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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb/IV - PHYSACTO; BRIEF: The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD ; DRUG USED: Stiolto Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - All patients must sign an informed consent consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions. - All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator forced expiratory volume in one second >=30% and <80% of predicted normal; Global Initiative for Chronic Obstructive Lung Disease grade II - III, and a post-bronchodilator Tiffeneau index <70% at Visit 1. - Male or female patients, aged >=40 years and <=75 years. - Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded. Exclusion criteria: - Patients with a significant disease other than chronic obstructive pulmonary disease. - Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis. - Patients with a history of asthma. - A diagnosis of thyrotoxicosis. - A diagnosis of paroxysmal tachycardia (>100 beats per minute). - A history of myocardial infarction within 1 year of screening visit. - Unstable or life-threatening cardiac arrhythmia. - Hospitalized for heart failure within the past year. - Known active tuberculosis. - A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years. - A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure. - A history of cystic fibrosis. - Clinically evident bronchiectasis. - A history of significant alcohol or drug abuse. - Any contraindications for exercise testing. - Patients who have undergone thoracotomy with pulmonary resection. - Patients being treated with any oral ß-adrenergics. - Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. - Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits. - Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program. - Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity. - Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit. - Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, benzalkonium chloride, disodium edentat, or any other component of the Respimat® inhalation solution delivery system. - Pregnant or nursing women. - Women of childbearing potential not using highly effective methods of birth control. - Patients who have previously been randomized in this study or are currently participating in another study. ; PRIMARY OUTCOME: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks; SECONDARY OUTCOME 1: Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 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 I/II - EGFR/HER2 Mutation; BRIEF: This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy. ; DRUG USED: DZD9008; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Dizal Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Aged at least 18 years old, be able to provide a signed and dated, written informed consent. 2. With documented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations. 3. (ECOG) performance status 0-1. 4. Predicted life expectancy ≥ 12 weeks 5. Patient must have measurable disease according to RECIST 1.1. 6. Patients with brain metastasis (BM) can be enrolled under the condition that BM is stable, neurologically asymptomatic and does not require corticosteroid treatment. 7. Adequate organ system function. Part A Dose expansion: 8. Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins, who have not received prior systemic therapy (treatment naïve). Part B dose extension: 9. Patients must have histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR Exon20ins mutation in tumor tissue from a local CLIA-certified laboratory (or equivalent) or Sponsor designated central laboratory prior to the study entry. 10. Patients should have received at least 1 line, but no more than 3 lines of systemic therapy for metastatic/locally advanced disease. Exclusion Criteria: 1. For part B: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded. Prior treatment with currently approved EGFR TKIs for sensitizing or T790M resistance mutations, such as gefitinib, erlotinib, osimertinib, afatinib and dacomitinb, are allowed. 2. Treatment with EGFR or HER2 antibodies, major surgery (excluding placement of vascular access), or onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1, PD-L1, CTLA-4) within 4 weeks before screening. 3. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before screening. 4. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose or with a wide field of radiation which must be completed within 4 weeks before screening. 5. Receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A within 2-3 weeks before screening. 6. Grapefruit, grapefruit juice, and orange marmalade (made with Seville oranges) within 1 week before screening. 7. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting DZD9008 with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy. 8. Spinal cord compression or leptomeningeal metastasis. 9. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 10. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs); (2) Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec. (3) Any factors that increase the risk of QTcF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval 11. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease 12. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of DZD9008 13. History of hypersensitivity to active or inactive excipients of DZD9008 or drugs with a similar chemical structure or class to DZD9008 14. Women who are pregnant or breast feeding 15. Involvement in the planning and conduct of the study. 16. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. ; PRIMARY OUTCOME: Part A: Safety and tolerability of DZD9008.; SECONDARY OUTCOME 1: Plasma DZD9008 concentration[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - KB001-03; BRIEF: The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa) ; DRUG USED: KB001A; DRUG CLASS: Biologic; INDICATION: Cystic Fibrosis (CF); TARGET: Pseudomonas aeruginosa; THERAPY: Monotherapy; LEAD SPONSOR: Humanigen, Inc.; CRITERIA: Inclusion Criteria: - Written informed consent - Confirmed diagnosis of CF based on the following criteria: Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype - Age >/= 18 years of age with the potential for age 12 >/= - Screening Pa sputum culture - FEV1% predicted >/= 40 (based on Wangs equations for Males aged 12-17 and females 12-15 years, and Hankinsons equations for all other patients) Exclusion Criteria: - Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0 - Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0. - History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction - Current cigarette smoker, history of drug addiction or alcohol abuse - Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0 - Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study ; PRIMARY OUTCOME: The Safety and Tolerability of a Single-dose of KB001.; 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 - 101; BRIEF: The purpose of this study is to determine whether dendritic cells collected via leukapheresis and incubated with antisense DNA oligonucleotides and then injected back into the same subject will serve as modulators of the immune system in a manner that disrupts the autoimmune process responsible for the destruction of pancreatic beta cells in subjects with new onset type 1 diabetes. ; DRUG USED: DV0100; DRUG CLASS: Biologic; INDICATION: Diabetes Mellitus, Type I; TARGET: Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: DiaVacs, Inc.; CRITERIA: Inclusion Criteria: 1. Fully executed, Institutional Review Board (IRB) approved, informed consent form 2. New onset type 1 diabetes randomized within 100 days of diagnosis 3. Positive for at least one islet cell auto-antibody; GAD, insulin (if sample within 7 days of the onset of insulin therapy), islet antibody 2 (IA-2), zinc transporter 8 antibody (ZnT8), and/or islet cell antibody (ICA) 4. Peak plasma c-peptide concentration >0.2 pmol/mL after ingestion of a standardized mixed meal 5. Serologic evidence of prior Epstein-Barr virus (EBV) infection 6. Immunoreactivity to alloantigens in mixed leukocyte culture and reactivity to viral antigens (CEF Pool Assay) in vitro 7. Adequate peripheral venous access for leukapheresis 8. Female participants with childbearing potential must agree to use effective birth control during study participation. Reliable and effective forms of birth control include: true abstinence, intrauterine device (IUD), hormonal-based contraception, double-barrier contraception (condom or occlusive cap (diaphragm or cervical cap) + spermicide, or surgical sterilization (vasectomy for male partner, tubal ligation or hysterectomy). 9. Sexually active male participants must agree to use condoms during intercourse Exclusion Criteria: 1. History of enrollment in a drug, or biologic therapy clinical trial within past 12 months impacting the immune system 2. Prior or current therapy known to cause a significant, ongoing change in the course of type 1 diabetes or immune status 3. Evidence of active infection at screening (e.g. common cold, influenza, hepatitis, tuberculosis, EBV, cytomegalovirus (CMV), herpes simplex virus (HSV), HIV, varicella, chlamydia, evidence of serious fungal infection) or screening laboratory evidence consistent with active microbial, viral, or fungal infection (minor cutaneous fungal infection is not an exclusion) 4. Leukopenia (<3,000 leukocytes/microliter, neutropenia (<1,500 neutrophils/microliter), lymphopenia (<800 lymphocytes/microliter) or thrombocytopenia (<125,000 platelets/microliter) 5. Positive screen for HIV, tuberculosis, hepatitis B, hepatitis C, herpes simplex virus 1 (HSV1) or herpes simplex virus 2 (HSV2) infection 6. Vaccination with any live vaccine product within the 3 months prior to the first cycle of study agent administration 7. Female subjects pregnant or unwilling to defer pregnancy for the study period 8. Females lactating at screening 9. History of significant heart disease (e.g., myocardial infarction, coronary artery disease, angina pectoris, arrhythmia, uncontrolled hypertension, congestive heart failure, structural defects) 10. Liver disease with alanine transaminase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal 11. Impaired renal function with a serum creatinine concentration > 1.5. 12. Any other significant immune disorder including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, vitiligo, ankylosing spondylitis and celiac disease. (Thyroiditis treated with a stable dose of thyroid replacement therapy is allowed.) 13. Any condition that interferes with accurate measurement of glycated hemoglobin (hemoglobin A1C) 14. Any condition that, in the investigators opinion, may compromise continuous study participation or confound study results 15. Any planned vaccinations scheduled prior to end of study participation 16. Chronic treatment with systemic corticosteroids (topical or inhaled corticosteroids are allowed) 17. Current use of diabetes medications other than insulin 18. Anticipated need for any of the following therapies during the 24-month study period: - Radiation therapy - Oncologic chemotherapy - Corticosteroids except for very short courses (≤ 2 weeks) - Agents used to treat attention deficit and hyperactivity disorder (ADHD) - Any protein, particle or cell vaccine immunomodulation therapy ; PRIMARY OUTCOME: Change from baseline in the mean 2-hour area under the curve (AUC) for plasma c-peptide at 12 and 24 months; SECONDARY OUTCOME 1: Reported 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 - GadaCAD 1; BRIEF: Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study. CMRI and CA/CTA images will be collected for an independent image review (blinded read). ; DRUG USED: Gadavist; DRUG CLASS: Non-NME; INDICATION: Coronary Artery Disease – Imaging; TARGET: Blood plasma; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male or female participants aged ≥18 years - Participants with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention or CTA within 4 weeks around gadobutrol-enhanced CMRI - Willingness to undergo stress/rest CMRI and to follow directions and complete all study procedures - Women of childbearing potential (e.g. age < 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test Exclusion Criteria: - Suspected clinical instability or unpredictability of the clinical course during the study period - Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers) - History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents according to the investigators assessment / judgment - Estimated glomerular filtration rate (eGFR) value <30 mL/min/1.73 m^2 derived from a serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any participant on hemodialysis or peritoneal dialysis is excluded from enrollment. - Acute renal insufficiency - Coronary artery bypass grafting (CABG) - Acute myocardial infarction (< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure - Irregular heart rhythm - Condition that precludes the safe administration of pharmacological stressor according to the respective approved label such as sinus node disease, 2nd or 3rd degree atrioventricular block, obstructive lung disease ; PRIMARY OUTCOME: Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers Assessment; SECONDARY OUTCOME 1: Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigators 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 - PANORAMA 3 - w/Velcade + Dex; BRIEF: NOTE: The study data was transferred to zr pharma& following the divestment of Panobinostat to pharma&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis. The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression. Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier. ; DRUG USED: Farydak; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Histone Deacetylase (HDAC); THERAPY: Combination; LEAD SPONSOR: pharmaand GmbH; CRITERIA: Inclusion Criteria: - multiple myeloma as per IMWG 2014 definition - requiring treatment for relapsed or relapsed/refractory disease - measurable disease based on central protein assessment - 1 to 4 prior lines of therapy - prior IMiD exposure - acceptable lab values prior to randomization Exclusion Criteria: - primary refractory myeloma - refractory to bortezomib - concomitant anti-cancer therapy (other than BTZ/Dex and bisphosphonates) - prior treatment with DAC inhibitors - clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization) - unresolved diarrhea ≥ CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease) Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Overall response rate (ORR) up to 8 cycles; SECONDARY OUTCOME 1: ORR throughout study[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - CLT008-02 (Leukemia or Myelodysplasia); BRIEF: Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after standard of care cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications. ; DRUG USED: Romyelocel-L; DRUG CLASS: Biologic; INDICATION: Neutropenia / Leukopenia; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Cellerant Therapeutics; CRITERIA: Key Inclusion Criteria: - Hematological malignancy, including: - AML, ALL or MDS - Planned treatment with cytarabine-based chemotherapy regimen - Adequate hepatic, renal, hematologic, cardiac and respiratory function Key Exclusion Criteria: - Prior allograft or history of active GVHD within 3 years - Pregnant or nursing ; PRIMARY OUTCOME: Incidence of serious adverse reactions; SECONDARY OUTCOME 1: Duration of neutropenia[/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 - Two F508del Mutations; BRIEF: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F) ; DRUG USED: Trikafta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Key Inclusion Criteria: - Homozygous for the F508del mutation (F/F) - Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height Key Exclusion Criteria: - Clinically significant cirrhosis with or without portal hypertension - Lung infection with organisms associated with a more rapid decline in pulmonary status - Solid organ or hematological transplantation Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1); SECONDARY OUTCOME 1: Absolute Change in Sweat Chloride (SwCl)[/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/Sorafenib; BRIEF: To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer. ; DRUG USED: Cixutumumab; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - The participant has histologically or cytologically confirmed, unresectable HCC - The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion - The participant has not received prior systemic therapy for HCC. Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery - The participant has fasting serum glucose <160 milligrams/deciliter (mg/dL) or below the upper limit of normal (ULN) and/or hemoglobin A1C <7%. If baseline nonfasting glucose <160 mg/dL, fasting glucose measurement is not required - The participant has the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - The participant has brain metastases - The participant has acute hepatitis - The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition - The participant has congestive heart failure > class II New York Heart Association (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy - The participant has experienced a hemorrhage or bleeding event ≥ National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior first dose of study therapy ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Number of Participants With Adverse Events (AEs)[/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 - GAUSS-3 (Statin Intolerant); BRIEF: The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE). ; 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: - Male or female ≥ 18 to ≤ 80 years of age - Subject not at LDL-C goal - History of statin intolerance - Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks - Fasting triglycerides ≤ 400 mg/dL Exclusion Criteria: - New York Heart Association (NYHA) III or IV heart failure - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension - Type 1 diabetes - Poorly controlled type 2 diabetes - Uncontrolled hypothyroidism or hyperthyroidism ; PRIMARY OUTCOME: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24; SECONDARY OUTCOME 1: Change From Baseline in LDL-C at the Mean of Weeks 22 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 I - SAD/MAD (China) ; BRIEF: This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants. ; DRUG USED: RG7907; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria - Chinese healthy male and female subjects, 18 to 60 years of age, inclusive. - A Body Mass Index (BMI) of between 19 to 27 kg/m2 inclusive, and a body weight of at least 45 kg. - Women should be of non-childbearing potential. Female subjects must be either surgically sterile (by means of hysterectomy and/or bilateral oophorectomy) or post-menopausal for at least one year (defined as amenorrhea >/=12 consecutive months without another cause, and confirmed by follicle stimulating hormone level >35 mIU/mL). - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria - Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are pregnant or lactating. - History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis. - Personal history of congenital long QT syndrome or family history of sudden death. - History of Gilberts syndrome. - History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids) </=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. - Subjects who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration. - Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable). - Electrocardiogram (ECG) with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QTS onset, low amplitude T-wave, merged T- and U waves, prominent U-waves) - Creatinine clearance (CrCl) </=70 mL/min (using the Cockcroft-Gault formula) - Positive test at screening of any of the following: hepatitis A (HAV IgM Ab), hepatitis B (HBsAg), hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus 1 and 2 (HIV Ab). - Participation in an investigational drug or device study within 90 days prior to screening or more than 4 times per year. - Donation or loss of blood over 500 mL within 3 months prior to screening. - Any suspicion or history of drug and/or alcohol abuse within the last year. - History (within 3 months of screening) of alcohol consumption exceeding two standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening, 48 hours before and 48 hours after each dose, and 48 hours before each scheduled visit. - Use of >5 cigarettes or equivalent nicotine-containing product per day. - Taking any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer). Occasional acetaminophen/paracetamol is allowed. - Subjects under judicial supervision, guardianship or curatorship. ; PRIMARY OUTCOME: Percentage of Participants With Adverse Events; SECONDARY OUTCOME 1: Maximum Observed Plasma Concentration (Cmax) of RO7049389[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Multiple Dose; BRIEF: This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion. ; DRUG USED: Mitapivat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Pyruvate kinase (PK); THERAPY: Monotherapy; LEAD SPONSOR: Agios Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Age 16 years or older (18 years or older [France and Germany]); participants age 16 or 17 years must physically have completed puberty; - Documented diagnosis of sickle cell disease (SCD) (HbSS, HbSC [combined heterozygosity for hemoglobins S and C], HbS/beta 0- thalassemia, HbS/ beta plus thalassemia, or other sickle cell syndrome variants); - At least 2 sickle cell pain crises (SCPCs) and no more than 10 SCPCs in the past 12 months; - Hemoglobin at least 5.5 and 10.5 gram per deciliter (g/dL) at the most. Hemoglobin concentration must be based on an average of at least 2 Hb concentration measurements (separated by ≥7 days) collected during the Screening Period; - If taking hydroxyurea, the hydroxyurea dose must be stable for at least 90 days before starting study drug; - Women capable of becoming pregnant and men with partners who are women that are capable of becoming pregnant must agree to use 2 forms of contraception. Exclusion Criteria: - Pregnant, breastfeeding, or parturient; - Receiving regularly scheduled transfusions; - Hepatobiliary disorders including but not limited to significant liver disease or gallbladder disease; - Severe kidney disease; - Prior exposure to gene therapy or prior bone marrow or stem cell transplantation; - Currently receiving treatment for SCD (eg, voxelotor, crizanlizumab, L-glutamine), with the exception of hydroxyurea. The last dose of such therapies must have been administered at least 90 days before starting study drug; - Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered at least 90 days before starting study drug; - Received treatment on another investigational trial within 90 days prior to start of study drug or plans to participate in another investigational drug trial; - Taking medications that are strong inhibitors of CYP3A4/5 or strong inducers of CYP3A4 that cannot be stopped in an acceptable timeframe before starting study drug (timeframe will be discussed with your doctor). ; PRIMARY OUTCOME: Phase 2: Percentage of Participants With Hemoglobin (Hb) Response; SECONDARY OUTCOME 1: Phase 2: Change From Baseline in Hb Concentration[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - First-In-Human; BRIEF: Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory AML. Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose [RP2D]). ; DRUG USED: AMG 427; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: FMS-like tyrosine kinase 3 (FLT-3) ; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subject has provided informed consent prior to initiation of any study-specific activities/procedures. - Subjects greater than or equal to 18 years of age at the time of signing consent. - For relapsed/refractory AML subjects only, AML as defined by the WHO Classification as persisting or recurring following 1 or more treatment courses (exceptions noted in exclusion criteria). - Myeloblasts greater than or equal to 5% in bone marrow, as confirmed by immunophenotype by flow cytometry. - Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2. - Renal function as follows: serum creatinine less than 2.0 mg/dL (176.84 mol/L); estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2. - Hepatic function as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 x upper limit of normal (ULN); bilirubin less than or equal to 1.5 x ULN (unless considered due to Gilberts syndrome or hemolysis). - No active tuberculosis in the setting of anti-TNF therapy - National guidelines should be followed for the appropriate tuberculosis screening in the setting of anti-TNF therapy, including a minimum of: - Subject has a negative test for tuberculosis during screening defined as either: - Negative purified protein derivative (PPD) (< 5 mm induration at 48 to 72 hours after test is placed) OR - Negative quantiferon test - Subjects with positive PPD and a history of bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test. - Subjects with a positive PPD test (without a history of bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following: - No symptoms, per tuberculosis worksheet provided by Amgen - Documented history of a completed course of adequate treatment or prophylaxis (per local standard of care) prior to the start of investigational product - No known exposure to a case of active tuberculosis after most recent prophylaxis - No evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product (substudy subjects only) Exclusion Criteria: - Patients with acute promyelocytic leukemia (APML). - Active extramedullary AML in the central nervous system (CNS) - Known hypersensitivity to immunoglobulins. - White blood cells (WBC) greater than 15,000 cells/mcL (15 cells x 10^9/L) at screening (hydroxyurea is permitted to enable eligibility). - Subjects with a prior or concurrent malignancy whose natural history or treatment is anticipated to interfere with the safety or efficacy assessment of the investigational regimen. Exception: Subjects with prior or concurrent malignancy not anticipated to interfere with the safety or efficacy of the investigational regimen may be included only after discussion with the Amgen Medical Monitor. - Autologous HSCT within 6 weeks prior to start of AMG 427 treatment. - Allogeneic HSCT within 3 months prior to start of AMG 427 treatment. - Any graft-versus-host disease requiring systemic therapy with immunomodulators. - History or evidence of significant cardiovascular risk including any of the following: symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias (eg, ventricular fibrillation, ventricular tachycardia etc.), recent coronary angioplasty, intra-cardiac defibrillators or any clinically relevant concurrent disorder that may pose a risk to subject safety or interfere with study evaluation, procedures, or completion. - History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months. - Active infection requiring intravenous antibiotics within 1 week of study enrollment (day 1). Antibiotics may be administered for prophylaxis as per institutional standards up to and after enrollment. - Known positive test for human immunodeficiency virus (HIV). - Positive for hepatitis B surface antigen (HepBsAg). - Positive for hepatitis C or chronic hepatitis C. Possible exceptions: acute hepatitis C and completely cleared of the virus (demonstrated by negative viral load), chronic hepatitis C with undetectable viral load defined by sustained virologic response 24 weeks (SVR24) after completion of anti-hepatitis C treatment. - Live vaccination(s) within 4 weeks before the start of AMG 427 treatment on day 1, during treatment, and until the end of the last study dose. - Unresolved toxicities from prior antitumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 grade 1 (with the exception of myelosuppression, eg, neutropenia, anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for greater than 2 months) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor. - Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, or investigational agent) within 14 days of day 1. Exception: hydroxyurea to control peripheral blood leukemic cell counts is allowed until start of investigational product treatment. Exception: antitumor therapies with short half-lives only require passing of 5 half-lives from last dose, and after discussion with sponsor. - Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids, cyclosporine, and tacrolimus within 2 weeks before enrollment (day 1). Exceptions: physiologic replacement steroids or steroids for treatment of transfusion/hypersensitivity reactions. - Prior treatment with a FLT3 targeting chimeric antigen receptor T cell (CAR-T) - Major surgery within 28 days of study day 1 with the exception of biopsy and insertion of central venous catheter. - History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. - Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 4 weeks after receiving the last dose of study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women). - Females who are lactating/breastfeeding or who plan to breastfeed while on study through 4 weeks after receiving the last dose of study drug. - Females with a positive pregnancy test. - Females planning to become pregnant while on study through 4 weeks after receiving the last dose of study drug. - Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subjects and investigators knowledge. - History of multiple sclerosis or any other demyelinating disease. - No active hepatitis secondary to alcoholic hepatitis or nonalcoholic steatohepatitis. - History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with Medical Monitor and meeting the following criteria: - Negative test for SARS-CoV-2 RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) within 72 hours of first dose of investigational product - No acute symptoms of coronavirus disease 2019 (COVID-19) disease within 10 days prior to first dose of investigational product (counted from day of positive test for asymptomatic subjects) ; PRIMARY OUTCOME: Number of subjects who experience a dose limiting toxicity (DLT); SECONDARY OUTCOME 1: Maximum observed concentration (Cmax) of AMG 427[/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 - Single Agent or w/SOC; BRIEF: Two part, dose escalation and dose expansion study. Open label, multi center, non randomized, multiple dose, safety, pharmacokinetic and pharmacodynamic study of single agent PF-06747143 in sequential dose levels of adult patients with refractory or relapsed AML in order to establish maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) or maximally permitted dose (MPD) following by a 3 arm dose expansion with PF-06747143 in combination with standard of care chemotherapy in adult patients with AML. ; DRUG USED: PF-06747143; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: Part 1 and Part 2 cohort 3: Patients diagnosed with AML ( bone marrow (BM) or peripheral blood (PB) blast counts >/= 20%) and have received prior chemotherapy and/or standard of care and have relapsed, refractory or Minimal Residual Disease (defined as patients showing residual blast 10-14 days post-induction chemotherapy). • Patients that are not candidates to receive standard of care and/or refusing the standard care of therapies will also be considered. Part 2 - Cohort 1 and 2: Newly diagnosed, previously untreated de novo or secondary AML population (AML with bone marrow or peripheral blast counts 20%): - Cohort 1: Fit to receive intensive remission induction chemotherapy. - Cohort 2: Unfit to receive or not considered a candidate for intensive remission induction chemotherapy. Part 1 and 2: - Life expectancy at least 12 weeks. - Hydroxyurea is allowed on study to control total peripheral white blood cell count but must be ceased 24 hours prior to first dose. - Off of prior therapy for 2-4 weeks prior to first dose. - ECOG performance status: 0 to 2. - Resolved acute effects of any prior therapy. - Adequate renal and hepatic function. Exclusion Criteria: - Patients with acute promyelocytic leukemia, AML with known central nervous system (CNS) involvement unless the patient has completed treatment for the CNS disease, has recovered from the acute effects of therapy prior to study entry, and is neurologically stable. - Patient is known refractory to platelet or packed red cell transfusions per institutional guidelines. - Prior treatment with a compound targeting CXCR4. - Chronic systemic corticosteroid treatment. - Known or suspected hypersensitivity to recombinant human proteins. - Chronic graft versus host disease (GVHD), active GVHD with other than Grade 1 skin involvement, or GVHD requiring systemic immunosuppressive treatment (Part 1 and cohort 3). - Not recovered from stem cell transplant associated toxicities (Part 1 and cohort 3). - Prior treatment with hypomethylating agents or chemotherapy for antecedent myelodysplastic syndrome (MDS) (Part 2, cohort 2) - AML associated with favorable risk karyotypes, including inv(16), t(8;21), t(16;16), or t(15;17) (cohort 2) - Candidates for allogeneic stem cell transplant (Part 2, cohort 2) - Known hypersensitivity to cytarabine or daunorubicin (Part 2, cohort 1) and decitabine or azacitidine or mannitol (Part 2, cohort 2). ; PRIMARY OUTCOME: Number of Participants With Dose-Limiting Toxicities (DLTs) [Part 1]; SECONDARY OUTCOME 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Part 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 - +/- Spartalizumab (mPDAC); BRIEF: The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in untreated mPDAC. ; DRUG USED: NIS793; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female ≥ 18 years of age at the time of informed consent. 3. Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1. 4. Participants must have a site of disease amenable to biopsy, and be candidate for tumor biopsy according to the treating institutions guidelines. Participants must be willing to undergo a tumor biopsy at screening and during therapy on the study. In the event a new biopsy cannot be safely performed at study entry, an archival sample (collected <6 months prior) may be substituted following documented discussion with Novartis. 5. ECOG performance status ≤ 1. Exclusion Criteria: 1. Previous radiotherapy, surgery (with exception of placement of biliary stent, which is allowed), chemotherapy or any other investigational therapy for the treatment of metastatic pancreatic cancer. Participants having received previous chemotherapy in the adjuvant setting. 2. Participants amenable to potentially curative resection. 3. Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors. 4. Having out of range laboratory values as pre-defined in the protocol. 5. Participants with MSI-H pancreatic adenocarcinoma. 6. Presence of symptomatic CNS metastases, or CNS metastases that require local CNS directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry. 7. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients. 8. The participant exhibits any of the events outlined in the contra-indications or special warnings and precautions sections of gemcitabine and nab-paclitaxel as per locally approved labels. 9. Impaired cardiac function or clinically significant cardiac disease. 10. Known history of testing positive HIV infection. 11. Active HBV or HCV infection. Participants whose disease is controlled under antiviral therapy should not be excluded. 12. History of or current interstitial lung disease or pneumonitis grade ≥ 2 13. High risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Incidence of DLTs during the Safety Run-in; SECONDARY OUTCOME 1: Incidence and severity of Adverse Events and Serious Adverse Events in Randomized part[/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 - SDD-1002-064; BRIEF: The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg) compared to vehicle in the treatment of subjects with inflammation and pain following cataract surgery. ; DRUG USED: Sonsuvi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: c-Jun N-terminal kinase (JNK); THERAPY: Monotherapy; LEAD SPONSOR: Xigen SA; CRITERIA: Key Inclusion Criteria: - Have provided written informed consent, approved by the appropriate institutional review board; - Be greater than or equal to 18 years of age of either sex or any race; - Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye; - Have a pin-hole visual acuity (VA) < 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1; - (For females of childbearing potential) agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control1 throughout the study duration. Women of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). Key Exclusion Criteria: - Have a known sensitivity or allergy to the class of medication of the active ingredient in the study medication or any of the study medications components; - Have any intraocular inflammation (e.g., white blood cells or flare) present in the study eye at the Visit 1slit lamp examination; - Have a score greater than 0 on the Ocular Pain Assessment at Visit 1 or 2 in the study eye; - Have an immunosuppressive or an autoimmune disease that in the opinion of the Investigator could affect intraocular inflammation or the normal healing process of the eye; - Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing; - Currently have suspected or known malignancy or be currently receiving antineoplastic therapy; - Be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration, or have a positive urine pregnancy test at Visit 1; - Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics and other pain medications) or immunomodulating agents, systemically, or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study ; PRIMARY OUTCOME: Absence of anterior chamber cells for the 900µg XG-102 sub-conjunctival injection compared to vehicle; SECONDARY OUTCOME 1: Use of rescue medication[/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 - 001; BRIEF: The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future. The study drug is designed to reduce the activity of a protein known as heat shock protein 90, or Hsp90. Hsp90 is found in every cell in the human body and normally helps those cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow the growth, and reduce the survival, of those cancer cells. ; DRUG USED: MPC-3100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cancer; TARGET: Heat Shock Protein 90 (HSP90); THERAPY: Monotherapy; LEAD SPONSOR: Myrexis Inc.; CRITERIA: Inclusion Criteria: - recurrent cancer refractory to available systemic therapy - 18 years old or older - predicted life expectancy equal or greater to 8 weeks - at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities - Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2 - adequate organ function based on hematological, liver, and renal function - LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography - wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued Exclusion Criteria: - pregnant or breastfeeding - received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1 - symptoms of heart failure equal or greater to Class III (by NYHA criteria) - impaired cardiac function or clinically significant cardiac diseases - concurrent treatment with medications that either markedly induce or inhibit CYP3A4 - concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug ; PRIMARY OUTCOME: Safety and Tolerability (Maximum Tolerated Dose); SECONDARY OUTCOME 1: Study Drug Pharmacokinetics[/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 - BLAZE-5; BRIEF: The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review. ; DRUG USED: Bamlanivimab; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Are currently not hospitalized. - Have one or more mild or moderate COVID-19 symptoms. - Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset - Are males or non-breastfeeding females. - Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies. - Are at high risk for progressing to severe COVID-19 and/or hospitalization. Exclusion Criteria: - Participants who: - are hospitalized due to COVID-19, OR - require oxygen therapy due to COVID-19, OR - require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. - Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute. - Have body weight <40 kilograms. - Require mechanical ventilation or anticipated impending need for mechanical ventilation. - Have known allergies to any of the components used in the formulation of the interventions. - Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention. - Have any comorbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days. - Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. - Have a history of a positive SARS-CoV-2 serology test. - Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study. - Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing. - Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-19. - Have received convalescent COVID-19 plasma treatment. - Have participated in a previous SARS-CoV-2 vaccine study. - Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. - Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. - Are breast-feeding. ; PRIMARY OUTCOME: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause; SECONDARY OUTCOME 1: Percentage of Participants With a COVID-19-related Hospitalization[/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 - MERCURY 1; BRIEF: To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution. Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension. ; DRUG USED: Rocklatan; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Prostaglandin F receptor (FP)/PGF2 alpha receptor , Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. 18 years of age or older 2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes 3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits 4. Corrected visual acuity equivalent to 20/200 Snellen or better 5. Able to give informed consent and follow study instructions Exclusion Criteria: 1. Clinically significant ocular disease 2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles 3. Unmedicated Intraocular pressure ≥36mmHg 4. Use of more than 2 ocular hypotensive medications within 30 days of screening 5. Known hypersensitivity to any component of the formulation 6. Previous glaucoma surgery or refractive surgery 7. Ocular trauma within 6 months prior to screening 8. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening 9. Recent or current ocular infection or inflammation in either eye 10. Used ocular medication in either eye of any kind within 30 days of screening 11. Mean central corneal thickness >620µm at screening 12. Any abnormality preventing reliable applanation tonometry of either eye 13. Clinically significant abnormalities in lab tests at screening 14. Clinically significant systemic disease 15. Participation in any investigational study within 60 days prior to screening 16. Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening 17. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control ; PRIMARY OUTCOME: Intraocular Pressure (IOP); SECONDARY OUTCOME 1: Extent of Exposure[/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 - Istituto Clinico Humanitas (w/Cetuximab); BRIEF: This is a single-arm, Simon 2-stage, phase 2 clinical study conducted in subjects with advanced or metastatic colorectal cancer who have previously received ≥ 1 prior line of systemic therapies and are resistant to EGFR inhibitor (cetuximab or panitumumab). This trial will be conducted to determine objective response rate (ORR), progression-free survival (PFS) and overall-survival (OS) of cetuximab plus tivantinib in patients with wild-type KRAS CRC that is resistant to anti-EGFR antibody treatment (cetuximab or panitumumab) and shows overexpression of cMET. ; DRUG USED: Tivantinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Combination; LEAD SPONSOR: Armando Santoro, MD; CRITERIA: Inclusion Criteria:Subjects must satisfy all of the following criteria to be included in the study: 1. Subjects with surgically unresectable locally advanced or metastatic disease who have received ≥ 1 prior line of systemic therapies for advanced or metastatic disease. The last treatment regimen must include EGFR inhibitor (cetuximab or panitumumab) on which the patient had a best response as CR or PR or SD, and must have either progressed on or after EGFR inhibitor based therapy within 3 months before enrollment. Subjects must have radiologically documented disease progression prior to enrollment. 2. All subjects must express the wild-type form of the gene KRAS. Previously existing KRAS mutation status from an accredited local laboratory will be accepted. 3. Fresh tumor biopsy tissue must be available for molecular sequencing and biomarker expression in >70% of patients. If prior radiotherapy, tissue biopsy must be outside radiotherapy field. In a minor percentage of patients (<30%) archival tumor tissue could be considered acceptable for molecular sequencing and biomarker expression. 4. Patients must be MET High testing by IHC (IHC 2+ or 3+ in ≥50% of tumor cells) analyzed by Ventana Test Kit. 5. Measurable disease according to RECIST criteria, Version 1.1. 6. Male or female ≥ 18 years of age. 7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 8. Resolution of any toxic effects of prior therapy to NCI CTCAE, Version 4.0, grade ≤ 1 (with the exception of alopecia and grade ≤ 2 neuropathy). 9. Adequate bone marrow, liver, and renal functions, defined as: Hemoglobin ≥ 9.0 g/dL (transfusion and/or growth factor support allowed). Absolute neutrophil count (ANC) ≥ 1.5 × 109/L. Platelet count ≥ 75 × 109/L. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min. Alanine transaminase (ALT), and aspartate transaminase (AST) ≤ 2.5 x ULN in subjects with no liver metastasis and ≤ 5.0 x ULN in subjects with liver metastasis. Total bilirubin ≤ 1.5 x ULN (≤ 4 x ULN and direct bilirubin ≤ 1.5 x ULN is acceptable for subjects with Gilberts syndrome). 10. Male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received. 11. All female subjects of childbearing potential must each have a negative pregnancy test (serum or urine) result before initiating study treatment. 12. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC- or IRB-approved ICF (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests. Exclusion Criteria: Subjects who meet any of the following criteria will be disqualified from entering the study: 1. History of malignancy other than CRC, unless there is an exception that the malignancy has been cured and no tumor- specific treatment for the malignancy has been administered within the 3 years prior to initiation of study treatment (subjects with a history of basal cell carcinoma or benign tumor of cervix can be enrolled if diagnosis and treatment occurred < 3 years prior to enrollment). 2. Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study. 3. Treatment with chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, or any other investigational anticancer agent within 3 weeks prior to start of study treatment. 4. History of cardiac disease: Congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); Previously diagnosed bradycardia (subjects with asymptomatic bradycardia and hear rate above 50 bpm are allowed) or other cardiac arrhythmia defined as ≥Grade 2 or higher according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to start of study treatment (myocardial infarction that occurred > 6 months prior the start of study treatment is permitted). 5. Malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction. 6. Known metastatic brain or meningeal tumors, unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of first dose of study treatment, and is clinically stable (no concomitant therapy, including supportive therapy with steroids or anticonvulsant medications) with respect to the tumor at the time of first dose of study treatment. 7. Uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis. 8. Pericardial or pleural effusion (requiring drainage) or pericardial involvement with the tumor. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor. 9. Clinically significant active infection that requires antibiotic therapy. 10. Previous administration of any MET inhibitor (including tivantinib) or EGFR inhibitor (except cetuximab or panitumumab). 11. Substance abuse or medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the subjects participation in the clinical trial or evaluation of the clinical trial results. 12. Any condition that is unstable or that could jeopardize the safety of the subject and the subjects protocol compliance. 13. Inability to swallow oral medications. 14. Pregnant or nursing females. ; PRIMARY OUTCOME: Study of Tivantinib (ARQ 197) plus Cetuximab in EGFR inhibitor-Resistant MET High Subjects with Locally Advanced or Metastatic Colorectal Cancer with Wild-Type KRAS; SECONDARY OUTCOME 1: Tivantinib (ARQ 197) plus Cetuximab in EGFR inhibitor-Resistant MET High Subjects[/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 - PEONY Study; BRIEF: The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension. ; DRUG USED: DE-117; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin E Receptor 2 (PTGER2); THERAPY: Monotherapy; LEAD SPONSOR: Santen Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Patients with open angle glaucoma or ocular hypertension in both eyes Exclusion Criteria: - Patients at risk of progression of visual field loss - Patients with severe visual field defect - Patients with any diseases that preclude participation in this study for safety reasons ; PRIMARY OUTCOME: Mean diurnal intraocular pressure; 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 - 06 (PIV); BRIEF: This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection. All subjects will have additional PK and Immunogenicity blood samples collected. ; DRUG USED: Fludase; DRUG CLASS: Biologic; INDICATION: Influenza (excluding vaccines); TARGET: Glycosaminoglycans (GAGs); THERAPY: Monotherapy; LEAD SPONSOR: Ansun Biopharma, Inc.; CRITERIA: Inclusion Criteria: 1. Age ≥12 years 2. Able to provide informed consent or child assent with parental consent 3. Immunocompromised, as defined by one of the following: - Allogeneic hematopoietic cell transplantation (HCT) - Lung or lung-heart transplantation - Patients treated with chemotherapy for hematologic malignancies or autologous HCT 4. Confirmed Parainfluenza virus by nasopharyngeal swab or tracheal aspirate for one of the following: - Respiratory virus panel - DFA - Qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study). 5. Female subjects of child-bearing potential who are capable of conception must be: post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject must agree to practice two acceptable methods of birth control during the 28 day study period. Abstinence is not an acceptable method of contraception. All reproductive female subjects must have a negative serum pregnancy test during the screening visit. 6. Male subjects must agree to use medically accepted form of contraception during the 28 day study period. Exclusion Criteria: 1. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance. 2. Any significant finding in the patients medical history or physical examination that, in the opinion of the investigator, would affect patient safety, ability to use the dry powder inhaler or compliance with the dosing schedule. 3. Subjects currently treated with oral, aerosolized or IV ribavirin 4. Subjects taking any investigational drug used to research or treat PIV ; PRIMARY OUTCOME: Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.; SECONDARY OUTCOME 1: Proportion of subjects with PIV viral load reduction at Day 28[/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 - EXPRESS II; BRIEF: The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the bodys immune system to help control the development of inflammation to help reduce painful disease. ; DRUG USED: Remicade; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Centocor, Inc.; CRITERIA: Inclusion Criteria: - Patients with diagnosis of plaque-type psoriasis for at least 6 months - Patients with plaque-type psoriasis covering at least 10% of the body Exclusion Criteria: - Patients with nonplaque forms of psoriasis - Patients who have current drug-induced psoriasis - Patients who are pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment - Patients who had any previous treatment with infliximab or any therapeutic agent targeted at reducing tumor necrosis factor ; PRIMARY OUTCOME: Proportion of patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.; SECONDARY OUTCOME 1: Improvement from baseline in Psoriasis Area and Severity Index response between weeks 16 and 30. Change in Dermatology Life Quality Index from baseline at week 10. Patients with a Physicians Global Assessment score of clear or excellent at week 10.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - COV001; BRIEF: A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM) into the deltoid region of the arm ; DRUG USED: Vaxzevria; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: University of Oxford; CRITERIA: Inclusion Criteria The volunteer must satisfy all the following criteria to be eligible for the study: - Healthy adults aged 18-55 years. - Able and willing (in the Investigators opinion) to comply with all study requirements (participants must not rely on public transport or taxis). - Willing to allow the investigators to discuss the volunteers medical history with their General Practitioner and access all medical records when relevant to study procedures. - For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination. - Agreement to refrain from blood donation during the course of the study. - Provide written informed consent. Exclusion Criteria The volunteer may not enter the study if any of the following apply: - Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination .with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccine. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine. - Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). - Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. - Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days) . - Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy. - History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 or MenACWY vaccines. - Any history of angioedema . - Any history of anaphylaxis . - Pregnancy, lactation or willingness/intention to become pregnant during the study. - History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). - History of serious psychiatric condition likely to affect participation in the study (e.g. ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication). - Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. - Any other serious chronic illness requiring hospital specialist supervision. - Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed) - Chronic cardiovascular disease (including hypertension), gastrointestinal disease, liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including diabetes) and neurological illness (excluding migraine) - Seriously overweight (BMI≥40 Kg/m2) or underweight (BMI≤18 Kg/m2) - Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week. - Suspected or known injecting drug abuse in the 5 years preceding enrolment. - Any clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis. - Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. - History of laboratory confirmed COVID-19. - New onset of fever or a cough or shortness of breath or anosmia/ageusia since February 2020. Should a reliable test become available, this exclusion criteria will be replaced with seropositivity for SARS-CoV-2 before enrolment. - Those who have been at high risk of exposure before enrolment, including but not limited to: close contacts of confirmed COVID-19 cases, anyone who had to self-isolate as a result of a symptomatic household member, frontline healthcare professionals working in A&E, ICU and other higher risk areas. Should a reliable test become available, this exclusion criteria will be replaced with seropositivity for SARS-CoV-2 before enrolment. - Living in the same household as any vulnerable groups at risk of severe COVID-19 disease (as per Public Health England guidance) Additional exclusion criteria (subset of participants receiving Paracetamol in group 4 only) • History of allergic disease or reactions likely to be exacerbated by Paracetamol Re-vaccination exclusion criteria: The following AEs associated with any vaccine, or identified on or before the day of vaccination constitute absolute contraindications to further administration of an IMP to the volunteer in question. If any of these events occur during the study, the subject will not be eligible to receive a booster dose and will be followed up by the clinical team or their GP until resolution or stabilisation of the event: - Anaphylactic reaction following administration of vaccine - Pregnancy. An exception to this will be prior to receipt of a booster dose at extra visit B. If a pregnant woman has discussed vaccination with their usual clinician (e.g. GP) and chooses to receive a COVID-19 vaccination, this may be administered by the trial team as part of extra visit B or as part of the provision of treatment to controls - Any AE that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results ; PRIMARY OUTCOME: Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases; SECONDARY OUTCOME 1: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms[/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 - NHLBI; BRIEF: Background: Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells. Objective: To see if gene transfer is safe and causes tumors to shrink. Eligibility: People at least 18 years old with certain kidney cancer Design: Participants will be screened with blood and urine tests. They may have: - Scans - Heart, lung, and eye tests - Lab tests - Tumor samples taken Participants will have leukapheresis. Blood will be removed by a needle in an arm. It will go through a machine that removes white blood cells. Plasma and red cells will be returned through a needle in the participant s other arm. Participants cells will be grown in the lab and genetically changed. Participants will stay in the hospital 2-3 weeks. There they will: - Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the chest. - Get the changed cells via catheter. - Get a drug to increase white blood cell count and one to make the cells active. - Recover for about a week. - Have lab and blood tests. After leaving the hospital, participants will: - Take an antibiotic for several months. - Have leukapheresis. - Have one- or two-day clinic visits every few weeks for 2 years, and then as determined by their doctor. These will include blood and lab tests, imaging studies, and physical exam. Participants will have follow-up checks for up to 15 years. Sponsoring Institute: National Heart, Lung, and Blood Institute ... ; DRUG USED: 800TCR; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Stem Cells/Other Cell Therapies, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: National Heart, Lung, and Blood Institute (NHLBI); CRITERIA: - INCLUSION CRITERIA: - Patients must have histologically confirmed RCC with clear-cell component by the Laboratory of Pathology of the NIH and/or outside Pathology Department prior to entering this study. - Patients must be HLA-A 11:01 positive (confirmed by HLA typing at the NIH DTM) - Patients must have measurable disease and have disease progression during or after the last treatment regimen and within 6 months before study enrollment - Patients must have received at least one antiangiogenic drug and an immune-checkpoint inhibitor (i.e. nivolumab) unless the patient has contraindications to receiving these medications, the agents are not available to the patient, or the patient declines to receive these drugs due to personal preference. - Patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 180 days (female patients) or 90 days (male patients) after the end of the treatment if sexually active and able to bear or beget children. In addition, male patients must refrain from sperm donation for 90 days after the final dose of investigational product. Female patients must refrain from egg cell donation for 180 days after the final dose of investigational product - Patients must be between the ages of 18 and 75 years. - Patient must have an anticipated life expectancy of at least 3 months. - Patients must have a performance status of 0 or 1 ECOG performance status (PS) scale. - Patients must have a caregiver willing to stay with them during the first month of treatment (30 days +/- 7 days). - Patients receiving treatment with bisphosphonates or denosumab are eligible for enrollment if on a stable dose for greater than or equal to 4 weeks - Serology: - Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) - Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. - Organ Function - Hematology - Absolute neutrophil count greater than or equal to 500/ microL - WBC greater than or equal to 1500/microL - Platelet count greater than or equal to 75.000/microL (without transfusional support - Chemistry - Serum AST/ALT less than or equal to 2.5 x upper limit of normal (ULN) - Total bilirubin less than or equal to 1.5 mg/dl except for patients with Gilbert s syndrome who must have a total bilirubin less than or equal to 3 mg/dl - Creatinine clearance greater than or equal to 50 ml/min/1.73m^2 by the method of CKI-EPI or >=50 ml/min by the method of 24h Clearence of Creatinine Calculation - INR < 1.5 - Cardiology - Estimated left ventricular ejection fraction by echocardiography greater than or equal to 45% - Respiratory - Predicted DLCO / Alveolar Volume Adjusted by PFT >= 45% EXCLUSION CRITERIA: - Patients that require immediate therapy due to tumor mass effects or spinal cord compression. - Patients must not have had standard of care anti-VEGFR therapy (mean half-life around 30 hours), mTOR inhibitors (mean half-life around 30 hours), at least for the last 7 days prior to T-cell infusion and radiotherapy, or major surgery within the last 2 weeks prior to T-cell infusion. For PD-1/PD-L1 inhibitors or CTLA-4 inhibitors, a 4-week period must have elapsed before T-cell infusion. For recent experimental therapies a 28-day period must have elapsed before infusing expanded T-cells. - Patients with active CNS involvement by malignancy either by imaging or cerebrospinal fluid involvement or biopsy-proven (due to poor prognosis and potential for neurological dysfunction that would confound evaluation of neurological and other adverse events) except for: 1. Patients with 3 or fewer brain metasteses of <1cm treated with either stereotactic or gamma knife radiotherapy and remained stable on MRI for 2 weeks are eligible. 2. Patients with surgically resected brain metastases and no evidence of active disease in the CNS at the time of screening evaluation are eligible. - Patients with hypercalcemia (>10 mg/dL) of malignancy. - Any prior Grade (Bullet) 3 immune-related adverse event (irAE) while receiving immunotherapy, including anti-CTLA4 treatment that requires long-term immunosuppressive therapy. Note: Active or history of vitiligo or hypothyroidism will not be a basis for exclusion. - Patients with second malignancies in addition to their clear cell RCC are not eligible if the second malignancy has required systemic treatment within the past 4 years or is not in complete remission. There are exceptions to this criterion: successfully treated non-metastatic basal cell, squamous cell skin carcinoma, in situ non-invasive cervical cancer and in situ non-invasive breast cancer. - Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. - Active coagulation disorders or other major uncontrolled medical illnesses of the respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, uncontrolled systemic infection, active obstructive or restrictive pulmonary disease. - Patients who have recent history of cerebrovascular accident, transient ischemic attack should be cleared by the neurology consult service before enrolling this study. - Patients who have recent history of coronary artery disease or cardiac arrhythmia should be cleared by the cardiology consult service before enrolling this study. - Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). - Patients with autoimmune diseases such as Crohn s disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis or pancreatitis, and systemic lupus erythematosus that requires treatment with chronic immunosuppressive therapy. - Systemic corticosteroid steroid therapy of any dose is not allowed within 2 days prior to enrollment. The following are exceptions to this criterion: - Intranasal, inhaled, and topical steroids - Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent - Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). In the case of short-term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to starting the leukapheresis is 7 days. - History of severe immediate hypersensitivity reaction to any of the agents used in this study. - Unable to understand the investigational nature of the study or give informed consent and does not have a legally authorized representative or surrogate that can provide informed consent. - Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. ; PRIMARY OUTCOME: Toxicity; 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 I - 117225; BRIEF: The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study), after topical administration on healthy subjects and acne patients. Study SCD117225 will be a randomized, single-blind, three part study, to evaluate the primary irritation potential (Part 1), cumulative irritation potential (Part 2) of two concentrations of GSK1940029 gel applied to the intact skin of healthy subjects, and the facial irritation potential of one or two concentrations of GSK1940029 applied to the face of acne patients (Part3). In Part 1 and Part 2 the following 6 treatments will be applied using individual patches: (A) 200 milligrams (mg) of 0.3% GSK1940029 gel, (B) 200 mg of 1% GSK1940029 gel, (C) 200 mg of 0.3%/1% vehicle gel only (vehicle control), (D) 200 microliters (µL) of sterile distilled water (negative irritant control), (E) 200 µL of - 0.5% sodium lauryl sulfate (SLS) in sterile distilled water for Part 1/0.1% SLS in sterile distilled water for Part 2 (positive irritant control), and (F) Patch only (patch control). Each treatment will be randomized to one of six designated locations on either upper arm or other locations, such as the lower or upper back, within each subject. The same treatment will be reapplied to the same location on subsequent days. Each treatment will be applied daily for 2 days in Part 1, and daily for 21 days in Part 2. In Part 3, each patient will apply a thin coat of one or two concentration of GSK1940029 gel or vehicle to acne affected facial/neck skin by hand, once daily for 28 days. Parts within Study SCD117225 and Study SCD117226 will have interdependencies. No significant primary irritation signal in Study SCD117225 Part 1 would allow initiation of Study SCD117226 Part 1 (single dose application). Once safety, tolerability and exposure information are determined in Study SCD117226 Part 1, Part 2 of Study SCD117225 may be initiated along with Part 2 (14-day repeat dose application). No significant cumulative irritation signal (study SCD117225 Part 2) in combination with adequate 14-day safety (study SCD117226 Part 2) would allow initiation of Part 3 of Study SCD117225. ; DRUG USED: GSK1940029; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Stearoyl-CoA Desaturase 1 (SCD1); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring for Parts 1 and 2 only. - Moderate/Moderate to Severe acne patients, otherwise healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring for Part 3 only. - A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, documented refers to the outcome of the investigators/designees review of the subjects medical history for study eligibility, as obtained via a verbal interview with the subject or from the subjects medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli international units (MIU)/millilitres (mL) and estradiol <40 picograms (pg)/mL (<147 picomoles [pmol]/liter [L]) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will not be allowed. - Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until after study follow-up visit. - Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Based on single or averaged assessments, QT duration corrected for heart rate (QTc) <450 msec; or QTc <480 msec in subjects with bundle branch block. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Exclusion Criteria: - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome for all study Parts and asymptomatic gallstones for Parts 1 and 2 only). Subjects with a history of gall stones, asymptomatic gallstones or cholecystectomy will be excluded. - A positive pre-study drug/alcohol screen. - A positive test for Human Immunodeficiency Virus (HIV) antibody. - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 standard drinks. One standard drink is equivalent to 10 grams (g) of alcohol: 285 mL of beer, 100 mL of wine or 30 mL of 40% alcohol by volume distilled spirits. - History of or current meibomian gland dysfunction or dry eye disease - History or presence of significant skin disorder (such as but not limited to severe (extensive) atopic dermatitis, severe eczema, psoriasis or skin cancer) that would in any way confound interpretation of the study results, or subjects who present with damaged skin including sunburn, moles, uneven skin tones, scar tissue, tattoos, body piercings, sunburn, branding or other disfiguration on or near the intended site of application which could interfere with the grading. Acne is allowed for Part 3. - History of cutaneous photodisorder, such as photoallergic reaction or polymorphic light eruption. History of cold urticaria and reactions to extreme temperatures. - History of allergy to soaps, lotions, cosmetics, tape/adhesives, petrolatum or latex or topical drugs of same class as the study medication. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. - History of sensitivity to heparin or heparin-induced thrombocytopenia. - History of severe, chronic asthma or significant allergies (including food, drug or cutaneous allergies). Subjects with the presence or a history of atopy (seasonal allergies, allergic rhinitis) or mild (limited) eczema will be allowed to participate in the study, although applications at sites with active eczema will not be allowed. - Use of topical medications such as but not limited to retinoids, steroids, and transdermal hormone replacement therapies on or near the intended site of application within 8 weeks prior to dosing through treatment follow up, for Parts 1 and 2 only or within 2 weeks period to dosing for Part 3. Use of other topical preparations such as those containing vitamins, supplements or herbal within 2 weeks prior to dosing through treatment follow up. - Unable to refrain from the use of topical medications from the initial dose of study medication through follow-up. - Foreseeable intensive Ultraviolet (UV) exposure during the study (solar or artificial) as follows: subjects must not be exposed to direct sunlight for sun tanning or exposed to skin tanning devices (e.g. sunbed) for the duration of the study. - Participation in any patch test for cumulative irritation or sensitization within 4 weeks preceding the first dose of study medication. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. - Unwillingness or inability to follow the procedures outlined in the protocol. - Subject is mentally or legally incapacitated. - Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication ; PRIMARY OUTCOME: Primary cutaneous irritation scores; SECONDARY OUTCOME 1: Safety and tolerability of GSK1940029 as assessed by clinical laboratory tests[/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 - OPuS-4 (Long-Term Safety); BRIEF: This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment. ; DRUG USED: Avoralstat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hereditary Angioedema (HAE); TARGET: Kinin-Kallikrein System ; THERAPY: Monotherapy; LEAD SPONSOR: BioCryst Pharmaceuticals; CRITERIA: Inclusion Criteria: - Males and non-pregnant, non-lactating females age ≥ 18 years. - Provide written, informed consent. - Prior completion of an avoralstat therapeutic study OR a confirmed diagnosis of HAE Type 1 or HAE Type 2. - Access to appropriate medication for the treatment of acute HAE attacks. - Adequate contraception. Exclusion Criteria: - Females who are pregnant or breast feeding. - Clinically significant medical condition or medical history. - Abnormal screening ECG, laboratory or urinalysis finding that is clinically significant. - Investigational drug exposure within 30 days (except avoralstat). - History of or current alcohol or drug abuse. - HIV or active HBV or HCV infection. ; PRIMARY OUTCOME: Proportion of subjects who discontinue due to a treatment-emergent adverse event, who experience a treatment-emergent serious AE, who experience a Grade 3 or 4 AE and who experience Grade 3 or 4 laboratory abnormalities; SECONDARY OUTCOME 1: Angioedema attack rate (subject-reported HAE attacks normalized for time on study)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric; BRIEF: The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients. ; DRUG USED: Ionsys; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Alza Corporation, DE, USA; CRITERIA: Inclusion Criteria: - The patients must: weigh >= 40 kg - be scheduled for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery - Be expected by the investigators staff to require injected opioid analgesia for at least 24 hours after surgery - Be judged by the investigators staff to be capable of understanding and cooperating with the requirements of the study. Exclusion Criteria: - Patients who have undergone any surgery on the airway, head or neck - Patients who are expected to require intensive care - Patients who require airway(breathing) support after their surgery - Patients who received intra-operative (during surgery) and/or post-operative (after surgery) administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil - Patients with active generalized skin disorders or active local skin disease that precludes the application of fentanyl iontophoretic transdermal system(40 mcg). ; PRIMARY OUTCOME: Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter.; SECONDARY OUTCOME 1: Patient Global Assessment, Investigator Global Assessment and Parent Assessment of Patient Use will be completed every 24 hours. Serum fentanyl concentration will be collected at Hours 3, 6,12, and 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 II - PH-ILD (Germany); BRIEF: The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521) given orally, to evaluate if it is safe and can help to improve the well-being, symptoms (e.g. disturbed breathing) and outcome of pulmonary hypertension associated with lung fibrosis. Patients living with pulmonary hypertension associated with interstitial lung disease have a risk of increased number of hospitalisations because of worsening of their condition. Until now there is no approved medication for this disease. The current treatment of pulmonary hypertension associated with interstitial lung disease consists: of oxygen and medical treatment with vasodilators, e.g. so-called Calcium-antagonists. Therefore, there is a need for new drugs in the treatment of pulmonary hypertension associated with interstitial lung disease. ; DRUG USED: Adempas; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Diagnosis of an interstitial lung disease (usual interstitial pneumonia [UIP], nonspecific interstitial pneumonia [NSIP] or sarcoidosis) with high resolution CT and a total lung capacity (TLC) ≤ 90% or scleroderma associated pulmonary arterial hypertension (PAH) with total lung capacity (TLC) ≤ 80%. - Interstitial lung disease (ILD) must have been stable for at least 3 months (decrease in forced vital capacity (FVC)< 10% and diffusing capacity of lung for carbon monoxide (DLco) < 15 % in 3 months), i.e. no significant changes in pulmonary function testing and stable medication in terms of ILD (e.g., corticosteroids, immunosuppressants) - Mean pulmonary vascular resistance (PVR) > 400 dyne sec cm-5 or mean pulmonary arterial pressure (PAP mean) > 30 mmHg - Pulmonary capillary wedge pressure (PCWP) < 15 mmHg - Hemodynamic parameters at baseline (PAP, PCWP, cardiac output [CO], systemic mean arterial pressure [SAP]) - High resolution computer tomography (HRCT) (should not be older than 12 months prior start of the study) - Heart rate > 55 beats per minute (BPM) and < 105 BPM at rest - Systolic blood pressure (SBP) > 90 mmHg - World Health Organisation (WHO) functional class II, III and IV - 6 Minute Walking Test (6MWT) > 100m and < 450 m - Stable controlled arterial hypertension according to current guidelines - Women of childbearing potential will be included in the study if the pregnancy test is negative and combination of condoms with a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intra-uterine devices [IUDs]) is granted. Exclusion Criteria: - Co-medication: - Patients pretreated with specific medication for pulmonary arterial hypertension (PAH) like endothelin receptor antagonists, prostaglandins or phosphodiesterase type 5 (PDE 5) blockers are excluded from the trial. - Requirement for concomitant use of nitrates are contraindicated. - Pre-existing clinically relevant lung disease other than ILD including. - Bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD) with a forced expiratory volume in one second (FEV1)/FVC <60% pred., active tuberculosis - Pulmonary hypertension of another WHO group (I, II, IV and V) - Severe congenital abnormalities of the lungs, thorax and diaphragm - Clinical or radiological evidence of a pulmovenoocclusive disease (PVOD) - Systemic hemodynamics - Acute or severe chronic left heart failure (ejection fraction (EF) < 50%) - Severe coronary artery disease (CAD; EF < 50%); CAD patients must be asymptomatic and stable - Congenital or acquired valvular or myocardial disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension - Pulmonary function - TLC predicted < 30% - FEV1 (related to FVC) < 60% predicted - Blood gases at room air - Arterial partial carbon dioxide pressure (Pa CO2) > 45 mmHg - Arterial partial oxygen pressure (Pa O2) < 50 mmHg at O2 supply >/= 4 L/min - Peripheral organ function - Moderate or severe hepatic insufficiency (Child-Pugh Class Band C and/or total bilirubin > 2.5 mg/dl (0.043 mmol/L); and/or hepatic transaminases >3 upper limit normal [ULN]) - Moderate or severe renal insufficiency (creatinine > 2 mg/dl) or creatinine clearance according to Cockroft-Gault formula < 35 mL/ min ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: Pharmacokinetics[/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 - Tinea Pedis; BRIEF: To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve complete clearance at 2 weeks post treatment. ; DRUG USED: Luzu; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fungal Infections - Non-Systemic; TARGET: Ergosterol biosynthesis; THERAPY: Monotherapy; LEAD SPONSOR: Tinea Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Subjects of either gender must be 12 years of age or older. 2. Subjects with a clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms. 3. Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount 4. Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception Exclusion Criteria: 1. Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot; 2. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial. 3. Subjects who are immunocompromised (due to disease, e.g., HIV or medications 4. Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream; 5. Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months. 6. Subjects using the following medications: 1. topical antifungal agent within 30 days of the baseline visit 2. systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine) 3. topical corticosteroid in treatment area(s) within 30 days of the baseline visit. 4. systemic corticosteroids within 30 days of the baseline visit; 5. any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit. ; PRIMARY OUTCOME: Proportion of subjects who achieve complete clearance at 2 weeks post treatment; SECONDARY OUTCOME 1: Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COMMODORE 1; BRIEF: A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants. ; DRUG USED: Crovalimab; DRUG CLASS: Biologic; INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Body weight >= 40 kg at screening. - Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1. - Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening. - Willingness and ability to comply with all study visits and procedures. - Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry. - Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration. - Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label). Exclusion Criteria: - History of allogeneic bone marrow transplantation. - History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high. - Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label). - Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment. - Positive for Active Hepatitis B and C infection (HBV/HCV). - Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participants safe participation in and completion of the study. - History of or ongoing cryoglobulinemia at screening. ; PRIMARY OUTCOME: Percentage of Participants with Adverse Events (AEs) and by Severity; SECONDARY OUTCOME 1: Serum Concentrations of Crovalimab or Eculizumab Over 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 III - AWARD-3 (vs. Metformin); BRIEF: The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organizations [WHO] Classification of Diabetes). - Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label. - Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin. - Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%. - Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding. - Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening. - Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2), inclusive. - Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary. Exclusion Criteria: - Have type 1 diabetes mellitus. - Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs. - Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening. - Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery. - Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke. - Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women. - Have a problem with the liver or pancreas. - Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality. - Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening. - Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B. - Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years. - Have had an organ transplant except for corneal transplant. - Have received treatment within the last 30 days with a drug which has not been regulatory approved. - Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening. - Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes. - Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples. - Have previously participated or signed an informed consent document for this same type of study and study drug. ; PRIMARY OUTCOME: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c); SECONDARY OUTCOME 1: Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PIONEER; BRIEF: The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients. ; DRUG USED: Zarxio; DRUG CLASS: Biosimilar; INDICATION: Neutropenia / Leukopenia; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Sandoz; CRITERIA: Inclusion Criteria: 1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy 2. Women ≥ 18 years of age 3. Estimated life expectancy of more than six months Exclusion Criteria: 1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry 2. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.: Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy; SECONDARY OUTCOME 1: Incidence of Febrile Neutropenia[/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 - Alzheimers Prevention Initiative (API) Substudy; BRIEF: This substudy will evaluate the effect of crenezumab on the longitudinal tau burden in a subgroup of preclinical Presenilin1 (PSEN1) E280A mutation carriers and non-carriers, who were enrolled in study NCT01998841 (GN28352). Participants will receive up to three intravenous (IV) injections of [^18F] Genentech Tau Probe 1 (GTP1) and will undergo a tau positron emission tomography (PET) scan after each IV injection of [18^F]GTP1. The purpose of this substudy is to increase the understanding of disease progression in the preclinical stage of familial Alzheimers Disease (AD). ; DRUG USED: Crenezumab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Enrolled in main Study NCT01998841 (GN28352). Exclusion Criteria: - Contraindication to PET scan procedures, possibly including, but not limited to current, past, or planned participation in studies involving radioactive agents, including the main Study NCT01998841 (GN28352) and this Tau PET substudy, such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361. ; PRIMARY OUTCOME: Change Over Time in tau Distribution Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by [^18F]GTP1 tau PET Scan; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Subcutaneous Infusion; BRIEF: The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus. ; DRUG USED: Cenderitide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Natriuretic Peptide Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Nile Therapeutics; CRITERIA: Inclusion Criteria: - Male or female ≥ 18 years of age. - Documented systolic heart failure with ejection fraction (EF) ≤ 40% - Clinical evidence of volume overload - Systolic blood pressure ≥ 120 mmHg and ≤ 200 mmHg and diastolic blood pressure > 60 mmHg and < 110 mmHg at the time of screening. - Stable doses of oral medication at least 24 hours prior to screening - No known allergy or contraindication to furosemide (Lasix®) - Female patients must be post-menopausal or surgically sterile. A woman may be considered to be surgically sterilized if she has had a bilateral tubal ligation (for at least 6 months), bilateral oophorectomy or complete hysterectomy. - Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication. Exclusion Criteria: - Acute or suspected acute myocardial infarction (AMI) or troponin levels > 5X the upper limit of normal at the institutions local laboratory and accompanied by dynamic ECG changes consistent with AMI - Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to screening. - Evidence of uncorrected volume or sodium depletion (NA ≤ 130) or other condition that would predispose the patient to adverse events. - Clinically significant aortic or mitral valve stenosis. - Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment. - ADHF associated with significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 beats per minute or atrial fibrillation/flutter with ventricular response of > 160 beats per minute). - Severe renal failure defined as creatinine clearance < 30 mL/min as estimated by both the Cockcroft-Gault and the Modification of Diet in Renal Disease (MDRD) equations. - Significant pulmonary disease (history of oral daily steroid dependency, history of CO2 retention or need for intubation for acute exacerbation, or currently receiving IV steroids). - Any organ transplant recipient, currently listed (anticipated in the next 60 days) for transplant, or admitted for cardiac transplantation. - Major surgery within 30 days. - Major neurologic event, including cerebrovascular events in the prior 60 days. - Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns). - Known hepatic impairment - Received an investigational drug within 30 days prior to screening. - Women who are pregnant or breastfeeding. - Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds. - Any condition which, in the opinion of the Investigator, could interfere with, or for which the treatment might interfere with the conduct of the study, or which would unacceptably increase the risk of the patients participation in the study. ; PRIMARY OUTCOME: Pharmacokinetics (PK); SECONDARY OUTCOME 1: Pharmacodynamics (PD)[/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 - REFINE; BRIEF: The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS). ; DRUG USED: Tysabri; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Integrin Alpha-4 beta-1/VLA-4, Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Ability to provide written informed consent - Subjects of childbearing potential must practice effective contraception during the study - A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) - Free of MS relapse for 12 months prior to randomization - Treatment with natalizumab for a minimum of 12 months immediately prior to randomization. - In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse. Key Exclusion Criteria: - Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B virus - Positive for anti-natalizumab antibodies at screening - MRI positive for Gd-enhancing lesions at study entry - Subjects for whom MRI is contraindicated - History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease - History of malignant disease, including solid tumors and hematologic malignancies (with the exception of cured basal cell and squamous cell carcinomas of the skin) - History of transplantation or any anti-rejection therapy - History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug - A clinically significant infectious illness within 30 days prior to screening or progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time - Signs or symptoms suggestive of any serious infection, based on medical history, physical examination or laboratory testing NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Cumulative Number of Combined Unique Active Lesions; 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 - CN138-165; BRIEF: The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy. ; DRUG USED: Abilify (Oral and IM); DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration. - Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials. ; PRIMARY OUTCOME: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS); SECONDARY OUTCOME 1: Mean Change in Sheehan Disability Scale (SDS) Mean Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Pivotal; BRIEF: This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored. ; DRUG USED: Farydak; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hodgkins Lymphoma; TARGET: Histone Deacetylase (HDAC); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Participant age is ≥ 18 years. 2. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 3. Participant has a history of classical Hodgkins Lymphoma (HL) (i.e. Nodular sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte depleted). 4. Participant has progressive disease after receiving high dose chemotherapy with autologous hematopoietic stem cell transplant (AHSCT). Note: If last therapy was ≥ 18 months ago, then biopsy should be performed to confirm diagnosis. Note: Participant should have received ≤ 5 prior systemic treatment regimens (See Post-text supplement 2 for definitions and examples). Note: Participant will be allowed on study who have also received an allogeneic hematopoietic stem cell transplant, however this therapy alone is not sufficient for inclusion into this study. 5. Participant has at least one site of measurable nodal disease at baseline ≥ 2.0 centimeter (cm) in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by computed tomography (CT) scan (magnetic resonance imaging [MRI] is allowed only if CT scan can not be performed). Note: Participant with bone marrow involvement are eligible, but this criteria alone should not be used for disease measurement. 6. Participant has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail): - Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/liter (L) [International System of Units {SI} units 1.5 x 10^9/L]. - Platelet count ≥ 75 x 10^9/L. - Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution. Note: Potassium, calcium, magnesium, sodium, and/or phosphorus supplements may be given to correct values that are < lower limits of normal (LLN). Post-correction values must not be deemed to be a clinically significant abnormality prior to participant being dosed. - Serum creatinine ≤ 1.5 x upper limits of normal (ULN). - Serum bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if participant has Gilbert syndrome). - Aspartate transaminase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and/or alanine transaminase (ALT)/ serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement. 7. Clinically euthyroid. Note: Participants are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism. 8. Written informed consent was obtained from the participant prior to any study-specific screening procedures. 9. Participant has the ability to swallow capsules or tablets. Exclusion Criteria: 1. Participant has a history of prior treatment with a deacetylase (DAC) inhibitor including panobinostat. 2. Participant will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment. 3. Participant has been treated with monoclonal antibody therapy (e.g., rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment. 4. Participant has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1. 5. Participant has been treated with > 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples). 6. Participant has received prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to ≤ grade 1. 7. Participant is using any anti-cancer therapy concomitantly. 8. Participant treated with allogeneic hematopoietic stem cell transplant who is currently on or has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD). 9. Participant has a history of another primary malignancy ≤ 3 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix. 10. Participant has a history of central nervous system (CNS) involvement with lymphoma. 11. Participant has impaired cardiac function including any of the following: - Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute [bpm]), QT interval (QTcF) > 450 milliseconds (msec) on screening electrocardiography (ECG), or right bundle branch block + left anterior hemiblock (bifascicular block). - Presence of atrial fibrillation (ventricular heart rate >100 bpm). - Previous history angina pectoris or acute myocardial infarction (MI) within 6 months. - Congestive heart failure (New York Heart Association functional classification III-IV) or baseline multigated acquisition (MUGA)/Echo shows left ventricular ejection fraction (LVEF) < 45%. 12. Participant has any other clinically significant heart disease (e.g., uncontrolled hypertension). 13. Participant has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection). 14. Participant has unresolved diarrhea ≥ grade 2. 15. Participant has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol. 16. Participant has a known history of human immunodeficiency virus (HIV) seropositivity (screening HIV testing is not required). 17. Participant is using medications that have a relative risk of prolonging the QT interval or of inducing Torsade de Pointes, where such treatment cannot be discontinued or switched to a different medication prior to starting study drug. 18. Participant is a woman who is pregnant or breast feeding, or a women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study through 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). WOCBP must have a negative serum pregnancy test at baseline. 19. Male participant whose sexual partner(s) are WOCBP who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment. Participants with any of the following contraindications to positron emission tomography (PET) are excluded from the [18F]- fludeoxyglucose (FDG) PET study (only applicable for centers participating in the PET study): 20. Fasting blood glucose above 200 milligrams per deciliter (mg/dL), at time of PET scan. 21. Inability to lay down for 60 minutes or has a history of claustrophobia. 22. Participant not at a participating center. ; PRIMARY OUTCOME: Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria; SECONDARY OUTCOME 1: Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - RRMS Study (EU, US); BRIEF: This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis. ; DRUG USED: ICP-022; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Beijing InnoCare Pharma Tech Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Are 18 to 55 years of age at the time of signing the informed consent. 2. Are diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS). 3. Are neurologically stable for ≥ 30 days prior to both Screening and Baseline. 4. One or more documented relapses within the 2 years before Screening 5. Have an EDSS score of 0 to 5.5 at Screening and Baseline (Day 1) 6. Women of childbearing potential must use effective method of contraception 7. Signed and dated informed consent 8. Patient currently participating in the Core Part who has completed the end of treatment visit and will be benefit from continued treatment per investigators assessment. (OLE Part only) Exclusion Criteria: 1. Diagnosed with progressive MS. 2. Disease duration > 10 years in participants with an EDSS ≤ 2.0 at Screening and Baseline (Day 1). 3. Immunologic disorder other than MS. 4. History or current diagnosis of other neurological disorders that may mimic MS. 5. History or current diagnosis of progressive multifocal leukoencephalopathy (PML). 6. History of myocardial infarction or cerebrovascular event within 6 months prior to Screening, 7. A history of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening. 8. An episode of major depression within the last 6 months prior to Screening (clinically stable minor depression is not exclusionary). 9. History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin 10. Breastfeeding/lactating or pregnant women 11. Participants are excluded from participation in the study if taken prohibited medications/treatments. 12. Participation in any investigational drug study within 6 months or 5 half-lives of the investigational drug, whichever is longest, prior to Screening. 13. Permanent discontinuation from the Core Part due to AE/ SAE or abnormal abnormalities or conditions leading to permanent study drug discontinuation. (OLE Part only) 14. Patient who has new abnormality appeared in the Core Part. (OLE Part only) 15. Any significant change in the subjects medical history that would preclude administration of the study drug. (OLE Part only) 16. Clinically significant laboratory abnormalities from the most recently available test in the Core Part that would preclude administration of the study drug. (OLE Part only) ; PRIMARY OUTCOME: The cumulative number of new GdE T1 MRI brain lesions; SECONDARY OUTCOME 1: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ][/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I- +/-Cetuximab; BRIEF: The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers. ; DRUG USED: CC-95251; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: SIRP-alpha; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkins lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma - Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1 - Eastern cooperative oncology group performance status of 0 or 1 Exclusion Criteria: - High-grade lymphomas (Burkitts or lymphoblastic) - Has cancer with symptomatic central nervous system (CNS) involvement - History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects; SECONDARY OUTCOME 1: Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)[/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 - TRANSFORM-2 (Adults, Flexible Doses); BRIEF: The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo. ; DRUG USED: Spravato; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Glutamate Receptor; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - At the time of signing the informed consent form (ICF), participant must be a man or woman 18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18) to 64 years of age, inclusive - At the start of the screening/prospective observational phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single-episode MDD, the duration must be greater than or equal to [>=] 2 years) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI) - At the start of the screening/prospective observational phase, participant must have an Inventory of Depressive Symptomatology-Clinician rated ( IDS-C30) total score of greater than or equal to (>=) 34 - At the start of the screening/prospective observational phase, participant must have had non-response (greater than or equal to [<=25] percent [%] improvement) to ≥1 but less than or equal to (<=) 5 (if current episode is >2 years, upper limit is applicable to only the last 2 years) oral antidepressant treatments in the current episode of depression, assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and documented by medical history and pharmacy/prescription records, for the current episode of depression. In addition, the participant is taking a different oral antidepressant treatment (on the MGH-ATRQ) for at least the previous 2 weeks at or above the minimum therapeutic dose - The participants current major depressive episode, depression symptom severity (Week 1 MADRS total score >=28 required), and antidepressant treatment response in the current depressive episode, must be confirmed using a Site Independent Qualification Assessment Exclusion Criteria: - Participants who have previously demonstrated nonresponse of depressive symptoms to esketamine or ketamine in the current major depressive episode, to all 4 of the oral antidepressant treatment options available for the double-blind induction phase (ie, duloxetine, escitalopram, sertraline, and venlafaxine extended release [XR]) in the current major depressive episode (based on MGH-ATRQ), or an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT - Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression - Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders (confirmed by the MINI), comorbid obsessive compulsive disorder, intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder - Participant has homicidal ideation/intent, per the investigators clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening/prospective observational phase, per the investigators clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS) - Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria ; PRIMARY OUTCOME: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis; SECONDARY OUTCOME 1: Percentage of Participants With Onset of Clinical Response on Day 2 and Day 8[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DAPA-HF; BRIEF: The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed informed consent prior to any study specific procedures - Male or female, aged ≥18 years - Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months - LVEF≤40% - Elevated NT-proBNP levels - Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines - eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1) Exclusion Criteria: - Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2 - Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment - Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization - Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device - Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization - HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease - Symptomatic bradycardia or second or third degree heart block without a pacemaker - Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization ; PRIMARY OUTCOME: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.; SECONDARY OUTCOME 1: Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart 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 - EXTEND; BRIEF: The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401). ; DRUG USED: Zinbryta; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 25 (CD25), IL-2 Receptor (IL-2R) ; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject currently participating in Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) who has completed End of Study Visit (Week 96 or later). - Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment. Key Exclusion Criteria: - Any subject who permanently discontinued study treatment in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). - Any significant change in the subjects medical history that would preclude administration of BIIB019, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects participation in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). The Investigator must re review the subjects medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS303. NOTE: Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Annualized Relapse Rate (ARR) in the 205MS303 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 - CheckMate-274; BRIEF: The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis - Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days - Must have disease free status as determined by imaging within 4 weeks of dosing - Tumor tissue must be provided for biomarker analysis - Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy Exclusion Criteria: - Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy) - Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer - Subjects with active, known or suspected autoimmune disease - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured - Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration - Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection ; PRIMARY OUTCOME: Disease Free Survival (DFS); SECONDARY OUTCOME 1: Non-Urothelial Tract Recurrence 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 - CTP-04 (Adults); BRIEF: The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in patients with β-thalassemia and other forms of anemia who experience iron overload - iron increases in the body as a result of regularly required blood transfusions. Patients who qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6 months) with a total study duration of up to 33 weeks. These patients will be eligible to participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be up to 96 weeks. The safety of patients will be monitored frequently during the study by physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart, each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the hospital for this study but will need to visit the outpatient clinic up to 28 times over the 96 week period. Patients currently taking an iron chelator will be required to stop for a total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be effective as an iron chelator. ; DRUG USED: SHP602; DRUG CLASS: New Molecular Entity (NME); INDICATION: Iron Overload; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Transfusional iron overload due to: hereditary anemias such as sickle cell disease, β-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure. Patients must also be transfusion-dependent and require chronic treatment with deferoxamine, deferasirox, and/or deferiprone. - Willing to discontinue all existing iron chelation therapies throughout study period. - Serum ferritin greater than 500 ng/mL at Screening. - Baseline liver iron concentration and cardiac MRI T2* per protocol requirements. - Mean of the previous three pre-transfusion hemoglobin concentrations greater than or equal to 7.5 g/dL. - Agrees to use an approved method of contraception throughout study period. Exclusion Criteria: - As a result of medical review, physical examination or Screening investigations, the Principal Investigator considers the patient unfit for the study. - Non-elective hospitalization within the 30 days prior to Baseline testing. (Patients with sickle cell anemia who are admitted to the hospital for management of sickle crisis pain whose uncomplicated hospital course was four days or less and who, 14 days prior to Baseline testing, have returned to their previous health status are acceptable.) - Evidence of clinically relevant oral, cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immunologic, bone marrow or skin disorder as determined by the Investigator. - Evidence of significant renal insufficiency; possible examples include: serum creatinine above the upper limit of normal, proteinuria greater than 2 gm per day or calculated creatinine clearance of less than 60 mL/minute. - Cardiac left ventricular ejection fraction outside of protocol requirements. - Known sensitivity to magnesium stearate, croscarmellose sodium or FBS0701. - Platelet count below 100,000/µL and/or absolute neutrophil count less than 1500/mm3 at Screening and <50% at Baseline testing by MRI - Alkaline phosphatase, AST or ALT outside of protocol requirements. - Liver Function Tests: ALT >5 times the local upper limit of normal on two occasions in the previous 12 months or ALT at Screening >200 IU/L - Use of any investigational agent within the 30 days prior to the Baseline testing. ; PRIMARY OUTCOME: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks; SECONDARY OUTCOME 1: Maximum Plasma Concentration (Cmax) of SPD602[/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/GVHD; BRIEF: Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010). The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms. ; DRUG USED: RGN-259; DRUG CLASS: Biologic; INDICATION: Dry Eye (Ophthalmology); TARGET: Actin Filaments, ATP Synthase, Integrin-linked kinase (ILK); THERAPY: Monotherapy; LEAD SPONSOR: Michigan Cornea Consultants, PC; CRITERIA: Inclusion Criteria: - Schirmers of < 5 mm at 5 minutes - TFBUT: less than 10 seconds - Corneal staining of >3 of 15: conjunctival staining of >3 of 18 - Ocular Surface Disease Index of > 50 - Presumed best corrected vision of 20/60 or better Exclusion Criteria: - Acute or inflammatory corneal disease - Pregnancy or lactation - Monocular status - Punctal occlusion within 30 days - Ocular surgery within 3 months - Corneal thinning of >50% - Active corneal infection - History of ocular malignancy - Retinal neovascularization - Current use of topical cyclosporin A ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Corneal Fluorescein Staining[/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 - Abuse Potential; BRIEF: This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users. ; DRUG USED: Remoxy; DRUG CLASS: Non-NME; INDICATION: Chronic Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Pain Therapeutics; CRITERIA: Inclusion Criteria: - Healthy male and/or female subjects between the ages of 18 and 55 years who are recreational opioid users and are NOT dependent on opioids. Exclusion Criteria: - Evidence or history of clinically significant medical conditions. - Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine). - Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine). - Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC). - Has a positive alcohol breath test. - Has any history of a condition in which an opioid is contraindicated. - History of sleep apnea in the past 5 years that has not been resolved or corrected. - Other severe acute or chronic medical or psychiatric condition 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 . - Positive test for Hepatitis B, Hepatitis C, or HIV. - Allergy or history of hypersensitivity to naloxone HCl, oxycodone HCl, other opioids, and/or lactose. - Any condition possibly affecting drug absorption (eg, gastrectomy). ; PRIMARY OUTCOME: Drug Liking: Peak Effect (Emax); SECONDARY OUTCOME 1: Take Drug Again Effect at 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 Ib/II - w/Rituximab or Acalabrutinib; BRIEF: Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575. ; DRUG USED: APG-2575; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Ascentage Pharma Group Inc.; CRITERIA: Inclusion Criteria: - 1. ≥18 years of age. 2. Histologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) according to the 2018 international workshop (IW) CLL criteria who must have relapsed or be refractory to at least one prior therapy for CLL/SLL and require treatment by 2018 IWCLL criteria. 3. ECOG) ≤2. 4. Patient must have objectively documented evidence of disease progression prior to study entry such as: escalating lymphocytes count with an increase > 50% over a period of two months or doubling time in less than 6 months; enlarging adenopathy or splenomegaly; increasing cytopenias; clinical B symptoms -night sweats, fatigue, > 1% weight loss in 6 months, fevers > 100.50F for ≥ one month without infection. 5. In Part 1 of the APG-2575 monotherapy dose escalation portion, patients eligible for dose expansion at doses lower than MTD will have received ≤ 3 prior systemic lines of therapy. 6. Adequate bone marrow function independent of growth factor: 1. Absolute neutrophil count (ANC)≥1.0× 109/L in patient without bone marrow involvement. This criterion does not apply to patients with bone marrow involvement by CLL/SLL. 2. Platelets count ≥30 x 109/L (entry platelet count must be independent of transfusion within 7 days of first dose of study drug). 7. Adequate renal and hepatic function as indicated by: a. Serum creatinine ≤1.5×upper limit of normal (ULN); if serum creatinine is >1.5×ULN, creatinine clearance must be ≥ 50 mL/min, calculated using the Cockcroft and Gault formula(140-Age)x mas (kg)/(72x creatinine mg/dL); multiply by 0.85 if female (Cockcroft 1976) b. Total bilirubin ≤1.5 x ULN, except patients with known Gilberts syndrome. c. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <2.5 x ULN, Alkaline phosphatase<2.5×ULN d. International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT)≤1.5×ULN unless the patient is receiving anticoagulant therapy as long as PT or APTT is within therapeutic range of intended use of anticoagulants. 8. Females of childbearing potential (i.e. not postmenopausal for at least 2 years or surgically sterile) must have negative results for pregnancy test performed: a. At Screening on a serum sample obtained within 14 days prior to the first study drug administration b. Prior to dosing on a urine sample obtained on the first day of study drug administration, if it has been>7 days since obtaining the serum pregnancy test results. 9. Females of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: 1. Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable; 2. Surgically sterile partner(s); acceptable sterility surgeries are: vasectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy; 3. Intrauterine device (IUD); 4. Double-barrier method (contraceptive sponge, diaphragm or cervical cap with spermicidal fellies or cream AND a condom); 5. Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 3 months prior to study drug administration. If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to study drug administration. 10. Male patients must refrain from sperm donation, from initial study drug administration until 90 days after the last dose of study drug. 11. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures). 12. Willingness and ability to comply with study procedures and follow-up examination. Exclusion Criteria: - 1. Patient has undergone allogeneic stem cell transplant < 90 days 2. Patient has active graft-versus-host disease or require immunosuppressive therapy. 3. Richters Syndrome. 4. Prior anti-Bcl-2 treatment (except patients who discontinued treatment for reasons other than disease progression) 5. For combination cohorts: 1. In the acalabrutinib and APG-2575 cohort, patients who are on anticoagulants or patients that discontinued due to acalabrutinib toxicity (Note: Patients who received a BTK inhibitor therapy may participate whether, or not, they progressed following BTK inhibitor treatment). 2. Prior CDK-9 inhibitor in the voruciclib plus APG-2575 cohort 6. Known human immunodeficiency virus syndrome (HIV) infection 7. Known active hepatitis B infection, as defined seropositivity for Hep B surface antigen (HBsAg) or known hepatitis C infection as determined by hepatitis C antibody with elevated liver enzymes as defined in the inclusion criteria or any other evidence of active hepatitis C such as currently on treatment 8. Has known central nervous system (CNS) involvement. 9. Prior malignancy that required treatment and has shown recurrence within 2 years of screening (except for non-melanoma skin cancer or adequately treated carcinoma in situ of cervix or breast). Cancer treated within 2 years with curative intent and without recurrence as well as prostate cancer on active surveillance are allowed. 10. Concurrent treatment with an investigational agent, received biologics (≤28 days), or small molecule targeted therapies (≤5 half-life) or other anti-cancer therapies (including chemotherapy) ≤14 days of first dose of study drug 11. Patient is pregnant or breast feeding 12. Has received the following within 7 days prior to the first dose of study drug: 1. Steroid therapy at a dose greater than prednisone 20 mg daily (or equivalent) for anti-neoplastic intent; 2. CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin; 3. Potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. Johns wort; 13. Radiation within 14 days of study entry 14. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ grade 1 or baseline, except alopecia or neuropathy. 15. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patient with active wound healing, patients who have had major surgery within 28 days from 1st dose of study drug 16. Has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain. 17. Unstable angina or myocardial infarction within 3 months of enrollment 18. QTc interval> 480ms (Bazett or Fredericia formulae) or other remarkable abnormal ECG findings, including second-degree type II atrioventricular block, third-degree atrioventricular block or bradycardia (ventricular rate of less than 50 beats per minute). 19. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator. 20. Uncontrolled concurrent illness including, but not limited to: uncontrolled diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. 21. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study. ; PRIMARY OUTCOME: Primary Toxicity Endpoint: dose limiting toxicity (DLT); 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 - Without Inhibitors; BRIEF: SIG-001-121 is a first-in-human (FIH), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A without inhibitors. Up to three dose cohorts (3 patients each) are planned. Cohort expansions (up to 3 additional patients) may be triggered to collect additional information about safety and efficacy. ; DRUG USED: SIG-001; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII; THERAPY: Monotherapy; LEAD SPONSOR: Sigilon Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Males aged 18 years or older - Diagnosis of Haemophilia A defined as ≤2% FVIII activity - Greater than 150 exposure days to treatment with FVIII products - Use of reliable barrier contraception if applicable - Normal levels of von Willebrand factor (VWF) antigen - Able and willing to provide informed consent - Willing to withdraw from FVIII prophylaxis during specified periods in the study Exclusion Criteria: - Body mass index (BMI) ≥35 - Current FVIII inhibitors (>0.6 Nijmegen Bethesda Units/mL) or prior Immune Tolerance Induction (ITI) - History of allergic reaction or anaphylaxis to recombinant FVIII products or SIG-001 components - Evidence of any bleeding disorder in addition to haemophilia A - Abnormal laboratory values as defined in the protocol - Active infection with Hepatitis B or Hepatitis C virus or currently managed with antiviral medications for Hepatitis B or C - Uncontrolled HIV infection - Active alcoholism or drug addiction during the 12 months before the screening visit - Active malignancy or history of malignancy in the 5 years prior to study entry - Participation in another investigational medicine or device study - Prior administration of a gene therapy product - Significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure ; PRIMARY OUTCOME: Number and proportion of participants with treatment emergent adverse events (TEAEs) overall and by dose/cohort.; SECONDARY OUTCOME 1: Number and proportion of participants with inhibitor titer values assessed by Nijmegen Bethesda Assay overall and by dose/cohort.[/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; BRIEF: The primary purpose for this study is to help answer the following research questions - The safety of ixekizumab (LY2439821) and any side effects that might be associated with it. - Whether ixekizumab can help participants with Psoriasis. - How much ixekizumab should be given to participants. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria Common to Both Part A: - Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization. - Participant is a candidate for systemic therapy - Participant has a Static Physicians Global Assessment (sPGA) score of at least 3 at screening and at randomization Inclusion Criterion Specific to Part B - Participant has completed the treatment period for part A (at least through week 20) Inclusion Criterion Specific to Part C - Participant has completed the treatment period for part B Exclusion Criteria Common to Part A, B and C: - Participant has pustular, erythrodermic and/or guttate forms of psoriasis - Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry - Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept >28 days, infliximab or adalimumab >56 days, alefacept >60 days, ustekinumab >8 months, or any other biologic agent/monoclonal antibody >5 half-lives prior to baseline - Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 [mild, such as desonide] or 7 [least potent, such as hydrocortisone] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia) - Participant has donated more than 500 mL of blood within the last month - Participant has another serious disorder or illness - Participant has suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months - Participant has a history of uncontrolled high blood pressure - Participant has clinical laboratory test results at entry that are outside the normal reference range - Participant is currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug - Participant is a woman who is lactating or breast feeding - If a participant is a woman and could become pregnant during this study, she must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study - If a participant is post menopausal woman, she must be at least 45 years of age and have not menstruated for the last 12 months - If a participant is a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, she must have an additional blood test to see if you can participate - If the participant is male, he must agree to reduce the risk of female partner becoming pregnant during the study Exclusion Criteria Specific to B: - If a participant experienced a serious adverse event during Part A considered possibly related to ixekizumab - If a participant experienced an adverse event during Part A that the study doctor believes continued ixekizumab treatment could cause harm to the participant. Exclusion Criteria Specific to C: - If a participant experienced a Serious Adverse Event during Part B considered possibly related to ixekizumab - If a participant experienced an adverse event during Part B that the study doctor believes continued ixekizumab treatment could cause harm to the participant. ; PRIMARY OUTCOME: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement; SECONDARY OUTCOME 1: Percentage of Participants With a Static Physicians Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement at Week 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 II - vs. Imipenem/Cilastatin; BRIEF: The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of relebactam (MK-7655) to imipenem/cilastatin in adults 18 years or older with Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin alone with respect to the percentage of participants with a favorable clinical response at completion of intravenous (IV) study therapy. ; DRUG USED: Recarbrio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Intra-Abdominal Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Clinically suspected and/or bacteriologically documented cIAI requiring hospitalization and treatment with IV antibiotic therapy. - Enrolled intraoperatively or postoperatively on the basis of operative findings OR enrolled preoperatively on the basis of compelling preoperative clinical findings. Exclusion Criteria: - Infection which should be managed by Staged Abdominal Repair (STAR) or open abdomen technique. - Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 30. - Any amount of effective antibiotic therapy after obtaining the culture for admission to this study and prior to the administration of the first dose of IV study therapy. - An infection which has been treated with >24 hours of systemic antibiotic therapy known to be effective against the presumed or documented etiologic pathogen(s) within the 72-hour period immediately prior to consideration for entry into the study. - History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to carbapenem antibiotics, any cephalosporins, penicillins, or other β-lactam agents. - History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to other β-lactamase inhibitors (e.g., tazobactam, sulbactam, clavulanic acid). - History of a seizure disorder (requiring ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy in the last 3 years). - Currently being treated with valproic acid or has used valproic acid in the 2 weeks prior to screening. - Rapidly progressive or terminal illness (unlikely to survive the approximately 6- to 8-week study period). - Pregnant or expecting to conceive, breastfeeding, or plans to breast feed within 1 month of completion of the study. - Participant in whom a response to IV study therapy within the timeframe of treatment specified in this protocol is considered unlikely. - Concurrent infection that would interfere with evaluation of response to the study antibiotics. - Need for concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups. - cIAI due to a confirmed fungal pathogen. - Currently receiving immunosuppressive therapy, including use of high-dose corticosteroids. - Prior recipient of a renal transplantation. - Estimated or actual creatinine clearance of <50 mL/minute. - History of any other illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient. - Laboratory abnormalities as specified in protocol. - Currently participating in, or has participated in any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of presentation or during the previous 30 days prior to screening or is anticipated to participate in such a clinical study during the course of the trial. ; PRIMARY OUTCOME: Percentage of Participants With a Favorable Clinical Response at Completion of IV Study Therapy; SECONDARY OUTCOME 1: Percentage of Participants With a Favorable Clinical Response at Completion of IV Study Therapy in Participants Who Have Imipenem-resistant, Gram-negative cIAI Infections.[/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 - CANTATA-MSU (w/ Met/Su); BRIEF: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control. ; DRUG USED: Invokana; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea - Patients in the study must have a HbA1c between >=7 and <=10.5% - Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L) Exclusion Criteria: - History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening ; PRIMARY OUTCOME: Change in HbA1c From Baseline to Week 26; SECONDARY OUTCOME 1: Percentage of Patients With HbA1c <7% at Week 26[/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 - DS-003 (1L); BRIEF: Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated AML with adverse or intermediate genetic risk. ; DRUG USED: DSTAT; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Chemokine (C-X-C motif) Ligand 12 (CXCL12)/Stromal Cell-Derived Factor 1 (SDF-1), Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Monotherapy; LEAD SPONSOR: Chimerix; CRITERIA: Inclusion Criteria: 1. Newly diagnosed, previously untreated AML (according to World Health Organization criteria) with at least 20% blasts in the peripheral blood or bone marrow. 2. Age ≥ 18 with Intermediate or Adverse genetic risk (per ELN criteria). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: 1. Acute promyelocytic leukemia (t(15;17)), myeloid sarcoma without bone marrow involvement, or blast transformation of chronic myelogenous leukemia. 2. Clinical evidence of active central nervous system leukemia. 3. AML treatment, including Vyxeos (CPX-351, liposomal cytarabine and daunorubicin), gemtuzumab ozogamicin, or any other prohibited concomitant AML therapy previously received or anticipated to start during the study. 4. Receiving any form of anticoagulant therapy (e.g., unfractionated heparin, low molecular weight heparin, coumadin, factor Xa inhibitors). Heparin flush of indwelling catheters is permitted. 5. Treatment with any other investigational agent within 28 days, or 5 half-lives, whichever is longer, prior to baseline. 6. Any major surgery or radiation therapy within 28 days prior to baseline. 7. Immediately life threatening, severe complications of leukemia such as pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation. 8. Active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant gastrointestinal bleeding within the 3 weeks prior to randomization. 9. Presence of significant active or uncontrolled infection, including HIV or hepatitis B or C. 10. Active (uncontrolled, metastatic) second malignancy. 11. History of severe congestive heart failure or other cardiac disease that contraindicates the use of idarubicin or daunorubicin (e.g., cardiac ejection fraction <45%). 12. QTc >480 msec. 13. Severe renal impairment, as determined by calculated creatinine clearance <30 mL/min or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2. 14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) or total bilirubin >2x ULN. ; 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 I - Healthy; BRIEF: Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing ; DRUG USED: BI 655088; DRUG CLASS: Biologic; INDICATION: Renal Disease / Renal Failure; TARGET: Chemokine Receptor 1 (CCR1); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Healthy male subjects - Age of 18 to 50 years - Body mass index (BMI) of 18.5 to 29.9 kg/m2 - Additional inclusion criteria may apply Exclusion criteria: - Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator - Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Any evidence of a concomitant disease judged as clinically relevant by the investigator - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders - Additional exclusion criteria may apply ; PRIMARY OUTCOME: Number of Subjects With Drug-related Adverse Events; SECONDARY OUTCOME 1: Maximum Measured Concentration of BI 655088 in Plasma (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 - WFI 01-01; BRIEF: Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD). This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI. ; DRUG USED: AS-013; DRUG CLASS: Non-NME; INDICATION: Peripheral Arterial Disease (PAD); TARGET: Prostaglandin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2 - The subject has exhausted all standard revascularization treatment options at this time. Exclusion Criteria: - Subjects with a previous major amputation (at or above ankle) - Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of < 20 cc/min, or receiving chronic hemodialysis therapy. ; PRIMARY OUTCOME: Reduction in proportion of subjects who experience a major amputation.; SECONDARY OUTCOME 1: Reduction in major amputation rate only.[/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 - I8G-MC-LMDA; BRIEF: The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored. This study will involve single doses of LY3303560 administered intravenously (IV), meaning into a vein or subcutaneously (SC), meaning under the skin. Screening is required within 28 days before the start of the study for healthy participants and within 70 days before the start of the study for AD participants. The study requires about 16 weeks of each participants time including a 4 day clinical research unit (CRU) admission and 10 follow-up appointments. This is the first time that this study drug is being given to participants. This study is for research purposes only, and is not intended to treat any medical condition. ; DRUG USED: Zagotenemab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Overtly healthy males or females of non-childbearing potential and who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures - AD participants must be at least 50 years of age and have diagnostic criteria consistent with either mild cognitive impairment due to AD or mild-to moderate AD and have a positive florbetapir positron emission tomography (PET) scan Exclusion Criteria: - Have known allergies to LY3303560, related compounds or any components of the formulation, or history of significant atopy - Have an increased risk of seizures - For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by magnetic resonance imaging (MRI) ; PRIMARY OUTCOME: Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration; SECONDARY OUTCOME 1: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560[/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 - Hypertriglyceridemia, T2DM, & NAFLD; BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver fat in participants with hypertriglyceridemia, Type 2 diabetes mellitus (T2DM), and nonalcoholic fatty liver disease (NAFLD). ; DRUG USED: Vupanorsen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Angiopoietin-like 3 (ANGPTL3); THERAPY: Monotherapy; LEAD SPONSOR: Akcea Therapeutics; CRITERIA: Key Inclusion Criteria: - Plasma triglycerides (TG) at Screening greater than (>)150 milligrams per deciliter (mg/dL) and at qualification of >150 mg/dL. - Documented history of hepatic steatosis with baseline magnetic resonance imaging (MRI) indicating hepatic fat fraction (HFF) greater than (>) 8%. - Diagnosis of Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and less than or equal to (≤) 10% at Screening. - Must have been on a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening. - Body mass index between 27- 40 kilograms per meter square (kg/m^2), inclusive, at Screening. Key Exclusion Criteria: - Type 1 diabetes mellitus. - Active chronic liver disease, alcoholic liver disease, Wilsons disease hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, genetic hemochromatosis, known or suspected hepatocellular carcinoma, history of or planned liver transplant for end-stage liver disease of any etiology. - Documented history of advanced liver fibrosis. - History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding. - History of clinically significant acute cardiac event within 6 months before Screening. - History of heart failure with New York Heart Association (NYHA) greater than Class II. - Use of Insulin or insulin analogs, glucagon-like peptide-1 (GLP-1) agonists, and peroxisome proliferator-activated receptor gamma (PPARᵞ) agonists (pioglitazone or rosiglitazone). - Weight change >5% within 3 months before Screening. - Conditions contraindicated for magnetic resonance imaging (MRI) procedures including any metal implant (example, heart pacemaker, rods, screws, aneurysm clips). ; PRIMARY OUTCOME: Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point; SECONDARY OUTCOME 1: Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ALL/LBL; BRIEF: This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity. ; DRUG USED: Rylaze; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Asparagine; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Pediatric and adult patients with a diagnosis of ALL or LBL. 2. Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation. 3. Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan. 4. Patients must have, in the opinion of the Investigator, fully recovered from their prior allergic reaction to E. coli-derived asparaginase. Exclusion Criteria: 1. Have previously received asparaginase Erwinia chrysanthemi or JZP-458. 2. Have relapsed ALL or LBL. 3. Are concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP-458 (within 48 hours) during Course 1 of JZP-458. 4. Have a history of ≥ Grade 3 pancreatitis. 5. Prior history of asparaginase-associated ≥ Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events. ; PRIMARY OUTCOME: Response Rate During the First Course of JZP-458 Administration; SECONDARY OUTCOME 1: Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration[/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 - EAGLE; BRIEF: This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner. ; DRUG USED: Bardoxolone Methyl; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: KEAP1 (Kelch-like ECH-associated protein 1), STAT3 Transcription Factor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: - Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial. - Meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable: 1. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigators judgement; subjects with eGFR <20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline > 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible); 2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable; 3. No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable. - Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures. Exclusion Criteria: - Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication; - Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl; - Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after the last study drug dose; - Women who are pregnant or breastfeeding; - Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason; - Known hypersensitivity to any component of the study drug. ; PRIMARY OUTCOME: Long-term safety: by incidence of adverse events and serious 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 II - 205.420; BRIEF: Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma. Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily. ; DRUG USED: Spiriva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice ( ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1). 2. Male or female patients aged at least 18 years but not more than 75 years. 3. All patients must have at least a 3 months history of asthma at the time of enrolment into the trial. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility resulting in a Forced Expiratory Volume in 1 Second (FEV1) increase of equal above 12% and equal above 200mL. 4. The initial diagnosis of asthma must have been made before the patients age of 40. 5. All patients must have a diagnosis of moderate persistent asthma and must be symptomatic despite their current maintenance treatment with medium doses of inhaled corticosteroids. 6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (alone or in a fixed combination with a Long Acting Betaadrenergic (LABA) or Short Acting Betaadrenergic (SABA)) for at least 4 weeks prior to Visit 1. 7. All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an Asthma Control Questionnaire (ACQ) Score 8. All patients must have a pre-bronchodilator FEV1 above equal 60% predicted and below equal 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to the European Coal and Steel Community Guidelines (ECSC). 9. All patients must have an increase in FEV1 of equal above 12% and equal above 200 mL 15 minutes after 400 µg salbutamol at Visit 1. 10. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30% . 11. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years. 12. Patients must be able to use the Respimat® inhaler correctly. 13. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the e-Diary/peak flow meter. 14. Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study (exception: times of acute disease deterioration). Exclusion criteria: 1. Patients with a significant disease other than asthma.A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patients ability to participate in the trial. 2. Patients with a clinically relevant abnormal screening hematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no. 1. 3. Patients with a recent history (i.e. six months or less) of myocardial infarction. 4. Patients who have been hospitalised for cardiac failure during the past year. 5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. 6. Patients with lung diseases other than asthma (e.g. Chronic Obstructive Lung Disease (COPD)). 7. Patients with known active tuberculosis. 8. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 9. Patients who have undergone thoracotomy with pulmonary resection. 10. Patients with significant alcohol or drug abuse within the past two years. 11. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to V 1. 12. Patients with known hypersensitivity to anticholinergic drugs, Benzalconiumchloride (BAC), Ethylenediaminetetraacetate (EDTA) or any other components of the study medication delivery systems. 13. Pregnant or nursing women. 14. Women of childbearing potential not using a highly effective method of birth control. 15. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 or during the screening period. Topical cardio-selective beta-blocker eye medications for non-arrow angle glaucoma are allowed. 16. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 or during the screening period. 17. Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 or during the screening period. 18. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 or during the screening period. 19. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 or during the screening period.20. Patients who have been treated with cromolyn sodium or nedocromil sodium within two weeks prior to Visit 1 or during the screening period. 21. Patients who have been treated with methylxanthines within two weeks prior to Visit 1 or during the screening period. 22. Patients who have taken an investigational drug within four weeks prior to Visit 1. 23. Patients who have been treated with other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy (e.g. TNFalpha blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 or during the screening period. 24. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period. Visit 1 and/or Visit 2 should be postponed in case of an asthma exacerbation or respiratory tract infection. 25. Patients who have previously been randomised in this trial or are currently participating in another trial. 26.Patients who have been treated with depot corticosteroids within six months prior to Visit 1 or during the screening period. 27.Patients who have been treated with leukotriene modifiers within two weeks prior to Visit 1 or during the screening period. ; PRIMARY OUTCOME: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response; SECONDARY OUTCOME 1: Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CONSERV 2; BRIEF: A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding ; DRUG USED: Ecallantide; DRUG CLASS: Biologic; INDICATION: Coronary Artery Bypass Graft (CABG); TARGET: Kinin-Kallikrein System ; THERAPY: Monotherapy; LEAD SPONSOR: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: - Written informed consent (by study subject) prior to any study-related procedure not part of normal medical care; - Male or female between the ages of 18 and 85 years old, inclusive; and - Planned cardiac surgery using cardio-pulmonary bypass, for one of the following procedures: any repeat sternotomy; surgery to repair or replace more than one valve; combined CABG plus repair or replacement of at least one valve - If female, subject is non-lactating, and is either:Not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;Of childbearing potential but is not pregnant as confirmed by negative pregnancy test at time of screening (based on the β-subunit of HCG), and is practicing the barrier method of birth control along with one of the following methods: oral or parenteral contraceptives for three months prior to study drug administration, a vasectomized partner, or abstinence from sexual intercourse. Exclusion Criteria: - Planned primary CABG, single valve repair or replacement surgery, or any off pump procedure; - Body weight <55 kg; - Planned hypothermia (<28ºC); - Planned transfusion in the peri-operative or post-operative periods; - Planned transfusion of pre-operatively donated autologous blood; - Female subjects who are pregnant or lactating; - Planned use of desmopressin, lysine analogs (other than study medication), atrial natriuretic hormone or recombinant activated Factor VII; - Planned use of corticosteroids in the pump prime solution; - Ejection fraction <30% within 90 days prior to surgery; - Evidence of a myocardial infarction within 5 days prior to surgery; - History of stroke or transient ischemic attack within 3 months prior to surgery; - Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery; - Serum creatinine >2.0 mg/dL within 48 hours prior to surgery; - Serum hepatic enzymes (aspartate aminotransferase or alanine aminotransferase) above 2.5 times the upper limit of normal for the applicable laboratory; - Hematocrit <32% within 48 hours prior to surgery; - Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery; - History of, or family history of, bleeding or clotting disorder (e.g. von Willebrands Disease, idiopathic thrombocytopenia purpura) or thrombophilia such as anti-thrombin III deficiency or Factor V Leiden mutation; - History of heparin-induced thrombocytopenia; - Prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 X normal range unless subject received heparin within 24 hours of test; - Serious intercurrent illness or active infection (e.g. endocarditis, sepsis, active malignancy requiring treatment); - Any previous exposure to ecallantide; - Receipt of an investigational drug or device 30 days prior to participation in the current study; - Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study; - Inability to comply with the protocol for the duration of the study; - Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and - Administration of: Eptifibatide within 6 hours prior to surgery, Tirofiban hydrochloride within 6 hours prior to surgery, (Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery), Prasugrel within 10 days prior to surgery, Clopidogrel within 3 days prior to surgery, Ticlopidine within 7 days prior to surgery, Abciximab within 5 days prior to surgery, (Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery), (Fondaparinux within 72 hours prior to surgery), Chlorpromazine within 7 days prior to surgery (Prophylactic use permitted for the prevention of deep vein thrombosis.) - Planned use of heparin bonded bypass circuits; - Known allergy or hypersensitivity to tranexamic acid or any of the other ingredients; - Disturbance of color sense; - Evidence of hematuria or any acute thromboses or thromboembolic diseases such as deep vein thrombosis, pulmonary embolism, or vertebral vein thrombosis. ; PRIMARY OUTCOME: Cumulative Volume of Packed Red Blood Cells Transfused; SECONDARY OUTCOME 1: Treatment-emergent Adverse Events.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - A2207 (CIAS); BRIEF: This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS). ; DRUG USED: AQW-051; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Diagnosis of schizophrenia - Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole. - Specific cognitive impairment - Smokers and non-smokers Exclusion Criteria: - Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing. - Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine. - History of neuroleptic malignant syndrome. - Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months. - Score 4 or 5 on the Suicidal Ideation item or any yes on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Visual learning and memory at 4 weeks; SECONDARY OUTCOME 1: Effect on cognitive function after 12 weeks of treatment - CogState test battery.[/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 - Treatment Resistant (Partial Onset); BRIEF: This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089. ; DRUG USED: Xcopri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: GABA, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: SK Life Science, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of treatment resistant partial epilepsy; - History of epilepsy for at least 2 years; - Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period. - Currently treated on a stable dose of : - 1 - 3 AEDs for at least 12 weeks prior to randomization. - VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline. - Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed. Exclusion Criteria: 1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years. 2. Subject has had status epilepticus within past 1 year. 3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED. 4. Subjects taking felbamate with less than 18 months continuous exposure. 5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs. 6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months. 7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt. 8. Subject meets criteria for current major depressive episode (within 6 months). 9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1. ; PRIMARY OUTCOME: Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days; SECONDARY OUTCOME 1: 50% Responder Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ECOG Study - w/Bortezomib/Lenalidomide/Dexamethasone (VRd); BRIEF: This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma ; DRUG USED: Kyprolis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: ECOG-ACRIN Cancer Research Group; CRITERIA: Inclusion Criteria: - STEP I: Patients must be diagnosed with symptomatic standard-risk multiple myeloma (SR-MM) as defined by all of the following (except gene expression profile [GEP]70 status if unknown): - No evidence of t(14;16) by fluorescence in situ hybridization (FISH) testing on bone marrow or not available - No evidence of t(14:20) by FISH testing on bone marrow or not available - No evidence of deletion 17p by FISH testing on bone marrow - FISH should be from within 90 days of registration - NOTE: If the FISH result states that no immunoglobulin heavy chain (IgH) abnormality is present, both t(14;16) and t(14;20) can be considered negative; in addition, if the patient has a t(11;14) or t(4;14) translocation present, they can be considered negative for t(14;16) and t(14;20); if testing for t(14;16) or t(14;20) could not be performed for lack of sufficient material or non-availability of the probe in the test panel, patients can be enrolled on the study - Standard Risk GEP70 signature within the past 90 days (only if GEP has been done and results are available) - NOTE: GEP testing is NOT a requirement for the study; if the test has been done, patients found to have a GEP70 status of high-risk will not be eligible - Serum lactate dehydrogenase (LDH) =< 2 x upper limit of normal (ULN) within the past 28 days - No more than 20% circulating plasma cells on peripheral blood smear differential or 2,000 plasma cells/microliter on white blood cell (WBC) differential of peripheral blood within the past 90 days - NOTE: This is NOT the plasma cell % from the marrow aspirate - STEP I: Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization: - >= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis - >= 200 mg/24 hours (hrs) of monoclonal protein on a 24 hour urine protein electrophoresis - Involved free light chain >= 10 mg/dL or >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65) - Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease) - Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay are required to be performed within 28 days prior to randomization; a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response - NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable; urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr; please note that if both serum and urine M-components are present, both must be followed in order to evaluate response - NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine; measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL; measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr - STEP I: Hemoglobin >= 8 g/dL (obtained within 28 days prior to randomization) - STEP I: Untransfused platelet count >= 75,000 cells/mm^3 (obtained within 28 days prior to randomization) - STEP I: Absolute neutrophil count >= 1000 cells/mm^3 (obtained within 28 days prior to randomization) - STEP I: Calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior to randomization) - STEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization) - STEP I: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 2.5 times the upper limit of normal (obtained within 28 days prior to randomization) - STEP I: Patients must have received no more than one cycle (4 weeks or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma; they should not have been exposed to lenalidomide, bortezomib or carfilzomib for treatment of symptomatic myeloma; prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts that meet the study requirements - STEP I: Prior systemic glucocorticoid use for the treatment of non-malignant disorders is permitted; prior or concurrent topical or localized glucocorticoid therapy to treat non-malignant comorbid disorders is permitted - STEP I: Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months - STEP I: Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome - STEP I: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (performance status [PS] 3 allowed if secondary to pain) - STEP I: Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible - STEP I: Patients must not have grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 - STEP I: Patients must not have active, uncontrolled infection - STEP I: Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation - STEP I: Patients should not have New York Heart Association classification III or IV heart failure or myocardial infarction within the previous 6 months - STEP I: Patients with a history of prior malignancy are eligible provided they were treated with curative intent and do not require active therapy (currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ?in situ? of the cervix or breast are not excluded) - STEP I: Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide throughout the entire duration of study treatment, and for 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; female subjects must agree to use contraception or abstinence for 30 days after last dose of carfilzomib - A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months - STEP I: Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 28 days after stopping lenalidomide; male subjects must also agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from lenalidomide; male subjects must be willing to use condoms for 90 days after discontinuation of carfilzomib - STEP I: The following patients will be excluded: - Pregnant women - Nursing women - STEP I: Human immunodeficiency virus (HIV) infection is not excluded; known HIV positive patients must meet the following criteria: - Cluster of differentiation (CD)4 cell count >= 350/mm^3 - No history of acquired immune deficiency syndrome (AIDS)-related illness - Not currently prescribed zidovudine or stavudine - STEP I: Patient enrolling to this study must agree to register to the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist - STEP II: Patients must have complete induction without experiencing progression or patients must have received at least 6 cycles on Arm A and 4 cycles on Arm B but stopped induction therapy due to adverse events - STEP II: Step 2 registration must be within 6 weeks of completing step 1 therapy - STEP II: Patients must not have received any non-protocol therapy outside of the assigned induction therapy including stem cell transplant - STEP II: ECOG performance status 0, 1, or 2 (PS 3 allowed if secondary to pain) - STEP II: Any adverse event related to step 1 therapy must have resolved to grade 2 or less - STEP II: Hemoglobin >= 8 g/dL (within 28 days prior to randomization to Step II) - STEP II: Platelet count >= 75,000 cells/mm^3 (within 28 days prior to randomization to Step II) - STEP II: Absolute neutrophil count >= 1000 cells/mm^3 (within 28 days prior to randomization to Step II) - STEP II: Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization to Step II) - STEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II) - STEP II: SGPT (ALT) and SGOT (AST) < 2.5 times the upper limit of normal (within 28 days prior to randomization to Step II) - STEP II: Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide throughout the entire duration of study treatment, and for 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure - A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months - STEP II: Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 28 days after stopping lenalidomide; male subjects must also agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from lenalidomide; males must agree to use contraception and agree to not donate sperm for at least 90 days after the last day of carfilzomib - STEP II: The following patients will be excluded: - Pregnant women - Nursing women - STEP II: Patient enrolling to this study must agree to register to the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist ; PRIMARY OUTCOME: Overall survival (OS) for the maintenance analysis; SECONDARY OUTCOME 1: Progression-free survival for the maintenance analysis[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - GEXMab73101; BRIEF: This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated. ; DRUG USED: TrasGEX; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Glycotope GmbH; CRITERIA: Main Inclusion Criteria: 1. Signed written informed consent granted prior to initiation of any study-specific procedures; 2. Male or female patients of ≥18 years of age; 3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression 4. Histologically or cytologically confirmed cancer, either locally advanced or metastatic; 5. No anti-tumor therapy of proven benefit available at study enrollment; 6. Life expectancy of >=3 months; 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2; 8. Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™; 9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™; and Main Exclusion Criteria: 1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™; 2. Major surgery within four weeks of the first dose of TrasGEX™; 3. Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required; 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™; 5. History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™; 6. History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™; 7. Left ventricular ejection fraction <50%; 8. Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™; 9. Pregnancy or lactation; and 10. Concurrent uncontrolled significant illness ; PRIMARY OUTCOME: optimal dose and regimen of TrasGEX™; SECONDARY OUTCOME 1: To determine preliminary evidence of activity[/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 - Ovarian Cancer/Peritoneal Mesothelioma; BRIEF: This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide. ; DRUG USED: MCY-M11; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Immune System, Mesothelin, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: MaxCyte, Inc.; CRITERIA: Inclusion Criteria: - Be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter - Be diagnosed with one of the following: metastatic or unresectable high grade serous adenocarcinoma involving the ovary, primary peritoneum, or fallopian tube with peritoneal involvement, not including mixed histologies, OR unresectable epithelioid or biphasic peritoneal mesothelioma - Be at least 4 weeks from previous anti-cancer therapy - Have a life expectancy of greater than 3 months. Exclusion Criteria: - Females who are pregnant, trying to become pregnant, or breastfeeding - Diagnosis of HIV or chronic active Hepatitis B or C - Symptomatic or uncontrolled brain metastases requiring current treatment - Impaired cardiac function or clinically significant cardiac disease - Lack of recovery of prior mild adverse events due to earlier therapies - Active infection - Another previous or current malignancy within the last 3 years, with exceptions - Concomitant chronic use of steroids or NSAIDs - Concomitant use of complementary or alternative medication or therapy - Autoimmune disease or inflammatory disease within previous 5 years ; PRIMARY OUTCOME: Incidence and severity of adverse events as assessed by CTCAE v.5.0; SECONDARY OUTCOME 1: Response Evaluation Criteria in Solid Tumors (RECIST)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Placebo or Ustekinumab; BRIEF: This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin involvement. Patients with pulmonary involvement constitute the primary population for analysis, and patients with skin involvement constitute the secondary population; a patient may be in both populations. The study will be conducted at approximately 40 sites globally. ; DRUG USED: Simponi (SQ); DRUG CLASS: Biologic; INDICATION: Sarcoidosis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Centocor, Inc.; CRITERIA: Inclusion Criteria: - Patients must have sarcoidosis with onset date of >=2 years prior to screening with at least 1 of the following: a. pulmonary sarcoidosis defined as 1) a diagnosis of sarcoidosis with evidence of lung parenchymal disease (Stage II, III or IV on chest radiograph), and 2) an FVC of >=45% and <=80% of predicted normal value at screening, and 3) an MRC dyspnea score of >2 at screening, and 4) a 6 minute walk distance between 100 to 550 meters at screening, and 5) <=15% absolute change in percent-predicted FVC at baseline relative to screening AND/OR b. skin sarcoidosis defined as 1) active chronic skin lesions for >=3 months either on face or elsewhere on body that have not resolved on current systemic and/or local therapy, and 2) have either: a single lesion of >=2 cm in longest dimension or multiple (3 or more) lesions with at least 1 lesion having a longest dimension of >=1 cm, and 3) have an SPGA score >=2 at screening - have been receiving treatment with oral corticosteroids and/or 1 or more immunomodulators for >=3-month period immediately prior to screening - on a stable dose of these medications for >=4 weeks before screening Exclusion Criteria: - Have a diagnosis of other significant respiratory disorder other than sarcoidosis that would complicate the evaluation of response to treatment - Have a smoking history of >=20 pack years - Have used an investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer - have received previous administration of a treatment with any other therapeutic agent targeted at reducing TNFalpha within 6 months or 5 half-lives of the agent, whichever is longer, prior to screening - Patients who have previously received biologic anti-TNFalpha agents outside of the above period are allowed to enter the study - Have previously used cyclophosphamide - Have previously used or received local therapy (including local injections) within 3 months before the screening visit or used or received treatment with prescription topical creams within 1 month before the screening visit for treatment of sarcoidosis skin lesions - Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but not limited to, ustekinumab and briakinumab within 6 months or 5 half-lives of the agent, whichever is longer, prior to the screening visit - have received natalizumab or agents that deplete or modulate the activity of B cells or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population - have used any antibody (monoclonal or polyclonal) or antibody-based agents <= 6 months or within 5 half-lives of the biologic prior to the screening visit, whichever is longer ; PRIMARY OUTCOME: Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16; SECONDARY OUTCOME 1: Change From Baseline in 6-minute Walk Distance at Week 28[/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 - A2308 - FEATURE (Prefilled Syringe); BRIEF: The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Moderate and severe plaque-type psoriasis diagnosed for at least 6 months. - Severity of psoriasis disease meeting all of the following three criteria: Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigators Global Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% or greater. -Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy. Exclusion criteria: - Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate). - Current drug-induced psoriasis. - Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor. - Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject. - Hematological abnormalities. - History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis. - History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. - Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.; SECONDARY OUTCOME 1: Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 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 II - 2202; BRIEF: The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when administered topically for up to 42 days, in subjects with severe dry eye disease. ; DRUG USED: OCS-02; DRUG CLASS: Non-NME; INDICATION: Dry Eye (Ophthalmology); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Alcon, a Novartis Company; CRITERIA: Inclusion Criteria: - Must sign written informed consent. - Physician diagnosis of DED of at least 6 months prior to Visit 1. - Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis. - Respond as often or constantly to the question How often do your eyes feel uncomfortable?. - Best Corrected Visual Acuity (BCVA) of 55 or greater in each eye as measured by ETDRS at Visit 1. - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Presence of any acute infection or non-infectious ocular condition in either eye within 1 month of Visit 1. - Contact lens wearers, defined as individuals who cannot be without their contact lenses for the entire duration of the study. - Any chronic ocular degenerative condition that in the opinion of the Investigator could possibly advance during the time course of the study. - Use of biologics treatments, such as systemic biologic anti-cytokines, including anti-TNFα drugs, or immunosuppressive therapy for the treatment of severe systemic autoimmune disorders. - Diseases or conditions affecting the ocular surface that are associated with clinically significant scarring and or destruction of conjunctiva and/or cornea. - Unwilling to abstain from topical ocular non-prescription medications during the course of the study, including concomitant use of artificial tears, gels, lubricants, re-wetting drops, allergy drops, etc. after Visit 2. - Use of nasal, inhaled, systemic (including injections), or topical corticosteroids within 30 days of Visit 1. - Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol. - Other protocol-specified exclusion criteria may apply. ; PRIMARY OUTCOME: Mean Change From Baseline in Global Ocular Discomfort Score at Day 71; SECONDARY OUTCOME 1: Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71[/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 - Solid Tumors/Lymphoma; BRIEF: The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma ; DRUG USED: AZD1208; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PIM Kinase Family; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study - Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist - Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks. - Patients who have at least one lesion that can be accurately assessed Exclusion Criteria: - Patients who have recently received or are receiving prohibited medications or treatments - Patients who have any unresolved side effects of previous treatments - Patients who have spinal cord compression or brain metastases - Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection) - Patients with significant abnormal ECG findings ; PRIMARY OUTCOME: Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria); 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 - Paradigm 2; BRIEF: This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B. ; DRUG USED: Rebinyn; DRUG CLASS: Biologic; INDICATION: Hemophilia B; TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records - History of at least 150 exposure days to other factor IX products - Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis Exclusion Criteria: - Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews - HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL - Congenital or acquired coagulation disorders other than haemophilia B - Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records) - Immune modulating or chemotherapeutic medication ; PRIMARY OUTCOME: Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units); SECONDARY OUTCOME 1: Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic 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 I - Umbrella (SR formulation); BRIEF: To investigate whether there is a food-effect with oral administration with EB-1020 as well as to obtain information on the safety, and tolerability of EB-1020 in a range of doses. ; DRUG USED: Centanafadine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Neurovance, Inc.; CRITERIA: Inclusion Criteria: 1. Aged 18-45 years inclusive 2. Body weight with the normal range for height (body mass index [BMI] between 19-30 kg/m2 inclusive) 3. If female, be of non-child bearing potential (surgically sterile, post-menopausal for 12 months or receiving a stable dose of implanted or injectable contraceptive for at least 3 months with last dose of injectable contraceptive within 2 months). Non-surgical menopause history must be confirmed by follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels as defined by established lab ranges. 4. Be in general good health without clinically significant medical history 5. Have clinical laboratory test results that are within the laboratory reference range; or if out of range are not clinically relevant and are acceptable to the Investigator and Sponsor medical representative 6. Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis Screening test 7. Able and willing to give written informed consent Exclusion Criteria: 1. Receipt of any investigational agent or drug within 3 months of entry into the study 2. Use of prescription drugs within 4 weeks prior to first dosing. Subjects who have used over the counter medication excluding paracetamol, topical over the counter medications and routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as non-clinically relevant by the Principal Investigator and Sponsor 3. A history of, or current evidence for, suicidal ideation, based upon clinical interview and a psychiatric questionnaire 4. A history of known or suspected seizures, spasms, infantile spasms, febrile convulsions, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits) 5. A history of sleep problems in the last 3 months 6. A history of relevant atopy or drug hypersensitivity 7. A history (within the last 5 years) or evidence of alcohol or drug abuse. Subject who consume more than 14 units (female) or 21 (male) units of alcohol a week (unit = 1 glass (125 mL) of wine = 1 measure of spirits = ½ pint of beer) will also be ineligible 8. A positive urine test for drugs of abuse or alcohol at Screening or on the day of admittance to the Study Unit 9. A history of smoking in the last 3 months 10. Have a significant infection (such as influenza) or known inflammatory process on screening or admission 11. Have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhea, heartburn ) 12. Have previously received EB-1020 13. Be vegetarians, vegans or have medical dietary restrictions 14. Any major surgical procedure within one month of entry into the study 15. Have difficulties communicating reliably with the Investigator or appear unlikely to co-operate with the requirements of the study in the investigators judgment. 16. Any other condition which in the view of the Investigator is likely to interfere with study or put the subject at risk. ; PRIMARY OUTCOME: Cmax; SECONDARY OUTCOME 1: Effect of food on Cmax[/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 - SAD; BRIEF: This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with progressive supranuclear palsy (PSP). ; DRUG USED: ABBV-8E12; DRUG CLASS: Biologic; INDICATION: Progressive Supranuclear Palsy; TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: C2N Diagnostics; CRITERIA: Key Inclusion Criteria: - Meets NINDS-SPSP possible or probable criteria as modified for NNIPPS and AL-108-231 clinical trials - Brain MRI at Screening is consistent with PSP; - Stable medications for Parkinsonism for at least 2 months prior to Screening; - Agree to use protocol specified methods of contraception. Key Exclusion Criteria: - Signs of a progressive neurological disorder that better meets the criteria for types of neurological disorders other than PSP; - Currently on any other biologic or immunomodulatory therapy; - Subjects that reside at a skilled nursing or dementia care facility; - Diagnosis of any other significant unrelated neurological or psychiatric disorders that could account for cognitive deficits; - Untreated major depression at baseline evaluation, based on clinical judgment and results in geriatric depression scale; - Unable to tolerate MRI scan at Screening or any other contraindication to MRI; - Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anti-coagulant medications. ; PRIMARY OUTCOME: Safety and tolerability, as measured by number of participants experiencing adverse events (AEs), serious AEs, and abnormalities in clinical laboratory tests, vital signs, ECGs, MRI, and physical and neurological exams.; SECONDARY OUTCOME 1: Immunogenicity as measured by the number of participants developing anti drug antibodies.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Nivolumab - Non-Clear Cell RCC (MSKCC); BRIEF: The purpose of this study is to compare any good and bad effects of using a combination of nivolumab (Opdivo®) and cabozantinib (Cabometyx®) in people with metastatic kidney cancer. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); 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: Memorial Sloan Kettering Cancer Center; CRITERIA: Inclusion Criteria: - Signed and dated IRB-approved Informed Consent Form - Pathologic or histologically confirmed unresectable advanced or metastatic nccRCC - 0 or 1 prior systemic therapies, including treatment in the adjuvant setting - Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of RCC, accompanied by an associated pathology report. Specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion. - Measurable disease, as defined by RECIST 1.1 - Age ≥18 years - KPS ≥ 70 - Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless adverse events (AE(s)) are clinically nonsignificant and/or stable on supportive therapy. - Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: - ANC ≥ 1500 cells/μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1) - WBC counts ≥ 2500/μL and ≤ 15,000/μL without G-CSF - Lymphocyte count ≥ 500/μL - Platelet count ≥100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1) - Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1) - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). ALP ≤ 5 x ULN if patient has documented bone metastases. - Serum bilirubin ≤ 1.5 x ULN . Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled. - Serum albumin ≥ 2.8 g/dl - Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled. - INR and aPTT ≤ 1.3 x ULN • within 14 days of first dose of study treatment.This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. - Creatinine ≤ 2.0 x ULN or Calculated Creatinine clearance ≥ 30mL/min - For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, including at least one method with a failure rate of ≥ 1% per year - Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) - Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of study treatment for females and 7 months for males. - Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who are surgically sterile as described above). However, 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 have signed the informed consent document. Exclusion Criteria: - Prior treatment with an immunotherapy agent including high dose IL-2, anti-CTLA-4, anti-PD1, and anti-PD-L1 agents - Prior treatment with cabozantinib for non-clear cell RCC - Receipt of any type of small molecule kinase inhibitor within 2 weeks of treatment. - Receipt of any type of anti-cancer antibody, cytotoxic anticancer therapy, or any other investigational agents within 4 weeks of treatment start - Known malignancies of the brain or spinal cord or leptomeningeal disease - Patients requiring pain medication must be on a stable regimen at study entry - Systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroids > 10 mg daily prednisone equivalents are allowed in the absence of autoimmune disease - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Uncontrolled hypercalcemia (≥ 1.5 mmol/L ionized calcium or Ca ≥ 12 mg/dL or corrected serum calcium ≥ ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab - Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy - Pregnant and lactating women History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - History of HIV infection - Patients with active or chronic hepatitis B or hepatitis C infection - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 6 months, unstable arrhythmias, unstable angina, or EF < 50% - Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment - Patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate - Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, biopsy, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible - History of stroke or transient ischemic attack within 6 months prior to Cycle 1, Day 1 - Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1 - Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) - Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding - Evidence of abdominal free air not explained by paracentesis or recent surgical procedure - Patients with a history of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment - Other clinically significant disorders that would preclude safe study participation - Serious non-healing wound/ulcer/bone fracture - Uncompensated/symptomatic hypothyroidism - Moderate to severe hepatic impairment (Child-Pugh B or C) - Corrected QT interval calculated by the Frederica formula (QTcF) > 500 ms per elFectrocardiogram (ECG) within 28 days before first dose of study treatment Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility - Inability to swallow tablets or capsules - Previously identified allergy or hypersensitivity to components of the study treatment formulations - Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study - Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following: - Low-dose aspirin for cardio protection (per local applicable guidelines) is permitted - Low-dose low molecular weight heparins (LMWH) are permitted - Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 1 week before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor - Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose - Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation - The subject has tumor invading or encasing any major blood vessels - The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib - Uncontrolled hypertension (>150 mmHg systolic or > 100 mmHg diastolic despite optimal antihypertensive treatment) - Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Radiation for palliation is allowable on study. ; PRIMARY OUTCOME: objective response 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 - PURE - 01; BRIEF: Patients with T2-T4a N0 urothelial bladder carcinoma (UBC) with residual disease after transurethral resection of the bladder (TURB, surgical opinion, cystoscopy or radiological presence) will receive 3 cycles of pembrolizumab (MK-3475) at the dose of 200mg 3 weekly prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 3 weeks of the last dose (accounting for a total of 9 weeks). Computed tomography (CT) scan and fluorodeoxyglucose positron emission tomography (FDG-PET)/CT scan will be done during screening and before surgery. After cystectomy, patients with the evidence of pathologic stage T3-4 (pT3-4) and/or pathologically node-positive disease will be managed according to local guidelines. Further anti programmed-death (PD)-1 or anti PD-ligand 1 (PD-L1) therapy will not be given post-operatively. PD-L1 status will be centralized and assessed on TURB specimen using an anti-PD-L1 antibody (Ab) and a prototype immunohistochemical (IHC) assay. PD-L1 positivity will be defined as any staining in the stroma or in ≥1% of tumor cells. Pathologic complete response (pCR) is the primary endpoint. All patients enrolled who receive at least 1 cycle of study drug will be includes in the intention-to-treat (ITT) analysis. The alternative hypothesis (H1) is pCR ≥20% and null hypothesis (H0) pCR≤10%. A 2-stage design will be used to estimate the number of pts required. Out of 90 pts overall, with the first stage of 49 pts, ≥6 pCR will be required in the first stage, and ≥13 pCR in the whole study population (80% power and a 2-sided test of significance at the 10% level). Correlative research on tissue/blood samples will include immune-cell profiling in tumor and blood during Pembrolizumab, cytokine assessment, and molecular profiling of tumor samples. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; CRITERIA: Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Ability to comply with the protocol. 3. Age ≥ 18 years. 4. Histopathologically confirmed transitional cell carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern. 5. Fit and planned for cystectomy (according to local guidelines). 6. Clinical stage T2-T4a N0 M0 disease by CT (or MRI) + PET/CT (within 4 weeks of randomization by RECIST v1.1). 7. Residual disease after TURB (surgical opinion, cystoscopy or radiological presence). 8. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for testing at the study sponsor site and determined to be evaluable for tumor PD-L1 expression prior to study enrolment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Merck representatives. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 10. Adequate hematologic and end-organ function tests. Exclusion Criteria: - Patients taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry. - Previously intravenous chemotherapy bladder cancer. Patients who have previously had radiotherapy or concurrent chemo-radiation would be eligible. - Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive). - Evidence of measurable nodal or metastatic disease. - Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome). - Pregnant female patients. All female patients of childbearing potential with a positive pregnancy test within 2 weeks prior to the first dose of study treatment will be excluded from the study. - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias, or unstable angina. - Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia. - Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis. - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the pembrolizumab formulation - History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegeners granulomatosis, Sjögrens syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. - Patients with a history of autoimmune-related hypothyroidism, unless on a stable dose of thyroid-replacement hormone. - Patients with uncontrolled Type 1 diabetes mellitus - Uncontrolled hypercalcemia - Patients with prior allogeneic stem cell or solid organ transplantation. - History of idiopathic pulmonary fibrosis - Positive test for HIV. - Patients with active hepatitis infection - Patients with active tuberculosis. - Prior treatment with anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents. - Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrolment - History of severe immune-related adverse effects from anti-CTLA-4 (CTCAE Grade 3 and 4). - Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment. ; PRIMARY OUTCOME: Pathologic complete response; SECONDARY OUTCOME 1: 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 II - KEYNOTE-180; BRIEF: In this study participants with advanced/metastatic adenocarcinoma of the esophagus (EAC), squamous cell carcinoma of the esophagus (ESCC), or advanced/metastatic Siewert type I adenocarcinoma of the esophagogastric junction (EGJ), who had been previously treated with two standard therapies, will be treated with pembrolizumab. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Esophageal Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy greater than 3 months - Histologically-proven advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ - Documented objective radiographic or clinical disease progression on two previous lines of standard therapy - Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 - Can provide either a newly obtained or archival tumor tissue sample for intratumoral immune-related testing and for anti-programmed cell death (PD-1) - Female participants of childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication - Male participants must agree to use adequate contraception starting with the first dose through 120 days after the last dose of study medication - Adequate organ function Exclusion Criteria: - Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication - Has active autoimmune disease that has required systemic treatment within the 2 years prior to the first dose of study medication - Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication - Known central nervous system (CNS) metastases and/or carcinomatous meningitis - Prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study medication or not recovered from adverse events due to a previously administered agent - Prior therapy with an anti-PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or previously participated in a Merck pembrolizumab (MK-3475) study - Has a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in-situ cervical cancer, and in-situ or intra-mucosal pharyngeal cancer - Received a live vaccine within 30 days of the first dose of study medication - Known history of Human Immunodeficiency Virus (HIV) infection - Known active Hepatitis B or C - History of non-infectious pneumonitis that required steroids or current pneumonitis - Active infection requiring systemic therapy - Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study - Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study medication ; PRIMARY OUTCOME: Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR); SECONDARY OUTCOME 1: Number of Participants Who Experienced an Adverse Event (AE)[/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 - ARROW; BRIEF: The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period. ; DRUG USED: Selonsertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Apoptosis Signal Regulating Kinase 1 (ASK1); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Diagnosis of idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug- and toxin-induced PAH, or PAH associated with connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital heart defects (repaired greater than 1 year prior to Screening) - Meet all of the following hemodynamic criteria by means of a screening right heart catheterization (RHC) completed prior to randomization: - Mean pulmonary artery pressure (mPAP) of greater than or equal to (≥) 25 millimeters of mercury (mm Hg) - Pulmonary vascular resistance (PVR) ≥ 400 dyne* second/centimeter^5 (dynes*sec/cm^5) - Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of less than or equal to (≤) 12 mm Hg if PVR ≥ 400 and less than (<) 500 dynes*sec/cm^5, or PCWP/LVEDP ≤ 15 mm Hg if PVR ≥ 500 dynes•sec/cm^5 - Be able to walk a distance of at least 100 meters - Have World Health Organization (WHO) Functional Class II or III symptoms - Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation: - Forced expiratory volume in one second (FEV1) ≥ 55 percent (%) of predicted normal - FEV1: forced vital capacity (FVC) ratio ≥ 0.60 - Receiving treatment with one or more drugs approved for PAH for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks Key Exclusion Criteria: - Diagnosis of PAH associated with significant venous or capillary involvement (PCWP greater than [>] 15 mm Hg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects - Pulmonary hypertension (PH) belonging to groups 2 to 5 of the 2013 NICE classification - Left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant ischemic, valvular or constrictive heart disease - Uncontrolled hypertension (≥ 180/110 mm Hg) at Screening - End stage renal disease (receiving peritoneal dialysis, hemodialysis, or status after renal transplantation) - Severe liver disease (Child-Pugh Class C, with or without cirrhosis) Individuals may be rescreened one additional time with prior notification to and approval by the sponsor. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24, as Measured by Right Heart Catheterization (RHC); SECONDARY OUTCOME 1: Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Cardiac Index[/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 - First-In-Human; BRIEF: The main purpose of this study is to learn about the safety of REGN5458 and to find out what is the best dose of REGN5458 to give to patients with multiple myeloma. An additional purpose is to look for any signs that REGN5458 can treat cancer. The study is looking at several other research questions, including: - Side effects that may be experienced by people receiving REGN5458 - How REGN5458 works in the body - How much REGN5458 is present in the blood - How REGN5458 may work to treat cancer ; DRUG USED: REGN5458; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: B-cell maturation antigen (BCMA), Cluster of Differentiation 3 (CD3); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol. - Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either: a. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibody and have disease that is double refractory to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor (PI). Refractory disease is defined as lack of response or relapse within 60 days of last treatment. - Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. - Phase 2 (Cohorts 1 and 2): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined as being refractory* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. - Phase 2 (Cohort 3): Patients with MM whose disease meets the following criteria: 1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR 2. Patients must be triple- refractory, defined as being refractory* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. - Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or <25% response to therapy. AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then: • Treatment with a CAR-T must have been associated with a response of PR or better, and • If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with REGN5458. Key Exclusion Criteria: 1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients with known MM brain lesions or meningeal involvement -Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA) 3. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excludedand BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3. 4. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment Note 1: Other protocol defined inclusion / exclusion criteria apply Note 2: US enrollment completed ; PRIMARY OUTCOME: Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period; SECONDARY OUTCOME 1: Concentrations of REGN5458 in the serum over 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 - C1061003; BRIEF: IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE ; DRUG USED: PF-06835919; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Ketohexokinase (KHK); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - BMI at least 28 kg/m2 - Type 2 diabetes and/or metabolic syndrome Exclusion Criteria: - Liver disease - Type 1 diabetes - Recent heart attack or stroke - Inability to have an MRI scan ; PRIMARY OUTCOME: Percent Change From Baseline in Whole Liver Fat at Week 6; SECONDARY OUTCOME 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Transpher A Study; BRIEF: The main objective of this study is to evaluate the efficacy and safety of ABO-102 for the treatment of MPS IIIA. ; DRUG USED: ABO-102; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis IIIA (MPS IIIA; Sanfilippo A Syndrome); TARGET: Heparan-N-sulfatase (N-sulphoglucosamine sulphohydrolase, sulfamidase), N-sulfo-D-glucosamine; THERAPY: Monotherapy; LEAD SPONSOR: Ultragenyx Pharmaceutical Inc; CRITERIA: Inclusion Criteria: - Diagnosis of MPS IIIA confirmed by the following methods: - No detectable or significantly reduced SGSH enzyme activity by leukocyte assay, and - Genomic DNA analysis demonstrating homozygous or compound heterozygous mutations in the SGSH gene - Age: From birth to 2 years or children older than 2 years with a minimum cognitive Developmental Quotient (DQ) of 60 or above (calculated by Bayley Scales of lnfant and Toddler Development - Third Edition) Exclusion Criteria: - Inability to participate in the clinical evaluation as determined by Principal Investigator (PI) - Identification of two nonsense or null variants on genetic testing of the SGSH gene - At least one S298P mutation in the SGSH gene - Has evidence of an attenuated phenotype of MPS IIIA - Presence of a concomitant medical condition that precludes lumbar puncture or use of anesthetics - Active viral infection based on clinical observations - Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer or precludes the child from participating in the protocol assessments and follow up - Subjects with total anti-AAV9 antibody titers ≥ 1:100 equivalent to a positive screen as determined by ELISA in serum - Subjects with a positive response for the enzyme-linked immunosorbent spot (ELISpot) for T-cell responses to AAV9 - Serology consistent with exposure to HIV, or serology consistent with active hepatitis B or C infection - Bleeding disorder or any other medical condition or circumstance in which a lumbar puncture (for collection of CSF) is contraindicated according to local institutional policy - Visual or hearing impairment sufficient to preclude cooperation with neurodevelopmental testing - Uncontrolled seizure disorder - Any item (braces, etc.) which would exclude the subject from being able to undergo MRI according to local institutional policy - Any other situation that precludes the subject from undergoing procedures required in this study - Subjects with cardiomyopathy or significant congenital heart abnormalities - The presence of significant non-MPS IlIA related CNS impairment or behavioral disturbances that would confound the scientific rigor or interpretation of results of the study - Abnormal laboratory values Grade 2 or higher as defined in CTCAE v4.03 for GGT, total bilirubin, creatinine, hemoglobin, WBC count, platelet count, PT and aPTT - Female participant who is pregnant or demonstrates a positive urine or bhCG result at screening assessment (if applicable) - Any vaccination with viral attenuated vaccines less than 30 days prior to the scheduled date of treatment (and use of prednisolone) - Previous treatment by Hematopoietic Stem Cell transplantation - Previous participation in a gene/cell therapy or enzyme replacement therapy (ERT) clinical trial ; PRIMARY OUTCOME: Change from Baseline in Cognitive Domain Bayley Scales of Infant and Toddler Development Raw Scores-Third edition (BSID-III); SECONDARY OUTCOME 1: Change From Baseline in Vineland Adaptive Behavior Scale II-Survey Interview Form[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 302; BRIEF: This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with congenital hemophilia A. ; DRUG USED: Obizur; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Inclusion Criteria: - Written informed consent/assent from participant and/or participants parent or legal representative. - Participants with congenital hemophilia A with human factor VIII inhibitor ≤30 BU assessed within 90 days prior to study entry. - Has previously or is currently demonstrating suboptimal hemostatic response to bypassing agents for treatment of bleeding episodes; suboptimal response is determined by the investigator , but minimally includes no or minimal evidence of response after at least two doses of bypassing agents, either for the current or a historic bleeding episode. - Has an anti-OBI-1 titer ≤ 10 BU - Has any serious or life-threatening bleeding episode; or requires a surgical procedure that could lead to a serious bleeding episode if not well controlled. - Is willing and able to follow all instructions and attend all study visits. - Has no other significant hemostatic abnormality and: - Platelets ≥100,000/mm-cubed - Prothrombin time < 15 seconds - INR < 1.3 - Participants taking anti-thrombotics (such as clopidogrel, heparin or heparin analogue) may be included provided three half-lives of the agent have elapsed since the last dose of the agent. Exclusion Criteria: - Hemodynamically unstable after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy. This hemodynamic instability is characterized by symptomatic hypotension resulting in vital organ dysfunction, such as cardiac ischemia, oliguria (urine volume <0.5 mL/kg in the previous six hours), central nervous system hypoperfusion manifested by mental status change such as confusion (unless head injury or intracranial hemorrhage is present), pulmonary compromise, and/or acidosis (manifested by pH and lactate levels). - Bleeding episode assessed likely to resolve on its own if left untreated. - Use of hemophilia medication: recombinant factor VIIa within 3 hours prior to OBI-1 administration or activated prothrombin complex concentrate (aPCC) treatment within 6 hours prior to OBI-1 administration - Prior history of bleeding disorder other than congenital hemophilia A - Known major sensitivity (anaphylactoid reactions) to porcine or hamster products. Examples include therapeutics of porcine origin (e.g. previously marketed porcine factor VIII, Hyate-C®) and recombinant therapeutics prepared from hamster cells (e.g. Humira®, Advate® and Enbrel®). - Received any other investigational treatment within 30 days of the first OBI-1 treatment. - Anticipated need for treatment or device during the study that may interfere with the evaluation of the safety or efficacy of OBI-1, or whose safety or efficacy may be affected by OBI-1. - Is planning to father a child during the study - Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the participants safety or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. - Inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures. ; PRIMARY OUTCOME: Proportion of Serious Bleeding Episodes Responsive to OBI-1; SECONDARY OUTCOME 1: Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator.[/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 - ERADICATE Hp; BRIEF: The test and treat strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients. ; DRUG USED: Talicia; DRUG CLASS: Non-NME; INDICATION: H. pylori Infection; TARGET: Penicillin Binding Proteins (PBP), Proton pump, RNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: RedHill Biopharma Limited; CRITERIA: Inclusion Criteria: 1. Be ≥18 years of age and ≤ 65 years 2. Have symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals) 3. Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test 4. Be informed of the nature of the study and provide written informed consent before any study specific procedures are performed (or have a legally authorized representative sign consent) Exclusion Criteria: 1. Have alarm symptoms/signs (including unexplained anemia [iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss) 2. Have taken antibiotics in the 4 weeks prior to screening 3. Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening 4. Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer 5. Have a history of gastric outlet obstruction 6. Have a history of hypersecretory state such as Zollinger-Ellison Syndrome 7. Have a history of gastric cancer 8. Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers ; PRIMARY OUTCOME: The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing; 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 Ib - 1363.2 (Europe); BRIEF: The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF). ; DRUG USED: BI 443651; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: Healthy volunteers: - Signed informed consent - Healthy male or female subjects - - Women of childbearing potential (WOCBP) should only be dosed after a confirmed menstrual period and/or with a progesterone level at Day -5 to Day -3 that demonstrates a dip from baseline, indicating a menstrual bleed prior to dosing. - Age of 18 to 55 years (incl.) - Body mass index (BMI) of 18.5 to 32.0 kg/m2 (incl.) - Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) of equal or greater than 80% of predicted normal, at screening and prior to randomisation Cystic Fibrosis (Cross over part): - Signed informed consent - Males or females with a documented diagnosis of cystic fibrosis - Women of childbearing potential (WOCBP) should only be dosed after a confirmed menstrual period and/or with a progesterone level at Day -5 to Day -3, that demonstrates a dip from baseline, indicating a menstrual bleed prior to dosing. For CF subjects of child bearing potential this must confirmed prior to second treatment period. - Age 18 to 55 years (each inclusive) - BMI of 18 to 32.0 kg/m2 (incl.) - Pre-bronchodilator FEV1 >/= to 70% of predicted normal at screening and prior to randomisation - Clinical stability as defined by no evidence of acute upper or lower respiratory tract infection; no pulmonary exacerbation requiring use of i.v. / oral / inhaled antibiotics, or oral corticosteroids; no change in pulmonary disease therapy; if on cycling antibiotics, these must be initiated within 2 weeks prior to randomisation; no acute (serious or non-serious) illness not related to cystic fibrosis; no infection with an organism associated with more rapid decline in pulmonary function (eg, Burkholderia cenocepacia, B dolosa, or Mycobacterium abscessus). - Able to perform technically acceptable pulmonary functions test (PFTs) - Further inclusion criteria apply. Exclusion criteria: - Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatologic, hematologic, neurological and psychiatric, oncological, coagulation or hormonal disorders as determined by medical history, examination, and clinical investigations at screening that may, in the opinion of the investigator, result in any of the following: - Put the subject at risk because of participation in the study. - Influence the results of the study. - Cast doubt on the subjects ability to participate in the study. - Chronic or relevant acute infections. - History of relevant orthostatic hypotension, fainting spells, or blackouts - History of myocardial infarction; history of acute coronary syndrome - History of and/or active life-threatening cardiac arrhythmia, as assessed by the investigator - Major surgery (major according to the investigators assessment) - History of chronic kidney disease (estimate glomerular filtration rate (EGFR) <59 mls/min including corrections as per ethnicity) - History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) - Unsuitable veins for venipuncture (for instance, veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture) as assessed by the investigator - Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG) is deviating from normal and judged as clinically relevant by the investigator - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, specifically volunteers with serum potassium > upper limit of normal should be excluded; Safety laboratory screening and Day -7 to Day -3, evaluation can be repeated twice during screening. - For healthy volunteers, repeated measurement (i.e. > 2 measurements) of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg. Volunteers will be excluded with a pulse rate outside the range of 45 to 90 bpm. - A marked baseline prolongation of mean QT/QTcF interval (such as QTcF intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening or prior to randomisation - A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome). - Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTcF interval - Intake of drugs with a long half-life (more than 24hrs) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication unless this is allowed medications. - CF subjects treated with non-permitted concomitant medication. Specifically medications causing changes in serum potassium are restricted - Current or previous participation in another interventional trial, including where an investigational drug has been or will be administered within 60 days or 5 half-lives (whichever is longer) prior to screening - For healthy volunteers and CF subjects: current smokers or ex-smokers of less than 12 months and/or with a pack year history of more than 5 years - Further exclusion criteria apply ; PRIMARY OUTCOME: Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2; SECONDARY OUTCOME 1: Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 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 - CD30-Positive (NHL/PTCL/DLBCL); BRIEF: This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C). ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Histologically-confirmed NHL (DLBCL only for Parts B and C) - Relapsed or refractory disease following at least 1 prior systemic therapy - Measurable disease of at least 1.5 cm as documented by CT - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria: - History of another primary invasive malignancy that has not been in remission for at least 3 years - Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides - B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy - Known cerebral/meningeal disease ; PRIMARY OUTCOME: Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy; SECONDARY OUTCOME 1: Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab[/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 - MEASURE 1; BRIEF: This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy. ; 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-lactating female patients at least 18 years of age - Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) - Patients should have been on NSAIDs with an inadequate response - Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose - Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response Exclusion criteria: - Chest X-ray with evidence of ongoing infectious or malignant process - Patients with total ankylosis of the spine - Patients previously treated with any biological immunomodulating agents except for those targeting TNFα - Previous treatment with any cell-depleting therapies - Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response; SECONDARY OUTCOME 1: Assessment of Responders for the SpondyloArthritis International Society ASAS 40 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 IIb - MAP; BRIEF: Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections. ; DRUG USED: Iluvien; DRUG CLASS: Non-NME; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Johns Hopkins University; CRITERIA: Inclusion Criteria: - Patients 50 or greater - Treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4-6 weeks apart) with no improvement in VA (worse or within one line better) or center subfield thickening (worse or within 30 um better). - Best Corrected Visual Acuity 20/320 or better in the study eye Exclusion Criteria: - Pregnant, lactating females or females of child bearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant , intrauterine device (IUD). - Glaucoma or ocular hypertension (defined as IOP > 21 mmHg or concurrent therapy at screening with IOP-lowering agents) in the study eye - Laser or photodynamic therapy within 12 weeks of screening - Any ocular surgery in the study eye within 12 weeks of screening - Yag capsulotomy in the study eye within 15 days of screening - Treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy other than Lucentis within 6 months prior to enrollment (e.g., triamcinolone injection, Avastin, Macugen.) Systemic treatment with Avastin is also not allowed within 6 months prior to screening or at any time during the study. - Any change in systemic steroid therapy within 3 months of screening - Retinal or choroidal neovascularization due to ocular conditions other than AMD. - Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus). - Known or suspected hypersensitivity to any of the ingredients of Lucentis, the investigational product or to other corticosteroids. - History of vitrectomy in the study eye - History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy - History or presence of any disease or condition (malignancy) that in the investigators opinion would preclude study treatment or follow-up - Any lens opacity which impairs visualization of the posterior pole - Participation in another clinical trial within 12 weeks before the screening visit or during the study - Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections. ; PRIMARY OUTCOME: Mean Change From Baseline in Visual Acuity; SECONDARY OUTCOME 1: Number of Patients Developing Cataracts[/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 - Postmenopausal with low BMD; BRIEF: This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib [MK-0822]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years). ; 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: - Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy - Bone mineral density T-score at the hip or spine of -2.0 or less - Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.) - At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures) - In a state of general health allowing for successful completion of the trial - Agreement to not use any medications to treat osteoporosis during the study Exclusion Criteria: - History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy) - Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details) - Significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason) ; PRIMARY OUTCOME: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months; SECONDARY OUTCOME 1: Percentage Change From Baseline in Total Hip BMD at 12 Months[/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 - Lactose Intolerance; BRIEF: This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance. ; DRUG USED: RP-G28; DRUG CLASS: New Molecular Entity (NME); INDICATION: Food Allergies; TARGET: Bacteria-miscellaneous; THERAPY: Monotherapy; LEAD SPONSOR: Ritter Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male and female subjects. Female subjects must be non-pregnant and non-lactating. - 18 to 64 years of age inclusive at Screening - Current or recent history of intolerance to milk and other dairy products - Acceptable Baseline Lactose Intolerance Symptom Scores - Acceptable Result on Baseline Hydrogen Breath Test - Subjects must agree to refrain from all other treatments and products used for lactose intolerance during the study Exclusion Criteria: - Disorders known to be associated with abnormal GI motility - History of surgery that alters the normal function of the gastrointestinal tract - Past or present; organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, inflammatory bowel disease (IBD), ulcerative colitis, Crohns disease, irritable bowel syndrome (IBS) - Active gastric or duodenal ulcers or history of severe ulcers - Diabetes mellitus (type 1 or type 2) - Congestive Heart Failure - History of Human Immunodeficiency Virus (HIV), Hepatitis B or C - Use of concurrent therapy(ies) for symptoms of lactose intolerance - Uncontrolled BP defined as sitting systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥95 mmHg at Visit 1 - History of ethanol abuse in the past 12 months - History of drug abuse within 12 months - History or presence of malignancy within the past 5 years (except basal cell or squamous cell carcinoma removed from a sun-exposed area) - Use of any investigational drug or participation in any investigational study within 30 days prior to Screening ; PRIMARY OUTCOME: 1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge; SECONDARY OUTCOME 1: Number of Subjects with Adverse Events as Measure of Safety and Tolerability[/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 - JAB-3312-1002 (China); BRIEF: This is a Phase 1, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles. ; DRUG USED: JAB-3312; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: KRas, MAPK/ERK (mitogen-activated protein kinases/extracellular signal-regulated kinases; Ras-Raf-MEK-ERK pathway); THERAPY: Monotherapy; LEAD SPONSOR: Jacobio Pharmaceuticals Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. 4. Subjects with life expectancy ≥3 months. 5. Patients must have at least one measurable lesion as defined by RECIST v1.1. 6. Patients who have sufficient baseline organ function Exclusion Criteria: 1. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent). 2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases. 3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain. 4. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 5. History or evidence of active infections (Grade ≥2). 6. History or evidence of significant inflammatory or vascular eye disorder. 7. History of an allogeneic bone marrow or solid organ transplant. 8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312. 9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312. 10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment. 11. Subjects experiencing unresolved Grade >1 toxicity before the start of treatment ; PRIMARY OUTCOME: Number of participants with dose limiting toxicities; SECONDARY OUTCOME 1: Number of participants with 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 - SM-A-06; BRIEF: The purpose of this study is to assess the efficacy and pattern of use of the combination drug product SM-1 in adults who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or placebo to take at home as needed over the course of 3 months treatment period. ; DRUG USED: SM-1; DRUG CLASS: Non-NME; INDICATION: Insomnia; TARGET: GABA Receptors, GABA-A Receptor, Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Sequential Medicine Ltd; CRITERIA: Inclusion Criteria: - Experienced at least 1 prior episode of transient insomnia meeting all of the following criteria: difficulty falling asleep or staying asleep; next day impairment or distress associated with the disturbed sleep; frequency of 1 to 7 nights per week; duration of less than 1 month or more than 1 month of intermittent episodes. - Routinely spends 6.5 - 9.5 hours in bed each night, with bed time varying no more than 2 hours over a week. - Body Mass Index (BMI) between 19 and 32 kg/m2. - Good general health, as determined by a thorough medical, sleep and psychiatric history review, brief physical examination including vital sign measurements, and an assessment of screening laboratory test results. - Agrees, for the duration of the study, to take only study drug to address difficulty falling asleep or staying asleep, and to not drink alcohol within 2 hours of expected bedtime. Exclusion Criteria: - Females who are pregnant, breast-feeding, or planning a pregnancy during the study period. - Clinically significant medical disorder or currently unstable medical condition that, in the opinion of the investigator, would confound the results of the study. - Abnormal laboratory value at screening, judged clinically significant by the investigator. - History or current evidence of severe hepatic (liver) impairment. - Clinically significant psychiatric illness, or the history or presence of a major psychiatric illness in the past year. - Has a significant risk (in the opinion of the investigator) for suicidal behavior during the course of participation in the study or a) At screening: the subject scores yes on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to screening; or b) At screening: the subject has had one or more suicidal attempts within a 2-year period prior to screening; or c) At the baseline visit: the subject scores yes on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to screening; or d) The subject is considered to be an imminent danger to self or others. - Has a history of chronic insomnia or other sleep disorders, such as sleep apnea, narcolepsy, parasomnia, restless leg syndrome, or circadian rhythm disorder. - Has used medications to aid sleep on most nights during the past 2 months. - Has a history of night work or shift work within the month prior to screening or a need to participate in night work or shift work during the study. - Has a history of alcohol or substance use disorder within the year prior to screening, or current evidence of alcohol or substance use disorder as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 5th Edition. - Self-report of a usual consumption of more than 14 units of alcohol per week: 1 unit of alcohol is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of liquor. - Has a history of routinely smoking during sleep period. - Has discontinued smoking or participated in a smoking cessation program within 28 days of screening, or plans to discontinue smoking during the study. - Has used within 2 weeks or 5 half-lives (whichever is longer) prior to screening of any medication that affects sleep-wake function. - Has a positive urine drug screen at the screening visit. - Has a history of allergy or known sensitivity, hypersensitivity, or adverse reaction to diphenhydramine, zolpidem, lorazepam, or related compounds. - Has had treatment with any other investigational drug within 28 days or 5 half-lives (whichever is longer) prior to screening. ; PRIMARY OUTCOME: Subjective Total Sleep Time; SECONDARY OUTCOME 1: Pattern of use[/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 - CCD05 (Pediatric); BRIEF: Treatment with liver cell infusion for children with urea cycle disorders (UCD). ; DRUG USED: Heparesc; DRUG CLASS: Biologic; INDICATION: Urea Cycle Disorders and Derangements (UCD); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Cytonet GmbH & Co. KG; CRITERIA: Inclusion Criteria: - Age: birth up to 5 years of age - Ornithine transcarbamylase deficiency [OTCD], Carbamyl phosphate synthetase I deficiency [CPSD], Argininosuccinate synthetase deficiency [ASSD, Citrullinaemia] - Written Informed Consent Exclusion Criteria: - Weight ≤ 3.5 kg - Presence of acute infection at the time of inclusion - Severe chronic or systemic disease other than study indication - Structural liver disease (eg, cirrhosis, portal hypertension) - Required valproate therapy ; PRIMARY OUTCOME: Changes in 13C urea formation from baseline to 2 and 4 months after first HHLivC infusion; SECONDARY OUTCOME 1: Frequency and severity of metabolic crises[/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 - Pain Treatment (Japan); BRIEF: The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated with uterine fibroids. ; DRUG USED: Orgovyx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine Fibroids; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: Inclusion Criteria for Entering the Screening Period (at VISIT 1) 1. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3. Prior to VISIT 1, the participant has a diagnosis of uterine fibroids confirmed by transvaginal ultrasound, abdominal ultrasound, magnetic resonance imaging (MRI), computed tomography (CT), or laparoscopy, and has never received any surgical treatment for the myoma (measurable noncalcified myoma with a longest diameter of ≥3 cm). 4. The participant is a premenopausal Japanese woman. 5. The participant is aged 20 years or older on the day of signing and dating the informed consent form. 6. The participant has 1 or more measurable noncalcified myomas with a longest diameter of ≥3 cm confirmed by transvaginal ultrasound. 7. The participant has experienced 1 or more regular menstrual cycles (25 to 38 days) immediately prior to VISIT 1 and that should include menstrual bleeding for at least 3 consecutive days. 8. The participant who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the study. Inclusion Criteria for Entering the Run-in Period (at VISIT 2) 9. The participant has experienced regular menstrual cycles (25 to 38 days) immediately prior to VISIT 2 that should include menstrual bleeding for at least 3 consecutive days (at least 2 regular menstruation cycles to be confirmed by Inclusion criteria #7 and #9). Inclusion Criteria for Entering the Treatment Period (at VISIT 3) 10. The participant has 1 or more measurable noncalcified myomas, with a longest diameter of ≥3 cm confirmed by transvaginal ultrasound (the same myoma should be measured in Inclusion criterion #6). 11. The participant has a maximum Numerical Rating Scale (NRS) score of ≥4 during 1 menstrual cycle just before VISIT 3. 12. The participant has pain symptoms associated with uterine fibroids for at least 2 days during 1 menstrual cycle just before VISIT 3. 13. The participant has experienced regular menstrual cycles (25 to 38 days) after VISIT 1 that should include menstrual bleeding for at least 3 consecutive days (at least 3 regular menstruation cycles to be confirmed by Inclusion criteria #7, #9 and #13). Exclusion Criteria: 1. The participant has received any investigational compound within 24 weeks prior to the start of the administration of the study drug for the day of first menstruation after VISIT 1. 2. The participant has received relugolix (including placebo) in a previous clinical study. 3. The participant is an immediate family member or study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, or sibling) or may consent under duress. 4. The participant has lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis. 5. The participant has a current history of thyroid gland disorder with irregular menstruation, or has a potential for irregular menstruation due to thyroid gland disorder, as determined by the investigator or subinvestigator. 6. The participant has a previous or current history of pelvic inflammatory disease within 8 weeks prior to VISIT 1. 7. The participant has a positive Pap smear test result obtained within 1 year prior to VISIT 1 (if there are no previous test results, those who were judged positive in the test conducted before VISIT 2). 8. The participant has a history of panhysterectomy or bilateral oophorectomy. 9. The participant has had markedly abnormal uterine bleeding or anovulatory bleeding, as determined by the investigator or subinvestigator. 10. The participant has a malignant tumor or a history of a malignant tumor within 5 years prior to VISIT 1. 11. The participant has been treated with selective estrogen receptor modulators (SERMs) (excluding drugs for external use and dietary supplements) within 4 weeks prior to VISIT 2. 12. The participant has been treated with any of the following drugs within 8 weeks prior to VISIT 2: oral contraceptive or sex hormone preparations (norethindrone, norethisterone, medroxyprogesterone, estrogen, or other progestins), and within 16 weeks prior to VISIT 2: gonadotropin-releasing hormone (GnRH) analogues, dienogest, danazol, or aromatase inhibitors (for 1- and 3-month sustained-release preparations, within 20 and 28 weeks prior to VISIT 2, respectively). 13. The participant has a previous or current history of severe hypersensitivity or severe allergies to drugs. 14. The participant has nondiagnosable abnormal genital bleeding. 15. Female participant who is pregnant, lactating, or intending to become pregnant or to donate ova prior to the signing of informed consent, during the study period, or within 1 month after the end of the study. 16. The participant has clinically significant cardiovascular disease (eg, myocardial infarction or unstable angina pectoris within 24 weeks prior to VISIT 1) or uncontrollable hypertension (eg, resting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg at Screening and Run-in Period). 17. The participant is ineligible for this study based on standard 12-lead electrocardiogram (ECG) findings, as determined by the investigator or subinvestigator. 18. The participant has active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin (total bilirubin) >1.5 times the upper limit of normal (ULN) in the clinical laboratory tests at VISIT 1 and 2. 19. The participant has a previous or current history of diseases considered to be ineligible for this study, including severe hepatic impairment, jaundice, renal impairment, cardiovascular disease, endocrine system disease, metabolic disorder, pulmonary disease, gastrointestinal disease, neurological disease, urological disease, immune disease, mental disorder (especially depression-like symptoms) and suicide attempt resulting from a mental disorder. 20. The participant has a previous or current history of drug abuse (defined as any illicit drug use) or alcohol abuse. 21. The participant is ineligible for this study for other reasons, as determined by the investigator or subinvestigator. ; PRIMARY OUTCOME: Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug; SECONDARY OUTCOME 1: Percentage of Participants With a Maximum NRS Score of 0 During the 28 Days Before the Final Dose of Study Drug[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 01; BRIEF: This is an open-label, dose-escalation Phase 1 study of the investigational agent, ON 013105. In laboratory animal studies, ON 013105 has demonstrated anti-cancer activity. The purpose of this study is to determine the highest dose of ON 013105 that can be given safely in patients with relapsed/refractory Lymphoma or B-cell Acute Lymphocytic Leukemia (Philadelphia chromosome negative). Patients will receive weekly 2-hour IV infusions of ON 013105 at higher and higher doses until intolerable side effects are observed. It is important to know the highest safe dose so additional studies can be done. ; DRUG USED: Briciclib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cyclin Dependent Kinase (CDK), Eukaryotic translation initiation factor 4E (eIF4E); THERAPY: Monotherapy; LEAD SPONSOR: Onconova Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - ≥ 18 years of age - Documented (cytologically confirmed) relapsed/ refractory Lymphoma or B-cell Acute Lymphocytic Leukemia (Philadelphia chromosome negative) - ECOG Performance Status score of 0, 1, or 2 (see Attachment 1) - Expected survival, in the opinion of the Investigator, of at least 3 months, to allow a sufficient observation period for evaluation of ON 013105 - Recovery to at least grade I from adverse effects of prior therapies - Adequate contraceptive [including prescription oral contraceptives (birth control pills), contraceptive injections, intrauterine device (IUD), double-barrier method (spermicidal jelly or foam with condoms or diaphragm), contraceptive patch, or surgical sterilization] before entry and throughout the study for female patients of reproductive potential - Female patient with reproductive potential must have a negative serum beta-HCG pregnancy test at screening - Willing to adhere to the prohibitions and restrictions specified in this protocol - Patient (or his/her legally authorized representative) must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study Exclusion Criteria: - Grade 3 thrombocytopenia (platelets <50,000/µL) or neutropenia (ANC <1000/µL) ) except if documented evidence of bone marrow involvement of lymphoma or leukemia contributing to cytopenias. - Any active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - History of HIV-1 seropositivity - Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia - Active infection not adequately responding to appropriate therapy. - Total bilirubin > 1.5 mg/dL not related to hemolysis or Gilberts disease, AST/ALT > 1.5 X ULN - Serum creatinine > 1.5 mg/dL or calculated creatinine clearance < 60 ml/min. - Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 Meq/L). - Women patients who are pregnant or lactating - Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol (see Section 4.4). - Major surgery without full recovery or major surgery within 3 weeks of ON 013105 treatment start. - Uncontrolled hypertension (defined as a systolic pressure ³ 180 and/or a diastolic pressure ³ 110) - New onset seizures (within 3 months prior to the first dose of ON 013105) or poorly controlled seizures - Any concurrent investigational agent or chemotherapy, radiotherapy or immunotherapy - Psychiatric illness/social situations that would limit the patients ability to tolerate and/or comply with study requirements ; PRIMARY OUTCOME: Safety based on adverse events, hematology and chemical laboratory values, urinalysis, coagulation, ECG, vital signs, physical examination.; SECONDARY OUTCOME 1: Tumor response (according to Cheson, B.D., et al., Revised Response Criteria for Malignant Lymphoma, J Clin Oncol 2007. 25: p. 579-86).[/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 - Open Label; BRIEF: This is a Phase 1, non-randomized, dose-escalating, open label, multi-center study to be conducted in two parts (Part A and Part B). RO6870810 is a small molecule, non-covalent inhibitor of bromodomain and extra-terminal (BET) family of bromodomains. This study is designed to characterize the safety, tolerability, pharmacokinetics and anti-tumor activity of RO6870810 in participants with histologically confirmed solid tumors with progressive disease (PD) which is refractory or intolerant to standard/approved therapies. In Part A, RO6870810 will be administered by subcutaneous (SC) injection daily for either 21 consecutive days in a 28-day cycle or for 14 consecutive days in a 21-day treatment cycle in participants with advanced solid tumor malignancies to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT). In Part B, RO6870810 will be administered at a dose up to the MTD to further characterize the safety profile and biological effect in a subset of participants with advanced solid tumor malignancies. It is anticipated that a total of 84 participants will be enrolled in to this study (54 in Part A and 30 in Part B). In addition, it is expected that up to 20 participants with histologically confirmed nuclear protein in testis (NUT)-midline carcinoma (NMC) with progressive disease requiring therapy will be enrolled in the sub-study of Parts A and B. In addition, up to 20 participants with diffuse large B-cell lymphoma (DLBCL) may be enrolled at selected study sites. ; DRUG USED: RG6146; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: BET Proteins/Bromodomains; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: General: - Participants with solid tumors must have one or more metastatic tumors evaluable or measurable on radiographic imaging - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor) - Life expectancy of greater than or equal to (>/=) 3 months - Disease-free of active second/secondary or prior malignancies >/= 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast - Adequate hematological, renal, hepatic and coagulation laboratory test results - Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug Advanced Solid Malignancies: - Participants with previously treated, histologically confirmed advanced solid malignancy with progressive disease requiring therapy - Participants must be refractory or intolerant to standard therapy NUT-midline carcinoma: - Participants with histologically confirmed newly diagnosed or relapsed/refractory NMC with PD requiring therapy - Diagnosis of one of the following is required: 1. NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by Immunohistochemistry (IHC) and/or; 2. Detection of NUT gene translocation as determined by Fluorescence In-Situ Hybridization (FISH) Advanced Aggressive DLBCL - Histologically confirmed advanced aggressive B-cell lymphoma with abnormal MYC expression with persistent disease requiring treatment - Participants must have relapsed or progressed after at least 2 lines of prior therapy and not eligible for any curative treatment - Participants must have measurable disease Exclusion Criteria: - Participants with hematologic malignancies - New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia - Have Fridericia-corrected QT interval (QTcF) greater than (>) 470 milliseconds (msec) (female) or > 450 (male), or history of congenital long QT syndrome - Active, uncontrolled bacterial, viral, or fungal infections - Known clinically important respiratory impairment - Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies - History of major organ transplant - History of an autologous or allogeneic bone marrow transplant. For DLBCL participants only: DLBCL participants may have had a previous autologous transplant but not within 90 days of study entry - Symptomatic central nervous system malignancy or metastasis - Pregnant or nursing - Treatment with surgery or chemotherapy within 28 days prior to study entry - Prior treatment with small molecule (BET) family inhibitor - Radiation for symptomatic lesions within 14 days of study enrollment ; PRIMARY OUTCOME: Number of Participants with DLTs; SECONDARY OUTCOME 1: Area Under the Concentration Versus Time Curve from Time 0 (Pre-dose) to Time 24 Hours (AUC0-24) of RO6870810[/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; BRIEF: The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks. ; DRUG USED: CPX-1; DRUG CLASS: Non-NME; INDICATION: Colorectal Cancer (CRC); TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Ability to understand and voluntarily sign an informed consent form - Age > 18 years at the time of signing the informed consent form - Histological confirmation of advanced stage, primary or metastatic colorectal carcinoma - Prior therapy (Group 1, irinotecan naive): - No more than one regimen for metastatic disease - No more than two regimens overall; one for neoadjuvant/adjuvant and one for metastatic/advanced disease - Prior therapy (Group 2, irinotecan refractory): - Disease progression on or within 3 months after prior irinotecan-containing regimen - CPX-1 treatment must start within 6 months after documentation of disease progression on irinotecan (other therapies are permitted after irinotecan and before study entry) - Must have measurable disease as defined by RECIST - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 - Able to adhere to the study visit schedule and other protocol requirements - Life expectancy of at least 24 weeks - Laboratory values fulfilling the following: - Absolute neutrophil count (ANC) >1500 cells/mm3 (1.5 x 109/L) - Platelet count > 100,000/mm3 (100 x 109/L) - Serum creatinine <1.5 x upper limits of normal (ULN) - Serum SGOT/AST and SGPT/ALT <3 x upper limits of normal (ULN) (<5 times ULN if caused by liver metastases) - Serum total bilirubin < 1.25 x upper limits of normal (<2 times ULN if caused by liver metastases) - All men and women must agree to practice effective contraception during the study period and for three months afterward if not otherwise documented to be infertile. - Prior radiation therapy must be completed at least 4 weeks prior to enrollment and the patient recovered from any toxicity related to the radiation therapy. Exclusion Criteria: - Prior treatment with irinotecan or an irinotecan-containing regimen (Group 1 only) - Intolerant of an irinotecan-containing regimen (Group 2 only) - Without documented evidence of irinotecan-refractoriness (Group 2 only) - Chemotherapy or investigational anticancer therapeutic drugs in the four weeks prior to study entry. - Hypersensitivity to irinotecan, floxuridine or liposomal products. - History of Wilsons disease or other copper-related disorder. - Clinically significant cardiac disease (New York Heart Association Class III or IV). - Severe debilitating pulmonary disease. - Active infection requiring continuing intravenous antibiotic treatment; recent infections must have resolved at least 5 days - Severe or active enteropathy or recurrent onset of diarrhea, defined as an excess of 2 to 3 stools above the normal daily rate within the past four weeks. - Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form. - Pregnant or lactating women. Continued use of a drug or other product known to induce or inhibit CYP3A4. ---Patients must discontinue these products for at least 2 week prior to enrollment. ; PRIMARY OUTCOME: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0; SECONDARY OUTCOME 1: Duration of Response (DoR) Per RECIST Version 1.0[/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 - PK/PD (114693); BRIEF: This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge ; DRUG USED: SB-705498; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Cough; TARGET: TRPV1, transient receptor potential vanilloid receptor 1, VR-1; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive. - Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol - Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked). - Body weight > 50 kg and body mass index (BMI) within the range 19 - 30.0 kg/m2 (inclusive). - Capable of giving written informed consent. - Agree to use contraception listed as acceptable - Normal 12-lead ECG at screening. - Chronic cough (Part B only) - Good general health, apart from chronic cough (part B only), as determined by a responsible physician. Exclusion Criteria: - A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors. - Positive pre-study drug/alcohol screen. - Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. - A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)). - History of regular alcohol consumption within 6 months of the study. - Exposure to more than four new chemical entities within 12 months prior to the start of the study. - Participation in a clinical trial with a new molecule entity or any other clinical trial within 30 days of the start of the study. - Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days prior to study. - known history of lung cancer - current treatment with oral corticosteriods or other immunosupressive agents - FEV1 less than 80% of predicted value at screening - Any subject who does not reach C5 following 250uM oral capsaicin - History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation. - Donation of blood or blood products in excess of 500mL within a 56 day period prior the start study. - Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing. - Lactating females. - Unwillingness or inability to follow the procedures outlined in the protocol. - Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. - consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to dosing. ; PRIMARY OUTCOME: Pharmacokinetic parameter of area under the plasma concentration-time curve from time zero to 4 hours AUC(0-4) and from time zero (pre-dose) to last time of quantifiable concentration AUC(0-t)- Part A; SECONDARY OUTCOME 1: Capsaicin concentration required to achieve two or more coughs (C2) following a single dose of SB-705498 at Tmax as compared to baseline- Part A[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Idiopathic MN (vs. Rituximab); BRIEF: This is a randomized, open-label, two arm, parallel group, proof-of-concept, non-confirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with membranous nephropathy (MN) who are at high risk of disease progression defined on the basis of antibody anti-PLA2R titre and proteinuria. ; DRUG USED: Iptacopan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immunoglobulin A (IgA) Nephropathy (Bergers Disease); TARGET: Factor D (alternate complement pathway); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Female or male adult (≥18 years) subjects at screening visit with a diagnosis of idiopathic (primary) MN confirmed by renal biopsy within 36 months prior to screening. A renal biopsy may be taken at any time during the run-in period to confirm the diagnosis of MN and facilitate subject eligibility, if the most recent biopsy was performed greater than 36 months prior to the screening visit. - Anti-PLA2R antibody titer of ≥ 60 RU/mL at screening visit. If sites opt to use a local laboratory, with prior agreement with sponsor, an anti-PLA2R titer performed within 4 weeks prior to screening visit can be used. - Urine protein ≥ 3.5 g/24h at screening and baseline visits - ≤50% reduction in both anti-PLA2R level and 24h urine protein between screening and baseline - Estimated GFR (using the CKD-EPI formula) ≥ 30 mL/min per 1.73 m2 at screening - Receiving stable dose at the maximum recommended dose according to local guidelines or maximum tolerated dose of ACEi and/or ARB and/or statins and/or diuretics for at least 8 weeks prior to Day 1 - Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae (in accordance with local guidelines) at least 28 days prior to Day 1 and no longer than 5 years prior to Day 1. Exclusion Criteria: - Secondary causes of MN, e.g. systemic autoimmune diseases, solid or haematological malignancies, infections or chronic intake of drugs (e.g. gold salts, NSAIDs, penicillamines) - Diagnostic renal biopsy showing evidence of crescent formation in glomeruli, suggestive of an alternative or additional diagnosis to primary idiopathic MN. - Previous treatment with B-cell depleting or B-cell modifying agents such as, but not limited to rituximab, belimumab, daratumomab or bortezomib. - Previous treatment with immunosuppressive agents such as cyclophosphamide, chlorambucil, mycophenolate mofetil (or equivalent), cyclosporine, tacrolimus or azathioprine within 90 days prior to Day 1. Low dose systemic corticosteroid therapy is permitted, though the subject should have been on stable dose equivalent to ≤10 mg prednisolone for at least 90 days prior to Day 1. - Previous treatment with gemfibrozil or strong CYP2C8 inhibitors such as clopidogrel within 7 days prior to Day 1 - Presence or suspicion (based on judgment of the investigator) of active infection within 30 days prior to Day 1, or history of severe recurrent bacterial infections - Known contra-indications for the use of rituximab, including hypersensitivity to the active substance or to murine proteins, or to any of the excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections). Other contra-indications for the use of rituximab, including active, severe infection, patients in a severely immunocompromised state, severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease. ; PRIMARY OUTCOME: Ratio between baseline Urine Protein Creatinine Ratio and Urine Protein Creatinine Ratio at 24 weeks of treatment (from 24h urine collection); SECONDARY OUTCOME 1: Meausrement of Plasma levels of Bb and sC5b-9[/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 - CheckMate 647; BRIEF: The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL) ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Testicular Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Pathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line of systemic therapy - Measurable disease requirements on scans: PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion - Have tumor tissue for PD-L1 expression testing - Must have a Karnofsky performance status of 70-100 Exclusion Criteria: - a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot undergo MRI assessments c) PCNSL patients with systemic disease - Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first dose of nivolumab are excluded Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: BICR-Assessed Objective Response Rate (ORR); SECONDARY OUTCOME 1: BICR-Assessed Progression Free Survival (PFS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - AMT/P2GI/001 Part III; BRIEF: The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma. The primary endpoint is progression free survival rate at 18 weeks after registration ; DRUG USED: AMT2003; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Auron Healthcare GmbH; CRITERIA: Inclusion Criteria: - Cancer confirmed by histology or cytology - At least one measurable lesion - Advanced disease refractory to standard therapy or for which no standard therapy exists - Life expectancy of at least 3 months Exclusion Criteria: - Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma - Body weight below 45 kg - Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control - Confirmed diagnosis of HIV - Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II - Chemotherapy or radiotherapy less than 4 weeks prior to entry - Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery) - Participation in a clinical trial less than 30 days prior to entry in the study ; PRIMARY OUTCOME: Progression free survival;at 18 weeks after registration; SECONDARY OUTCOME 1: Best overall response rate (ORR, CR and PR) within 18 weeks after registration[/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 - ECHO-301/KEYNOTE-252; BRIEF: The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Have histologically or cytologically confirmed melanoma - Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy - A minimum of 1 measurable lesion by CT or MRI - Provide a baseline tumor biopsy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Exclusion Criteria: - Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy) - Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting - Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) - Has an active infection requiring systemic therapy - Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) - Has known history of or is positive for Hepatitis B or Hepatitis C - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]No</s>