labeled peptide for the treatment of CEA-expressing small cell lung cancers (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC) ; DRUG USED: TF2; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Carcinoembryonic antigen (CEA), Histamine Receptors (unspecified) , Radiopharmaceutical; THERAPY: Combination; LEAD SPONSOR: Centre René Gauducheau; CRITERIA: Inclusion Criteria: • Patients with histologic diagnosis of SCLC who are in partial response or who have failed at least two lines of standard radiation and/or chemotherapy. Outside formal contra-indication, patients must have received at least one prior platinum-based chemotherapy. or - Patients with histologic diagnosis of NSCLC (without activating mutation of EGFR gene) who have failed at least one line of chemotherapy (platinum in combination with a third generation drug or combination of 2 third generation drug +/-bevacizumab in case of predominance of non-squamous tumor) - Age ≥ 18 years - At least 4-weeks after the previous treatment and have recovered from previous radio- or chemotherapy - Women of child-bearing potential must have a negative pregnancy test. - Karnofsky performance status ≥ 60 or ECOG performance status 0-2Karnofsky - Minimum life expectancy of 3 months - Positive CEA on immunohistology or plasma CEA ≥ 10 ng/mL - At least one measurable lesion by CT - At least one abnormal focus by FDG-PET - Imaging studies must be performed within 1-4 weeks before PRAIT study to document extent of disease - Signed informed consent form. Exclusion Criteria: - Pregnant or lactating woman. Women of child-bearing potential will be asked to practice adequate means of birth control for a minimum of 12 months after treatment. - Male patient refusing effective contraception for a minimum of 12 months after treatment. - Brain metastases but patients with brain metastases controlled after treatment by Surgery or radiotherapy since more than 4 weeks are eligibles for the study. An treatment by associated corticotherapy is authorized for these patients. - Known HIV or hepatitis - Any serious active disease or comorbid medical condition (according to the investigators decision and information provided in the IDB) - Severe disorders of hemostasis or anticoagulant treatment cure - Extensive irradiation to more than 25% of their red marrow - Bone marrow involvement to more than 25% - External radiation to specific organs or areas at the maximum tolerated level - EGFR gene mutation in tumor (only for NSCLC) - Febrile aplasia during a previous chemotherapy - Neutrophils < 1.5 G/l - Platelets < 100 G/l - Uncontrolled diabetes - Poor renal function (creatinine level > 2.5 maximum normal level) - Poor hepatic function (total bilirubin level > 30 mmol/l, transaminases > 2.5 maximum normal level) - Treatment with any investigational drug within 30 days before planned PRAIT and during the study - Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma, - Presence of anti-antibody reactivity - Known hypersensitivity to murine antibodies or proteins - Adult patient unable to give informed consent because of intellectual impairment. ; PRIMARY OUTCOME: Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Transferred T-Cells; BRIEF: This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed disease after an allogeneic hematopoietic cell transplant (HCT). The study will enroll AML or MDS patients who have either Minimal Residual Disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic HCT. Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study. Eligible patients for this study must also have ≥ 50% T-cell chimerism from the original donor at the time study entry. The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigators discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-001 T cell product. ; DRUG USED: NEXI-001; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: PRAME/MAPE/OIP4, Wilms Tumor Protein 1 (WT1); THERAPY: Monotherapy; LEAD SPONSOR: NexImmune Inc.; CRITERIA: Inclusion Criteria: General 1. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patients disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens 2. Age ≥ 18 years old 3. Expression of HLA-A*0201 as determined by high resolution sequence-based typing method (e.g. TruSight HLA v2 Sequence Panel) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Patients must have a confirmed diagnosis of AML (according to World Health Organization (WHO) classification) or MDS with evidence of MRD or morphological relapse after HLA-matched allogeneic HCT MRD includes: 1. Detection of blasts <5% in bone marrow 2. Detection of a clonal abnormal blast population via multi-color flow cytometry 3. Detection of known or new myeloid gene mutations 6. Donor match at 10 of 10 loci for HLA-A, -B, -C, -DRB1 and DQB1, with each typed at high resolution by DNA-based methods. a. Patients who have had prior HLA-mismatched or haploidentical allogeneic HCT will not be eligible 7. T-cell chimerism ≥ 50% to donor (by PCR analysis) 8. Acceptable laboratory parameters as follows: 1. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) 2. Total bilirubin ≤ 1.5 × ULN, except patients with Gilberts syndrome, who may enroll if the conjugated bilirubin is within normal limits 3. Creatinine < 1.5 mg/dL or a calculated or measured creatinine clearance (CL) ≥ 50 mL/min per standard calculation 9. Recovery to Grade 1 or baseline of non-hematologic toxicities from prior treatments, excluding alopecia 10. Female patients of childbearing potential must test negative for pregnancy at enrollment and during the study. Sexually active women of child-bearing potential, unless surgically sterile, must be willing to use a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs) or vasectomized partner 11. Male patients with partners of childbearing potential must be either vasectomized or agree to use a condom in addition to having their partners use another method of contraception resulting in a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) such as implants, injectables, combined oral contraceptives, or IUDs. Patients should not have sexual intercourse with females who are either pregnant or lactating without double-barrier contraception Is not pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through one year from administration of NEXI-001 cells Exclusion Criteria: 1. Active acute or chronic graft versus host disease (GvHD) 1. Eligible patients will not be on any steroids ≥10 mg per day prednisone or equivalent or other immunosuppressants such as tacrolimus, cyclosporine, etc. 2. Intermittent topical, inhaled or intranasal corticosteroids are allowed 2. Have active or uncontrolled infections with positive cultures and/or requiring treatment with IV anti-infective agents 3. History of clinically significant cardiovascular disease including but not limited to: 1. Myocardial infarction or unstable angina within the 6 months prior to the initiation of study 2. Stroke or transient ischemic attack within 6 months prior to initiation of study 3. Clinically significant cardiac arrhythmia 4. Uncontrolled hypertension: systolic blood pressure (SBP) > 180 mmHg, diastolic blood pressure (DBP) > 100 mmHg 5. Congestive heart failure (New York Heart Association [NYHA] class III-IV) 6. Pericarditis or clinically significant pericardial effusion 7. Myocarditis 4. Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation 5. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus, etc.) resulting in end organ injury or requiring systemic immunosuppression / systemic disease modifying agents within the last 2 years prior to enrollment. Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and subjects with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for the study 6. Human immunodeficiency virus (HIV) seropositive; HIV testing within 2 years of enrollment 7. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). Patients who are hepatitis B surface antigen (HBsAg) negative and HBV viral DNA negative are eligible 1. Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible 2. Patients who are seropositive because of HBV vaccine are eligible 8. Seropositive for and with active viral infection with hepatitis C virus (HCV) a. Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible 9. Second primary invasive malignancy that has not been in remission for greater than 2 years. Exceptions that do not require a 2-year remission include: resected non-melanoma skin cancer; carcinoma in situ (cervix, bladder, breast, etc.) or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ 10. History of trauma or major surgery within 4 weeks prior to the study enrollment 11. Any serious underlying medical or psychiatric condition that would impair the ability of the patient to receive or tolerate the planned treatment and follow up 12. Known hypersensitivity to any component of NEXI-001 T cells, cyclophosphamide, fludarabine or tocilizumab 13. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment. Inactivated annual influenza vaccination is allowed. 14. Dementia or altered mental status that would preclude understanding and rendering of informed consent 15. History of seizures, aphasia, psychosis or other chronic clinically significant neurologic disorders a. Patients with remote history of seizures that are well controlled on anti-seizure medications and without any seizure episode for 6 months are eligible 16. Any issue that in the opinion of the investigator, would contraindicate the patients participation in the study or confound the results of the study ; PRIMARY OUTCOME: Adverse Events of Special Interest (AESIs) events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - nmDMD (Age 2-5); BRIEF: This is a Phase 2, multiple-dose, open-label study evaluating the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ataluren in participants aged ≥2 to <5 years old with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation in the dystrophin gene. ; DRUG USED: Translarna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: RNA translation; THERAPY: Monotherapy; LEAD SPONSOR: PTC Therapeutics; CRITERIA: Inclusion Criteria: - Males ≥2 to <5 years of age - Body weight ≥12 kg - Diagnosis of DMD - Nonsense mutation in at least 1 allele of the dystrophin gene Exclusion Criteria: - Participation in any other drug or device clinical investigation - Ongoing use of prohibited concomitant medications ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Pharmacokinetics: Maximum Observed Plasma Concentration From Time Zero up to 6 Hours After the Morning Dose (Cmax0-6hr)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Lidocaine; BRIEF: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs. ; DRUG USED: ABT-639; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Voltage-gated calcium channels; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria - Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. - Subject must have an average score of greater than or equal to 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit. Exclusion Criteria - Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from diabetic neuropathic pain or interfere with the pain assessments of diabetic neuropathic pain. - A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with diabetic neuropathic pain assessments or other functions. - Subject has clinically significant abnormalities in clinical laboratory tests. ; PRIMARY OUTCOME: Spontaneous activity in peripheral c-nociceptors; SECONDARY OUTCOME 1: Pain intensity measurements[/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 - PEP005-009; BRIEF: The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk ; DRUG USED: Picato Gel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin Cancer - Basal Cell Carcinoma (BCC); TARGET: Mitochondria, Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: Peplin; CRITERIA: 1. Male or female patients at least 18 years of age. 2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass 3. Ability to follow study instructions and likely to complete all study requirements. 4. Written informed consent has been obtained. 5. Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package. ; PRIMARY OUTCOME: Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.; SECONDARY OUTCOME 1: Efficacy (complete sBCC clearance rate and composite sBCC clearance rate)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ADMA-001; BRIEF: RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract. ; DRUG USED: Asceniv; DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: ADMA Biologics, Inc.; CRITERIA: Inclusion Criteria: 1. An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors. 2. Documented Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT), Pulmonary/Cardiac Transplant, Pulmonary Transplant or Liver Transplant within the 2 years prior to randomization to the study drug. 3. Male/Female patients age: (Pediatric) ≥2 years and <16 years at the time of informed consent. 4. Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent. 5. Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1. 6. Patients must be actively taking at least one immunosuppressive agent. 7. Patients must have a positive RSV RT-PCR at the time of the randomization procedures. 8. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy. 9. Female patients who are not breast-feeding. 10. Patient/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries and questionnaires), visit schedules or treatment regimen according to the judgment of the Investigator. Exclusion Criteria: 1. Documented RSV lower respiratory tract infection (respiratory assessment score is greater than 1) as determined by the site investigators or research staff. 2. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support 3. Unstable respiratory status so severe that survival is not expected for longer than 6 months. 4. End organ dysfunction resulting in anticipated survival of less than 6 months. 5. Known to be HIV positive. 6. Administration of any RSV specific products, including palivizumab (Synagis®) in the 3 months prior to randomization procedures. 7. Previous, current, or planned administration of an investigational RSV vaccine. 8. Known hypersensitivity to immunoglobulin. 9. Known Immunoglobulin (IgA) deficiency 10. Known renal impairment requiring any form of dialysis (HD, PD, CRRT). 11. Known hemodynamically significant congenital heart disease. 12. Previous poor compliance with visit schedules. 13. Severe medical, neurological or psychiatric disorders or laboratory values which may have an impact on the safety of the patient. 14. Concurrent participation in other investigational drug product studies; any exception must be approved by the ADMA Biologics Medical Director. ; PRIMARY OUTCOME: Circulating RI-001 Titer; SECONDARY OUTCOME 1: Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.[/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 - BLOOM-DM (Study 010) - Diabetes; BRIEF: The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents. ; DRUG USED: Belviq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: - Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s). - Body mass index (BMI) 27 to 45 kg/m2, inclusive. - Ability to complete a 1 year study Exclusion Criteria: - Pregnancy - Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening - History of symptomatic heart valve disease - Serious or unstable current or past medical conditions ; PRIMARY OUTCOME: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52; SECONDARY OUTCOME 1: Percent Change in Body Weight From Baseline to Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - KRAS Wild-Type (DARECK); BRIEF: This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. ; DRUG USED: Duligotuzumab; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3; THERAPY: Combination; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with KRAS wild-type status - Progressive disease on or after first-line oxaliplatin-containing regimen for mCRC; participants must have received oxaliplatin-containing chemotherapy for greater than or equal to (>/=) 3 months; no more than one prior chemotherapy regimen for metastatic disease is allowed - Measurable disease per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic and end-organ function Exclusion Criteria: - Prior treatment with irinotecan - Prior treatment with an investigational or approved human epidermal growth factor receptor (HER)-targeted agent - Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1 - Leptomeningeal disease as the only manifestation of the current malignancy - Active infection requiring intravenous antibiotics - Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs - Current severe, uncontrolled systemic disease - Known human immunodeficiency virus (HIV) infection - Untreated/active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) - Pregnant or lactating women - Malignancies other than colorectal cancer within 5 years prior to randomization, except for adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix ; PRIMARY OUTCOME: Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria; SECONDARY OUTCOME 1: Plasma Concentration of 5-Fluorouracil[/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 - CQBW251B2201; BRIEF: This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS. ; DRUG USED: QBW-251; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. - Current or ex-smokers who have a smoking history of at least 10 pack years. - Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening. - Patients featuring chronic bronchitis Exclusion Criteria: - Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or between screening and randomization. - Patients with any documented history of asthma, or with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years. - Patients with a body mass index (BMI) of more than 40 kg/m2. - Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations. - Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation. ; PRIMARY OUTCOME: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Forced Expiratory Volume in One Second (FEV1)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - PIONEER; BRIEF: The objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called GS030-DP (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called GS030-MD (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis Pigmentosa ; DRUG USED: GS-030; DRUG CLASS: Biologic; INDICATION: Retinitis Pigmentosa (RP) (Ophthalmology); TARGET: Channelrhodopsins; THERAPY: Monotherapy; LEAD SPONSOR: GenSight Biologics; CRITERIA: Main selection criteria: - Age ≥18 years to ≤75 years at the time of ICF signature. - Diagnosis of non-syndromic RP defined as: - Clinical diagnosis of non-syndromic RP based on history, mid-peripheral visual dysfunction, and fundoscopic appearance. - Diagnosis of non-syndromic RP is confirmed on full-field ERG - Visual acuity: - Visual acuity in the dose-escalation cohorts of no better LP. - Visual acuity in the extension cohort of no better than CF pending review of dose-escalation cohort data by the DSMB. - Relatively preserved ganglion cell layer volume and retinal nerve fiber layer thickness, as measured with spectral domain optical coherence tomography (SD-OCT). - Interpupillary distance of ≥51 mm and ≤72 mm. - Refractive error of the study eye between -6 diopters and +6 diopters. Main non-selection criteria - Prior receipt of any gene therapy. - Subjects who have undergone significant ocular surgery (per investigator determination) within 3 months prior to Visit 1. - Presence of narrow iridocorneal angles contraindicating pupillary dilation. - Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including SD-OCT, during the study period. - Presence of any systemic or ocular diseases, or pathologies, other than non-syndromic RP, or their associated therapies, that can cause or have the potential to cause vision loss. - Prior vitrectomy or vitreomacular surgery. - Presence of vitreo-macular adhesion or traction, epiretinal membrane, macular pucker and macular hole, evident by ophthalmoscopy and/or by SD-OCT examinations and assessed by the investigator to significantly affect central vision. - Current evidence of retinal detachment assessed by the investigator to significantly affect central vision. - Active ocular inflammation or recurrent history of idiopathic or autoimmune associated uveitis. - Presence of an Active Implantable Medical Device. - Subjects who have undergone thermal laser procedure to the retina within 3 months of trial entry, or any prior thermal laser procedure to the macular region. ; PRIMARY OUTCOME: The safety and tolerability of escalating doses of GS030-DP administered via a single IVT and repeated light stimulation using GS030-MD in subjects with non-syndromic Retinitis Pigmentosa; SECONDARY OUTCOME 1: Evaluate the treatment effect of GS030 as assessed by visual acuity[/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 - MSK-003 (Long Term Safety Study; MuSK-MG); BRIEF: Evaluate the long-term safety of amifampridine phosphate in the symptomatic relief of antibody positive MuSK-MG. ; DRUG USED: Firdapse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myasthenia Gravis (MG); TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: Catalyst Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Participated in the MSK-002 study Exclusion Criteria: - Epilepsy and currently on medication - Clinically significant abnormalities in ECG, in the opinion of the Investigator ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Cetuximab; BRIEF: This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors. ; DRUG USED: NT219; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: Insulin receptor substrate 1 (IRS-1), STAT3 Transcription Factor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: TyrNovo Ltd.; CRITERIA: Portion #2: Dose escalation of NT219 in combination with ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma head and neck and colorectal adenocarcinoma Inclusion Criteria 1. Subject with previously treated colorectal or head and neck cancer with documentation of incurable locally advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, stage III/IV that must have failed or not be a candidate for available standard of care therapies and not deemed amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) by a multidisciplinary committee to include an oncologist, surgeon, and radiation oncologist 2. Subjects with head and neck cancer should have received up to 2 previous regimens for recurrent/metastatic disease; Only subjects with documented wild-type KRAS and BRAF colorectal cancer are allowed to enroll; subjects with colorectal cancer should have received up to 3 previous regimens for metastatic disease. 3. Subjects with HPV negative status only to be enrolled (for subjects with head and neck cancer) 4. Completion of curative radiation therapy at least 4 weeks prior to study treatment initiation; For subjects with head and neck cancer - prior focal palliative radiotherapy must be completed at least 2 weeks prior to study drug administration 5. Availability of archival tumor samples prior to treatment initiation; When not available or feasible for any reason, this requirement can be waived after discussion with the Sponsor. 6. Fresh tumor biopsy should be obtained unless deemed by the investigator that the procedure may pose a risk of bleeding to the subject or otherwise deemed not medically safe and/or feasible for any reason. This biopsy must be either formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue samples, obtained within 3 months prior to enrollment and after the last systemic treatment was completed, with an associated pathology report. Biopsy should be excisional, incisional or core needle. Fine needle aspiration biopsy of the involved neck lymph nodes is permitted however, fine needle aspiration or biopsies of bone lesions that do not have a soft tissue component are unacceptable for submission. 7. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new lesions since last antitumor therapy. 8. Age ≥18 years at the time of signing ICF; 9. ECOG performance status score of <2 at Screening and Baseline (Day 0); 10. Adequate safety lab results at Screening and at Baseline (Day 0) for those tests that require repeating at Baseline, including the following: 1. Albumin ≥3 g/dL 2. Bilirubin ≤1.5 times the upper limit of normal (ULN) or <3 times the ULN in the case of Gilbert Syndrome 3. Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT), and alkaline phosphatase <3 times the ULN 4. Creatinine clearance >60 mL/minute based on the Cockcroft-Gault equation [creatinine clearance in mL/min = (140 - age in years) x body weight (kg)/72 x serum creatinine (mg/dL); multiplied by 0.85 for women] 5. White blood cell (WBC) count ≥2000/uL; hemoglobin ≥9 g/dL; 11. Brain metastases should be stable following radiosurgery with at least 4 weeks since the end of definitive therapy (i.e., radiotherapy) 12. Subjects must have a wash out period of at least 4 weeks prior to first study drug administration from all previous chemotherapy and/or experimental agents except for anti-PD-1 antibodies which must have a wash out period of at least 6 weeks prior to first study drug administration, and all adverse events (AEs) have either returned to baseline or stabilized at Grade 1 or less. 13. Subject can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol; 14. WCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0) 15. WCBP must agree to abstain from sex or use an adequate method of contraception* from the time of informed consent through 2 months after the last dose of NT219; 16. Males must abstain from sex with WCBP or use an adequate method of contraception* from the time of informed consent through 2 months after the last dose of study drug. - Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as some double barrier methods (condom with spermicide) in conjunction with use by the partner of an intrauterine device, diaphragm with spermicide, oral contraceptives, birth control patch or vaginal ring, or injectable or implanted contraceptives. Abstinence is acceptable only as true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. A woman that is postmenopausal (≥2 years since last menstrual period) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) is not considered a WCBP. Portion #3: Expansion cohort of NT219 in combination with ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma head and neck Inclusion Criteria 1. Subject with previously treated head and neck cancer, with documentation of incurable locally advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck, stage III/IV and not deemed amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) by a multidisciplinary committee to include an oncologist, surgeon, and radiation oncologist 2. Patient has received up to 2 previous regimens for recurrent/metastatic disease; 3. Subjects with HPV negative status only to be enrolled Completion of curative radiation therapy at least 4 weeks prior to study treatment initiation; prior focal palliative radiotherapy must be completed at least 2 weeks prior to study drug administration 4. Availability of archival tumor samples prior to treatment initiation; When not available or feasible for any reason, this requirement can be waived after discussion with the Sponsor. 5. Fresh tumor biopsy should be obtained unless deemed by the investigator that the procedure may pose a risk of bleeding to the subject or otherwise deemed not medically safe and/or feasible for any reason. This biopsy must be either formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue samples, obtained within 3 months prior to enrollment and after the last systemic treatment was completed, with an associated pathology report. Biopsy should be excisional, incisional or core needle. Fine needle aspiration biopsy of the involved neck lymph nodes is permitted however, fine needle aspiration or biopsies of bone lesions that do not have a soft tissue component are unacceptable for submission. 6. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new lesions since last antitumor therapy. 7. Age ≥18 years at the time of signing ICF; 8. ECOG performance status score of <2 at Screening and Baseline (Day 0); 9. Adequate safety lab results at Screening and at Baseline (Day 0) for those tests that require repeating at Baseline, including the following: 1. Albumin ≥3 g/dL 2. Bilirubin ≤1.5 times the upper limit of normal (ULN) or <3 times the ULN in the case of Gilbert Syndrome 3. Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT), and alkaline phosphatase <3 times the ULN 4. Creatinine clearance >60 mL/minute based on the Cockcroft-Gault equation [creatinine clearance in mL/min = (140 - age in years) x body weight (kg)/72 x serum creatinine (mg/dL); multiplied by 0.85 for women] 5. White blood cell (WBC) count ≥2000/uL; hemoglobin ≥9 g/dL 10. Brain metastases should be stable following radiosurgery with at least 4 weeks since the end of definitive therapy (i.e., radiotherapy) 11. Subjects must have a wash out period of at least 4 weeks prior to first study drug administration from all previous chemotherapy and/or experimental agents except for anti-PD-1 antibodies which must have a wash out period of at least 6 weeks prior to first study drug administration, and all adverse events (AEs) have either returned to baseline or stabilized at Grade 1 or less. 12. Subject can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol 13. WCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0) 14. WCBP must agree to abstain from sex or use an adequate method of contraception* from the time of informed consent through 2 months after the last dose of NT219; 15. Males must abstain from sex with WCBP or use an adequate method of contraception* from the time of informed consent through 2 months after the last dose of study drug. - Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as some double barrier methods (condom with spermicide) in conjunction with use by the partner of an intrauterine device, diaphragm with spermicide, oral contraceptives, birth control patch or vaginal ring, or injectable or implanted contraceptives. Abstinence is acceptable only as true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. A woman that is postmenopausal (≥2 years since last menstrual period) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) is not considered a WCBP. Exclusion Criteria for Study Portions #2 & #3: The exclusion criteria for Study Portion #2 drug combination dose escalation and Study Portion#3, the expansion phases of the trial are identical. Subjects meeting any of the following exclusion criteria will not be enrolled in the trial: 1. Nasal, paranasal sinus, or nasopharyngeal carcinoma and mutated KRAS colorectal adenocarcinoma, aside from World Health Organization (WHO) Type I and II [keratinizing, non-Epstein-Barr virus (EBV) positive] nasopharyngeal carcinoma which will be allowed; 2. In Study Part 2: For subjects with HNSCC: Received more than 2 prior systemic regimens for their HNSCC; For subjects with CRC: Received more than 3 prior systemic regimens for their CRC; In Study Part 3: For subjects with HNSCC: Received more than 2 prior regimens for their recurrent/metastatic HNSCC 3. Received cetuximab as part of the most recent regimen and/or within the last 6 months prior to study registration 4. Any invasive cancer (other than non-melanoma skin cancer) different from the current disease within 3 years of Screening 5. Known hypersensitivity to ERBITUX® or other epidermal growth factor receptor (EGFR), Janus kinase (JAK), or signal transducer and activator of transcription (STAT) antagonists/inhibitors, or inactive ingredients of NT219 Injection. 6. Radiation or major surgery within 4 weeks prior to the first dose of NT219; 7. Treatment with another investigational therapy within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer 8. Parenteral vitamin C administration and oral supplements containing vitamin C 9. History of weight loss >10% over the 2 months prior to Screening 10. Active, untreated central nervous system (CNS) metastases 11. Severely immunocompromised as defined by white blood cell (WBC) count <2000/mm3 and/or CD4+ lymphocyte count ≤200/mm3 12. Major surgery within 4 weeks of study administration; 13. Known allergy to tick bites or red meat, or known immunoglobulin E (IgE) antibodies directed against galactose-α-1,3-galactose 14. Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study 15. Clinically relevant serious co-morbid medical conditions including, but not limited to: 1. Active infection 2. History of long QT syndrome or corrected QT interval (QTc) or QT/QTc interval measured as prolonged at screening (>480 ms; using Fredericias QT correction formula). Note: subjects who screen fail due to this criterion are not eligible to be re-screened; 3. A history of additional risk factors for TdP including clinically significant prolonged electrolytes imbalance, left ventricular dysfunction and left ventricular hypertrophy, prolonged diarrhea, bradycardia < 60 bpm, past history of syncope or a family history of sudden death at age <40 years 4. The use of concomitant medications that prolong the QT/QTc interval or experienced arrhythmias with use of agents known to induce TdP. 5. Recent (within six months of Screening) New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction, or severe or unstable angina; 6. History of serious arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications 7. Global Initiative for Chronic Obstructive Lung Disease (GOLD) score ≥3 chronic obstructive or chronic restrictive pulmonary disease, pulmonary hypertension, or interstitial pneumonitis 8. Active CNS disease including carcinomatous meningitis; 9. Psychiatric illness/social situation that would limit compliance with study requirements; Prior organ allograft 10. Subjects with active, known or suspected autoimmune disease. Subjects with the following are permitted to enroll: (subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid patients with a history of Graves disease (subjects with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study drug), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. 11. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses >10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating study drug is permitted. 12. History of active or latent tuberculosis infection 13. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) as follows: Subjects with HIV: detectable viral load and CD4 count below 200 cells/mm3; Subjects with HBV (HepBsAg+): serum HBV DNA polymerase chain reaction (PCR) that is above the limit of detection Subjects with HCV (Ab +): detectable HCV RNA by PCR 16. Pregnant or lactating women 17. Use of UGT inhibitors within 14 days prior to first dose of study treatment. Morphine and similar agents and statins which are commonly used in oncology subjects are permitted. See Appendix E for sample list of prohibited UGT inhibitors. ; PRIMARY OUTCOME: Part 1: Incidence of treatment emergent adverse events; SECONDARY OUTCOME 1: Area under the plasma concentration curve [AUC][/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 - Europe; BRIEF: This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia. Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil as opioid analgesics and a neuromuscular blocker. In total, 530 patients will be randomized. This group of 530 patients will be split randomly into 2 groups as follows: • 106 patients will be randomized to induction with propofol plus fentanyl or sufentanil or remifentanil and a neuromuscular blocker. Throughout maintenance, the patients will receive propofol and remifentanil until weaning from the mechanical ventilation on the ICU or PACU within 24 hours after induction. Afterwards, sedation with propofol as study medication has to be ended. If necessary, the sedation is to be continued with the hospitals own supplies (propofol or other sedative). • 424 patients will be randomized to induction with remimazolam 6.0 mg/kg/hr together with fentanyl or sufentanil or remifentanil and a neuromuscular blocker. Throughout maintenance, the patients will receive remimazolam and remifentanil until weaning from the mechanical ventilation on the ICU or PACU within 24 hours after induction. The primary endpoint is successful sedation is defined as a Narcotrend index of 60 or less during at least 85% of the maintenance time and no rescue sedative medication administered. The maintenance starts at arrival at the operation theater and ends with the completion of the last skin suture. ; DRUG USED: ByFavo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Paion UK Ltd.; CRITERIA: Inclusion Criteria: 1. Scheduled for major non-emergency cardiac surgery, i.e. surgery assumed to require more than 2 hours of maintenance of general anesthesia and to require the use of extracorporeal circulation, including coronary bypass(es), valve replacement(s), and associated procedures and on-pump minimal invasive surgery 2. Scheduled to receive mechanical ventilation via tracheal intubation (oropharyngeal or nasotracheal) 3. Age at least 18 years 4. Body mass index 18 to ≤40 kg/m2 5. Willingness and ability to give informed consent, to understand, participate and comply with all study requirements 6. For women of childbearing potential: negative pregnancy test (serum or urine strip) as well as using a highly effective method of birth control. Such methods include: 7. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, with the following routes of administration: oral, intravaginal, transdermal 8. Progestogen-only hormonal contraception associated with inhibition of ovulation, with the following routes of administration: oral, injectable, implantable 9. Intrauterine device 10. Intrauterine hormone-releasing system 11. Bilateral tubal occlusion 12. Sexual abstinence A woman was considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods included hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Exclusion Criteria: 1. Re-do cardiac surgery 2. Surgical procedures that comprised the use of drugs and/or devices that were not approved for marketing 3. Severe tricuspidal insufficiency (III grade) 4. Planned cooling of the patients body below 32ºC 5. History of or planned stop of circulation, e.g. due to repair of type A dissection of aorta or removal of thrombi from pulmonary artery 6. Planned to receive epidural/spinal anesthesia together with general anesthesia 7. Evidence of uncontrolled hepatic, central nervous system, respiratory, or metabolic dysfunction, or other clinically significant findings at screening that, in the investigators or medical monitors opinion, excluded patients from the study 8. Poorly controlled hypertension (e.g. systolic blood pressure ≥160 mmHg under antihypertensive medication at screening) 9. Patients with severe renal insufficiency or end-stage renal disease (creatinine clearance below 30 mL/min or estimated glomerular filtration rate below 30 mL/min/1.73 m2). Measuring only one of both parameters was sufficient to assess the eligibility of a patient. 10. Patients with clinically uncontrolled coagulation abnormalities, or with coagulation abnormalities not under adequate treatment 11. Patients scheduled for heart or lung transplantation 12. Patients with infectious cardiac disorders (e.g. endocarditis, myocarditis) 13. Patients with sepsis 14. Emergency surgery, status of shock or coma 15. Patients with an ejection fraction from the left ventricle of less than 20% 16. Patients with acute right heart failure 17. Pre-operative use of phosphodiesterase 3 inhibitors 18. Patients with a history of resuscitation 19. Known resistance to benzodiazepines or history of paradoxical effects after administration of benzodiazepines 20. History of hypersensitivity to benzodiazepines, propofol, remifentanil hydrochloride, neuromuscular blockers, flumazenil or other anesthetic agents 21. Use of benzodiazepines within 5 times their half-life or 5 times the half-life of their active metabolites. Exception: Pre-medication with a benzodiazepine according to local standards was allowed. 22. Epilepsy 23. Myasthenia gravis or myasthenic syndrome 24. History of any severe allergy defined as urticaria, angioedema or anaphylaxis 25. Dependence from drugs or history of drug abuse 26. Dependence from alcohol or history of alcohol abuse within the last 5 years 27. Acute alcoholic intoxication or ethanol intake within 48 hours prior to surgery 28. Acute narrow-angle glaucoma 29. Female patients of childbearing potential without acceptable method of birth control (for definitions: see inclusion criterion 6). 30. Pregnant or breast-feeding female patients 31. Patients in receipt of any investigational drug within 30 days or less than 7 half-lives (whichever was longer) before the start of the study, or scheduled to receive one during the study period. 32. Administration of remimazolam in the past 33. Patients unable to communicate with the investigator as required for the study 34. Other reasons that, according to the investigator, excluded the patient from the study. ; PRIMARY OUTCOME: Success of Procedure; SECONDARY OUTCOME 1: Hemodynamic stability[/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 - MD-25 (Bipolar I Depression); BRIEF: 1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day ; DRUG USED: Vraylar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria: - Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior); - OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel). Exclusion Criteria: - Four or more episodes of a mood disturbance within the 12 months before Visit 1; - Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias. ; PRIMARY OUTCOME: Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 003 (Multiple Dose); BRIEF: The study was conducted as a placebo-controlled, randomized, 22-week double-blind study which included a dose titration period. An additional transition period occurred for those patients who elected to enroll into the open-label extension study, APD811-007. A total of 61 patients with PAH were enrolled. ; DRUG USED: Ralinepag; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: - Males or females aged 18-75 years, inclusive - Symptomatic WHO Group 1 PAH classified by one of the following subgroups: - Idiopathic pulmonary arterial hypertension (IPAH); - Heritable pulmonary arterial hypertension (HPAH); - Drugs and toxins induced; - Associated pulmonary arterial hypertension (APAH); specifically connective tissue diseases, HIV infection and congenital heart disease. - Has had the diagnosis of PAH confirmed by cardiac catheterization - Has WHO/NYHA functional class II- IV symptomatology - Previously diagnosed with PAH and on stable oral disease-specific PAH therapy with either an ERA and/or an agent acting on the nitric oxide pathway, i.e. a PDE5 inhibitor or a soluble guanylate cyclase stimulator. Stable is defined as no change in dose within 3 months of the start of Screening and for the duration of the study - Has 6MWT distances of 100-500 m, and within 15% of each other on 2 consecutive tests done on different days at Screening - Has pulmonary function tests (PFTs) within 6 months prior to the start of Screening with no evidence of significant parenchymal lung disease - Has a ventilation-perfusion (V/Q) lung scan or pulmonary angiogram within 5 years prior to Screening and concomitant with or following diagnosis of PAH that shows no evidence of thromboembolic disease - If on vasodilators (including calcium channel blockers), digoxin, spironolactone, or L-Arginine supplementation; the patient must be on a stable dose for at least 1 month prior to the start of Screening Exclusion Criteria: - Newly diagnosed with PAH and on no disease-specific PAH therapy - Previous participation in any clinical study with an investigational drug, biologic, or device within 2 months prior to the Screening visit - Acutely decompensated heart failure within 1 month prior to start of Screening - Systolic blood pressure <90 mm Hg at Screening - Evidence or history of left-sided heart disease and/or clinically significant cardiac disease - Use or chronic administration (defined as >30 days) of a prostacyclin or prostacyclin analogue within 3 months of Screening - Any previous use of a prostacyclin or prostacyclin analogue that was stopped for safety or tolerability issues associated with pharmacology/mechanism of action - Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study ; PRIMARY OUTCOME: Change From Baseline in Pulmonary Vascular Resistance (PVR); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - BESIDE; BRIEF: The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone. ; DRUG USED: Solifenacin/Mirabegron; DRUG CLASS: Non-NME; INDICATION: Overactive Bladder (OAB); TARGET: Beta-3 adrenergic receptor (ß3 adrenoceptor), Muscarinic acetylcholine receptor; THERAPY: Combination; LEAD SPONSOR: Astellas Pharma Europe Ltd.; CRITERIA: Inclusion Criteria: - Main Inclusion at Screening: 1. Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for >= 3 months prior to the screening visit 2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit; 3. Subject has symptoms of wet OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day. - Main Inclusion at Run-in (Visit 2): 1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period. 2. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period. 3. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period. - Main Inclusion at Randomization (Visit 3): 1. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms. Exclusion Criteria: - Main Exclusion at Screening: 1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO). 2. Subject has significant Post-void residual (PVR) volume (PVR > 150 ml). 3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator 4. Subject has an indwelling catheter or practices intermittent self catheterization. 5. Subject has evidence of a UTI. 6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs 7. Subject has moderate to severe hepatic impairment 8. Subject has severe renal impairment or End Stage Renal disease 9. Subject has a clinically significant abnormal Electrocardiogram (ECG) 10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. 11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia). 12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin. 13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg. - Main Exclusion at Randomization (visit 3): 1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3). 2. Subject does not desire an increase in study medication. 3. Subject has an average total daily urine volume > 3000ml as recorded in the micturition diary. 4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg. 5. Subject has a clinically significant abnormal ECG ; PRIMARY OUTCOME: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours; SECONDARY OUTCOME 1: Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 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 II - PLEODIAL-I; BRIEF: The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease. ; DRUG USED: PXT864; DRUG CLASS: Non-NME; INDICATION: Alzheimers Disease (AD); TARGET: GABA Receptors, NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pharnext S.C.A.; CRITERIA: Inclusion Criteria: - Male or female patients aged ≥ 60 years. - Patient with a diagnosis of probable AD - Progressive decline in cognition for more than six months which story is documented in patient medical records - A Mini-Mental State Examination (MMSE) score of 20-26 - With a minimum of educational background - Naïve to anti-dementia treatment - MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and excludes other potential causes of dementia especially cerebrovascular lesions - If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels which corroborate the clinical diagnosis - Ambulatory patient living at home with a caregiver available and living in the same household or interacting with the patient daily and available if necessary to ensure administration of the investigational product - Absence of major or severe depressive disease - Patient with a willingness to participate in this study and who have signed an informed consent form Exclusion Criteria: - Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms - Significant neurological disease other than AD - Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder) - Seizure disorders - Other infectious, metabolic or systemic diseases affecting central nervous system - Other active clinically significant illness - Hospitalization or change of chronic concomitant medications one month prior to screening - Patients with severe respiratory, hepatic or renal failure or with any other significantly potentially disabling abnormality detected during screening - Known hypersensitivity to the tested treatment including active substance and excipients. - Patients participating in another study and exposed to any investigational therapy within the 30 days prior to the entry in this study. - Patient without medical care insurance ; PRIMARY OUTCOME: Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog); SECONDARY OUTCOME 1: Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - GWID10160; BRIEF: This study was conducted to determine the efficacy and safety of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a Mayo score of 2 or less (with no sub-score >1) after 10 weeks of treatment. ; DRUG USED: GWP42003; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: Cannabinoid reuptake/Endocannabinoid system, Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor, GPR55, Serotonin 5-HT1A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female participants aged 18 years or above; - Participant diagnosed with mild to moderate ulcerative colitis and on a fixed dose of 5-Aminosalicylic (5-ASA) treatment and have been on a stable dose for at least 2 weeks prior to screening (0 mg dose of 5-ASA was acceptable); - Participants at screening and baseline with a Mayo assessment score of greater than or equal to 4 (≥4) but less than or equal to 10 (≤10) and with an endoscopy score of at least 1 (≥1) , following an adequate exposure to oral and/ or topical 5-ASA, in the opinion of the investigator; - In the opinion of the investigator, capable of complying with the study requirements and completing the study; - Willing and able to give informed consent; - Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable; - Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study; Exclusion Criteria: - Severe ulcerative colitis (Mayo score of greater than 10 (>10); - Ulcerative colitis only affecting the rectum (proctitis) - Gastrointestinal infection evident from stool culture and testing for Clostridium difficile toxin (in the opinion of the investigator); - Currently using or had used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid-based medications within 1 month prior to study entry and unwilling to abstain for the duration of the study; - Any known or suspected history of alcohol or substance abuse, epilepsy or recurrent seizures, or hypersensitivity to cannabinoids; - Was receiving a prohibited medication prior to screening and for the duration of the study; - Previous non-responders to mono or polyclonal anti-Tumor Necrosis Factor antibodies; - Personal or first degree relative, with history of schizophrenia or other psychosis; - History of other significant psychiatric disorder or severe personality disorder (at the discretion of the investigator); - Any known or suspected history of depression sufficient to require treatment with antidepressants or disrupt ordinary life (excluding episodes of reactive depression at the discretion of the investigator); - Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator; - Female participants who were pregnant, lactating or planning pregnancy during the course of the study and for 3 months from the date of last dose; - Female participants of child bearing potential, unless willing to use 2 forms of contraception, 1 of which must have been a barrier contraception (for example, a female condom or occlusive cap [diaphragm or cervical vault/caps] with spermicide) during the study and for 3 months from the date of last dose (however a male condom should not have been used in conjunction with the female condom); - Male participants whose partner was of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (for example, an occlusive cap [diaphragm or cervical vault/caps] with spermicide) during the study and for 3 months from date of last dose (however a male condom should not have been used in conjunction with a female condom); - Planned to travel outside the country of residence during the treatment phase of the study; - Received an Investigational Medicinal Product (IMP) within 30 days prior to the screening visit; - In the opinion of the investigator, was not considered to be suitable for the study; - Any other significant disease or disorder which, in the opinion of the investigator, may either have put the participant at risk because of participation in the study, or may have influenced the result of the study or the participants ability to participate in the study; - Participant with any abnormalities that, in the opinion of the investigator, would prevent the participant from safe participation in the study; - Unwilling to abstain from donation of blood during the study; - Participants previously randomized into this study. ; PRIMARY OUTCOME: Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT; SECONDARY OUTCOME 1: Distribution On The PGAS At 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 II - Study 240 (w/Vemurafenib); BRIEF: The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma. ; DRUG USED: Yervoy; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: - Men and women 18 years of age and older - Histologic diagnosis of malignant melanoma tested positive for the BRAF V600 mutation - Previously untreated unresectable Stage III or Stage IV melanoma - Complete set of brain/neck, chest, abdomen/pelvis axial radiographs taken within 28 days of first dose of study drug - Measurable melanoma by physical or radiographic examination - Brain metastases stable after radiation for at least 1 month and off corticosteroid therapy for ≥30 days prior to enrollment - Eastern Cooperative Oncology Group performance status of 0 or 1 - Adequate hematologic parameters and renal and hepatic function Key Exclusion Criteria: - Primary ocular melanoma - Active brain metastases with symptoms or requiring corticosteroid treatment - Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix - History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies - History of or current immunodeficiency disease, splenectomy, or splenic irradiation - Prior anticancer therapy or investigational products <4 weeks prior to enrollment - Prior therapy with a BRAF or MEK inhibitor and prior investigational anticancer immunotherapies; - Prior therapies with immunosuppressive agents within the past 2 years - Concomitant therapy with any anticancer or potent immunosuppressive agent, surgery, radiotherapy, other investigational anticancer therapies, or chronic use of systemic corticosteroids ; PRIMARY OUTCOME: Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs); SECONDARY OUTCOME 1: Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Gastrointestinal Adverse Events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - COMBI-TED (Italy); BRIEF: This is a phase II, non-comparative, randomized study assessing combination of Tedopi with docetaxel or with nivolumab in NSCLC patients failing after first- line chemoimmunotherapy. In this non-comparative study, the standard arm (arm C) will serve as a calibration arm. All NSCLC patients candidate for second- line therapy are considered eligible for the study if they are HLA-A2+ and if they progressed after at least 4 cycles of previous first-line chemo-immunotherapy. After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will be treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C- standard arm). Docetaxel therapy will be given until disease progression, unacceptable toxicity or patient refusal, and up to maximum 6 cycles. Tedopi or nivolumab will be given until disease progression, unacceptable toxicity or patient refusal. ; DRUG USED: Tedopi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Fondazione Ricerca Traslazionale; CRITERIA: Inclusion Criteria: 1. Male and female patients willing and able to give written informed consent; 2. Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of EGFR mutations or ALK or ROS1 rearrangement; 3. Evidence of disease progression at the end of at least 4 cycles of chemo-immunotherapy or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies that patients with immunotherapy primary resistance are excluded; 4. Patients must have experienced progressive disease (PD), either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after previous clear benefit (any complete -CR- or partial response -PR), or after previous stable disease (SD); 5. Performance status 0-1 (ECOG); 6. Patient compliance to trial procedures; 7. Age ≥ 18 years; 8. Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl); 9. Adequate liver function (bilirubin < G2, transaminases no more than 3xULN/<5xULN in present of liver metastases); 10. Normal level of creatinine; 11. Female patient: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device] until 5 months after end of treatment. or Male patient: should practice complete abstinence or if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year and they should not donate semen as follows: in arm A and C until 6 months since the last dose of docetaxel; in arm B until 3 months since last dose of tedopi. 12. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment. Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization; 13. Patients must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Exclusion Criteria: 1. Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement; 2. No previous chemoimmunotherapy for metastatic disease or evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance). Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded; 3. Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy; 4. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent); 5. Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors considered cured; 6. Pregnancy or lactating; 7. Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll; 8. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease; 9. Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection; 10. Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). ; PRIMARY OUTCOME: 1-year Survival Rate; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II (2) - Multidose Trial; BRIEF: The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo. ; DRUG USED: Striverdi Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. All patients must sign an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, i.e. prior to any study procedures which includes medication washout and restrictions. A separate informed consent is required for pharmacogenomic sampling. 2. Male or female patients, aged between 18 and 70 years of age, diurnally active 3. A history of asthma diagnosed by physician at least 3 months prior to Visit 1 at GINA treatment steps 3 or 4. The diagnosis of asthma must have been made before the age of 40. 4. Pre-bronchodilator FEV1 between 60% predicted and 90% predicted at Visit 1. 5. Increase in FEV1 greater or equal to 12% and 200 ml 15 minutes after 400mcg salbutamol (albuterol) at Visit 1. 6. Patient must have been taking inhaled corticosteroids (ICS) for at least 12 weeks prior to screening, and must have been receiving at a stable dose for at least 6 weeks prior to screening either: - a medium to high dose ICS or - a low to high dose ICS in combination with Long acting beta agonist (LABA). 7. All patients must be symptomatic. Exclusion criteria: 1. Patients with a significant disease other than asthma; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patients ability to participate in the study 2. Patients who have been hospitalised for an asthma exacerbation within 3 months or had an admission to an intensive care unit for asthma within 3 years of Visit 1 3. Patients will be excluded when they have: - an aspartate aminotransferase (AST) >80 IU/L, alanine aminotransferase (ALT) >80 IU/L, bilirubin >1.5 X upper limit of normal (ULN) or creatinine >1.5 X ULN - clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis 4. Patients with any of the following conditions: - a diagnosis of thyrotoxicosis - a diagnosis of paroxysmal tachycardia (>100 beats per minute) - a marked baseline prolongation of QT/QTc interval at Visit 1 (e.g., repeated demonstration of a QTc interval >450 ms) as recommended by ICH E14 - a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) as recommended by ICH E14. 5. Patients with any of the following conditions: - a history of myocardial infarction within 1 year of screening visit (Visit 1) - a diagnosis of clinically relevant cardiac arrhythmia - a history of cor pulmonale - known active tuberculosis - a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) - a history of life-threatening pulmonary obstruction - a history of chronic obstructive pulmonary disease - history of cystic fibrosis - clinically evident bronchiectasis - a history of significant alcohol or drug abuse ; PRIMARY OUTCOME: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period; SECONDARY OUTCOME 1: FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - C-SURFER (HCV + CKD); BRIEF: This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%. ; DRUG USED: Zepatier; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type) - Evidence or no evidence of liver cirrhosis based on one of the following: - Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy) - Fibroscan performed within 12 months of Day 1 of this study - Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index [APRI] obtained during the screening period) - Has HCV status that is one of the following: - Treatment naïve - Prior interferon or pegylated interferon with or without ribavarin failures (null responder, partial responder, or relapser) - Intolerant to prior interferon or pegylated intereferon with or without ribavarin regimen - Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29) non-dialysis dependent or on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy) - Female participant of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if dictated by local regulations Exclusion Criteria: - Evidence of decompensated liver disease - On peritoneal dialysis for management of kidney disease - Co-infection with hepatitis B virus or human immunodeficiency virus (HIV) - History of malignancy <=5 years prior to signing informed consent - Clinical diagnosis of substance abuse - Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose, or longer if dictated by local regulations - Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair - Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial - Uncontrolled or poorly controlled hypertension - Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or cardiovascular procedure within 3 months prior to signing informed consent - New or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent - Severe active peripheral vascular disease - Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures - Evidence or history of chronic hepatitis not caused by HCV ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II; BRIEF: The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Repertaxin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of repertaxin in preventing the primary graft dysfunction (PGD) after lung transplantation. ; DRUG USED: Reparixin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Lung Transplant Rejection; TARGET: Chemokine (C-X-C motif) Receptor 2 (CXCR2) / IL-8 receptor, Chemokine Receptor 1 (CCR1); THERAPY: Monotherapy; LEAD SPONSOR: Dompé Farmaceutici S.p.A; CRITERIA: Inclusion Criteria: - Patients accepted and listed for transplantation due to irreversible, progressive disabling, end-stage pulmonary disease - Body weight 30 - 95 kg, inclusive (i.e. up to 95.99 kg) - Planned isolated (single and bi-lateral) lung transplant from a non-living donor with brain death - Normal renal function at the time of transplant - Patient willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations - Patient given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Exclusion Criteria: - Recipients of an intended multiple organ transplant, including heart-lung and liver-lung transplantation - Recipients of a lung from a living lobar donor - Recipients of a lung from a non-heart beating donor - Re-do lung transplantation - Recipients requiring mechanical ventilation at the time of transplant - Recipients with extra-respiratory tract site of infection - Recipients with hepatic dysfunction at the time of transplant - Hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID) - Hypersensitivity to medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib - Patients simultaneously participating in any other studies involving a study drug to be administered concomitantly with the Investigational Product and/or a study drug intended to prevent ischemia/reperfusion injury - Planned use of anti-CD3 monoclonal antibody (Orthoclone OKT3) or alemtuzumab (Campath) induction immunosuppression - Planned use of sirolimus in the first three months after transplantation - Pregnant or breast-feeding women ; PRIMARY OUTCOME: PaO2/inspired oxygen fraction ratio on ICU admission and at 24 hours after ICU admission; SECONDARY OUTCOME 1: PGD 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 - SPIRIT A1; BRIEF: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) - Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS) - Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response - Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose - Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response - Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks - Men must agree to use a reliable method of birth control or remain abstinent during the study - Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Exclusion Criteria: - Participants with a total ankylosis of the spine - Prior or current treatment with adalimumab - Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF - Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis - Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab - Serious disorder or illness other than ankylosing spondylitis - Serious infection within the last 3 months - Breastfeeding or nursing (lactating) women ; PRIMARY OUTCOME: Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20); SECONDARY OUTCOME 1: Efficacy of Ixekizumab in Participants with AS. Measure: ASAS[/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 - STARS (Angelman Syndrome); BRIEF: The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory efficacy outcome measures will be investigated. ; DRUG USED: OV101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Angelman Syndrome; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ovid Therapeutics Inc.; CRITERIA: Inclusion Criteria 1. Age 13- 49 years 2. Diagnosis of Angelman syndrome 3. Receiving a stable regimen of concomitant medications for at least 4 weeks prior to Baseline, and able to maintain these throughout the duration of the study 4. Has a caregiver capable of providing informed consent on behalf of the subject and able to attend scheduled study visits 5. Able to ingest study medication 6. Caregivers must agree not to post any subject or study information on social media Exclusion Criteria 1. Unable to perform the study related safety and exploratory efficacy assessments, such as motor function 2. Poorly controlled seizure activity 3. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study 4. Pregnancy or women of child-bearing potential who are not using and acceptable method of contraception 5. Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon, and cannabinoid derivatives, or any other use of any investigational agent, device, and/or investigational procedure 4 weeks prior to Baseline and during the study 6. Allergy to OV101 or any excipients 7. At increased risk of harming self and/or others based on investigator assessment 8. Any condition or reason that in the opinion of the investigator makes the subject unsuitable for enrollment 9. Inability of subject or caregiver to comply with study requirements Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Incidence of Adverse Events in Placebo and Active Treatment Groups; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - GHADERM-2-001; BRIEF: This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total. Study visits will occur every 4 weeks. AEs/SAEs, changes to concomitant medications will be noted, vital signs will be taken, and efficacy evaluations will be performed as well. The last estimation of variable scores will occur for all subjects. ; DRUG USED: Hocena; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: DNA Methyltransferase (DNMT); THERAPY: Monotherapy; LEAD SPONSOR: Golden Biotechnology Corporation; CRITERIA: Inclusion Criteria: - Patients between the ages of 20 and 65 years who had moderate-to-severe atopic dermatitis (using the Hanifin and Rajka Diagnostic Criteria) - Patients with body weight ≥ 25 kg and ≤ 120 kg, singing informed consent - To be eligible to participate, patients were required to havea. 1. score of at least 5 on the Eczema Area and Severity Index (EASI), which rangesfrom 0 to 72, with higher scores indicating worse disease severity; 2. a score for pruritus of at least 30 mm on a visual-analogue scale, which ranges from 0 (no itch) to 100 mm (worst itch imaginable); 3. a score of at least 2 on the static Investigators Global Assessment (sIGA), which ranges from 0 (clear) to 4 ( severe disease). 4. BSA affected or PSAI ≥ 5% Exclusion Criteria: 1. Patients with active dermatologic diseases concomitant with atopic dermatitis. 2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study 3. Subjects with defective epidermal barrier(e.g Nethertons syndrome) 4. Any subject who is immunocompromised or has a history of malignant disease. This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test. 5. Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol 6. Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection. 7. Ongoing participation in another investigational trial 8. Use of any oral or topical antibiotic for up to four weeks prior to the reatment visit or active infection that in the opinion of the investigator would compromise the patients ability to tolerate therapy 9. Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit. 10. Participant who has a condition or is in a situation that, in the investigators opinion, may put the patient at significant risk, or may significantly interfere with the patients participation in the study. 11. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices. 12. History of food or drug related severe anaphylactoid or anaphylactic reaction(s) 13. Pregnancy or breast feeding 14. History or presence of epilepsy, significant neurological disorders, cerebrovascular attack or ischemia 15. History or presence of myocardial infarction or cardiac arrhythmia under drug therapy 16. Patients who are unable to complete questionnaires on paper. 17. Clinically significant laboratory abnormalities. 18. History of malignancy of any organ system, treated or untreated. ; PRIMARY OUTCOME: EASI value; SECONDARY OUTCOME 1: SCORAD[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Sunitinib; BRIEF: Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF). ; DRUG USED: Ofev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , Platelet-derived growth factor receptor (PDGFR), Src Kinase Family, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment. 2. Histological-confirmed diagnosis of renal cell cancer with clear cell component. 3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment. Exclusion criteria: 1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment 2. Treatment with other investigational drugs or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. 3. Patients unable to comply with the 1199.26 protocol. 4. Pregnancy or breast feeding. 5. Active alcohol or drug abuse. 6. Women of child bearing potential, or men who are able to father a child, unwilling to use a medically acceptable form of contraception during the study period. ; PRIMARY OUTCOME: Probability Rates of Progression-free Survival at 9 Months; 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 - INO-VATE; BRIEF: This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigators choice of chemotherapy. ; DRUG USED: Besponsa; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 22 (CD22), DNA; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - CD22 expression - Adequate liver and renal functions Exclusion Criteria: - Isolated extramedullary disease - Active Central Nervous System [CNS] disease ; PRIMARY OUTCOME: Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC); SECONDARY OUTCOME 1: Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Necrotizing Soft Tissue Infection; BRIEF: A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. ; DRUG USED: Reltecimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Cluster of Differentiation 28 (CD28) /ICOS and B7RP-1 Pathway, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Atox Bio Ltd; CRITERIA: Inclusion Criteria - Clinical diagnosis of NSTI due to bacterial infection (Necrotizing Fasciitis, Group A streptococcal infection or non group A streptococcal infection, Fourniers gangrene, Bacterial synergistic gangrene, Synergistic Necrotizing Cellulitis, Clostridial gas gangrene/ myonecrosis) that may be supported by specific signs and symptoms, e.g. tense edema outside area of compromised skin, pain disproportionate to appearance, skin discoloration, ecchymosis, blisters/bullae, necrosis, tense edema, crepitus and/or subcutaneous gas AND a decision for urgent surgical exploration and debridement; - Patient who did not receive the study drug prior to the surgery need to have a definite diagnosis of NSTI confirmed surgically (e.g. presence of necrotic tissue, thrombosed vessels in the subcutaneous tissue, lack of bleeding and dishwater (cloudy, thin, gray) fluid) in order to get the drug during or after operation; - IV drug administration within 6 hours from the clinical diagnosis and from the documented decision to have an urgent surgical exploration and debridement; - Signed and dated ICF as defined by the IRB and, if applicable, California Bill of Rights. By signing the ICF, the patient agrees to release any medical records pursuant to current Health Insurance Portability and Accountability Act (HIPAA) Guidelines. If patient is unable to comprehend or sign the ICF, patients legally acceptable representative may sign the ICF; Exclusion Criteria - Age < 18 years; - Weight > 150 Kg / 330 pounds; - Pregnant or lactating women; Female of childbearing potential, the patient must have a negative beta subunit hCG pregnancy test immediately prior to study entry (performed by urine or blood test, whichever is faster); - Patient who has been operated at least once for the current NSTI infection and had a curative deep tissue debridement (diagnostic surgery is allowed to enter into the study); - Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes; - Diabetic patients with below ankle infection; - Patients with overt peripheral vascular disease in the involved area - condition associated with ischemic ulcers and /or symptoms of inadequate vascular supply (e.g. intermittent claudication) where limb amputation is considered likely within 7 days; - Current status of: a. Mean arterial pressure < 50 mmHg and/or systolic blood pressure < 70 mmHg despite treatment with vasopressors and/or IV fluids or b. a patient with respiratory failure such that an SaO2 of 80% cannot be achieved or c. a patient with refractory coagulopathy (INR > 3) or d. thrombocytopenia (platelet count < 20,000) that does not partially correct with administration of appropriate factors, or e. likely severe neurological impairment secondary to cardiac arrest. - Patients with cardiac arrest requiring cardiopulmonary resuscitation within the past 30 days; - Patient is not expected to survive 30 days because of underlying medical condition, such as poorly controlled neoplasm (e.g. Stage III or IV cancer); - Any concurrent medical condition, which in the opinion of the investigator, may compromise their safety or the objectives of the study or the patient will not benefit from treatment, (e.g. end stage organ disease {CHF {NYHA class III-IV}, COPD {stage III-IV}, Liver dysfunction {Childs-Pugh class C}, Renal dysfunction {Dialysis}), immunosuppression, receiving or about to receive chemotherapy or known severe neutropenia < 1,000 cells/mm3; - Patients with Necrotizing Soft Tissue Infection post intra-abdominal operation; - Patient with burn wounds; - Patient or patients family are not committed to aggressive management of the patients condition, or the combination of necrotizing skin infection and underlying illness makes it unlikely that life support will be maintained; - Previous enrolment in an previous clinical trial involving investigational drug or a medical device within 30 days before provision of written informed consent for the study or within five half lives of the investigational drug, whichever is longer; ; PRIMARY OUTCOME: Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period; SECONDARY OUTCOME 1: C-reactive Protein (CRP)[/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 - ACCENTUATE; BRIEF: The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes. ; DRUG USED: Evacetrapib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Cholesteryl Ester Transfer Protein (CETP); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening - Have an LDL-C >70 mg/deciliter(dL) or non-HDL-C >100 mg/dL - Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter) - Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes Exclusion Criteria: - Have a hemoglobin A1c (HbA1c) >9.5% - New York Heart Association (NYHA) class III or IV congestive heart failure - History of either a transient ischemic stroke or ischemic stroke <30 days - History of acute coronary syndrome (ACS) <30 days ; PRIMARY OUTCOME: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)[/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 - BREEZE-AD-PEDS; BRIEF: The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis. ; DRUG USED: Olumiant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - At or above the 5th percentile of weight for age. - Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old). - Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening. - Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). - Agree to use emollients daily. Exclusion Criteria: - Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. - A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past. - Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. - Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). - Have been treated with the following therapies: - Monoclonal antibody for less than 5 half-lives prior to beginning study treatment. - Received prior treatment with any oral Janus kinase (JAK) inhibitor. - Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug or are anticipated to require parenteral injection of corticosteroids during the study. - Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug. - Have high blood pressure characterized by a repeated systolic or diastolic blood pressure >95th percentile based on age, sex and height. - Have had major surgery within the past eight weeks or are planning major surgery during the study. - Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. - Have a history of VTE or are considered at high risk of VTE as deemed by the investigator. - Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. - Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis. - Have specific laboratory abnormalities. - Have received certain treatments that are contraindicated. - Pregnant or breastfeeding. ; PRIMARY OUTCOME: Percentage of Participants Achieving Investigators Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement; SECONDARY OUTCOME 1: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 201012; BRIEF: Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled, double-blind, parallel group study primarily designed to assess the dose response, efficacy and safety of five dose regimens of batefenterol administered via the dry powder inhaler (DPI) once-daily in the morning for 42 days in subjects with COPD. The information obtained from this study will be used to select the minimal, optimally effective and safe dose of batefenterol and also to evaluate the pharmacokinetic profile and established pharmacodynamic (PD) responses of batefenterol. These data will support for future studies with batefenterol in COPD subjects. The study will consist of a pre-screening visit, screening visit; a run-in period (2 weeks), treatment period of 42 days and a follow-up visit 7 days post-treatment. The total duration of the study for each subject will be approximately 9 weeks. Approximately 460 subjects will be screened in order to randomize approximately 320 subjects, assuming that 280 subjects will complete the study. During treatment period, subjects will be randomized to one of the following treatments delivered via DPI once daily in the morning: Batefenterol 37.5 mcg, 75 mcg, 150 mcg, 300 mcg and 600 mcg, umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and placebo. All subjects will receive supplemental albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. ; DRUG USED: GSK961081; 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: - Type of subject: Outpatient - Informed Consent: A signed and dated written informed consent prior to study participation - Age: 40 years of age or older at Visit 1. - Gender: Male and female subjects are eligible to participate in the study. Female subjects are eligible to participate if not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion Hysterectomy Documented Bilateral Oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment. Reproductive potential and agrees to follow one of the options listed below 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit. This list does not apply to females of reproductive potential with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. Contraceptive subdermal implant that meets <1 percent (%) rate of failure per year, as stated in the product label Intrauterine device or intrauterine system that meets <1% rate of failure per year, as stated in the product label Oral Contraceptive, either combined or progestogen alone Injectable progestogen Contraceptive vaginal ring Percutaneous contraceptive patches Male partner sterilization with documentation of azoospermia prior to the female subjects entry into the study, and this male is the sole partner for that subject These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society as follows: Chronic obstructive pulmonary disease is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. - Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g. 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years). Note: pipe and cigar cannot be used to calculate pack-year history. - Severity of Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <=0.70 and a post-albuterol/salbutamol FEV1 >=30 and <=70% of predicted normal at Visit 1. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Exclusion Criteria: - Asthma: Subjects with a current diagnosis of asthma. (subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). - Other Respiratory Disorders: Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension unrelated to COPD, and interstitial lung disease. Allergic rhinitis is not exclusionary. - Other Diseases/Abnormalities: Any significant diseases (including uncontrolled hypertension, diabetes and thyroid disease) that in the opinion of the investigator or the study medical monitor would put the safety of the subject at risk through study participation, or which would affect study analyses if the diseases/condition exacerbated during the study. - Hepatitis: Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening Visit 1 or within 3 months prior to first dose of study treatment. (subjects with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) polymerase chain reaction (PCR) test is obtained). - Liver Disease: Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Cancer: A current malignancy or previous history of cancer in remission for <5 years prior to Visit 1 (localised basal cell or squamous cell carcinoma of the skin that has been resected is not exclusionary.) Any current or previous history of throat cancer. - Chest X-Ray: A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Visit 1 if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For subjects in Germany, if a chest X-ray (or CT scan) is not available in the 6 months prior to Visit 1 the subject will not be eligible for the study. - Drug Allergy: A history of hypersensitivity or allergy to any beta adrenergic receptor-agonist, sympathomimetic, anticholinergic/anti-muscarinic receptor antagonist, or lactose/milk protein, which in the opinion of the investigator or GlaxoSmithKline (GSK) medical monitor contraindicates study participation. - Diseases Preventing Use of Anticholinergic: Medical diagnosis of narrow- angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholinergic. - Poorly controlled COPD: defined as the occurrence of acute worsening of COPD that is managed with corticosteroid and/or antibiotics or that requires treatment prescribed by a physician in the 6 weeks prior to Screening (Visit 1), or subjects who are hospitalized due to acute worsening of COPD within 12 weeks of Visit 1. - History of COPD exacerbation: Subjects who have had more than one exacerbation (moderate or severe) within the 12 months prior to Visit 1. - Pneumonia and lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1 or subjects hospitalized due to pneumonia within 12 weeks of Visit 1. - Lung Resection: Lung volume reduction surgery within the 12 months prior to Visit 1. - 12-lead ECG: An abnormal and clinically significant 12-lead electrocardiogram (ECG). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of subject eligibility. For this study, an abnormal and clinically significant ECG that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to the criteria mentioned in the protocol. - Screening Labs: Clinically significant abnormal finding from clinical chemistry or hematology tests at Visit 1. - Medication Prior to Spirometry: Unable to with hold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. - Excluded Medications: Use of the following medications are not permitted within the defined time intervals prior to Visit 1 and throughout the study: depot corticosteroids (12 weeks), antibiotics (for lower respiratory tract infection) (6 weeks), cytochrome P450 3A4 strong inhibitors and P-glycoprotein inhibitors (4 weeks), systemic, oral or parenteral corticosteroids (2 weeks), inhaled corticosteroids (ICS) or long-acting beta2- agonist (LABA)/ ICS combination products (2 weeks), phosphodiesterase 4 (PDE4) inhibitor (roflumilast) (2 weeks), LABA/ long acting muscarinic receptor antagonist (LAMA) combination (eg vilanterol /umeclidinium bromide) (2 weeks), Once-daily beta2-agonist ( eg Olodaterol and Indacaterol) (10 days), long acting muscarinic antagonists (eg tiotropium, aclidinium, glycopyrronium, umeclidinium) (7 days), theophyllines (48 h), oral leukotriene inhibitors (zafirlukast, montelukast, zileuton) (48 h), oral beta2-agonists long-acting (48 h), short-acting (12 h), inhaled long acting beta2-agonists (LABA, e.g. salmeterol, formoterol, indacaterol) (48 h), inhaled sodium cromoglycate or nedocromil sodium (24 h), inhaled short acting beta2-agonists (4 h), inhaled short-acting anticholinergics (4 h), inhaled short-acting anticholinergic/ short-acting beta2-agonist combination products (4 h), any other investigational medication (30 days or within 5 drug half-lives [whichever is longer]). The complete list of excluded cytochrome P450 inhibitors and P-glycoprotein inhibitors will be provided in study reference manual (SRM). Use of study provided albuterol/salbutamol is permitted during the study, except in the 4-hour period prior to spirometry testing. - Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 h a day. As-needed oxygen use (i.e. <=12 h per day) is not exclusionary. - Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g. albuterol/salbutamol) via nebulized therapy. - Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. - Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1. - Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits. - Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study - Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study. - Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a diary. ; PRIMARY OUTCOME: Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42; SECONDARY OUTCOME 1: Change From Baseline in Trough FEV1 at Day 42[/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 - Abdominal/Orthopedic - vs. Morphine; BRIEF: The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital. ; 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 or older - Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. - 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 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 - Female patients who are pregnant or breast-feeding ; PRIMARY OUTCOME: Patient Global Satisfaction; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - CL-08-01; BRIEF: The purpose of the study is to determine whether AM-111 is effective in the treatment of acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL). ; DRUG USED: Sonsuvi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hearing Loss - General; TARGET: c-Jun N-terminal kinase (JNK); THERAPY: Monotherapy; LEAD SPONSOR: Auris Medical AG; CRITERIA: Inclusion Criteria: - Patients with unilateral acute sensorineural hearing loss (ASNHL) with onset 48 hours or less ago - Mean earing loss compared with the unaffected contralateral ear of at least 30 dB in the 3 most affected contiguous frequencies - Age ≥ 18 years and ≤ 60 years - Negative pregnancy test for women of childbearing potential - Able to attend the on-study visits - Written informed consent before participation in the study Exclusion Criteria: - Bilateral ASNHL, if not resulting from acoustic trauma - Suspected perilymph fistula or membrane rupture - Barotrauma - Average air bone gap higher than 20 dB in 3 contiguous frequencies - History of Meniere disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion or fluctuating hearing loss - Previous ASNHL incident within the past 6 weeks - Evidence of acute or chronic otitis media or otitis externa on examination - Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks - Any ongoing or planned concomitant medication for the treatment of tinnitus until 30 days after administration - Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion - History of drug abuse or alcoholism - Any clinically relevant respiratory, cardiovascular, neurological (except vertigo or tinnitus), or psychiatric disorders - Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction - Women who are breast-feeding, pregnant or who plan a pregnancy during the trial - Women of childbearing potential who declare being unwilling or unable to practice contraception such as combined oral contraceptives, injectables, hormonal intra-uterine devices, vasectomised partner or sexual abstinence - Concurrent participation in another clinical trial or participation in another clinical trial within 30 days prior to study entry - Any current anticoagulant therapy (e.g. Aspirin, Marcumar, etc) ; PRIMARY OUTCOME: Hearing loss; SECONDARY OUTCOME 1: Hearing loss[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - CD-002; BRIEF: This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02. ; DRUG USED: DFA-02; DRUG CLASS: Non-NME; INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Bacterial ribosome, Cell wall synthesis, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion Criteria: 1. Males and females 18 years of age or older; 2. If female, the patient must be: - postmenopausal (if amenorrheic for < 1 year, postmenopausal status must be confirmed by an elevated follicle stimulating hormone [FSH] level > 30 mIU/mL; if amenorrheic for > 1 year, FSH level not required); - surgically sterilized (does not have a uterus or has had bilateral tubal ligation); or - if of child-bearing potential, she must have a negative serum pregnancy test on entry in the study, and agree to use adequate birth control during the study and for 30 days after the administration of study agent. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); 3. BMI 25-40, inclusive; 4. Scheduled to undergo nonemergent colorectal surgery involving a laparotomy incision of 7 cm or greater (hand-assisted laparoscopic surgery is allowed). List of eligible procedures: left, right or transverse colectomy, segmental/sleeve left colon resection, total abdominal colectomy with ileorectal anastomosis, total abdominal colectomy with ileostomy, total abdominal proctocolectomy, low anterior resection, sigmoid resection, non-emergent Hartmanns procedure, colotomy with polypectomy distal to hepatic flexure, colostomy takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis, abdominal perineal resection of the rectum; 5. Willing and able to give informed consent; 6. Available for evaluation from baseline until final evaluation at 30 days post surgery. Exclusion Criteria: 1. Known history of hypersensitivity to gentamicin or vancomycin, other aminoglycoside antibiotics or the excipients of the study products (soy bean products or sesame oil); 2. Emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed); 3. Significant concomitant surgical procedure (Note: concomitant appendectomy, cholecystectomy, oophorectomy, and liver biopsy/wedge resection are allowed); 4. Prior laparotomy within the last 60 days of this planned procedure; 5. Planned second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 30 days of this planned first procedure; 6. Expectation that a surgical drain will be placed; 7. Preoperative sepsis, severe sepsis, or septic shock; 8. Abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason; 9. Active systemic infection or systemic (oral or intravenous) antibiotic therapy within the 1 week prior to the date of surgery other than specified preoperative antimicrobial prophylaxis (Note: single dose antibiotic therapy for dental or other minor procedures is allowed as is the use of oral non-absorbable antibiotics for preoperative bowel decontamination); 10. Requirement for gentamicin or vancomycin preoperative antimicrobial prophylaxis (Note: systemic antibiotic therapy within 72 hours after surgery with gentamicin or vancomycin must be avoided and any systemic antibiotic therapy during that time should be discussed with the Coordinating Center PI or Medical Monitor); 11. Requirement for concomitant use or use during the 30 days prior to Day 1 of any prescription or OTC drug that would interfere with the study or place the patient at undue risk. Concurrent systemic or topical use of other potentially neurotoxic, nephrotoxic, and/or ototoxic drugs, such as gentamicin, cisplatin, cephaloridine, kanamycin, amikacin, polymyxin B, colistin, paromomycin, streptomycin, tobramycin, vancomycin, ethacrynic acid, furosemide, and viomycin, should be avoided; 12. Preoperative evaluation suggests an intra-abdominal process that might preclude full closure of the skin; 13. Ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer; 14. History of significant drug or alcohol abuse within the past year; 15. Serum Creatinine > 1.3 mg/dL 16. Serum Bilirubin > 2.5 times upper limit of normal; 17. History of uncontrolled diabetes mellitus (controlled diabetic patients whose hemoglobin A1c is ≤ 9.0% may be included); 18. Patients who are immunocompromised including but not limited to systemic corticosteroid use or chemotherapy/radiation during the 30 days prior to surgery, organ transplantation, or HIV infection (Note: inhaled corticosteroids are not exclusionary and single dose use of corticosteroids to prevent PONV is allowed.); 19. Any clinically meaningful hearing loss (from Medical History); 20. Clinically exclusionary results on clinical laboratory, ECG, or physical examination including but not limited to positive hepatitis B or C or HIV; 21. Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability; 22. Refusal to accept medically indicated blood products; 23. Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated; 24. Patients with anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure; 25. Unable to participate in the study for any reason in the opinion of the Principal Investigator; 26. Postsurgical life expectancy of less than 30 days, in the Investigators or Sponsors opinion; 27. Expected discharge from the hospital less than 3 days after surgery. ; PRIMARY OUTCOME: Number of Patients With Adverse Events, Laboratory, Physical Examination Changes; SECONDARY OUTCOME 1: Maximal Plasma Concentration (Cmax)[/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 - 15353A (OLE Irritability); BRIEF: To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability. ; 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: Inclusion Criteria: Main selection criteria at screening visit: - The patient has a Major Depressive Episode (MDE) associated to Major Depressive Disorder (MDD) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI) - The patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current MDE, as documented by self-report as less than a pre-defined percentage response on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ). - Pre-defined MADRS total score - Pre-defined CGI-S total score - The patient has had the current MDE for ≥10 weeks - The patient is receiving a SSRI or SNRI antidepressant treatment for ≥6 weeks, at same dosage for ≥2 weeks - Pre-defined Inventory of Depressive Symptomatology - Clinician-Rated - 30 items (IDS-C 30) Item 6 Mood (irritable) score Main inclusion criteria at baseline visit: - The patient still fulfils DSM-IV-TR™ criteria for MDE - Pre-defined MADRS total score - Pre-defined CGI-I (Lead-in period) score - The patient received the same SSRI or SNRI antidepressant treatment at adequate doses during the entire lead-in period - The patient has less than a pre-defined percentage decrease in MADRS score at the end of the lead-in period as compared to the screening visit - The patient still has the pre-defined IDS-C 30 Item 6 Mood (Irritable) score Exclusion Criteria: - The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the principal diagnosis, other than MDD. All anxiety disorders, impulse-control disorders such as intermittent explosive disorder, as well as non-suicidal self-injury are not excluded diagnoses as far as they are not considered as principal diagnosis. - The patient has a current Axis II (DSM-IV-TR™) diagnosis of antisocial, borderline, paranoid, schizoid, schizotypical, or histrionic personality disorder. - The patient has experienced/experiences hallucinations, delusions, or any psychotic symptomatology in the current MDE. - The patient, in the opinion of the investigator or based on C-SSRS rating, is at significant risk of suicide. - The patient has started formal cognitive or behavioural therapy or systematic psychotherapy within 6 weeks prior to screening, or plans to start such therapy during the study. Any ongoing formal psychotherapy initiated more than 6 weeks prior to screening should be continued with the same methodology and at the same frequency and intensity during the entire study. - The patient has a current diagnosis or history of substance abuse or dependence (excluding nicotine or caffeine) or alcohol abuse or dependence (DSM-IV-TR™ criteria) <6 months prior to the Screening Visit. - The patient reports adjunctive treatment with an antipsychotic medication together with an antidepressant for 3 weeks or more during the current MDE. - The patient has received electroconvulsive therapy (ECT) <6 months prior to the Screening Visit or at any time during the current MDE (if its duration is longer than 6 months). - The patient has had vagus nerve stimulation or a deep brain stimulation device implanted for the management of depression. Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline to Week 6 in SIS Total Score; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PARADIGM; BRIEF: This study will test a drug called MGAWN1 for the treatment of West Nile infections. ; DRUG USED: MGAWN1 ; DRUG CLASS: Biologic; INDICATION: West Nile Virus; TARGET: West Nile Virus; THERAPY: Monotherapy; LEAD SPONSOR: MacroGenics; CRITERIA: Inclusion Criteria: 1. Provide written informed consent 2. Be >=18 years of age at the time of enrollment 3. Have West Nile Fever defined as: 1. temperature >38°C, headache, AND 2. positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF) OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as: • West Nile encephalitis (must meet criteria a and b below) 1. Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours) 2. CSF pleocytosis >=5 cells/mm^3 AND/OR • West Nile meningitis (must meet criteria c and d) 3. Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or Brudzinski sign, photophobia, or phonophobia 4. CSF pleocytosis >=5 cells/mm^3 AND/OR • Acute flaccid paralysis (must meet criteria e and f) 5. Acute onset of limb weakness with marked progression over 48 hours 6. Two or more of the following conditions: - asymmetry to weakness - areflexia or hyporeflexia of affected limb(s) - absence of pain, paresthesia, or numbness in affected limb(s) - CSF pleocytosis >=5 cells/mm^3 - CSF elevated protein levels (4.5 g/L) - electrodiagnostic studies consistent with an anterior horn cell process - or abnormal increased signal in the anterior gray matter as documented by spinal cord magnetic resonance imaging 4. Have epidemiological factors consistent with West Nile Virus infection (must meet criterion a or b below): 1. Appropriate time of year for West Nile Virus transmission in region 2. Travel history to a region where West Nile Virus is active 5. Develop signs and/or symptoms within 14 days before study enrollment. 6. If female of childbearing potential or male and in a sexual relationship with a female of childbearing potential, agree (or have partner agree) to practice abstinence or use 2 of the following methods of contraception for 120 days (approximately 4 months) after study drug administration: 1. Oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches 2. An intrauterine device 3. Barrier contraception (condom) with a spermicide (i.e., female subject ensures use by male partner[s]) 4. Any other equivalent method of contraception (as judged by the investigator) ; PRIMARY OUTCOME: The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score); SECONDARY OUTCOME 1: The Number of Participants With a Favorable Neurologic Outcome[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SURPASS; BRIEF: The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS). ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or non-pregnant, non-nursing female patients at least 18 years of age - Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy - Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10 - Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10) - Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) - hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray Exclusion Criteria: - Patients with total ankylosis of the spine - Pregnant or nursing (lactating) women - Evidence of ongoing infectious or malignant process - Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα - Subjects taking high potency opioid analgesics - Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set); SECONDARY OUTCOME 1: Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full 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 II - Active Lupus; BRIEF: The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE). ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Adults ≥ 18 years - Diagnosis of SLE for at least 6 months prior to screening - Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening - Must have failed a treatment for SLE after a trial of at least 3 months Exclusion Criteria: - The subject has any serious health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study - Subject has had recent serious or ongoing infection, or risk for serious infection - Subject has a history of new or recurrent malignancy within the past 5 years - The subject is pregnant and/or breastfeeding - The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study - The subject has urgent, severe SLE disease activity, which, in the opinion of the Investigator, warrants immediate immunosuppressive therapy and would not be appropriate for the study ; PRIMARY OUTCOME: Number and Percentage of Subjects Having an Adverse Event (AE); SECONDARY OUTCOME 1: Proportion of Subjects Achieving an SRI Response at Day 85[/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 - E1608 (NCI); BRIEF: This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patients immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma. ; DRUG USED: Yervoy; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting - Histologic diagnosis of metastatic melanoma; for unknown primary disease, diagnosis of metastatic disease by cytology fine needle aspiration (FNA) is not acceptable - Women must not be pregnant or breast-feeding due to unknown effects of ipilimumab and GM-CSF on the unborn fetus; all women of childbearing potential must have a blood test within 72 hours prior to randomization to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential - White blood cells (WBC) >= 2000/uL (obtained =< 4 weeks prior to randomization) - Absolute neutrophil count (ANC) >= 1500/mcL (obtained =< 4 weeks prior to randomization) - Platelets >= 100,000/mcL (obtained =< 4 weeks prior to randomization) - Hemoglobin >= 8 g/dL (obtained =< 4 weeks prior to randomization) - Creatinine =< 3.0 x upper limit of normal (ULN) (obtained =< 4 weeks prior to randomization) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (obtained =< 4 weeks prior to randomization) - Bilirubin =< 3.0 x ULN, (except patients with Gilberts syndrome, who must have a total bilirubin less than 3.0 mg/dL) (obtained =< 4 weeks prior to randomization) - No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks - No infection with human immunodeficiency virus (HIV); due to the mechanism of action of ipilimumab and GM-CSF, activity and side effects in an immune compromised patient are unknown - No active infection with hepatitis B - No active or chronic infection with hepatitis C - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: - Patients with any history of central nervous system (CNS) metastases are excluded - Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix - Patients are excluded if they have a history of any autoimmune disease; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy - Patients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea - Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to four weeks (28 days) prior to or after any dose of ipilimumab - Patients are excluded if they have a history of prior treatment with ipilimumab or prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor or agonist - Any concurrent medical condition requiring the use of systemic steroids is not permitted (the use of inhaled or topical steroids is permitted) ; PRIMARY OUTCOME: Overall Survival; 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 II - LiFT Open Label Extension Study; BRIEF: This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH. ; DRUG USED: LPCN 1144; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Lipocine Inc.; CRITERIA: Inclusion Criteria: 1. Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144 2. Subject must sign the Informed Consent Form to participate in the study Exclusion Criteria: 1. Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study 2. Subjects who are currently receiving any androgens or estrogens 3. Subjects who are not willing to use adequate contraception for the duration of the study 4. Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment 5. Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study ; PRIMARY OUTCOME: Measure the safety and tolerability of LPCN 1144 by assessing the number of treatment-related adverse events; 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 - ZA-003 (Secondary); BRIEF: Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6. ; DRUG USED: Enclomiphene; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypogonadism; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Repros Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Total serum testosterone concentrations < 300 ng/dL at baseline Exclusion Criteria: - Presence or history of prostate cancer - Elevated PSA > 3.5 ng/mL Additional inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Evaluate the safety of Androxal™ administered in men with secondary hypogonadism; SECONDARY OUTCOME 1: Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®[/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 - RP-BP-EF002; BRIEF: This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old. ; DRUG USED: Aptensio XR; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Rhodes Pharmaceuticals, L.P.; CRITERIA: Inclusion Criteria: - Males and females ages 6 up to 18 - ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile - In need of treatment for ADHD and able to have 2-day washout from previous medication - Females of child-bearing potential not pregnant and practice birth control - Subject and parent/guardian willing to comply with protocol - Signed consent and assent Exclusion Criteria: - Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence (WASI) - Current primary psychiatric diagnosis of other listed disorders - Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma - Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days from screening - Planned use of prohibited drugs - Is pregnant or breast-feeding - Significant ECG or laboratory abnormalities - Experimental drug or medical device within 30 days prior to screening - Hypersensitivity to methylphenidate - Inability or unwillingness to comply with protocol - Well controlled on current ADHD treatment - Inability to take oral capsules ; PRIMARY OUTCOME: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - STRIDE; BRIEF: This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo (dummy) medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiovascular Disease; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan: Male or female, age above or equal to 20 years at time of signing informed consent - Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. - Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following: 1. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview. 2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet. 3. Screening constant load treadmill test with fixed inclination of 12% and a fixed speed of 3.2 km/h (2 mph): Walking distance equal to or less than 600 meters/1968 feet. 4. Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease). Exclusion Criteria: - Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) within 90 days prior to the day of screening. - Walking ability limited by conditions other than PAD (e.g. aortic aneurism, dysregulated arrhythmia or hypertension, angina pectoris, heart failure, chronic obstructive or restrictive pulmonary disease, Parkinsons disease, severe peripheral neuropathy, amputations, wheel chair or walker dependency, osteoarthritis, morbid obesity, severe varicose veins, etc.). - Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability). - Vascular revascularisation procedure of any kind 180 days prior to the day of screening. - Planned arterial revascularisation known on the day of screening. - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening. - Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV. ; PRIMARY OUTCOME: Change in maximum walking distance on a constant load treadmill test; SECONDARY OUTCOME 1: Follow-up change in maximum walking distance on a constant load treadmill test[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Lung-MAP; BRIEF: This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth of tumor cells. ; DRUG USED: Lumakras; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: KRas; THERAPY: Monotherapy; LEAD SPONSOR: SWOG Cancer Research Network; CRITERIA: Inclusion Criteria: - Participants must be assigned to S1900E. Assignment to S1900E is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker eligibility for S1900E is based on the identification of a KRAS^G12C mutation - Participants must have confirmed stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). Mixed histology NSCLC with less than 50% squamous component is allowed - Participants must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration - Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration - Participants with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to sub-study registration - Participants with EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, or BRAF V600E mutation must have progressed following all standard of care targeted therapy - Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study registration - Participants must have received at least one line of systemic treatment for stage IV or recurrent NSCLC - Participants must have progressed (in the opinion of the treating physician) following the most recent line of systemic therapy for NSCLC - Participants must have recovered (=< grade 1) from side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity) - Participants must be able to swallow tablets whole - Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration - Absolute neutrophil count (ANC) >= 1,500/uL obtained within 28 days prior to sub-study registration - Platelet count >= 75,000/uL obtained within 28 days prior to sub-study registration - Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study registration - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study registration. For participants with liver metastases, and ALT and AST must be =< 5 x IULN - Participants must have a serum creatinine =< 1.5 x IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration - Participants must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration - Participants of reproductive potential must have a negative serum pregnancy test within 28 days prior to sub-study registration - Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA) - Participants must be offered the opportunity to participate in specimen banking and in correlative studies for collection and future use of specimens. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System - Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines - NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institutions identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institutions identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator). For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations Exclusion Criteria: - Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids prior to sub-study registration - Participants must not have leptomeningeal disease unless: (1) asymptomatic and (2) only detected on radiographic imaging (i.e., not present in cytology from cerebral spinal fluid [CSF] if CSF sampled) - Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration - Participants must not have received any radiation therapy within 14 days prior to sub-study registration, with the exception of stereotactic radiation to CNS metastases which must have been completed at least 7 days prior to sub-study registration - Participants must not have received prior AMG 510 or other KRAS^G12C specific inhibitor - Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study - Participants must not have had a major surgery within 14 days prior to sub-study registration. Participant must have fully recovered from the effects of prior surgery in the opinion of the treating investigator - Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia - Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen - Participants must not have gastrointestinal disorders that may impact drug absorption - Participants must not have received strong inducers of CYP3A4 (including herbal supplements such as St. Johns wort) within 14 days prior to sub-study registration and must not be planning to use strong inducers of CYP3A4 throughout protocol treatment - Participants must not have received CYP3A4 sensitive substrates (with a narrow therapeutic window) within 14 days prior to sub-study registration and must not be planning to use CYP3A4 sensitive substrates (with a narrow therapeutic window) throughout protocol treatment - Participants must not be pregnant or nursing. Participants with uteri must have agreed to use an effective contraceptive method for at least one month after the last dose of AMG 510. Participants with sperm must have agreed to use an effective contraceptive method for at least 3 months after the last dose of AMG 510. Participants are considered to be of reproductive potential if they have had menses at any time in the preceding 12 consecutive months and no prior oophorectomy and/or hysterectomy. In addition to routine contraceptive methods, effective contraception for participants with uteri also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. Acceptable methods of birth control for participants with sperm include sexual abstinence (refraining from heterosexual intercourse); vasectomy with testing showing there is no sperm in the semen; bilateral tubal ligation or occlusion in the partner; or a condom (the female partner should also consider a form of birth control). However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures ; PRIMARY OUTCOME: Response rate (confirmed, complete or partial); SECONDARY OUTCOME 1: Incidence of adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Neoadjuvant (HER2+); BRIEF: An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992. ; DRUG USED: Gilotrif; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Female, age 18 years or older. 2. Histologically proven breast cancer who have not received any prior therapy. 3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes. 4. HER2-positive. Exclusion criteria: 1. Absolute neutrophil count (ANC) less than 1500/mm3. 2. Platelet count less than 100 000/ mm3. 3. Hemoglobin level less than 9.0 g/dl. 4. Bilirubin greater than 1.5 mg/dI. 5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal. 6. Serum creatinine greater than 1.5 times of the upper normal limit. 7. Significant or recent acute gastrointestinal disorders with diarrhea 8. Pregnancy or breast-feeding. 9. Organ system dysfunction including cardiac (LVEF < 50%). 10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors. 11. Other malignancies diagnosed within the past five years. 12. Serious active infection. HIV, active hepatitis B or C. ; PRIMARY OUTCOME: Objective Response (OR); SECONDARY OUTCOME 1: Number of Participants Who Achieved Clinical Benefit (CB)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - w/Atezolizumab + INO-9012; BRIEF: This is a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population is divided into two cohorts: Cohort A: Participants with locally advanced unresectable or metastatic/recurrent UCa, who have confirmed disease progression during or following treatment with anti-Programmed Death receptor-1/Programmed Death receptor Ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: Participants with locally advanced unresectable or metastatic/recurrent UCa, who are treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in will be performed with up to six participants (safety analysis participants) from cohort A. ; DRUG USED: INO-5401; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: Immune System, Prostate-specific Membrane Antigen (PSMA), Reverse Transcriptase, Wilms Tumor Protein 1 (WT1); THERAPY: Combination; LEAD SPONSOR: Inovio Pharmaceuticals; CRITERIA: Inclusion Criteria: - Sign an Informed Consent Form (ICF); - Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra); - For Cohort A: Subjects who have radiographically confirmed disease progression during or following treatment with an anti-PD-1/PD-L1 based therapy; - For Cohort B: No prior chemotherapy for inoperable locally advanced or metastatic or recurrent UCa and ineligible (unfit) for cisplatin-based chemotherapy; - Have measurable disease, as defined by RECIST version 1.1; - Have a performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Performance Scale; - Have life expectancy of >/= 3 months; - Be willing to provide a tissue sample for pre-treatment intra-tumoral assessment of proinflammatory and immunosuppressive factors; - Have electrocardiogram (ECG) with no clinically significant findings as assessed by the investigator performed within 28 days prior to first dose; - Demonstrate adequate hematological, renal, hepatic, and coagulation function; - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study treatment; - For male subjects: agreement not to father a child. Participants must be surgically sterile (e.g, vasectomy) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study treatment. Exclusion Criteria: - Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0 as well as current participation or recipient of treatment on a clinical trial within 28 days prior to Day 0; - Documented active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis; - Malignancies other than UCa within 3 years prior to Day 0, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome; - Prior treatment with CD137 agonists or immune checkpoint blockade therapies; - Treatment with systemic immunostimulatory agents; - Treatment with systemic immunosuppressive medication; - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; - Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation; - Active or history of autoimmune disease or immune deficiency; - History or any evidence of interstitial lung disease; - History of human immunodeficiency virus (HIV); - Active hepatitis B or active hepatitis C; - Severe infections within 4 weeks prior to enrollment; - Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0; - History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial; interfere with the subjects participation for the full duration of the trial, or is negatively impacted by EP treatment, or is not in the best interest of the subject to participate in the opinion of the treating investigator; - Prior allogeneic stem cell or solid organ transplant; - Uncontrolled tumor-related pain; pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; or, hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab. ; PRIMARY OUTCOME: Number of Adverse Events; SECONDARY OUTCOME 1: ORR by RECIST version 1.1 by Investigator Review in Cohort B[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DAWN; BRIEF: The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults ; DRUG USED: FE 201836; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Symptoms (e.g. Nocturia, Polyuria); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion Criteria: - Adults ≥18 years of age (at the time of written consent) - Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1 - ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2 - The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2 - Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2 - ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3 Exclusion Criteria: - Current diagnosis of Obstructive Sleep Apnoea (OSA) - Restless Legs Syndrome (RLS) - Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2 - Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary) - Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures - Genito-urinary tract pathology that can in the investigators opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms - A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin - History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinsons, spinal cord injury, spina bifida) - Habitual (fluid intake >3L per day) or psychogenic polydipsia - Uncontrolled hypertension, as judged by the investigator - Uncontrolled diabetes mellitus, as judged by the investigator - Central or nephrogenic diabetes insipidus - Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion - History of gastric retention - Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV) - Hyponatraemia: - Serum sodium level <135 mmol/L at Visit 1(re-tested, with results available within 7 days) - Serum sodium level <130 mmol/L at Visit 3 (re-tested, with results available within 7 days) - Use of any prohibited therapy listed below: - Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP) - Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable) - Thiazide diuretics - Antiarrhythmic agents - V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin) - Loperamide - Botulinum toxin (cosmetic non-urological use is acceptable) - Valproate ; PRIMARY OUTCOME: Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment; SECONDARY OUTCOME 1: Change From Baseline in Mean Number of Nocturnal Voids at Week 1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Study 010 (w/ERT); BRIEF: This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease. ; DRUG USED: AT2220 (oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Pompe Disease; TARGET: Alpha-glucosidase; THERAPY: Combination; LEAD SPONSOR: Amicus Therapeutics; CRITERIA: Inclusion Criteria: - Male or female, diagnosed with Pompe disease and between 18 and 65 years of age, inclusive - Participant has been on a stable regimen and dose of rhGAA for at least 3 months before screening (stable regimen defined as currently receiving rhGAA every 2 weeks and stable dose defined as not varying by more than ± 10%) - Participant has an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min at Screening; eGFR to be estimated using the 4-parameter Modification of Diet in Renal Disease (MDRD) equation: eGFR (mL/min/1.73 m^2) = 175 x (Scr)^(-1.154) x (Age)^(-0.203) x (0.742 if female) x (1.212 if African-American) - Male and female participants of childbearing potential agree to use medically accepted methods of contraception during the study and for 30 days after study completion - Participant is willing and able to provide written informed consent and is able to comply with all study procedures Exclusion Criteria: - Participant has had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before Screening - Participant has clinically significant unstable cardiac disease (for example, cardiac disease requiring active management, such as symptomatic arrhythmia, unstable angina, or New York Heart Association class III or IV congestive heart failure) - Participant requiring mechanical ventilation or is confined to a wheelchair - Participant has a history of allergy or sensitivity to study drug (including excipients) or other iminosugars (for example, miglustat, miglitol) - Participant is pregnant or breastfeeding - Participant tests positive for hepatitis B surface antigen or hepatitis C antibody - Participant has received any investigational/experimental drug or device within 30 days of Screening - Participant has any intercurrent illness or condition that may preclude the participant from fulfilling the protocol requirements or suggests to the investigator that the potential participant may have an unacceptable risk by participating in this study ; PRIMARY OUTCOME: Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Total GAA Activity In Skeletal Muscle[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - B2101 (w/Paclitaxel) (HER2-); BRIEF: This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid. ; DRUG USED: RTB101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria (phase lb): - Females with Breast cancer that is histologically or cytologically confirmed, HER2 negative and locally advanced or metastatic as confirmed by radiology - ECOG performance status 0 and 1 - Adequate bone marrow and organ function Exclusion Criteria (Phase lb): - Previous treatment with PI3K and/or mTOR inhibitors - Symptomatic Central Nervous System (CNS) metastases - Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment - Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug - Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF > 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) - Inadequately controlled hypertension - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 and/or paclitaxel - Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists - Sensitivity to paclitaxel treatment - Uncontrolled diabetes mellitus - Pregnant or nursing (lactating) woman Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Phase lb: Dose Limiting Toxicities (DLTs) the first cycle of treatment; SECONDARY OUTCOME 1: Phase lb: Frequency and severity of adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GEMINI III; BRIEF: This study in patients with moderately to severely active Crohns disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission. ; DRUG USED: Entyvio; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Age 18 to 80 - Diagnosis of moderately to severely active Crohns disease - Crohns Disease involvement of the ileum and/or colon - Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol - May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol Exclusion Criteria - Evidence of abdominal abscess at the initial screening visit - Extensive colonic resection, subtotal or total colectomy - History of >3 small bowel resections or diagnosis of short bowel syndrome - Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine - Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol - Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection - Active or latent tuberculosis ; PRIMARY OUTCOME: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation; SECONDARY OUTCOME 1: Percentage of Participants in Clinical Remission at Week 6 in the Overall 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 - ADVANCE Ext; BRIEF: The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine. ; DRUG USED: Qulipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures. - Participants must be using a medically acceptable and effective method of birth control during the course of the entire study. - Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures). Exclusion Criteria: - Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1. - Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1. - Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease. ; PRIMARY OUTCOME: Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs); SECONDARY OUTCOME 1: Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EBI-005-4; BRIEF: This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada. ; DRUG USED: Isunakinra; DRUG CLASS: Biologic; INDICATION: Dry Eye (Ophthalmology); TARGET: IL-1 Receptor (IL-1R); THERAPY: Monotherapy; LEAD SPONSOR: Eleven Biotherapeutics; CRITERIA: Key Inclusion Criteria: 1. Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to Visit 1 2. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study Key Exclusion Criteria: 1. Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc) 2. Have had penetrating intraocular surgery within 12 months prior to Visit 1 3. Be unwilling to comply with the study requirements ; PRIMARY OUTCOME: Safety of EBI-005 (vital signs); SECONDARY OUTCOME 1: Biological effect of EBI-005 (Changes over time in the OSDI)[/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 - TACTI-003 (w/Pembrolizumab); BRIEF: Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive (CPS ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors. ; DRUG USED: Eftilagimod Alpha; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Immune System, LAG3 (Lymphocyte-Activation Gene)/CD223; THERAPY: Combination; LEAD SPONSOR: Immutep S.A.S.; CRITERIA: Main Inclusion Criteria: 1. Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies and to be treated in the first line palliative setting and who are PD-X naïve. 2. Availability of tissue for PD-L1 biomarker analysis from a core or excisional biopsy. 3. Availability of PD-L1 biomarker result by using the FDA approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx). 4. Availability of tissue for testing of human papillomavirus (HPV) status for oropharyngeal cancer (p16 expression testing). 5. ECOG performance status 0-1. Main Exclusion Criteria: 1. Disease is suitable for local therapy administered with curative intent. 2. Previously treated with ≥ 1 systemic regimen for recurrent and/or metastatic disease (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally or locoregionally advanced disease). 3. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including subjects with HNSCC of unknown primary, squamous cell carcinoma originating from skin, or non-squamous histologies (e.g. nasopharynx, salivary gland or mucosal melanoma). 4. Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for locally or locoregionally advanced HNSCC, or requires chemotherapy based therapeutic regimen due to e.g., rapidly progressing disease or need of aggressive sympton control. 5. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 6. Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery, another systemic cancer therapy or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to cycle 1 day 1. 7. Known active central nervous system metastasis and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable: i.e. without evidence of progression documented by repeat imaging performed after therapy completed for CNS metastasis and with at least 4 weeks difference, clinically stable and without requirement for steroid treatment for at least 14 days prior to cycle 1 day 1. 8. Receives continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease. ; PRIMARY OUTCOME: Objective response rate (ORR) according to RECIST1.1; SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RAP-MD-04 (Relapse Prevention); BRIEF: This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD). ; DRUG USED: Rapastinel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Receptor - Glycine Site; THERAPY: Monotherapy; LEAD SPONSOR: Naurex, Inc, an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD - Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening - Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant - If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test. Exclusion Criteria: - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening - Lifetime history of meeting DSM-5 criteria for: - Schizophrenia spectrum or other psychotic disorder - Bipolar or related disorder - Major neurocognitive disorder - Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participants ability to consent, follow study directions, or otherwise safely participate in the study - Dissociative disorder - Posttraumatic stress disorder - MDD with psychotic features - Significant suicide risk, as judged by the Investigator. ; PRIMARY OUTCOME: Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period; SECONDARY OUTCOME 1: Time to First Relapse During the Entire Double-Blind Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CUSTOMIZE (US); BRIEF: Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks. ; DRUG USED: Cabenuva; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Be able to understand and comply with protocol requirements, instructions, and restrictions; - Understand the long-term commitment to the study and be likely to complete the study as planned; - Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.). All Participants eligible for enrolment in the study must meet all of the following criteria: - Aged 18 years or older at the time of signing the informed consent. - HIV-1 infected and must be on an active highly active antiretroviral therapy (HAART) (2 or 3 drug) regimen for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA >=200 c/mL). Acceptable stable ARV regimens prior to Screening include 2 NRTIs plus: • INI (either the initial or second Combination antiretroviral therapy (cART) regimen) - NNRTI (either the initial or second cART regimen) - Boosted prediction interval (PI) (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability) - Any suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of dolutegravir (DTG)/RPV - Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: at least one within 6 months prior to Screening; - Plasma HIV-1 RNA <50 c/mL at Screening; - A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test at screen and at Day 1), not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: - Pre-menopausal females with one of the following: - Documented tubal ligation - Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion - Hysterectomy - Documented Bilateral Oophorectomy - Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures. Exclusion Criteria: - Within 6 months prior to Screening, plasma HIV-1 RNA measurement >=50 c/mL; - During the previous 12 months, any confirmed HIV-1 RNA measurement >=200 c/mL Exclusionary medical conditions - Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study - Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposis sarcoma not requiring systemic therapy, and Cluster of Differentiation (CD4+) counts <200 cells/microliter are not exclusionary - Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participants ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. - Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. - Participants who, in the investigators judgment, pose a significant suicide risk. Participants recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. - The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. - Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: - Participants positive for HBsAg are excluded; - Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. - Participants who are anticipated to require HCV treatment within 12 months must be excluded. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded; investigators must carefully assess if therapy specific for HCV infection is required. (HCV treatment on study may be permitted, following consultation and approval of the direct acting antiviral (DAA) drug based therapy being considered with the medical monitor). - Participants with HCV co-infection will be allowed entry into this study if: - Liver enzymes meet entry criteria - HCV Disease has undergone appropriate work-up, and is not advanced. Additional information (where available) on participants with HCV coinfection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. - In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility - Fib-4 score >3.25 is exclusionary - Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: (Age x AST) / (Platelets x ( sqr [ ALT ]) - Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). - History of liver cirrhosis with or without hepatitis viral co-infection. - Ongoing or clinically relevant pancreatitis. - Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. - Ongoing malignancy other than cutaneous Kaposis sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to inclusion. - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. - Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (<=325 milligram (mg) per day) or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease. - Corrected QT interval (QTc [Bazett]) >450 milli second (msec) or QTc (Bazett) >480 msec for subjects with bundle branch block). Exclusionary Laboratory Values or Clinical Assessments (a single repeat to determine eligibility is allowed). - Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International acquired immune deficiency syndrome [AIDS] Society [IAS]-USA) by any historical resistance test result. - ALT >=5 × Upper Limit Normal (ULN) or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin) over the last 6 months. - Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result. - Participant has estimated creatinine clearance <50 mL/min/1.73meter^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Concomitant Medications - 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 Day 1 of this study; - Treatment with any of the following agents within 28 days of Day 1: - radiation therapy; - cytotoxic chemotherapeutic agents; - tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]); - anti-coagulation agents; - Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Participants using short-term (e.g. <=21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. - Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility. - Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease CAB or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose and any other prohibited medications should be discontinued for a minimum of two weeks or a minimum of three half-lives (whichever is longer) prior to the first dose. ; PRIMARY OUTCOME: Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4; SECONDARY OUTCOME 1: Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4[/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 - 08-211; BRIEF: Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT. ; 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: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria - The current depressive episode must be equal to or greater than 8 weeks in duration - Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments. Exclusion Criteria: - Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. - Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration. - Subjects with a current Axis I (DSM-IV-TR) diagnosis of: - Delirium, dementia,amnestic or other cognitive disorder - Schizophrenia, schizoaffective disorder, or other psychotic disorder - Bipolar I or II disorder - Subjects with a clinically significant current Axis II (DSM-IV-TR) - diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder. ; PRIMARY OUTCOME: Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.; SECONDARY OUTCOME 1: Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (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 - HAM-001; BRIEF: The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan. ; DRUG USED: Poteligeo; DRUG CLASS: Biologic; INDICATION: Inflammatory Disorders; TARGET: Chemokine Receptor 4 (CCR4); THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Kirin Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Voluntary written informed consent to participate in the study 2. Diagnosis as HAM according to the second edition of HAM Treatment Manual 3. At least 1-year history of HAM 4. Ongoing medication*1 for HAM, with no changes in 3 months before enrollment; or inadequate response or intolerance to prior medication,*2 which must have been discontinued for at least 3 months before enrollment. Subjects on maintenance therapy with steroids must have been receiving ≤ 10 mg/day prednisolone equivalent continuously for at least 3 months before enrollment. - 1 Steroids, salazosulfapyridine, or ≥ 1.5 g/day vitamin C - 2 Steroids, Interferon-α, salazosulfapyridine, or ≥ 1.5 g/day vitamin C 5. No change in the degree of motor dysfunction for at least 3 months before the date of screening, as judged by the investigator or subinvestigator 6. A OMDS of ≥3 at screening and able to walk ≥10 m at screening (use of a single cane or double canes is allowed) Exclusion Criteria: 1. Any of the following significant concomitant diseases: Type 1 diabetes mellitus, Poorly controlled type 2 diabetes mellitus (HbA1c (NGSP) > 8.5%), Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification), Myocardial infarction within 1 year before enrollment, Unstable angina within 1 year before enrollment, Poorly controlled hypertension (systolic blood pressure > 150 mm Hg and diastolic blood pressure > 90 mm Hg at screening), Sever chronic lung disease requiring oxygen therapy, Multiple sclerosis or any other demyelinating disease, Epilepsy requiring treatment with antiepileptics (with the exception of epilepsy controlled by antiepileptics, with no occurrence of seizures for at least 3 years before informed consent), and Active malignancy (including ATL); or onset of malignancy or previous treatment for malignancy (with the exception of resected or surgically cured intraepithelial carcinoma of the uterine cervix, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or ductal breast carcinoma) within 5 years before informed consent 2. Active infection 3. Concurrent spinal cord compression lesion (e.g., cervical spine diseases, disk herniation, or ossification of the ligamentum flavum) , with the exception of conditions that would not affect efficacy evaluation in the study, as judged by the investigator or subinvestigator 4. Concurrent dementia 5. Concurrent psychiatric disorder, with the exception of conditions that would not affect obtaining informed consent or efficacy evaluation in the study, as judged by the investigator or subinvestigator 6. History of or current alcohol or drug dependence 7. Planned surgery during the study period 8. Any other conditions unsuitable for participation in the study in the opinion of the investigator or subinvestigator ; PRIMARY OUTCOME: Improvement in Osames motor disability score; SECONDARY OUTCOME 1: HTLV-1 Proviral load in peripheral blood[/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 - COMMODORE (China); BRIEF: The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study will evaluate safety as well as determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy. ; DRUG USED: Xospata; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Anaplastic lymphoma kinase (ALK), Axl Receptor Tyrosine Kinase, FMS-like tyrosine kinase 3 (FLT-3) ; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization (WHO) classification as determined by pathology review at the treating institution. - Subject is refractory to or relapsed after first-line AML therapy (with or without HSCT) - Refractory to first-line AML therapy is defined as: a. Subject did not achieve CR/CRi/CRp under initial therapy. A subject eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject. - Untreated first hematologic relapse is defined as: 1. Subject must have achieved a CR/CRi/CRp with first-line treatment and has hematologic relapse. - Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab. A subject with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on a local test performed after completion of the last interventional treatment. Subjects can be enrolled from a local test result if the subjects have any of the following FLT3 mutations: FLT3-internal tandem duplication (ITD), FLT3-tyrosine kinase domain (TKD)/D835 or FLT3-TKD/I836. - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. - Subject is eligible for preselected salvage chemotherapy. - Subject must meet the following criteria as indicated on the clinical laboratory tests: - Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) - Serum total bilirubin (TBL) ≤ 1.5 x ULN - Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as calculated by the Modification of Diet in Renal Disease equation. - Subject is suitable for oral administration of study drug. - Subject agrees not to participate in another interventional study while on treatment. Inclusion Criteria for COE: Subject is eligible for the COE if they continue to meet all inclusion criteria from the main protocol in addition to the following when the subject is evaluated for eligibility to participate in the COE portion of the study: - Subject has received study treatment of either LoDAC, MEC or FLAG and has no response or progressive disease. - Subject have not received other antileukemic therapy after EOT (hydroxyurea is allowed for the control of peripheral leukemic blasts in subjects with leukocytosis). - Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: - Subject was diagnosed as acute promyelocytic leukemia. - Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis). - Subject has AML secondary to prior chemotherapy for other neoplasms (except for MDS). - Subject is in second or later hematologic relapse or has received salvage therapy for refractory disease. - Subject has clinically active central nervous system leukemia.. - Subject has been diagnosed with another malignancy, unless disease-free for at least 5 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy. - Subject has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib and midostaurin used in first-line therapy regimen as part of induction, consolidation and/or maintenance). - Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation. - Subject has had major surgery within 4 weeks prior to the first study dose. - Subject has radiation therapy within 4 weeks prior to the first study dose. - Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram (ECHO) performed within 1 month prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%. - Subject with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading. - Subject with Long QT Syndrome at Screening. - Subject with hypokalemia and hypomagnesemia at Screening (defined as values below lower limit of normal [LLN]). - Subject requires treatment with concomitant drugs that are strong inducers of CYP3A. - Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the subject. - Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject. - Subject has an active uncontrolled infection. - Subject is known to have human immunodeficiency virus infection. - Subject has active hepatitis B or C or other active hepatic disorder. - Subject has any condition which makes the subject unsuitable for study participation. - Subject has active clinically significant (graft-versus-host disease) GVHD or is on treatment with systemic corticosteroids for GVHD. - Subject has an FLT3 mutation other than the following: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836. Exclusion Criteria for COE: Subject will be excluded from participation in the COE if they meet any of the exclusion criteria listed in the main protocol or when the subject is evaluated for eligibility to participate in the COE portion of the study. ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Event-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 002; BRIEF: This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients suffering from a malignant brain tumor called glioblastoma having a first or second progression can be included. They will be randomized to RT or RT + APG101. APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly infusion. Patients can stay in this study as long as they benefit from the participation (no fixed end). In this trial, 30-35 sites in Germany, Austria and Russia take part. ; DRUG USED: Asunercept; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Fas receptor (FasR)/CD95/Apo-1/TNFRSf6); THERAPY: Monotherapy; LEAD SPONSOR: Apogenix GmbH; CRITERIA: Inclusion Criteria: - Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence - Diagnosis of glioblastoma must be proven histologically and progress must be documented by MRI. MRI images must not be older than 2 weeks before first dosing/start of RT - Not more than two prior therapy regimens including one or two resections, one or two chemotherapies of which one must have been TMZ-containing and one radiotherapy (RT) for the brain tumour - Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation - Candidate for reirradiation with recurrent tumour visible on MRI-T1 (Gd) and with the largest diameter measuring 1 cm to 4 cm - Informed consent - Age at least 18 years, smoking or non-smoking, of any ethnic origin - Karnofsky performance index (KPI) ≥ 60% - Neutrophile counts > 1500/μl / Platelet counts > 80.000/μl / Haemoglobin > 10 g/dl / Serum creatinine < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range - Adequate contraception - Stable or decreasing treatment with steroids within 5 days before treatment start Exclusion Criteria: - More than one RT of brain, prior first radiotherapy with more than 60 Gy - Cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, α/β=2 - Prior treatment with bevacizumab, iodine seeds and/or brachytherapy - Unable to undergo MRI - Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation - HIV or hepatitis infection - Pregnancy or breast feeding - Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion - Known active coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III - IV) ; PRIMARY OUTCOME: 6 months rate of progression free survival (PFS6); SECONDARY OUTCOME 1: Safety and tolerability of APG101[/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 - Intravenous Infusion (Premature Infants); BRIEF: The purpose of this study is to determine if an investigational drug can reduce the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone. ; DRUG USED: TAK-607; DRUG CLASS: Biologic; INDICATION: Bronchopulmonary Dysplasia (BPD); TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) , Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: OHB Neonatology Ltd.; CRITERIA: Inclusion Criteria: 1. Written informed consents and/or assents must be signed and dated by the participants parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations). 2. Written informed consents and/or assents must be signed and dated by the participants birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations). 3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive. Exclusion Criteria: 1. Detectable major (or severe) congenital malformation identified before randomization. 2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigators opinion. 3. Hypoglycemia at Baseline (blood glucose less than (<) 45 milligrams per deciliter [mg/dL] or 2.5 milli moles per liter [mmol/L]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism. 4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigators opinion. 5. Any other condition or therapy that, in the investigators opinion, may pose a risk to the participant or interfere with the participants potential compliance with this protocol or interfere with interpretation of results. 6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis). 7. The participant or participants parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator. 8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy. ; PRIMARY OUTCOME: Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death, whichever comes first as compared to the SNC group; SECONDARY OUTCOME 1: Occurrence of severe (Grade 3 and 4) IVH at 36 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Pembrolizumab; BRIEF: This phase II trial studies how well cabozantinib and pembrolizumab work for the first-line treatment of patients with liver cancer who are not eligible for local therapy (i.e. advanced stage). Cabozantinib may stop the growth of tumor cells by blocking some cell surface receptors and signaling pathways inside the tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the bodys immune system attack the cancer. Giving cabozantinib and pembrolizumab together may work better in treating patients with advanced liver cancer compared to cabozantinib or pembrolizumab alone. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: University of Washington; CRITERIA: Inclusion Criteria: - Must have a histologically confirmed diagnosis of HCC or a non-invasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) criteria - If available, archival tissue must be submitted - Mixed HCC-cholangiocarcinoma is not allowed - Patient has Barcelona Clinic Liver Cancer (BCLC) stage C disease, or BCLC stage B disease that is not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to curative treatment - Previous locoregional therapy is allowed (e.g. surgical resection, external beam radiation, catheter-based therapy), and patients must have evidence of disease progression from locoregional therapy - Must have measurable disease by RECIST v1.1 - Lesions that were previously radiated or ablated cannot be target lesions unless there was subsequent radiographic progression at those sites - No prior systemic therapy for HCC. Prior chemotherapy given locally into the liver (e.g. transarterial chemoembolization [TACE]) is allowed - Must have Child-Pugh class A hepatic function within 7 days prior to first dose of study intervention - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Life expectancy of at least 12 weeks - Recovery to baseline or =< grade 1 toxicities (CTCAE v5) related to any prior treatments, unless adverse events (AEs) are clinically nonsignificant and/or stable on supportive therapy - Absolute neutrophil count (ANC) >= 1500/mm^3 without granulocyte colony-stimulating factor support (within 14 days before first dose of study treatment) - Platelets >= 60,000/mm^3 without transfusion (within 14 days before first dose of study treatment) - Hemoglobin >= 9 g/dL (>= 90 g/L) without transfusion or erythropoietin (EPO) dependency (within 14 days before first dose of study treatment) - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 x upper limit of normal (ULN) (within 14 days before first dose of study treatment) - Total bilirubin =< 2 mg/dL OR direct bilirubin =< ULN for participants with total bilirubin levels > 2 mg/dL (within 14 days before first dose of study treatment) - Serum albumin >= 2.8 g/dl (>= 28 g/L) without albumin infusion (within 14 days before first dose of study treatment) - Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test =< 1.5 x ULN (within 14 days before first dose of study treatment) - Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 40 mL/min using the Cockcroft-Gault equation (within 14 days before first dose of study treatment) - Urine protein/creatinine ratio (UPCR) =< 1 mg/mg (=< 113.2 mg/mmol) or 24 hour(h) urine protein =< 1 g (within 14 days before first dose of study treatment) - Hemoglobin A1c (HbA1c) =< 8% within 28 days before randomization or fasting serum glucose =< 160 mg/dL (within 14 days before first dose of study treatment) - Patients with positive hepatitis B surface antigen (HBsAg) and/or hepatitis B virus (HBV) viral load > 100 IU/mL at the time of enrollment are eligible to enroll on study if they meet the following criteria: - Anti-HBV therapy as per institutional practice must be given at least 4 weeks and HBV viral load must be < 100 IU/mL prior to initiating study treatment. Patients on active HBV therapy with viral loads < 100 IU/mL should remain on the same therapy throughout study treatment - Note: Patients with positive anti-hepatitis B core antibody (HBcAb), negative HBsAg, and negative or positive anti-hepatitis B surface antibody, and who have an HBV viral load < 100 IU/mL do not require anti-viral prophylaxis - Patients with past or ongoing hepatitis C infection (HCV) are eligible to enroll on study, with or without prior anti-viral treatment, as long as the other eligibility criteria are met. Treated patients must have completed their anti-viral treatment at least 1 month prior to initiating study treatment - Sexually active fertile subjects and their partners must agree to use effective methods of contraception during the course of the study and for at least 4 months after the last dose cabozantinib. They must also refrain from donating sperm during this time period - Female subjects of childbearing potential must not be pregnant at screening and not breastfeeding. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy) - Women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons - Capable of understanding and complying with the protocol requirements and must provide written informed consent/assent for the study Exclusion Criteria: - Prior treatment with any systemic therapy for HCC, including anti-VEGF therapy or any systemic investigational agent - If the patient previously received systemic treatment for reasons other than HCC: small molecule kinase inhibitors are not allowed within 2 weeks and cytotoxic/biologic agents are not allowed within 4 weeks of study treatment - Prior exposure to immune checkpoint inhibitors or other immunotherapeutic agents - Currently participating in or has participated in a study of an investigational agent or device within 4 weeks prior to the first dose of study treatment - Major surgery within 6 weeks or minor surgery (e.g. dental extraction) within 10 days prior to first dose of study treatment - Complete wound healing from major surgery must have occurred at least 1 month before first dose and from minor surgery (e.g. simple excision, tooth extraction) at least 7 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible - Local liver-directed therapy within 4 weeks of initiating study treatment - Palliative radiation for the purpose of symptomatic relief to non-liver and non-central nervous system (CNS) disease within 2 weeks of starting treatment. Other radiation treatments within 4 weeks of starting treatment - Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and have not had radiation pneumonitis - Prior liver or other allogenic tissue/organ transplantation - History of primary immunodeficiency - Active autoimmune or inflammatory disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). This includes, but is not limited to, inflammatory bowel disease, celiac disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, Graves disease, etc. - The following autoimmune conditions are allowed: vitiligo or alopecia; hypothyroidism on stable hormone replacement therapy; psoriasis/eczema not requiring systemic treatment - Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed - Chronic use of systemic steroid (in dosing exceeding 10 mg daily of prednisone equivalent) or immunosuppressive therapy or use within 14 days prior to enrollment - The following treatments are allowed: intranasal, inhaled, topical or local steroid injections; systemic corticosteroids at physiologic doses equivalent to no more than prednisone 10 mg/day; steroids as premedication for contrast dye allergy - History of (non-infectious) pneumonitis that required steroids or has current pneumonitis - History of hepatic encephalopathy or treatment to prevent or control encephalopathy within the past 12 months. Subjects on lactulose and/or rifaximin to control hepatic encephalopathy are not allowed - Esophageal or gastric variceal bleeding within the past 6 months. All subjects will be screened for esophageal varices unless performed in the last 6 months before study treatment. If varices are present, they should be treated according to institutional standards before starting study treatment - Uncontrolled ascites, clinically significant or symptomatic ascites requiring paracenteses or increasing doses of diuretics within the past 3 months - Patients who are on stable diuretic doses for at least 3 months are eligible if they meet other eligibility criteria - Asymptomatic ascites detected on imaging are allowed - Has known history or any evidence of CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are asymptomatic and radiologically stable (i.e. without progression for at least 4 weeks by repeat imaging [which must be performed during study screening], clinically stable, and without the need steroids for at least 4 weeks prior to first dose of study treatment) - Concomitant anticoagulation with oral anticoagulants (e.g. warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (e.g. clopidogrel). Allowed anticoagulants are the following: - Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted - Low molecular weight heparin (LMWH) is permitted - Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 4 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor - The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: - Cardiovascular disorders: - Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias with risk of hemodynamic instability within 12 months before the first dose of study treatment - Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 95 mm Hg diastolic despite optimal antihypertensive treatment, and/or change in antihypertensive medications within 1 week before starting treatment. Note: eligibility of a subject receiving 4 or more antihypertensive medications prior to study entry will require approval from the principal investigator (PI) - Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or arterial thromboembolic within 12 months before the first dose - Asymptomatic venous thromboembolic event (e.g. deep venous thrombosis, pulmonary embolism) is allowed if the patient has been stable on anticoagulation with LMWH for at least 4 weeks - Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: - The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g. Crohns disease), GI malabsorption, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction - Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose - Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose - Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, other history of significant bleeding (e.g. pulmonary hemorrhage) within 12 weeks before first dose, or known thrombotic disorder - Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation - Lesions invading any major blood vessels, including main portal vein, inferior vena cava, or cardiac involvement of HCC based on imaging - Note: Main and branch portal vein and hepatic vein invasion is allowed - Ongoing active infection requiring antibiotics. Antibiotics must be completed at least 7 days before initiating study treatment - Known active tuberculosis - Serious non-healing wound, ulcer, or bone fracture - Patients with proteinuria > 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein >= 1 g/24 hours will be ineligible - Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (EKG) within 28 days before first dose of study treatment - Note: If a single EKG shows a QTcF with an absolute value > 500 ms, two additional EKGs at intervals of approximately 3 min must be performed within 30 min after the initial EKG, and the average of these three consecutive results for QTcF will be used to determine eligibility - Inability to swallow tablets or any other condition that might interfere with oral absorption of medications - Previously identified allergy or hypersensitivity to study drugs and/or any of their excipients - Ongoing secondary malignancy that is progressing and/or has required active treatment within the past year. Adjuvant treatment for resected breast cancer is allowed - Subjects with basal cell carcinoma of the skin, squamous cell carcinoma or the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially therapy are allowed - Has a known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not mandated for screening - Co-infection with HBV (HBsAg [+] and /or detectable HBV DNA) and HCV (anti-HCV Ab [+] and detectable HCV ribonucleic acid [RNA]) at study entry - Co-infection with HBV and hepatitis D virus (HDV) at study entry - Live attenuated vaccine within 30 days prior to first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed - Pregnant or lactating females - Known psychiatric illness, substance abuse disorder, or other condition that would interfere with the ability to comply with the requirements of the study - Has history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subjects participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator ; PRIMARY OUTCOME: Number of Participants With Objective Response (Complete or Partial Response); SECONDARY OUTCOME 1: Number of Participants With Disease Control (Complete + Partial Response + Stable 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 IIb - POWER 2 (TMC114-C202); BRIEF: The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir. ; DRUG USED: Prezista; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV-1 protease (HIV PR); THERAPY: Combination; LEAD SPONSOR: Tibotec Pharmaceuticals, Ireland; CRITERIA: Inclusion Criteria: - Male or female, age 18 years or older - Documented HIV-1 infection - Stable PI regimen for at least 8 weeks prior to screening - Plasma viral load at screening above 1000 HIV-1 RNA copies/ml - Prior use of more than 1 NRTI for at least 3 months - Prior use of one or more NNRTIs as part of a failing regimen - At least 1 primary PI mutation as defined by the IAS guidelines - Treatment with at least 1 PI for a total of at least 3 months - Patient has given informed consent Exclusion Criteria: - Presence of any currently active AIDS defining illness except stable cutaneous Kaposis Sarcoma and Wasting syndrome due to HIV infection - Current or past history of alcohol and/or drug abuse which, in the investigators opinion, would compromise the subjects safety or compliance to the study protocol procedures - NNRTI as part of therapy at screening - Patients on a treatment interruption at screening - Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening - Hepatitis A, B, or C. ; PRIMARY OUTCOME: To evaluate the dose-response relationship of antiviral activity of the TMC114/RTV dose regimens at 24 Wks in order to determine the optimal dose.; SECONDARY OUTCOME 1: To evaluate safety and tolerability over 24 to 144Wks; The durability of the antiviral activity; The effect of functional monotherapy with TMC114 over 2 weeks in different doses; and The dose-response by comparing the different TMC114/RTV dosages.[/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 - UNCOVER-2; BRIEF: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug - At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug - Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug - Candidate for phototherapy and/or systemic therapy - Men must agree to use a reliable method of birth control or remain abstinent during the study - Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Exclusion Criteria: - Pustular, erythrodermic, and/or guttate forms of psoriasis - History of drug-induced psoriasis - Prior use of etanercept - Clinically significant flare of psoriasis during the 12 weeks prior to randomization - Concurrent or recent use of any biologic agent - Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization - Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study - Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab - Serious disorder or illness other than plaque psoriasis - Serious infection within the last 3 months - Breastfeeding or nursing (lactating) women ; PRIMARY OUTCOME: Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]); SECONDARY OUTCOME 1: Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])[/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. Symbicort Turbuhaler (Japan); BRIEF: A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler® ; DRUG USED: Breztri Aerosphere; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR), Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pearl Therapeutics, Inc.; CRITERIA: Inclusion Criteria - Given their signed written informed consent to participate. - Subjects must have agreed to participate and complete the lead-in Study PT010006. - Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study. - Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines. - Current or former smokers with a history of at least 10 pack-years of cigarette smoking. - Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions). - Required COPD maintenance therapy: - All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies. Please refer to the study protocol for the complete inclusion criteria list. Exclusion Criteria - Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subjects ability to participate in the study. - Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception. - Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma. - Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period - Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period - Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia. - Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated. - Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs. Please refer to the study protocol for the complete exclusion criteria list. ; PRIMARY OUTCOME: Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values; 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 - LUME-Lung 1 - w/Docetaxel; BRIEF: The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis. ; DRUG USED: Ofev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , Platelet-derived growth factor receptor (PDGFR), Src Kinase Family, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - male or female patient aged 18 years or older; - histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC; - relapse or failure of one first line prior chemotherapy; - at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured ; - life expectancy of at least three months; - Eastern Cooperative Oncology group (ECOG) score of 0 or 1; - patient has given written informed consent Exclusion criteria: - more than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC; - more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) prior to first line chemotherapy; - previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC; - persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy; - treatment with other investigational drugs or other anti-cancer therapy or treatment in another clinical trial within the past four weeks before start of - therapy or concomitantly with this trial ; - radiotherapy (except extremities and brain) within the past three months prior to baseline imaging; - active brain metastases or leptomeningeal disease; - radiographic evidence of cavitary or necrotic tumours; - centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels; - history of clinically significant haemoptysis within the past 3 months; - therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy; - history of major thrombotic or clinically relevant major bleeding event in the past 6 months; - known inherited predisposition to bleeding or thrombosis; - significant cardiovascular diseases ; - inadequate safety laboratory parameters; - significant weight loss (> 10 %) within the past 6 weeks; - current peripheral neuropathy greater than CTCAE grade 2 except due to trauma; - preexisting ascites and/or clinically significant pleural effusion; - major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing; - serious infections requiring systemic antibiotic therapy; - decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy; - gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug; - active or chronic hepatitis C and/or B infection; - serious illness or concomitant non-oncological disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration; - patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for at least twelve months after end of active therapy; - pregnancy or breast feeding; - psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; - patients unable to comply with the protocol; - active alcohol or drug abuse; - other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix; - any contraindications for therapy with docetaxel; - history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80); - hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs; - hypersensitivity to contrast media ; PRIMARY OUTCOME: Progression Free Survival (PFS) as Assessed by Central Independent Review; SECONDARY OUTCOME 1: Overall Survival (Key Secondary Endpoint)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Human Chorionic Gonadotropin; BRIEF: This study will assess if corifollitropin alfa (MK-8962), when administered in combination with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who remain azoospermic after treatment with hCG alone. Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in testicular volume from Day 1 to Week 52 is greater than one. ; DRUG USED: Elonva; DRUG CLASS: Biologic; INDICATION: Hypogonadism; TARGET: Follicle-Stimulating Hormone Receptor (FSHR) ; THERAPY: Combination; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion Criteria: - Diagnosed with hypogonadotropic hypogonadism, either congenital or acquired - Have low circulating levels of testosterone - Have low circulating levels of gonadotropins (follicle stimulating hormone [FSH]; luteinizing hormone) - Presence of both scrotal testes - Have azoospermia (no measurable level of sperm) - Adequate replacement of other pituitary hormones - Good general physical and mental health Exclusion Criteria: - Primary hypogonadism, such as Klinefelters syndrome - History of unilateral or bilateral cryptorchidism (maldescended testes) - History or presence of testicular pathology of clinical importance (e.g., epididymitis, orchitis, testicular torsion, varicocele stage III, testicular atrophy, occlusive azoospermia, etc), and/or vasectomy - Treated with FSH, hCG or gonadotropin-releasing hormone (GnRH) within previous 3 months or for more than 1 month within previous 6 months - Proven spermatogenesis with hCG treatment alone - Previous unsuccessful attempt with hCG in combination with human menopausal gonadotropin (hMG)/FSH to achieve spermatogenesis - Required a dose of hCG of more than 6000 international units (IU) per week in a previous attempt to normalize T levels - Untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or hypothalamic tumor that is likely to progress during the study - History or presence (known or suspected) of testicular, prostatic or breast cancer - Prostate pathology of clinical importance - Past or present oncologic treatment (chemo/radiotherapy) - Diabetes mellitus - Clinically significant, untreated hyperprolactinaemia - Uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders) - Tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C - User of recreational or illicit drugs or has had a recent history (within the past year) of drug abuse or dependence, or increased alcohol consumption - Allergy/sensitivity to gonadotropins or its/their excipients - Has received within previous 1 month or plans to use: Hormonal preparations other than the study medication, drugs that are known to impair testicular function, agents known to affect sex hormone secretion and/or drugs that are known or suspected to be teratogenic - Used any investigational drugs within three months or actively participating in another study ; PRIMARY OUTCOME: Change From Baseline in Log-Transformed Testicular Volume at Week 52; SECONDARY OUTCOME 1: Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52[/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 - A3051036 - vs. Zyban (12 Weeks); BRIEF: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation. ; DRUG USED: Chantix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Smoking Cessation; TARGET: Nicotinic Acetylcholine Receptor - a4ß2 subtype &lt;br&gt;(a4ß2 nAChR), Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: - Subjects who have used bupropion (Zyban or Wellbutrin) previously. ; PRIMARY OUTCOME: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.; SECONDARY OUTCOME 1: Continuous abstinence Weeks 9-52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ENSIGN - Pediatric (UPenn); BRIEF: This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or relapsed after allogeneic stem cell transplant. ; DRUG USED: Kymriah; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Relapsed or refractory pediatric B-cell ALL and lymphoblastic lymphoma: 1. 2nd or greater Bone Marrow (BM) relapse OR 2. Any BM relapse after allogeneic SCT and must be > 6 months from SCT at the time of CTL019 infusion OR 3. Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapse leukemia OR 4. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated OR 5. Ineligible for allogeneic SCT - For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry - Adequate organ function defined as: 1. Renal function defined as (Calculated creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) > 60 mL/min/1.73 m2 OR serum creatinine based on age/gender 2. Alanine Aminotransferase (ALT) <= 5 times the upper limit of normal (ULN) for age; 3. Bilirubin < 2.0 mg/dL; 4. Must have a minimum level of pulmonary reserve defined as ≤Grade 1 dyspnea and pulse oxygenation > 91% on room air 5. Left Ventricular Shortening Fraction (LVSF) ≥ 28% confirmed by echocardiogram, or Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or MUGA within 7 days of screening - Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening - Life expectancy > 12 weeks - Age 3 at the time of screening per protocol to age 21 at the time of initial diagnosis - Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening - Signed written informed consent and assent forms (if applicable) must be obtained prior to any study procedures - Once all other eligibility criteria are confirmed, must have an apheresis product of non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis product will not be shipped to or assessed for acceptance by the manufacturing site until documented confirmation of all other eligibility criteria is received. - Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their CTL019 infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are not eligible. However, such patients with other forms of CNS-3 leukemic involvement (non-CSF involvement) are eligible if there is documented evidence of disease stabilization for at least 3 months prior to CTL019 infusion. Patients must have no acute/ongoing neurologic toxicity > Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable/improving over the past 3 months. Exclusion Criteria: - Isolated extra-medullary disease relapse - Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded. - Patients with Burkitts lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [surface Immunoglobulin (sIg) positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation) - Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease - Prior treatment with gene therapy product - Treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy - Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) - Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening - Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion - Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening - HIV positive test within 8 weeks of screening - The following medications are excluded: 1. Steroids: Therapeutic systemic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent 2. Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 6 weeks prior to CTL019 infusion 3. GVHD therapies: Any systemic drug used for GVHD must be stopped > 4 weeks prior to CTL019 infusion to confirm that GVHD recurrence is not observed (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20 (rituximab), anti-tumor necrosis factor [anti-TNF], anti-interleukin 6 [anti-IL6] or anti-interleukin 6 receptor [anti-IL6R], systemic steroids) 4. Chemotherapy: - Tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to CTL019 infusion - The following drugs must be stopped > 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate < 25 mg/m2, cytosine arabinoside < 100 mg/m2/day, asparaginase (non-pegylated) - The following drugs must be stopped >2 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide, methotrexate ≥ 25 mg/m2), excluding the required lymphodepleting chemotherapy drugs - Pegylated-asparaginase must be stopped > 4 weeks prior to CTL019 infusion e. CNS disease prophylaxis: - CNS prophylaxis treatment must be stopped > 1 week prior to CTL019 infusion (e.g. intrathecal methotrexate) f. Radiotherapy: - Non-CNS site of radiation must be completed > 2 weeks prior to CTL019 infusion - CNS directed radiation must be completed > 8 weeks prior to CTL019 infusion g. Anti T-cell Antibodies: Administration of any T cell lytic or toxic antibody (e.g. alemtuzumab) within 8 weeks prior to CTL019 is prohibited since residual lytic levels may destroy the infused CTL019 cells and/or prevent their in vivo expansion. If such an agent has been administered within 8 weeks prior to CTL019, contact the Sponsor, consider consultation with an pharmacology expert, and consider measuring residual drug levels, if feasible, prior to CTL019 infusion Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CTL019 infusion. Highly effective contraception methods include: 1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are NOT acceptable methods of contraception 2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment 3. Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient 4. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception 5. Use of IUDs are excluded due to increased risks of infection and bleeding in this population. However, IUD inserted prior to consent may remain in place, and a second method of contraception is mandated 6. In case of use of oral contraception, women must be stable on the same pill for a minimum of 3 months before taking study treatment. Women who are not of reproductive potential (defined as either <11 years of age, Tanner Stage 1, post-menopausal for at least 24 consecutive months (i.e. have had no menses) or have undergone hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) are eligible without requiring the use of contraception. Women who are not yet of reproductive potential are to agree to use acceptable forms of contraception when they reach reproductive potential if within 1 year of CTL019 or if CAR cells are present in the blood by PCR. Acceptable documentation includes written or oral documentation communicated by clinician or clinicians staff of one of the following: 1. Demographics show age < 11 2. Physical examination indicates Tanner Stage 1 3. Physician report/letter 4. Operative report or other source documentation in the patient record 5. Discharge summary 6. Follicle stimulating hormone measurement elevated into the menopausal range ; PRIMARY OUTCOME: Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants); SECONDARY OUTCOME 1: Percentage of Participants With Clinical Response Without Stem Cell Transplantation (SCT) at Month 6 - Per IRC Assessment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BALANCE (vs. Fabrazyme); BRIEF: This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients who had been treated for approximately 1 year with agalsidase beta and who had been on a stable dose of that product for at least 6 months were randomized in a 2:1 ratio to either switch to PRX-102 or to continue treatment with agalsidase beta. Both treatments were delivered by intravenous infusions every two weeks, at a dosage of 1 mg/kg. ; DRUG USED: Pegunigalsidase alfa; DRUG CLASS: Biologic; INDICATION: Fabrys Disease; TARGET: Globotriaosylceramide glycolipid; THERAPY: Monotherapy; LEAD SPONSOR: Protalix; CRITERIA: Inclusion Criteria: - Symptomatic adult Fabry disease patients, age 18-60 years 1. Males: Plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than 30% mean normal levels and one or more of the characteristic features of Fabry disease i. neuropathic pain ii. cornea verticillata iii. clustered angiokeratoma 2. Females: a. historical genetic test results consistent with Fabry pathogenic mutation and one or more of the described characteristic features of Fabry disease: i. neuropathic pain ii. cornea verticillata iii. clustered angiokeratoma b. or in the case of novel mutations a first degree male family member with Fabry disease with the same mutation, and one or more of the characteristic features of Fabry disease i. neuropathic pain ii. cornea verticillata iii. clustered angiokeratoma - Screening eGFR by CKD-EPI equation 40 to 120 mL/min/1.73 m² - Linear negative slope of eGFR based on at least 3 serum creatinine values over approximately 1 year (range of 9 to 18 months, including the value obtained at the screening visit) of ≥ 2 mL/min/1.73 m²/year - Treatment with a dose of 1 mg/kg agalsidase beta per infusion every 2 weeks for at least one year and at least 80% of 13 (10.4) mg/kg total dose over the last 6 months. - Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically accepted method of contraception, not including the rhythm method. Exclusion Criteria: - History of anaphylaxis or Type 1 hypersensitivity reaction to agalsidase beta - Known non-pathogenic Fabry mutations - History of renal dialysis or transplantation - History of acute kidney injury in the 12 months prior to screening, including specific kidney diseases (e.g., acute interstitial nephritis, acute glomerular and vasculitic renal diseases); non-specific conditions (e.g, ischemia, toxic injury); as well as extrarenal pathology (e.g., prerenal azotemia, and acute postrenal obstructive nephropathy) - Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy initiated or dose changed in the 4 weeks prior to screening - Patient with a screening eGFR value between 91-120 mL/min/1.73 m², having an historical eGFR value higher than 120 mL/min/1.73 m² (during 9 to 18 months before screening) - Urine protein to creatinine ratio (UPCR) > 0.5 g/g and not treated with an ACE inhibitor or ARB - Cardiovascular event (myocardial infarction, unstable angina) in the 6 month period before randomization - Congestive heart failure NYHA Class IV - Cerebrovascular event (stroke, transient ischemic attack) in the 6 month period before randomization - Known history of hypersensitivity to Gadolinium contrast agent that is not managed by the use of pre-medication - Female subjects who are pregnant, planning to become pregnant during the study, or are breastfeeding - Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patients compliance with the requirements of the study ; PRIMARY OUTCOME: Annualized Change (Slope) in Estimated Glomerular Filtration Rate (eGFR); SECONDARY OUTCOME 1: Estimated Glomerular Filtration Rate (eGFR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/MEDI4736; BRIEF: The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in subjects with relapsed or refractory lymphomas. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Combination; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: - Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) - Measurable disease sites on CT scan (>1.5 cm in longest dimension) - Adequate hematologic function: 1. Absolute Neutrophil Count >1500 cells/mm3 2. Platelets >50000 cells/mm3 3. Hemoglobin >8.0 g/dL - Adequate hepatic and renal function: 1. AST or ALT ≤2.5 x ULN 2. Bilirubin ≤1.5 x ULN 3. Estimated creatinine clearance (Cockcroft-Gault) >40 mL/min - ECOG 0 or 1 Exclusion Criteria: - Received prior therapies: ibrutinib, or other BTK inhibitor and/or anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody - Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor - Primary CNS lymphoma or evidence of CNS involvement by lymphoma ; PRIMARY OUTCOME: Phase 1b/2 : Overall Response Rate of Number of Participants; SECONDARY OUTCOME 1: Phase 1b/ 2: Duration of Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EXPEDITION-2 (GT 1-6, HIV); BRIEF: The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Male or female, at least 18 years of age at time of Screening. 2. Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection. 3. Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit. 4. Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening. 5. Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have - CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or equal to 14%) at Screening; and - Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening. Exclusion Criteria: 1. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 2. Positive test result at Screening for hepatitis B surface antigen (HBsAg). 3. Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening. 4. Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir). 5. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-treatment Virologic Failure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PRIME; BRIEF: This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Men or women must be at least 18 years of age at the time of screening - Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by: - PASI score of >10 - Affected body surface area (BSA) > 10% - DLQI >10 - Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patients medical history or reported by the patient or determined by the investigator at screening. Exclusion Criteria (abbreviated): - Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline - Ongoing use of other prohibited psoriasis and non-psoriasis treatment. - Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations - Patients with severe liver diseases - Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers - Patients with severe kidney diseases or serum creatinine above 1 x ULN - Patients with known hematological disease or lab abnormalities - Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary) ; PRIMARY OUTCOME: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24; SECONDARY OUTCOME 1: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/OLE; BRIEF: The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC). ; DRUG USED: Itacitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of UC at least 12 weeks before screening based on clinical, endoscopic, and histopathological evidence. - Have a 3-component Mayo score of 4 to 9, which includes a modified Mayo Endoscopy Score (mMES) of ≥ 2 as determined by a central reader, a rectal bleeding score of ≥ 1, and a stool frequency score of ≥ 1. - Must have failed or be intolerant to (discontinued the medication due to an adverse event as determined by the investigator) at least 1 of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine, biologic therapy (eg, infliximab, vedolizumab or adalimumab). - Participants currently receiving the following treatment(s) for UC are eligible, provided they have been receiving acceptable and stable dose(s): oral 5-ASA or oral corticosteroids. - No evidence of active or latent or inadequately treated tuberculosis infection. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Clinical signs of fulminant colitis or toxic megacolon. - Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohns disease. - Disease limited to the distal 15 cm of the colon. - Receiving (or expected to receive) the following therapies within protocol-designated timeframes before the baseline visit or during the study: Natalizumab; anti-TNF therapy; Vedolizumab or any investigational anti-adhesion molecule therapy; Ustekinumab or any on or off label biologic therapy; interferon therapy; cyclosporine, mycophenolate, or tacrolimus; daily dose of oral corticosteroids ≥ 25 mg prednisone or equivalent; intravenous corticosteroids; rectally administered formulation of corticosteroids or 5-aminosalicylic acid; and AZA, 6-MP, or methotrexate. - Enema treatments within 2 weeks of the baseline visit, with the exception of enema bowel preparations for clinical assessments. - Positive stool examinations for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin at the screening visit. - Other immunocompromised states and history of opportunistic infections. - History of stomach or intestinal surgery, including bariatric surgery (Note: appendectomy and/or cholecystectomy, is allowed). o surgery for UC or likely to require surgery for UC during the study. - If at risk for colorectal cancer, must have had a colonoscopy within protocol-defined timeframes. - History of recurrent, disseminated, or multiple dermatomal herpes zoster. - History of alcohol or drug abuse. - History of active malignancy within 5 years of screening, excluding superficial basal and squamous cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix. - Current or recent history (within 30 days before randomization) of a clinically meaningful viral, bacterial, fungal, parasitic, or mycobacterial infection. - Previously received either lymphocyte apheresis or selective monocyte granulocyte apheresis (eg, Cellsorba) within 1 year of baseline. - History of unstable ischemic heart disease or uncontrolled hypertension. - Positive serology test results for HIV, for hepatitis B surface antigen or core antibody, or for HCV antibody with detectable RNA at screening. - Participants taking potent systemic CYP3A4 inhibitors or inducers or fluconazole within 2 weeks or 5 half-lives (whichever is longer) of baseline. - Participants taking P-gp substrates with narrow therapeutic index, including digoxin within 2 weeks or 5 half-lives (whichever is longer) of baseline. ; PRIMARY OUTCOME: Proportion of participants with a Clinical Response; SECONDARY OUTCOME 1: Proportion of participants with Endoscopic 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 - Self-Administration; BRIEF: The primary objective of this study was to assess users ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen). ; DRUG USED: Repatha; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Fasting LDL-C at screening > 85 mg/dL - Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria: - New York Heart Association (NYHA) III or IV heart failure - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension - Type 1 diabetes or poorly controlled type 2 diabetes - Uncontrolled hypothyroidism or hyperthyroidism ; PRIMARY OUTCOME: Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8; SECONDARY OUTCOME 1: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 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 - ELDERCARE-AF; BRIEF: The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy. ; DRUG USED: Savaysa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stroke Prevention in Atrial Fibrillation (SPAF); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo Co., Ltd.; CRITERIA: Inclusion Criteria: - Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy Exclusion Criteria: - Patients with active bleeding - Patients who have poorly controlled hypertension - Patients who have liver dysfunction accompanied with disorder of blood coagulation ; PRIMARY OUTCOME: Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo; SECONDARY OUTCOME 1: Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and Death Due to Cardiovascular in Participants Who Were Administered DU-176b Compared With Placebo[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - BUP-201 - Dental Pain ; BRIEF: The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain. ; DRUG USED: Belbuca; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: BioDelivery Sciences International; CRITERIA: Inclusion Criteria: - extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone - males or non-pregnant females, aged 18 to 45 years - good general health and capable of providing informed consent Exclusion Criteria: - history of substance abuse or dependence - positive urine toxicology screen or alcohol breath test - history of hypersensitivity to or allergy to any study drug - donation of blood within prior 30 days - use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours ; PRIMARY OUTCOME: Sum of Pain Intensity Difference From Baseline to 8 Hours; SECONDARY OUTCOME 1: Total Pain Relief Over 8 Hours[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - VX11-950-118; BRIEF: The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B. ; DRUG USED: Incivek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Males or females ages 3 to 17 years of age - Chronic hepatitis C - Hepatitis C virus genotype 1a or b at the Screening Visit - Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator. - Signed informed consent form (ICF), and where appropriate, signed Assent Form Exclusion Criteria: - History of or prior evidence of a medical condition associated with chronic liver disease other than HCV - Body weight <15 kg or >90 kg - Prior evidence of hepatic decompensation - Contraindications to pegylated interferon/ribavirin (Peg-IFN/RBV) - History or other evidence of severe retinopathy or clinically significant ophthalmological disorder - History of non-genotype 1 HCV - Participation in investigational drug study as described in Study Protocol - Use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)[/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 - 0118 (w/Obinutuzumab); BRIEF: The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated. ; DRUG USED: Zydelig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: p110 delta/PIK3CD, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Not a candidate for fludarabine therapy based on either: 1. creatinine clearance < 70 mL/min, or 2. Cumulative Illness Rating Scale score > 6, by assessment of the investigator - Diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) - No prior therapy for CLL other than corticosteroids for disease complications. - CLL that warrants treatment - Presence of measurable lymphadenopathy - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: - Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) - Known presence of myelodysplastic syndrome - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization - Ongoing liver injury - Ongoing drug-induced pneumonitis - Ongoing inflammatory bowel disease - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation - Ongoing immunosuppressive therapy other than corticosteroids - Concurrent participation in another therapeutic clinical trial - Undergone major surgery within 30 days prior to randomization - Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idelalisib, obinutuzumab, or chlorambucil - History of non-infectious pneumonitis - Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Progression-Free Survival; SECONDARY OUTCOME 1: Overall Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PED-201 ; BRIEF: The primary aim of the study is to evaluate the clinical response of ST266 treated subjects with persistent corneal epithelial defects during 28 days of therapy. The secondary endpoint is the response rate within 14 days of treatment. ; DRUG USED: ST266; DRUG CLASS: Biologic; INDICATION: Other Ophthalmological Indications (Ophthalmology); TARGET: PI3K/AKT pathway, SIRT1; THERAPY: Monotherapy; LEAD SPONSOR: Noveome Biotherapeutics, formerly Stemnion; CRITERIA: Inclusion Criteria: - Male and female subjects aged 18 years and over. - Subjects with a PED present for at least seven (7) days. - The defect may be of any size and must be measurable by slit lamp. - In the Investigators opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses. - The original defect to the cornea must be the result of any injury, infection, disease or surgery to the eye. Exclusion Criteria: - Subjects currently being treated with cenegermin. - Subjects who require treatment with autologous serum eyedrops throughout the duration of the trial. If, in the opinion of the investigator, autologous serum eyedrop treatment can be safely stopped, the subject may be included in the clinical trial. - Subjects who require treatment with other amnion products throughout the duration of the trial. If, in the opinion of the investigator, the amniotic product treatment can be safely stopped, the subject may be included in the clinical trial. - Subject who requires treatment with amniotic membrane throughout the duration of the trial. If the amniotic membrane can be safely stopped, the subject may be included in the clinical trial. Note: The amniotic membrane must be removed at least one (1) day prior to the baseline visit. - Subjects who require treatment with bandage contact lens that cannot be removed at least 24 hours prior to screening. If the bandage contact lens can be safely removed, the subject may be included in the clinical trial. - Subject with an uncontrolled lid or ocular infection. - History of alkali burns of the cornea. - The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the circumference. - Subjects with severe lid abnormalities contributory to the persistence of the PED such as the inability to close the lids. - Subjects who have a history of AIDS or HIV. - Treatment with systemic corticosteroids (equivalent to >10 mg/day of prednisone) or immunosuppressive (including Plaquenil) or chemotherapeutic agents within 7 days prior to Day 1, or likely to receive one of these therapies during study participation. - Subjects who have participated in a clinical trial within 30 days prior to Day 1. - Subjects who have more than one distinct PED in the study eye prior to screening visits. Subjects who develop PEDs after the screening visit will remain in the study; however, only the original study PED will be assessed. - Subjects with bullous keratopathy. - Subjects with corneal perforation or impending corneal perforation. - For subjects with bilateral PEDs, only the eye with the larger PED should be entered in to the study. The non-study eye will receive standard of care treatment and will be observed throughout the trial. - Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test on Day 1 visit. - Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Moorens ulceration. - Subjects with recurrent corneal erosion. ; PRIMARY OUTCOME: Proportion of subjects with complete healing of PED during 28 days of treatment starting; SECONDARY OUTCOME 1: Safety endpoint of the incidence of adverse and serious adverse events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MANDARA; BRIEF: This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year). ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Antineutrophil Cytoplasmic Antibodies (ANCA) Associated Vasculitis; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Male or female subjects age 18 years or older. 2. EGPA diagnosis based on history or presence asthma and eosinophilia (>1.0x10^9/L and/or >10% of leucocytes) and at least 2 of; biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar haemorrhage; palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positivity (Myeloperoxidase or proteinease 3). 3. History of relapsing (at least 1 confirmed EGPA relapse within last 2 years and > 12 weeks prior to screening), or refractory (failure to attain remission, defined as BVAS=0 and oral corticosteroid (OCS) dose <=7.5 mg/day of prednisolone or equivalent, following standard induction regimen for at least 3 months and within 6 months prior to screening, or recurrence of symptoms upon OCS tapering at any dose of ≥7.5 mg/day prednisolone or equivalent. If induction with glucocorticoidsalone, patient must have failed to attain remission after 3 months and the glucocorticoid dose must be ≥15 mg/day prednisolone or equivalent for the 4 weeks prior to randomization. 4. Must be on a stable dose of oral prednisolone or prednisone of ≥7.5 mg/day (but not >50mg/day) for at least 4 weeks prior to randomization. 5. If receiving immunosuppressive therapy (excluding cyclophosphamide) the dose must be stable for the 4 weeks prior to randomization and during the study (dose reductions for safety reasons will be permitted). 6. QTc(F)<450 msec or QTc(F)<480 msec for patients with bundle branch block. 7. Females of childbearing potential must use an acceptable method of birth control from signing the informed consent for at least 12 weeks after the last study drug administration. Exclusion Criteria: 1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) 2. Organ or life-threatening EGPA < 3 months prior to screening 3. Currently pregnant or breastfeeding, or planning to become pregnant during study participation. 4. Current malignancy or history of malignancy, unless received curative therapy >5 years ago, or >1 year ago for basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix 5. An untreated or refractory helminth parasitic infection < 24 weeks prior to screening 6. Unstable liver disease 7. Severe or clinically significant, uncontrolled cardiovascular disease 8. Other concurrent disease that may put the patient at risk, or may influence the results of the study, or the patients ability to complete entire duration of the study 9. Chronic or ongoing infectious disease requiring systemic anti-infective treatment 10. Known immunodeficiency disorder or positive HIV test 11. Prior receipt of mepolizumab, reslizumab, dupilumab or benralizumab. Receipt of intravenous/intramuscular/subcutaneous corticosteroids within 4 weeks prior to randomization, receipt of omalizumab within 130 days prior to screening, rituximab within 6 months prior to screening (or B-cells not recovered), interferon-α or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening or an investigational non-biologic product within 30 days or 5 half-lives prior to screening, whichever is longer. Receipt of any other marketed or investigational biologic products within 4 months or 5 half-lives prior to screening, whichever is longer. ; PRIMARY OUTCOME: Proportion of patients who are in remission at both weeks 36 and 48; SECONDARY OUTCOME 1: Number of patients in each category of accrued duration of remission[/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 IIIa - Ellipse; BRIEF: This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population Exclusion Criteria: - Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigators opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics ; PRIMARY OUTCOME: Change in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG)[/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 - POD1UM-301; BRIEF: The purpose of this study is to assess the efficacy and safety of INCMGA00012 in combination with chemoradiation therapy (CRT) in participants with unresectable, Stage III non-small cell lung cancer (NSCLC). The study will randomize approximately 360 participants in a 2:1 ratio into the INCMGA00012 in combination with CRT followed by consolidation therapy with INCMGA00012 treatment group and placebo in combination with CRT followed by consolidation therapy with placebo treatment group. ; DRUG USED: Retifanlimab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed NSCLC that is locally advanced and unresectable. - Adequate tumor sample from fresh biopsy or archival tissue block must be available. - Evaluable disease per RECIST v1.1. - Eastern Cooperative Oncology Group performance status 0 to 1. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Receipt of cancer treatment for this malignancy, including but not limited to radiation therapy, investigational agents, chemotherapy, and immunotherapy for disease under consideration. - Recent major surgery within 4 weeks before entry into the study. - Any medical contraindication to platinum-based doublet chemotherapy. - Active autoimmune disease requiring systemic immunosuppression in excess of physiologic consolidation doses of corticosteroids (> 10 mg/day of prednisone or equivalent). - Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids). - Mixed small cell and NSCLC histology. - Evidence of interstitial lung disease or active noninfectious pneumonitis. - Participants who are HIV-positive. - History of organ transplant, including allogeneic stem cell transplantation. ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - +/- Advate (Surgical Procedures); BRIEF: The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von Willebrand disease (VWD). ; DRUG USED: Vonvendi; DRUG CLASS: Biologic; INDICATION: Von Willebrand Disease; TARGET: Von Willebrand Factor (vWF); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Inclusion Criteria: - Diagnosis of severe von Willebrand disease (VWD) as listed below and elective surgical procedure planned 1. Type 1 (Von Willebrand factor : Ristocetin cofactor activity (VWF:RCo) <20 IU/dL), or 2. Type 2A (as verified by multimer pattern), Type 2B (as diagnosed by genotype), Type 2N (FVIII:C<10% and historically documented genetics), Type 2M, or 3. Type 3 (Von Willebrand factor antigen (VWF:Ag) ≤ 3 IU/dL) - VWD with a history of requiring substitution therapy with von Willebrand factor (VWF) concentrate to control bleeding - If type 3 VWD (VWF Antigen /VWF:Ag ≤ 3 IU/dL), participant has a medical history of at least 20 exposure days to VWF/FVIII coagulation factor concentrates (including cryoprecipitate or fresh frozen plasma) - If type 1 or type 2 VWD, participant has a medical history of 5 exposure days or a past major surgery requiring VWF/FVIII coagulation factor concentrates (including cryoprecipitate or fresh frozen plasma) - Participant is at least 18 years of age - If female of childbearing potential, participant presents with a negative pregnancy test - If applicable, participant agrees to employ adequate birth control measures for the duration of the study - Participant is willing and able to comply with the requirements of the protocol Exclusion Criteria: - Diagnosis of pseudo VWD or another hereditary or acquired coagulation disorder (eg, qualitative and quantitative platelet disorders or elevated prothrombin time [PT] / international normalized ratio [INR] > 1.4) - History or presence of a VWF inhibitor at screening - History or presence of a factor VIII (FVIII) inhibitor with a titer ≥ 0.4 BU (Nijmegen-modified Bethesda assay ) or ≥ 0.6 BU (by Bethesda assay) - Known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins - Medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies - Medical history of a thromboembolic event - HIV positive with an absolute CD4 count < 200/mm3 - Platelet count < 100,000/mL - Diagnosis of significant liver disease, as evidenced by, but not limited to, any of the following: serum alanine aminotransferase (ALT) 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg. presence of otherwise unexplained splenomegaly, history of esophageal varices) or liver cirrhosis classified as Child B or C - Diagnosis of renal disease, with a serum creatinine level ≥ 2 .5mg/dL - Participant has been treated with an immunomodulatory drug, excluding topical treatment (eg, ointments, nasal sprays), within 30 days prior to signing the informed consent - Participant is pregnant or lactating at the time informed content is obtained - Participant has participated in another clinical study involving an investigational product (IP), other than rVWF with or without ADVATE, or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. However, eligible patients participating in the rVWF Prophylaxis Study (071301) may be enrolled. - Progressive fatal disease and/or life expectancy of less than 3 months - Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures - Participant suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude - Participant is in prison or compulsory detention by regulatory and/or juridical order - Participant is a member of the study team conducting this study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees. ; PRIMARY OUTCOME: Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician); SECONDARY OUTCOME 1: Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon[/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 - MOSAIC (Diabetic Kidney Disease); BRIEF: The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD). ; DRUG USED: Selonsertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: Apoptosis Signal Regulating Kinase 1 (ASK1); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines. - Estimated glomerular filtration rate (eGFR) value calculated by central laboratory utilizing samples collected during screening and prior to enrollment of ≥ 20 mL/min/1.73 m^2 to < 60 mL/min/1.73 m^2 with albuminuria - eGFR and urine albumin to creatinine ratio (UACR) must meet criteria a, b, or c - a: eGFR (mL/min/1.73 m^2): ≥ 45 to < 60; UACR (mg/g): ≥ 600 to 5000 - b: eGFR (mL/min/1.73 m^2): ≥ 30 to < 45; UACR (mg/g): ≥ 300 to 5000 - c: eGFR (mL/min/1.73 m^2): ≥ 20 to < 30; UACR (mg/g): ≥ 150 to 5000 - Treatment with either an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) - Individuals not receiving an ACEi or ARB may be enrolled if there is documented intolerance to ACEi and ARB - Individuals receiving less-than-maximal dose of an ACEi or ARB may be enrolled if there is a documented reason that the maximum labeled dose of ACEi and ARB could not be reached - Individuals already receiving sodium-glucose co-transporter-2 (SGLT-2) inhibitors must be on a stable dose for at least 2 weeks prior to enrollment - Mean systolic blood pressure (SBP) must be <160 mmHg and mean diastolic blood pressure (DBP) must be <100 mmHg - Required baseline laboratory data, analyzed by central laboratory, within 30 days prior to enrollment Key Exclusion Criteria: - Hemoglobin A1c (HbA1c) > 12.0% within 30 days prior to enrollment - Individuals with diagnosis of type 1 diabetes mellitus (T1DM) or maturity onset diabetes of the young (MODY) - Body mass index (BMI) > 50 kg/m^2 - UACR > 5000 mg/g on any measurement during screening - End stage kidney disease (ESKD) (i.e., chronic hemodialysis, chronic peritoneal dialysis, or history of kidney transplantation) - Anticipated progression to ESKD (need for chronic hemodialysis, chronic peritoneal dialysis or receipt of kidney transplant) within 3 months after enrollment - Unstable cardiovascular disease - Pregnant or lactating females or planning to become pregnant or breastfeed during the study - Concurrent use of either 1. ACEi and ARB or 2. Mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to Enrollment - Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigators opinion, could adversely affect the safety of the individual or impair the assessment of study results Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr); SECONDARY OUTCOME 1: Percentage of Participants With Kidney Clinical Events at 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 II - PoC; BRIEF: The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis, kidney problems, and anemia, among other problems). ; DRUG USED: Stelara; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Subjects must have documented medical history to meet SLICC classification criteria for SLE for a minimum of 3 months prior to first dose - At least 1 well-documented (subject file, referring physician letter, or laboratory result), unequivocally positive, documented test for autoantibodies in medical history including either of the following: ANA, and/or anti-dsDNA antibodies, and/or anti-Smith antibodies - At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA antibodies and/or anti-Smith antibodies detected during screening - At least 1 BILAG A and/or 2 BILAG B domain scores observed during screening prior to first administration of study agent - Demonstrate active disease based on SLEDAI-2K score greater than or equal to (>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization. Must also have SLEDAI-2K score >= 4 for clinical features (ie, SLEDAI excluding laboratory results) at Week 0 prior to the first administration of study agent Exclusion Criteria: - Have other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis or active Lyme disease - Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent - Have received systemic or topical cream/ointment preparations of cyclosporine A or other systemic immunomodulatory agents other than those described in inclusion criteria within the past 3 months prior to first administration of study agent - Have received a single B cell targeting agent within 3 months prior to first study agent administration; or received more than 1 previous B cell targeting therapy including belimumab or epratuzamab within 6 months prior to first administration of the study agent; or received B cell depleting therapy (eg, rituximab) within 12 months prior to first administration of the study agent or have evidence of continued B-cell depletion following such therapy - Have ever received ustekinumab - Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin that has been treated with no evidence of recurrence for at least 3 months before the first study agent administration and carcinoma in situ of the cervix that has been surgically cured) ; PRIMARY OUTCOME: Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 053 - w/Calcium/Vitamin D (Men); BRIEF: The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants. ; DRUG USED: Odanacatib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoporosis / Osteopenia; TARGET: Cathepsin K (CTSK); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Is a male between 40 and 95 years of age - Has osteoporosis - Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip - Is ambulatory Exclusion Criteria: - Is currently on oral bisphosphonates or other treatment for osteoporosis - Had previous hip fragility fracture and is a candidate for standard of care therapy - Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months - Has had more then one previous vertebral fracture - Has been diagnosed with metabolic bone disorder other than osteoporosis - Is Vitamin D deficient - Has a history of renal stones - Has active parathyroid disease - Has history of thyroid disease not well controlled by medication - Is diagnosed with secondary osteoporosis - Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg - Has a history of malignancy ≤5 years prior to signing informed consent - Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems ; PRIMARY OUTCOME: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24; SECONDARY OUTCOME 1: Percentage Change From Baseline in Total Hip BMD at Month 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 - RELY-ABLE (RE-LY Ext.); BRIEF: The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes ; DRUG USED: Pradaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stroke Prevention in Atrial Fibrillation (SPAF); TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: Participation in RE-LY, requires long term anticoagulation, provides written informed consent Exclusion criteria: Permanent discontinuation of dabigatran during RE-LY ; PRIMARY OUTCOME: Major Bleeding, Annualized Rate of Subjects With Major Bleeds; SECONDARY OUTCOME 1: Stroke, Annualized Rate of Subjects With Stroke[/INST]Yes</s>