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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 II - 003; BRIEF: The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control. ; DRUG USED: DMT210; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rosacea; TARGET: FPRL1 - Formyl peptide receptor homolog-1, Toll-Like Receptor 2 (TLR2); THERAPY: Monotherapy; LEAD SPONSOR: Dermata Therapeutics; CRITERIA: Inclusion Criteria: - Patient is male or non-pregnant female at least 18 years of age. - Clinical diagnosis of moderate to severe facial rosacea as determined by Investigators Global Assessment (IGA) at Randomization - Patient has at least ten inflammatory lesions of rosacea on the face at Randomization - Patient is willing to apply the Investigational Product as directed - Patient is willing and able to comply with the protocol Exclusion Criteria: - Patient is pregnant or planning to become pregnant - Patient is taking a topical therapy which may affect the patients rosacea ; PRIMARY OUTCOME: Efficacy as measured by Inflammatory lesion counts; SECONDARY OUTCOME 1: Incidence of adverse events as a measure of safety and tolerability[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ECOG E3A06 (Smoldering MM; NCI); BRIEF: This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following: - Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization - Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain (FLC) assay; FLC assay must be performed within 28 days of randomization - Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization - Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL) - Hemoglobin >= 11 g/dL within four weeks prior to randomization - Platelet count >= 100,000/mm^3 within four weeks prior to randomization - Absolute neutrophil count (ANC) >= 1,500/mm^3 within four weeks prior to randomization - Calculated creatinine clearance >= 30 mL/min within four weeks prior to randomization - Bilirubin =< 1.5 mg/dL within four weeks prior to randomization - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGPT) (aspartate aminotransferase [AST]) =< 2.5 times upper limit of normal within four weeks prior to randomization - No prior or concurrent systemic or radiation therapy for the treatment of myeloma - Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted - Prior or concurrent use of erythropoietin is disallowed - Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted - Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day - Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted - Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months - 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 - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 - Patients must not have baseline bone lesions or plasmacytomas - Patients with monoclonal gammopathy of undetermined significance are not eligible - Patients must not have grade 2 or higher peripheral neuropathy - Patients must not have active, uncontrolled infection - Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation - Patients should not have New York Heart Association classification III or IV heart failure - Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years - Patients should not be felt to have an immediate need for chemotherapy - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting cycle 1 of 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; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 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); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure - Human immunodeficiency virus (HIV) infection is not excluded; HIV+ 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 ; PRIMARY OUTCOME: Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint); SECONDARY OUTCOME 1: Proportion of Participants With Response (Phase II Secondary Endpoint)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ZEST (Elderly DLBCL); BRIEF: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy. ; DRUG USED: Zevalin; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 20 (CD20), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Participant was 60-years of age or older at time of randomization 2. Histologically confirmed Ann Arbor stage II, III, or IV diffuse large B-cell lymphoma (DLBCL); or follicular lymphoma (FCL) Grade 3B according to the Revised European American lymphoma (REAL)/ World health organization (WHO) classification (from initial diagnosis made prior to starting R-CHOP therapy. Results from a pre R-CHOP marrow shall be available for review. 3. Local pathology review confirming the DLBCL diagnosis and cluster of differentiation 20 (CD20) positivity, and no evidence of DLBCL in bone marrow upon confirmation of complete remission (CR). 4. A paraffin block or original slides available for confirmatory pathology review. Participants may be randomized based on the local pathology result. 5. Age-adjusted international prognostic index (IPI) of 1, 2, or 3. The age-adjusted IPI was defined by one point for Lactate dehydrogenase (LDH) > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ eastern cooperative operations group (ECOG) performance status >1. 6. First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) chemotherapy. Participants who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible. 7. Complete remission (CR) according to the International Workshop Response Criteria for non-Hodgkins lymphoma (NHL) described by Cheson et al after first-line treatment. Computerized tomography (CT) scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of chemotherapy. Applicability of the neck CT means that the participant had involvement of the neck region by palpation / physical examination at first diagnosis. 8. A negative Fluorine-18-deoxyglucose positron emission tomography (FDG-PET) scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735). 9. Bone marrow cellularity greater than 15%, no evidence of myelodysplasia morphologically and no evidence of involvement with lymphoma either at the pre R-CHOP marrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeat marrow is required for participant randomized to the Zevalin arm only. 10. A world health organization/eastern cooperative oncology group (WHO/ECOG) performance status of 0, 1 or 2. 11. Adequate hematopoietic functions: Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/ liter (L), Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 10^9/L. 12. Life expectancy of 6 months or longer. 13. Written informed consent obtained according to local guidelines. Exclusion Criteria: 1. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, participants treated for Stage I or II cancers are eligible provided they have a life expectancy of > 5 years. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer. 2. Prior radioimmunotherapy, including radiation therapy for Non-Hodgkins lymphoma) NHL, or any other NHL therapy. 3. Presence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis. 4. Histological transformation of low-grade NHL. 5. Active hepatitis B or C. 6. Known history of human immunodeficiency virus (HIV) infection. 7. Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease. 8. Abnormal renal function: serum creatinine > 2.0 × ULN. 9. Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment. 10. Known hypersensitivity to murine or chimeric antibodies or proteins. 11. Granulocyte-colony stimulating factor (G-CSF) or Granulocyte macrophage-colony stimulating factor (GM-CSF) therapy within 4 weeks prior to Zevalin or observation. 12. Concurrent severe and/or medically uncontrolled disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study. 13. Treatment with investigational drugs less than 4 weeks prior to Zevalin or observation. 14. Major surgery less than 4 weeks prior to Zevalin or start of observation. 15. Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment. Participants on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20 milligram (mg) daily, stable for 4 weeks, are permissible. 16. Unwillingness or inability to comply with the protocol. ; PRIMARY OUTCOME: Overall Survival (OS) for Living Participants; SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Lateral Canthal Lines; BRIEF: A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL). ; DRUG USED: DAXI; DRUG CLASS: Biologic; INDICATION: Wrinkles; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Revance Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed - Be outpatient, male or female subjects, in good general health, 18-65 years old - Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS - Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study. Exclusion Criteria: - Active skin disease, infections, or inflammation at the injection sites - History of clinically significant bleeding disorders - Clinically significant laboratory values at screening that may interfere with a subjects ability to complete the study, as determined by the investigator - Planned or anticipated need for surgery or hospitalization through the end of the study - Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception - Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study ; PRIMARY OUTCOME: Percentage of Participants With None or Mild in LCL Severity at Maximum Smile; 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 - Extension; BRIEF: This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy ; DRUG USED: Iptacopan; DRUG CLASS: New Molecular Entity (NME); INDICATION: C3 Glomerulopathy (C3G), including Dense Deposit Disease (DDD) and C3 Glomerulonephritis (C3GN); TARGET: Factor D (alternate complement pathway); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients must have completed the treatment period of the CLNP023X2202 or CLNP023B12301 trial on study drug Exclusion Criteria: - Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study - Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening. - History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects - History of HIV or any other immunodeficiency disease ; PRIMARY OUTCOME: CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint; SECONDARY OUTCOME 1: CLNP023X2202: Number of participants who achieve the 2-component composite renal endpoint[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CPA368-10; BRIEF: Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by monitoring vital signs, ECG and adverse events. ; DRUG USED: Rapibloc; DRUG CLASS: Non-NME; INDICATION: Dysrhythmia (Arrhythmia); TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: AOP Orphan Pharmaceuticals AG; CRITERIA: Inclusion Criteria: - Male and female human subjects, age 18-45 years - Body weight of at least 50 kg, maximum of 90 kg. Body-mass index 18.5 to 30.0 kg/m2 - Caucasians - Subjects without clinically relevant abnormalities - Subjects agreeing to not using any prescription and over the counter medications including vitamins and minerals for 7 days prior to study and during the course of the study - No drug or alcohol abuse - Non-smokers, ex smokers and mild smokers Exclusion Criteria: - Subjects with history or presence of clinically relevant cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or skin diseases. - Subjects with bradycardia (heart rate below 50 bpm), tachycardia (heart rate above 100 bpm), hypotension (systolic blood pressure below 100 mmHg, and/or diastolic blood pressure below 70 mm Hg) at screening, clinically relevant or history of clinically relevant arrhythmias - Subjects with clinically relevant cardiac supraventricular or ventricular arrhythmias. - Subjects with atrioventricular block of grade II and III, sick sinus syndrome, sinoatrial block or congestive heart failure - Participation in a clinical drug study or bioequivalence study 60 days prior to present study. - History of malignancy or other serious diseases. - Any contraindication to blood sampling. - History of i.v. drug abuse. - Subjects with positive HIV tests, HBsAg or Hepatitis C tests or other acute, subacute or chronic infectious disease. ; PRIMARY OUTCOME: Pharmacokinetics/dynamics; SECONDARY OUTCOME 1: Local 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 IIa - ICP-3718-201; BRIEF: This study is meant to assess the effect of IW-3718 as an added treatment to ongoing once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience symptoms of their gastroesophageal reflux disease (GERD). ; DRUG USED: IW-3718; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Bile Acids; THERAPY: Monotherapy; LEAD SPONSOR: Ironwood Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Patient is between 18 and 65 years of age at the Screening Visit; females must not be pregnant or must not be breastfeeding; - Patient has a confirmed diagnosis of gastroesophageal reflux disease, must be currently taking a proton pump inhibitor (PPI), and must be experiencing GERD symptoms as specified by the protocol. Exclusion Criteria: - Patient may not meet any of the excluded conditions specified in the protocol; - Patient is experiencing alarm symptoms such as GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss; - Patient has a clinically significant hypersensitivity or allergies to any of the active ingredients or excipients in the study medication. ; PRIMARY OUTCOME: Exploratory Endpoints - GERD Symptoms; 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 - vs. Placebo (High Recurrance Risk); BRIEF: The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to placebo in the treatment of patients with localized, primary gastrointestinal stromal tumor (GIST) after complete surgery and with high risk of recurrence. ; DRUG USED: Masitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastrointestinal Stromal Tumor (GIST); TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: AB Science; CRITERIA: Inclusion Criteria: 1. Patient with histologic diagnosis of localized, primary GIST 2. Patient with measurable primary tumor lesion using conventional techniques or spiral CT scan assessed before tumor resection 3. Patient stopped imatinib as adjuvant therapy without progression OR patient not eligible for imatinib as adjuvant therapy 4. Patient with a high risk of recurrence, i.e., patients with primary tumor diameter > 5 cm and mitotic count > 5/50 HPF, or tumor diameter > 10 cm and any mitotic count, or tumor of any size with mitotic count > 10/50 HPF, or tumors that have ruptured into the peritoneal cavity 5. Patient without peritoneal or distant metastasis 6. Patient with c-kit (CD117) positive primary tumor detected immuno-histochemically 7. Patient after gross tumor resection (regardless of microscopic margins) within the past 14-70 days after surgery (R0 resection: negative microscopic margins or R1 resection: positive microscopic margins) 8. Patient free of tumor by post-operative imaging that included a baseline chest x-ray (or chest CT) and a post-operative abdomen and pelvis CT scan with intravenous and oral contrast or MRI with intravenous contrast within 28 days before the randomization 9. Patient with ECOG ≤ 2 10. Patient with adequate organ functions: - Absolute neutrophils count (ANC) ≥ 1.5 x 109/L - Hemoglobin ≥ 10 g/dL - Platelets (PTL) ≥ 75 x 109/L - AST/ALT ≤ 3x ULN - Gamma GT < 2.5 x ULN - Bilirubin ≤ 1.5x ULN - Normal creatinine or if abnormal creatinine, creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula) - Albumin > 1 x LLN - Proteinuria < 30 mg/mL (1+) on the dipstick. If proteinuria is ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours 11. Patient with life expectancy > 3 months 12. Male or female patient, age >18 years 13. Patient weight > 40 kg and BMI > 18 kg/m² 14. Male and female patient of child bearing potential must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. Female patient of child bearing potential must have a negative pregnancy test at screening and baseline 15. Patient able and willing to comply with study procedures as per protocol 16. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment 17. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent 18. Patient covered by insurance Exclusion Criteria: 1. Patient with metastases of the primary GIST tumor 2. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ 3. Patient progressed under imatinib as adjuvant therapy 4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis 5. Patient presenting with cardiac disorders defined by at least one of the following conditions: - Patient with recent cardiac history (within 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) - Patient with cardiac failure class III or IV of the NYHA classification - Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) - Syncope without known etiology within 3 months - Uncontrolled hypertension or symptomatic hypertension, where hypertension is defined by systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg and uncontrolled means that SBP lower than 140 mmHg and DBP lower than 90 mmHg are not achieved despite anti-hypertensive drugs, whatever the reason of failure (inadequate treatment, poor compliance, secondary hypertension or resistant hypertension). 6. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 7. Pregnant, or nursing female patient Previous treatment 1. Patient previously treated with chemotherapy, radiation therapy, or investigational treatment following surgery Wash-out 1. Treatment with any investigational agent within 4 weeks prior to Baseline visit 2. For patients treated with imatinib as adjuvant therapy, end of imatinib treatment must be between 5 days and 12 weeks prior to baseline ; PRIMARY OUTCOME: Recurrence Free Survival (RFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ARDS (Korea); BRIEF: Prevention of COVID-19 infection to severe pneumonea or ARDS ; DRUG USED: EC-18; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Triglycerides; THERAPY: Monotherapy; LEAD SPONSOR: Enzychem Lifesciences Corporation; CRITERIA: Inclusion Criteria: - Signed informed consent - Male or female age 19 years or older - Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia Exclusion Criteria: - Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia - Pregnant or nursing at the time of signing informed consent - Known sensitivity to any study medication - Unwilling or unable to complete study diary - Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol ; PRIMARY OUTCOME: Rate of transition to ARDS; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - On Hemodialysis; BRIEF: Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period ; DRUG USED: Ibsrela; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Sodium-hydrogen exchanger 3 (NHE3) ; THERAPY: Monotherapy; LEAD SPONSOR: Ardelyx; CRITERIA: Inclusion Criteria: 1. Females and males aged ≥18 years 2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months 3. Prescribed and taking at least 3 doses of phosphate binder per day 4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening 5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening 6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out Exclusion Criteria: 1. Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit. 2. Serum parathyroid hormone >1200 pg/mL 3. Significant metabolic acidosis 4. Clinical signs of hypovolemia at randomization - ; PRIMARY OUTCOME: Change in Serum Phosphate Levels; SECONDARY OUTCOME 1: Change From Baseline in Calcium x Phosphorus Product[/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 - Biomarker Study (MDACC); BRIEF: The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical markers in the blood and/or tissue that may be related to a reaction to study treatment. The safety of the study treatments will also be studied. ; DRUG USED: Cixutumumab; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types II and III according to the World Health Organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. Patients with skin squamous cell carcinomas of the head and neck region will also be included in this study. 2. There is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. No anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. If a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization. 3. Prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months. 4. The patient has a fasting serum glucose < 130 mg/dL and HbA1C < 7.0%. Patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition. 5. The patient has adequate renal function, defined by serum creatinine </= 1.5 x the institutional upper limit of normal (ULN), or creatinine clearance >/=60 mL/min for patients with creatinine levels above the ULN. 6. Because the teratogenicity of cetuximab and IMC-A12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 7. The patient is age >/= 18 years. 8. The patient or the patients legally authorized representative has the ability to understand and the willingness to sign a written informed consent document. 9. ECOG performance status of 0-2. Exclusion Criteria: 1. Patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation. 2. Patients receiving concomitant radiation. 3. Prior treatment with an agent targeted at the insulin-like growth factor-1 receptor. 4. History of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or IMC-A12. 5. Pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded). 6. Patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s). ; PRIMARY OUTCOME: AKT Modulation; SECONDARY OUTCOME 1: Number of Participants With Objective Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RLM-MD-02; BRIEF: This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms. ; DRUG USED: Relamorelin; DRUG CLASS: Biologic; INDICATION: Diabetic Gastroparesis; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Diagnosis of Type 1 or Type 2 diabetes mellitus - Meet the per protocol criteria of diabetic gastroparesis - Compliance with diary - Compliance with the per protocol study treatment dosing instructions Exclusion Criteria: - Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube - Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1) - Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity - History of gastrointestinal disorders that may be similar to gastroparesis - Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus ; PRIMARY OUTCOME: Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS); SECONDARY OUTCOME 1: Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EMERALD (ER+/HER2-); BRIEF: This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) . ; DRUG USED: Elacestrant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Selective Estrogen Receptor Degrader (SERD); THERAPY: Monotherapy; LEAD SPONSOR: Stemline Therapeutics, Inc.; CRITERIA: Critical Inclusion Criteria: 1. Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy. 2. Subjects must be appropriate candidates for endocrine monotherapy 3. Subjects must have measurable disease or nonmeasurable (evaluable) bone-only disease 4. Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women and male subjects must not allow pregnancy with their sperm (abstain, do not donate sperm, etc). 5. Subjects must have ER+/HER2- tumor status 6. Subjects must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria. 7. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI). 8. Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting. 9. Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing with Guardant360CDx® before subject is randomized. Critical Exclusion Criteria: 1. Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist. 2. Prior anticancer or investigational drug treatment within the following windows: 1. Fulvestrant treatment < 28 days before first dose of study drug 2. Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects) 3. Chemotherapy < 21 days before first dose of study drug 4. Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor 3. Presence of symptomatic visceral disease as defined in protocol. ; PRIMARY OUTCOME: Progression-free Survival in ESR1-mut Subjects; SECONDARY OUTCOME 1: Overall Survival in ESR1-mut 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 II - Polycystic Ovary Syndrome; BRIEF: The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women. ; DRUG USED: LIK066; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycystic Ovary Syndrome (PCOS); TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or oligomenorrhea and exclusion of other causes of hyperandrogenism. - Overweight/obese female subjects with BMI of 28 - 45 kg/m^2, inclusive, and stable weight +/- 3 kg over previous 3 months - Subjects must use non-hormonal methods of contraception during the study. Key Exclusion Criteria: - Subjects with exogenous causes of hirsutism - Menstruation in the 30 days prior to screening or treatment - Pregnant or nursing (lactating) women - Use of prohibited medications - Preexisting medical condition which may significantly alter the absorption, metabolism, or excretion of the study drug, or which may jeopardize the subject in case of participation in the study ; PRIMARY OUTCOME: Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline; SECONDARY OUTCOME 1: Change From Baseline in Luteinizing Hormone (LH) at Day 15[/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 IIa - Viral Load (Study 202); BRIEF: The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV) ; DRUG USED: Vebicorvir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV; THERAPY: Combination; LEAD SPONSOR: Assembly Biosciences; CRITERIA: Key Inclusion Criteria: - Male or female between ages 18 and 70 years - HBeAg-positive at screening - In good general health except for cHBV - HBV viral load ≥2×105 IU/mL - Hepatitis B surface antigen (HBsAg) >1000 IU/mL at screening Key Exclusion Criteria: - Any prior treatment with lamivudine or telbivudine, previous treatment with an investigational agent for HBV other than ABI-H0731; or any other SOC treatment for >4 weeks - Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV) - History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening - Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the participant unsuitable for the study - Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening - History of hepatocellular carcinoma (HCC) - Females who are lactating or pregnant or wish to become pregnant are excluded from the study - Exclusionary laboratory parameters at screening: - Platelet count <100,000/mm3 - Albumin <lower limit of normal (LLN) - Direct bilirubin >1.2×upper limit of normal (ULN) - Alanine aminotransferase (ALT) >10×ULN at screening - Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is >ULN but <100 ng/mL, participant is eligible if a hepatic imaging study prior to the initiation of study drug reveals no lesions suspicious of possible HCC - International Normalized Ratio (INR) >1.5×ULN - Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation ; PRIMARY OUTCOME: Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV; SECONDARY OUTCOME 1: Number of Participants One or More 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 I/II - EVOLVE; BRIEF: This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA). ; DRUG USED: Elamipretide (Systemic Delivery); DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: Mitochondria, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Stealth BioTherapeutics Inc.; CRITERIA: Inclusion Criteria: - ≥40 and ≤80 years old. - Patients with hypertension (systolic blood pressure [BP] >155 mm Hg) and/or requiring 2 or more antihypertensive medications: no restrictions will be placed on antihypertensive agents, although loop diuretics will be temporarily changed to diluting site agents (eg, hydrochlorothiazide, indapamide, metolazone) prior to each blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI) study performed during the trial, unless, in the judgment of the Investigator, the change represents a hazard to the patient. ARAS patients will be identified based upon radiologic and clinical criteria suggestive of renovascular hypertension and/or hemodynamically significant renovascular disease >60% lumen occlusion (determined by quantitative computed tomography angiography or Doppler ultrasound velocity >200 cm/sec). - Have an estimated glomerular filtration rate of ≥15 ml/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula. - Have no contraindications to angiography such as severe contrast allergy. - Have no contraindications to non-contrast magnetic resonance evaluations such as a pacemaker or magnetically active metal fragments. - Able to comply with protocol. - Women of childbearing age must: - Have a negative pregnancy serum human chorionic gonadotropin test prior to receiving study drug. - Agree to use two forms of contraception for 3 months following receipt of the study drug. - Men who are sexually active and able to father a child, must agree to use one of the birth control methods listed below for the entire study and for at least 2 months after receiving the study drug: - Barrier methods (such as a condom or diaphragm) used with a spermicide. - Hormonal methods used by his partner, such as birth control pills, patches, injections, vaginal ring, or implants. - Intrauterine device (IUD) used by his partner. - Abstinence (no sex). - Competent and able to provide written informed consent Exclusion Criteria: - Advanced chronic kidney disease defined as either Stage 5 or end-stage renal disease requiring dialysis. - Have other clinically significant abnormalities or laboratory results that would, in the opinion of the investigators, compromise the safety of the patient including evidence of diabetic ketoacidosis, paraproteinemia, or triglycerides above 600 mg/dL. - Clinically significant medical conditions within the six months before administration of Bendavia (e.g., cancer, stroke, myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient. - Have received an investigational drug within thirty (30) days of baseline. - Have a serum sodium <135 mmol/L on the day of, and prior to, the PTRA. - Are pregnant or breast feeding. ; PRIMARY OUTCOME: Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.; SECONDARY OUTCOME 1: Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.[/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 - 002; BRIEF: This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503. The primary hypotheses are as follows: 1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated. 2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3. 3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3. 4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3. ; DRUG USED: Gardasil 9; DRUG CLASS: Vaccine; INDICATION: Human papillomavirus (HPV) Prevention (Antiviral, Vaccines); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: Boys and Girls Age 9 to 15: - Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7 Women Age 16 to 26: - Participant has never had Pap testing or has had only normal results - Participant has had 0 to 4 sexual partners at the time of enrollment Exclusion Criteria: Boys and Girls Age 9 to 15: - History of allergic reaction that required medical intervention - Currently enrolled in any other clinical study - Participant is pregnant - Participant is immunocompromised or has taken immunosuppressants in the last year - Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial - Participant has a history of positive test for HPV Women Age 16 to 26: - History of allergic reaction that required medical intervention - Currently enrolled in any other clinical study - Participant is pregnant - Participant is immunocompromised or has taken immunosuppressants in the last year - Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial - Participant has a history of positive test for HPV - Participant has a history of abnormal cervical biopsy result - Participant has a history of external genital lesions ; PRIMARY OUTCOME: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]); SECONDARY OUTCOME 1: Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 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 - KEYNOTE-630 (Adjuvant); BRIEF: This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS). ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Skin Cancer - Squamous Cell Carcinoma (SCC) ; 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 histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another type of primary cancer or from an unknown primary cancer is not permitted) - Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy - Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided - Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization - Has received an adequate post-op dose of RT (either hypofractionated or conventional) - Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization - Is not pregnant or breastfeeding - Is not a person of childbearing potential (POCBP) - Has a negative pregnancy test ≤72 hours before the first dose of study intervention. - Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing - Has a life expectancy of >3 months - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days prior to the first dose of study intervention. Exclusion Criteria: - Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization - Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowens disease; Merkel cell carcinoma; or melanoma - Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another costimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) - Has received prior systemic anticancer therapy including investigational agents for cSCC ≤4 weeks prior to before start of study intervention. - Has not recovered from all radiation-related toxicities and has not had radiation pneumonitis - Has received a live vaccine ≤30 days prior to the first dose of study intervention - Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. - Has known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Other exceptions may be considered with Sponsor consultation. Note: Participants with low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or T2a with a Gleason score ≤6 and a prostate-specific antigen (≤10 ng/ml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation. Early stage asymptomatic CLL without prior treatment and without any of the risk features (unmutated IGHV, lymphocytes >15,000μL, palpable lymph nodes) will be eligible for the study - Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid). - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has an active infection requiring systemic therapy - Has a known history of human immunodeficiency virus (HIV) infection - Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection - 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 intervention - Has had an allogeneic tissue/solid organ transplant ; PRIMARY OUTCOME: Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy; SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - IFN-Free w/Asunaprevir (Japan, GT-1b); BRIEF: To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment. ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Subjects chronically infected with HCV Genotype 1 - HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening Exclusion Criteria: - Subjects with evidence of liver cirrhosis - Evidence of HCC - Co-infection with hepatitis B virus, HIV ; PRIMARY OUTCOME: Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs; SECONDARY OUTCOME 1: The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities[/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 - 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 III - ELATIVE; BRIEF: The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study has two main parts; the first part will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment), and will last between a minimum of one year and a maximum of two years. In the second part, all participants will receive elafibranor, for a period between 4-5 years. The main aim of this study is to determine if elafibranor is better than placebo at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participants disease. This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as pruritus and fatigue. ; DRUG USED: Elafibranor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: PPAR alpha, PPAR delta; THERAPY: Monotherapy; LEAD SPONSOR: Ipsen; CRITERIA: Inclusion Criteria - Males or females age of 18 to 75 years (inclusive) - Definite or probable PBC diagnosis - ALP ≥ 1.67x upper limit of normal (ULN) - Total bilirubin (TB) ≤ 2x ULN - UDCA for at least 12 months (stable dose ≥ 3 months) prior to screening, or unable to tolerate UDCA treatment (no UDCA for ≥ 3 months) prior to screening (per country standard-of-care dosing) - Must have PBC Worst Itch NRS collected prior to randomization - Females participating in this study must be of non-child bearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the last drug intake Exclusion Criteria: - History or presence of other concomitant liver disease - Clinically significant hepatic decompensation, including patients with complications of cirrhosis/portal hypertension - Medical conditions that may cause non-hepatic increases in ALP (e.g., Pagets disease) or which may diminish life expectancy to < 2 years, including known cancers - Patient has a positive test for HIV Type 1 or 2 at screening, or patient is known to have tested positive for HIV - Evidence of any other unstable or untreated clinically significant disease - History of alcohol abuse - For female patients: known pregnancy or lactating - Use of fibrates and glitazones within 2 months prior to screening - Use of OCA, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs - (including α-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin) within 3 months prior to screening - Use of antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines within 12 months prior to screening - For patients with previous exposure to obeticholic acid (OCA), OCA should be discontinued 3 months prior to screening - Patients who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to screening; for patients with previous exposure to seladelpar, seladelpar should be discontinued 3 months prior to screening - ALT and/or AST values > 5 x ULN - For patients with AT or TB>ULN at SV1, variability of AT or TB > 40% (see section 3.5.1) - Albumin<3.0 g/dl - Severely advanced patients according to Rotterdam criteria (TB > ULN and albumin <LLN) - INR > 1.3 due to altered hepatic function - CPK > 2 x ULN - Screening serum creatinine > 1.5 mg/dl - Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney failure damage or eGFR < 60 mL/min/1,73 m2) calculated by MDRD - Platelet count < 150 x 103/μL - AFP > 20 ng/mL with 4-phase liver CT or MRI imaging suggesting presence of liver cancer - Known hypersensitivity to the investigational product or to any of the formulation excipients of the elafibranor or placebo tablet Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain ; PRIMARY OUTCOME: Percentage of participants with response to treatment measured by the combination levels of Alkaline Phosphate Levels (ALP) and Total Bilirubin (TB); SECONDARY OUTCOME 1: Percentage of participants who normalised ALP levels[/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 - Pediatric ; BRIEF: Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects ; DRUG USED: Cat-SPIRE; DRUG CLASS: Vaccine; INDICATION: Allergic Rhinitis; TARGET: Immune System, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Circassia Limited; CRITERIA: - Inclusion Criteria - Male or female, aged 5-12 years. - Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years. - Subjects may optionally also have GINA Step 1 controlled asthma. - Positive skin prick test to cat hair. - Cat dander specific IgE ≥0.35 kU/L. - Exclusion Criteria - Asthma falling under the GINA definitions partly controlled and uncontrolled or Steps 2 to 5. - FEV1 <80% of predicted. - Clinically relevant abnormalities detected on physical examination. - History of severe drug allergy, severe angioedema or anaphylactic reaction to food. ; PRIMARY OUTCOME: Number of Subjects With AEs; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Following TURBT (Japan & Korea); BRIEF: The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT. ; DRUG USED: Qapzola; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Nippon Kayaku Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Patients who have provided written informed consent 2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria: - The maximum number of tumors is 5. - Each tumor diameter: ≤ 3.5 cm. 3. Age: ≥20 years old at enrollment. 4. The functions of the major organs are adequate, and the following test value criteria are satisfied: - Neutrophil count ≥1,500/μL - Platelet count ≥10×10^4/μL - Hemoglobin ≥10 g/dL Exclusion Criteria: 1. Patients with a single, primary bladder cancer of <0.5 cm. 2. Patients with CIS lesions in the bladder or a history thereof. 3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease. 4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months). 5. Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening 6. Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof. 7. Patients who had been administered EO9 in the past. 8. Patients who had been administered any other investigational drug within the past 30 days. 9. Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia. ; PRIMARY OUTCOME: The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer; SECONDARY OUTCOME 1: The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer[/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 - LixiLan-D; BRIEF: Primary Objective: - To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population. - To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians). Secondary Objective: - To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated. - To assess the change in daily insulin glargine dose within each ethnic/racial subgroup. - To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup. ; DRUG USED: Soliqua 100/33; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the screening visit (signing of informed consent). - Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c (HbA1c) between 7.5% and 10% (inclusive). - Participants who were Hispanics of any race, non-Hispanic black/African Americans or non-Hispanic Asians. Note: Decision for ethnic/racial inclusion was made based on the participants self-identification. Mixed-race participants must select 1 of the above-mentioned categories. If such selection could not be made, the candidate would be ineligible to participate in the study. - Participants who had been treated with any basal insulin (ie, glargine - U100 or U300, detemir, degludec, intermediate-acting [human Neutral Protamine Hagedorn (NPH]) for at least 6 months prior to Visit 1. - The basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to Visit 1. - The basal insulin dose had been stable (defined as up to ±20% [1/5 of the dose] variability) for at least 2 months prior to Visit 1 within the following dose ranges: - 15 to 50 units/day if HbA1c at Visit 1 is less than or equal to (<=)8.5%, and - 15 to 40 units/day if HbA1c at Visit 1 is greater than (>)8.5%. - Participants receiving 1 or 2 of the following OAD drugs: metformin, pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (SGLT-2) inhibitor or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1. Exclusion criteria: - Age <18 years of age at Visit 1. - A body mass index (BMI) <=20 or >40 kg/m^2 at Visit 1. - Fasting plasma glucose (FPG) >200 mg/dL (by central lab measurement) at Visit 1 (1-time repeat measurement before Visit 2 is permitted). - Type 1 DM or any diabetes other than T2DM. - Any use of OAD drugs other than those described in the inclusion criteria (e.g., but not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl peptidase 4 (DPP4) inhibitors) within 12 weeks prior Visit 1. - Use of any other type of insulin except for basal insulin (e.g., prandial or premixed insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term treatment (i.e, <=10 days) with other insulin types due to intercurrent illness was permitted at the discretion of the Investigator. - Known history of discontinuation of treatment with a GLP-1 RA due to safety/tolerability reasons. - Use of systemic glucocorticoids for a total duration of >7 days within 12 weeks prior to Visit 1. - Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit 1. The above information is not intended to contain all considerations relevant to a participantss potential participation in a clinical trial. ; PRIMARY OUTCOME: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26; SECONDARY OUTCOME 1: Percentage of Participants Achieving HbA1c Target of <7% at Week 26[/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 IIa - EU SOM; BRIEF: GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM) ; DRUG USED: Avasopasem Manganese; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mucositis; TARGET: SOD1; THERAPY: Monotherapy; LEAD SPONSOR: Galera Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT. 2. Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy. 3. Patients who have had prior surgery may be eligible, 4. Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses). 5. Age 18 years or older 6. ECOG performance status ≤ 2 7. Adequate hematologic function 8. Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN Exclusion Criteria: 1. Metastatic disease 2. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites 3. Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT 4. Planned concurrent chemotherapy other than single agent cisplatin 5. Receiving any approved or investigational anti-cancer agent 6. Concurrent participation in another interventional clinical study 7. Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures 8. Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline 9. Malignant tumors other than head and neck cancer (HNC) within the last 5 years 10. Active infectious disease excluding oral candidiasis 11. Presence of oral mucositis at baseline. 12. Known history of human immunodeficiency virus (HIV) or active hepatitis B/C 13. Female patients who are pregnant or breastfeeding 14. Known allergies or intolerance to cisplatin and similar platinum-containing compounds 15. Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating Investigator, create a risk for a precipitous decrease in blood pressure. ; PRIMARY OUTCOME: Incidence of Treatment Emergent AEs; SECONDARY OUTCOME 1: Cumulative Incidence of Severe OM[/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 - ELOQUENT-1; BRIEF: The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS) ; DRUG USED: Empliciti; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: CS1/SLAMF7, Immune System; THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who: - have not received any prior systemic anti-myeloma therapy AND - have measurable disease AND - are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old Exclusion Criteria: - Subjects with non-secretory or oligo-secretory or free light-chain only myeloma - Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions - Monoclonal Gammopathy of Undetermined Significance (MGUS) - Active plasma cell leukemia - Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/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 - w/Keytruda; BRIEF: You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma. The goal of Part 2 of this study is to learn if the combination can help to control metastatic melanoma. The safety of this drug combination will also be studied. This is an investigational study. APX005M is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. The combination of these drugs to treat metastatic melanoma is investigational. The study doctor can explain how the study drug is designed to work. Up to 41 participants will be treated in this study. All will take part at MD Anderson. ; DRUG USED: APX005M; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Histologically or cytologically confirmed malignant melanoma from skin, or mucosal melanoma (i.e. ocular melanoma subjects are not eligible) 3. Measurable, unresectable stage III (in transit lesions) or stage IVA, IVB, IVC disease 4. At least two injectable lesions (amenable for direct injection or through the use of image guidance such ultrasound [US], CT or MRI) defined as any injectable cutaneous, subcutaneous, nodal, or visceral melanoma lesion >/= 10 mm in longest diameter 5. Age >/= 18 years 6. ECOG performance status 0 or 1 7. Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilberts Syndrome who must have a total bilirubin less than 3.0 mg/dl. 8. Platelet count greater than or equal to 100,000/mm^3 9. WBC >3000/mm^3 10. ANC>= 1500/mm^3 11. Hemoglobin >9 g/dL 12. Serum ALT and AST <3 the upper limit of normal (ULN); <5 ULN if there is liver involvement secondary to the tumor 13. Serum creatinine </= 2.0 mg/dl 14. Seronegative for HIV antibody 15. Patients with a negative pregnancy test (urine or serum) must be documented within 14 days of screening for women of childbearing potential (WOCBP). A WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e. who has not had menses at any time in the preceding 12 consecutive months). 16. Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study and for 4 months after the last dose of APX005M or Pembrolizumab such as: condom, diaphragm, hormonal, IUD, or sponge plus spermicide. Abstinence is an acceptable form of birth control. Exclusion Criteria: 1. Patients who have previously received pembrolizumab or PD-/L1 blockade therapy. Adjuvant IFN-a, is allowed if last dose was received at least 6 months of starting study treatment. 2. Active autoimmune disease requiring disease-modifying therapy. 3. Concurrent systemic steroid therapy higher than physiologic dose (>7.5 mg/day of prednisone or equivalent). 4. Any form of active primary or secondary immunodeficiency. 5. Patients with history of hematologic malignancy. 6. Active coagulopathy. 7. History of New York Heart Association class 3-4 congestive heart failure or history myocardial infarction within 6 months of starting study treatment. 8. History of arterial thrombosis within 3 months of starting study treatment. 9. History of clinically manifested CNS metastases, except if brain metastases have been treated, are stable and are asymptomatic 10. Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years. 11. Subjects who have received prior immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1), anti-CD40. 12. Subjects that have received experimental vaccines or other immune therapies should be discussed with the Principal Investigator to confirm eligibility. 13. Active known clinically serious infections (> Grade 2 NCI-CTCAE version 4.03). 14. Prior systemic therapy, radiation therapy, or surgery within the 28 days of starting study treatment. Palliative radiotherapy to a limited field or palliative cryoablation is allowed after consultation with the Principal Investigator, at any time during the study participation including screening. 15. Women of child-bearing potential (WOCBP), women who are pregnant, or women who are nursing. ; PRIMARY OUTCOME: Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D) of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma - Dose Escalation Phase; SECONDARY OUTCOME 1: Immune-Related Best Overall Response (irBOR) of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma[/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 - A2223 - Chronic Plaque; BRIEF: This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Chronic plaque-type psoriasis diagnosed for at least 6 months - Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10% - Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy Exclusion criteria: - Forms of psoriasis other than chronic plaque-type - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis - History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit - Pregnant or nursing (lactating) women ; PRIMARY OUTCOME: Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12; SECONDARY OUTCOME 1: Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Pregabalin; BRIEF: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs. ; DRUG USED: ABT-639; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Voltage-gated calcium channels; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. - Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit. Exclusion Criteria: - Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP. - A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions. - Subject has clinically significant abnormalities in clinical laboratory tests. ; PRIMARY OUTCOME: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subjects daily diary; SECONDARY OUTCOME 1: Patients Global Impression of Change[/INST]No</s>

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

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - A3921040 - Japan; BRIEF: To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity. Exclusion Criteria: - Current therapy with any DMARD ; PRIMARY OUTCOME: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12; SECONDARY OUTCOME 1: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 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 - 1218.61 (w/Metformin/Pioglitazone); BRIEF: The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control. ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of diabetes mellitus prior to informed consent 2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks) 3. Glycosylated haemoglobin A1 >= 7.5% and <= 10% 4. Age between 18 and less than 80 5. - Body Mass index less or equal to 45 Exclusion criteria: 1. Uncontrolled hyperglycaemia during run in period 2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent 3. Impaired hepatic function 4. Gastric by pass surgery 5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent 6. Treatment with anti-obesity drugs 7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent 8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial ; PRIMARY OUTCOME: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks; SECONDARY OUTCOME 1: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pulmonary Function (115805); BRIEF: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Signed and dated written informed consent - Male or females ≥ 40 years of age - Females must be post-menopausal or using a highly effective method for avoidance of pregnancy - Established clinical history of COPD by ATS/ERS definition - Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III) - Former or current smoker ≥10 pack years - A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following: - Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD) - Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD) - Previous stroke - Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional) - Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary) OR - Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker): - Current diagnosis of hypertension - Current diagnosis of hypercholesterolemia - Diabetes mellitus treated with pharmacotherapy Exclusion Criteria: - Current diagnosis of asthma - Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases - Lung volume reduction surgery within previous 12 months - Clinically significant abnormalities not due to COPD by chest X-ray or CT scan - Hospitalized for poorly controlled COPD within 12 weeks of Screening - Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician - Lower respiratory infection requiring antibiotics 6 weeks prior to Screening - A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period - An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization - An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization - An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects) - Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities - Carcinoma not in complete remission for at least 5 years - History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subjects participation will also be excluded - Known/suspected history of alcohol or drug abuse in the last 2 years - Women who are pregnant or lactating or plan to become pregnant - Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit - Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications) - Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day - Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study - Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments - Non-compliance or inability to comply with study procedures or scheduled visits - History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study - Affiliation with investigator site - Women who are pregnant or lactating or are planning on becoming pregnant during the study ; PRIMARY OUTCOME: Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84; SECONDARY OUTCOME 1: Time to Onset on Treatment Day 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 - w/Cemiplimab; BRIEF: The purpose of this study is to evaluate the safety and clinical activity of plerixafor in combination with cemiplimab in patients with metastatic pancreatic cancer. ; DRUG USED: Mozobil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Combination; LEAD SPONSOR: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; CRITERIA: Inclusion Criteria: Age ≥18 years. - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Have histologically or cytologically-proven ductal pancreatic cancer. - Have metastatic disease. - Have documented radiographic disease progression after previous systemic chemotherapy given in a neoadjuvant, adjuvant, locally advanced or metastatic setting. - Patients with the presence of at least one measurable lesion. - Willing to have to a tumor biopsy. - Life expectancy of greater than 3 months. - Patients must have adequate organ and marrow function defined by study - specified laboratory tests. - Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol. - Men must use acceptable form of birth control while on study. - Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: - Known history or evidence of brain metastases. - Had chemotherapy, radiation, or steroids within 14 days prior to study treatment. - Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment. - Require any antineoplastic therapy. - Had surgery within 28 days of dosing of investigational agent. - Has received any prophylactic vaccine within 14 days of first dose of study drug. - History of prior treatment with anti-cxcr4. - Have used any systemic steroids within 14 days of study treatment. - Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, within 14 days of study drug administration. - Hypersensitivity reaction to any monoclonal antibody. - Evidence of clinical or radiographic ascites. - Have clinically significant and/or malignant pleural effusion. - Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Has an active known or suspected autoimmune disease. - Prior tissue or organ allograft or allogeneic bone marrow transplantation. - All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 5) or baseline before administration of study drug. - Infection with HIV or hepatitis B or C at screening. - Patient has a pulse oximetry of <92% on room air. - Patient is on supplemental home oxygen. - Has uncontrolled intercurrent acute or chronic medical illness or any use of illicit drugs or substance abuse. - Patient is unwilling or unable to follow the study schedule for any reason. - Woman who are pregnant or breastfeeding. - Have rapidly progressing disease, as judged by the investigator. - History of significant, recurrent, unexplained postural hypotension in the last 6 months. ; PRIMARY OUTCOME: Objective response rate (ORR) using immune RECIST (iRECIST) criteria; SECONDARY OUTCOME 1: Overall Response Rate (ORR) using RECIST 1.1 criteria[/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/Repevax - Young Adults; BRIEF: This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax. The study will be done in healthy adolescents. ; DRUG USED: Trumenba; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study. - Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures. - Male or female subject aged ≥11 and <19 years at the time of enrollment. - Available for the entire study period and can be reached by telephone. - Healthy subject as determined by medical history, physical examination, and judgment of the investigator. - Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations applicable at the time of receipt. - All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination. For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study. - Negative urine pregnancy test for female subjects. Exclusion Criteria: - Previous vaccination with any meningococcal serogroup B vaccine. - Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination. - A previous anaphylactic reaction to any vaccine or vaccine-related component. - Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine. - Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. - A known or suspected disease of the immune system or those receiving immunosuppressive therapy. - History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. - Significant neurological disorder or history of seizure (excluding simple febrile seizure). - Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination. - Current chronic use of systemic antibiotics. - Participation in other studies during study participation. Participation in purely observational studies is acceptable. - Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination. - Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. - 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 and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. - Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. - Subject is a direct descendant (eg, child, grandchild or other family member) of study site or Pfizer personnel. - Subject is pregnant or breastfeeding. ; PRIMARY OUTCOME: Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen; SECONDARY OUTCOME 1: Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Oxycodone; BRIEF: Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain. ; DRUG USED: Nucynta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Pain; TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Ortho-McNeil Janssen Scientific Affairs, LLC; CRITERIA: Inclusion Criteria: - At Visit 1 (study entry) patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute low back pain that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1 - At Visit 1 patients must report qualifying pain intensity scores - Patients must be appropriate candidates for treatment with oral opioid pain medication in the investigators clinical judgment - Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance - Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening Exclusion Criteria: - History of back (cervical, thoracic or lumbosacral) pain =50% of the time in the 1 year prior to the first visit - History of any low back pain episode, with the exception of the current acute low back pain episode, within 3 months prior to the first visit that was greater than mild in pain intensity, or was associated with disability (e.g., loss of time from work, family, or activities of daily living), or necessitated the use of an opioid (narcotic) analgesic including tramadol - Medical history or physical examination results that suggest the acute low back pain or any of the neurological symptoms or signs are caused by a serious medical condition (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or incontinence, bilateral leg weakness, progressive weakness, paralysis) - There is a high probability for surgical intervention for the back pain during the projected time on the study or that there will be an increase in the severity of the leg pain or deficits - Had either a surgical procedure involving the spine or intervertebral discs in the lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s) involving the spine or intervertebral discs in the lower back region - has any painful condition that could interfere with the study assessments or with the patients ability to differentiate the pain associated with the acute low back pain episode from pain associated with another condition - History of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis - history of epilepsy or recurrent seizures - Unable or unwilling to discontinue all prohibited medications at the time of randomization and during the time of their participation in the study - Known or suspected history of alcohol or drug abuse based on medical history, physical examination, urine drug screening, or the investigators clinical judgment - History of cancer malignancy within 2 years prior to the first visit, with the exception of basal cell skin carcinoma - Have filed or plan to file a workers compensation claim for any issue related to the current acute low back pain episode - Currently involved in litigation or plan to seek legal recourse for any issue related to their acute low back pain - Known allergies, hypersensitivity, or intolerance to tapentadol or the comparator (oxycodone) or any excipients used in their manufacture - Had previously been enrolled in a tapentadol clinical study - is pregnant or are breast-feeding ; PRIMARY OUTCOME: Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation); SECONDARY OUTCOME 1: Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)[/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 - CLEAR Harmony OLE; BRIEF: The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Successfully completed CLEAR Harmony (1002-040) parent study Exclusion Criteria: - Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study. - Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78[/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 - T-CALM (001); BRIEF: This is a multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks (with the exception of participants on primidone at baseline who will be allowed 6 weeks of screening to allow for safe discontinuation). Screening results from all patients meeting the eligibility requirements will be further assessed by the sponsor medical personnel for final approval of suitability for inclusion in the study. Randomized participants will enter a 4 week double-blind dose-titration treatment period, followed by a 1 week safety follow-up period following the last dose of study medication, and a scheduled follow-up safety telephone call one week later. ; DRUG USED: JZP-385; DRUG CLASS: New Molecular Entity (NME); INDICATION: Essential Tremor; TARGET: Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Signed informed consent form indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. 2. Men or non-pregnant, non-breastfeeding women 18 to 75 years-of-age who are able to read and understand English. 3. Diagnosis of definite or probable essential tremor (ET) as defined by the Tremor Investigational Group with involvement of the hands and arms without present causes of enhanced physiologic tremor (Deuschl et al.,1998). 4. Diagnosis of ET before the age of 65. 5. Tremor severity score of at least 2 in at least one upper extremity on at least one of the three maneuvers on the TETRAS scale. 6. Total TETRAS performance score of at least 15. 7. One concomitant anti-tremor medication (other than primidone) is allowed. Note: Primidone is NOT an allowed anti-tremor medication. If on primidone, subjects are allowed to extend their screening period by 2 weeks (for a total of 6 weeks) and discontinue primidone under the supervision of the investigator. 8. Subjects with reproductive capability including all males and women of child-bearing potential (WOCBP) must agree to practice continuous abstinence or adequate contraception methods (appropriate double barrier method or oral, patch, implant, or injectable contraception) from as soon as feasible during screening period until at least 30 days after the last dose. 9. Approval by the sponsor medical personnel as to final suitability for the study. Exclusion Criteria: 1. Exposure to tremorigenic drugs or drug withdrawal states within the 30 days prior to the first planned dose of study drug. 2. Direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor 3. History or clinical evidence of psychogenic tremor origin 4. Known history of other medical or neurological conditions that may cause or explain subjects tremor, including, but not limited to: a. Parkinsons disease b. dystonia c. cerebellar disease, other than essential tremor d. Traumatic Brain Injury e. alcohol abuse or withdrawal f. mercury poisoning g. hyperthyroidism h. pheochromocytoma i. head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor j. multiple sclerosis k. polyneuropathy l. family history of Fragile X syndrome 5. Prior MR-guided Focused Ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy). 6. Botulinum toxin injection in the 6 months prior to screening. 7. Currently using more than one anti-tremor medication. 8. Experiencing clinical benefit from and/or is not willing to discontinue primidone 9. Use of medication(s) in the past month that might produce tremor or interfere with the evaluation of tremor, such as, but not limited to: CNS-stimulants, lithium, amiodarone, metoclopramide, theophylline, and valproate 10. Inability to refrain from use of medication/substance(s) that might produce tremor or interfere with the evaluation of tremor on study visit days, such as but not limited to stimulant decongestants, beta-agonist bronchodilators, caffeine, alcohol and tobacco, based on Investigator assessment at baseline. 11. Positive urine drug screen. 12. Regular use of more than two units of alcohol per day. 13. Sporadic use of a benzodiazepine, sleep medication or anxiolytic to improve sleep performance. Stable use at a consistent dose is allowed as long as tremor persists against the background of regular medication use. Use on the evening prior to a study visit is prohibited. 14. Use of prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be strong inhibitors or inducers of CYP3A4 which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study, including primidone. 15. Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to: a. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening b. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure c. Clinically significant ECG d. Known infection with HIV, hepatitis B, or hepatitis C, unless curative therapy completed for hepatitis C with negative PCR for HCV RNA e. Significant hepatic (AST/ALT > 2X upper limit of normal) or renal disease (creatinine clearance <39 mL/min) f. Significant psychiatric history including mood disorders and alcohol or substance abuse within the last year g. A current C-SSRS score of 4 or 5 at screening or history of suicide attempt at any time during the past year h. Clinically significant impaired balance or is considered at increased risk for falls i. Symptomatic orthostatic hypotension. 16. Treatment with an investigational agent within 30 days prior to the first dose of CX-8998 or planning to receive an investigational agent during the study. ; PRIMARY OUTCOME: Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total Score; SECONDARY OUTCOME 1: Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale 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 - MOR-007 (<5 Years); BRIEF: This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome) for up to 208 weeks. ; DRUG USED: Vimizim; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis IV (MPS IV; Morquio Syndrome); TARGET: N-Acetylgalactosamine-6-Sulfate Sulfatase ; THERAPY: Monotherapy; LEAD SPONSOR: BioMarin Pharmaceutical; CRITERIA: Inclusion Criteria: - Less than 5 years of age at the time of the first study drug infusion - Documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IVA - Written informed consent provided by parent or legally authorized representative after the nature of the study has been explained and prior to any research-related procedures. Exclusion Criteria: - Previous hematopoietic stem cell transplant (HSCT). - Previous treatment with BMN 110. - Known hypersensitivity to any of the components of BMN 110. - Major surgery within 3 months prior to stuy entry or planned major surgery during the 52-week treatment period. - Use of any investigational product or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. - Concurrent disease or condition, including but not limited to symptomatic cervical spine instability, clinically significant spinal cord compression, or severe cardiac disease that would interfere with study participation or safety as determined by the Investigator. - Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study. ; PRIMARY OUTCOME: To Evaluate Safety and Tolerability of Infusions of BMN 110 at a Dose of 2.0 mg/kg/Week Over a 52-week Period in MPS IVA Subjects Less Than 5 Years of Age at Time of First Study Drug Infusion; SECONDARY OUTCOME 1: Percent Change From Baseline to Week 52 in Urinary Keratan Sulfate Measures[/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 - DUO-E; BRIEF: A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Age ≥18 years at the time of screening and female. - Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed. - Patient must have endometrial cancer in one of the following categories: 1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), 2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) 3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor. - Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse - FPPE tumor sample must be available for MMR evaluation. - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment. Exclusion Criteria: - History of leptomeningeal carcinomatosis. - Brain metastases or spinal cord compression. - Prior treatment with PARP inhibitors. - Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines. ; PRIMARY OUTCOME: Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A; SECONDARY OUTCOME 1: Second Progression (PFS2)[/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 - SEBK-201; BRIEF: Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects. ; DRUG USED: Eskata; DRUG CLASS: Non-NME; INDICATION: Benign Pigmented Lesions; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Aclaris Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Is at least 18 years of age 2. Has a clinical diagnosis of stable clinically typical seborrheic keratosis 3. Has at least 4 appropriate seborrheic keratosis target lesions on the back 4. If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study 5. Is non-pregnant and non-lactating 6. Is in good general health and free of any disease state or physical condition which, in the investigators opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation 7. Is willing and able to follow all study instructions and to attend all study visits 8. Is able to comprehend and willing to sign an Informed Consent Form (ICF). Exclusion Criteria: 1. Has clinically atypical and/or rapidly growing seborrheic keratosis lesions 2. Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat) 3. Has used any of the following systemic therapies within the specified period prior to Visit 1: - Retinoids; 180 days - Glucocorticosteroids; 28 days - Anti-metabolites (e.g., methotrexate); 28 days 4. Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1: - Retinoids; 90 days - Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days - Glucocorticosteroids or antibiotics; 14 days - Moisturizers/emollients, sunscreens; 12 hours 5. Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1 6. Has a history of keloid formation or hypertrophic scarring 7. Has a current systemic malignancy 8. Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area 9. Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area 10. Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations 11. Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations 12. Has experienced a sunburn on the treatment area within the previous 4 weeks 13. Has a history of sensitivity to any of the ingredients in the study medications 14. Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations 15. Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1. ; PRIMARY OUTCOME: Mean Change in Physician Lesion Assessment Scale; SECONDARY OUTCOME 1: Subjects Self Assessment Scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric (107112); BRIEF: This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive), will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the eligibility criteria will enter the 2 week run-in period. After completing run-in period, each subject will be randomly allocated to one of two treatment sequences: inhaled fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate. Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment periods will be separated by a two-week wash-out period. Subjects completing two treatment period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US for adults and adolescents aged 12 and above. ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies. ; DRUG USED: Arnuity Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Aged 5 years to less than 12 years at Visit 1. At least 15 (25%) children of the total study population must be aged 5 to less than 8 years. - Male or pre-menarchial female subjects. - Subjects must be pre-adolescent without any signs of puberty (Tanner Stage 1). - Normal range for their height and weight. Weight and height measurements should fall within the percentile range 3-97% of normal values for age according to Danish growth charts. - Have a documented diagnosis of persistent asthma, as defined by the National Institutes of Health for at least 3 months prior to the Screening Visit. - A pre-bronchodilatory forced expiratory flow in 1 second (FEV1) at Visit 1 (Screening) >=80% predicted. There should be no Short acting beta-agonist (SABA) use within 4 hours of this measurement. - Using one of the following asthma therapies prior to entry into the study: SABA inhaler alone (e.g. salbutamol) on an as required basis and/or Regular non-inhaled corticosteroid (ICS) controller medications for asthma (e.g. cromones or leukotriene receptor antagonists) and/or Previously treated with ICS (equipotent to inhaled budesonide <=400 micrograms (mcg) total daily dose). There must be no ICS use within 2 weeks of Visit 1 (Screening). - Able to replace their current SABA treatment with study supplied rescue SABA provided at Visit 1 for use as needed for the duration of the study. - Written informed consent from at least one parent/care giver (legal guardian) and accompanying informed assent from the subject (where the subject is able to provide assent) prior to admission to the study: (1) If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement. The study investigator is accountable for determining a childs capacity to assent to participation in a research study, taking into consideration any standards set by the responsible independent ethics committee (IEC). (2) Subject and their legal guardian(s) understand that the study requires them to be treated on an outpatient basis. (3) Subject and their legal guardian(s) understand that they must comply with study medication and study assessments including recording of peak expiratory flow and rescue SABA use, attending scheduled study visits, and being accessible by a telephone call. Exclusion Criteria: - A history of life-threatening asthma defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s). - Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection or emergency room attendance (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening. - Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis). - Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subjects asthma status or the subjects ability to participate in the study. - Any fracture in the leg to be measured within 6 months prior to the screening visit. - Any metabolic disorders or other diseases that may impact on normal growth patterns. - No major surgery requiring general anaesthesia for at least 3 months prior to the screening visit. - No febrile illnesses with temperature >39 degree celsius for more than five consecutive days within the week preceding the Screening Visit. - Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) that in the Investigators opinion, preclude entry into the study due to risk to the subject or that may interfere with the outcome of the study. - Clinical visual evidence of candidiasis at Visit 1 (Screening). - Use of any of the prohibited medications listed in protocol. - Strenuous physical exercise within 3 hours of Visit 1 (Screening) - Drug allergies: Any adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the ELLIPTA Inhaler (i.e., lactose, FF). - Milk Protein Allergy: History of severe milk protein allergy. - 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). - Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day. - Unable to use the ELLIPTA inhaler and peak flow meter correctly. - An affiliation with the Investigator site: the parents/guardians or child is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. - The Parent or Guardian has a history of psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect: validity of consent to participate in the study; adequate supervision of the subject during the study; compliance of subject with study medication and study procedures (e.g. completion of daily diary, attending scheduled clinic visits); subject safety and well-being. - Children in care: Children who are wards of the government or state are not eligible for participation in this study. ; PRIMARY OUTCOME: Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.; SECONDARY OUTCOME 1: Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).[/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 - Cyst-HD; BRIEF: The purpose of this study is to evaluate the effect of cysteamine in patients with symptomatic Huntingtons disease by comparing two groups of patients (cysteamine vs placebo) on the results of the Unified Huntingtons Disease Rating Scale (UHDRS, Huntington study group 1996). ; DRUG USED: Procysbi; DRUG CLASS: Non-NME; INDICATION: Huntingtons Disease; TARGET: Lysosomal Cysteine Transporter; THERAPY: Monotherapy; LEAD SPONSOR: University Hospital, Angers; CRITERIA: Inclusion Criteria: - Clinically disease-registered for at least one year, leading to consult (abnormal movements, neuropsychiatric disorders, neuropsychological impairment). - Unified Huntingtons Disease Rating Scale motor ≥ 5 - Total Functional Capacity > 10 (≥ 11) - Huntington Disease diagnosed with abnormal number of CAG repeats: 38 < nucleotide expansion (CAG) - Age between 18 and 65 - Voluntarily Patient Consent - Patients willing and able to take oral medications, and comply with the specific procedures of the study Exclusion Criteria: - Severe cognitive impairment or neuropsychiatric troubles. - No drug compliance to previous treatment. - Patients with contra indication to the realization of imaging studies (including claustrophobia ) . - Patients who have not given their written and informed consent signed . - No national health insurance affiliation - Private patients of their liberty by judicial or administrative decision, or patients under supervision. - Pregnant women ( pregnancy test will be carried out systematically for women at risk) or lactating . - Women who could become pregnant during the study period and with no contraception. - Patients who have developed hypersensitivity to cysteamine or penicillamine ( against indication of cysteamine ) . - Brain Damage intercurrent MRI. Brain morphological abnormalities , other than those characteristic of the disease . - Disease - associated with neurological repercussions. - Affection - visceral serious , scalable , involving life-threatening. - Mental - disorder may disrupt accession to the Protocol , including a history of spontaneous and / or drug-induced hallucinations history of severe depression that required repeated hospitalizations , history of repeated suicide attempts . - Participation in progress, or interrupted for less than three months, a therapeutic protocol of Huntingtons disease . - Patients with a history of surgical interventions to improve the symptoms of Huntington s disease such as graft neuron, deep brain stimulation, infusion of neurotrophic agent ; PRIMARY OUTCOME: Unified Huntingtons Disease Rating Scale motor; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OL006; BRIEF: The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body. ; DRUG USED: Aptocine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Combination; LEAD SPONSOR: Light Sciences Oncology; CRITERIA: Inclusion Criteria: - Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI - Biopsy proven evidence of colorectal cancer - At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed) - ECOG Performance Status 0-2 - Life expectancy of at least 16 weeks - At least 30 days must have elapsed since the completion of any prior antineoplastic therapy and the patient must have recovered from acute side effects before day 0 - Understanding and ability to sign written informed consent - 18 years of age or more - Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2.5 × 10^9/L ; Platelet Count > 100 × 10^9/L ; Hemoglobin > 90 g/L ; Neutrophils >1.5 × 10^9/L ; PT and PTT < 1.5 Control ; SGOT, SGPT < 5 × ULN ; GGT < 5 × ULN ; Alkaline phosphatase < 5 × ULN ; Bilirubin < 3 × ULN ; Creatinine < 1.5 × ULN Exclusion Criteria: - Patients who are candidates for complete surgical resection - Patients who received bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizumab or cetuximab is prohibited while participating in this study - Patients who would require more than a total number of 12 light source applications over three Litx™ experimental treatments (no more than 4 light sources per treatment). - Patients who have a single measurable tumor greater than 7.5 cm in any organ - Target lesions irradiated within 3 months of randomization - Patients with tumor involvement in greater than 50% of parenchyma of the liver - Evidence of major vessel invasion of any organ - Patients with any non-colorectal cancers except for adequately treated basal or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient has been disease-free for ≥ 3 years, or other cancer from which the patient has been disease-free for ≥ 5 years - Known sensitivity to porphyrin-type drugs or known history of porphyria - Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study - Concurrent participation in another clinical trial involving experimental treatment - Any concurrent disease or condition that in the opinion of the investigator impairs the patients ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigators opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trials data. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ProTECT III (Emory University); BRIEF: The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury. ; DRUG USED: BHR-100; DRUG CLASS: Non-NME; INDICATION: Traumatic Brain Injury (TBI); TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: David Wright; CRITERIA: Inclusion Criteria: - Moderate to severe brain injury (GCS 12-4) - Age 18 years or older - Blunt, closed head injury - Study drug initiated within 4 hours of injury Exclusion Criteria: - Non-Survivable injury - Bilateral dilated unresponsive pupils - Severe intoxication (ETOH > 250 mg %) - Spinal cord injury with neurological deficits - Inability to perform activities of daily living prior to injury - Cardiopulmonary arrest - Status epilepticus on arrival - Systolic blood pressure (SBP) < 90 on arrival or for at least 5 minutes prior to enrollment - O2 Sat < 90 on arrival or for at least 5 minutes prior to enrollment - Prisoner or ward of state - Pregnant - Active breast or reproductive organ cancers - Known allergy to progesterone or intralipid components (egg yolk) - Known history of clotting disorder - Active thromboembolic event - Concern for inability to follow up at 6 months - Anyone listed in the Opt out registry ; PRIMARY OUTCOME: Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE); SECONDARY OUTCOME 1: Mortality[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Study 1249; BRIEF: This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: - Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive - Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed ; DRUG USED: Genvoya; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Cytochrome p450, DNA polymerase, HIV Integrase, Reverse Transcriptase; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Both Cohorts 1 and 2: - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - HIV/HBV co-infected adult males and non-pregnant and non-lactating females - No evidence of hepatocellular carcinoma (HCC) or clinical or imaging evidence of cirrhosis (ascites, variceal bleeding, encephalopathy). --- Subjects should have documentation of an abdominal ultrasound in the 12 months prior to screening, or an abdominal ultrasound at screening, demonstrating the absence of cirrhosis and HCC. - Acute Hepatitis A virus (HAV) immunoglobulin M (IgM) negative - Hepatitis C virus (HCV) Ab negative, or HCV Ab positive with negative HCV RNA - Hepatitis D virus (HDV) Ab negative, or HDV Ab positive with negative HDV RNA - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula - CD4+ count of > 200 cells/μL - Chronic HBV infection as defined by - HBsAg positive for ≥ 6 months Or - HBsAg positive at screening and either hepatitis B e antigen (HBeAg) or HBV DNA positive ≥ 6 months Or - At screening: positive total hepatitis B core antibody (HBcAb) and negative immunoglobulin M antibody to hepatitis B core antigen (HBcIgM) antibody, and - HBsAg positive, or - HBeAg positive, or - HBV DNA positive - Cohort 1 (HIV and HBV treatment naive) only: - No current or prior anti-HIV treatment, including antiretroviral medications received for prevention (PrEP), or post exposure prophylaxis (PEP) - No current or prior anti-HBV treatment - Plasma HIV-1 RNA level ≥ 500 copies/mL at screening - Screening HBV DNA ≥ 3 log10 IU/mL and < 9 log10 IU/mL - Cohort 2 (HIV suppressed) only: - Receiving current antiretroviral regimen for at least 4 consecutive months - No current or prior regimen containing 3 active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/Entecavir or TDF/lamivudine(3TC)/Entecavir) - Maintained plasma HIV-1 RNA < 50 copies/mL for 6 consecutive months prior to and at the time of the screening visit. Unconfirmed virologic evaluation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or blip) and prior to screening is acceptable - Documented positive HIV antibody test - Screening HBV DNA < 9 log10 IU/mL Key Exclusion Criteria: - Females who are breastfeeding - Positive serum pregnancy test (female of childbearing potential) - Have an implanted defibrillator or pacemaker - Current alcohol or substance use - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposis sarcoma (KS), basal cell carcinoma, or resected, non-invasive carcinoma. - Received solid organ or bone marrow transplant - Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage). - Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses), or multiple bone fractures - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 - Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone, and dexamethasone) - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements - Investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL; SECONDARY OUTCOME 1: Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - w/Spriva (Long-Acting Bronchodilator; Add-on Therapy); BRIEF: The purpose of this study is to investigate the dose response of RPL554 in patients with moderate to severe CHRONIC OBSTRUCTIVE PULMONARY DISEASE that are still symptomatic despite treatment with a stable background of tiotropium over 4 weeks of treatment. This study is intended to support optimal dose selection for a Phase III program evaluating RPL554 as an add-on treatment to standard of care therapy. ; DRUG USED: RPL554 (Inhaled); DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Phosphodiesterase 3 (PDE3), Phosphodiesterase 4 (PDE4); THERAPY: Combination; LEAD SPONSOR: Verona Pharma plc; CRITERIA: Inclusion Criteria: - Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. - Male or female aged between 40 and 80 years inclusive, at the time of informed consent. - Must agree to meet the following from the first dose up to 1 month after the last dose of study medication: - If male: - Not donate sperm - Either: be sexually abstinent in accordance with a patients usual and preferred lifestyle (but agree to abide by the contraception requirements below should their circumstances change) - Or: use a condom with all sexual partners. If the partner is of childbearing potential the condom must be used with spermicide and a second reliable form of contraception must also be used (e.g., diaphragm/cap with spermicide, established hormonal contraception, intra-uterine device) - If female: - be of non-childbearing potential or use a highly effective form of contraception - Have a 12-lead ECG recording at Screening showing the following (and no changes in the pre-dose value at the first treatment deemed clinically significant by the Investigator): - Heart rate between 45 and 90 beats per minute - QT interval corrected for heart rate using Fridericias formula (QTcF) ≤450 msec for males, and ≤ 470 msec for females - QRS interval ≤ 120 msec - No clinically significant abnormality including morphology (e.g., left bundle branch block, atrio-ventricular nodal dysfunction, ST segment abnormalities consistent with ischemia) - Capable of complying with study restrictions and procedures, including ability to use the nebulizer correctly. - Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) with a minimum weight of 45 kg. - COPD diagnosis: Patients with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli and MacNee, 2004) with symptoms compatible with COPD for at least 1 year prior to Screening. - Ability to perform acceptable and reproducible spirometry. - Post-bronchodilator (four puffs of albuterol) spirometry at Screening demonstrating the following: - FEV1/ FVC ratio of ≤0.70 - FEV1 ≥30% and ≤70% of predicted normal* *National Health and Nutrition Examination Survey (NHANES) III (Hankinson et al, 1999) will be used as the reference for normal predicted values. - Clinically stable COPD in the 4 weeks prior to Screening (Visit 1) and during the period between Visits 1 and 2. - A score of ≥2 on the modified Medical Research Council (mMRC) dyspnea scale at Screening. - A chest X-ray (posterior-anterior) at Screening, or in the 12 months prior to Screening showing no clinically significant abnormalities unrelated to COPD. - Meet the concomitant medication restrictions and be expected to do so for the rest of the study. - Current and former smokers with smoking history of ≥10 pack years. - Capable of withdrawing from long acting bronchodilators (other than tiotropium) for the duration of the study, and short acting bronchodilators for 6 hours prior to dosing. Exclusion Criteria: - A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation. - COPD exacerbation requiring oral or parenteral steroids, or lower respiratory tract infection requiring antibiotics, within 3 months of Screening or prior to the first treatment. - A history of one or more hospitalizations for COPD or pneumonia within 6 months of Screening or prior to the first treatment. - Intolerance or hypersensitivity to albuterol, tiotropium or other muscarinic receptor antagonists. - Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, uncontrolled or unstable sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension or other active pulmonary diseases. - Previous lung resection or lung reduction surgery. - Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study. - Oral therapies for COPD (e.g. oral steroids, theophylline, and roflumilast) or antibiotics within 3 months prior to Screening, or ICS therapy within 4 weeks prior to Screening - Prior exposure to RPL554. - History of, or reason to believe a patient has, drug or alcohol abuse within the past 5 years. - Received an experimental drug within 30 days or five half-lives, whichever is longer. - Women who are pregnant or breast-feeding. - Patients with uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant. This includes any hepatic disease or moderate to severe renal impairment. - Documented clinically significant cardiovascular disease such as: any history of arrhythmias, angina, recent (<1 year) or suspected myocardial infarction, congestive heart failure, unstable or uncontrolled hypertension, or diagnosis of hypertension within 3 months prior to Screening. - Use of non-selective oral β-blockers. - Major surgery (requiring general anesthesia) within 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study. - Required use of oxygen therapy, even on an occasional basis. - History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell). - Clinically significant abnormal values for laboratory safety tests (hematology, blood chemistry, viral serology or urinalysis) at Screening, as determined by the Investigator. In particular, alanine aminotransferase or aspartate aminotransferase cannot be more than twice the upper limit of normal. - Patients with conditions which are sensitive to antimuscarinic effects such as narrow angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction. - Current marijuana use (all forms). - A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications. - Any other reason that the Investigator considers makes the patient unsuitable to participate. ; PRIMARY OUTCOME: Least Square (LS) Mean Change From Baseline Forced Expiratory Volume in 1 Second (FEV1) to Peak FEV1 at Week 4; SECONDARY OUTCOME 1: LS Mean Change From Baseline FEV1 to Average Area Under the Curve Over 3 Hours (AUC0-3h) FEV1 on Day 1 and at Weeks 1 to 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CARTITUDE-4; BRIEF: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). ; DRUG USED: Ciltacabtagene Autoleucel; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), B-cell maturation antigen (BCMA), Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Measurable disease at screening as defined by any of the following: (a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or (b) Light chain multiple myeloma without measurable M-protein in the serum or the urine: Serum free light chain >=10 mg/dL and abnormal serum free light chain ratio - Have received 1 to 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) - Have documented evidence of PD by International Myeloma Working Group (IMWG) criteria based on investigators determination on or within 6 months of their last regimen - Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy. However, participants must be refractory to lenalidomide in at least one prior line - Have clinical laboratory values meeting the following criteria during the Screening Phase (re testing is allowed but the below criteria must be met in the latest test prior to randomization): 1. Hemoglobin >=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted); 2. Absolute neutrophil count (ANC) >=1 * 10^9 per liter (L) (without recombinant human granulocyte colony-stimulating factor [G-CSF] within 7 days and without pegylated G-CSF within 14 days of the laboratory test); 3. Platelet count >=75 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom less than (<) 50 percent (%) of bone marrow nucleated cells are plasma cells; platelet count >=50 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom >=50% of bone marrow nucleated cells are plasma cells; 4. Lymphocyte count >=0.3 * 10^9/L; 5. Aspartate aminotransferase (AST) less than or equal to (<=)3 * upper limit of normal (ULN); 6. Alanine aminotransferase (ALT) <=3 * ULN; 7. Total bilirubin <=2.0 * ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=1.5 * ULN is required); 8. Estimated glomerular filtration rate >=40 milliliter per minute (mL/min) per 1.73 meter square (m^2) (to be calculated using the Modification of Diet in Renal Disease [MDRD] formula) Exclusion Criteria: - Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy directed at any target - Any previous therapy that is targeted to B-cell maturation antigen (BCMA) - Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia - Participants with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive pomalidomide, bortezomib, and dexamethasone (PVd) as standard therapy or bridging therapy; however, participants may receive daratumumab, pomalidomide, and dexamethasone (DPd) as standard therapy or bridging therapy - Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days prior to randomization - Monoclonal antibody treatment within 21 days - Cytotoxic therapy within 14 days - Proteasome inhibitor therapy within 14 days - Immunomodulatory drug (IMiD) therapy within 7 days ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Complete Response (CR) or Stringent Complete Response (sCR) Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Proof-Of-Concept ; BRIEF: A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome. ; DRUG USED: Glepaglutide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Short Bowel Syndrome (SBS); TARGET: GLP-2 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Zealand Pharma; CRITERIA: Inclusion Criteria: - Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out. - Age ≥ 18 years and ≤ 90 years - Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago - A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to randomization for patients requiring PS - Wet weight of fecal excretion ≥ 1500 g/day demonstrated during a hospital stay prior to screening or during at least one day of the first baseline balance study. - Stable body weight (<5% weight deviance in the three months prior to screening) Exclusion Criteria: - Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator - Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator. - Crohns disease patients not being in clinical remission for the last 12 weeks prior to randomization - Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening - History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded) - eGFR (by the MDRD formula) <30 mL/min/1.73 m2 - Clinically meaningful renal disease as judged by the Investigator ; PRIMARY OUTCOME: The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods.; SECONDARY OUTCOME 1: Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods[/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/Lenalidomide + Dexamethasone (NCI); BRIEF: Background: - Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is sometimes used to treat (alone or with other drugs) certain types of cancer, especially multiple myeloma. This combination of drugs has not been tested in people with multiple myeloma. Researchers want to see whether it is safe and effective for this group. Objectives: - To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma. Eligibility: - People at least 18 years of age who have multiple myeloma that has not been treated. Design: - Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, a bone marrow sample, and molecular imaging studies. - Participants will have eight 28-day cycles of treatment. The combined study drugs will be given as tablets and injections. Those in the study will be monitored with frequent blood tests, bone marrow samples, and molecular imaging studies. In addition to current standard measures to determine clinical responses, molecular tests will be conducted to define evidence of minimal residual disease. - After the first four cycles of therapy, those who are eligible for a stem cell transplant will have stem cells collected and stored for use if the cancer returns. - After stem cell collection, participants will have the second four treatment cycles. -, If the disease has improved or is stable at the end of eight cycles, those in the study may have another 12 cycles of low-dose (maintenance) lenalidomide alone. - Participants will have regular follow-up visits after the end of the study chemotherapy. ; DRUG USED: Kyprolis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: - INCLUSION CRITERIA: - Newly diagnosed patients with histologically confirmed multiple myeloma (MM) based on the following criteria: 1. Clonal plasma cells in the bone marrow 2. Measurable disease within the past 4 weeks defined by any one of the following: 1. Serum monoclonal protein greater than or equal to 1.0 g/dL 2. Urine monoclonal protein greater than 200 mg/24 hour 3. Serum immunoglobulin free light chain greater than 10 mg/dL AND abnormal kappa/lambda ratio 3. Evidence of underlying end organ damage attributed to underlying plasma cell proliferative disorder meeting at least one of the following: 1. Hypercalcemia: serum calcium greater than or equal to 2.65 mmol/L 2. Renal Insufficiency: serum creatinine greater than 2.0 mg/dL 3. Anemia: hemoglobin value less than10 g/dL or 2 g/dL less than normal reference 4. Bone disease: lytic lesions, severe osteopenia or pathological fractures - Creatinine Clearance (CrCl) greater than or equal to 60 ml/min. CrCl will be calculated by Cockcroft-Gault method. CrCl (calculated) = (140 Age) x Mass (in kilograms) x [0.85 if Female] 72 times Serum Creatinine (in mg/dL). If calculated CrCl based on Cockcroft-Gault method is <60 mL/min, patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must be also greater than or equal to 60 ml/min. - Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of carfilzomib in combination with lenalidomide in patients less than18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Absolute neutrophil count (ANC) greater than or equal to 1.0 K/uL, hemoglobin greater than or equal to 8 g/dL (transfusions are permissible), and platelet count greater than or equal to 75 K/uL - Adequate hepatic function, with bilirubin less than 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3.0 times ULN. - All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin). - All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist . - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) 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. Females of child bearing potential (FCBP) must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. - Subjects must be able to give informed consent EXCLUSION CRITERIA: - Prior or concurrent systemic treatment for MM. - Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with corticosteroids is permitted. - Bisphosphonates are permitted. - Treatment with corticosteroids for indications other than MM is permitted. - Radiotherapy is permitted. - Treatment for smoldering myeloma is permitted. - Plasma cell leukemia - Pregnant or lactating females. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with carfilzomib in combination with lenalidomide, breastfeeding should be discontinued if the mother is treated with carfilzomib and lenalidomide. These potential risks may also apply to other agents used in this study. - Uncontrolled hypertension or diabetes - Active hepatitis B or C infection - Has significant cardiovascular disease with New York Heart Association (NYHA) Class III or IV symptoms, or hypertrophic cardiomyopathy, or restrictive cardiomyopathy, or myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia as determined by history and physical examination. Echocardiogram will be performed if clinically warranted. - Has refractory gastrointestinal (GI) disease with refractory nausea/vomiting, inflammatory bowel disease, or bowel resection that would prevent absorption - Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements - Significant neuropathy greater than or equal to Grade 3 at baseline - Contraindication to any concomitant medication, including antivirals, anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy - Major surgery within 1 month prior to enrollment - Recruitment Strategies: - Patients that progress from the smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significance (MGUS) Natural History Study (NCI Protocol: 10-C-0096) will be potential candidates. - Other participant sources will be from outside physician referrals. - Our ongoing natural history study and outside physician referral network has a high representation of minorities. ; PRIMARY OUTCOME: Number of Participants With Serious and Non-serious Adverse Events; SECONDARY OUTCOME 1: Overall Response Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LAL-CL08; BRIEF: This was an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly progressive lysosomal acid lipase deficiency (LAL-D). Eligible participants received once-weekly infusions of sebelipase alfa for up to 3 years. ; DRUG USED: Kanuma; DRUG CLASS: Biologic; INDICATION: Lysosomal Acid Lipase Deficiency ; TARGET: Cholesterol/Cholesteryl Ester, Triglycerides; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Participants parent or legal guardian (if applicable) consent to participation in the study 2. Confirmation of documented decreased LAL activity relative to the normal range of the lab performing the assay or confirmation of LAL-D diagnosis as determined by a Sponsor-approved central laboratory 3. Substantial clinical concerns, in the opinion of Investigator and Sponsor, of rapid disease progression requiring urgent medical intervention including, but not restricted to the following: - Marked abdominal distension and hepatomegaly - Failure to thrive - Disturbance of coagulation - Severe anemia - Sibling with rapidly progressive course of LAL-D Exclusion Criteria: 1. Clinically important concurrent disease 2. Participant was > 8 months of age at the time of first dosing 3. Participant received an investigational medicinal product other than sebelipase alfa within 14 days prior to the first dose of sebelipase alfa in this study 4. Myeloablative preparation, or other systemic pre-transplant conditioning, for hematopoietic stem cell or liver transplantation 5. Previous hematopoietic stem cell or liver transplant 6. Known hypersensitivity to eggs ; PRIMARY OUTCOME: Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percentage Of Participants Surviving To 12, 18, 24, And 36 Months Of Age[/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 - SUBQ-HF (NHLBI); BRIEF: To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care. ; DRUG USED: Furoscix; DRUG CLASS: Non-NME; INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Na-K-Cl cotransporter (NKCC2); THERAPY: Monotherapy; LEAD SPONSOR: Adrian Hernandez; CRITERIA: Inclusion Criteria for Pathway 1 (patients hospitalized with acute heart failure) 1. Age >18 years 2. Willingness and ability to provide informed consent 3. Hospitalization for AHF with at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography, BNP > 250 ng/mL or NTproBNP > 1000 ng/mL) of congestion 4. Persistent congestion defined by the presence of at least 2 or more of the following at the time of consent: 1. Peripheral edema 2. Rales 3. Elevated JVP 4. Ascites 5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during index hospitalization 6. Orthopnea 5. Total anticipated daily IV furosemide dose (at time of screening) >80-240 mg (or equivalent)/day 6. Anticipated need for at least 24 more hours of parenteral diuretic therapy Exclusion Criteria for Pathway 1 1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment 2. Requirement for inotropes (other than digoxin) or mechanical support during hospitalization 3. Clinically significant electrical instability during hospitalization 4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.) 5. Planned discharge to location other than home (e.g., hospice, skilled nursing facility, etc.) 6. Anticipated cardiac transplantation or left ventricular assist device within the next 30 days 7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade 8. Known or anticipated pregnancy in the next 30 days 9. Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump, on-body infusion devices or patients who give regimented injections at the intended site of the furosemide infusion device. 10. Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting 11. Known allergy to furosemide 12. Known sensitivity or allergy to medical adhesive tape 13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months 14. Presentation is for indication other than CHF Inclusion Criteria for Pathway 2 (Outpatients with heart failure presenting with volume overload necessitating treatment with parenteral loop diuretics) 1. Age >18 years 2. Willingness and ability to provide informed consent 3. HF now presenting with volume overload defined by the presence of at least 2 or more of the following at the time of consent: 1. Peripheral edema 2. Rales 3. Elevated JVP 4. Ascites 5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during this episode of decompensation 6. Orthopnea 4. Need for parenteral furosemide with an estimated SQ furosemide requirement between 80-240 mg/day 5. Anticipated need for at least 24 hours of parenteral diuretic therapy Exclusion Criteria for Pathway 2 1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment 2. Anticipated need for inotropes (other than digoxin) or mechanical support to treat current episode of decompensation 3. Clinically significant electrical instability requiring hospitalization 4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.) 5. Residence at location other than home (e.g., hospice, skilled nursing facility, etc.) 6. Anticipated cardiac transplantation or left ventricular assist device within the next 30 days 7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade 8. Known or anticipated pregnancy in the next 30 days 9. Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump, on-body infusion devices or patients who give regimented injections at the intended site of the furosemide infusion device. 10. Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting 11. Known allergy to furosemide 12. Known sensitivity or allergy to medical adhesive tape 13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months. 14. Presentation is for indication other than CHF. ; PRIMARY OUTCOME: Patient Safety Measured by Serious Adverse Events; SECONDARY OUTCOME 1: Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia[/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 - PIONEER-PEDS2; BRIEF: The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits. ; DRUG USED: Reyvow; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1F receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined) - Participants must weigh at least 15 kilograms (kg) Exclusion Criteria: - Participants must not be pregnant or nursing - Participants must not have any acute, serious, or unstable medical condition - Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator ; PRIMARY OUTCOME: Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack; SECONDARY OUTCOME 1: Percentage of Treated Attacks with Pain Freedom at 2 Hours[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FF/VI w/UMEC (Study 1); BRIEF: After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks. ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Type of subject: Outpatient. - Informed Consent: A signed and dated written informed consent prior to study participation. - Age: Subjects 40 years of age or older at Visit 1. - Gender: Male or female subjects. - A female is eligible to enter and participate in the study if she is of: - Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, >45 years, in the absence of hormone replacement therapy. OR - Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact): - Abstinence - Oral Contraceptive, either combined or progestogen alone - Injectable progestogen - Implants of levonorgestrel - Estrogenic vaginal ring - Percutaneous contraceptive patches - Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label - Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subjects entry into the study, and this male is the sole partner for that subject. For this definition, documented refers to the outcome of the investigators/designees medical examination of the subject or review of the subjects medical history for study eligibility, as obtained via a verbal interview with the subject or from the subjects medical records. - Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) - Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. - Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history. - Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of <=70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey (NHANES) III reference equations. - Dyspnea: A score of >=2 on the mMRC Dyspnea Scale at Visit 1. - QTc Criteria: - QTc(F) <450 milliseconds (msec) or - QTc(F) <480msec for patients with QRS duration >=120msec - The QTc is the QT interval corrected for heart rate according to either Bazetts formula (QTcB), Fridericias formula (QTcF), or another method, machine or manual overread. - For subject eligibility and withdrawal, QTcF will be used. - For purposes of data analysis, QTcF will be used as primary. - The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. Exclusion Criteria: - Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Asthma: A current diagnosis of asthma. - Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. - Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. - Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction, that, in the opinion of the study physician contraindicates study participation or use of an inhaled Long acting muscarinic antagonist (LAMA), Long acting beta agonist (LABA) or Inhaled corticosteroids (ICS). - Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. - Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1. - Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1. - 12-Lead ECG: An abnormal and clinical significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The study investigator will determine the medical significance of any ECG abnormalities. - Clinically significant and abnormal laboratory finding at Screening (Visit1). After discussion with the Medical Monitor, the investigator may have the option to verify the abnormal lab result prior to Visit2 - Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. - Excluded Medications: Use of the following medications are not permitted within the defined time intervals prior to Visit 1and throughout the study: - No use within 12 weeks prior to Screening Visit 1 or thereafter at any time during the study: Depot corticosteroids. - No use within 6 weeks prior to Screening Visit 1 or thereafter at any time during the study: Systemic, oral or parenteral corticosteroids (Intra-articular corticosteroid injections are permitted.), Antibiotics (for lower respiratory tract infection), Cytochrome P450 3A4 strong inhibitors. - No use within 14 days prior to Screening Visit 1 or thereafter at any time during the study: Phosphodiesterase 4 inhibitors (roflumilast). - No use within 10 days prior to Screening Visit 1 or thereafter at any time during the study: Olodaterol and Indacaterol. - No use within 7 days prior to Screening Visit 1 or thereafter at any time during the study: Long acting muscarinici antagonists (tiotropium, aclidinium, glycopyrronium). - No use within 48 hrs prior to Screening Visit 1 or thereafter at any time during the study: Theophyllines, Oral leukotriene inhibitors (zafirlukast, montelukast, zileuton), Salmeterol and formoterol, ICS/LABA combinations (e.g., fluticasone propionate/salmeterol, mometasone furoate/formoterol fumarate, budesonide/formoterol fumarate), Oral beta2-agonists Long-acting. - No use within 24 hrs prior to Screening Visit 1 or thereafter at any time during the study: Inhaled sodium cromoglycate or nedocromil sodium. - No use within 12 hrs prior to Screening Visit 1 or thereafter at any time during the study: Oral beta2-agonists Short-acting. - No use within 4 hrs prior to Screening Visit 1 or thereafter at any time during the study: Inhaled short acting beta2-agonists (use of study provided prn albuterol/salbutamol is permitted during the study, except in the 4-hour period prior to spirometry testing.), Inhaled short-acting anticholinergics, Inhaled short-acting anticholinergic/short-acting beta2-agonist combination products. - No use within 30 days or 5 half lives whichever is longer prior to Screening Visit 1 or thereafter at any time during the study: Any other investigational drug. - Prior enrolment in one of the replicate studies: subjects who have previously been assigned a subject number (enrolled) in study 200110 that is a replicate study of 200109. - Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., <=12 hours per day) is not exclusionary. - Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy. - Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1, or who will enter the acute phase of a pulmonary rehabilitation program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. - Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1. - Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator. - Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire. ; PRIMARY OUTCOME: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85; SECONDARY OUTCOME 1: Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84[/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 - LAC-MD-36 (AUGMENT EXTENSION); BRIEF: The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo. ; DRUG USED: Duaklir Pressair; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Completion of the treatment phase of the lead-in study, LAC-MD-31 - Written informed consent obtained from the patient before the initiation of any study specific procedures - No medical contraindication as judged by the PI - Compliance with LAC-MD-31 study procedures and IP dosing. Exclusion Criteria: - No specific exclusion criteria ; PRIMARY OUTCOME: Percentage of Patients to Experience Any Treatment-emergent Adverse Event; SECONDARY OUTCOME 1: Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis[/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 - A2404 - LASOR; BRIEF: There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD. ; DRUG USED: Tasigna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: 1. Male or female ≥ 18 years old; 2. ECOG of 0, 1, or 2; 3. Ph+ CML in CP defined as: - <15% blasts in peripheral blood or bone marrow; - <30% blasts + promyelocytes in peripheral blood or bone marrow; - <20% basophils in the peripheral blood; •≥100x109/L (≥ 100,000/mm3) platelets; - no evidence of extramedullary leukemia involvement, with the exception of hepatosplenomegaly; 4. SoR to 400 mg imatinib, defined as (min of 20 metaphases): - No cytogenetic response at ≥ 3 to <6 months (> 95% Ph+ metaphases);or - No PCyR at ≥ 6 to <12 months (36 to 95% Ph+ metaphases on bone marrow); or - No CCyR at ≥ 12 to <18 months (1 to 35% Ph+ metaphases on bone marrow); Confirmation of SoR by FISH is allowed if BMK is done outside the screening window up to 4 wks. 5. 400mg/daily imatinib (no higher doses) for at least 3months but no longer than 18 months; 6. Previous use of IFN, taken prior to imatinib treatment, is allowed at a maximum of 90 days unless reason for switch from IFN to imatinib was intolerance. 7. Parameters must be present: - Creatinine <2.0 X ULN - Total bilirubin <1.5 X ULN (< 3.0 X ULN if related to disease); - SGOT and SGPT < 2.5 X ULN; - Serum lipase ≤1.5 X ULN; - Alkaline phosphatase ≤2.5 X ULN - Serum potassium, phosphorus, magnesium and calcium ≥ LLN or corrected to WNL with supplements prior to first dose of study drug; 8. Written informed consent prior to any study procedures being performed. Exclusion criteria: 1. Prior accelerated phase including clonal evolution or blast crisis CML; 2. Prior therapy with imatinib in combination with any other CML drug other than Hydroxyurea and/or Anagrelide; 4.Imatinib therapy started more than 12 months after the date of the original diagnosis; 5.Unable to tolerate imatinib at 400mg; 6.Previous treatment with any other tyrosine kinase inhibitor except Glivec and/or CML therapy other than IFN, hydroxyurea, and /or anagrelide; 7.Myelotoxicity ≥ Grade 2 present at the time of randomization, 8.Previously documented T315I mutations; 9.Impaired cardiac function including one of these: - Long QT syndrome or family history of long QT syndrome - Clinically significant resting brachycardia (<50 bpm) - QTcF >450 msec on screening ECG (using the QTcF formula). If QTc >450 and electrolytes are not with normal ranges, electrolytes should be corrected and then the patient rescreened for QTc to certify QTc <450 msec; - Myocardial infarction ≤ 12 months prior to the first dose of study drug; - Other clinically significant heart disease (e.g., CHF, uncontrolled hypertension, unstable angina, significant ventricular or atrial tachyarrhythmias) 10. Impairment of GI function or disease that may significantly alter the absorption of study drug; 11. Treated with strong CYP3A4 inhibitors that cannot be either discontinued or switched to a different medication prior to starting study drug; 12.Currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug; 13.History of previous acute pancreatitis within one year of study entry or medical history of chronic pancreatitis; 14.Known cytopathologically confirmed CNS 15.Women who are pregnant, breast feeding or of a childbearing potential without a negative urine pregnancy test at screening. Female patients of childbearing potential unwilling to use effective contraceptive precautions throughout the trial and for 3 months post trial end. Post-menopausal women must be ammenorrheic for at least 12 months to be considered of non-childbearing potential; 16. History of another primary malignancy that is currently clinically significant or currently requires active intervention; 17.Any other clinically significant medical or surgical condition which, according to investigators discretion, should preclude participation; 18.Use of investigational agent within 28 days prior to enrollment; 19.Patients unwilling or unable to comply with the protocol. ; PRIMARY OUTCOME: Percentage of Participants With Complete Cytogenetic Response (CCyR); SECONDARY OUTCOME 1: Percentage of Participants With Major Molecular Response (MMR)[/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 - DART (w/Axitinib); BRIEF: The purpose of Part 1 of this study is to evaluate the safety and tolerability of dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (RCC) to determine the recommended dose level of dalantercept in combination with axitinib for Part 2. The purpose of Part 2 of this study is to determine whether treatment with dalantercept in combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone in patients with advanced renal cell carcinoma (RCC). ; DRUG USED: Dalantercept; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Activin-like kinase 1, Bone morphogenetic protein (BMP); THERAPY: Combination; LEAD SPONSOR: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; CRITERIA: Key Inclusion Criteria: - Histologically confirmed, advanced, predominantly clear cell renal cell carcinoma (RCC). - Part 1: Progression of disease following up to three lines of prior therapy, including at least one approved VEGF receptor tyrosine kinase inhibitor for RCC. Adjuvant therapy is permitted as one line of prior therapy. - Part 2: Progression of disease following one VEGF pathway inhibitor for RCC (e.g. sunitinib, pazopanib, sorafenib, bevacizumab, tivozanib, or cabozantinib) inclusive of adjuvant therapy if there was documented disease progression during treatment. Patients may have received one additional line of an approved mTOR kinase inhibitor (e.g. everolimus, temsirolimus). Prior exposure to investigational and/or approved anticancer immune therapies is permitted. - A minimum of 1 week since the last dose of prior therapy (a minimum of 4 weeks since anticancer immune therapy or bevacizumab +/- interferon). - Measurable disease that is evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Life expectancy of at least 12 weeks. - Clinical laboratory values within acceptable ranges within 72 hours prior to study day 1. Key Exclusion Criteria: - Clinically significant organ/system disease unrelated to RCC that in the judgment of the investigator should preclude treatment with dalantercept or axitinib. - Clinically significant cardiovascular risk. - Known CNS metastases or leptomeningeal disease: For Part 1, patients with CNS metastases treated with whole brain radiotherapy, gamma knife, and/or surgery who are considered stable by CNS imaging and are not being treated with corticosteroids 6 weeks prior to study day 1 may be enrolled. For Part 2, patients with CNS metastases treated stereotactic radio-surgery (SRS), and/or surgery who are considered stable by CNS imaging for at least 2 months prior to enrollment and are not being treated with corticosteroids 6 weeks prior to study day 1 may be enrolled. - Any active malignancy, other than RCC, for which chemotherapy or other anti-cancer therapy is indicated. Patients with adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 3 years will be permitted. - Any lesion invading or having encasement ≥ 180 degrees around the wall of a major blood vessel as assessed by computed tomography (CT) scan and/or magnetic resonance imaging (MRI). - Radiotherapy within 2 weeks prior to study day 1. - Lack of recovery from toxic effects of previous treatment for RCC ≤ grade 1 with the exception of alopecia, unless stabilized under adequate medical control. - Patients undergoing renal dialysis. - Major surgery within 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery prior to study day 1). - Any active infection requiring antibiotic therapy within 2 weeks of study day 1. - Anti-coagulation therapy. Aspirin, other anti-platelet agents, and low molecular weight heparin are permitted unless the investigator deems the patient is at a significant risk for bleeding. - Current use or anticipated inability to avoid potent CYP3A4/5 inhibitors or inducers (please refer to the Inlyta® [axitinib] prescribing information) during participation in the study. - Peripheral edema requiring medical intervention within 2 weeks prior to study day 1. - Bleeding diathesis including clinically significant platelet disorders or active hemoptysis (defined as bright red blood of ≥ 1/2 teaspoon [2.5 mL] in any 24 hour period) within 6 months prior to study day 1. For clinically significant epistaxis within 4 weeks prior to study day 1, no risk of further bleeding must be clearly documented. - Known history of hereditary hemorrhagic telangiectasia (HHT). - Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections or positive human immunodeficiency virus (HIV) antibody results. Patients with sustained virologic response to HCV treatment or immunity to HBV from prior infection without cirrhosis may be included. - History of severe (defined as ≥ grade 3, using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current active minor version) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent. - Any prior treatment with dalantercept or any other agent targeting ALK1 pathway. - Any prior treatment with axitinib. - A morbidity (per the prescribing information) that would require starting a patient at a reduced dose of axitinib. - Treatment with another investigational drug (with the exception of anticancer immune therapy) or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half life is not known. - Pregnant or lactating female patients. ; PRIMARY OUTCOME: Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability.; SECONDARY OUTCOME 1: Part 1: Progression Free Survival (PFS).[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LEAP 1; BRIEF: This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia. ; DRUG USED: Xenleta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Nabriva Therapeutics AG; CRITERIA: Inclusion Criteria: 1. Be male or female at least 18 years of age. 2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions. 3. Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening): - Dyspnea - New or increased cough - Purulent sputum production - Chest pain due to pneumonia 4. Have at least 2 of the following vital sign abnormalities: - Fever (body temperature >38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site) - Hypotension (systolic blood pressure <90 mmHg) - Tachycardia (heart rate >100 beats/min) - Tachypnea (respiratory rate >20 breaths/min) 5. Have at least 1 other clinical sign or laboratory finding of CABP: - Hypoxemia (i.e., O2 saturation <90% on room air or while receiving supplemental oxygen at subjects baseline requirement or PaO2 <60 mmHg) - Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness) - White blood cell (WBC) count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count 6. Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia). 7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III. Exclusion Criteria: 1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization 2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens 3. Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted. 4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung). 5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis). 6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions). 7. Require mechanical ventilation. ; PRIMARY OUTCOME: Early Clinical Response (ECR); SECONDARY OUTCOME 1: Investigators Assessment of Clinical Response (IACR)[/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 - Balise; BRIEF: The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression. ; DRUG USED: Emibetuzumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC - Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) - Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q) - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 - Havent received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment) - Availability of adequate tumor material (block or slides) Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device - Have previously completed or withdrawn from this study or any other study investigating LY2875358 - Have a serious concomitant systemic disorder or significant cardiac disease - Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently - Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study - Have major surgery less than 2 weeks prior to the initiation of study treatment therapy - Pregnant or lactating women ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Change in Tumor Size (CTS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/ Pomalidomide & Dexamethasone; BRIEF: Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: - Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen. - Measurable disease defined by at least ONE of the following: 1. Serum monoclonal protein (SPEP) ≥1 g/dL. 2. Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine. - Adequate hematologic, hepatic, and renal function - ECOG performance status of ≤ 2 Exclusion Criteria: - Subject must not have primary refractory disease - Plasma cell leukemia, primary amyloidosis or POEMS syndrome - Unable to swallow capsules or disease significantly affecting gastrointestinal function - Requires treatment with strong CYP3A inhibitors - Women who are pregnant or breast feeding. ; PRIMARY OUTCOME: Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment; SECONDARY OUTCOME 1: Clinical Benefit Response (CBR)[/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 - IFN-Free w/TMC435 (GT1) (LEAGUE-1); BRIEF: The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy. ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Key Inclusion Criteria: - Hepatitis C virus (HCV) genotype 1a or 1b - Males and females, ≥18 years of age - HCV RNA ≥10,000 IU/mL - Participants with compensated cirrhosis are permitted - Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 patients - If no cirrhosis, a liver biopsy within 3 years prior to enrollment - If cirrhosis is present, any prior liver biopsy Key Exclusion Criteria: - Liver or any other transplant (other than cornea and hair) - Evidence of a medical condition contributing to chronic liver disease other than HCV infection - Current or known history of cancer, (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment - Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy - Patients infected with HIV or hepatitis B virus - Gastrointestinal disease impacting absorption of study drug - Uncontrolled diabetes or hypertension - Prior exposure to an HCV direct-acting agent - Any criteria that would exclude the patient from receiving ribavirin - Absolute neutrophil count <1.5*1,000,000,000 cells/L (<1.2*1,000,000,000 cells/L for Black/African Americans) - Platelets <90*1,000,000,000 cells/L - Hemoglobin <12 g/dL for females, <13 g/dL for males - Alanine aminotransferase ≥5*upper limit of normal - In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a documented history of Gilberts disease - In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL - International normalized ratio ≥1.7 - QTcF or QTcB >500 mSec - Creatinine clearance ≤50 mL/min - Alpha fetoprotein (AFP) >100 ng/mL OR - AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound - Albumin <3.5 g/dL ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Rapid Virologic Response (RVR) at Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - X052173; BRIEF: The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG). ; DRUG USED: Gevokizumab; DRUG CLASS: Biologic; INDICATION: Neutrophilic Dermatoses; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: XOMA (US) LLC; CRITERIA: Inclusion Criteria: - A clinical diagnosis of classic pyoderma gangrenosum - An active pyoderma gangrenosum ulcer - Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: - Clinical evidence of acutely infected pyoderma gangrenosum - History of allergic or anaphylactic reactions to monoclonal antibodies - History of recurrent or chronic systemic infections - Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment; SECONDARY OUTCOME 1: The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Surgery; BRIEF: This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma. ; DRUG USED: Imlygic; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for complete surgical resection. - Prior systemic, regional and radiation anticancer therapies for melanoma must have been completed at least 3 months prior to randomization. - Subject must have measurable disease and must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm. - Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must have a serum lactate dehydrogenase (LDH) ≤ 1.0 X upper limit of normal and adequate hematologic, hepatic, renal, and coagulation organ function- Other criteria may apply Exclusion Criteria: - Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia). - Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease. - Subject must not have evidence of clinically significant immunosuppression or active herpetic skin lesions or prior complications of herpes simplex type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) and must not require intermittent or chronic systemic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use. - Subject known to have acute or chronic active hepatitis B, hepatitis C, or human immunodeficiency virus infection will also be excluded. - Subject must not have been treated previously with talimogene laherparepvec or tumor vaccine. Other criteria may apply ; PRIMARY OUTCOME: Recurrence-Free Survival (RFS); SECONDARY OUTCOME 1: RFS[/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 - REVEAL (w/NKTR-262 and Nivolumab); BRIEF: Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable toxicity, death, or disease progression per RECIST 1.1. Based on Phase 1 results of the study, the decision was made not to start the Phase 2 part of the study and the study was terminated. ; DRUG USED: Bempegaldesleukin; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Cluster of Differentiation 122 (CD122), IL-2 Receptor (IL-2R) ; THERAPY: Combination; LEAD SPONSOR: Nektar Therapeutics; CRITERIA: Key Inclusion Criteria: - Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer, head and neck squamous cell carcinoma (HNSCC), or sarcoma. - Life expectancy > 12 weeks as determined by the Investigator. - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. - Measurable disease per RECIST 1.1. - Patients enrolled in Cohorts 1-10, Cohort A, Cohort B and Phase 2 Doublet must be refractory to all therapies known to confer clinical benefit to their disease. - Fresh tumor tissue available for cellular characterization and programmed cell death protein 1 (PD-L1) status. - Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies. Any liver lesion targeted for injection must not exceed 50 mm at the time of injection. - Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1). Key Exclusion Criteria: - Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s). - Patients treated with prior interleukin-2 (IL-2). - Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who have received experimental cancer vaccines. - Patients who have received systemic interferon (IFN)α within the previous 6 months prior to enrollment to the study. - Other active malignancy, except non-melanomic skin cancer - Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis. - Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis. - Prolonged Fridericias corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening. History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following: - Unstable angina or myocardial infarction. - Congestive heart failure (NYHA Class III or IV). - Uncontrolled clinically significant arrhythmias. - Patients with a history of any retinal disorders (e.g., retinal detachment, diabetic retinopathy, retinal hemorrhage, macular degeneration). - Uveal melanoma will be excluded - Patients with tumor that invade the superior vena cava or other major blood vessels. Additional general and tumor specific inclusion and exclusion criteria will apply. ; PRIMARY OUTCOME: Number of Participants Experiencing Dose-Limiting Toxicities (DLTS); 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 IIa - CL-0101; BRIEF: The purpose of this study was to assess analgesic efficacy of ASP8062 relative to placebo as well as the safety and tolerability. This study also assessed the treatment differences in physical function as well the improvements in overall subject status (e.g., fibromyalgia symptoms, global functioning) of ASP8062 relative to placebo. ; DRUG USED: ASP8062; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibromyalgia; TARGET: GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Global Development, Inc.; CRITERIA: Inclusion Criteria: - Subject has a body mass index (BMI) ≤ 45 kg/m^2. - Female subject must either: - Be of nonchildbearing potential: - Postmenopausal (defined as at least 1 year without any menses) prior to Screening, or, - Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy). - Or, if of childbearing potential, agree not to try to become pregnant during the study and for 28 days after the final study drug administration, have a negative blood pregnancy test at Screening and negative urine test on Day 1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration. - Female subject must agree not to breastfeed at Screening and throughout the study period, and for 28 days after the final study drug administration. - Female subject must not donate ova starting at Screening, throughout the study period, and for 28 days after the final study drug administration. - Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after the final study drug administration. - A sexually active male subject with female partner(s) who are of childbearing potential is eligible if: - Agree to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile the male subjects female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment, and for 90 days after the male subject receives final study drug administration. - Male subject with a partner of child-bearing potential, or a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period and for 90 days after the final study drug administration. - Subject meets the American College of Rheumatology (ACR) 1990 fibromyalgia diagnostic criteria at Screening: - Widespread pain for at least 3 months, defined as the presence of all of the following: Pain above and below the waist and pain in the axial skeleton (cervical spine or anterior chest or thoracic spine or low back) must be present. - Pain in at least 11 of 18 tender point sites on digital palpation. Digital palpation should be performed with an approximate force of 4 kg. - Subject meets the ACR 2010 fibromyalgia diagnostic criteria at Screening: - Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3-6 and SS scale score ≥ 9. - Symptoms have been present at a similar level for at least 3 months. - The subject does not have a disorder that would otherwise explain the pain. - Subject has a pain score ≥ 4 on the revised fibromyalgia impact questionnaire (FIQR) pain item at Screening. - Subject is compliant with daily pain recordings during the Baseline Diary Run-In period, as defined by the completion of a minimum of 5 of 7 daily average pain ratings and agrees to complete daily diaries throughout the duration of the study. - Subject has a mean daily average pain score ≥ 4 and ≤ 9 on an 11-point 0 to 10 NRS as recorded in the subject e-diary during the Baseline Diary Run-In period, and meeting pre-specified criteria for daily average pain scores. - Subject agrees to use only acetaminophen as rescue medication for fibromyalgia pain throughout the course of the trial (up to 1000 mg per dose and not to exceed 3000 mg/day). - Subject agrees not to initiate or change any non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) during the course of the study. Non-pharmacologic interventions must be stable for a minimum of 30 days prior to Screening. And subject agrees to maintain usual level of activity for the duration of the study. - Subject is capable of completing study assessments and procedures. - Subject agrees not to participate in another interventional study from Screening through the End of Study (EOS) visit. Exclusion Criteria: - Subject has received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening. - Subject has had no meaningful improvement from 2 or more prior treatments (commercially available) for fibromyalgia (in at least 2 pharmacologic classes). - Subject has had known hypersensitivity or intolerance to the use of acetaminophen or associated formulation components; known hypersensitivity to the formulation components of ASP8062. - Subject has pain due to diabetic peripheral neuropathy, post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome, or other source of pain that would confound or interfere with the assessment of the subjects fibromyalgia pain or require excluded therapies during the subjects study participation. - Subject has infectious or inflammatory arthritis (for example, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout), autoimmune disease (for example, systemic lupus erythematosus), or other widespread rheumatic disease other than fibromyalgia. - Subject has a current, untreated moderate or severe major depressive disorder as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). Subject with current, treated major depressive disorder can be included provided that it is without clinically significant changes in symptoms while on the same dose of a protocol allowed antidepressant for greater than 60 days prior to Screening. - Subject has initiated any non-pharmacologic interventions for the treatment of fibromyalgia or depression within 30 days prior to Screening or during the Screening period. - Subject has a history of any psychotic and/or bipolar disorder as assessed by the M.I.N.I. - Subject has a Hospital Anxiety and Depression Scale (HADS) score > 14 on the Depression subscale at Screening or at the time of Visit 3 (Randomization). - Subject has a history of suicide attempt or suicidal behavior within the last 12 months, or has suicidal ideation within the last 12 months (a response of yes to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale C-SSRS]), or who is at significant risk to commit suicide at Screening and at the time of Visit 3 (Randomization). - Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine > 1.5 x the ULN at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period). - Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of the reference range at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period). - Subject has a positive test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV [IgM]) or hepatitis C virus antibodies (anti-HCV) at Screening or has history of a positive test for human immunodeficiency virus type 1(HIV-1) and/or type 2 (HIV-2). - Subject has a resting systolic blood pressure > 180 mmHg or < 90 mmHg, and/or a sitting diastolic blood pressure > 100 mmHg at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period). - Subject has a clinically significant abnormality on 12-lead electrocardiogram (ECG) at Screening or Visit 3 (Randomization). If the ECG is abnormal an additional ECG can be carried out. If this also gives an abnormal result, the subject must be excluded. - Subject has a history of myocardial infarction (within 6 months of Screening), unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease or a family history of Long QT Syndrome. - Subject has evidence of any clinically significant, uncontrolled cardiovascular, gastrointestinal, endocrinologic (low thyroid stimulating hormone [TSH], but euthyroid is allowed), hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary (including obstructive sleep apnea not controlled by a continuous positive airway pressure device) neurologic, dermatologic, psychiatric, renal and/or other major disease (exclusive of fibromyalgia). - Subject has planned surgery during the study participation. - Subject has an active malignancy or a history of malignancy (except for treated nonmelanoma skin cancer) within 5 years of Screening. - Subject has a positive drug or alcohol test at Screening, Baseline Diary Run-In or prior to Randomization. However, a positive test for tetrahydrocannabinol (THC) and/or opioids is allowed at the Screening visit, but must be confirmed negative prior to Baseline Diary Run-In and Randomization. - Subject has a current or recent (within 12 months of Screening) history of a substance use disorder including cannabinoid and/or alcohol abuse disorder. Subject has used opioids for pain for more than 4 days during the week preceding the Screening visit. - Subject is currently using protocol specified prohibited medications and is unable to wash-out including over-the-counter (OTC) products and grapefruit and/or grapefruit juice. - Subject has filed or is awaiting judgment on a disability claim or has any pending workers compensation litigation or related monetary settlements. - Subject has any condition which makes the subject unsuitable for study participation. - Subject is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site personnel directly affiliated with this study and/or immediate families (spouse, parent, child, or sibling, whether biological or legally adopted). ; PRIMARY OUTCOME: Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS); SECONDARY OUTCOME 1: Percentage of Participants With ≥ 30% Reduction From Baseline to Week 8 and End of Treatment (EOT) in Mean Daily Average Pain Score as Assessed by NRS[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Humira; BRIEF: Primary Objective: The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohns disease (CD). Secondary Objectives: The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases. ; DRUG USED: Cyltezo; DRUG CLASS: Biosimilar; INDICATION: Crohns Disease; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Males and females aged >=18 and =<80 years at Screening who have a diagnosis of moderate to severely active Crohns Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following: - Crohns Disease Activity Index (CDAI) score of >=220 and =<450 - A diagnosis of Crohns Disease (CD) confirmed by ileocolonoscopy during Screening - Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization - Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria: - Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion - Responded and became intolerant - Further inclusion criteria apply Exclusion criteria: - Patients with ulcerative colitis or indeterminate colitis - Patients with symptomatic known obstructive strictures - Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial - Patients with an ostomy or ileoanal pouch - Patients with short bowel syndrome - Patients who have previously used infliximab and have never clinically responded - Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial - Further exclusion criteria apply ; PRIMARY OUTCOME: Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4; SECONDARY OUTCOME 1: Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - OPTIMUS (w/Pembrolizumab); BRIEF: The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints. ; DRUG USED: NOX-A12; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Chemokine (C-X-C motif) Ligand 12 (CXCL12)/Stromal Cell-Derived Factor 1 (SDF-1); THERAPY: Combination; LEAD SPONSOR: TME Pharma AG; CRITERIA: Inclusion Criteria: - Patient with confirmed microsatellite-stable tumor pathology, if data available - Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who 1. Arm 1: stopped first-line treatment with gemcitabine/nab-paclitaxel after documented objective radiographic progression OR 2. Arm 2: stopped first-line treatment with FOLFIRINOX or modified FOLFIRINOX after documented objective radiographic progression - Measurable disease based on RECIST 1.1 as determined by the investigational site - Estimated minimum life expectancy 3 months - Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1 - Adequate organ function laboratory values within the ranges specified: Serum albumin ≥ 3.0 g/dL; Hematological system: Hemoglobin (Hb) ≥ 9.0 g/dL or ≥5.6 mmol/L, Absolute neutrophil count (ANC) ≥ 1,500/mm³, Platelets ≥ 100,000/mm³; Renal system: Creatinine ≤ 1.5 x ULN OR eGFR ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN; Hepatic system: Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN, ALT and AST ≤ 2.5 x ULN (≤5 × ULN for patients with liver metastases); Coagulation: INR OR PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Exclusion Criteria: - Prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment. - Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. - If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention - Prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. - Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and discontinued from that treatment due to a Grade 3 or higher irAE - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug - Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed - Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). - History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease - Active infection requiring systemic therapy - Known additional malignancy that is progressing or has required active treatment within the past 2 years. - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - 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 - Previous allogeneic tissue/solid organ transplant ; PRIMARY OUTCOME: Go/no-go decision for a randomized expansion study; SECONDARY OUTCOME 1: Safety and tolerability[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - B14-02 (PK/PD); BRIEF: This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinsons disease patients will be randomized to 1 of 3 dosing sequences. Objectives: - Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinsons disease. - Characterize the safety of IPX203 in subjects with advanced Parkinsons disease. ; DRUG USED: IPX203; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Aromatic L-amino acid decarboxylase (AADC), Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: Impax Laboratories, LLC; CRITERIA: Inclusion Criteria: Male or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD. Requiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose. Dosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing. Have an average of at least 2 hours per day off time during the waking hours and at least 1 hour off time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1. Exclusion criteria: Have used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1. Female subjects who are currently breastfeeding or lactating. Had prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period. Allergic to study drugs History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection. History of peptic ulcer disease or upper gastrointestinal hemorrhage. History of narrow angle glaucoma. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias; neuroleptic malignant syndrome; or nontraumatic rhabdomyolysis. History of psychosis. Employees or family members of the Investigator, study site, or Sponsor. Subjects who, in the opinion of the clinical investigator, should not participate in the study. Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary. ; PRIMARY OUTCOME: Off time per the Assessment of Subjects Motor State; SECONDARY OUTCOME 1: Duration of effect estimated using the timepoint at which an improvement of at least 4 points in the MDS-UPDRS Part III score from predose is first observed and continuing until the timepoint at which the improvement is no longer observed[/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 - Characteristics of Metabolic Syndrome; BRIEF: Metabolic syndrome increases the risk for development of heart disease. Another condition associated with metabolic syndrome is fatty liver disease which is also referred to as nonalcoholic fatty liver disease (NAFLD). Recently, drugs that block fatty acid synthesis have been developed to treat cancer. These drugs are now being considered for the treatment of NAFLD. A research test designed to measure liver fatty acid synthesis involves consumption of a sugary solution and measurement of blood fats over a six-hour period. The present study will test the drug 3-V Bioscience-2640 in healthy subjects with characteristics of the metabolic syndrome before and after 10 days of treatment to determine if 50 mg/d significantly reduces liver fat synthesis and lowers liver fat storage. ; DRUG USED: TVB-2640; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Fatty acids; THERAPY: Monotherapy; LEAD SPONSOR: University of Missouri-Columbia; CRITERIA: Inclusion Criteria: 1. Men with characteristics of metabolic syndrome 1. Waist circumference greater than 40 in (102 cm) 2. Plasma TG greater than 150 mg/dL 3. HDL cholesterol less than 40 mg/dL 4. Blood pressure greater than or equal to 130/85 mmHg 5. Fasting plasma glucose greater than 100 mg/dL but less than 126 mg/dL 6. Fasting insulin great than 10 microunits/mL 2. 35-60 years of age 3. Overweight/obese subjects with BMI 27.1 - 35.0 kg/m2 4. Family history of cardiovascular disease or diabetes 5. Habitual diets containing ≥ 5.0% of energy from added sugars 6. Creatinine clearance of ≥80 mL/min Exclusion Criteria: 1. Diagnosed cardiovascular disease (unstable angina, New York Heart Association angina > Grade 2), abnormal thyroid function or liver/kidney disease, renal dysfunction (defined by a glomerular filtration rate <80 mL/min) 2. Chronic skin disorder or treatment for acne 3. History of clinically significant dry eye or eye diseases such as glaucoma 4. Diabetes defined as fasting glucose ≥ 125 mg/dL or HbA1c ≥ 6.5% 5. Habitual diets with low content of added sugars (<5% of total energy) 6. Any tobacco use 7. Elevated liver enzymes ≥ 3x normal (regional norms Alanine transaminase <42 U/L, aspartate aminotransferase <40 U/L, and gamma-glutamyl transferase 8-61 U/L) 8. Contraindications of MRI 9. Alcohol intake weekly greater than 56 g/week (4 standard drinks/wk). 10. Major surgery or donation of blood of >500 mL within the past 8 wks. 11. Patients with uncontrolled hypertension, i.e. ≥160/95 mmHg. 12. Patients with known cardiac abnormalities. ; PRIMARY OUTCOME: Change in Hepatic Lipogenesis; SECONDARY OUTCOME 1: Change in Liver Fat Measured by 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 - Hip OA; BRIEF: This is a multi-center, single-arm, open-label study of FX006 in patients with hip OA. A maximum number of approximately 30 patients may be enrolled in this protocol. All enrolled patients will receive a single intra-articular (IA) injection of FX006. ; DRUG USED: Zilretta; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions - Patients 40 to 80 years of age, inclusive, on the day of consent - Body Mass Index (BMI) ≤ 40 kg/m^2 - Has a documented clinical diagnosis of unilateral or bilateral hip OA for at least six months - Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by local read of X-ray obtained during Screening or ≤ 6 months of Screening visit - Has clinically significant pain in the index hip Exclusion Criteria: - Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine - Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat) - Has had any previous surgery on the index hip - Presence of surgical hardware or other foreign body in the index hip - Has a history of infection of the index hip - Has a diagnosis of other disorders in the index hip that can cause pain - Has received any intra-articular injection in the index hip of corticosteroids, investigational (including FX006) or marketed (including Zilretta®) within the 3 months prior to Screening - Has had trauma to the index hip in the past 3 months requiring immobilization - Has a history or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex - Has within the past 3 months received corticosteroids by mouth, or by parenteral injection. Multiple courses or chronic intermittent use of inhaled, intranasal, or topical steroids is also exclusionary. Single courses of 14 days or less by those routes are permitted - Has, at screening, or any time prior to day of scheduled injection (Day 1), clinical suspicion of local or systemic infection, including any infection in the index leg. - Has a history of or active significant concomitant illness (known or suspected) - Any bacterial or viral infection requiring parental antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1 - Is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the study - Is a man who plans to conceive during the study ; PRIMARY OUTCOME: Number of Patients With Successful Study Drug Administrations; 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 - 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 - 801 (Rollover); BRIEF: This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the parent protocol. Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria. ; DRUG USED: Itacitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol). - Currently tolerating treatment as defined by the parent Protocol. - Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator. - Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. - Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol. - Willingness to avoid pregnancy or fathering children.. - Ability to comprehend and willingness to sign an ICF. Exclusion Criteria: - Able to access itacitinib therapy commercially. - Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigators opinion, would jeopardize the safety of the participant or compliance with the Protocol. - Pregnant or breastfeeding women. ; PRIMARY OUTCOME: Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Moderate Symptoms/Early CRS; BRIEF: The purpose of this study is to assess the safety and efficacy of orally administered NLRP3 inhibitor, dapansutrile, for the treatment of moderate COVID-19 symptoms and early cytokine release syndrome (CRS) in patients with confirmed SARS-CoV-2 infection and moderate symptoms. Coronavirus disease 2019 (COVID-19) is caused by infection from a new strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 is characterized by fever, cough and shortness of breath, which in certain patients can lead to systemic organ failure and mortality. The data show that SARS-CoV-2 activates the innate immune signaling sensor NLRP3. Activation of NLRP3 initiates the cytokine release syndrome (CRS), which includes the production of primary cytokine, IL-1, triggering an intense inflammatory response that is prevalent in symptomatic COVID-19 patients. When CRS advances further to a fulminant cytokine storm, the data show that respiratory distress syndrome and multiple-organ failure take place. A specific inhibitor of NLRP3, dapansutrile may reduce or prevent the hyperinflammation associated with CRS by inhibiting the production of IL-1β early to arrest the progression to a severe cytokine storm. The end result would be a reduction in the need for COVID-19 patients to receive intensive medical treatment, allowing for fewer hospitalizations, administration of mechanical ventilation and deaths. ; DRUG USED: OLT1177 (Capsule); DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: NLRP3/Inflammasome; THERAPY: Monotherapy; LEAD SPONSOR: Olatec Therapeutics LLC; CRITERIA: Inclusion Criteria: 1. Male and female subjects ≥ 18 years of age; 2. SARS-CoV-2-positive, confirmed by Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-authorized COVID-19 test ≤ 7 days prior to randomization; 3. Less than or equal to 7 days from first symptom onset to randomization; 4. Subjects with moderate COVID-19 consistent with the definition of moderate as set forth by the February 2021 FDA Guidance for Industry: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (FDA, 2021) who at the Screening/Baseline/Day 1 Visit: 1. have felt feverish within the past 24 hours, 2. have an SpO2 > 93% on room air at sea level when sitting, and 3. meet at least one of the following criteria: i). Respiratory rate: ≥ 20 breaths/minute, when the subject is sitting, ii). SpO2: ≤ 96% on room air at sea level, when the subject is sitting, iii). Shortness of breath: with exertion, not requiring oxygen, or vi). Heart rate: ≥ 90 beats/minute, when the subject is sitting; 5. If all the criteria in Inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met: 1. 70 years or more of age, 2. Obesity (BMI ≥ 30 kg/m2), 3. Diabetes (type 1 or 2), 4. Uncontrolled hypertension, defined as diastolic > 100 mm Hg and/or systolic > 150 mm Hg without any current anti-hypertensive medications. At the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the Medical Monitor, 5. Known respiratory disease (including asthma or chronic obstructive pulmonary disease [COPD]), 6. Known heart failure (note: subjects with New York Heart Association Class IV congestive heart failure cannot be enrolled per Exclusion Criterion 4), or 7. Known coronary disease; 6. Plasma CRP level must be collected at Screening/Baseline/Day 1 Visit; 7. Acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the Investigator; 8. Ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the Investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. 9. Subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating. Exclusion Criteria: 1. Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who: 1. Are or intend to become pregnant (including use of fertility drugs) during the study; 2. Are nursing (female subjects only); 3. Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. 2. Evidence of pre-existing or new-onset organ failure; 3. Evidence of moderate concurrent nervous system, renal, endocrine, or gastrointestinal disease, unrelated to COVID-19 as determined by the Investigator; 4. Evidence of cardiovascular disease with significant arrhythmia, congestive heart failure (New York Heart Association Class IV), unstable angina, cor pulmonale, or symptomatic pericardial effusion, not related to COVID-19 as determined by the Investigator; 5. Required use of vasoactive drug support; 6. History of myocardial infarction in the 6 months prior to the Screening/Baseline/Day 1 Visit; 7. Evidence of current liver disease, not related to COVID-19 as determined by the investigator; 8. History or evidence of active tuberculosis (TB) infection at Screening/Baseline/Day 1 Visit or one of the risk factors for tuberculosis such as but not limited or exclusive to: 1. History of any of the following: residence in a congregate setting (e.g., jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g., injection or non-injection), health-care workers with unprotected exposure to subjects who are at high risk of TB or subjects with TB disease before the identification and correct airborne precautions of the subject or 2. Close contact (i.e., share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last 12 months. 9. History of or currently active primary or secondary immunodeficiency; 10. Past or present requirement for oxygen (e.g., nasal cannula, proning, mechanical ventilation and/or supplemental oxygen). 11. Use of any prohibited concomitant medications/therapies over the defined or planned use of any concomitant medications/therapies during the Treatment Period, including specifically: 1. use of ibuprofen or diclofenac 2. use of colchicine 3. use of systemic steroids within 30 days of randomization 4. use of janus kinase (JAK) inhibitors 5. use of off-label agents (e.g., hydroxychloroquine, remdesivir, dexamethasone) and biologic and oral anti-cytokine agents (e.g., current treatment with adalimumab, infliximab, etanercept, golimumab, certolizumab pegol, tocilizumab, sarilumab, anakinra, canakinumab, rilonacept, baricitinib, tofacitinib, or upadacitinib); Note: During the treatment period a patient may meet the criteria for a treatment approved by the FDA specifically for COVID-19 (e.g. remdesivir). In this situation the investigator and medical monitor should confer and take the most appropriate decision for the patient. If possible, the preference would be for the patient to complete the 14 days of dosing before adding on the 2nd treatment. If that is not possible the preference would be for the patient to continue their 14 days on dapansutrile and complete all study related visits. 12. Known history of renal impairment (e.g., calculated glomerular filtration rate [GFR] < 45 mL/min); 13. Evidence of malignant disease, or malignancies diagnosed within the previous 5 years (except for local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured); 14. History of infection or known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV); 15. Any other concomitant medical or psychiatric conditions, diseases, or prior surgeries that, in the opinion of the Investigator, would impair the subject from safely participating in the trial and/or completing protocol requirements; 16. Individuals who have been in a chronic care facility in the past 30 days; 17. Individuals who are incarcerated; 18. Participation in any clinical trial and/or use of any investigational product within the immediate 30-day period prior to the Screening/Baseline//Day 1 Visit; or receipt prior to Screening/Baseline/Day 1 Visit or intending to receive during the trial a COVID-19 vaccination. ; PRIMARY OUTCOME: Proportion of subjects with clinical deterioration; SECONDARY OUTCOME 1: Proportion of subjects with complete resolution of fever symptoms and shortness of breath[/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 - Korean; BRIEF: The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis. ; DRUG USED: Prolia (Osteoporosis); DRUG CLASS: Biologic; INDICATION: Osteoporosis / Osteopenia; TARGET: RANK Ligand (RANKL); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Ambulatory Korean postmenopausal women with osteoporosis - greater than 5 years postmenopausal - aged 60 to 90 years old - absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded. Exclusion Criteria: - previous or current metabolic bone disease, Pagets or Cushings disease, or hyperprolactinemia - current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria - rheumatoid arthritis - cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal - medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates - medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists - malignancy within 5 years except certain resected types - malabsorption syndrome or gastrointestinal disorders associated with malabsorption - abnormal calcium level - vitamin D deficiency - any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results - severe renal impairment or on dialysis - impaired immune system or subject is taking immunosuppressants - oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery - any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures - any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results - known to have tested positive for HIV - less than two lumbar vertebrae evaluable for DXA measurements - height, weight, or girth that may preclude accurate DXA measurements - drug or alcohol abuse within 12 months that interferes with understanding or completing the study - known sensitivity to mammalian cell-derived drug products - use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s) ; PRIMARY OUTCOME: Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6; SECONDARY OUTCOME 1: Mean Percent Change From Baseline in Lumbar Spine BMD at Month 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 - Gingival Mucosal Tissue; BRIEF: The purpose of this study is to determine if the topical application to gingival tissue of the combination of benzocaine and tetracaine has a longer duration of local anesthetic activity than benzocaine alone. ; DRUG USED: CTY-5339; DRUG CLASS: Non-NME; INDICATION: Anesthesia; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Cetylite Industries; CRITERIA: Inclusion Criteria: - Male and female subjects between 18-75 years of age with a Body Mass Index (BMI) ≤32; - Subjects are category I or II on the American Society of Anesthesiologists physical status classification system (ASA category I or II) and are in normal physical health as judged by physical and laboratory examinations; - Subjects have normal appearance of the oral mucosal tissues; - At screening and at Baseline during Stage 1 and Sessions 1 and 2, of Stage 2 subjects with Pin-Prick-Test (PPT) scores of at least 3 (on a 10 point numerical rating scale [NRS]) on the 2 readings, 1 of which must be a score of at least 4; - Subjects have mean quantitative sensory test of heat (QST-Heat) pain sensation temperature assessments on the gingival mucosa of 46.5 °C or less based on the average of the 2 readings at screening and at the Baseline Study Sessions for Stages 1 and 2; - Subjects must agree to refrain from ingesting any systemic or topical analgesic medication for 3 days or 5 half-lives of the drug prior to and during the study period and alcohol for 1 day prior to and during the study period; - Subjects must agree to refrain from using mouth rinses, cough drops or throat lozenges on the day of each test session; - Female subjects must be physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization. At Screening and at Baseline of both sessions, all females of childbearing potential must have a negative urine pregnancy test and not be breastfeeding; - Negative urine drug screen for drugs of abuse at Screening and at Baseline for each Study Session. A positive drug screen result may be permitted if the subject has been on a stable dose of an allowed medication for >30 days; - Subjects must be capable of reading, comprehending, and signing the informed consent form. Exclusion Criteria: - Subjects with a history of any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis; - Subjects with a history of any type of cancer other than skin related cancers; - Subjects with conditions that affect the absorption, metabolism, or passage of drugs out of the body, (e.g., sprue, celiac disease, Crohns disease, colitis, or liver, kidney, or thyroid conditions); - Subjects with any history of alcohol or substance abuse (including a positive drug screen test); - Subjects that currently have or have a history of uncontrolled hypertension; - Subjects with a known hypersensitivity to any local anesthetic drug; - Subjects with a hematocrit level significantly below the normal range on the screening laboratory examination (as judged by the PI); - Subjects with any clinically significant abnormal lab result (as judged by the PI); - Subjects with any condition or history felt by the Investigator to place the subject at increased risk; - Subjects who have smoked or chewed tobacco-containing substances within 6 months prior to the start of the study; - Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol; - Subjects who have used an investigational drug within 30 days prior to entering the study; - Subjects who have donated blood within 3 months prior to the start of the study; - Subjects who have previously participated in the trial; - Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study. ; PRIMARY OUTCOME: Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB; SECONDARY OUTCOME 1: Stage II: Onset of Anesthesia for Pin Prick Test (PPT)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - ENCORE; BRIEF: A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy. ; DRUG USED: Molgradex; DRUG CLASS: Biologic; INDICATION: Cystic Fibrosis (CF); TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116; THERAPY: Monotherapy; LEAD SPONSOR: Savara Inc.; CRITERIA: Inclusion Criteria: 1. Written informed consent obtained from participant. 2. Confirmed diagnosis of CF according to the Cystic Fibrosis Foundation (CFF) 2017 Consensus Guidelines. 3. History of chronic pulmonary infection with M. avium complex (MAC) or M. abscessus complex (MABSC) (defined as at least three positive NTM cultures (sputum or BAL for the same species (MAC) or subspecies (MABSC) within the 2 years prior to the screening visit, with at least one positive within the past 6 months and a minimum of 50% of NTM cultures positive over the past 2 years) that does not demonstrate response to current treatment course based on decreasing NTM burden or frequency of positive cultures, and in the opinion of the Investigator is unlikely to resolve with current treatment course. 4. Subject fulfills criteria for inclusion in one of the following groups: Group 1: Subject with chronic pulmonary MAC or MABSC infection currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 9 months prior to the Baseline visit. Group 2: Subject with chronic pulmonary MAC or MABSC infection who has stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance. Group 3: Subjects with chronic pulmonary MAC or MABSC infection not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen based on failure to meet ATS/IDSA criteria for NTM pulmonary disease (i.e. absence of radiologic findings and clinical symptoms beyond what is expected from underlying CF). 5. Ability to produce sputum or be willing to undergo an induction protocol that produces sputum for clinical evaluation. 6. An additional sputum culture performed by the central laboratory, which is positive for the same species (MAC) or subspecies (MABSC) of NTM as before the trial within 10 weeks of Baseline. 7. CF which in the Investigators opinion is clinically stable and not expected to require lung transplantation within the next year. 8. FEV1 ≥ 30% of predicted at screening that is normalized for age, gender, race, and height, using the Global Lung Function Initiative (GLI) equation. 9. Subjects who are co-infected with a respiratory pathogen, e.g. P. aeruginosa or S. aureus, must either be stable on a regular suppression antibiotic regimen or must be, in the opinion of the Investigator, stable despite the lack of such treatment. 10. Female or male ≥18 years of age. 11. If female, subjects who have been post-menopausal for more than 1 year or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with less than 1% failure rate) during and until 30 days after last dose of trial treatment, having a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at dosing at Baseline (Visit 2) and must not be lactating. For purposes of this study, the Sponsor defines acceptable methods of contraception as: - Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug. - A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion. - Intrauterine devices (IUDs), inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration. - Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion. - Hysterectomy or surgical sterilization. - Vasectomized partner - Abstinence. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam) is not considered an acceptable form of contraception. NOTE: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal contraceptive exposure, reducing the effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi. 12. If male, subjects who, if sexually active of reproductive potential and non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months and not diagnosed with infertility through demonstration of azoospermia in a semen sample and/or absence of vas deferens through ultrasound) are willing to use a barrier method of contraception, or their female partner must use an acceptable method of contraception, during the study and until 30 days after last dose of medication. 13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in the protocol as judged by the Investigator. Exclusion criteria: 1. Use of non-maintenance antibiotic for a concurrent pulmonary or extrapulmonary infection within 28 days prior to the Baseline visit. 2. Use of a maintenance antibiotic regimen containing azithromycin for a concurrent non-NTM pulmonary infection within 28 days prior to the Baseline visit. For subjects in Group 1, azithromycin is allowed if part of ongoing multidrug NTM guideline-based antimycobacterial regimen. 3. Prior therapy with inhaled or systemic granulocyte macrophage colony stimulating factor (GM-CSF). 4. Subjects with hemoptysis of ≥60 mL in a 24-hour period within 4 weeks prior to Screening. 5. Life expectancy of less than 6 months according to Investigators judgement. 6. History of, or present, myeloproliferative disease, leukemia or other hematological malignancy. 7. Active pulmonary malignancy (primary or metastatic); or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study period. 8. Active autoimmune disorder or other condition requiring therapy associated with significant immunosuppression, e.g. such as systemic corticosteroids at a dose equivalent of 10 mg/day or more of prednisolone or other significant immunosuppressant medications, within 3 months prior to Screening or anticipated during the study period. Inhaled or topical corticosteroids, or brief courses (<14 days) of systemic corticosteroids for pulmonary exacerbations or other self-limited conditions are permitted. 9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications, or changes in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators, within 28 days prior to the Baseline visit. 10. Pulmonary tuberculosis requiring treatment or treated within 2 years prior to Screening. 11. History of human immunodeficiency virus (HIV) infection or other disease associated with significant immunodeficiency. 12. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation. 13. History of congestive heart failure (CHF) New York Heart Association (NYHA) Class III or greater in severity. 14. History of cardiovascular ischemic event within 6 months of Baseline. 15. Any change in chronic NTM multi-drug antimycobacterial regimen within 28 days prior to Screening. 16. Treatment with any investigational medicinal product within 28 days of Screening. 17. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product. 18. Any other condition that, in the opinion of the Investigator, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. ; PRIMARY OUTCOME: Number of Participants With Sputum NTM Culture Conversion to Negative; SECONDARY OUTCOME 1: Number of Participants With NTM Sputum Culture Microbiological Cure[/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 - ZUMA-12 (1L); BRIEF: The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma. After the end of KTE-C19-112 (ZUMA-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968. ; DRUG USED: Yescarta; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Kite, A Gilead Company; CRITERIA: Key Inclusion Criteria: - Histologically confirmed large B-cell lymphoma - High-grade large B-cell lymphoma - Individuals must have a positive interim positron emission tomography (PET) per Cheson, 2014 (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of chemoimmunotherapy - No evidence, suspicion and/or history of central nervous system (CNS) involvement of lymphoma - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Absolute neutrophil count ≥ 1000/μL - Platelet count ≥ 75,000/μL - Absolute lymphocyte count ≥ 100/μL - Adequate renal, hepatic, pulmonary, and cardiac function defined as: - Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min - Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal (ULN) - Total bilirubin ≤1.5 mg/dL, except in individuals with Gilberts syndrome - Cardiac ejection fraction ≥ 50% , no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings - No clinically significant pleural effusion - Baseline oxygen saturation > 92% on room air Key Exclusion Criteria: - History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years - History of Richters transformation of chronic lymphocytic leukemia or primary mediastinal B-cell lymphoma - History of autologous or allogeneic stem cell transplant - Prior CD19-targeted therapy - Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy - Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management - History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection - Presence of any indwelling line or drain dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted - Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or active CNS lymphoma - History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement - History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment - History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years - History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators; SECONDARY OUTCOME 1: Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators[/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 - Australia/New Zealand; BRIEF: The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes. ; DRUG USED: ZGN-1061; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Methionine aminopeptidase 2 (MetAP2); THERAPY: Monotherapy; LEAD SPONSOR: Zafgen, Inc.; CRITERIA: Inclusion Criteria: Subjects must meet the following criteria to participate in this study: - Be between the ages of 18 and 70 years, inclusive. - Overweight or obese with a body mass index of at least 27 kg/m². - Have type 2 diabetes with HbA1c between 7% and 11%. - For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor. - For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery. Exclusion Criteria: Subjects cannot participate in this research study if they meet any of the following: - Have taken another study drug or study device within the past 6 months. - Are taking certain prescribed medications including narcotics or opiates. - Consistent recent use of insulin. - Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study. - Have a history of bleeding disorders or risk factors for excessive blood clotting. - Have difficulty giving blood. - Have a history of drug and/or alcohol abuse. ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Change in body weight[/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 - ODYSSEY Long Term (Higher/Very High CV Risk, HeFH); BRIEF: Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters. ; DRUG USED: Praluent; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: Either A or B below and who were not adequately controlled with their lipid-modifying therapy: A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents OR B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents. Exclusion criteria: - Age < 18 years - LDL-C <70 mg/dL (< 1.81 mmol/L) - Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L) The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percentage of Participants Who Experienced Adverse Events (AEs); SECONDARY OUTCOME 1: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ZEUS; BRIEF: The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of hospitalized patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). ; DRUG USED: Contepo; DRUG CLASS: Non-NME; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Cell wall synthesis, Gram-Negative Bacteria; THERAPY: Monotherapy; LEAD SPONSOR: Nabriva Therapeutics AG; CRITERIA: Inclusion Criteria: 1. A signed informed consent form (ICF); 2. Male or female, at least 18 years of age; 3. Diagnosis requires hospitalization and treatment with intravenous (IV) antibiotics; 4. Documented or suspected cUTI or AP including at least 2 protocol defined signs and symptoms and a urine specimen with evidence of pyuria plus at least one protocol defined associated risk 5. Pretreatment baseline urine culture specimen 6. Expectation that any implanted urinary instrumentation will be removed or replaced not longer than 24 hours, after randomization; 7. Expectation that patient will survive anticipated duration of the study; 8. Patient requires initial hospitalization to manage the cUTI or AP; 9. Women of childbearing potential have had a negative pregnancy test before randomization and be willing to consistently use a highly effective method of contraception 10. Male study participants will be required to use condoms with a spermicide throughout study Exclusion Criteria: 1. Presence of any of the following conditions: perinephric abscess, renal corticomedullary abscess, uncomplicated urinary tract infection, recent history of trauma to the pelvis or urinary tract, polycystic kidney disease, chronic vesicoureteral reflux, previous or planned renal transplantation; patients receiving dialysis/hemodialysis/CVVH, previous or planned cystectomy or ileal loop surgery; known or suspected infection; caused by pathogen resistant to study treatment antibiotics 2. Presence of suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination; 3. Gross hematuria requiring intervention; 4. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period; 5. Creatinine clearance <20 mL/min using the Cockcroft-Gault formula; 6. Non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization; 7. Signs of severe sepsis as defined per protocol; 8. Pregnant or breastfeeding women; 9. Known seizure disorder requiring current treatment with anti-seizure medication which would prohibit the patient from complying with the protocol; 10. Cancer chemotherapy, immunosuppressive medications for transplantation, or medications for rejection of transplantation with 30 days of randomization; 11. Significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy; 12. ALT/AST >5 × ULN or total bilirubin >3 × ULN at Screening; 13. Receipt of any potentially-effective systemic antibiotic with activity against Gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization (exceptions defined in protocol); 14. Requirement for additional systemic antibiotic therapy (other than study drug) or antifungal therapy for vaginal candidiasis; 15. Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the study; 16. Known history of HIV virus infection and known recent CD4 count <200/mm3; 17. Presence of significant immunodeficiency or an immunocompromised condition and long-term use of systemic corticosteroids; 18. Presence of neutropenia; 19. Presence of thrombocytopenia; 20. A QT interval corrected using Fridericias formula >480 msec; 21. History of significant hypersensitivity or allergic reaction to fosfomycin, any contraindication to the use of piperacillin/tazobactam; 22. Participation in a clinical study involving investigational medication or investigational device within the last 30 days prior to randomization; 23. Inability, in the judgment of the Investigator, to tolerate the salt load required for study drug administration; 24. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol; 25. Any patients previously randomized in this study. ; PRIMARY OUTCOME: Number of Patients With an Overall Success; SECONDARY OUTCOME 1: Number of Patients With a Response of Clinical Cure in Various Protocol Populations[/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 - AMPLITUDE-D; BRIEF: Primary Objective: To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Secondary Objectives: - To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control. - To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight. - To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide. ; DRUG USED: Efpeglenatide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Participant must be greater than or equal to (>=) 18 years of age at the time of signing the informed consent. - Participants with T2DM. - Diabetes diagnosed at least 1 year before screening. - Participants on stable dose of at least 1500 milligram per day (mg/day) of metformin, or tolerated maximum dose, or as per country regulation if less, for at least 3 months prior to screening. - HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening. Exclusion criteria: - Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery. - Clinically relevant history of gastrointestinal (GI) disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease requiring medical treatment within 6 months prior to screening or history of surgery affecting gastric emptying. - History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy. - Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes). - Body weight change of greater than or equal to (>=) 5 kilogram within the last 3 months prior to screening. - Systolic blood pressure greater than (>)180 millimeter of mercury (mmHg) and/or diastolic blood pressure >100 mmHg at randomization. - Severe renal disease as defined by estimated glomerular filtration rate (eGFR), by Modification of Diet in Renal Disease (MDRD)] of less than (<)30 mL/min/1.73 m^2. - Laboratory findings at the screening visit: - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 * upper limit of normal (ULN) or total bilirubin >1.5 * ULN (except in case of documented Gilberts syndrome); - Amylase and/or lipase: >3 * ULN; - Calcitonin >=5.9 picomoles per liter (pmol/L) (20 picograms per milliliter). - Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to screening, or planned during study period. - Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women. - Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control or who are unwilling to be tested for pregnancy during the study period and for at least 5 weeks after the last dose of study intervention. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Change From Baseline to Week 56 in HbA1c; SECONDARY OUTCOME 1: Change From Baseline to Week 56 in Body Weight[/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 - Sickle Cell Anemia/Beta-0 Thalassemia; BRIEF: The purpose of this research is to evaluate the effects of L-glutamine as a therapy for Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of sickle cell crises. ; DRUG USED: Endari; DRUG CLASS: Non-NME; INDICATION: Sickle Cell Anemia; TARGET: Nicotinamide Adenine Dinucleotide (NAD+/NADH) ; THERAPY: Monotherapy; LEAD SPONSOR: Emmaus Medical, Inc.; CRITERIA: Inclusion Criteria: - Patient is at least five years of age. - Patient has been diagnosed with sickle cell anemia or sickle ß°-thalassemia (documented by hemoglobin electrophoresis). - Patient has had at least two documented episodes of sickle cell crises within 12 months of the screening visit. - If the patient has been treated with an anti-sickling agent within three months of the screening visit, the therapy must have been continuous for at least three months with the intent to continue for the duration of the study. - Patient or the patients legally authorized representative has given written informed consent. - If the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g. barrier, birth control pills, abstinence). Exclusion Criteria: - Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit. - Patient has prothrombin time INR > 2.0. - Patient has serum albumin < 3.0 g/dl. - Patient has received any blood products within three weeks of the Screening Visit. - Patient has uncontrolled liver disease or renal insufficiency. - Patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female and of child-bearing potential). - Patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit. - Patient has been treated with an experimental anti-sickling medication/ treatment within 30 days of the screening visit (with the exception of hydroxyurea in pediatric patients). - Patient is currently taking or has been treated with an investigational drug within 30 days of the screening visit (with the exception of hydroxyurea in pediatric patients). - Patient is currently enrolled in an investigational drug or device study and/or has participated in such a study within 30 days of the screening visit. - There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study. ; PRIMARY OUTCOME: The Number of Occurrences of Sickle Cell Crises; SECONDARY OUTCOME 1: The Number of Hospitalizations for Sickle Cell Pain[/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/Meshed Split-Thickness AG (US Army); BRIEF: The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds. The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patients own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will be performed by taking healthy skin from one area of the body and placing it on the burned area. ; DRUG USED: Engineered Skin Substitute (ESS); DRUG CLASS: Biologic; INDICATION: Burn Injury; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Amarantus BioScience Holdings, Inc.; CRITERIA: Inclusion Criteria: - Has deep partial or full-thickness thermal burns ≥50% of the TBSA and fulfills the total grafting area requirement ranging from 288 cm2 up to 5,600 cm2, divided between two (or more) recipient sites. - Is expected to require multiple skin grafting procedures. - Is ≥18 years and ≤40 years of age at the time of enrollment. - Females of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use appropriate birth control methods during the pre-grafting period and for three months following the last Grafting Day. - Subject (or a legally authorized representative (LAR)) has provided written informed consent for study participation and procedures to be performed. Exclusion Criteria: - Has a current diagnosis of septic shock or Multiple Organ Dysfunction Syndrome, which in the opinion of the Investigator would put the potential subject at risk of serious morbidity or death by participating in the study. - Has a current diagnosis of an invasive burn wound infection in unexcised burn wound. - Is pregnant. - Is a prisoner at the time of obtaining written informed consent. - Has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of ESS-W including the irrigation solution used before and after grafting. These include aminoglycosides, polymyxin B, mupirocin, ciprofloxacin, amphotericin B, hydrocortisone, and insulin. - Has a documented history of allergy or sensitivity to any of the animal products used in preparation of ESS-W. These products include bovine blood, bovine collagen, bovine collagenase, and porcine trypsin-versene. - Has a documented history of allergy or sensitivity to glycosaminoglycan, the polymer component of ESS-W. - Has a documented ongoing condition which could delay wound healing such as insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C). - Has a severe malnutrition or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing. ; PRIMARY OUTCOME: Incidence and severity of infections at grafting sites; SECONDARY OUTCOME 1: Scar outcome assessment using the modified Vancouver Scar Scale (mVSS).[/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 - Meibomian Gland Dysfunction; BRIEF: To evaluate the efficacy and safety of two strengths of HY02 Ointment versus Vehicle administered twice daily for twelve weeks in subjects with a diagnosis of Inflamed Meibomian Gland Dysfunction. ; DRUG USED: HY02; DRUG CLASS: Non-NME; INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Hovione Scientia Limited; CRITERIA: Inclusion Criteria: - At Visit 1, individuals of any gender or any race will be eligible for study participation if they: 1. Have provided written informed consent prior to any study procedures. 2. Are 18 years of age or above. 3. Have a clinical diagnosis of moderate to severe MGD and who meet the following criteria, in a qualifying eyelid, at both Visit 1 (Screening) and Visit 2 (Randomization) examinations: 1. Clinical sign severity score of at least 2 (moderate) on vascular engorgement at the eyelid margin and 2. Clinical sign severity score of at least 2 (moderate) on plugging of the meibomian glands. 3. Eye Discomfort Symptom score of ≥ 40 using VAS (0-100 point scale) 4. Meet the following criteria, in a qualifying eye (same eye that qualifies for Inclusion #3), at both the Visit 1 (Screening) and Visit 2 (Randomization) examinations: 1. Fluorescein corneal staining (FCS) total score ≥ 3 in the inferior, central, and nasal region combined score (NEI/Industry Workshop sections 1, 4 and 5 with 0-9 scale) 2. Schirmer score of >7 mm without topical anesthesia 5. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study. 6. Have a BCVA, using corrective lenses if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) or modified ETDRS. 7. If female, are non-pregnant, non-lactating and women of childbearing potential (WOCBP) must be using an acceptable method of birth control [e.g., an Intrauterine Contraceptive Device (IUCD) with a failure rate of <1%, hormonal contraceptives, or a barrier method] for the duration of the study. If a female subject is currently abstinent, they must agree to use one of the acceptable methods of birth control before they become sexually active. Exclusion Criteria: In order for subjects to be eligible at Visit 1 they may not: 1. Have presence of inflammation and/or active structural change in the iris or anterior chamber. 2. Have lid structural abnormalities such as entropion or ectropion. 3. In the eyelid that qualifies (based on Inclusion #3), have grade level 4 (Obstructed) on Character of Secretion of Meibomian Glands or grade level 4 (No glands are expressible) on the Expressibility of Meibomian Glands. 4. Subjects with ocular inflammatory conditions (e.g., conjunctivitis, keratitis, anterior blepharitis, etc.) not related to MGD. 5. Subjects who have FCS total score = 15 or a score = 3, in either eye, in the superior region NEI/Industry Workshop scale or subjects who have FCS with diffuse confluent staining, filaments or frank epithelial defects. 6. Have suspected ocular fungal, viral or bacterial infection. 7. Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study. 8. Have had ocular surface surgery within 12 months of Visit 1 (e.g., LASIK, refractive, pterygium removal). 9. Subjects who within the past 90 days have had cauterization of the punctum or changes to the status (insertion or removal) of punctal plug(s) before the Screening Visit. 10. Have used topical ocular or oral antibiotics within 30 days of the study or expect to use during the study. 11. Have used LipiFlow or hypochlorous acid spray within 30 days of the study or expect to use during the study. 12. If using inhaled or intranasal corticosteroids, unable to maintain a stable dose for the duration of the study. 13. Have ever used isotretinoin. 14. If using Omega-3 supplements, dose must be stable for 3 months prior to Visit 1 and for the duration of the study. 15. Have used topical cyclosporine within 30 days of the study or during the study. 16. Have used topical lifitegrast within 30 days of the study or during the study. 17. Have used systemic corticosteroids within 30 days prior to study entry or during study participation. 18. Have used topical ocular corticosteroids or ocular non-steroidal anti-inflammatory drugs (NSAIDs) within 30 days prior to study entry and during study participation. 19. Have used topical ocular antihistamine and/or mast cell stabilizers within 30 days prior to study entry or during study participation. 20. Are unable or unwilling to discontinue using any preserved or unpreserved topical ocular medications (including artificial tears) upon Screening and for the duration of the study. 21. Are unwilling to discontinue use of contact lenses during the study. 22. Are unwilling to discontinue use of cosmetic makeup applied to the eyelids or eye lashes at the Screening Visit and during the study. If makeup was used, it should be removed at least 12 hours prior to Visit 1. 23. Have a known hypersensitivity to minocycline, any other tetracycline antibiotic, or to any of the other ingredients in the investigational product. 24. Are unable or unwilling to withhold the use of eyelid scrubs or use of mechanical therapy during the study. 25. Have been diagnosed with glaucoma or are currently using any glaucoma medication. 26. Have a history of herpetic keratitis. 27. Have a concomitant ocular pathology other than condition under study assessed as potentially confounding by the investigator. 28. Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance. 29. Have been exposed to any investigational drug or investigational device within the preceding 30 days. 30. Are an employee of the site that is directly involved in the management, administration, or support of this study or be an immediate family member of the same. 31. Have trigger factors including conjunctivochalasis, allergic conjunctivitis, contact lens intolerance, trichiasis, epithelial basement membrane dystrophy, infectious keratitis or conjunctivitis. 32. Have a documented history of ocular allergies, which, in the judgment of the investigator, are likely to have an acute increase in severity due to the expected timing of the exposure to the allergen to which the subject is sensitive. Subjects sensitive to seasonal allergens that are not expected to be present during the study are permitted. ; PRIMARY OUTCOME: Change from baseline in Vascular Engorgement in 1% HY02 Ointment compared to vehicle at week 12; 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 - ATLAS Ext.; BRIEF: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN). ; DRUG USED: BIIB023; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: TWEAK/TWEAK receptor; THERAPY: Combination; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment. - Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment. Key Exclusion Criteria: - Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects participation. The Investigator must re-review the subjects medical fitness for participation and consider any diseases that would preclude treatment under this protocol. - Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201. - Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding. - Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subjects ability to comply with the protocol. - Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for enrollment. NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply. ; PRIMARY OUTCOME: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs); 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; BRIEF: The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma ; DRUG USED: Tremelimumab; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Histologically confirmed: Stage III (AJCC 6th edition)xxl unresectable melanoma, with measurable disease (either locally relapsed unresectable, in-transit lesions or unresectable draining nodes) or Stage IV melanoma, including: - Metastasis to skin, subcutaneous tissues or distant lymph nodes, or - Metastasis to lungs, or - Metastasis to all other visceral sites with either LDH <= ULN (upper limit of normal) or a single site of metastasis - Note: Patients with melanoma of ocular origin will be considered ineligible - Documented progressive disease following adjuvant therapy, localized therapy or other therapy for metastatic disease - Measurable disease defined by at least one target lesion that can be accurately measured and whose size is at least 1.0 cm (by spiral CT) or 2.0 cm (by conventional techniques) in its longest diameter - ECOG performance status of 0 or 1 Life expectancy of > 3 months - Either gender, aged 18 years and above - Adequate bone marrow, hepatic, and renal functions determined within 2 weeks prior to starting therapy, defined as: - Absolute neutrophil count >= 1.5 x 10(9)cells/L - Platelets >= 100 x 10(9)/L - Hemoglobin >= 10 g/dL - Aspartate and alanine aminotransferases (AST, ALT) <= 2.5 x ULN (<= 5 x ULN, if documented liver metastases are present) - Total bilirubin <= 1.5 x ULN - Creatinine <= 1.5 x ULN - Patients must have recovered from all prior treatment related toxicities, to baseline status, or a CTC grade of 0 or 1. Post-surgical pain shall not be considered a basis for exclusion. - Females must either be not of childbearing potential [surgically sterilized, which includes tubal ligation, or at least 2 years postmenopausal; not breastfeeding], or practicing 1 form of approved contraception for at least three months prior to entry into the study with 1 of the following methods: (a) oral contraceptives, (b) intrauterine device, (c) implanted contraceptive (such as Norplant®), (d) injected contraceptives (such as Depo-Provera®), (e) diaphragm, (f) sexual partner must use condom or be surgically sterilized, or (g) sexually inactive. Females of childbearing potential must be instructed to avoid pregnancy during study participation. Negative serum or urine pregnancy test must be documented during screening evaluation. - Must be willing and able to provide written informed consent. Exclusion Criteria: - Received immunotherapy for cancer within one month prior to the start of screening - Patients previously treated on this protocol - History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (e.g. Addisons disease, asthma, celiac disease, multiple sclerosis, Graves Disease, Hashimotos thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc.) - Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history. - History of autoimmune colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin. - Pregnant or lactating women. - Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. - Diagnosed or suspected brain metastases. Patients with past history of brain metastases but with no radiologic evidence within 12 weeks prior to enter into the protocol will be eligible. - Any serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment. - Coexisting malignancies except for basal or squamous cell carcinoma of the skin. - Received any prior CTLA4 inhibiting agent ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Monitor for human anti-human antibodies at the end of the 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 - KB001-04; BRIEF: Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections. ; DRUG USED: KB001A; DRUG CLASS: Biologic; INDICATION: Pseudomonas-Specific Agents (Antibacterial); TARGET: Pseudomonas aeruginosa; THERAPY: Monotherapy; LEAD SPONSOR: Humanigen, Inc.; CRITERIA: Inclusion Criteria: - Provision of written informed consent obtained from patient or patients surrogate if unconscious or altered sensorium - Age >18 years - On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days - Documented pulmonary Pa colonization Exclusion Criteria: - Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis) - Patient currently diagnosed with Pa VAP - Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours - Use of an investigational medication within 4 weeks prior to randomization ; PRIMARY OUTCOME: The safety and tolerability of a single dose of KB001.; SECONDARY OUTCOME 1: To measure the pharmacodynamic effects of a single-dose of KB001.[/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 - 003; BRIEF: The purpose of this study is to evaluate and compare the efficacy of B244 in treating patients with hypertension. ; DRUG USED: B-244; DRUG CLASS: Biologic; INDICATION: Hypertension (Systemic); TARGET: Bacteria-miscellaneous; THERAPY: Monotherapy; LEAD SPONSOR: AOBiome LLC; CRITERIA: Inclusion Criteria: - Male and female subjects ≥18 years of age - In good general health as determined by a thorough medical history and physical examination, and vital signs - Clinical diagnosis of elevated Blood Pressure defined as: - Having systolic prehypertension measurements having systolic BP (mmHg) of 120-139 and Diastolic BP (mmHg) of 90 - OR - Having systolic Stage 1 hypertension measurements having systolic BP (mmHg) of 140-159 and Diastolic BP (mmHg) of 100 - Hypertension treatment naïve patients, defined as those patients who have never been treated with antihypertensive medications or have been off any hypertensive treatment for a period of 12 weeks or longer. - Willing to refrain from using any antihypertensive treatments, other than the investigational product, including herbal supplements, systemic use of steroids, chronic use of NSAIDS, any antihypertensive agents, such as beta-blockers, diuretics, ACE inhibitors, CA channel blockers, Alpha blockers, Central Acting agents and vasodilators. - Ability to comprehend and comply with procedures - Agree to commit to participate in the current protocol - Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read) Exclusion Criteria: - Pregnant and/or lactating women - Patients on treatment for Benign Prostatic Hyperplasia (BPH) - Clinically significant history of cardiovascular disease (i. e. PCI, CABG MI (if event occurred 12 months), atrial fibrillation, frequent PAC, cardiac rhythm disorder, syncope, valve repair/replacement, heart transplantation, PTA, peripheral bypass surgery, endarterectomy, unstable angina, TIA, stroke and NYHF category II, II and IV heart failure. - Patients with renal failure, significant kidney or renal disease defined as having creatinine level of mg/dL - Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patients successful participation for the duration of the study - History of migraines and/or anxiety, where patient is unable to refrain from the use of beta blockers - 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 Medical Monitor, contraindicates their participation. - The participant has been previously randomized in this study - Subjects with clinical diagnosis of Type I Diabetes - Subjects with arm circumference of 42 cm - Any condition that would prevent the subject from participating in the trial in the opinion of the evaluation physician - The participant has received an investigational product within 30 days prior to randomization - Prior use of any product containing B244 or Nitrosomonas eutropha - Unable to lie flat or sit for 15 minutes - Concurrent participation in other trials ; PRIMARY OUTCOME: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0; SECONDARY OUTCOME 1: Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Study 0001; BRIEF: This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo. ; DRUG USED: Arbaclofen Placarbil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alcohol Use Disorder; TARGET: GABA Receptors, GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Indivior Inc.; CRITERIA: Inclusion Criteria: 1. 18 to 65 years of age. 2. Diagnosis of AUD confirmed by the Mini-International Neuropsychiatric Interview. 3. For those requiring medical detoxification from alcohol, subjects will be required to have completed a program for detoxification from alcohol within 4 days prior to screening. 4. Provide written informed consent prior to any study-specific procedures. 5. Self-report of at least 2 heavy drinking days per week in each of the 4 weeks prior to the screening interview. 6. Willing to abstain from drinking for the time he/she is participating in the study. 7. Able to identify at least 1 locator person to assist study staff in tracking the subject for the non-residential clinic days. 8. Able to read, speak, and understand English and be willing to cooperate with study procedures. 9. For female subjects, women of childbearing potential must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of IMP. Male subjects with female partners of childbearing potential must agree to use medically acceptable contraception from informed consent through at least 3 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 3 months after receiving the last dose of IMP (Investigational Medicinal Product). Exclusion Criteria: 1. Has present symptoms or history of any of the following disorders: - Schizophrenia - Schizoaffective Disorder - Delusional Disorder - Bipolar I Disorder - Any mood disorder with psychotic features or any psychotic disorder - Anorexia Nervosa - Bulimia Nervosa - Post-Traumatic Stress Disorder that could interfere with the study - Any Personality Disorder that could interfere with the study 2. Current diagnosis of any substance use disorder, except for nicotine, cannabis (mild or moderate), or alcohol. 3. Positive result for any prohibited medication. 4. History of suicidal ideation within 30 days prior to providing written informed consent. 5. History of seizures or delirium tremens. 6. Intention to initiate or continue additional formal alcohol-related treatment, including pharmacotherapy, during the active treatment period. 7. Have had inpatient treatment for a non-alcohol substance use disorder in the 12 weeks prior to informed consent. 8. Total bilirubin >1.5× the upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN, aspartate aminotransferase (AST) >3×ULN, serum creatinine >2×ULN, international normalized ratio (INR) >1.5×ULN, lipase >3×ULN, amylase >3×ULN, or any abnormal pancreatic enzyme value above ULN that is associated with clinically significant active pancreatic disorder. 9. Creatinine clearance of <80 mL/min, as calculated according to the Cockcroft-Gault equation. 10. Hemoglobin at screening of <11.5 g/dL (for females) or <12.5 g/dL (for males). 11. Body mass index (BMI) >30. 12. Diagnosed with unstable medical disorders that could increase the potential risk of study treatment or interfere with study participation, including the following: 1. Abnormal cardiac conditions, including: - Uncontrolled hypertension. - History of myocardial infarction in the last year or any prior history of myocardial infarction with active complication. - Syncopal event within the past year. - Congestive heart failure. - Angina pectoris. - QTcF (QT Fridericia-corrected) ≥450 msec for males and ≥470 msec for females at screening or randomization. - Clinically significant abnormal finding on the physical exam or 12-lead ECG. 2. Diabetes mellitus (type 1 or 2) fulfilling any of the following criteria: - Glycosylated hemoglobin (HbA1c) >7.5% at screening. - Uncontrolled diabetes mellitus. 13. Have any other clinically significant abnormal laboratory result 14. Must not have donated blood or have had any therapeutic phlebotomy (in an amount >300 mL) or received blood transfusion within 90 days preceding enrollment. 15. Must not have a history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (eg, Alzheimers or Parkinsons Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS), or a history of significant head trauma within the past 2 years, or currently receiving anticonvulsant therapy for any reason. 16. Must not have acquired immunodeficiency syndrome (AIDS). 17. Have any other active medical condition or organ disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the IMP. 18. History or presence of allergic or adverse response (including rash or anaphylaxis) to baclofen or any ingredient of the IMP. 19. Have used baclofen within 30 days prior to informed consent. 20. Taking medications which may be expected to significantly interfere with the metabolism or excretion of AP, may be associated with a significant drug interaction with AP, or may pose a significant risk to the subjects participation in the study. 21. Participation in an interventional clinical study within 30 days prior to informed consent. 22. Use of exclusionary drugs (e.g. antipsychotics, anticonvulsants, benzodiazepines, naltrexone, acamprosate). 23. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study. 24. Be unable to comply fully with the study requirements. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) of Arbaclofen Placarbil; SECONDARY OUTCOME 1: The Number of Participants Who Experienced Serious or Non-Serious 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 - DIC3-08-04; BRIEF: The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain. ; DRUG USED: Zorvolex; DRUG CLASS: Non-NME; INDICATION: Mild to Moderate Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Iroko Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - Patient is male or female between 18 and 65 years of age - For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control - Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures - Patient must be willing to stay at the study site ≥ 72 hours Exclusion Criteria: - Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs - Patient has a current disease or history of a disease that will impact the study or the patients well-being - Patient has used or intends to use any of the medications that are prohibited by the protocol - Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test - Patient has taken another investigational drug within 30 days prior to screening ; PRIMARY OUTCOME: The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48), ANCOVA Model.; SECONDARY OUTCOME 1: VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 025 (Low/High Dose); BRIEF: The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimers disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor. ; DRUG USED: Encenicline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: FORUM Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Ages ≥55 and ≤85 years - Informed consent form (ICF) signed by the subject or legally acceptable representative before any study-specific procedures for the subject are performed and an ICF signed by the support person/caregiver before any study-specific procedures for the support person/caregiver are performed - Clinical diagnosis of dementia due to probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimers Disease Association - Clinical decline within 12 months before screening and onset of symptoms at least 12 months or longer before screening, which may include any documented cognition, functional, or other objective assessment or the clinical judgment of the investigator or the subjects referring physician that the subject has experienced a clinical decline within the last 12 months - Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12 months before screening, with findings consistent with the diagnosis of dementia due to AD without any other clinically significant comorbid pathologies. If an MRI or CT scan is unavailable or occurred greater than 12 months before screening, this assessment should be completed and the findings confirmed before the subject enters the run-in period (Day -14) (copy of the report will be available at the study site) - Mini-Mental State Examination (MMSE) score ≥14 and ≤24 at screening and confirmed on Day 1 prior to randomization (fluctuations of ±2 points are acceptable on Day 1/baseline) - Clinical Dementia Rating Global score (CDR-GS) ≥1 (at least mild dementia) at screening and confirmed on Day 1 prior to randomization - Modified Hachinski Ischemic Scale (mHIS) score ≤4 at screening - Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method]) - Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible - Subject living at home, senior residential setting, or an institutional setting without the need for continuous (ie, 24-hour) nursing care - General health status acceptable for participation in a 26-week study - Fluency (oral and written) in the language in which the standardized tests will be administered - Receiving a stable dose of an acetylcholinesterase inhibitor (AChEI) (donepezil, rivastigmine or galantamine) for at least 3 months (90 days) before screening and with continuous dosing for at least 6 months OR not presently receiving an AChEI (at least 30 days before screening), but with a history of previous AChEI treatment (subjects receiving donepezil 23 mg currently or within 3 months before screening are ineligible) Exclusion Criteria: - Exposure to an experimental drug, experimental biologic or experimental medical device within 2 months (60 days) before screening - Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening - Inability to swallow a tablet - In the judgment of the investigator, inability of the subject or the support person/caregiver to complete a 26-week study - Inability to be ≥75% compliant with single-blind study drug - Inability to adequately cooperate or complete the cognitive testing procedures or any study assessment - Residence in a skilled nursing facility - Untreated vitamin B12 or folate deficiency (if treated, must be stably treated for at least 6 months before screening) - Clinically significant (in the judgment of the investigator) abnormal serum electrolytes (sodium, potassium, magnesium) after repeat testing - Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating hormone level and thyroid supplementation dose must be stable for at least 6 months before screening) - Insufficiently controlled diabetes mellitus (in the judgment of the investigator) or requiring insulin - Renal insufficiency (serum creatinine >2.0 mg/dL) - Malignant tumor within 3 years before screening (except squamous and basal cell carcinoma or cervical carcinoma in situ or localized prostate cancer) - Female subjects who are pregnant, nursing, or planning to become pregnant during the study - Unstable medical condition that is clinically significant in the judgment of the investigator - Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times the upper limit of normal - History of myocardial infarction or unstable angina within 6 months before screening - History of more than 1 myocardial infarction within 5 years before screening - Clinically significant (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (subjects with a pacemaker are acceptable) - Symptomatic hypotension or hypertension (supine diastolic blood pressure >95 mmHg) (in the judgment of the investigator) - Clinically significant abnormality on screening or baseline electrocardiogram (ECG), including but not necessarily limited to a confirmed corrected QT interval (QTc) value ≥450 msec for males or ≥470 msec for females. In subjects with a QRS value >120msec, those with a QTc value <500 msec may be eligible following discussion with the Medical Monitor. - Stroke within 18 months before screening, or history of a stroke concomitant with onset of dementia - History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI - Head trauma with clinically significant (in the judgment of the investigator) loss of consciousness within 12 months before screening or concurrent with the onset of dementia - Onset of dementia secondary (in the judgment of the investigator) to cardiac arrest, surgery with general anesthesia, or resuscitation - Specific degenerative central nervous system (CNS) disease diagnosis other than AD (eg, Huntingtons disease, Creutzfeld-Jacob disease, Downs syndrome, Fronto-Temporal Dementia, Parkinsons disease) - Subjects with no history of prior treatment with an AChEI (donepezil, rivastigmine, or galantamine) - Memantine currently or within 30 days before screening - Antipsychotics; low doses (in the judgment of the investigator, except clozapine) are allowed only if given for sleep disturbances, agitation and/or aggression, and only if the subject has received a stable dose for at least 3 months before screening (but not within 8 hours before any cognitive test) - Tricyclic antidepressants and monoamine oxidase inhibitors; all other antidepressants are allowed only if the subject has received a stable dose for at least 3 months before screening - Antiepileptic medications if taken for control of seizures - Chronic intake of opioid-containing analgesics - Sedating H1 antihistamines - Nicotine therapy (including the patch), varenicline (Chantix), or similar therapeutic agent within 30 days before screening - Clinically significant urine drug screen or serum alcohol test result in the judgment of the investigator - History of ischemic colitis or ischemic enterocolitis ; PRIMARY OUTCOME: Change from Baseline in Alzheimers Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog-13) to Day 182; SECONDARY OUTCOME 1: Change from Baseline in activities of daily living using the Disability Assessment for Dementia (DAD)[/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 - REVOLVE; BRIEF: The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohns disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohns disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks. ; DRUG USED: GED 0301; DRUG CLASS: New Molecular Entity (NME); INDICATION: Crohns Disease; TARGET: Smad; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: - Male or female ≥ 18 years - Active Crohns disease (CD) disease as determined by the Crohns Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohns Disease (SES-CD) - Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period - Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: - Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis - Local manifestations of Crohns Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy - Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit - Ileostomy or a colostomy - Subject has a history of any clinically significant medical condition that, in the investigators opinion, would prevent the subject from participating in the study. ; PRIMARY OUTCOME: The Percentage of Participants Who Achieved a Clinical Remission at Week 12; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved Clinical Remission at Week 52[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb ; BRIEF: The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer. ; DRUG USED: CoFactor; DRUG CLASS: Non-NME; INDICATION: Colorectal Cancer (CRC); TARGET: Thymidylate Synthase; THERAPY: Combination; LEAD SPONSOR: Mast Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma. - Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age. - If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughout their participation in this study and for 30 days after discontinuation of study medication. - If, female of childbearing potential, have a negative pregnancy test prior to the start of the study. - Have a life expectancy of at least 6 months. - Have radiologically or clinically measurable disease for response assessment. Presence of ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but may be present if dimensional or other discrete measurable disease is present for evaluation. - Have an ECOG Performance Level of 0-2 (or Karnofsky of 100-70). A lower ECOG or Karnofsky is acceptable only if clearly due to non-oncologic conditions (e.g., prior paraplegia from polio). - Have had no prior chemotherapy for established, metastatic disease. (Subjects may have received adjuvant chemotherapy with fluoropyrimidine therapy). - Have at least 6 months elapsed since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy. - Have had at least an 8 week interval since any prior radiation therapy or 4 weeks since any major surgery. - Have recovered from any toxicities resulting from prior therapies (except for alopecia). - Adequate renal, bone marrow, liver function defined as serum creatinine less than 1.5 times the upper limit of normal, serum bilirubin less than 2 times the upper limit of normal, ANC greater than 1.5 x 109/L, Platelet count greater than 90 x 109/L, SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal. Exclusion Criteria: - Failure by the subject or the subjects legal representative to sign the Informed Consent. - An inability to obtain Informed Consent because of psychiatric or complex medical problems. - Have concurrent infection including diagnoses of FUO or evidence of possible central line sepsis (subjects must be afebrile at the start of therapy). - Have unstable oncologic emergency syndromes: superior vena cava (SVC) syndrome, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc. - Have unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc. - Have cerebellar neurologic syndromes such as Parkinsons disease, multiple sclerosis, and amyotonia. - Have a known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase deficiency). - Patients with vomiting, diarrhea, or nausea of grade greater than 1. - Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug. ; PRIMARY OUTCOME: ; 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 - BLISS-76 (US/EU); BRIEF: The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease. ; DRUG USED: Benlysta; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: B-cell activating factor (BAFF); THERAPY: Combination; LEAD SPONSOR: Human Genome Sciences Inc.; CRITERIA: Key Inclusion Criteria: - Clinical diagnosis of SLE by ACR criteria. - Active SLE disease. - Autoantibody-positive. - On stable SLE treatment regimen. Key Exclusion Criteria: - Pregnant or nursing - Have received treatment with any B cell targeted therapy. - Have received treatment with a biological investigational agent in the past year. - Have received IV cyclophosphamide within 180 days of Day 0. - Have severe lupus kidney disease. - Have active central nervous system (CNS) lupus. - Have required management of acute or chronic infections within the past 60 days. - Have current drug or alcohol abuse or dependence. - Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C. ; PRIMARY OUTCOME: SLE Responder Index (SRI) Response Rate at Week 52; SECONDARY OUTCOME 1: SRI Response Rate at Week 76[/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 - Open Label (GS-US-342-1138 Ext.); BRIEF: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138. ; DRUG USED: Epclusa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent - Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy - Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138 - HCV RNA ≥ 10^4 IU/mL at screening - Classification as treatment naive or treatment experienced - Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Key Exclusion Criteria: - Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded. - Screening electrocardiogram (ECG) with clinically significant abnormalities - Laboratory results outside of acceptable ranges at screening - Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - US; BRIEF: This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms. ; DRUG USED: COVI-DROPS; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Sorrento Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment - Either have no COVID-19 symptoms (asymptomatic) or mild symptoms - Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol - Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity - Willing to follow contraception guidelines Exclusion Criteria: - In the investigators opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) - Any medical condition that, in the Investigators opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process. - Has a documented infection other than COVID-19 - Pregnant or lactating women who are breast feeding or planning on either during the study - Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit - Has a high risk of progressing to severe COVID-19 per CDCs risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-c onditions.html) - Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection. ; PRIMARY OUTCOME: Proportion of subjects who have COVID-19-related visit or hospitalization; SECONDARY OUTCOME 1: Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29[/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 - MET43 (Age 10-55); BRIEF: The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine Menactra®, and describe the safety and additional immunogenicity of these study vaccines in adolescents and adults 10 to 55 years of age in the United States (US). Primary Objectives: - To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers (GMTs). - To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra®. Secondary Objective: - To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adult population (18 to 55 years old). - To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adolescent population (10 to 17 years old). - To compare the hSBA vaccine seroresponses of meningococcal serogroups A, C, Y, and W for each of 3 lots of MenACYW Conjugate vaccine 30 days (+14 days) after vaccination. - To compare the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of Menactra®. Observational Objectives: - To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed Menactra®. ; DRUG USED: MenQuadfi; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: - Aged 10 to 55 years on the day of inclusion. - Informed consent form was signed and dated by the participant (aged 18 to 55 years) or assent form was signed and dated by the participant and informed consent form was signed and dated by the parent(s) or guardian (for participants aged 10 to < 18 years). - Participant (>= 18 years) or participant (10 to < 18 years) and parent / guardian were able to attend all scheduled visits and comply with all trial procedures. Exclusion Criteria: - Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must have been pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination). - Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. - Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. - Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine). - Receipt of immune globulins, blood or blood-derived products in the past 3 months. - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. - At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease). - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. - Verbal report of thrombocytopenia, as reported by the participant or the participants parent / guardian, contraindicating intramuscular vaccination in the Investigators opinion. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigators opinion. - Personal history of Guillain-Barre syndrome. - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination. - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. - Current alcohol abuse or drug addiction. - Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion. - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 100.4 degree Fahrenheit [°F]). A prospective participant was not be included in the study until the condition was resolved or the febrile event had subsided. - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. ; PRIMARY OUTCOME: Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine; SECONDARY OUTCOME 1: Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults[/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 - USA; BRIEF: A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers ; DRUG USED: CT041; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Claudin 18 (CLDN18), Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: CARsgen Therapeutics Co., Ltd.; CRITERIA: Inclusion Criteria: Patients are eligible for screening for potential inclusion in the study: 1. Voluntarily signed the ICF; 2. Age ≥ 18 and < 76 years with pathologically/histologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction, referred to collectively as STAD, or pancreatic adenocarcinoma (PAAD); 3. Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay; 4. Failed or been intolerant of prior lines of systemic therapy; 5. Estimated life expectancy > 4 months; 6. At least 1 measurable lesion per RECIST 1.1; 7. ECOG performance status of 0 or 1; 8. Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis; 9. Patients should have reasonable CBC counts, renal and hepatic functions; 10. Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception; 11. Men must be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion; 12. Sufficient nutritional status. Exclusion Criteria: 1. Pregnant or lactating women; 2. HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infusion; 3. Any uncontrolled active infection; 4. AEs from previous treatment that have not recovered; 5. Patients who have clinically significant thyroid dysfunction; 6. Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell; 7. Patients who have received prior cellular therapy such as (CAR T, TCR, tumor-infiltrating lymphocytes) or organ transplantation; Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression; 8. Untreated CNS, leptomeningeal disease or cord compression 9. Patients with heavy tumor burden such as significant lung disease 10. Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding; 11. Patients who have a history of esophageal or gastric resection with increased risk of bleeding or perforation; 12. Patients requiring anticoagulant therapy such as warfarin or heparin; 13. Patients requiring long-term antiplatelet therapy; 14. Use of prednisone or other equivalent within 14 days before leukapheresis or preconditioning; 15. Anticancer treatment within approximately 2 weeks prior to leukapheresis or approximately preconditioning; 16. Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning; 17. Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients; 18. Patients have clinical significant pulmonary conditions; 19. Patients known to have active autoimmune diseases; 20. Patients with second malignancies in addition to STAD or PAAD; 21. Patients have significant neurologic disorders; 22. Patients are unable or unwilling to comply with the requirements of clinical trial. ; PRIMARY OUTCOME: Phase 1b: Incidence of Treatment Related adverse events (AEs); SECONDARY OUTCOME 1: Phase 1b: Objective Response Rate (ORR) per local assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 205684; BRIEF: This study will be conducted in adult participants with symptoms of common cold assessing if 1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo. The study will also evaluate the safety of 1146A compared to placebo. ; DRUG USED: Carbomer 980; DRUG CLASS: New Molecular Entity (NME); INDICATION: Viral Rhinitis (Common Cold); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. - Aged between 18 to 75 years inclusive. - Male or female. - Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical and Investigator-led nasal examination. - Females of childbearing potential who are, in the opinion of the Investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)) OR male partner sterilization prior to the female participants entry into the study, and this male is the sole partner for that participant. - Investigator confirmed diagnosis of symptomatic common cold with an onset of less than 48 hours prior to randomization. Symptomatic common cold is defined as TSS > 9 AND a score >1 for at least one of the following symptoms: sore throat, runny nose, or blocked nose. Exclusion Criteria: - Women who have a positive urine pregnancy test. - Women who are breast-feeding. - During the entire study (Screening - last participant visit): - A. Participant who have used medications or therapies that could interfere with study evaluations and have not had the proper washout period from these medications or therapies or are anticipated to require any concomitant intranasal medication during that period or at any time throughout the study. - B. Nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities. - C. Nasal surgery or sinus surgery within the previous year. - D. Any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers). - E. Clinically relevant abnormal physical findings which, in the opinion of the Investigator or sponsors medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures. - F. Uncontrolled cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrine, metabolic, autoimmune, neurological, psychiatric or other diseases at screening that would interfere with the study in the opinion of the Investigator. - G. Participants with seasonal allergic rhinitis if randomization occurs during their expected allergy season or perennial allergic rhinitis. - H. Severe COPD, persistent asthma, or recent COPD/asthma exacerbation. - I. An inability to comprehend and satisfactorily use the measurement instruments as determined by the study sites staff on screening. - J. Participants with a fever > 38°C (100.4°F). - K. Frequent uses of analgesics (i.e. have taken an analgesic for pain in headache and pain in muscle/joints for at least 1 dose per week on average over the past 6 months). - Known or suspected intolerance or hypersensitivity to any of the study medications, excipients or investigational device material or to medications of similar chemical classes, any history of drug hypersensitivity or other significant allergic diathesis that could affect study participation and known or suspected contraindications, including history of allergy or photosensitivity to study medication/s. - Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit or 5 half-lives of enrollment, whichever is longer and previous participation in this study (i.e. participants cannot be re-screened or randomized). Recent history (within the last 5 years) of alcohol or other substance abuse and positive urine drug screen. - An employee of the sponsor or the study sites or members of their immediate family and persons directly or indirectly involved in the execution of this protocol, including employees of the contract research organization (CRO) and persons related to them. - On nasal examination by Investigator, the presence of nasal disease likely to affect deposition of intranasal treatment or any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at the screening visit. Participants with difficulty in using the nasal spray applicator, vulnerable individual (as defined by the IRB e.g. incarcerated person) and any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk. ; PRIMARY OUTCOME: Average Nasal Symptom Score Over Days 1-4 (ANSS1-4); SECONDARY OUTCOME 1: Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)[/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 - ASTEFANIA (w/Tecentriq, High-Risk HER2+, Adjuvant); BRIEF: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically confirmed invasive breast carcinoma - Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer - Centrally confirmed PD-L1 and hormone receptor status - Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible) - Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted) - <=12 weeks between primary surgery and randomization - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55% - Life expectancy >= 6 months - Adequate hematologic and end organ function Exclusion Criteria: - Stage IV breast cancer - An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy - Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors - History of exposure to various cumulative doses of anthracyclines - History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS) - Current grade >=2 peripheral neuropathy - History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis - History of or active autoimmune disease or immune deficiency - Treatment with immunostimulatory or immunosuppressive agents - Cardiopulmonary dysfunction - Any known active liver disease ; PRIMARY OUTCOME: Invasive Disease-free Survival (IDFS); SECONDARY OUTCOME 1: IDFS Including Second Primary Non-breast Invasive Cancer[/INST]No</s>