Datasets:

mi-rei

/

CT_III_efficient_full

like 0

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - STOP (maintenance); BRIEF: Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer. Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer. ; DRUG USED: Lucanix; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Transforming Growth Factor-beta (TGF-beta) and Superfamily; THERAPY: Monotherapy; LEAD SPONSOR: NovaRx Corporation; CRITERIA: Inclusion Criteria: - Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements: - Stage IIIA (T3N2 only) or - Stage IIIB or - Stage IV. - Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy. - Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study. - Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months. - Signed informed consent. - Not less than 18 years and not more than 75 years old. - Estimated life expectancy of at least 12 weeks. - Performance status (ECOG) ≤ 2. - Absolute neutrophil count ≥ 1,500/mm3. - Hemoglobin ≥ 9 g/dL. - Platelet count ≥ 100,000/mm3. - Albumin levels ≥ 2.5 g/dL. - Bilirubin ≤ 1.5 times the upper limit of normal (ULN). - Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN. - Creatinine ≤ 1.5 × ULN. - Alkaline phosphatase ≤ 5 × ULN. Exclusion Criteria: - Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone). - Prior splenectomy. - Any surgery involving general anesthesia < 4 weeks prior to study registration. - Chemotherapy more than 4 months or less than 4 weeks prior to study registration. - Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration. - Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months. - Painful bone metastases, or bone metastases that require immediate therapy. - Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry. - Known allergies to eggs or soy. - Significant weight loss (≥ 10% body weight in preceding 6 weeks). - Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV). - Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives. - NCI CTC Grade 3 or 4 peripheral neuropathy at study registration. - Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years. - History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements. - Pregnant or nursing women, or refusal to practice contraception if of reproductive potential. - Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. - Known active Epstein-Barr infection within ≤ 60 days of study registration. ; PRIMARY OUTCOME: Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.; SECONDARY OUTCOME 1: Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the Best Support Care control group.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - CD02 (Extension); BRIEF: This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with CCR5-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 study. ; DRUG USED: Vyrologix; DRUG CLASS: Biologic; INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5); THERAPY: Monotherapy; LEAD SPONSOR: CytoDyn, Inc.; CRITERIA: Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study. 1. Subjects who have completed 24 weeks of treatment in PRO 140_CD 02 study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression 2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 study 3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug. 4. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent. Exclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment. 1. Not currently enrolled in PRO 140_CD 02 study 2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposis sarcoma) 3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study 4. Any other clinical condition that, in the Investigators judgment, would potentially compromise study compliance or the ability to evaluate safety measures ; PRIMARY OUTCOME: Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period; SECONDARY OUTCOME 1: Mean change in CD4 cell count at the conclusion of 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 - EVOLVE-1 (Episodic Migraine); BRIEF: The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with episodic migraine. ; DRUG USED: Emgality; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine Headache Days (MHD). Exclusion Criteria: - Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. - Current use or prior exposure to Galcanezumab or another CGRP antibody. - Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab. - History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta. ; PRIMARY OUTCOME: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days; SECONDARY OUTCOME 1: Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days[/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 - ZONDA (Oral CS Reducing); BRIEF: The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Female and male aged from 18 to 75 years, inclusively. 3. History of physician-diagnosed asthma requiring treatment with medium dose ICS and LABA. 4. Elevated level of peripheral blood eosinophil 5. Documented treatment with high-dose ICS and LABA for at least 6 months prior to Visit 1 6. Chronic oral corticosteroid therapy for at least 6 continuous months directly preceding Visit 1. Subjects must be on doses equivalent to 7.5 - 40 mg/day of prednisolone/prednisone at Visit 1 and be on a stable dose for at least 2 weeks prior to randomization. Patients must agree to switch to study required prednisone/prednisolone as their oral corticosteroid for the duration of the study. 7. Patients with documented failures of OCS reduction within 6 months prior to Visit 1 will not be required to proceed through the dose optimization phase during run-in. 8. Morning pre-bronchodilator (Pre-BD) FEV1 of <80% predicted 9. Evidence of asthma as documented by either: Airway reversibility (FEV1 ≥12% and 200 mL) demonstrated at Visit 1, Visit 2, or Visit 3 using the Maximum Post-bronchodilator Procedure OR Documented reversibility in the previous 24 months prior to Visit 1 OR Airway hyperresponsiveness (PC20 FEV1 methacholine concentration ≤8mg/mL) documented in the previous 12 months prior to planned date of randomization OR Airflow variability in clinic FEV1 ≥20% between 2 consecutive clinic visits documented in the 12 months prior to the planned date of randomization (FEV1 recorded during an exacerbation should not be considered for this criterion). All patients must have reversibility testing performed before randomization to establish a baseline characteristic. If patients do not demonstrate airway reversibility at either Visit 1 or Visit 2 and this is needed to qualify the patient for randomization, the site should reiterate the need to withhold short- and long-acting bronchodilators prior to Visit 3 in an effort to meet this inclusion criterion. 10. At least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained 11. Optimized OCS dose reached at least 2 weeks prior to randomization 12. Additional asthma controller medication must not have been initiated during run in/optimization period (not applicable for management of exacerbations during screening/ run in optimization phase) 13. At least 70% compliance with OCS use 14. At least 70% compliance with usual asthma controller ICS-LABA 15. Minimum 70% (i.e. 10 of 14 days) compliance with asthma daily diary (morning and evening diary) Exclusion criteria: 1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts. 2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patients ability to complete the entire duration of study 3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during run-in/optimization period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete entire duration of the study 5. History of life-threatening asthma 6. Asthma control reached at an OCS dose of ≤5mg during run-in/OCS optimization phase 7. Qualifies for 3 consecutive dose reductions at Visits 2-4 and continues to meet OCS dose reduction criteria at Visit 5 8. Receipt of oral corticosteroids, other than prednisone or prednisolone, as the maintenance oral steroid controller for asthma symptoms from Visit 1 and throughout the study. 9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) confirmed during screening period ; PRIMARY OUTCOME: Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control; SECONDARY OUTCOME 1: Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control[/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 - WC28325; BRIEF: This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks. ; DRUG USED: Aleglitazar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: PPAR alpha, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/=18 years of age - Diagnosis of diabetes mellitus, type 2 - Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening - HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit - Fasting plasma glucose </=240 mg/dL at pre-randomization visit - Agreement to maintain diet and exercise habits during the study Exclusion Criteria: - Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months - Any previous treatment with thiazolidinedione or a dual PPAR agonist - Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin) - Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening - Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening ; PRIMARY OUTCOME: Change from baseline in hemoglobin HbA1c; SECONDARY OUTCOME 1: Change in lipid profile[/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 - OSKIRA-2 (DMARD-IR); BRIEF: The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year. ; DRUG USED: Tavalisse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Active rheumatoid arthritis (RA) diagnosed after the age of 16 - Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine - 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more - At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test) Exclusion Criteria: - Females who are pregnant or breast feeding - Poorly controlled hypertension - Liver disease or significant liver function test abnormalities - Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders - Recent or significant cardiovascular disease - Significant active or recent infection including tuberculosis - Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent - Severe renal impairment - Neutropenia ; PRIMARY OUTCOME: Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo; SECONDARY OUTCOME 1: Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 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 - 010; BRIEF: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema. ; DRUG USED: Ozurdex; DRUG CLASS: Non-NME; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Key Inclusion Criteria: - 18 years of age or older with diabetic macular edema; - Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse); - Visual acuity in other eye no worse than 20/200 Key Exclusion Criteria: - Known anticipated need for ocular surgery within first 12 months of study; - History of glaucoma or current high eye pressure requiring more than 1 medication; - Uncontrolled systemic disease; - Known steroid-responder; - Use of systemic steroids - Use of Warfarin/Heparin ; PRIMARY OUTCOME: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye; SECONDARY OUTCOME 1: Average Change From Baseline in BCVA in the Study Eye[/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 - CRUISE-2; BRIEF: The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb). ; DRUG USED: Triferic; DRUG CLASS: Non-NME; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Rockwell Medical Technologies, Inc.; CRITERIA: Stage 1: Main Inclusion Criteria: - Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD) for at least 4 months, and expected to remain on hemodialysis three to four times weekly and be able to complete the duration of the study. - Received IV iron therapy between 6 months and 2 weeks prior to enrollment in order to replace iron losses resulting from hemodialysis procedure. - Mean Screening Hgb ≥ 9.5 to ≤ 11.5 grams per deciliter (g/dL). - Mean Screening Transferrin Saturation (TSAT) ≥ 15% to ≤ 40%. - Mean Screening serum ferritin ≥ 200 to ≤ 800 micrograms per liter (µg/L). - If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 Units (U)/week, darbepoetin dose ≤ 200 micrograms (µg)/week, or CERA dose ≤ 400 micrograms (µg)/month during the four weeks prior to enrollment. Main Exclusion Criteria: - Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.) - Vascular access for dialysis with femoral catheter or non-tunneled catheter. - Received a total of > 800 milligrams (mg) IV iron during the 8 weeks prior to enrollment. - If being administered an ESA, route of administration change or ESA dose change > 35% (i.e., [max - min dose]/max dose > 0.35) over the 2 weeks prior to screening. - Serum albumin < 3.0 grams per deciliter (g/dL) any time over the 8 weeks prior to enrollment. - Red Blood Cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment. Stage 2: Main Inclusion Criteria: - Patient currently enrolled in the Stage 1 run-in period of study. - Undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD), and expected to remain on hemodialysis three to four times weekly and be able to complete duration of the study. - Mean Hgb ≥ 9.5 to ≤ 11.5 g/dL over the three most recent consecutive every-week measurements prior to randomization. - Stable Hgb defined as ≤ 1.0 g/dL difference between the maximum and minimum Hgb values over the 3 weeks immediately prior to randomization. - Mean TSAT ≥ 15% to ≤ 40% over the two most recent consecutive every-other-week measurements prior to randomization. - Mean serum ferritin ≥ 200 to ≤ 800 µg/L over the two most recent consecutive every-other-week measurements prior to randomization. - If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 U/week, darbepoetin dose ≤ 200 µg/week, or CERA dose ≤ 400 µg/month during the four weeks prior to randomization. Main Exclusion Criteria: - Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.) - Vascular access for dialysis with femoral catheter or non-tunneled catheter. - Received any amount of IV iron during the 4 weeks prior to randomization. - If being administered an (Erythropoietin Stimulating Agent) ESA, change in dose over the 6 weeks immediately prior to randomization. - Serum albumin < 3.0 g/dL any time over the 8 weeks prior to randomization. - RBC or whole blood transfusion during Stage 1. Stage 3: Main Inclusion Criteria: - Patient randomized in Stage 2 who has completed the full duration of Stage 2 and less than 4 weeks have elapsed since completion of Stage 2, OR - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for protocol-defined Protocol-Mandated Change in Anemia Management and less than 4 weeks have elapsed since withdrawal from Stage 2, OR - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for Hgb >11.5 g/dL over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in Hgb by ≥ 1 g/dL over 4 weeks. Main Exclusion Criteria: - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason other than as noted in inclusion criteria above. ; PRIMARY OUTCOME: Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean; SECONDARY OUTCOME 1: Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis[/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 - Pain of the Shoulder; BRIEF: A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder. ; DRUG USED: Etoreat; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: MEDRx USA, Inc.; CRITERIA: Inclusion Criteria: - Females of child bearing potential must have a negative pregnancy test and be using an adequate method of birth control. - Subject has a diagnosis of acute supraspinatous or subacromial bursitis/tendonitis and/or subdeltoid bursitis of one shoulder with the onset of the current episode ≥ 24 hours and ≤ 7 days preceding the screening visit. - Subject has a Current Pain Intensity rated prior to study entry ≥ 6 but ≤ 8 on a Numeric Pain Rating Scale (NPRS). Exclusion Criteria: - Subject has a suspected tear in the rotator cuff, calcific tendonitis, adhesive capsulitis, shoulder fractures, bilateral shoulder pain, bilateral tendonitis and/or bursitis of the shoulders, bicipital tendonitis; or orthopedic surgical treatment is required. - Subject has a positive Drop Arm Test indicative of a suspected tear; a positive OBriens Test suggestive of a glenoid labral tear; a positive Apprehension Test which would be indicative of glenohumeral instability; a positive Yergasons Test which would be indicative of bicipital tendonitis. - Subject had a previous episode of shoulder pain in the same area within two weeks prior to the current episode; history of chronic pain in the target shoulder; history of rotator cuff injury or previous surgery in the same area. - Subject received passive physical therapy treatments for the pain in the target shoulder within the past 24 hours. - Subject has used oral pharmacologic treatment less than 5 half-lives before the baseline assessments. - Subject has used any form of opioid within 24 hours of study entry or use of opioids for 5 or more consecutive days within the 30 days preceding enrollment. - Subject has received systemic corticosteroids in the 30 days preceding the screening visit; or local injections such as intra-articular, bursal, peritendinous; topical corticosteroids are acceptable unless applied to the target joint; and inhaled or intranasal steroids acceptable (e.g., Flonase®). - Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants (within the past 30 days). - Subject used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the past 60 days. - Subject has a history or physical assessment finding of clinically significant GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled lung, stomach, heart, or other vital organ disease as determined by the study investigator/physician. - Subject has fibromyalgia, spondyloarthropathies (SpA) or other systemic arthritis such as rheumatoid arthritis. Arthritis typically localized such as gout or osteoarthritis is acceptable as long as it does not affect the injured area. - Subject has a painful syndrome (e.g. sciatica) or cervical spine disorder leading to a nerve entrapment syndrome or other medical problem that in the investigators opinion may interfere with pain measurement of the target joint. - Subject has active skin lesions or disease at the intended site of study medication application, which may be covered by the patch. Skin lesions include open wounds, rash, papules and vesicles; abrasions, lacerations or any break in skin. - Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape). - Subject is scheduled for elective surgery or other invasive procedures during the period of study participation. ; PRIMARY OUTCOME: Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.; 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/III - N01272; BRIEF: This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use. ; DRUG USED: Seletracetam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Seizure Disorders (Epilepsy); TARGET: SV2A synaptic vesicle protein; THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Subjects from 16 to 70 years old - Confirmed diagnosis of focal epilepsy - Partial seizures uncontrolled while taking 1 or 2 AEDs - At least 8 partial seizures during the 8-week baseline period Exclusion Criteria: - Seizures occurring only in clusters - Status epilepticus within 1 year - Progressive CNS disorder - Other serious or uncontrolled diseases ; PRIMARY OUTCOME: Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs; SECONDARY OUTCOME 1: Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients Health-Related Quality of Life (HRQoL)[/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 - 201190; BRIEF: The purpose of this study is a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2 additional doses in two subgroups of older adults. ; DRUG USED: Shingrix; DRUG CLASS: Vaccine; INDICATION: Chickenpox and Shingles - Vaccines and Treatments; TARGET: Immune System, Varicella Zoster Virus (VSV); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, availability for follow-up contacts). - Written informed consent obtained from the subject prior to performance of any study specific procedure. - Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of HZ/su vaccine. Additional inclusion criteria for the 1-Additional Dose Revaccination and Control groups, ONLY: - Female subjects of non-childbearing potential may be enrolled in this study. - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. - Female subjects of childbearing potential may be enrolled in this study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination and - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: - Use of any investigational or non-registered product (pharmaceutical product or device) at the time of enrolment or planned use during the study period. - Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than the HZ/su vaccine administered in studies ZOSTER-006/022). - Chronic administration (defined as ≥ 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed. - Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). - Administration of immunoglobulins and/or any blood products within 3 months prior to Visit Month 0 of study ZOSTER-049 or planned administration during the study period. - Prolonged use (> 14 consecutive days) of oral and/or parenteral antiviral agents that are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be used during the study period for an indication other than to treat suspected or confirmed HZ or an HZ-related complication (topical use of these antiviral agents is allowed). - Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study. Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups, only: - Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049 that was considered related to study vaccine by either the investigator or the sponsor. - Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049. - Use of any investigational or non-registered product (pharmaceutical product or device) within 30 days preceding the first dose of study vaccine or planned use during the study period. - Administration or planned administration of any other immunizations within 30 days before the first study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not contain latex. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential). - Previous episode/history of HZ. ; PRIMARY OUTCOME: Number of subjects with confirmed herpes zoster (HZ).cases; SECONDARY OUTCOME 1: Number of subjects with confirmed herpes zoster (HZ) cases[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RRMS; BRIEF: The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively. ; DRUG USED: Biosimilar Interferon Beta (Nuron); DRUG CLASS: Biosimilar; INDICATION: Multiple Sclerosis (MS); TARGET: Interferon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Nuron Biotech Inc.; CRITERIA: Inclusion Criteria: Patients will be eligible to participate in the study if all of the following criteria are met at both screening (V-1) and baseline (V0): 1. Female or male patients, aged between 18 and 60 years, inclusive 2. Signed and dated statement of informed consent 3. Diagnosis of RRMS according to McDonalds Criteria - revision 2010 (Polman et al., 2011) 4. Interferon (IFN) beta-1b naïve 5. Expanded Disability Status Scale (EDSS) score of < 5.5 6. At least 1 documented relapse in the past year (defined as the appearance of a new clinical sign/symptom [one that had been stable for at least 30 days] that persisted for a minimum of 24 hours in the absence of fever) ---or--- a subclinical sign/symptom (defined as a Gd-enhancing lesion or a new T2 lesion demonstrated on MRI examination on a prior MRI that has been completed within 1 year of the screening MRI). The Screening (V-1) MRI should not be used for this determination. 7. No relapse in the 4 weeks prior to the screening visit (V-1). 8. Must be in a clinically stable or improving neurological state 4 weeks preceding the screening visit (V-1). Exclusion Criteria: Patients meeting any of the following exclusion criteria at screening (V-1) and baseline (V0) will not be enrolled in the study: 1. Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1) 2. Intake of glatiramer acetate within 3 months prior to the screening (V-1) visit 3. Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit 4. Intake of or previously received therapy with cladribine or alemtuzumab 5. An active viral, bacterial, or systemic fungal infection within 1 week of baseline (V0) 6. Use of systemic steroids within 3 weeks prior to the screening (V-1) MRI 7. Progressive disease 8. Level of liver enzymes 2.5 x the upper limit of normal 9. Abnormal renal function (estimated Glomerular Filtration Rate [eGFR] < 60 ml/min/1.73 m2 ) 10. Positive serology or history for Hepatitis B, C, or human immunodeficiency virus (HIV) 11. Serious or acute coronary diseases, defined by at least 1 of the following conditions: - Clinical symptoms of ischemic heart disease - ST elevation or depression > 2 mm on the electrocardiogram (ECG) - Clinical symptoms of cardiac failure and/or current medical treatment for cardiac failure - Severe ventricular arrhythmia (frequent premature ventricular beats) - Atrioventricular block at third level 12. Chronic use of non-steroidal anti-inflammatory drugs 13. History of any of the following: - Severe depression or suicide attempt - Uncontrolled seizure disorder - Cancer, excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix - Previous contrast reaction to gadolinium or any other contraindications to MRI (e.g., metal in the eye, pacemakers, aneurysm clip) 14. Allergy to human albumin or to mannitol 15. Excessive alcohol use or illicit drug use 16. Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on study 17. Medical, psychiatric, or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 18. Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study Current participation in other clinical trials ; PRIMARY OUTCOME: New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months; SECONDARY OUTCOME 1: Incidence of annualized relapse rates[/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 - ARTISTS2; BRIEF: Standard placebo-controlled, double-blind study design (TEV-50717 [low dose and high dose] vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in a statistically significant effect on the tics in participants with TS. ; DRUG USED: Austedo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tourettes Syndrome; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - Participant weighs at least 44 pounds (20 kg) at baseline. - Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the participants active tics are causing distress or impairment. - Participant has a TTS of 20 or higher on the YGTSS at screening and baseline. - Participant is able to swallow study medication whole. - -Additional criteria apply, please contact the investigator for more information Exclusion Criteria: - Participant has a neurologic disorder other than TS that could obscure the evaluation of tics. - The participant s predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder. - Participant has clinically significant depression at screening or baseline. - Participant has a history of suicidal intent or related behaviors within 2 years of screening - Participant has a history of a previous actual, interrupted, or aborted suicide attempt. - Participant has a first-degree relative who has completed suicide. - Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder. - Participant has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of screening. - Participant has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics. - Participant has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure. - Participant has participated in an investigational drug or device study and received investigational medicinal product (IMP)/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer. - Participant is a pregnant or lactating female, or plans to be pregnant during the study. - -Additional criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants; SECONDARY OUTCOME 1: Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants[/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 - TAK-491CLD-308; BRIEF: The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in adults with essential hypertension. ; DRUG USED: Edarbyclor; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Na/Cl transporter - Thiazide-sensitive; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on Day, or has not received antihypertensive treatment within 14 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day 1. - Females of childbearing potential who are sexually active agree to routinely use adequate contraception, and can neither be pregnant nor lactating from before study participation to Screening to 30 days after the last study drug dose. - Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant. - Is willing to discontinue current antihypertensive medications up to 3 weeks before enrollment. Exclusion Criteria: - Has a mean clinic diastolic blood pressure (sitting, trough) greater than 119 mm Hg on Day 1. - Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushings syndrome). - Has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack. - Has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome). - Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. - Has severe renal dysfunction or disease. - Has known or suspected unilateral or bilateral renal artery stenosis. - Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. - Has poorly-controlled type 1 or 2 diabetes mellitus at Screening. - Has hypokalemia or hyperkalemia at Screening. - Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening. - Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow according to the protocol. - Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds. - Has been randomized/enrolled in a previous azilsartan or azilsartan medoxomil plus chlorthalidone study. - Currently is participating in another investigational study or has received any investigational compound within 30 days prior to Screening. - Has a history of drug abuse or a history of alcohol abuse within the past 2 years. - Is taking or expected to take any excluded medication, including: - Antihypertensive medications must be discontinued completely by Day -14, except antihypertensive medications used in the open-label treatment period in accordance with the titration-to-target blood pressure titration. - Angiotensin II receptor blockers or thiazide-type diuretics other than study medication. - Over-the-counter products not permitted by investigator. ; PRIMARY OUTCOME: Percentage of Participants With at Least 1 Adverse Event; SECONDARY OUTCOME 1: Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ALIVE; BRIEF: This is a randomized, controlled multi-site, multi-national clinical trial conducted in Thailand and Malaysia for naïve Asian adults (males or females), 18 years of age and older presenting with advanced HCC (BCLC stage C) including subjects with vascular involvement and/or extrahepatic spread (not eligible for TACE, surgery or locoregional treatment) with Child-Pugh stage A or B liver function. 150 subjects will be randomized 2:1 to AlloStim® immunotherapy vs Physicians Choice of Sorafenib, Levantinib or FOLFOX4. ; DRUG USED: AlloStim; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Immunovative Therapies, Ltd.; CRITERIA: Inclusion Criteria: 1. Males and females who are at least 18 years of age at time of enrollment 2. Histologically or cytologically documented advanced HCC (BCLC stage C) disease at diagnosis. 3. No prior treatment for BCLC class C disease. 4. Child-Pugh Class A or subset of Child-Pugh Class B 5. Performance status: ECOG < 2 with no deterioration over the previous 2 weeks 6. With or without positive HBV and/or HCV 7. With or without extrahepatic disease and with or without macrovascular invasion 8. Measurable enhancing disease in liver with at least one target lesion evaluable by mRECIST 9. Adequate hematological, liver and renal function as assessed by the following: - Hemoglobin > 10.0 g/dl - Platelet count > 75,000/μl - ALT and AST < 5.0 x ULN - Serum creatinine < 1.5 10. Women of child-bearing potential: negative pregnancy test 11. Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study 12. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate Exclusion Criteria: 1. Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma). 2. Child-Pugh liver function combined score >9 (Class C or Class D) 3. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator) 4. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy 5. Severe stomach/esophageal varices requiring interventional treatment. 6. Unable to tolerate radiological contrast dye 7. Any prior experimental, approved or off-label treatment for HCC (including levantinib, nivolumab, duvalumab, tremelimumab, brivananib, cabozantinib or ramucircumab) or any approved or experimental procedures such as surgery, radiation or ablation. 8. Enrollment in any previous clinical trial for HCC 9. Any history of autoimmune disorder (type I, insulin-dependent diabetes allowed) 10. History of COPD or oxygen saturation <92% at room air 11. Any clinical condition requiring systemic steroids (inhaled steroids allowed) or any current immunosuppressive therapy or anti-epileptic drug therapy. 12. Known history of HIV infection 13. Clinically significant gastrointestinal bleeding within 30 days prior to study entry 14. History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) 15. Uncontrolled hypertension (SBP >150 or DBP>90). 16. Active clinically serious infections (> grade 2 CTCAE version 5.0) 17. History of organ transplant or tissue allograft 18. Uncontrolled concurrent serious medical or psychiatric illness 19. Clinically apparent central nervous system metastases or carcinomatous meningitis 20. History of drug abuse or current alcohol abuse 21. History of blood transfusion reactions 22. Pregnant or lactating women ; PRIMARY OUTCOME: overall survival; SECONDARY OUTCOME 1: Quality of Life Survey[/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 - UNITY 3 (Japan; G1); BRIEF: The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC). ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and females, ≥ 20 years of age - Subjects chronically infected with HCV GT-1 - HCV RNA viral load of ≥ 100,000 IU/mL Exclusion Criteria: - Hepatocellular carcinoma - Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) - Severe or uncontrollable complication ; PRIMARY OUTCOME: Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12; SECONDARY OUTCOME 1: The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV[/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 - EDGE; BRIEF: The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective was to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) was administered QD and BID in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). ; DRUG USED: Cerdelga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gauchers Disease; TARGET: Glucosylceramide Synthase; THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria: - The participant who was willing and provided signed informed consent prior to any study-related procedures. - The participant was ≥18 years of age. - The participant diagnosed with GD 1 confirmed by a documented deficiency of acid β-glucosidase activity by enzyme assay. - Female participants of childbearing potential had a documented negative pregnancy test prior to administration of the first dose of eliglustat tartrate (Genz-112638) in this study. In addition, all female participants of childbearing potential used a medically accepted form of contraception throughout the study, i.e., either a barrier method or hormonal contraceptive with norethindrone and ethinyl estradiol or similar active components - The participant met all of the following criteria at the time of screening: hemoglobin level ≥9 g/dL (mean of 2 measurements); platelet count ≥70,000/mm^3 (mean of 2 measurements); spleen volume ≤25 multiples of normal (MN); liver volume ≤2.0 MN. - The participant consented to provide a blood sample for genotyping for Gaucher disease and for CYP2D6 to categorize the participants predicted rate of metabolism, if these genotyping results were not already available for the participant. - The participant was willing to abstain from consumption of grapefruit, grapefruit juice, or grapefruit products for 72 hours prior to administration of the first dose of Genz-112638 and throughout the duration of the study. Exclusion Criteria: - The participant was participating in GZGD02607 study, A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Participants with GD1 who have been Stabilized with Cerezyme ® , or was eligible for inclusion in GZGD02607 (while enrollment was ongoing) and had access to a physician participating in GZGD02607, or the participant was participating in GZGD02507 study, A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Participants with GD1, or was eligible for inclusion in GZGD02507 (while enrollment was ongoing) and had access to a physician participating in GZGD02507. - The participant received miglustat within 6 months prior to administration of the first dose of Genz-112638 in this study. - The participant had a partial or total splenectomy within 3 years prior to randomization. - The participant received pharmacological chaperones or miglustat within 6 months prior to administration of the first dose of eliglustat tartrate (Genz-112638) in this study. - The participant had any evidence of neurologic disorder (e.g., peripheral neuropathy, tremor, seizures, Parkinsonism or cognitive impairment) or pulmonary involvement (e.g., pulmonary hypertension) as related to Gaucher disease. - The participant was transfusion-dependent. - The participant had a documented deficiency of iron, vitamin B-12, or folate that requires treatment not yet initiated or, if initiated, the participant had not been stable under treatment for at least 3 months prior to administration of the first dose of Genz-112638 in this study. - The participant had documented prior esophageal varices or clinically significant liver infarction or current liver enzymes (alanine transaminase [ALT]/aspartate aminotransferase [AST]) or total bilirubin >2 times the upper limit of normal (ULN), unless the participant had a diagnosis of Gilbert Syndrome. - The participant had any clinically significant disease, other than Gaucher disease, including cardiovascular, renal, hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic (including hypokalaemia or hypomagnesemia), or psychiatric disease, other medical conditions, or serious intercurrent illnesses that, in the opinion of the Investigator, precluded participation in the study. - The participant was known to have any of the following: Clinically significant coronary artery disease including history of myocardial infarction [MI] or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; or clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree AV block, complete bundle branch block, prolonged QTc interval, or sustained ventricular tachycardia (VT). - The participant who tested positive for the human immunodeficiency virus (HIV) antibody, Hepatitis C antibody, or Hepatitis B surface antigen. - The participant received an investigational product (other than eliglustat tartrate (Genz-112638)) within 30 days prior to administration of the first dose of eliglustat tartrate (Genz-112638) in this study. - The participant was scheduled for in-participant hospitalization, including elective surgery, during the study. - The participant had a history of cancer, with the exception of basal cell carcinoma, within 5 years prior to administration of the first dose of Genz-112638 in this study. - The participant was pregnant or lactating. - The participant had received any medication that may cause QTc interval prolongation within 30 days prior to the first dose of Genz-112638. Exception: Diphenhydramine (Benadryl) or other medications used as premedication for ERT infusions were allowed up to 7 days prior to the first dose of Genz-112638. - The participant had received for the first time (i.e., the participant was not already chronically using) any of the following medications within 30 days prior to the first dose of Genz-112638: - Strong inhibitors of CYP2D6 or CYP3A4; - Inducers of CYP3A4. Exception: Premedications for ERT infusions were allowed up to 7 days prior to the first dose of Genz-112638. - The participant was a CYP2D6 non-poor metabolizer or an indeterminate metabolizer with one allele identified as active who was chronically receiving both a strong competitive inhibitor of CYP2D6 and a strong competitive inhibitor of CYP3A4 and for whom no reasonable alternative medication exists. or - The participant was a CYP2D6 poor metabolizer or an indeterminate metabolizer with neither allele known to be active who was chronically receiving a strong competitive inhibitor of CYP3A4 and for whom no reasonable alternative medication exists. Exception for both cases: Premedications for ERT infusions were allowed up to 7 days prior to the first dose of Genz-112638. ; PRIMARY OUTCOME: PAP: Percentage of Participants Who Remained Stable for 52 Weeks During the PAP; SECONDARY OUTCOME 1: PAP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26 and 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EXTEND II (China); BRIEF: The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study results will support the regulatory submission in China to make ranibizumab available for clinical use. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female Chinese patients 50 years of age or greater. - Patients with primary or recurrent subfoveal CNV secondary to AMD. - Patients who have a BCVA score from 73 to 24 characters in the study eye. Exclusion Criteria: - Active, or history of, ocular inflammation or infection in the study eye within the last 30 days. - Uncontrolled glaucoma in the study eye. Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: To evaluate efficacy of ranibizumab 0.5 mg by mean change in best-corrected visual acuity (BCVA) from Baseline to Month 4 as assessed with early treatment of diabetic retinopathy study (ETDRS) like charts at a distance of 4 meters.; SECONDARY OUTCOME 1: To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EMPA-REG OUTCOME (1245.25 - CV Safety); BRIEF: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk. ; DRUG USED: Jardiance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization. 3. Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients 4. Age >= 18 years 5. Body Mass index <= 45 at Visit 1 6. Signed and dated informed consent 7. High cardiovascular risk Exclusion criteria: 1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day) 2. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in. 3. Planned cardiac surgery or angioplasty within 3 months 4. Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in. 5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia) 7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 8. Contraindications to background therapy according to the local label 9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight 10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus 11. Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) 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 throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner 12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake 13. Participation in another trial with an investigational drug within 30 days prior to informed consent 14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial 15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent ; PRIMARY OUTCOME: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.; SECONDARY OUTCOME 1: Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris[/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 - Fixed/Flexible (LNBQ); BRIEF: The purpose of this study is to assess if LY2216684 (flexible dose of 12 to 18 milligrams [mg] or fixed dose of 6 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with Major Depressive Disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase. ; DRUG USED: Edivoxetine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Clinical diagnosis of Major Depressive Disorder (MDD) - Using a reliable method of birth control - Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participants country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country - Have a partial response to SSRI treatment - Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment - Reliable and able to keep all scheduled appointments Exclusion Criteria: - Presence of another primary psychiatric illness: - Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening - Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias) - Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder - Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine - Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol - Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, and history of urinary hesitation or retention - Use of excluded concomitant or psychotropic medication other than SSRI - Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment - History of treatment-resistant depression as shown by lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression - Have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic stimulation (TMS), or psychosurgery - Have received electroconvulsive therapy (ECT) in the past year - Enrollment in a clinical study for an investigational drug - Serious or unstable medical condition - History of seizure disorders - Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study - Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others ; PRIMARY OUTCOME: Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score; SECONDARY OUTCOME 1: Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - U-Accomplish; BRIEF: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC). ; DRUG USED: Rinvoq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities. Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit. - Diagnosis of Ulcerative Colitis (UC) for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available. - Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3. - Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies. Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above. - Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit. - If female, participant must meet the contraception recommendation criteria. Exclusion Criteria: - Participant with current diagnosis of Crohns disease (CD) or diagnosis of indeterminate colitis (IC). - Current diagnosis of fulminant colitis and/or toxic megacolon. - Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy. - Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline. - Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days of Baseline. - Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period. - Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib). - Screening laboratory and other analyses show any prespecified abnormal hematologic results. ; PRIMARY OUTCOME: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8; SECONDARY OUTCOME 1: Percentage of Participants With Endoscopic Improvement at Week 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 - KEYLYNK-008 (First-Line); BRIEF: The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The studys 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: 1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC. 2. Have Stage IV squamous NSCLC. 3. Have measurable disease based on RECIST 1.1. 4. Have not received prior systemic treatment for their advanced/metastatic NSCLC. 5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time. 6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention 7. Have a life expectancy of at least 3 months. 8. Has adequate organ function. 9. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards. 10. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards. Exclusion Criteria: 1. Has non-squamous histology NSCLC. 2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment. 3. Has known active central nervous system metastases and/or carcinomatous meningitis. 4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib. 5. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 6. Has an active autoimmune disease that has required systemic treatment in past 2 years. 7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. 8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection. 9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment. 10. Has received prior therapy with olaparib or with any other polyadenosine 5 diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor. 11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). 12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML. ; PRIMARY OUTCOME: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); SECONDARY OUTCOME 1: Number of Participants With One or More Adverse Events (AEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PNEU-AGE; BRIEF: The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination. ; DRUG USED: Vaxneuvance; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigators judgment. - Male or female ≥50 years of age at the time of signing the informed consent. (For Japan only: Is male or female ≥65 years of age at the time of signing the informed consent) - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention. - Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. Exclusion Criteria: - History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1). - Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine. - Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease. - Coagulation disorder contraindicating intramuscular (IM) vaccinations. - Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine. - History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. - A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1). - Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol. - Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry. - Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted.) - Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. - Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.) - Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine. - Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion. - Currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study. - In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities. - History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participants participation for the full duration of the study. - An immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study. ; PRIMARY OUTCOME: Percentage of Participants With a Solicited Injection-site Adverse Event; SECONDARY OUTCOME 1: GMT of Serotype-specific OPA for Serotype 3 at Day 30[/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 - HZ-CA-304; BRIEF: The purpose of this study is to evaluate the safety of long-term treatment with HZT-501. ; DRUG USED: Duexis; DRUG CLASS: Non-NME; INDICATION: Arthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Histamine H2 Receptor (HRH2); THERAPY: Monotherapy; LEAD SPONSOR: Horizon Pharma Ireland, Ltd., Dublin Ireland; CRITERIA: Inclusion Criteria: - Expected to continue to require daily administration of an NSAID for at least the coming 6 months. - Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303 Exclusion Criteria: - Subject didnt meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303 - Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303 - Malignant Disease of the gastrointestinal tract - Erosive esophagitis - Clinically significant cardiac, renal or hepatic disease - Uncontrolled diabetes - Positive pregnancy test on Study Day 0 - Please note that there are other additional criteria. The study center will determine if you meet all of the criteria. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Evaporative-010; BRIEF: The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE ; DRUG USED: AGN-195263; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Male, 18 years of age or older, at the screening (day -51) visit OR - Females, who are naturally postmenopausal (permanent cessation of menstrual periods for at least 12 consecutive months) or are permanently sterilized (ie, eg, tubal occlusion,hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) at the screening (day -51) visit - In at least 1 eye, all of the following objective measures of evaporative dry eye (EDE) must be present at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits - Tear film break-up time (TBUT) ≥ 2 seconds and ≤ 7 seconds - Corneal sodium fluorescein staining score ≥ 1 and ≤ 4 (Oxford scheme) - Anesthetized Schirmers tear test score ≥ 10 mm after 5 minutes - At the standardization (day -21) and baseline (day 1) visits, patients must have: - Ocular Surface Disease Index© (OSDI) score > 12 (0 to 100 scale) - Overall ocular discomfort score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe) - Ocular burning score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe) - Blurred vision score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe) - In at least 1 eye, a lower lid margin meibum quality global assessment score ≥ 1 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits - In at least 1 eye, the number of lower lid margin expressible meibomian glands must be ≥ 3 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits - Use of an artificial tear product, lid hygiene (ie, warm compress, lid massage, lid scrub), omega-3 supplementation (topical ocular or systemic), or antibiotics (ie, systemic or topical macrolides, tetracyclines, tetracycline derivatives [including doxycycline and minocycline]) for the treatment of dry eye disease, or meibomian gland disease within 1 year of the standardization (day -21) visit Exclusion Criteria: - Male patients with a history of, known, or suspected prostate cancer - Male patients with a prostate-specific antigen (PSA) level ≥ 4 μg/L - Female patients with a history of known or suspected breast, cervical, ovarian, or uterine cancer - Female patient who is of child-bearing potential - At standardization (day -21) and / or baseline (day 1) visits, a lower lid margin meibum quality global assessment score of non-expressible (NE) in either eye - Patients who are currently using estrogen and/or progesterone containing products (including herbal and nutritional supplements) and not on a stable dose (at least 90 days prior to the standardization visit (day -21) and/or anticipate initiating use and/or changing use during the study - Patients who are currently using or have used any androgen or anti-androgen treatment (including herbal and nutritional supplements), within 90 days of the standardization (day -21) visit or anticipated use during the study - Patients who are currently using or have used any hair growth product within 90 days of the standardization (day -21) visit or anticipated use during the study - Patients who are currently using or have used topical corticosteroids in the eyes or on the eyelids within 60 days prior to the standardization visit (day -21), or any such use anticipated prior to the month 6 visit - Patients who are currently using or have used oral or topical macrolides, tetracyclines, tetracycline derivative drugs (including doxycycline and minocycline), retinoids (eg, isotretinoin), calcineurin inhibitors (ie, RESTASIS®, Ikervis®), oral (systemic) corticosteroids, or lifitegrast (Xiidra™) or any other therapeutic dry eye treatment within 60 days of the standardization visit (day -21), or anticipated use before the month 6 visit ; PRIMARY OUTCOME: Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe); SECONDARY OUTCOME 1: Change From Baseline in Tearfilm Break Up Time (TBUT)[/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 - FSS-AS-30003; BRIEF: This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma. ; DRUG USED: ArmonAir RespiClick; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - The participant has a diagnosis of asthma as defined by the National Institutes of Health (NIH). - The participant has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV). - The participants persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Participants currently on a short-acting β2-agonist (SABA) only, regimen or as needed (PRN), are not eligible. - The participant has demonstrated ≥10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol. - The participant (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device. - All participants must be able to replace their current SABA with albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) inhalation aerosol at the SV for use as needed for the duration of the study. - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: - The participant has a history of life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures. - The participant is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the participants last study-related visit. - The participant has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the investigational medicinal product (IMP) or rescue medication formulation (that is, lactose). - The participant has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (for example, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study. - The participant currently smokes or has a smoking history. The participant must not have used tobacco products within the past year (for example, cigarettes, cigars, chewing tobacco, or pipe tobacco). - The participant has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV. - The participant has used immunosuppressive medications within 30 days before the SV. - The participant has untreated oral candidiasis at the SV. Participants with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period. - The participant has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection. - The participant is an immediate relative of an employee of the clinical investigational center. - A member of the participants household is participating in the study at the same time. - Vulnerable participants (that is, people kept in detention) are excluded from participation. - Additional criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Post-HERCULES; BRIEF: The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP). ; DRUG USED: Cablivi; DRUG CLASS: Biologic; INDICATION: Thrombotic Thrombocytopenic Purpura (TTP); TARGET: Von Willebrand Factor (vWF); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: 1. Completed the Final (28 day) follow-up visit in Study ALX0681-C301. 2. >= 18 years of age at the time of signing the informed consent form. 3. Provided informed consent prior to initiation of any study specific activity/procedure. Exclusion Criteria: 1. Not being able/willing to comply with the study protocol procedures. 2. Currently enrolled in a clinical study with another investigational drug or device. ; PRIMARY OUTCOME: Percentage of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Related Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PA-CL-05B - Extension; BRIEF: This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks. ; DRUG USED: Velphoro; DRUG CLASS: Non-NME; INDICATION: Hyperphosphatemia; TARGET: Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Vifor Pharma; CRITERIA: Inclusion Criteria: - Subjects who have completed treatment in Protocol PA-CL-05A - Written Informed Consent Exclusion Criteria: - Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH) - Other significant medical conditions - Pregnancy ; PRIMARY OUTCOME: Change From Baseline and Levels at Each Time Point for Serum Phosphorus; 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 - AFFIRM-AL; BRIEF: A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis. ; DRUG USED: Birtamimab; DRUG CLASS: Biologic; INDICATION: Amyloid light-chain (AL) Amyloidosis; TARGET: Amyloid - light chain; THERAPY: Monotherapy; LEAD SPONSOR: Prothena Biosciences Ltd.; CRITERIA: Key Inclusion Criteria: - Aged ≥18 years and legal age of consent according to local regulations - Newly diagnosed and AL amyloidosis treatment-naïve with cardiac involvement - Confirmed diagnosis of AL amyloidosis - Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥1800 pg/mL and Troponin-T ≥0.025 ng/mL or high sensitivity cardiac troponin T≥40ng/L and dFLC ≥18 mg/dL - Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly. Key Exclusion Criteria: - Non-AL amyloidosis. - NT-proBNP >8500 pg/mL. - Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma except for malignancy biomarker of involved/uninvolved serum free light chain ratio ≥100 - Subject is eligible for and plans to undergo ASCT or organ transplant during the study. - Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit. - Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease. - ECG evidence of acute ischemia or active conduction system abnormalities - Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1. - Prior radiotherapy within 4 weeks of Month 1-Day 1. - Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11- 1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid . - Waldenströms macroglobulinemia and/or immunoglobulin M monoclonal gammopathy ; PRIMARY OUTCOME: Time to all-cause mortality; SECONDARY OUTCOME 1: 6MWT distance[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PETIT2 (Pediatric); BRIEF: The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag. ; DRUG USED: Promacta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Written informed consent must be obtained from the patients guardian and accompanying informed assent from the patient (for children over 6 years old) - Patients must be between 1 year and <18 years of age at Day 1 - Patients will have a confirmed diagnosis of chronic ITP for at least 1 year, at screening, according to the guidelines published in the International Working Group Report - A peripheral blood smear or bone marrow examination will support the diagnosis of ITP with no evidence of other causes of thrombocytopenia. - Patients must be refractory or have relapsed after at least one prior ITP therapy, or patients must be unable, for a medical reason, to continue other ITP treatments. - Patients must have a Day 1 (or within 48 hours prior) platelet count <30 Gi/L. - Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1, or these therapies must have been completed at least 1 week prior to Day 1 and have been clearly ineffective. - Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1. - Patients treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1. - Patients must have a complete blood count (CBC) not suggestive of another hematological disorder. - Patients must have the following laboratory results: - prothrombin time international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range. - clinical chemistries that do NOT exceed the upper limit of normal reference range by more than 20% for the following: creatinine, ALT, AST, total bilirubin, and alkaline phosphatase. - total albumin that is not below the lower limit of normal by more than 10%. - Female patients of child-bearing potential (after menarche) must: - have a negative pregnancy test within 24 hours of first dose of study treatment, - agree and be able to provide a blood or urine specimen for pregnancy testing during the study, - agree to use effective contraception during the study and for 28 days following the last dose of study treatment, and not be lactating. - Male patients with a female partner of childbearing potential must agree to use effective contraception from 2 weeks prior to administration of the first dose of study treatment until 3 months after the last dose of study treatment. - In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: - Patients with any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the patient unsuitable for participation in the study or suggests another primary diagnosis (e.g. Thrombocytopenia is secondary to another disease). - Patients with concurrent or past malignant disease, including myeloproliferative disorder. - Patients expected not to be suitable for continuation of their current therapy for at least 13 additional weeks. - Patients with a history of platelet agglutination abnormality that prevents reliable measurement of platelet counts. - Patients with a diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis c virus infection, or any evidence of active hepatitis at the time of subject screening. - Patients with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis). - Patients with known inherited thrombocytopenia (e.g. MYH9 disorders). - Patients treated with any medication that affects platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDS) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1. - Patients who have received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1. - Patients who have previously received eltrombopag or any other thrombopoietin receptor agonist. - Any patient considered to be a child in care, defined as one who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. This can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or who has an appointed legal guardian. - Patients who have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or excipients that contraindicates their participation. - Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with the patients safety or compliance to the study procedures. ; PRIMARY OUTCOME: Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1; SECONDARY OUTCOME 1: Percentage of Responders[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Bacterial Vaginosis Prevention (1); BRIEF: A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV. ; DRUG USED: VivaGel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Cell Membrane, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Starpharma Pty Ltd; CRITERIA: Inclusion Criteria: - Current active episode of BV (diagnosis defined as: At least 3 of the 4 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms) - History of recurrent BV (at least 3 episodes in previous year including current episode) - Using an effective method of contraception Exclusion Criteria: - Test positive for a sexually transmitted infection - Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment - Abnormal pelvic exam, including presence of other vaginal or urinary tract infections - Pregnancy ; PRIMARY OUTCOME: Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings; SECONDARY OUTCOME 1: Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings[/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 Extension (12 Weeks); BRIEF: This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study. ; DRUG USED: Tonmya; DRUG CLASS: Non-NME; INDICATION: Post-Traumatic Stress Disorder (PTSD); TARGET: Alpha 2 Adrenergic Receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Tonix Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment. - The patient has provided written informed consent to participate in this extension protocol. - Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study. Exclusion Criteria: - None. ; PRIMARY OUTCOME: Evaluate the incidence of adverse events of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study; SECONDARY OUTCOME 1: Evaluate the change from both baselines in the Total CAPS-5 score of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EMERALD-2; BRIEF: A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence. ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation) - Imaging to confirm disease-free status within 28 days prior to randomization - ECOG 0-1 at enrolment - Child-Pugh score of 5 or 6 - Adequate organ and marrow function. Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC - Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging - History of hepatic encephalopathy within 12 months prior to randomization - Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging - Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded - Active co-infection with HBV and HDV. - Receipt of prior systemic anticancer therapy for HCC - Those on a waiting list for liver transplantation ; PRIMARY OUTCOME: Recurrence-free survival (RFS) for Arm A vs Arm C; SECONDARY OUTCOME 1: Recurrence-free survival (RFS) Arm B vs Arm C[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SAVOIR; BRIEF: This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause. ; DRUG USED: Orpathys; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Histologically confirmed PRCC, which is unresectable/locally advanced or metastatic with measurable disease as per RECIST 1.1. Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney are not considered PRCC and are not eligible. 2. Confirmation of MET-driven PRCC without co-occurring FH or VHL mutations from an FFPE tumour sample using the sponsor-designated central laboratory validated NGS assay 3. Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC in the advanced setting.* Patients can be treatment-naïve, or previously treated, but cannot have previously received sunitinib or a MET inhibitor. Patients who have received prior systemic therapy must have had disease progression in soft tissue disease or bone within 6 months of the last dose of the most recent systemic therapy 4. Adequate haematological, renal, cardiac and liver functions 5. Karnofsky performance status ≥ 80 Exclusion Criteria: 1. Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <28 days from the date of randomisation. Most recent non cytotoxic targeted therapy <14 days from the date of randomisation. 2. Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb. 3. Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 week before the date of randomisation. Herbal medications cannot be taken within 7 days of the date of randomisation (3 weeks for St Johns wort). 4. Wide field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to the date of randomisation 5. Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement. 6. Previously untreated brain metastases 7. Serious active infection or gastrointestinal disease 8. Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years. 9. Mean resting QTcF >470 msec for women and >450 msec for men on the Part 2 screening triplicate ECGs or factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes ; PRIMARY OUTCOME: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ESSENTIAL I ; BRIEF: To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure. ; DRUG USED: Enoximone Oral; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Phosphodiesterase 3 (PDE3); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: In order to be considered eligible subjects, the following entry criteria must be met: - At least 18 years of age - ischemic or nonischemic cardiomyopathy - NYHA Class III or IV - one hospitalization, or two outpatient visits, for the treatment of worsening heart failure within 12 months requiring the administration of I.V. heart failure therapy - LVEDD >3.2 cm/m2 or >=6.0 cm - LVEF of less than or equal to 30% - concomitant treatment with optimal conventional heart failure therapy Exclusion Criteria Subjects who meet any one of the following criteria will be deemed ineligible for participation in the study: Subjects on the following concomitant medications: - Calcium antagonists other than amlodipine or felodipine - Flecainide, encainide, propafenone, dofetilide or disopyramide - Subjects receiving I.V. positive inotropic agents within seven days of the Screening Visit or Randomization Visit - Subjects receiving a human B-type natriuretic peptide, including nesiritide, within seven days of the Screening Visit or Randomization Visit - Subjects receiving oral or I.V. phosphodiesterase III inhibitors (PDEI III), including levosimendan and cilostazol, within seven days of the Screening Visit or Randomization Visit - Subjects with active hepatic (screening serum total bilirubin >= 3.0 mg/dl (>=51.3 umol/l), renal (screening serum creatinine >= 2.0 mg/dl (=178.8 umol/l)), hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease - Subjects with a serum potassium <4.0 mEq/L or >5.5 mEq/L (<4.0 mmol/l or >5.5 mmol/l) at Randomization Visit - Subjects with a magnesium level of <1.0 mEq/L (<0.5 mmol/l) at Randomization Visit (Visit 0) - Subjects with a serum digoxin of >1.2 ng/ml (>1.5 nmol/l) or a serum digitoxin of >20 ng/ml (>26.2 nmol/l) at the Randomization Visit are excluded. A target serum digoxin level of <=1.0 ng/ml (<=1.3 nmol/l) is recommended ; PRIMARY OUTCOME: Time from randomization to all-cause mortality or cardiovascular hospitalization; SECONDARY OUTCOME 1: Change in Patient Global Assessment score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUSTAIN 9; BRIEF: This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive) - Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - Any disorder which in the investigators opinion might jeopardise subjects safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed - Subjects with alanine aminotransferase above 2.5 x upper normal limit - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Change in Body Weight (kg)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 802NP301 (Trigeminal Neuralgia); BRIEF: The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN). Secondary objectives of this study are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetics (PK) of BIIB074. ; DRUG USED: Vixotrigine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuropathic Pain; TARGET: Sodium Channel Nav1.7 (SCN9A); THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - A diagnosis of trigeminal neuralgia (TN) for at least 3 months based on International Headache Society (IHS) diagnostic criteria. - Participant must have failed at least 1 prior standard of care pharmacologic treatment for TN (defined as an inadequate response or intolerance to treatment), as determined by the Investigator based on medical history. - Age ≥18 years at the time of informed consent. - Allowed concomitant medications must have been stable for at least 4 weeks prior to Day 1 of the dose-optimization period. The maximum dosage of carbamazepine allowed on Day 1 is 400 mg/day (or 600 mg/day for oxcarbazepine). - Participants must have recorded their pain score in their eDiary on at least 5 days during the run-in period (Days -7 to -1). Key Exclusion Criteria: - History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). - Positive history of human immunodeficiency virus (HIV) or a positive HIV test at Screening. - Participants with facial pain other than TN. - Personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury. - Known hypersensitivity to BIIB074 or components of the BIIB074 formulation or matching placebo. - Positive pregnancy test result at Screening (women of childbearing potential only) - Has donated blood or blood products within a 30-day period prior to Screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants Classified as Responders at Week 12 of the Double-Blind Period; SECONDARY OUTCOME 1: Percentage of Participants Classified as Responders Achieving Patient Global Impression of Change (PGIC) Response at Week 12 of the Double- Blind Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - STARS; BRIEF: This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing respiratory abnormalities in Rett Syndrome in an initial double blind 24 week period followed by an open label treatment phase of up to 168 weeks (the latter for patients with no safety and tolerability issues). ; DRUG USED: Sarizotan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rett Syndrome; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Newron Pharmaceuticals SPA; CRITERIA: Inclusion Criteria: - Body weight ≥ 10 kg - Age ≥ 4 years - Diagnosis of Rett syndrome based on consensus clinical criteria and patients with MECP2 duplications will not be eligible. - Has at least 10 episodes of breathing dysrhythmia, defined by episodes ≥10 seconds of breath holding (apnea), per hour during cardiorespiratory monitoring - Ability to take study medication provided either as capsules or combined with food/drink. - Patient is cooperative, willing to complete all aspects of the study, and capable of doing so with assistance of a caregiver. Exclusion Criteria: - Meets any of the diagnostic exclusion criteria for Rett syndrome, Typical (Neul et al, 2010); - Patient is participating in a clinical trial with another investigational drug - Hypersensitivity to sarizotan or other 5-HT1a agonists; - Current clinically significant (as determined by Investigator) cardiovascular, respiratory (e.g. severe asthma), gastrointestinal, renal, hepatic, hematologic or other medical disorders, in addition to those directly related to the patients Rett syndrome; - QTcF interval on the ECG is greater than 450 msec. - Surgery planned during the study (except for insertion of gastrostomy tube); - Severe diabetes mellitus or fatty acid oxidation disorder. - Ophthalmologic history including any of the following conditions: albino patients, family history of hereditary retinal disease, retinitis pigmentosa, any active retinopathy or severe diabetic retinopathy. - Females who are pregnant, breastfeeding, or of childbearing potential and not using a hormonal contraceptive. ; PRIMARY OUTCOME: Reduction in Respiratory Abnormality in Patients With Rett Syndrome; SECONDARY OUTCOME 1: Efficacy of Sarizotan Assessed by the Caregiver-rated 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 - CheckMate 459 (vs. Sorafenib); BRIEF: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies - Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan - Child-Pugh Class A - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - Prior liver transplant - Active, known, or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Objective Response Rate (ORR) Per BICR RECIST 1.1[/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 - ALOFT - BNP; BRIEF: This study was designed to determine if patients, who have both high blood pressure and heart failure and are currently receiving drug treatment for heart failure, have an improvement in their heart failure signs and symptoms and other indicators of heart failure after being treated with aliskiren on top of their current heart failure treatment. Aliskiren is an investigational drug; its safety will also be evaluated in this trial. ; DRUG USED: Tekturna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Renin; THERAPY: Combination; LEAD SPONSOR: Novartis; CRITERIA: Inclusion Criteria: - History of diagnosis or currently have high blood pressure - Stable heart failure (NYHA Class 2-4) for at least 1 month before study entry. Subject should be on a stable dose regimen of heart failure medication. - Brain natriuretic peptide (BNP) > 150 pg/ml at baseline (to be evaluated by physician at first visit) Exclusion Criteria: - Previous treatment with aliskiren - High blood pressure due to secondary reasons or constant low blood pressure (systolic < 90 mmHg) - History of heart attack or coronary bypass surgery in the past 6 months Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Measurement of safety information and tolerability of drug after 12 weeks; SECONDARY OUTCOME 1: Change from baseline in the heart failure biochemical markers of N-terminal pro-brain natriuretic peptide (NT-proBNP) and brain natriuretic (BNP) after 12 weeks[/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 - PYRENEES; BRIEF: This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia. ; DRUG USED: Roxadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Europe B.V.; CRITERIA: Inclusion Criteria: Main Inclusion: - Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization. - Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization). - Mean of the participants three most recent Hb values, as measured by central laboratory, during the Screening Period. - Participants alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN Exclusion Criteria: Main Exclusion: - Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization. - Participant has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD). - Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization. - Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization. - Participant has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps. - Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation. ; PRIMARY OUTCOME: Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)]; SECONDARY OUTCOME 1: Percentage of Participants With Hb Response During Weeks 28 to 36[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INSPIRE - vs. Tacrolimus (US/Canada); BRIEF: The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant. ; DRUG USED: Lupkynis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Kidney Transplant Rejection; TARGET: Calcineurin phosphatase ; THERAPY: Monotherapy; LEAD SPONSOR: Aurinia Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - Males and females aged 18-65 years inclusive at the time of screening. - Recipients of a first or second deceased donor or living donor renal transplant. Exclusion Criteria: - Subjects presently receiving immunosuppression for a previously failed transplant. - Females who are pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication. - Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are not practicing a highly effective method of birth control. - Subjects receiving a HLA identical living related transplant. - Subjects wth a positive T-cell lymphocytotoxic cross match, or positive flow T and B cell cross match. - Subjects undergoing primary transplant with a current PRA (or CPRA) ≥ 25%. - Subjects who experienced graft loss within 1 year of transplant. - Subjects receiving a kidney from a ABO incompatible donor. - Subjects receiving a kidney from a deceased donor positive for HIV, HBV, HCV or tuberculosis. - Subjects receiving a a kidney from a non-heart beating donor. - Subjects receiving paired (en bloc or paired) kidney transplants. - Transplantation of multiple grafts (e.g. kidney and pancreas). - Subjects receiving a kidney with a cold ischemia time > 30 hours. - Subjects receiving any transplanted organ other than a kidney. - Recipients of a bone marrow or stem cell transplant. - Any systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against CMV and/or PCP infection will be permitted). - Subjects with positive results of the following serological tests: HIV I Ab, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and the anti-hepatitis C virus antibody (HCV Ab). Negative results for these serological tests must be documented within 12 months prior to randomization. - Subjects with active tuberculosis (Tb) requiring treatment within the last 3 years. Subjects with a known positive purified protein derivative (PPD) test are not eligible unless they have completed treatment for latent Tb and have a negative chest X-ray at time of enrollment. PPD testing must have been done within the last 12 months, and a positive result is defined as ≥ 10 mm induration, a Heaf score of >1 in non-Bacille Calmette-Guérin (BCG) immunized subjects, or >2 in BCG immunized subjects. - Subjects with a current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodessication. ; PRIMARY OUTCOME: The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.; 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 - IFN-Free FISSION (w/RBV, GT-2,3); BRIEF: This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority. ; DRUG USED: Sovaldi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Chronic Genotype 2 or 3 HCV-infection - Naive to all HCV antiviral treatment(s) Exclusion Criteria: - Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab - History of any other clinically significant chronic liver disease - A history consistent with decompensated liver disease - History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study. - Participation in a clinical study within 3 months prior to first dose ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12); SECONDARY OUTCOME 1: Number of Participants Who Experienced Adverse Events (AEs) and Graded 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 III - MET35 (Age 2-9); BRIEF: The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US) and Puerto Rico. Primary objective: - To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years. Secondary objectives: - To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age. - To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. - To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. Observational objective: - To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed MENVEO®. ; 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 2 to 9 years on the day of inclusion. - Assent form had been signed and dated by the participant (as required by local regulations) and informed consent form had been signed and dated by parent(s) or guardian. - Participant and parent/guardian were able to attend all scheduled visits and complied with all trial procedures. Exclusion Criteria: - Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche. - 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 might be received at least 2 weeks before or after the study investigational vaccines. This exception included monovalent, multivalent, live, and attenuated influenza vaccines. - Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, W; or meningococcal B serogroup containing 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, contraindicating intramuscular vaccination by the Investigators judgment. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigators opinion. - Personal history of Guillain-Barré syndrome. - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. - 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 Investigators judgment) on the day of vaccination or febrile illness (temperature ≥100.4°F). A prospective participant should not be included in the study until the condition had 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 a natural or adopted child of the Investigator or employee with direct involvement in the proposed study. ; PRIMARY OUTCOME: Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine; SECONDARY OUTCOME 1: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age[/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 - RICE ; BRIEF: The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy. ; DRUG USED: Xifaxan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatic Encephalopathy (HE); TARGET: Gram-Negative Bacteria, RNA polymerase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: University of Miami; CRITERIA: Inclusion Criteria: 1. Cirrhosis of any cause 2. History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment 3. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated. 4. Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation. 5. Subject is ≥18 years of age. 6. Subject is capable and willing to comply with all study procedures. 7. If the subject has a history of a portal-systemic shunt, shunt placement or revision must be >6 months from Screening for TIPS or a surgical shunt. Exclusion Criteria: 1. Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study. 2. Subject has a history of allergy or intolerance to lactulose. 3. Subject has a history of allergy or intolerance to rifampin or rifaximin. 4. Subject has participated in an investigational drug or device study within the 30 days prior to study screening. 5. Subject is pregnant or is lactating. 6. Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator. 7. Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests. 8. Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits. 9. Subjects current, required medications are on prohibited concurrent medication listing. 10. Hemoglobin < 8.0 at time of screening 11. Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening 12. Ongoing gastrointestinal bleeding at time of screening 13. Chronic renal insufficiency with a serum creatinine > 3.0 at time of screening 14. History of tuberculosis infection ; PRIMARY OUTCOME: Number of Hospitalizations for Hepatic Encephalopathy (HE); SECONDARY OUTCOME 1: Number of Hospitalization Days for All Causes[/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 - Pediatric; BRIEF: This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major Elective Surgery. It will be conducted at approximately 5 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of 19 months, and the study population will consist of at least 60 male and female pediatric subjects between 0 days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery with an approximately equal number of subjects (n=10 to 25) in three of the four age groups: (29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts. ; DRUG USED: Kedbumin; DRUG CLASS: Biologic; INDICATION: Hypovolemia; TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Kedrion S.p.A.; CRITERIA: Inclusion Criteria: 1. Male or female aged 0 days to 12 years, inclusive: - (0 to 28 days); - (29 days to 23 months); - (2 to 5 years 11 months); - (6 to 12 years). 2. Subjects undergoing elective cardiac, abdominal, orthopedic, or transplant surgery. 3. Subjects with a clinical diagnosis of hypovolemia developed within 24 hours from the completion of surgery, as judged by the Investigator. 4. Admitted to ICU or acute care floor for post-operative recovery and care, in relatively stable condition. 5. Subject, parent or guardian agrees to comply with the requirements of the protocol. 6. Subject, parent or guardian has signed an informed consent form (ICF) and a child assent form if appropriate. 7. Subject, parent or guardian has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization. Exclusion Criteria: 1. Intra-operative blood loss > 50 mL/kg. 2. Severe hypoalbuminemia with serum albumin levels < 1g/dL. 3. Known intolerance or allergy to albumin and/or plasma proteins. 4. Preterm neonates, defined as neonates with a gestational age of <37 weeks (this criteria would only affect the 0-28 days group). 5. Burn and trauma patients. 6. Renal surgery. 7. Subjects with acute CNS injury or trauma would be excluded from the study. 8. Chronic renal insufficiency or acute renal failure (creatinine > 1.5 of normal value or based on age-appropriate renal function parameters), or a history of renal transplantation. 9. Subjects with hypernatremia, defined as a Na level of ≥ 155 mEq/L. 10. Severe congestive heart failure (CHF) using one of the following classification systems: Ross Heart Failure Classification, modified Ross Heart Failure Classification, or New York University Pediatric Heart Failure Index (NYU PHFI). 11. Any concurrent medical, surgical or psychiatric condition that may, in the Investigators opinion, affect the subjects ability to meet the protocol requirements. 12. Subject has participated in another interventional clinical study within 30 days prior to study enrollment. Subjects who are participating in another observational study are not excluded. ; PRIMARY OUTCOME: Incidence, Severity, and Seriousness of Fluid Overload and Edema (Pulmonary Portal or Systemic) and/or Other Complications Secondary to Fluid Resuscitation With Kedbumin 25% Compared to Normal Saline.; SECONDARY OUTCOME 1: Resolution of Hypovolemia With Adequate Fluid Resuscitation and Restoration of Hemodynamic Stability After Treatment With Kedbumin 25% Compared to Normal Saline Within 72 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 - APOLLOE4; BRIEF: This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimers disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo. ; DRUG USED: ALZ-801; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Alzheon Inc.; CRITERIA: Inclusion Criteria: - Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimers Association (NIA-AA) Working Group Criteria. - Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4). - MMSE score at Screening of 22 to 30 (inclusive). - CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5. - RBANS delayed memory index score ≤ 85. - Evidence of progressive memory loss over the last 12 months per investigator assessment Exclusion Criteria: - Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI. - Diagnosis of neurodegenerative disorder other than AD. - Diagnosis of major depressive disorder (MDD) within one year prior to screening. - Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit. - History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation. - History of seizures, excluding febrile seizures of childhood or a single distant seizure (> 5 years). - Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening. ; PRIMARY OUTCOME: Primary cognitive efficacy endpoint; SECONDARY OUTCOME 1: Functional assessment 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 - PK/Safety Study; BRIEF: The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24. ; DRUG USED: Biosimilar Rituximab (Boehringer Ingelheim); DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Must give written informed consent and be willing to follow the protocol. 2. Male or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active RA for at least 6 months as defined by at least six swollen joints (66 joint count) and at least eight tender joints (68 joint count) at Screening and Baseline (Day 1), and either an erythrocyte sedimentation rate (ESR) of > 28 mm/hour OR a C-reactive protein (CRP) level > 1.0 mg/dL (normal: < 0.4 mg/dL) at Screening. Patients must have had an inadequate response or intolerance to conventional DMARD therapy including at least one tumor necrosis factor (TNF) inhibitor. 3. Positive for Radio Frequency and/or anti-CCP (Anti-cyclic citrullinated peptide) antibodies. 4. Current treatment for RA on an outpatient basis: 1. Must be currently receiving and tolerating oral or parenteral MTX therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose) for at least 12 weeks immediately prior to Day 1. The dose should be stable for at least 4 weeks prior to Day 1 until Week 24. After Week 24 the administration route can be changed at the investigators discretion. 2. Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or equivalent during the entire study (mandatory co-medication for MTX treatment). 3. Biologic agents and DMARDs (other than MTX) must be withdrawn at least 2 weeks prior to Day 1, except azathioprine and etanercept which must be withdrawn at least 4 weeks prior to Day 1; abatacept, adalimumab, anakinra, certolizumab, infliximab, and golimumab at least 8 weeks prior to Day 1; tocilizumab at least 10 weeks prior to Day 1. 4. Leflunomide must be withdrawn at least 8 weeks prior to Day 1 or a minimum of 2 weeks prior to Day 1 if after 11 days of standard cholestyramine washout. 5. If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent. During the 4 weeks prior to Baseline (Day 1) the dose must remain stable. 6. Intra-articular and parenteral corticosteroids are not permitted within 6 weeks prior to Baseline Day 1 or throughout the trial, with the exception of IV administration of 100 mg methylprednisolone 30 to 60 minutes prior to each infusion as this is part of the trial procedures. 7. Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable for at least 2 weeks prior to Day 1. 8. Patients may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day or chloroquine provided that the dose is not greater than 250 mg/day. These doses must have been stable for a minimum of 12 weeks prior to Day 1. The hydroxychloroquine or chloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the trial. 5. For participants of reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, intrauterine device, physical barrier) has to be used throughout trial participation. Females of child-bearing potential must also agree to use an acceptable method of contraception for 12 months following completion or discontinuation from the trial. Exclusion criteria: 1. ACR functional Class IV or wheelchair/bed bound. 2. Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus infection. 3. History of positive purified protein derivative test (positive tuberculosis [TB] test) without treatment for TB infection or chemoprophylaxis for TB exposure. 4. Positive HIV or TB at screening. 5. Known coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (New York Heart Association classes III or IV), or interstitial lung disease observed on chest X-ray. 6. History of IgE-mediated (immunoglobulin E) or non-IgE-mediated hypersensitivity or known anaphylaxis to mouse proteins or a history of hypersensitivity to antibody therapy. 7. History of cancer including solid tumors, hematologic malignancies, and carcinoma in situ (except participants with previous resected and cured basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer within 5 years prior to the Screening Visit). 8. History of pancreatitis or current peptic ulcer disease. 9. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit. 10. Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial. 11. Pregnancy or breast feeding. 12. History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, pulmonary fibrosis, or Feltys syndrome, scleroderma, inflammatory myopathy, mixed connective tissue disease, or any overlap syndrome). 13. Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA, and/or RA before age 16. 14. Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to the Screening Visit or planned within 24 weeks of the Screening Visit. 15. Lack of peripheral venous access. 16. Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders which, in the investigators opinion, would preclude patient participation. 17. Known concurrent viral hepatitis or known positivity to HBe-ag, HBV DNA, HBV DNA polymerase, HCVRNA, anti HCV antibodies. 18. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit. 19. History of deep space/tissue infection (e.g., fasciitis, abscess, osteomyelitis) within 52 weeks of the Screening Visit. 20. History of serious infection or opportunistic infection in the last 2 years. 21. Any neurological (congenital or acquired), vascular or systemic disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinsons disease, cerebral palsy, diabetic neuropathy). 22. Currently active alcohol or drug abuse or history of alcohol or drug abuse (as determined by the investigator) within 52 weeks of the Screening Visit. 23. Treatment with IV Gamma Globulin or the Prosorba® Column within 6 months of the Screening Visit. 24. Treatment with IV or intramuscular corticosteroids. 25. Previous treatment with a B cell modulating or cell depleting therapy. 26. Intolerance or contraindications to IV glucocorticoids. 27. AST (aspartate aminotransferase) or ALT (alanine aminotransferase)> 3 times ULN (Upper Limit of Normal) 28. Hemoglobin < 8.0 g/dL. 29. Levels of IgG < 5.0 g/L. 30. Absolute neutrophil count < 1500/µL. 31. Platelet count < 75000/µL. 32. Participation in any previous clinical trial within 12 weeks of Screening. ; PRIMARY OUTCOME: Change of Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 [ESR]) From Baseline to Week 24 (BI 695500 Versus Rituxan®) - Part I; SECONDARY OUTCOME 1: Percentage of Patients Meeting the ACR20 (American College of Rheumatology 20% Response Criteria) at Week 24 in Both Part-I and II[/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 - HAVEN 4; BRIEF: This multicenter, open-label, non-randomized study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part. ; DRUG USED: Hemlibra; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor IX, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Body weight greater than or equal to (>/=) 40 kilograms (kg) at screening - Diagnosis of severe congenital hemophilia A or hemophilia A with FVIII inhibitors - Participants using rFVIIa or willing to switch to recombinant activated factor VII (rFVIIa) as primary bypassing agent for the treatment of breakthrough bleeds - FVIII inhibitor test during screening with titer results available prior to first administration of study drug - Participants without FVIII inhibitors, that is with less than (<) 0.6 Bethesda unit per milliliter [BU/mL];< 1.0 BU/mL only for laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL, who completed successful immune tolerance induction (ITI) must have done so at least 5 years before screening and must have no evidence of inhibitor recurrence (permanent or temporary) indicated by detection of an inhibitor greater than (>) 0.6 BU/mL (> 1.0 BU/mL only for laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL) since ITI - Adequate hematologic, hepatic, and renal function Exclusion Criteria: - Inherited or acquired bleeding disorder other than hemophilia A - Ongoing or planned ITI therapy; participants in whom ITI has failed will be eligible with a 72-hour washout period prior to the first emicizumab administration - History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the investigators judgment - Participants who are at high risk for thrombotic microangiopathy (TMA) (for example, have a previous medical or family history of TMA), in the investigators judgment - Previous (within the last 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease - Other conditions (for example, certain autoimmune diseases) that may currently increase the risk of bleeding or thrombosis - History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection - Known HIV infection with cluster of differentiation (CD) 4 cells counts <200 cells per microliter (cells/mcL) - Use of systemic immunomodulators (for example, interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy - Concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an additional unacceptable risk in administering study drug to the participant - Pregnancy or lactation or intention to become pregnant during the study - Women with a positive serum pregnancy test result within 7 days prior to initiation of study drug ; PRIMARY OUTCOME: Expansion Part: Annualized Bleeding Rate (ABR) for Treated Bleeds; SECONDARY OUTCOME 1: Expansion Part: Change From Baseline to Week 25 in the Hemophilia A Quality of Life (Haem-A-QoL) Questionnaire Total Score for Adult Participants (≥18 Years of Age)[/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 - GEMINI 1; BRIEF: A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia. ; DRUG USED: Presbysol; DRUG CLASS: Non-NME; INDICATION: Refractive Errors (Ophthalmology); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Subjective complaints of poor near vision that impact activities of daily living Exclusion Criteria: - History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery - Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study - Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes - Corneal abnormalities (including keratoconus, corneal scar, Fuchs endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity - Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy - Diagnosis of any type of glaucoma or ocular hypertension ; PRIMARY OUTCOME: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3; SECONDARY OUTCOME 1: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ADACCESS; BRIEF: The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis. ; DRUG USED: Hyrimoz; DRUG CLASS: Biosimilar; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Sandoz; CRITERIA: Inclusion Criteria: - Men or women at least 18 years of age at time of screening - Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization - Moderate to severe psoriasis as defined at baseline by: - PASI score of 12 or greater - Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and, - Body Surface Area affected by plaque-type psoriasis of 10% or greater - Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator. Exclusion Criteria: - Forms of psoriasis other than chronic plaque-type - Drug-induced psoriasis - Ongoing use of prohibited psoriasis treatments - Previous exposure to adalimumab - Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab Other In-/Exclusion criteria may apply ; PRIMARY OUTCOME: PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab; SECONDARY OUTCOME 1: Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)[/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 - Acute Psychotic Agitation (Japan); BRIEF: The primary objectives of the study is to confirm if the efficacy of intramuscular injection (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with acute psychotic agitation is greater than intramuscular placebo by comparing changes from baseline to 2 hours after the first IM injection of agitation. ; DRUG USED: Zyprexa (Oral and IM); DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 4 (D4) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) criteria for schizophrenia. - Patients with an exacerbation of schizophrenia with acute psychotic agitation. - Patients who are hospitalized during the study. - Patients, or proxy consenters, understand the nature of the study and sign on an informed consent document. - The investigator or sub-investigator(s) judges that the patients are able to cooperate with all protocol procedures. - Patients who are considered to be with agitation and appropriate candidates for treatment with intramuscular (IM) medication by the investigator or sub-investigator(s). - The investigator or sub-investigator(s) believes that it is safe to administer IM olanzapine to the patients in consideration of safety, including the anticholinergic action of IM olanzapine. - Patients who have a score of 1 or 2 on Agitation-Calmness Evaluation Scale (ACES) before the first IM injection of investigational product. Exclusion Criteria: - Patients whose Global Assessment of Functioning (GAF) score is less than or equal to 40 within last 1 year before informed consent. - Patients with defect. - Patients whose agitation continues more than 2 weeks before informed consent. - Patients who were previously treated with antipsychotics and were considered by the investigator or sub-investigator(s) to be treatment-resistant to antipsychotics. - Patients who were treated by oral olanzapine at a dose of more than 20 milligrams (mg) for more than 4 weeks but did not improve. - Patient who have a history of participation in clozapine trials or treatment with clozapine. - Patients who have co-morbidity of mental retardation and personality disorder. - Patients whose agitation is possibly due to brain lesions such as (but not limited to) head injury, stroke, brain breeding, and cerebral infection. - Patients with sub-stupor or stupor. - One or more seizures without a clear and resolved etiology. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. - Patients who have a history of DSM-IV-TR substance (except caffeine and nicotine) abuse within the past 30 days or substance dependence within the past 6 months before informed consent. Or patients who have a history of using illegal drug. - Patients whose agitation is caused by substance abuse or neurologic conditions, in the opinion of the investigator or sub-investigator(s). - Patients who have a diagnosis of Parkinsons disease or dementia. - Patients who are actively suicidal (at high risk for suicide attempt) in the opinion of the investigator or sub-investigator(s). - Patients with inadequately controlled diabetes, or patients whose treatment for diabetes has been changed within 4 weeks before the first IM injection of the investigational product. The investigators discretion will supersede even if the patients do not meet the above criteria for concurrent diabetes. - Patients who have received haloperidol decanoate fluphenazine decanoate, or fluphenazine enanthate within 8 weeks before the first IM injection of investigational product. - Patients who have received risperidone long-acting injection within 12 weeks before the first IM injection of investigational product. - Patients who have a history of receiving injectable depot antipsychotics other than haloperidol decanoate, fluphenazine decanoate, fluphenazine enanthate and risperidone long-acting injection. - Patients who have received antipsychotics or other prohibited concomitant medicines within 2 hours before the first IM injection of investigational product. - Patients who have received benzodiazepines within 4 hours before the first IM injection of investigational product. ; PRIMARY OUTCOME: Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection; SECONDARY OUTCOME 1: Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection[/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 - A5361022; BRIEF: This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder. ; DRUG USED: PD 332,334; DRUG CLASS: New Molecular Entity (NME); INDICATION: Generalized Anxiety Disorder (GAD); TARGET: Voltage-gated calcium channels; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Subjects must have completed all phases of one of the four preceding double-blind GAD studies. - Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment. Exclusion Criteria: - Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsors medical monitor. - Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsors medical monitor, would make it unsafe for the subject to participate in the study. - Serious suicidal risk per the clinical investigatorss judgement. ; PRIMARY OUTCOME: The nature, incidence, and duration of adverse events monitored throughout the study by physical exam; SECONDARY OUTCOME 1: The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time 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 - Classroom Setting (Pediatric); BRIEF: This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase. ; DRUG USED: Jornay PM; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Ironshore Pharmaceuticals and Development, Inc; CRITERIA: Inclusion Criteria: 1. Subjects must be male or female children (6 to 12 years at the time of consent). 2. Subjects must have a diagnosis of ADHD as defined by DSM5 criteria and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 3. Subjects must have a Baseline ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in at least 1 of the following categories: 1) Hyperactive Impulse; 2) Inattentive; or 3) Total Score. In addition, this ADHD-RS-IV Total Score must be greater or equal to 26. 4. Subjects must have a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 and a CGI-P score >10 at the Baseline Visit. 5. Subjects who are not currently on MPH treatment must either 1) have prior experience with MPH treatment and have shown clinical response to therapy during that time; or 2) be treated with the same dose of MPH and show a clinical response with acceptable tolerability to MPH for ≥2 weeks prior to screening. 6. Parental or legal guardian confirmation of before-school function impairment and difficulties performing morning routine. 7. Regular weekday morning routine of no less than 30 minutes. 8. Subject must be considered clinically appropriate for treatment with MPH and HLD200, including ability to swallow treatment capsules. 9. Subject must be in general good health based upon medical history, physical examination, and laboratory results (including urine drug screen). 10. Subject and parent or legal guardian must be able to read, write, and/or understand at a level sufficient to provide informed consent (parent/legal guardian) and assent (subject) prior to study participation and to complete study-related materials. Subject and a parent/legal guardian must plan to be available for the entire study period. 11. Female subjects of childbearing potential (i.e., post-menarche) are required to have a negative result on urine pregnancy testing at screening (and will be given specific instructions for avoiding pregnancy during the study). 12. A medically highly effective form of birth control must be used during the study and for 90 days thereafter for subjects of either sex of childbearing potential. Examples of medically highly effective forms of birth control are as follows: - No sexual activity - Use of acceptable methods of birth control including intra-uterine device, oral, implantable, or injectable contraceptives. Exclusion Criteria: 1. History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures. 2. Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug. 3. History of seizure disorder (except febrile seizures prior to age 5 and at least 1 year prior to study participation), Tourettes disorder, or intellectual disability of minor severity or greater (DSM5 criteria). 4. History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigators opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures. 5. Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS. 6. History of severe allergic reaction to MPH. 7. History of no response or intolerance to the adverse effects of MPH; 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or creatinine greater than 1.5x the upper limit of normal. Elevated bilirubin due only to Gilberts syndrome is not exclusionary. 9. History of alcohol abuse or illicit drug use. 10. Use of prescription medications (except allowed medications; see Section 8.1.2) within 7 days of Baseline (Visit 2), except for ADHD stimulant medication (5 days) and monoamine oxidase inhibitors (MAOIs) (14 days), and over-the-counter medications (except birth control and allowed medications) within the 3 days preceding Baseline (Visit 2). Medications not covered in allowed medications or prohibited medications (Section 8.1.1) must be cleared by the medical monitor prior to enrolling the subject. 11. Participation in a clinical study with an investigational drug within the 30 days preceding study enrollment. 12. Previous treatment experience with HLD200. 13. Positive screening for illicit drug use or nicotine and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject. 14. In the opinion of the investigator, the subject may have problems complying with the protocol or the procedures of the protocol, or could face unnecessary safety risks from the study. This includes current health conditions or use of medications that might confound the results of the study or increase risk to the subject. 15. Subjects systolic or diastolic blood pressure measurement exceeds the 95th percentile for age, sex, and height at the Baseline visit. 16. Subject is significantly underweight based on Centers for Disease Control and Prevention body mass index (BMI)-for-age sex-specific values at the Screening Visit. Significantly underweight is defined as a BMI <5th percentile. 17. Subject is significantly overweight based on Centers for Disease Control and Prevention BMI-for-age sex specific values at the Screening Visit. Significantly overweight is defined as a BMI >95th percentile. ; PRIMARY OUTCOME: Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9).; SECONDARY OUTCOME 1: Parent Rating of Evening and Morning Behavior Revised, Morning Subscale (PREMB-R AM).[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACES 263; BRIEF: This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participants self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participants medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ. ; DRUG USED: Aripiprazole/Escitalopram; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration - Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period - Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline for the Prospective Treatment Phase Exclusion Criteria: - Lack of prior treatment with an antidepressant during the current depressive episode - Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode. - Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode - Participants with epilepsy or significant history of seizure disorders - Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder - Participants who have received electroconvulsive therapy (ECT) in the last 10 years ; PRIMARY OUTCOME: Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14); SECONDARY OUTCOME 1: Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CRYSTAL (ext.); BRIEF: This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe. ; DRUG USED: Zurampic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gout; TARGET: URAT1 (urate trans-porter 1, SLC22A12/Solute carrier family 22, member 12); THERAPY: Combination; LEAD SPONSOR: Ardea Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. - Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit. - Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication. Exclusion Criteria: - Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subjects ability to comply with the protocol requirements, or to complete the study. ; PRIMARY OUTCOME: Percentage of Participants With an sUA Level That is < 5.0 mg/dL; SECONDARY OUTCOME 1: Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus[/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 - CLARITY (India, Romania, Moldova); BRIEF: This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints will occur after 12 and 24 weeks of treatment. Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study will utilize a flexible dose escalation scheme designed to allow patients to titrate to their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design). ; DRUG USED: BL-1020; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Dopamine 2 (D2) Receptor, GABA Receptors, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: BioLineRx, Ltd.; CRITERIA: Inclusion Criteria: 1. Male or non-pregnant or lactating female, 18-50 years of age inclusive 2. Patients must have exhibited symptoms meeting the criteria of schizophrenia for at least one year, but not more than 20 years, prior to Screening 3. Recent onset (not more than 30 days) of worsening of psychiatric symptoms at Screening. 4. Currently experiencing an acute exacerbation of schizophrenia, as defined by the following results at Screening and Baseline: - ≥70 total score on the PANSS - ≥4 (moderate) on two of the following four PANSS items: (1) delusions, (2) hallucinatory behaviors, (3) conceptual disorganization or (4) suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors 5. CGI-S score between 4 and 6 (moderately ill to severely ill) at the Screening and Baseline visits. 6. Has exhibited a sufficient clinical response to at least one previous course of an anti-psychotic agent prescribed at a generally recognized therapeutic dose. 7. Must have completed at least 5 years of formal education or its equivalent Exclusion Criteria: 1. Breastfeeding or pregnant 2. Symptoms of schizophrenia for more than 20 years at the time of screening. 3. Psychotic symptoms that have failed to improve (based on Investigators opinion or documented medical history) following sufficient treatment with therapeutic doses of two or more anti-psychotics agents over the preceding 2 years 4. Prior history of neuroleptic malignant syndrome 5. Prior history or current evidence of moderate or severe tardive dyskinesia (mild is acceptable). 6. Abnormal ECG evaluation 7. History of confirmed epilepsy or prior seizure disorder (history of a single febrile seizure is not exclusionary) 8. In the opinion of the investigator, unstable medical disease (e.g., malignancy, poorly controlled diabetes or hypertension, ischemic cardiac disease, dilated cardiomyopathy or valvular heart disease, pulmonary disease, liver disease, kidney disease) 9. Acute infectious disease (e.g., malaria, dengue fever, hepatitis A), or chronic infectious disease (e.g., history of AIDS or HIV positivity, tuberculosis) 10. Likely allergy, sensitivity or intolerance to BL-1020, perphenazine, risperidone, paliperidone, or any of the drug product excipients 11. Any suicide attempt within the preceding 2 years 12. Any Substance Dependence disorder 13. High likelihood of substance abuse 14. Diagnosis with one of the following DSM-IV-TR Axis I diagnoses: schizophreniform disorder, schizoaffective disorder, bipolar disorder, substance dependency, mood disorder with psychotic features; psychotic disorder NOS 15. Requiring chronic treatment with benzodiazepines 16. Requiring chronic treatment with mood stabilizers 17. Previously treated with clozapine within 6 months prior to screening 18. Any abnormal clinical laboratory test result that is judged by the Investigator to be clinically significant 19. History of, or serologic evidence of, acute or chronic active hepatitis B or C ; PRIMARY OUTCOME: Cognition; SECONDARY OUTCOME 1: Long Term Cognition[/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 - HARBOR (High Dose); BRIEF: This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Results are presented for the first 12 months of the study. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study. Ocular Inclusion Criteria (Study Eye) - Best corrected visual acuity (BCVA), using Early Treatment Diabetic Retinopathy Study (ETDRS) charts, of 20/40-20/320 (Snellen equivalent). - Choroidal neovascularization (CNV) lesions with classic CNV component, occult CNV, or with some classic CNV component were permissible. - Total area of lesion < 12 disc area or 30.48 mm^2. Exclusion Criteria: - History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye. - Prior treatment with Visudyne(R), external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye. - Previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation) in the study eye. - Previous treatment or participation in a clinical trial involving anti-angiogenic drugs (Avastin(R), anecortave acetate, protein kinase C inhibitors, etc), in the non-study eye within 3 months of Day 0 (first day of treatment). The patient may not have received Lucentis(R) or Macugen(R) in the non-study eye within 7 days of Day 0. - Treatment with Visudyne(R) in the non-study eye < 7 days preceding Day 0. - Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm^2) in size. - Subfoveal fibrosis or atrophy in the study eye. - CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia. - Retinal pigment epithelial tear involving the macula in the study eye. - Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity (BCVA) over the 24-month study period. - Uncontrolled blood pressure. - Atrial fibrillation not managed by patients primary care physician or cardiologist within 3 months of screening visit. - History of stroke within the last 3 months of screening visit. - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications. - Current treatment for active systemic infection. - Active malignancy. - History of allergy to fluorescein, not amenable to treatment. - Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals). ; PRIMARY OUTCOME: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12; SECONDARY OUTCOME 1: Number of Ranibizumab Injections up to But Not Including Month 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Nivolumab; BRIEF: The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC). ; DRUG USED: Linrodostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Exclusion Criteria: - Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer - Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted ; PRIMARY OUTCOME: Pathological Complete Response (pCR) rate, in all randomized participants; SECONDARY OUTCOME 1: Overall Survival (OS) in all randomized participants[/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 - PROTI; BRIEF: This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreichs ataxia. The objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment (placebo or idebenone) they received during the randomised phase of the trial, and identify any potential changes on symptoms or activities. ; DRUG USED: Catena; DRUG CLASS: New Molecular Entity (NME); INDICATION: Friedreichs Ataxia; TARGET: Mitochondrial Electron Transport Chain, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Santhera Pharmaceuticals; CRITERIA: Inclusion Criteria: - Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study - Patients who in the opinion of the investigator are able to comply with the requirements of the study - Body weight ≥ 25kg - Negative urine pregnancy test Exclusion Criteria: - AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone - Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine - Parallel participation in another clinical drug trial - Pregnancy or breast-feeding - Abuse of drugs or alcohol - Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study ; PRIMARY OUTCOME: Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone; SECONDARY OUTCOME 1: Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OPTIC-X; BRIEF: The overall objective is to evaluate the safety and efficacy of teprotumumab in the treatment of thyroid eye disease (TED) in participants who participated in the lead-in study HZNP-TEP-301 (NCT03298867; OPTIC) and who were either proptosis non-responders at Week 24 of HZNP-TEP-301 or were proptosis responders at Week 24 but met the criteria for re-treatment due to relapse during the Follow-Up Period of HZNP-TEP-301. ; DRUG USED: Tepezza; DRUG CLASS: Biologic; INDICATION: Thyroid Eye Disease (TED); TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Monotherapy; LEAD SPONSOR: Horizon Pharma USA, Inc.; CRITERIA: Inclusion Criteria: - Written informed consent. - Completed the 24-week double-masked Treatment Period in Study HZNP-TEP-301 (NCT03298867). - Proptosis non-responder (< 2 mm reduction in proptosis in the study eye) at Week 24 of Study HZNP-TEP-301 OR proptosis responder at Week 24 who relapses during the Follow-Up Period of Study HZNP-TEP-301. - Participant must be euthyroid with the baseline disease under control, or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine [FT3] levels < 50% above or below the normal limits) at the most recent clinic visit. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the clinical trial. - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN) or serum creatinine <1.5 times the upper limit of normal (ULN; according to age) at the most recent clinic visit. - Diabetic participants must have well-controlled disease (defined as hemoglobin A1C [HbA1c] < 9.0% at most recent clinic visit). - Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the study. - Women of childbearing potential must have a negative urine pregnancy test at Baseline/Day 1. Participants who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial and continue for 180 days after the last dose of study drug. One of the 2 forms of contraception is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be in use for at least one full cycle prior to Baseline. Highly effective contraceptive methods (with a failure rate less than 1% per year), when used consistently and correctly, includes implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner. - Male participants must be surgically sterile or, if sexually active with a female partner of childbearing potential, must agree to use a barrier contraceptive method from Baseline through 180 days after the last dose of study drug. - Participant is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study. - Has not received any treatment for TED since Week 24 of the of the HZNP-TEP-301 study. Exclusion Criteria: - Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the study protocol or have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the participant at unacceptable risk. - The exclusion criteria (except those related to screening) of protocol HZNP-TEP-301(NCT03298867) also apply to this open-label extension study. ; PRIMARY OUTCOME: Percentage of Participants With a ≥ 2 mm Reduction From Baseline in the Study Eye Without Deterioration of Proptosis in the Fellow Eye at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With a European Group on Graves Ophthalmopathy (EUGOGO) Amended Clinical Activity Score (CAS) Total Score of 0 or 1 in the Study Eye at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EPOCH 2 (Herniorrhaphy); BRIEF: This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing unilateral open inguinal herniorrhaphy. ; DRUG USED: Zynrelef; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Heron Therapeutics; CRITERIA: Inclusion Criteria: - Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia. - Has an American Society of Anesthesiologists Physical Status of I, II, or III. - Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. Exclusion Criteria: - Had any prior inguinal hernia repair. - Has a planned concurrent surgical procedure. - Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. - Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. - Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. - Has taken NSAIDs within 10 days prior to the scheduled surgery. - Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting). - Has been administered bupivacaine within 5 days prior to the scheduled surgery. - Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. - Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. - Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. - Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C. - Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments. - Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. - Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study. - Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. - Has undergone 3 or more surgeries within 12 months. - Has a body mass index (BMI) >39 kg/m2. ; PRIMARY OUTCOME: Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX 011 Compared With Saline Placebo.; SECONDARY OUTCOME 1: Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.[/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 - HAUSER-RCT; BRIEF: A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia. ; DRUG USED: Repatha; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Male or female ≥ 10 to ≤ 17 years of age (before 18th birthday) - Diagnosis of heterozygous familial hypercholesterolemia - On an approved statin with stable optimized dose for ≥ 4 weeks - Other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6 weeks) - Fasting LDL-C ≥ 130 mg/dL (3.4 mmol/L) - Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) Exclusion Criteria: - Type 1 diabetes, or type 2 diabetes that is or poorly controlled - Uncontrolled hyperthyroidism or hypothyroidism - Cholesterylester transfer protein (CETP) inhibitor in the last 12 months, or mipomersen or lomitapide in the last 5 months - Previously received evolocumab or any other investigational therapy to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9). - Lipid apheresis within the last 12 weeks prior to screening. - Homozygous familial hypercholesterolemia ; PRIMARY OUTCOME: Percent Change From Baseline to Week 24 in LDL-C; SECONDARY OUTCOME 1: Mean Percent Change From Baseline to Mean of Weeks 22 and 24 in LDL-C[/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 - IFM2013-04 (Nantes); BRIEF: This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma. Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD. ; DRUG USED: Thalomid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: Nantes University Hospital; CRITERIA: Inclusion Criteria: Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient 1. - 18 ≤ age < 66 years 2. - Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2 3. - Patients must be eligible for Autologous Stem Cell Transplantation 4. - Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day 5. - Female patients of child-bearing potential (FCBP): - Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence. - Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. 6. - Male Patients: - Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy - Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy 7. - All patients must: - Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy - Agree not to share study medication with another person. 8. - Patients must be capable of giving informed consent 9. - Patients must be affiliated with French social security system Exclusion Criteria: 1. - Asymptomatic Multiple myeloma 2. - Non-secretory Multiple myeloma 3. - Proven AL-amyloidosis 4. - Age ≥ 66 years old 5. - Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg) 6. - Radiation therapy in the 2 weeks preceding randomization 7. - National Cancer Institute grade ≥ 2 peripheral neuropathy 8. - Haemoglobin < 8g/dL 9. - Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL 10. - Creatinine level > 170 µmol/L or requiring dialysis. 11. - Bilirubin, transaminases or GamaGT > 3 UNL (upper normal limit) 12. - Positive HIV serology, evidence of active Hepatitis B and C infection 13. - Severe active infection 14. - Inability to comply with an anti-thrombotic treatment regimen 15. - A personal medical history of severe psychiatric disease 16. - Uncontrolled diabetes contraindicating the use of high-dose dexamethasone 17. - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) 18. - A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation > or = 5 years (except for basocellular skin cancer or in situ cervical cancer) 19. - Use of any investigational drug in the 30 days preceding randomization 22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines ; PRIMARY OUTCOME: Response assessment according to the criteria IMWG; SECONDARY OUTCOME 1: Response assessment according to the criteria IMWG[/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 304 (Extension); BRIEF: Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge resulting in symptomatic cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of NOH. The present study will evaluate the long-term safety of droxidopa. ; DRUG USED: Northera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Orthostatic Hypotension; TARGET: Alpha Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Chelsea Therapeutics; CRITERIA: Inclusion Criteria: To be eligible for inclusion, each patient must fulfill the following criteria: - Demonstrated a symptomatic response (an improvement of at least 1 point in Item #1 of the OHSA) to treatment with droxidopa during open-label titration in Droxidopa Protocol 301 ; - Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care. Exclusion Criteria: Patients are not eligible for this study if they fulfill one or more of the following criteria: - Currently taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine; patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their study entry visit (Visit 1). - Currently taking anti-hypertensive medication; the use of short-acting anti-hypertensive medications at bedtime is permitted. - Currently taking tri-cyclic antidepressant medication or other norepinephrine re-uptake inhibitors; - Have changed dose, frequency and or type of prescribed medication, within two weeks of starting droxidopa treatment within Protocol 304, with the following exceptions: - vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine (see exclusion a), - short courses of antibiotics or other medications/treatments that do not interfere with, or exacerbate the patients condition under study. - History of known or suspected drug or substance abuse; - Women of childbearing potential who are not using a medically accepted contraception; - Reproductive potential: Female subjects should be either post-menopausal (amenorrhoea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) who are using or agree to use acceptable methods of contraception. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. - For WOCP a serum beta HCG pregnancy test must be conducted at screening, and a urine pregnancy test must be conducted at baseline and study termination; the results must be negative at screening and at baseline for the patient to receive study medication. WOCP must be advised to use acceptable contraceptives throughout the study period and for 30 days after the last dose of investigational product. If hormonal contraceptives are used they should be taken according to the package insert. WOCP who are not currently sexually active must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of the study and for 30 days after the last dose of investigational product. - Sexually active males whose partner is a WOCP and who do not agree to use condoms for the duration of the study and for 30 days after the last dose; - Women who are pregnant or breast feeding; - Known or suspected hypersensitivity to the study medication or any of its ingredients; - Pre-existing, sustained, severe hypertension (BP greater than or equal to 180/110 mmHg in the sitting position); - Have atrial fibrillation or, in the investigators opinion, have any other significant cardiac arrhythmia; - Any other significant systemic, hepatic, cardiac or renal illness; - Diabetes mellitus or insipidus; - Have a history of closed angle glaucoma; - Have a known or suspected malignancy; - Patients with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigators opinion, affect the absorption of study drug; - In the investigators opinion, have clinically significant abnormalities on clinical examination or laboratory testing; - In the investigators opinion, are unable to adequately co-operate because of individual or family situation; - In the investigators opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia; - Are not able or willing to comply with the study requirements for the duration of the study; - Have participated in another clinical trial with an investigational agent other than droxidopa (including named patient or compassionate use protocol) within 4 weeks before starting droxidopa treatment within Protocol 304; - Previous enrolment in the study. ; PRIMARY OUTCOME: Patients With Treatment-emergent Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DORA; BRIEF: The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself. ; DRUG USED: Xofigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: DNA, Radiopharmaceutical, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Memorial Sloan Kettering Cancer Center; CRITERIA: Inclusion Criteria: - Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. - Males 18 years of age and above - Histological or cytological proof of prostate cancer - Documented progressive mCRPC based on at least one of the following criteria: 1. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. 2. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 3. Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan. - Two or more bone lesions - ECOG 0- 1 - Normal organ function with acceptable initial laboratory values within 14 days of randomization: - Albumin > 30 g/L - ANC ≥ 1.5 x 10^9/L - Hemoglobin ≥ 10 g/dL - Platelet count ≥ 100 x 10^9/L - Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) - Bilirubin ≤ ULN (unless documented Gilberts disease) - SGOT (AST) ≤ 1.5 x ULN - SGPT (ALT) ≤ 1.5 x ULN - WBC count ≥ 3 x 10^9/L - Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent. - Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy. - All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less. - Willing and able to comply with the protocol, including follow-up visits and examinations Exclusion Criteria: - Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization. - Received external beam radiotherapy within the 4 weeks prior to randomization. - Has an immediate need for external beam radiotherapy. - Has received any systemic bone-seeking radiopharmaceutical in the past. - Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel. - Has received four or more systemic anticancer regimens for mCRPC. - Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC - A line is a regimen. Combinations of hormones and other types of therapies count as single lines. - Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation. - Has received blood transfusions or growth factors within the last 4 weeks prior to randomization. - Symptomatic nodal disease (i.e., scrotal, penile, or leg edema). - Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization. - Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms. - Subjects with a currently active second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a currently active malignancy if they have completed therapy and are free of disease for ≥ 3 years. - Has imminent or established cord compression based on clinical findings and/or MRI. - Known bone marrow dysplasia - Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans - Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to: - Uncontrolled infection - NYHA III or IV heart failure - Crohns disease or those with ulcerative colitis who have not undergone a colectomy - Known active infection with HIV, Hepatitis B or Hepatitis C ; 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 - SNT-III-011; BRIEF: The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON. ; DRUG USED: Catena; DRUG CLASS: New Molecular Entity (NME); INDICATION: Lebers Hereditary Optic Neuropathy (LHON) (Ophthalmology); TARGET: Mitochondrial Electron Transport Chain, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Santhera Pharmaceuticals; CRITERIA: Inclusion Criteria: - Age > or equal 10 years and < 65 years - Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR - No explanation for visual loss besides LHON Exclusion Criteria: - Any previous use of idebenone - Participation in another clinical trial of any investigational drug within 3 months prior to Baseline - Previous participation in Study SNT-II-003 (RHODOS) for idebenone. ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric; BRIEF: The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control group) receiving sequentially Priorix (Month 0) and Infanrix (Month 6) vaccines. ; DRUG USED: Cervarix; DRUG CLASS: Vaccine; INDICATION: Human papillomavirus (HPV) Prevention (Antiviral, Vaccines); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. - A female between, and including, 4 and 6 years of age at the time of the first vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Subjects who received four doses of DTP vaccine (i.e., three doses in the first year of life and a fourth dose in the second year of life) according to the schedule applicable in the participating countries. - Subjects who received a first dose of MMR vaccine according to the schedule applicable in the participating countries. Exclusion Criteria: - Child in care. - Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol. - Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine(s). Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza and/or poliomyelitis vaccines up to 8 days before the first dose of study vaccine(s) is allowed. Enrolment will be deferred until the subject is outside of specified window. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period. - History of any reactions or hypersensitivity likely to be exacerbated by any component of the study vaccines, including latex and/or obvious allergic reactions to neomycin (a history of contact dermatitis to neomycin is not a contraindication), egg protein, etc. (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock subsequent to egg ingestion). - Cancer or autoimmune disease under treatment. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). - Previous administration of MPL or AS04 adjuvant. - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine(s) or planned administration during the study period. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Family history of congenital or hereditary immunodeficiency. - Documented human immunodeficiency virus (HIV)-positive subject. - Major congenital defects or serious chronic illness. - History of seizures or serious neurological disorder, which, according to the judgment of the investigator, precludes administration of any of the study vaccines. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine(s). - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. Enrolment can be deferred until condition is resolved. - Previous administration of the fifth dose of DTP vaccine and/or the second dose of MMR vaccine or planned administration of DTP vaccine and/or MMR vaccine outside the study (during the study period from Day 0 to Month 12). - History of tetanus, diphtheria, pertussis, measles, mumps and/or rubella. - Known exposure to diphtheria or household exposure to pertussis within 30 days prior to vaccination with DTPa. - Known exposure to measles, mumps and/or rubella 30 days prior to vaccination with the MMR study vaccine. - Confirmed or suspected tuberculosis. - Severe allergic reactions (e.g. anaphylaxis or severe Arthus-type hypersensitivity reactions) following the administration of previous dose(s) of DTP or MMR vaccines. - Hyperpyrexia (≥ 40.5°C) within 48 hours of administration of previous doses of DTP or MMR vaccines. - Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours of administration of previous doses of DTP vaccine. - Collapse or shocking-like state (hypotonic-hyporesponsive episode) within 48 hours of administration of previous doses of DTP vaccine. - Idiopathic thrombocytopenic purpura or bleeding disorders. - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose(s). (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.) ; PRIMARY OUTCOME: Number of Subjects With Any and Grade 3 Solicited Local Symptoms; SECONDARY OUTCOME 1: Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix 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 III - RA-BEYOND; BRIEF: The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib. ; DRUG USED: Olumiant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705) Exclusion Criteria: - Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered - Have a known hypersensitivity to baricitinib or any component of this investigational product - Had investigational product permanently discontinued at any time during a previous baricitinib study - Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study - Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol ; PRIMARY OUTCOME: Number of Participants Who Experienced Adverse Events (AEs) or Serious AE; SECONDARY OUTCOME 1: Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20[/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 - PANTHER; BRIEF: The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML). ; DRUG USED: Pevonedistat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: NEDD8-activating enzyme (NAE) ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or CMML (i.e., with white blood cell [WBC] <13,000/microliter [mcL]) or low-blast acute myelogenous leukemia (AML). 2. Has MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R): - Very high (>6 points). - High (>4.5-6 points). - Intermediate (>3-4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >=5% bone marrow myeloblasts. 3. Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2. 4. Participants with AML (20%-30% blasts) must have a treatment-related mortality (TRM) score >=4 for intensive, induction chemotherapy as calculated using the simplified model described by Walter and coworkers. Calculation of TRM score: - 0 for (age <61 years), +2 for (age 61-70 years), +4 for (age >=71 years). - + 0 for (PS=0), +2 for (PS=1), +4 for (PS >1). - + 0 for (platelets <50), +1 for (platelets >=50). Exclusion Criteria: 1. Has previous treatment for HR MDS or CMML or low-blast AML with chemotherapy or other antineoplastic agents including hypomethylating agent (HMAs) such as decitabine or azacitidine. Previous treatment is permitted with hydroxyurea and with lenalidomide, except that lenalidomide may not be given within 8 weeks before the first dose of study drug. 2. Has acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis. 3. Participants with AML with a WBC count >50,000/mcL. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria. 4. Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation. The reason a participant is not eligible for intensive chemotherapy and/or allogeneic stem cell transplantation may consist of one or more of the following factors: - Age >75. - Comorbidities. - Inability to tolerate intensive chemotherapy (e.g., participants with AML with 20%-30% blasts and TRM >=4). - Physician decision (e.g., lack of available stem cell donor). - The reason a participant is not eligible should be documented in the electronic case report form (eCRF). 5. Has either clinical evidence of or history of central nervous system involvement by AML. 6. Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia. 7. Is diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. 8. Has nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection. 9. Has prothrombin time (PT) or aPTT >1.5× upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment. 10. Has known human immunodeficiency virus (HIV) seropositive. 11. Has known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. 12. Has known hepatic cirrhosis or severe preexisting hepatic impairment. 13. Has known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), and/or myocardial infarction within 6 months before first dose, or severe pulmonary hypertension. 14. Has treatment with strong cytochrome P 3A (CYP3A) inducers within 14 days before the first dose of pevonedistat. ; PRIMARY OUTCOME: Event-Free Survival (EFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MIVI-TRUST 007 (EU/US); BRIEF: This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks. ; DRUG USED: Jetrea; DRUG CLASS: Biologic; INDICATION: Vitreomacular Adhesion (Ophthalmology); TARGET: Fibrin (Coagulation Factor Ia) ; THERAPY: Monotherapy; LEAD SPONSOR: ThromboGenics; CRITERIA: Inclusion Criteria: - Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint) Exclusion Criteria: - Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR)) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye - Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye - Subjects with macular hole diameter > 400 µm in the study eye - Aphakia in the study eye - High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion). ; PRIMARY OUTCOME: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28; SECONDARY OUTCOME 1: Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - innovaTV 301 ; BRIEF: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take. ; DRUG USED: Tivdak; DRUG CLASS: Biologic; INDICATION: Cervical Cancer; TARGET: Antibody-drug Conjugate (ADC), Tissue Factor; THERAPY: Monotherapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria - Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and: - Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: - paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or - paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or - paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent - Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required. - Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted. - Measurable disease according to RECIST v1.1 as assessed by the investigator. - Has ECOG performance status of 0 or 1 prior to randomization. - Has life expectancy of at least 3 months. Exclusion Criteria - Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above. - Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry. - Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack >1 month prior to screening is allowed). - Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion. - Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration. - Peripheral neuropathy ≥grade 2. - Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met. ; PRIMARY OUTCOME: Overall survival (OS); SECONDARY OUTCOME 1: Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MK-0431D-266; BRIEF: The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone. ; DRUG USED: Juvisync; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4), HMG CoA Reductase (HMGR); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - has T2DM - (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 14 days after the last dose of study drug - is currently on metformin monotherapy at a daily dose of at least 1500 mg for at least 10 weeks - is not on a lipid-lowering agent for at least 6 weeks prior to entering the study Exclusion Criteria: - has history of type 1 diabetes mellitus (T1DM), or a history of ketoacidosis or possibly has T1DM - has been on a thiazolidinedione (TZD) within the previous 16 weeks - has been treated with a statin or other lipid-lowering agent (including over-the-counter [OTC] supplements) within the previous 6 weeks - currently participating in or has participated in another clinical study within the past 12 weeks - intends to consume >1.2 liters of grapefruit juice daily during the study - is on or likely to require treatment for at least 2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted) - intolerance or hypersensitivity to sitagliptin, simvastatin, metformin or glimepiride - is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery in the previous 12 months - has undergone a surgical procedure in the past 4 weeks or planned major surgery during the study - has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy - has a history of myopathy or rhabdomyolysis with any statin - has cardiovascular disease, a diagnosis of congestive heart failure, or uncontrolled high blood pressure - has a history of active liver disease - has chronic progressive neuromuscular disorder, human immunodeficiency virus (HIV), hematological disorder, or uncontrolled endocrine or metabolic disease - is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks - has a history of malignancy in the previous 5 years (excluding adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer) - is pregnant or breast feeding, or is expecting to conceive or donate eggs during the course of the study, including 14 days after the last dose of study drug - is a user of recreational or illicit drugs or has had a recent history of drug abuse - consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin); SECONDARY OUTCOME 1: Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)[/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 - BRIGHTE; BRIEF: The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance. ; DRUG USED: Rukobia; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Cluster of Differentiation 4 (CD4), gp120; THERAPY: Monotherapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Men and non-pregnant women with chronic HIV-1 infection - Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes - Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs) - Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety - Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort - Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort Exclusion Criteria: - Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible) - HIV-2 infection - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN - Alkaline Phosphatase > 5 x ULN - Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia) ; PRIMARY OUTCOME: Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - MAGELLAN; BRIEF: The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder. ; DRUG USED: Hetlioz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Melatonin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria; - Current episode ≥4 weeks and ≤1 year; - CGI-Severity score ≥4 at screening and baseline. Exclusion Criteria: - Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder; - Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder; - A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months; - Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable; - Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D); 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 - DIC3-08-06; BRIEF: The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip. ; DRUG USED: Zorvolex; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Iroko Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - Male or female ≥ [greater than or equal to] 40 years of age - If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety - Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain - Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening Exclusion Criteria: - Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac - Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip - Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease - Has significant difficulties swallowing capsules or is unable to tolerate oral medication ; PRIMARY OUTCOME: Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination; 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 - J02 (PD-CKD, Japan); BRIEF: To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease ; DRUG USED: Vadadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of CKD - Receiving peritoneal dialysis for more than 4 weeks prior to the screening period. However, receiving hemodialysis is excluded - Not expected to start hemodialysis during the study - Correction group: Not being treated with ESAs for the recent 8 weeks prior to the screening period - Conversion group: Being treated with ESAs for the recent 8 weeks prior to the screening period - Mean of the two screening Hb levels closest in time to the baseline visit. Correction group: ≥8.0 g/dL and < 11.0 g/dL Conversion group: ≥9.0 g/dL and ≤12.5 g/dL - Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL - Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period - Folate and vitamin B12 ≥ lower limit of normal during the screening period Exclusion Criteria: - Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia - Active bleeding or recent blood loss within 8 weeks prior to the screening period - RBC transfusion within 8 weeks prior to the screening period - Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period - Peritonitis within 4 weeks prior to the screening period - AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period - Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) during the screening period and Day 1 - Ophthalmic examinations during the screening period correspond to either of the following criteria; - No available fundal findings - Findings indicating the presence of active fundal disease - Severe heart failure (New York Heart Association Class IV) - Cerebrovascular disorder or acute coronary syndrome (e.g. hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous intervention for coronary or heart failure within 12 weeks prior to the screening period - Current or history of malignancy. History of malignancy with no recurrence for the recent 5 years is not an exclusion criterion - New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the screening period - Current or history of hemosiderosis or hemochromatosis - History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow - Males and females of childbearing potential who are unwilling to use an acceptable method of contraception during the designated period (Males: during the study and 90 days after the last dose, Females: during study and 30 days after the last dose) - Females who are pregnant or breast feeding, or are predicted to be pregnant ; PRIMARY OUTCOME: Mean Hb Level of Week 20 and Week 24; 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 - PANDA; BRIEF: This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day. ; DRUG USED: Pantoprazole/Domperidone; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Proton pump; THERAPY: Combination; LEAD SPONSOR: Eurofarma Laboratorios S.A.; CRITERIA: Inclusion Criteria: 1. Subscription of IC; 2. Age ≥ 18 years and <70 years 3. Diagnosis initial clinical or previous symptomatic GERD; 4. Symptom score ≥ 4; 5. Ability to conduct examinations of endoscopy; 6. Ability to perform washout of drug classes PPIs, H2 antagonists, and prokinetics for at least 14 days. Exclusion Criteria: 1. Presence of esophagitis requiring intervention, esophageal varices, Barretts esophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomy pangastritis detected at the time of study enrollment; 2. Eradication treatment of H. pylori completed less than 15 days of V0; 3. Presence of alarm symptoms (weight loss greater than 5% in the last 60 days, no evidence of gastrointestinal bleeding); 4. Gastric or esophageal surgery prior (except for simple ulcer closure); 5. Females in pregnancy, lactation, or who wish to become pregnant if they refuse to use adequate contraception during the study period. 6. Concomitant serious diseases such as kidney failure, heart and liver; 7. Suspected or confirmed any cancer except carcinoma in situ or nonmelanoma skin cancer diagnosed in the last 5 years; 8. History of gastric cancer in relatives of 1st degree; 9. Use of illicit drugs or alcohol abuse according to the investigator; 10. Values changed (outside the normal range for the local laboratory) in leukocytes, platelets or hemoglobin; 11. Significant changes in serum sodium, potassium, calcium or creatinine; 12. Intolerance or allergy to any component of the drugs evaluated in the study; 13. Use of anti-inflammatory drugs (NSAIDs), antiemetics, macrolides and systemic steroids for a period of not less than 2 weeks prior to the study or who have expected necessity of prolonged use during the study treatment; 14. Current use of bisphosphonates, as well as those who need calcium channel blockers or other drugs that affect esophageal motility or lower esophageal sphincter tone. 15. Use of other scheduled medications metabolized by cytochrome CYP3A4 during the study; 16. Participation recent (past 12 months) or participation in a clinical trial expected during this study in other clinical trials involving drugs of any kind. ; PRIMARY OUTCOME: Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms; SECONDARY OUTCOME 1: Quality of life during the study treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CONTACT-03; BRIEF: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation. - Radiographic disease progression to prior ICI therapy for RCC. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed. - Measurable disease per RECIST v1.1 - Evaluable IMDC risk score - Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred. - KPS score of >=70 - Recovery to baseline or Grade </= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation - Adequate hematologic and end-organ function - Negative HIV test at screening - Negative hepatitis B testing at screening - Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: - Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment - Patients received cabozantinib at any time prior to screening - Patients who received more than one ICI treatment in the locally advanced or metastatic setting - Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting - Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting - Symptomatic, untreated, or actively progressing CNS metastases - History of leptomeningeal disease - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab - History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death - Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1 - Active tuberculosis - Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study - Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib - Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety - Pharmacologically uncompensated, symptomatic hypothyroidism - Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment (all countries except France); sustained BP > 140 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment (France only) - Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment - Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1 - History of congenital QT syndrome - History or presence of an abnormal ECG that is clinically significant in the investigators opinion - Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel) ; PRIMARY OUTCOME: Progression-Free Survival (PFS), as assessed by Independent Review Facility (IRF); SECONDARY OUTCOME 1: PFS Assessed by the Investigators (INV-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 - LOSVID; BRIEF: The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesizes that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate COVID-19 disease. ; DRUG USED: Losmapimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: Fulcrum Therapeutics; CRITERIA: Inclusion Criteria: - Able and willing to provide written informed consent - Willing and able to comply with all study procedures - Age ≥50 years at time of screening - Confirmed infection with SARS-CoV-2 virus at or before the baseline visit by polymerase chain reaction (PCR) testing - ≤7 days to the time of randomization from the time of collection of the specimen that tested positive for the SARS-CoV-2 virus - Hospitalization at the time of the baseline visit - ≥90% oxygen saturation on room air and/or ≥94% oxygen saturation on oxygen administration at 2 L/min by nasal cannula at the baseline visit - Radiographic (X-ray or computed tomography scan, per local standard of care) and/or clinical evidence of pulmonary involvement consistent with COVID-19 at screening or baseline, per the judgment of the investigator - Clinical syndrome consistent with COVID-19 at screening, per the judgment of the investigator (CDC 2020) - CRP at screening >15 mg/L (i.e., >1.5 mg/dL) on local laboratory testing - Agrees to practice an approved method of birth control Exclusion Criteria: - Inability to take oral medication at screening or baseline visit - Evidence at screening or baseline of critical COVID-19 disease (e.g., cardiac failure, septic shock) or severe pulmonary involvement) - Positive pregnancy test at screening for women of childbearing potential - Lactating female at baseline for women of childbearing potential Note: A female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose - ≥5 × upper limit of normal (ULN) for alanine or aspartate aminotransferases or total bilirubin >1.5 × ULN at screening or known history of Child-Pugh Class C, hepatitis B or C, or HIV infection - Glomerular filtration rate <30 mL/min/1.73 m2 at screening - QTcF >450 msec for male or >470 msec for females or evidence of cardiac dysrhythmia at screening - Significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion - Has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (IL)-6 inhibitors, tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents, and Janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period - Treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or SOC any time during the study period - Recent (within 30 days) or current participation in other COVID-19 therapeutic trials or expanded access programs - Prior or current participation in COVID-19 vaccine trials ; PRIMARY OUTCOME: Day 28 Mortality; SECONDARY OUTCOME 1: Clinical Status Assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SPARTA; BRIEF: This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160. ; DRUG USED: PROLASTIN-C; DRUG CLASS: Biologic; INDICATION: Alpha-1 Antitrypsin Deficiency (A1AD or AATD); TARGET: Alpha-1-antitrypsin (A1AT), Protease; THERAPY: Monotherapy; LEAD SPONSOR: Grifols Therapeutics LLC; CRITERIA: Inclusion Criteria: - Have a documented total alpha1-PI serum level < 11 µM. - Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or at-risk alleles. - At the Screening (Week -3) Visit, have a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and < 80% of predicted and FEV1/forced vital capacity (FVC) < 70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II or III). - Have a carbon monoxide diffusing capacity (DLCO) ≤ 60% of predicted (corrected for HgB) within the past 2 years OR evidence of pulmonary emphysema on CT scan within the past 2 years per the Investigators judgment. - Have clinical evidence of pulmonary emphysema per the Investigators judgment. Exclusion Criteria: - Has received alpha1-PI augmentation therapy for more than 1 month within the six months prior to the Screening Visit. - Has received alpha1-PI augmentation therapy within one month of the Screening Visit. - Has had a chronic obstructive pulmonary disease (COPD) exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase. - Unable to physically (e.g., unable to fit inside the CT scanner) or mentally (e.g., claustrophobic) undergo a CT scan. - History of lung or liver transplant. - Any lung surgery during the past 2 years (excluding lung biopsy). - On the waiting list for lung surgery, including lung transplant. - Smoking during the past 12 months or a positive urine cotinine test at screening that is due to smoking. Maybe on Nicotine replacement, including vapor cigarettes. - History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s). - Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 5 weeks prior to the Screening Visit (inhaled steroids are not considered systemic steroids) or during the Screening Phase. - Use of systemic or aerosolized antibiotics for a COPD exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase. - Known selective or severe Immunoglobulin A (IgA) deficiency. ; PRIMARY OUTCOME: Change from Baseline in Whole lung PD15 (15th percentile point); SECONDARY OUTCOME 1: Adverse Events (AEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric (Ages 10-18); BRIEF: The purpose of this research study is to evaluate the efficacy and safety of the drugs dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18 years old and are currently taking metformin, insulin, or both drugs. Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged 18 years or older. Dapagliflozin (alone or in combination with other antidiabetic drugs) is available for use in adults in approximately 115 countries worldwide including the USA and Europe. Saxagliptin (alone or in combination with other antidiabetic drugs) is available for use in adults in approximately 100 countries worldwide. This study will assess how well dapagliflozin and saxagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Dapagliflozin and saxagliptin are considered investigational products in this study since while they have been approved for use in adults (patients 18 years or older), they havent been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease.The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Dapagliflozin is a drug that helps to reduce blood glucose levels by helping the kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the kidneys from returning glucose from the urine back into the bloodstream. Saxagliptin increases insulin production when blood glucose levels are high. Saxagliptin helps to improve blood sugar levels in response to a meal and between meals if blood glucose levels are not lowered effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps to decrease the amount of sugar made by the body. Together, these processes reduce blood glucose levels and help to control Type 2 Diabetes. The subject will either receive one of the active study drugs or a placebo (a pill that looks identical but contains inactive drug). This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a random assignment. For this study, there will first be a screening phase of up to 6 months if Investigator thinks that some of the screening tests can be repeated, followed by a 2 week lead in phase.Thereafter there will be a 26W short-term treatment phase (W1-26), and a 26 W long-term treatment phase (W27-52). Following this there will be a follow-up telephone call on week 56 and a post study visit at W104. At day1 visit after the lead in phase the subject will be randomly assigned to receive one of 3 treatments: dapagliflozin 5mg, saxagliptin 2.5mg or placebo in a blinded manner.This treatment will continue up to week 14. After week 14, the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5mg,dapagliflozin 10mg,saxagliptin 2.5 mg, saxagliptin 5 mg compared with placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups will receive them at a higher dose.Starting at W32 or W40, i.e., after the end of the primary endpoints, patients with background medication of metformin only, and an HbA1c value < 7.5% at W26 or W32, will undergo a third randomization. Eligible subjects from the treatment arms will undergo the randomized withdrawal of background medication, while eligible patients from the placebo arm will undergo, in addition to rand withdrawal of background medication a randomized switch to active treatment. Short/ long-term period study visits can be delayed by a maximum of 11 months in total. If the duration of IP administration is longer than 52(+1)weeks, the safety follow-up period should be shortened such that the complete study duration does not exceed 104 weeks(+7 days). A window period of -28 days to +7 days from the original scheduled date will be allowed for the Week-104 visit.If more than 12 weeks elapse between the HbA1c collection at W26 and the third rand at W32, or the HbA1c collection at W32 and the third rand at W40, the subject should not go through this rand as the HbA1c value would no longer be reliable to ascertain eligibility for the third rand ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Signed Written Informed Consent - Target Population - Previously diagnosed with Type 2 Diabetes Mellitus by World Health Organization/ADA criteria - HbA1c between 6.5% and 10.5% obtained at screening. - Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum of 8 weeks prior to randomization. For those children on insulin, investigators will confirm that attempts at removing insulin from the subjects therapeutic regimen had been previously made but had not been successful. - Age and Reproductive Status - Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third, but no more than two thirds, female subjects. - Women of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug. - Women must not be breastfeeding. - Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: saxagliptin, and dapagliflozin, plus 5 half-lives of study drugs or 30 days (whichever is longer), plus 30 days (duration of ovulatory cycle) for a total of 60 days post treatment completion. Exclusion Criteria: - Target Disease Exceptions - Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1 diabetes, - Previous diagnosis of monogenic etiology of Type 2 diabetes - Diabetes ketoacidosis (DKA) within 6 months of screening - Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study: - Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified. - Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors) - Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable during the study. - Medical History and Concurrent Diseases - Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding - History of unstable or rapidly progressive renal disease - History of unresolved vesico-ureteral reflux - History of or current, acute or chronic pancreatitis - History of hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis - Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma) - Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit - Physical and Laboratory Test Findings - Abnormal renal function, - An abnormal thyroid-stimulating hormone (TSH) value at enrollment will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded. - Hematuria (confirmed by microscopy at screening) with no explanation as judged by the Investigator up to randomization. - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limit of normal (ULN), or clinically significant hepatic disease. - Serum total bilirubin (TB) > 2x ULN unless exclusively caused by Gilberts syndrome - Positive serologic evidence of current infectious liver disease including anti hepatitis A virus (HAV) (IgM), hepatitis B surface antigen (HBsAg), or anti hepatitis C virus (HCV). Patients who have isolated positive anti-hepatitis B surface antibodies may be included. - Anemia of any etiology - Volume-depleted subjects. - Allergies and Adverse Drug Reaction - Known allergy, sensitivity or contraindication to any study drug or its excipient/vehicle - Other Exclusion Criteria - Subject is currently abusing alcohol or other drugs or has done so within the last 6 months prior to the screening visit. - Prisoners or subjects who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a subject. Strict conditions apply and Sponsor/designee approval is required.) - Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. - Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the subjects ability to comply with the study medications and monitoring. - Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure or local package inserts. - Participation and receiving IP in another clinical study during the prior 3 months ; PRIMARY OUTCOME: Change from baseline in HbA1c at Week 26; SECONDARY OUTCOME 1: Change from baseline in Fasting Plasma Glucose 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 III - Renaissance 5 (Fixed Dose); BRIEF: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant. ; DRUG USED: TC-5214; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Nicotinic Acetylcholine Receptor - a3ß4 subtype , Nicotinic Acetylcholine Receptor - a4ß2 subtype &lt;br&gt;(a4ß2 nAChR); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed and dated informed consent before initiation of any study-related procedures. - The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant. - Outpatient status at enrollment and randomization. Exclusion Criteria: - Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder. - Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide. - History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product. ; PRIMARY OUTCOME: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.; SECONDARY OUTCOME 1: Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SIRROUND-M (Japan); BRIEF: The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ). ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Pharmaceutical K.K.; CRITERIA: Inclusion Criteria: - Be a Japanese man or woman with a diagnosis of rheumatoid arthritis (RA), according to the revised 1987 criteria of the American Rheumatism Association, for at least 3 months before screening - Has moderately to severely active RA with at least 6 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline - Has been unresponsive to adequate treatment with methotrexate (MTX), sulfasalazine (SSZ), or combination of MTX or SSZ with other disease-modifying antirheumatic drugs (DMARDs) at screening due to lack of benefit after at least 12 weeks of marketed dose of MTX or SSZ, as assessed by the treating physician. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or overall disease activity - If using oral corticosteroids, must be on a stable dose equivalent to <=10 mg/day of prednisolone for at least 2 weeks prior to first dosing with study agent. If currently not using corticosteroids, the patient must not have received oral corticosteroids (by mouth) for at least 2 weeks prior to first dosing with study agent - If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain relievers) for RA, must be on a stable dose for at least 2 weeks prior to first dosing with study agent Exclusion Criteria: - Has a history of intolerance to at least 2 or inadequate response to at least one anti-tumor necrosis factor-alpha (anti-TNF-alpha) agent after 3 months of therapy; has received anti-TNF-alpha (eg, infliximab, golimumab, adalimumab, or etanercept) within 3 months of first study agent dosing - Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy; has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent dosing or has evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy; has used any other biologic therapy for the treatment of RA within 3 months of first study agent dosing; has a history of sirukumab use - Has received intra-articular (IA), intramuscular (IM), or intravenous (IV) corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent dosing - Has received leflunomide within 24 months before first study agent dosing and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable. Drug elimination procedure must be completed prior to obtaining informed consent - Has a history of cyclophosphamide or cytotoxic agent use; has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of first study agent dosing; has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before first study agent dosing ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 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 - Europe; BRIEF: This trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating the efficacy, safety and convenience of the MC2-01 cream. ; DRUG USED: Wynzora Cream; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Glucocorticoid Receptor (GR), Vitamin D receptor; THERAPY: Monotherapy; LEAD SPONSOR: MC2 Therapeutics; CRITERIA: Inclusion Criteria: - Have provided written informed consent - Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening - Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 15 g of trial medication per day - Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs) - Have an mPASI score of at least 3 - Have a treatment area involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%. Exclusion Criteria: - Current diagnosis of unstable forms of psoriasis - Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris - Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas - Planned excessive or prolonged exposure to either natural or artificial sunlight - History of hypersensitivity to any component of the test product or reference product - Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders - Systemic treatment with biological therapies - Use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to Visit 1/Baseline and during the trial - Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial - Use of topical treatments except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline - Presence of infections in the treatment area (bacteria, viruses, parasites or fungi) or skin manifestations of atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment area - Known Human Immunodeficiency Virus (HIV) infection - Have any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial - Initiation of, or expected changes to, concomitant medication that may affect psoriasis ; PRIMARY OUTCOME: Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score; SECONDARY OUTCOME 1: The Psoriasis Treatment Convenience Scale (PTCS)[/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 - Pediatric; BRIEF: The primary purpose of your childs participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it. ; DRUG USED: Edivoxetine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD based on Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL) prior to randomization. - Patients must have an Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score at least 1.5 standard deviations above the age/gender norm prior to randomization. They must have a Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) score greater than or equal to 4 at both the patients screening visit, prior to randomization. - Patients must have laboratory results; showing no clinically significant abnormalities. - Patients must be of normal intelligence, as assessed by the investigator. - Patients/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venous punctures and examinations required by the protocol. - Patients of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test. Exclusion Criteria: - Patients who weigh less than 18 kg or greater than 75 kg at screening and at randomization. - Female patients who are pregnant or who are breast-feeding. Patients who have a history of Bipolar I/ II, psychosis, or pervasive developmental disorder. - Patients who have current motor tics or a diagnosis of Tourettes Syndrome. - Patients with marked anxiety, tension, and agitation sufficient, to contraindicate treatment with extended-release methylphenidate. - Patients with a history of any seizure disorder, known electroencephalographic (EEG) abnormalities in the absence of seizures. - If the electrocardiogram (ECG) assessed at screening/prior to randomization shows an abnormality meeting one or more of the absolute exclusion criteria listed in the Pediatric ECG Alert Criteria must be excluded from the study. - Patients who, in the opinion of the investigator, are at serious suicidal risk. - Patients with a history of severe allergies to more than one class of medications, multiple adverse drug reactions, or known hypersensitivity to extended-release methylphenidate. - Patients with a history of alcohol or drug abuse within the past 3 months prior to, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse. - Patients who screen positive for drugs of abuse not prescribed by a physician cannot participate. Drug screen may be repeated at the discretion of the investigator, and the patient may be allowed to enter the study if the repeat screen is negative. All patients must have a negative drug screen before enrollment in the study. - Patients who have a medical condition that would increase sympathetic nervous system activity markedly, or who are taking a medication on a daily basis that has sympathomimetic activity are excluded. Such medications can be taken on an as-needed basis. - Patients with problems that would be exacerbated by increased norepinephrine tone, including a history of cardiovascular disease, thyroid dysfunction, glaucoma, urinary retention, or severe gastrointestinal narrowing. - Patients who, at any time during the study, are likely to need psychotropic medications apart from the drugs under study. - Patients who, at any time during the study, are likely to begin structured psychotherapy aimed at ADHD symptoms are excluded. Psychotherapy initiated at least 1 month prior to screening is acceptable. - Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior to randomization. - Patients with current or past history of clinically significant hypertension. - Patients who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug, or concurrently enrolled in any other type of medical research. - Patients who have participated in a prior study of LY2216684. ; PRIMARY OUTCOME: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8; SECONDARY OUTCOME 1: Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8[/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 - GALE (OLE); BRIEF: This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600). ; DRUG USED: Empaveli; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Age-Related Macular Degeneration (Dry AMD)/Geographic Atrophy (Ophthalmology); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Apellis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Ocular-specific inclusion criteria apply to the study eye only. - Subjects must have participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600). - For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study. - Subjects who did not fully stop study drug treatment, but missed the visit at Month 24, can also participate in the study. However, to participate, subjects must be seen within 60 days from the last day of the period allowed for the 24 months visit in the previous study. - The eyes of subjects must have transparency to permit visualization of parts inside the eye such as the retina and subjects must be able to look steadily at a provided target allowing the doctor to get good quality pictures from the eye. - Female subjects must be: - Women that cannot have children, or - Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication. - Males with female partners who can get pregnant must also agree to use ways to avoid pregnancy and agree not to donate sperm while in the study or until 90 days after administering the last dose of the study medication. - Agree to participate in the study by signing the consent document providing information about the study; and take part in all tests and assessments as required. Exclusion Criteria: Subjects cannot take part in the study if the eye that will be treated during the study currently meets any of the following conditions: - Participants in APL2 303/304 studies who fully stopped study drug treatment before the visit in month 24 but remain in the study to observe the study medications safety. Those subjects who temporarily paused study drug treatment are still eligible to participate. - If, according to your doctor you currently have any disease affecting your eyes that could interfere with your vision, including diseases that affect your retina or macula (the center of the back of your eyes). And, if according to your doctor, the disease in your eyes is benign and does not interfere with the study (e.g. diseases that affects the periphery of the retina), you are also eligible to take part in the study. - If, according to your doctor you currently have any inflammation/infection in or around your eyes that could prohibit you from receiving an injection inside your eyes. - If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three yearsover the next 36 months. - If you have known allergies to fluorescein sodium, a solution that is injected into your body for eye testing; or to pegcetacoplan (the study drug) or any inactive substances in pegcetacoplan solution. - If you currently are pregnant, breastfeed or have a positive pregnancy test. ; PRIMARY OUTCOME: Incidence and severity of ocular and systemic adverse events; SECONDARY OUTCOME 1: Change from baseline in the total area of GA lesion(s) in the study eye (in mm2)[/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 - ANNEXA-A (w/Eliquis); BRIEF: The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban. ; DRUG USED: Andexxa; DRUG CLASS: Biologic; INDICATION: Drug Toxicity; TARGET: Factor X Inhibitors; THERAPY: Combination; LEAD SPONSOR: Portola Pharmaceuticals; CRITERIA: Inclusion Criteria: - Reasonably healthy men and women aged 50 to 75 Exclusion Criteria: - History of abnormal bleeding, active bleeding or risk factors for bleeding - History of thrombosis or risk factors for thrombosis - History of adult asthma or use of inhaled medications ; PRIMARY OUTCOME: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II); SECONDARY OUTCOME 1: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Part II)[/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 - MODIFY I; BRIEF: This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in participants receiving SOC therapy for CDI as compared to placebo. ; DRUG USED: MK-3415; DRUG CLASS: Biologic; INDICATION: Clostridium difficile-Associated Diarrhea/Infection (CDAD/CDI); TARGET: Clostridium difficile toxins A and B; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - participant has a confirmed diagnosis of CDI as defined by: a. diarrhea, as defined by passage of 3 or more loose stools in 24 or fewer hours, AND b. A positive test for toxigenic C. difficile from a stool collected no more than 7 days before study infusion. - participant must be receiving SOC therapy for CDI. SOC therapy is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole. - participant is highly unlikely to become pregnant or to impregnate a partner since they meet at least one of the following criteria: a. A female participant who is not of reproductive potential is eligible without requiring the use of contraception. A female participant who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or (3) bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa). b. A participant who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control starting at enrollment and through the 12 Week study period. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy and any registered and marketed hormonal contraceptives that contain an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents) - participant or legal representative must have voluntarily agreed to participate by providing written informed consent after the nature of the study has been fully explained. Exclusion Criteria: - participant with an uncontrolled chronic diarrheal illness such that their normal 24-hour bowel movement habit is 3 or more loose stools. - participant with a planned surgery for CDI within 24 hours. - participant has a positive pregnancy test in the 48 hours before the infusion or is unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child. - participant is breast-feeding or plans to breast-feed prior to the completion of the 12-week study period. - A female participant who plans to donate ova prior to the completion of the 12-week study period, or a male participant who is planning to impregnate or provide sperm donation prior to the completion of the 12-week study period. - participant has previously participated in this study, has previously received MK-3415 or MK- 6072 (either alone or in combination), has received a C. difficile vaccine, or has received another experimental monoclonal antibody against C. difficile toxin A or B. - participant plans to donate blood and/or blood products within 6 months following the infusion. - participant has received immune globulin within 6 months prior to receipt of the infusion or is planning to receive immune globulin prior to the completion of the 12-week study period. - treatment with SOC therapy is planned for longer than 14 days. - participant has received more than a 24-hour regimen of cholestyramine, colestimide, rifaximin, or nitazoxanide within 14 days prior to receipt of the infusion or is planning to receive these medications prior to the completion of the 12-week study period. - participant plans to take medications that are given to decrease gastrointestinal peristalsis, such as loperamide (Imodium™) or diphenoxylate hydrochloride/atropine sulfate (LOMOTIL™), at any time during the 14 days following infusion. Participants receiving opioid medications at the onset of diarrhea may be included if they are on a stable dose or if there is anticipation of a dose decrease or cessation of use. - participant plans to take the probiotic Saccharomyces boulardii or receive fecal transplant therapy, or any other therapies that have been demonstrated to decrease CDI recurrences at any time following infusion (Day 1) and through the completion of the 12-week study period. - participant has received another investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical trial with an investigational agent during the 12-week study period. - participant is not expected to survive for 72 hours. - participant has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant participating in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study. ; PRIMARY OUTCOME: Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence; SECONDARY OUTCOME 1: Percentage of Participants With Global 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 III - MERMAID-1; BRIEF: This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria: Patients must be capable of giving signed informed consent, which includes a mandatory genetic informed consent and compliance with the requirements and restrictions listed in the informed consent forms (ICFs) and in this protocol. Provision of signed and dated, written ICFs must occur prior to any mandatory study-specific procedures, sampling, and analyses. In addition to ICF1 and ICF2, patients will provide signed and dated written optional genetic informed consent prior to collection of a sample for optional genetic analysis at the time of second screening (Table 2). This is different from the genetic samples and testing covered by ICF1, which are mandatory for participation in this study. Criteria and procedures initiated with the signing of ICF1 1. ICF1 must be signed and dated prior to any study procedures and prior to the planned surgical resection of the primary NSCLC, with the exceptions noted below. This consent will cover the study-specific first screening procedures outlined in Table 1. Exception: Patients will be permitted to sign ICF1 up to Week 3 (Day 21) postsurgery. Patients identified after Week 3 post-surgery but prior to Week 5 (Day 35) post-surgery may be allowed to sign ICF1 depending on the outcome of the discussion with the study physician. In these cases, a whole blood sample and resected tumor tissue must be collected and sent to the diagnostic lab as soon as possible after ICF1 is signed for development of the personalized panel. A plasma sample must still be collected at Week 3-5 (Day 21-35) post-surgery, even if creation of the personalized panel for MRD detection is delayed. Age 2. Age ≥18 years at the time of screening. Sex 3. Male and/or female. Type of patient and disease characteristics 4. Individuals who have diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease (according to IASLC Staging Manual in Thoracic Oncology v8.0). Select (ie, T3N2 or T4N2) stage IIIB patients will be eligible, provided that they are upstaged to T3N2 or T4N2 based on confirmed pathology. Patients who are staged asT3N2 or T4N2 prior to surgery are not eligible. 5. A contrast-enhanced CT or MRI scan of the chest must have been done for surgical planning prior to surgery. It is recommended that patients undergo combined FDG-PET (18F-Fluoro-deoxyglucose positron emission tomography) and CT scan (contrastenhanced or low-dose CT component) in order to rule out detectable extrathoracic, extracranial metastasis and to assess for potential mediastinal lymph node involvement prior to surgery. In the absence of pre-operative FDG-PET CT imaging, pre-operative contrast-enhanced CT imaging or MRI scan must cover liver and adrenal glands. If only CT is available, or FDG-PET reveals suspicious lymph node mediastinal involvement, it is recommended that invasive pre-operative mediastinal staging is performed according to the algorithm of the European Society of Thoracic Surgeons guidelines (algorithm to follow for primary mediastinal staging if only pre-operative CT is available [De Leyn et al 2007], algorithm to follow for primary mediastinal staging when PET-CT is available [De Leyn et al 2014]). It is preferred that imaging occurs within 6 weeks prior to surgery. Brain MRI (preferred) or brain CT with IV contrast is required for complete staging of the tumor. 6. Complete resection of the primary NSCLC is mandatory. The primary tumor must be deemed resectable by a multidisciplinary evaluation that must include a thoracic surgeon certified or trained according to local standards and who performs lung cancer surgery as a significant part of their practice. Surgical resection of the primary NSCLC can occur by open thoracotomy or by video-assisted thoracic surgery (VATS) and resection can be achieved by segmentectomy, lobectomy, sleeve resection, bilobectomy, or pneumonectomy. Patients undergoing wedge resection are not eligible for this study. Note: Patients undergoing segmentectomy must have tumors less than 2 cm in maximum diameter. Where a resection has been extended by means of a wedge resection of an adjacent lobe to ensure complete resection of a tumor at or crossing a fissure between lobes, this is acceptable if surgical margins are clear of disease. Where the resection of a second tumor nodule (eg, a T4 lesion) is undertaken by means of a wedge resection of a separate lobe, then the patient is not eligible. At a minimum, the following parameters should be met for a tumor to be declared completely resected: 1. The surgeon performing the resection should remove all gross disease by the end of surgery. All surgical margins of resection must be macroscopically negative for tumor. 2. Pathology and/or operative reports must include the examination of at least 2 different mediastinal lymph node (N2) levels, one of which is the subcarinal node-group (level 7) and the second of which is lobe-specific (defined below). Note: In the uncommon clinical situation where the surgeon thoroughly examines a mediastinal lymph node level and does not find any lymph nodes, that mediastinal lymph node level may be counted among the minimum 2 required levels. However, the surgeon must clearly document in the operative report or in a separate written statement that the lymph node level was explored and no lymph nodes were present. Normal appearing lymph nodes, if present, must be biopsied or removed. Exploration of nodes must clearly be documented in medical file if not recorded in operative report. Note: Lobe-specific lymph node stations are classified based on the location of the primary tumor as follows (based on IASLC 2009 lymph node map terminology [Rusch et al 2009]): Stations 2R and 4R for right upper lobe or middle lobe tumors, stations 4L, 5, and 6 for left upper lobe tumors, stations 8 and 9 for lower lobe tumors of both sides (Adachi et al 2017, Rami-Porta et al 2005). 3. No extracapsular nodal extension of the tumor is observed in resected mediastinal N2 lymph nodes. Note: Extracapsular nodal extension in resected N1 nodes is permitted. Note: The highest mediastinal node resected can be positive for malignancy. Note: Carcinoma-in-situ can be present at the bronchial margin. 7. All patients who enrol in the study prior to surgery must have a pre-surgical plasma sample collected for MRD evaluation. Patients will not be excluded from randomization based on the results of analysing the pre-surgical plasma samples. The following criteria must be met prior to signing ICF2: 8. Confirmation of suitable samples of resected tumor tissue and whole blood for WES of tumor and germline DNA, respectively, and creation of Sponsor-approved personalized panel for MRD detection. Tumor tissue and whole blood samples must be provided to the diagnostic laboratory for development of the personalized panel as soon as possible. Germline sequencing of whole blood is mandatory. Note: If a patients tumor has less than the requisite 50 tumor-specific variants, a panel cannot be built and the patient will no longer be able to participate in the study. 9. Established MRD status (MRD+ or MRD-) based on Sponsor-approved personalized assay of a plasma sample collected at Week 3-5 (Day 21-35) post-surgery. 10. Known tumor PD-L1 status determined at a central reference laboratory testing service using a validated Ventana SP263 PD-L1 immunohistochemistry (IHC) assay prior randomization. Patients with unknown PD-L1 status are not eligible for the study. Criteria and procedures initiated with the signing of ICF2 11. Post-operative CT scan of the chest (including liver and adrenal glands) performed within 28 days + 7 days prior to randomization. If clinically indicated, additional scans (such as brain MRI [preferred] or brain CT with IV contrast) should be performed to confirm no evidence of metastasis. 12. ICF2 must be signed and dated after MRD status is determined and prior to initiation of any study-specific procedures, sampling, and analyses outlined in SoAs in Table 2 and Table 3. Randomization must occur within the 12 weeks (+ 7 days) following surgery. 13. WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 14. Complete postoperative wound healing must have occurred prior to randomization; patients must have recovered from all acute, reversible toxic effects from prior treatments (excluding alopecia) that could potentially adversely impact further administration of durvalumab/placebo or chemotherapy according to the Investigators judgment. 15. Eligible to tolerate 4 cycles of platinum-based adjuvant chemotherapy 16. Adequate organ and marrow function as described in the protocol. 17 Must have a life expectancy of at least 12 weeks Weight 18 Body weight >30 kg Exclusion criteria: Diagnostic assessments 1. Post-operative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence. In the event of lymphadenopathy on imaging that would lead to exclusion, histopathological confirmation of lymph node metastasis should be obtained prior to excluding a patient from the study. If pathological confirmation of lymph-node metastasis is not technically feasible and imaging appearance are deemed unequivocal for relapse, the patient will be excluded. 2. EGFR-mutant and/or ALK-translocation-positive, as assessed either from a pre-surgical biopsy sample (preferred) or the resected tumor tissue (if biopsy was not evaluable or available). Any of the following scenarios are acceptable for this study: Where EGFR/ALK results are obtained from a pre-surgical tissue biopsy as part of standard local practice, the patient must be confirmed EGFR/ALK wild-type prior to enrolling in the study. Results obtained from testing the patients primary tumor tissue during screening for another AstraZeneca study may be used in this study. Results from local testing of a pre-surgical biopsy. All local EGFR/ALK testing performed locally must be performed using a well-validated, local regulatory-approved test. EGFR/ALK may be tested centrally if local testing is unavailable. Patients will still be allowed to continue with first screening procedures while testing is ongoing but will not be able to continue into second screening if their tumor tests positive for EGFR mutations and/or ALK translocations. 3. Mixed small cell and NSCLC histology. 4. Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice. 5. Patients who are candidates to undergo only wedge resections. Medical conditions 6. History of allogeneic organ or bone marrow transplantation. 7. Non-leukocyte-depleted whole blood transfusion within 120 days of genetic sample collection. Note: This exclusion criterion only relates to whole blood and does not include other blood products (eg, packed red blood cells). 8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohns disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: - Patients with vitiligo or alopecia - Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement - Any chronic skin condition that does not require systemic therapy - Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician - Patients with celiac disease controlled by diet alone 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent. 10. History of another primary malignancy, except for - Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated carcinoma-in-situ without evidence of disease 11. History of active primary immunodeficiency 12. Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (HBV; known positive HBV surface antigen [HBsAg] result), hepatitis C (HCV), or human immunodeficiency virus infection (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 13. Known allergy or hypersensitivity to any of the IPs or any of the IP excipients. 14. Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labeling. Prior/concomitant therapy 15. Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab. 16. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. 17. Radiotherapy treatment for NSCLC in the neoadjuvant setting. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP. 18. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP. 19. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. 20. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab/placebo. The following are exceptions to this criterion: - Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection) - Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent - Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) Prior/concurrent clinical study experience 21. Participation in another clinical study with an IP administered since completion of surgery. 22. Previous IP assignment in the present study. 23. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study, or during the follow-up period of an interventional study. 24. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment group assignment. Other exclusions 25. Patients who are never-smokers; defined as no more than 100 cigarettes or its equivalent in his/her lifetime. 26. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab/placebo. 27. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. ; PRIMARY OUTCOME: DFS in FAS (using Investigator assessments according to RECIST 1.1); SECONDARY OUTCOME 1: DFS in MRD+ analysis set (using Investigator assessments according to RECIST 1.1)[/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 - REDWOOD (MDD-302); BRIEF: This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD). ; DRUG USED: SAGE-217; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: 1. Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period. 2. Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode). 3. Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion. Exclusion Criteria: 1. Participant had attempted suicide associated with the current episode of MDD. 2. Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose. 3. Participant had a positive pregnancy test at screening or on Day 1 prior to dosing. ; PRIMARY OUTCOME: Time to Relapse During the DB Phase; SECONDARY OUTCOME 1: Percentage of Participants Who Relapsed During the DB Phase[/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 - AMAG-FER-IDA-301; BRIEF: To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA). ; DRUG USED: Feraheme; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: AMAG Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria include: 1. Males and females ≥18 years of age 2. Participants with IDA defined as having: 1. Hemoglobin <10.0 g/deciliter (dL) 2. Transferrin saturation <20% 3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used 4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study Key Exclusion Criteria include: 1. History of allergy to IV iron 2. Allergy to two or more classes of drugs 3. Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m^2 4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test 5. Hemoglobin ≤7.0 g/dL 6. Serum ferritin >600 nanograms/mL ; PRIMARY OUTCOME: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5; SECONDARY OUTCOME 1: Mean Change In Hemoglobin From Baseline To Week 5[/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 - LATITUDE w/Prednisone & ADT; BRIEF: The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration). ; DRUG USED: Zytiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Cytochrome P450c17; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology - Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan - At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan - Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 - Adequate hematologic, hepatic, and renal function - Agrees to protocol-defined use of effective contraception Exclusion Criteria: - Active infection or other medical condition that would make prednisone use contraindicated - Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day - Pathological finding consistent with small cell carcinoma of the prostate - Known brain metastasis - Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1) ; PRIMARY OUTCOME: Radiographic Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Time to Initiation of Chemotherapy[/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 - SP513OL; BRIEF: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinsons disease ; DRUG USED: Neupro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial Exclusion Criteria: - Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication ; PRIMARY OUTCOME: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study; SECONDARY OUTCOME 1: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ZS-01-302 (China); BRIEF: Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure ; DRUG USED: Neucardin; DRUG CLASS: Biologic; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Zensun Sci. & Tech. Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Age: 18-75 years old, no limitation in gender; 2. Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO); 3. Patients with chronic heart failure (NYHA class II or III); 4. In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable; 5. Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month; 6. Understand and sign the informed consent form; Exclusion Criteria: 1. Atrial fibrillation; 2. Subject underwent cardiac pacemaker treatment; 3. Subject underwent metal graft treatment; 4. Claustrophobia; 5. Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension; 6. Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months; 7. Subject underwent cardiac surgery or cerebrovascular events within the previous six months; 8. Subjects who plan to have cardiac transplantation; 9. Severe hepatic and renal insufficiency (serum creatinine>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range); 10. Subject needs mechanical ventilation; 11. Systolic blood pressure < 90mmHg, or > 160mmHg; 12. Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month; 13. Mobitz Type II or III° atrial ventricular block，severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia); 14. Serum potassium<3.2mmol/L, or>5.5mmol/L; 15. Female subject is pregnant or plan to become pregnant 16. Childbearing-aged female subject who is unmarried or dose not bear child; 17. Subject with life expectancy less than 6 months as assessed by investigators; 18. Subject participated in any other clinical trial within the previous three months; 19. Subject with previous history of tumor, or current tumor patient, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ or cervical epithelial dysplasia) 20. Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement); 21. The Investigator deemed for whatever reason that the subject is not likely to complete the study or comply with the study procedures (due to administration or any other reason). ; PRIMARY OUTCOME: cardiac function measured by MRI; SECONDARY OUTCOME 1: cardiac function[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RGH-MD-05; BRIEF: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia. ; DRUG USED: Vraylar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Patients who have provided informed consent prior to any study specific procedures - Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) - Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120 - Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 - Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG) Exclusion Criteria: - Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder - Patients in their first episode of psychosis - Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study - Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders - Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study - Substance abuse or dependence within the prior 3 months ; PRIMARY OUTCOME: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score; SECONDARY OUTCOME 1: Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)[/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 - ECZTRA 2; BRIEF: Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16. ; DRUG USED: Tralokinumab; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: 1. Written informed consent and any locally required authorisation obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 2. Age 18 and above. 3. Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (33; Appendix 5). 4. Diagnosis of AD for ≥1 year. 5. Subjects who have a recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., due to important side effects or safety risks). - Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0=clear to 2=mild) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information (e.g., 14 days for super potent TCS), whichever is shorter. - Subjects with documented systemic treatment for AD in the past year are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with tralokinumab after appropriate washout. - Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects, as assessed by the investigator or by the subjects treating physician. 6. AD involvement of ≥10% body surface area at screening and baseline (visit 3). 7. An EASI score of ≥12 at screening and 16 at baseline. 8. An IGA score of ≥3 at screening and at baseline. 9. A Worst Daily Pruritus numeric rating scale (NRS) average score of ≥4 during the week prior to baseline. • Worst Daily Pruritus NRS at baseline will be calculated from daily assessments of worst itch severity (Worst Daily Pruritus NRS) during the 7 days immediately preceding randomisation (Day 6 to 0). A minimum of 4 Worst Daily Pruritus NRS scores out of the 7 days is required to calculate the baseline average score. For subjects who do not have at least 4 scores reported during the 7 days immediately preceding the planned randomisation date, randomisation should be postponed until this requirement is met, but without exceeding the 6 weeks maximum duration for screening. 10. Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation (refer to exclusion criterion no. 8 for limitations regarding emollients). 11. Women of childbearing potential must use a highly effective* form of birth control (confirmed by the investigator) throughout the trial and at least for 16 weeks (5 half lives) after last administration of IMP. - A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), vasectomised partner (given that the subject is monogamous). The subjects must have used the contraceptive method continuously for at least 1 month prior to the pregnancy test at baseline. A female is defined as not being of child-bearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy). Exclusion Criteria: 1. Concurrent enrolment in another clinical trial where the subject is receiving an IMP. 2. Previous randomisation in tralokinumab trials. 3. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis. 4. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD. 5. Use of tanning beds or phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), within 6 weeks prior to randomisation. 6. Treatment with the following medications within 4 weeks prior to randomisation: - Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors etc.). - Systemic corticosteroid use (excludes topical, inhaled, or intranasal delivery). - Three or more bleach baths during any week within the 4 weeks. 7. Treatment with the following medications within 2 weeks prior to randomisation - TCS. - TCI. - Topical PDE 4 inhibitor. 8. Initiation of treatment of AD with prescription emollients or emollients containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (subjects may continue using stable doses of such emollients if initiated before the screening visit). 9. Receipt of live attenuated vaccines 30 days prior to the date of randomisation and during the trial including the safety follow-up period. • Receipt of inactive/killed vaccinations (e.g. inactive influenza) are allowed, provided they are not administered within 5 days before/after any study visit. 10. Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic agent, including dupilumab: - Any cell-depleting agents including but not limited to rituximab: within 6 months prior to randomisation, or until lymphocyte count returns to normal, whichever is longer. - Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to randomisation. 11. Receipt of any investigational non-biologic agent within 5 half-lives prior to randomisation. 12. Receipt of blood products within 4 weeks prior to screening. 13. Major surgery within 8 weeks prior to screening, or planned in-patient surgery or hospitalisation during the trial period. 14. Known or suspected allergy or reaction to any component of the IMP formulation. 15. History of any active skin infection within 1 week prior to randomisation. 16. History of a clinically significant infection within 4 weeks prior to randomisation which, in the opinion of the investigator or sponsors medical expert, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subjects ability to participate in the trial. Clinically significant infections are defined as: - a systemic infection. - a serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication. 17. A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy. 18. History of anaphylaxis following any biologic therapy. 19. History of immune complex disease. 20. History of cancer: - Subjects who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained. - Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained. 21. Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care. 22. History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subjects verbal report. 23. History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator. 24. History of attempted suicide or is at significant risk of suicide (either in the opinion of the investigator or defined as a yes to suicidal ideation questions no. 4 or 5 or answering yes to suicidal behaviour on the Columbia-Suicide Severity Rating Scale [C-SSRS] Screening version). 25. Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could: - Affect the safety of the subject throughout the trial. - Influence the findings of the trial or their interpretations. - Impede the subjects ability to complete the entire duration of trial. 26. Any clinically significant abnormal findings in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during the screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the trial, or may influence the results of the trial, or the subjects ability to complete entire duration of the trial. 27. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the ULN (upper limit of normal) at screening. 28. Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb. 29. Subjects who are not willing to abstain from donating blood and/or plasma from the time of informed consent and for 16 weeks (5 half-lives) after last dose of IMP. 30. Subjects who are legally institutionalised. 31. Pregnant, breastfeeding, or lactating women. 32. Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals. ; PRIMARY OUTCOME: Subjects With Investigators Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16.; SECONDARY OUTCOME 1: Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/SoC Treatment; BRIEF: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment. ; DRUG USED: JNJ-3872; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Influenza Virus, Polymerase Basic Protein 2 (PB2), RNA polymerase; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay - Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU) - Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms - Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening - Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4 Exclusion Criteria: - Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one day prior to screening - Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive) - Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome - Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy - Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, any history of a lung transplant) - Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients ; PRIMARY OUTCOME: Number of Participants With Hospital Recovery Scale on Day 6; SECONDARY OUTCOME 1: Time to Hospital Discharge[/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 - UK; BRIEF: This is a study to evaluate the efficacy, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults aged 18-84 years in the United Kingdom. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, bodys immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Approximately 15,000 participants will take part in the study. The first approximately 400 participants who meet additional criteria will receive a flu vaccine, in addition to the SARS-CoV-2 rS vaccine or placebo, as part of a sub-study. An effort will be made to enroll a target of at least 25% of participants who are ≥ 65 years of age, as well as prioritizing other groups that are most affected by COVID-19, including racial and ethnic minorities. Unblinding of treatment assignment may occur in order to allow a participant to make an informed decision regarding receipt of an already approved or deployed SARS-CoV-2 vaccine. Participants who choose to receive an approved or deployed SARS-CoV-2 vaccine as per UK government guidance will be encouraged to remain in the study for scheduled safety assessments. ; DRUG USED: NVX-CoV2373; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Combination; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria: - Able and willing to comply with all study requirements. - Willing to allow investigators to discuss medical history with their General Practitioner and access all relevant medical records. - Willing and able to give informed consent. - Women of child-bearing potential must agree not to have sexual intercourse with men, or must consistently use an agreed method of contraception, from at least 28 days prior to enrolment in the study, through 3 months after the last vaccination. - Room air oxygen saturation > 95% at Screening/Day 0. - Seasonal Flu Vaccine Co-Administration Sub-Study only: Participant should not have received a current season flu vaccine, should have no reason why the specific sub-study flu vaccine cannot be administered, and should not have any prior history of allergy or severe reaction to seasonal flu vaccines. Exclusion Criteria: - Participation in other COVID-19 vaccine or preventative drug trials for the duration of the study. - Future participation in any blood tests for the duration of the study where participants are informed of their levels of COVID-19 antibodies or antigens. - Participation in any trial involving an investigational drug, biologic or device within 45 days prior to the first study vaccination. - History of laboratory-confirmed COVID-19 infection any time prior to first study vaccination. - Receipt of any immunoglobulins and/or any blood products within 3 months prior to planned administration of study vaccine. - Any confirmed or suspected immunosuppressive or immunodeficient state. Chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days). Note: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted if other chronic disease conditions do not exclude a participant from the study. - History of allergic disease or reactions likely to be made worse by any component of the study vaccines. - History of anaphylaxis to any prior vaccine. - Pregnancy, breast-feeding or willingness/intention to become pregnant within 3 months following the last study vaccination. - Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ. - Bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections or venepuncture (e.g. to draw blood for tests). - Continuous use of anticoagulants or anti-platelet agents. Note: The preventative use of ≤ 325 mg of aspirin per day is permitted. - Suspected or known current alcohol or drug dependency. - Study team member or first-degree relative of any study team member (inclusive of sponsor, contract research organization (CRO), and site personnel involved in the study). - Participants having any current workup of undiagnosed illness within 8 weeks prior to start of study which could lead to new condition or diagnosis. - Received any live vaccine within 4 weeks or any vaccine (excluding flu) within 2 weeks prior to first study vaccination; or any licensed flu vaccine within 1 week prior to first study vaccination or plans to receive any vaccine from these time periods until 28 days after the second study vaccination. - Have clinically significant chronic cardiovascular, endocrine (hormones), gastrointestinal, hepatic (including hepatitis B and C), renal (kidney), neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria, that are assessed by the investigator as being clinically unstable within the prior 4 weeks as evidenced by: a) Hospitalisation for the condition, including day surgical interventions; b) New significant organ function deterioration; or c) Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed). - History of chronic neurological disorders that have required prior specialist physician review for diagnosis and management (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinsons disease, degenerative neurological conditions, and neuropathy) or a history of stroke or previous neurological disorder within 12 months with residual symptoms. Participants with a history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded. - Any autoimmune disease/condition (iatrogenic or congenital). - Any other significant disease, disorder or finding that, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data. - Participant requires the use of continuous oxygen therapy or any oxygen therapy while awake or is anticipated to require daytime oxygen therapy during the course of the study. Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19); SECONDARY OUTCOME 1: Participants with Symptomatic Moderate or Severe COVID-19[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Long-term Safety; BRIEF: The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries. ; DRUG USED: Gilenya; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Patients who have completed selected ongoing or planned trials with FTY720. Key Exclusion Criteria: - Premature permanent discontinuation of a previous fingolimod study. - Pregnant or nursing (lactating) women. - Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partners vasectomy or intrauterine device. - Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment. - Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%. - Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. - Previous treatment with cladribine, cyclophosphamide or mitoxantrone. - Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study: - Any of the following cardiovascular conditions that have developed during the previous fingolimod study: - Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease; - Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; - Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide) - History or presence of a third degree AV block - Proven history of sick sinus syndrome or sino-atrial heart block - Known history of angina pectoris due to coronary spasm or Raynauds phenomenon - Any of the following pulmonary conditions during the previous fingolimod study: - Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study) - Active tuberculosis - Alcohol abuse, chronic liver disease during the previous fingolimod study. The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial. ; PRIMARY OUTCOME: Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death; SECONDARY OUTCOME 1: Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod[/INST]Yes</s>