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

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - iTAP (Thailand); BRIEF: Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma, even if her infant receive specific immunoglobulin and vaccine. The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant women participating in this study will receive tenofovir or placebo during the last trimester of pregnancy and two months postpartum. The risk of perinatal transmission will be compared between the two groups. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission. ; DRUG USED: Viread; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: DNA polymerase, Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Institut de Recherche pour le Developpement; CRITERIA: Inclusion Criteria: - Pregnancy - At least 18 years of age - Negative Human Immunodeficiency Virus (HIV) serology - Positive HBsAg and hepatitis B e antigen (HBeAg) tests - Gestational age of 28 weeks (+ or - 10 days) as determined by obstetrician - Alanine Aminotransferase (ALT)≤30 U/L, confirmed ≤60 U/L on a subsequent blood draw - Agreeing to bring their infants at the planned study visits at one study site until one year after delivery and to inform the site investigators if they plan to move to another place and not be able to return to the clinic. - Understanding the need for adequate infant immunization and agreeing to the blood draws from their infants and the need for close follow up to manage possible exacerbation of hepatitis. Exclusion Criteria: - History of tenofovir treatment at any time, or any other anti-HBV treatment during the current pregnancy - Creatinine clearance <50 ml/min, calculated using the Cockcroft-Gault formula - Dipstick proteinuria>1+ (>30 mg/dL) or normoglycemic glucosuria confirmed on two separate occasions - Positive serology for Hepatitis C infection less than 12 months prior to enrollment - Evidence of pre-existing fetal anomalies incompatible with life - Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or satisfactory follow up in the study. - Concurrent participation in any other clinical trial without written agreement of the two study teams ; PRIMARY OUTCOME: Percentage of Infants With Hepatitis B Infection at 6 Months of Age; SECONDARY OUTCOME 1: Percentage of Participants With Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - vs. Fluticasone/Salmeterol (116974); BRIEF: This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects. Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subjects adherence with study treatment, study procedures and assessment of disease stability. At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period. A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks. ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - A male or female >=40 years of age at Screening (Visit 1). - Capable of giving written informed consent. - Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. - Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society. - Subject with a measured post-albuterol (salbutamol) FEV1/forced vital capacity(FVC) ratio of <=0.70 at Screening. - Subjects with a measured post-albuterol (salbutamol) FEV1 <=70% of predicted normal values. - Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening. Exclusion Criteria: - Current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). - Other respiratory disorders (alpha1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases). - Lung volume reduction surgery within the 12 months prior to Screening. - Hospitalized due to poorly controlled COPD within 12 weeks of Screening. - Poorly controlled COPD (occurrence of the following in the 6 weeks prior to Screening -Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician). - Lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening. - Moderate/severe COPD exacerbation/lower respiratory tract infection during Run-In Period. - Abnormal and clinically significant 12-lead ECG at Screening - Historical or current evidence of uncontrolled or clinically significant disease like cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. - History of hypersensitivity to any of the study medications or components of the inhalation powder; or history of severe milk protein allergy. - Known or suspected history of alcohol or drug abuse within the last 2 years. - Subjects who are medically unable to withhold their albuterol (salbutamol) and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit. - The subject has taken any other investigational drug within 30 days or 5 half-lives of the investigational product (IP) prior to the first dosing day in the current study. - Use of additional medications prior to Screening (list of medications and time intervals are different for different class of medications and are indicated in the protocol) - Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., <=12 hours per day) is not exclusionary. - Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening - Subjects at risk of non-compliance, or unable to comply with study procedures. - Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. - Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Previously randomized to either the HZC113109 or HZC112352 clinical studies. ; PRIMARY OUTCOME: Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84; SECONDARY OUTCOME 1: Time to Onset on Treatment Day 1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PATENCY-2; BRIEF: This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF. ; DRUG USED: Vonapanitase; DRUG CLASS: Biologic; INDICATION: End-Stage Renal Disease (ESRD); TARGET: Elastin; THERAPY: Monotherapy; LEAD SPONSOR: Proteon Therapeutics; CRITERIA: Inclusion Criteria: 1. Age of at least 18 years. 2. Life expectancy of at least 6 months. 3. Diagnosis of CKD. 4. Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible). 5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team. 6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). 7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device. Exclusion Criteria: 1. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ. 2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. 3. Previous treatment with vonapanitase (PRT-201). 4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent. ; PRIMARY OUTCOME: Kaplan-Meier Estimate of Secondary AVF Patency; 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 - 31-97-303; BRIEF: The primary objective of the study was to determine the safety of aripiprazole administered long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects with chronic or first episode of schizophrenia. Information on the continued efficacy of aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until aripiprazole was otherwise available through marketed means and/or reimbursed). ; DRUG USED: Abilify Maintena; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: 1. Complete a Prior Study: each patient must meet one of the following conditions for completion of the prior study: - A patient who has completed 52 weeks of post-randomization treatment in the prior double blind study (31-97-301 or 31-98-304-01) is eligible, with no further qualifications. - A patient who was early-terminated from the study 31-97-301 or 31-98- 304-01 for either of the following two reasons is eligible to enter this open label study with no minimal required duration of prior double-blind participation: - Early termination was due to a marked deterioration of clinical status and no serious adverse events (SAE) other than hospitalization has occurred. The marked clinical deterioration must be documented by at least a one-point increase in CGI-Severity score from the baseline and a score of 6 (much worse) or 7 (very much worse) in CGI-Global Improvement at the time of termination, or - Early termination was due to a non-serious AE requiring discontinuation of the study drug - A patient who was early terminated after a minimum of 4 weeks participation in the double-blind treatment in study 31-97-301 or 31-98- 304-01 and the reason for early termination was withdrawal of consent due to lack of effect but not marked deterioration. This must be documented by no change from baseline in the CGI-Severity score and a score of 4 (no change) or 5 (minimally worse) on the CGI-Global Improvement scale. 2. Signing of Informed Consent Form: Prior to any procedure or drug administration, each patient must sign an informed consent form. In addition, if required by the Ethical Committee, each patients next-of-kin or responsible caregiver will co-sign the patients consent form or a separate consent form. Exclusion Criteria: 1. Patients suffering from any significant somatic disease or medical problem that would obscure the results of treatment, or that might require frequent changes of concomitant medication. 2. Patients with any acute or unstable medical condition requiring pharmacotherapy, other than schizophrenia. 3. Patients with an abnormal laboratory test value in the most recent analysis (from the study 31-97-301 or 31-98-304-01) which is considered by the investigator as presenting a significant risk to the patient for continuing treatment with aripiprazole. 4. Patients who were early-terminated from the prior double-blind studies (31-97-301 or 31-98-304-01) due to a serious adverse event (SAE) other than worsening of psychosis or hospitalization. 5. Female patients of child bearing potential with a positive serum pregnancy test at the baseline (last visit of prior study) of this open-label follow-on study. 6. Patients who have positive result in the urine screen for drugs of abuse (except for cannabis or medically-prescribed analgesics or benzodiazepines.) ; PRIMARY OUTCOME: Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week; 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 - BUILDER 1 - TNF Naive; BRIEF: This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks. ; DRUG USED: Actemra (Intravenous) ; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria - Adult patients, ≥ 18 years of age - Ankylosing Spondylitis as defined by the modified New York criteria for ≥ 3 months prior to baseline - Active disease at screening and baseline (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥4.0, spinal pain visual analog scale [VAS] ≥40) - Inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (NSAIDs) - Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline) - Oral corticosteroids (≥ 10 mg/day prednisone or equivalent) and NSAIDs/COX-2 inhibitors must be at stable dose for at least 4 weeks prior to baseline Exclusion Criteria: - Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization - Total ankylosis of spine (as determined by investigator) - Inflammatory rheumatic disease other than ankylosing spondylitis - Active, acute uveitis at baseline - Treatment with tumor necrosis factor (TNF) antagonist therapy at any time prior to baseline - Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection - History of or currently active primary or secondary immunodeficiency - Body weight > 150 kg ; PRIMARY OUTCOME: Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12; SECONDARY OUTCOME 1: Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PRECiSE 2; BRIEF: A 26 week maintenance study of CDP870 in Crohns disease ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Definitive diagnosis of Crohns disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3)*. * Vienna Classification (1998) - Active Crohns disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug. - Patients aged 18 years or above at screening. Exclusion Criteria: - Crohns Disease Related - Fistula abscess present at screening. - Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months. - Short bowel syndrome. - Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study). - Positive stool laboratory results for enteric pathogens. ; PRIMARY OUTCOME: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.; SECONDARY OUTCOME 1: In population with CRP ≥ 10 mg/L at baseline; Time to disease progression up to and including Week 26; Proportion of patients with clinical remission at Week 26; Proportion of patients with IBDQ response at Week 26; F-36 sub-scores and change from basel[/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 - INTEREST (ARDS; EU); BRIEF: In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patients chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients. ; DRUG USED: Traumakine; DRUG CLASS: Biologic; INDICATION: Acute Respiratory Failure, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS); TARGET: Interferon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Faron Pharmaceuticals Ltd; CRITERIA: Inclusion Criteria: All patients must be intubated and mechanically ventilated to diagnose ARDS and be eligible for the study 1. Patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS: - Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms - Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload (an objective assessment of cardiac failure or fluid overload is needed if no risk factors for ARDS [moderate or severe ARDS] are present) - Radiological abnormalities on chest X-ray or on computerised tomography scan, i.e., bilateral opacities that are not fully explained by effusions, nodules, masses or lobar/lung collapse - Hypoxaemia: - Moderate ARDS: PaO2/FiO2 >100 mmHg (>13.3 kPa) to ≤200 mmHg (≤26.6 kPa) with positive end expiratory pressure (PEEP) ≥5 cmH2O - Severe ARDS: PaO2/FiO2 ≤100 mmHg (≤13.3 kPa) with positive end expiratory pressure [PEEP] ≥5 centimeter of water [cmH2O] 2. The radiological and hypoxaemia criteria (1.3 and 1.4) must be met within the same 24-hour period. The time of onset of ARDS is when the last of the two specified ARDS criteria is met 3. Administration of the first dose of study drug must be planned to take place within 48 hours of moderate or severe ARDS diagnosis 4. Patient is intubated and mechanically ventilated 5. A signed informed consent form from the patient or the patients personal legal representative or a professional legal representative must be available 6. Patient is aged ≥18 years Exclusion Criteria: 1. Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test 2. Patient is simultaneously taking part in another pharmacotherapy protocol 3. Patient is not expected to survive for 24 hours 4. Patient has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely unlikely that the patient would come off ventilation, e.g., motor neurone disease, Duchenne muscular dystrophy or rapidly progressive interstitial pulmonary fibrosis 5. Patient has severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (non-invasive ventilation or via tracheotomy) except for continuous positive airway pressure (CPAP) or bi-level positive airway pressure used solely for sleep-disordered breathing 6. Patient has congestive heart failure, defined as New York Heart Association class IV 7. Patient has acute left ventricular failure 8. Patient has liver failure (Child-Pugh grade C) 9. Patient has received any prior interferon 10. Patient has known hypersensitivity to natural or recombinant IFN beta or to any of the excipients 11. Patient is receiving renal dialysis therapy for chronic renal failure 12. Patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support 13. Patient has had any form of mechanical ventilation (invasive or non-invasive, excluding CPAP alone) for longer than 48 hours prior to the diagnosis of ARDS. Non-invasive ventilation has to be continuously applied for at least 12 hours per day in these 48 hours 14. Patient has burns to ≥15% of their total body surface area ; PRIMARY OUTCOME: Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28; SECONDARY OUTCOME 1: Efficacy Endpoint: All-cause Mortality[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NHL; BRIEF: The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkins lymphoma patients for autologous transplantation. ; DRUG USED: Mozobil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bone Marrow Transplant and Stem Cell Transplant; TARGET: Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Combination; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria (Abbreviated List): - Non-Hodgkins lymphoma in first or second complete or partial remission - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - White Blood Cell count (WBC) > 2.5*10^9/L - Platelet (PLT) > 100*10^9/L Exclusion Criteria (Abbreviated List): - Failed previous stem cell collection - Prior autologous or allogeneic transplant - Brain metastases or bone marrow involvement > 20% - Radiation to pelvis - Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality ; PRIMARY OUTCOME: Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis; SECONDARY OUTCOME 1: Number of Participants With Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KEYNOTE-183 (w/Pomalidomide/Dexamethasone); BRIEF: The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment. The studys 2 primary hypotheses are: 1. Pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs PFS as assessed by Clinical Adjudication Committee (CAC) blinded central review using International Myeloma Working Group Criteria for Response Assessment in Multiple Myeloma (IMWG) criteria compared to treatment with pomalidomide and low dose dexamethasone standard of care (SOC) alone. 2. Pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs OS compared to treatment with pomalidomide and low dose dexamethasone (SOC) alone. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); 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: - Has a confirmed diagnosis of active multiple myeloma and measurable disease - Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy and must have failed last line of treatment (refractory to last line of treatment) - Prior anti-myeloma treatments must have included an immunomodulatory drug (IMiD) AND proteasome inhibitor alone or in combination and participant must have failed therapy with an IMiD OR proteasome inhibitor - Has performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale - Female participants of childbearing potential must have 2 negative urine human chorionic gonadotropin tests within 10 to 14 days and within 24 hours prior to receiving study medication - Female participants of childbearing potential and male participants must agree to use adequate contraception 28 days prior to study start and continuing for up to 28 days after the last dose of pomalidomide (or 120 days after the last dose of pembrolizumab) Exclusion Criteria: - Has had prior anti-myeloma therapy within 2 weeks prior to study start and has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events due to a previously administered agent - Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease [GVHD]). - Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or is planning for or is eligible for auto-SCT - Has received previous therapy with pomalidomide - Has peripheral neuropathy ≥ Grade 2 - Has a known additional malignancy that is progressing or requires active treatment within the last 5 years (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy) - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis - Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) - Is pregnant or breast-feeding ; PRIMARY OUTCOME: Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria; SECONDARY OUTCOME 1: Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review[/INST]No</s>

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

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TELESTAR (Carcinoid Syndrome); BRIEF: The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy. ; DRUG USED: Xermelo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET); TARGET: Tryptophan hydroxylase; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor - Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period - Currently receiving stable-dose somatostatin analog (SSA) therapy - Minimum dose of long-acting release (LAR) or depot SSA therapy - Octreotide LAR at 30 mg every 4 weeks - Lanreotide Depot at 120 mg every 4 weeks - Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose - Ability and willingness to provide written informed consent Exclusion Criteria: - Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome - Karnofsky Performance status ≤60% - Treatment with any tumor directed therapy, including interferon, chemotherapy, mechanistic target of rapamycin (mTOR) inhibitors <4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking <12 weeks prior to Screening - History of short bowel syndrome (SBS) - Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study - Previous exposure to telotristat etiprate ; PRIMARY OUTCOME: Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks; SECONDARY OUTCOME 1: Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels[/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 - Central Precocious Puberty; BRIEF: The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks). ; DRUG USED: Triptodur; DRUG CLASS: Non-NME; INDICATION: Endocrine Disorder; TARGET: Gonadotropin-Releasing Hormone (GnRH); THERAPY: Monotherapy; LEAD SPONSOR: Debiopharm International SA; CRITERIA: Inclusion criteria: 1. Onset of development of sex characteristics before 8 and 9 years in girls and boys, respectively (breast development in girls or testicular enlargement in boys according to the Tanner method), and candidate to receive at least 12 months of GnRH agonist therapy after study entry. 2. Aged 2-8 years inclusive (i.e. < 9 years) for girls and 2-9 years inclusive (i.e. < 10 years) for boys at initiation of triptorelin treatment. 3. Initiation of triptorelin treatment at the latest 18 months after onset of the first signs of precocious puberty. 4. Difference (Δ) bone age (Greulich and Pyle method) - chronological age ≥ 1 year. 5. Pubertal-type LH response 30 minutes following a GnRH agonist stimulation test before treatment initiation (leuprolide acetate 20 μg/kg SC) ≥ 6 IU/L. 6. Clinical evidence of puberty, defined as Tanner Staging ≥ 2 for breast development for girls and testicular volume ≥ 4 mL (cc) for boys. 7. Informed consent signed by one parent or both parents (as per local requirements), by the liable parent or by the legal guardian (when applicable); assent signed by the child if ≥ 7 years. Non-inclusion criteria: 1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. 2. Non-progressing isolated premature thelarche. 3. Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Patients with hamartomas not requiring surgery are eligible. 4. Evidence of renal (creatinine > 2 x ULN) or hepatic impairment (bilirubin or ASAT > 3 x ULN). 5. Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use [except mild topical steroids], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumour). 6. Prior or current therapy with a GnRH agonist, medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF 1). 7. Major medical or psychiatric illness that could interfere with study visits. 8. Diagnosis of short stature, i.e. > 2.25 SD below the mean height for age. 9. Positive pregnancy test. 10. Known hypersensibility to any of the test materials or related compounds. 11. Use of anticoagulants (heparin and coumarin derivatives). ; PRIMARY OUTCOME: Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6; SECONDARY OUTCOME 1: Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 302; BRIEF: A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. Study duration is up to five days and includes a maximum of 3 days confinement in the clinic. Opioid dependent subjects who provide informed consent meet all entry criteria are eligible for enrollment into the study. ; DRUG USED: Bunavail; DRUG CLASS: Non-NME; INDICATION: Substance Use Disorder; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: BioDelivery Sciences International; CRITERIA: Inclusion Criteria: 1. Signed informed consent obtained prior to any study procedure being performed 2. Pre-specified plan for continued treatment following study participation 3. Male or non-pregnant and non-nursing female. A female of childbearing potential is eligible to participate in this study if she is not pregnant and is using an acceptable method of birth control. 4. Subject is aged 18 to 55 years, inclusive 5. Current diagnosis of opioid substance use disorder per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5) 6. Clinical opioid withdrawal scale (COWS) total score ≥12 prior to dosing on Day 1 7. Subject is otherwise in good general health in the judgment of the Investigator as determined from the physical and oral examination findings. 8. Subject is committed to getting help for their opioid dependence, in the judgment of the Investigator. 9. Subject has at least 1 verified contact. Exclusion Criteria: 1. Inability to meet study participation requirements, including a stay of up to 2 nights in the clinic 2. Positive buprenorphine or methadone result on urine drug screen at Screening or Baseline 3. Concurrent Diagnostic and Statistical Manual of Mental Disorders - 5th edition diagnosis of substance use disorder (excluding opioids and tobacco) 4. Prolonged QT interval by medical history, family history, or current electrocardiogram (ECG) finding 5. History of clinically significant hepatic impairment as determined by the Investigator. 6. Use of any medication, nutraceutical or herbal product with CYP3A4 inhibition or induction properties within the past 30 days. This exclusion also extends to grapefruit juice and grapefruit juice-containing products as well as St. Johns wort and St. Johns wort-containing products (prescription or nonprescription drugs, vitamins, minerals, or dietary/herbal supplements). 7. Use of an investigational drug or device within the last 30 days 8. History of hypersensitivity, allergy, or intolerance to buprenorphine or naloxone 9. Increased suicidal risk, as determined by meeting any of the following: - History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4 (intent to act) or 5 (specific plan and intent) on the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) - History of suicidal behavior ≤1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) 10. Lack of motivation or a pattern of prior poor response to treatment, as judged by the investigator 11. A history or current evidence of any clinically significant disorder or any other condition which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results ; PRIMARY OUTCOME: Change from Baseline in COWS total score for BEMA Buprenorphine NX vs BEMA Buprenorphine NX Control; 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 - CLOVER I (Adjunctive); BRIEF: The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome. ; DRUG USED: Onfi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dravet Syndrome (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - Onset of seizures in the first year of life - History of fever-induced prolonged seizures as determined by the Investigator - These may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures - Multiple seizure types which may include: - generalised tonic-clonic (required for inclusion) - clonic (required for inclusion) - myoclonic jerks/seizures - history of normal development prior to seizure onset followed by development delay or regression after seizure onset - abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks Exclusion Criteria: 1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives 2. The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives 3. The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids 4. The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed 5. The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts; SECONDARY OUTCOME 1: Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts during 4 weeks of maintenance[/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 - A0081224; BRIEF: The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles) ; DRUG USED: Lyrica CR; DRUG CLASS: Non-NME; INDICATION: Postherpetic Neuralgia (PHN); TARGET: Voltage-gated calcium channels; THERAPY: Monotherapy; LEAD SPONSOR: Pfizers Upjohn has merged with Mylan to form Viatris Inc.; CRITERIA: Inclusion Criteria: - Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash. - At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period). - At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4. - Male or female of any race, at least 18 years of age, and using appropriate methods of contraception Exclusion Criteria: - Creatinine clearance <30 mL/min (estimated from serum creatinine). - Skin conditions in the affected dermatome that could alter sensation - Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin ; PRIMARY OUTCOME: Number of Participants With Loss of Therapeutic Response.; SECONDARY OUTCOME 1: Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results[/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; BRIEF: This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy. ; DRUG USED: Votrient (Oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - written informed consent - At least 18 years old. - Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy. - Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved. - No evidence of disease progression - ECOG status of 0 or 2 - Able to swallow and retain oral medication. - Adequate hematologic, hepatic, and renal system function as follows: Hematologic - Absolute neutrophil count (ANC) at least 1.5 X 10^9/L - Hemoglobin at least 9 g/dL (or 5.59 mmol/L) - Platelets at least 100 X 10^9/L - Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN - Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic - Total bilirubin up to 1.5 X ULN - AST and ALT up to 2.5 X ULN Renal - Serum creatinine up to 1.5 mg/dL Or, if greater than 1.5 mg/dL: Calculated creatinine clearance at least 50 mL/min Urine Protein - Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24- hour urine protein analysis. - Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. Exclusion Criteria: - Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy - Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met. - Clinically significant gastrointestinal abnormalities - Prolongation of corrected QT interval (QTc) > 480 msecs - History of any one or more cardiovascular conditions within the past 6 months prior to randomization - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Symptomatic peripheral vascular disease - Class III or IV congestive heart failure - Poorly controlled hypertension - History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization - Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer. - Evidence of active bleeding or bleeding diathesis. - Hemoptysis within 6 weeks prior to randomization. - Endobronchial metastases. - Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures. - Investigational or anti-VEGF anticancer therapy prior to study randomization. - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib - Invasive malignancies that showed activity of disease within 5 years prior to randomization ; PRIMARY OUTCOME: Investigator-assessed Progression-free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival - Median[/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 - University of Colorado; BRIEF: This study plans to learn more about the effects of a medicine called ruxolitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Ruxolitinib is FDA-approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. This study intends to define the impact of ruxolitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: University of Colorado, Denver; CRITERIA: Inclusion Criteria: - Male or female aged 18 - 89 years at time of enrollment - Hospitalized (or documented plan to hospitalize if patient is in the emergency department) with symptoms suggestive of COVID-19 - lllness of any duration that meets each of the following: - Evidence of pneumonia, including radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or clinical assessment (rales/crackles on exam) - Requires supportive care, including non-invasive supplemental oxygen - Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay within 7 days of enrollment - Understands and agrees to comply with planned study procedures - Provides informed consent signed by study patient or legally acceptable representative Exclusion Criteria: - Absolute platelet counts are less than 75 x 10^9/L - Absolute neutrophil count is less than 0.5 x 10^9/L - Hemoglobin is less than 8 g/dL - Severe renal impairment defined by serum creatinine greater than 2 mg/dL or CrCl less than 30 mL/min - Treatment with other JAK inhibitors, strong CYP3A4 inhibitors, biologic disease-modifying anti-rheumatic drugs (DMARDs, including anti-IL-6 or anti-IL-6R antibodies), or potent immunosuppressants such as azathioprine and cyclosporine concurrently or within the past 5 days. Note: recent or concurrent treatment with hydroxychloroquine or chloroquine is allowable, as these are non-biologic DMARDs with potential antiviral activity. - History of HIV infection and on active immunosuppressant therapy - Current hematological or solid organ malignancy and on active immunosuppressant therapy - Active tuberculosis (TB) infection or known or suspected systemic bacterial or fungal infection - Pregnancy or breast feeding - Known allergy to ruxolitinib - In the opinion of the investigator, they are unlikely to survive for >48 hours from screening - Any physical examination findings and/or history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study Additional Exclusion Criteria for Phase 2 only: - Invasive oxygen supplementation, including mechanical ventilation and extracorporeal membrane oxygenation (ECMO) ; PRIMARY OUTCOME: Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs); SECONDARY OUTCOME 1: Phase 2: Change in the 8-point ordinal scale[/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 - Breast Cancer Bone Metastasis Prevention (D-CARE; Adjuvant 359); BRIEF: This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence. ; DRUG USED: Xgeva; DRUG CLASS: Biologic; INDICATION: Bone Complications (Including Bone Metastases); TARGET: RANK Ligand (RANKL); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Histologically confirmed, American Joint Committee on Cancer (AJCC) stage II or III breast cancer - High risk of breast cancer recurrence, defined as documented evidence of one or more of the following criteria: i) Biopsy evidence of breast cancer in regional lymph node(s) (LN) (node-positive disease); Nodal micrometastases only are not considered node positive ii) Tumor size > 5 cm (T3) or locally advanced disease (T4) - Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER-2 status - Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy - For subjects receiving adjuvant therapy only: - subjects must have undergone complete resection of the primary tumor with clean surgical margins, or subjects must have undergone resection of the primary tumor and be scheduled for further treatment of the primary tumor with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization - Time between definitive surgery and randomization must be ≤ 12 weeks. Definitive surgery may include secondary interventions (e.g. to clear inadequate surgical margins) - Subjects with node positive disease must have undergone treatment of axillary LN with curative intent, or subjects must be scheduled for further treatment of regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization - Subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment - For subjects receiving neoadjuvant therapy only: - Time between start of neoadjuvant treatment and randomization must be ≤ 8 weeks and subjects must be scheduled to undergo definitive treatment (including surgery and/or radiotherapy) with curative intent within approximately 9 months of starting neoadjuvant treatment - Female subjects with age ≥ 18 years - Subjects with reproductive potential must have a negative pregnancy test within 14 days before randomization - Serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Written informed consent before any study-specific procedure is performed Exclusion Criteria: - Prior or current evidence of any metastatic involvement of any distant site - History of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosis - Osteoporosis requiring treatment at the time of randomization or treatment considered likely to become necessary within the subsequent six months - Any prior or synchronous malignancy (other than breast cancer), except i) Malignancy treated with curative intent and with no evidence of disease for ≥ 5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician ii) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Active infection with Hepatitis B virus or Hepatitis C virus - Known infection with human immunodeficiency virus (HIV) - Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw - Active dental or jaw condition which requires oral surgery - Planned invasive dental procedure for the course of the study - Non-healed dental or oral surgery - Use of oral bisphosphonates within the past 1 year - Prior or current IV bisphosphonate administration - Prior administration of denosumab - Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or investigational drug study(s), or subject is receiving other investigational agent(s) - Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment. - Subject is of child bearing potential and is not willing to use, in combination with her partner, 2 highly effective methods of contraception or abstinence during treatment and for 5 months after the end of treatment - Subject has known sensitivity to any of the products to be administered during the study (e.g., mammalian derived products, calcium, or vitamin D) - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. - Any major medical or psychiatric disorder that in the opinion of the investigator prevent the subject from completing the study or interfere with the interpretation of the study results ; PRIMARY OUTCOME: Bone Metastasis-free Survival (BMFS); SECONDARY OUTCOME 1: Disease-free Survival (DFS)[/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-8835-001); BRIEF: This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin. ; DRUG USED: Steglatro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Diagnosis of Type 2 diabetes mellitus in accordance with American Diabetes Association guidelines - Have Stage 3 chronic kidney disease - On stable diabetes therapy (diet/exercise therapy alone or anti-hyperglycemic agents [AHA] monotherapy or combination therapy) for at least 6 weeks prior to study participation OR on metformin (with or without diet/exercise therapy or other AHA therapy) and is willing to undergo a 10-week metformin wash-off period - Have an estimated glomerular filtration rate (eGFR) of ≥30 to <60 mL/min/1.73m^2 - Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2 - Male, postmenopausal female or surgically sterile female - If a female of reproductive potential, agrees to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug. Exclusion Criteria: - History of type 1 diabetes mellitus or a history of ketoacidosis - History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrine disorders, drug - or chemical-induced, and post-organ transplant) - History of nephrotic range proteinuria with hypoalbuminemia and edema - History of rapidly progressive glomerulonephritis, lupus nephritis, renal or systemic vasculitis, renal artery stenosis with renovascular hypertension, or ischemic nephropathy - History of familial renal glucosuria - History of renal dialysis or renal transplant or renal disease requiring treatment with any immunosuppressive agent - A known hypersensitivity or intolerance to any (sodium-glucose co-transporter 2) SGLT2 inhibitor - On a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable - Has undergone bariatric surgery within the past 12 months - Has been treated with rosiglitazone or other SGLT2 inhibitors within 12 weeks of study participation - Has active, obstructive uropathy or indwelling urinary catheter - History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation - A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer - Known history of Human Immunodeficiency Virus (HIV) - Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or active symptomatic gallbladder disease - Has any clinically significant malabsorption condition - If taking thyroid replacement therapy, has not been on a stable dose for at least 6 weeks prior to study participation - Has been previously randomized in a study with ertugliflozin - Has participated in other studies involving an investigational drug within 30 days prior or during study participation - Has undergone a surgical procedure within 6 weeks prior to or during study participation - Has a positive urine pregnancy test - Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of study medication - Planning to undergo hormonal therapy in preparation to donate eggs during the trial, including 14 days following the last dose of study medication - Excessive consumption of alcoholic beverages or binge drinking - Has donated blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial ; PRIMARY OUTCOME: Change From Baseline in A1C at Week 26 - Excluding Rescue Approach; SECONDARY OUTCOME 1: Change From Baseline in A1C at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Peginterferon Alfa-2a; BRIEF: The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin. ; DRUG USED: Pegylated Interferon Lambda; DRUG CLASS: Biologic; INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: IL-10 (Interleukin-10) and IL-10 Receptor (IL-10R), IL-28R (Interleukin-28 Receptor), Immune System, Interferon Receptor; THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Chronic hepatitis C, Genotype 1 or 4 - HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening - Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10% - Naive to prior anti-HCV therapy Exclusion Criteria: - Infected with HCV other than Genotype 1 or 4 - Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening - Evidence of liver disease other than HCV - Active substance abuse - Use of hematologic growth factors within 90 days prior to study randomization - Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria ; PRIMARY OUTCOME: Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response; SECONDARY OUTCOME 1: Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional 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 - IMAGINE 8 (11 Weeks); BRIEF: The primary purpose of this study is to compare the effect of a double dose of a study drug known as insulin peglispro to a double dose of insulin glargine in participants who have type 2 diabetes. Participants will be treated with study insulin daily, in two 4-week study periods. Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period. ; DRUG USED: LY2605541; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO) classification, for ≥1 year. - Use any type of basal insulin (except degludec), including once-or twice-daily human insulin neutral protamine Hagedom (NPH), insulin detemir, or insulin glargine. - Have hemoglobin A1c (HbA1c) levels ≤9.0% according to local laboratory testing at screening. - Have body mass index (BMI) ≤40.0 kilograms/square meter (kg/m^2). - Have been treated with stable doses of insulin for at least 30 days before screening with: - Basal insulin with daily doses ±30% of mean during the last 4 weeks. - Doses of a basal insulin must be between 0.3 unit/kg/day and 1 unit/kg/day. - If on metformin, thiazolidinediones (TZDs), sodium glucose co-transporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase (DPP4) inhibitors, must be on stable doses for the last 30 days. Exclusion Criteria: - Are using prandial, self-mixed, or premixed insulin. Participants using prandial insulin may be switched to everyday (qd) glargine if investigator judges that the participant will still meet fasting glucose requirements for randomization. - Are using insulin pump therapy. - Have excessive insulin resistance: Defined as >1.0 unit/kg/day as baseline treatment. - If being treated with sulfonylureas (SUs) before screening, then must have SUs washed out between screening and randomization. - Use any of these concomitant medications: morphine, codeine, antidiuretics, glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide, exenatide once weekly, lixisenatide or liraglutide), or pramlintide, used concurrently or within 90 days before screening. - Have hypoglycemia unawareness, defined as confirmed by laboratory test results or by historical episodes of hypoglycemia <54 mg/dL (3.0 mmol/L) without symptoms. - Have fasting hypertriglyceridemia >400 mg/dL (>4.5 mmol/L) at screening, as determined by the local laboratory. - Have had any episode of severe hypoglycemia (defined by requiring assistance due to neurologically disabling hypoglycemia) within 6 months before entry into the study. - Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months. - Have had a previous clinically significant episode of ketoacidosis as determined by the investigator (ketone bodies at fasting and without acidosis is acceptable) in the past 6 months. - Have history of renal transplantation, are currently receiving renal dialysis, or have estimated Glomerular Filtration Rate (eGFR) <60 milliliters/minute. - Have obvious clinical signs or symptoms of liver disease (excluding nonalcoholic fatty liver disease), acute or chronic hepatitis, nonalcoholic steatohepatitis, or elevated liver enzyme measurements. - Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator. ; PRIMARY OUTCOME: Percentage of Participants With Clinically Significant Hypoglycemia; SECONDARY OUTCOME 1: Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose[/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 - CB-03-01/26; BRIEF: The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris. ; DRUG USED: Winlevi / Breezula; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Cassiopea SpA; CRITERIA: Inclusion Criteria: 1. Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit. 2. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. 3. Subject has an Investigators Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale]. 4. Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones). 5. Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits. 6. Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study. Exclusion Criteria: 1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy. 3. Subject has greater than two (2) facial nodules. 4. Subject has nodulocystic acne. 5. Subject has any condition which, in the investigators opinion, would make it unsafe for the subject to participate in this research study. 6. Subject is currently enrolled in an investigational drug or device study. 7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline). 8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator. 9. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. 10. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits. 11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles. 12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial. 13. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented. 14. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented. ; PRIMARY OUTCOME: Percentage of Participants Achieving Success in Investigators Global Assessment (IGA); SECONDARY OUTCOME 1: Change From Baseline in Total Lesion Counts[/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 - SENSE (Subcutaneous); BRIEF: The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD) ; DRUG USED: Binocrit; DRUG CLASS: Biosimilar; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Erythropoietin Receptor (EPOR); THERAPY: Monotherapy; LEAD SPONSOR: Sandoz; CRITERIA: Main Inclusion Criteria: - Adult male and female patients w or w/o dialysis treatment - Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve. - Adequate iron substitution Main Exclusion Criteria: - History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies - Contraindications for ESA therapy - Serum albumin < 3.0 g/dL - Immunocompromized patients (immunosuppressive treatment, chemotherapy) - Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection - Systemic lupus erythematosus - Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months - History of malignancy of any organ system within the last 5 years - History of use of any non-EU approved ESA ; PRIMARY OUTCOME: Anti-Erythropoietin (EPO) Antibodies; SECONDARY OUTCOME 1: Hemoglobin Level and Change From Baseline Period at Visit 16 (End of 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 - AGATE-II (w/ABT-450, Ritonavir + Ribavirin, GT4, Egypt); BRIEF: This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis. ; DRUG USED: Ombitasvir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening) - Subjects must meet one of the following: - Treatment-naive: Subject has never received antiviral treatment for HCV infection OR - Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV); - Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control - In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan - In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma Exclusion Criteria: - Females who are pregnant or breastfeeding - Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody - HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype - abnormal laboratory tests - self-reports current drinking more than 2 drinks per day - current enrollment in another investigational study - previous treatment with a direct acting antiviral agent (DAA) containing regimen - In substudy 1, evidence of liver cirrhosis - In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm; SECONDARY OUTCOME 1: Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm[/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 - IG1102; BRIEF: This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel. ; DRUG USED: Fibrin Sealant; DRUG CLASS: Biologic; INDICATION: Hemostasis; TARGET: Fibrinogen (Coagulation Factor I), Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Instituto Grifols, S.A.; CRITERIA: Inclusion Criteria: - Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure). - Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume). - A target bleeding site can be identified. - Target bleeding site is identified on the cut raw liver surface (resection area). - Target bleeding site has moderate bleeding according to the Investigators judgment. Exclusion Criteria: - Require hepatic resection due to trauma. - Infection in the anatomic surgical area. - History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product. - Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component. - Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure). - Receiving an organ transplant during the same surgical procedure. - Undergone a therapeutic surgical procedure within 30 days from the screening visit. - A target bleeding site cannot be identified. - The target bleeding site has a mild or severe bleeding. - Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure. - Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment. ; PRIMARY OUTCOME: Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start; SECONDARY OUTCOME 1: Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start[/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 - PATENCY-1; BRIEF: This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF. ; DRUG USED: Vonapanitase; DRUG CLASS: Biologic; INDICATION: End-Stage Renal Disease (ESRD); TARGET: Elastin; THERAPY: Monotherapy; LEAD SPONSOR: Proteon Therapeutics; CRITERIA: Inclusion Criteria: 1. Age of at least 18 years. 2. Life expectancy of at least 6 months. 3. Diagnosis of Chronic Kidney Disease (CKD). 4. Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible. 5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team. 6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB). 7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device. Exclusion Criteria: 1. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ. 2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. 3. Previous treatment with PRT 201. 4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent. ; PRIMARY OUTCOME: Time to AVF Primary Unassisted Patency; 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 - Elderly Patients; BRIEF: To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with: - Reported duration of the current episode of at least 4 weeks - MADRS total score >=26 - At least one previous MDE before the age of 60 years Exclusion Criteria: - Mini Mental State Exam (MMSE) <24 - Any current anxiety disorder as defined in the DSM-IV-TR - Current or past history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR - Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR - Presence or history of a clinically significant neurological disorder (including epilepsy) - Neurodegenerative disorder (Alzheimers disease, Parkinson disease, multiple sclerosis, Huntington disease, etc) - Any Axis II disorder that might compromise the study - Significant risk of suicide according to the investigators opinion, or has a score >=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment; SECONDARY OUTCOME 1: Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GENTL 1; BRIEF: Primary Objective: • To compare the immunogenicity of Gan & Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM Secondary Objectives: - To evaluate the safety of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM - To evaluate the efficacy of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM ; DRUG USED: Prandilin; DRUG CLASS: Biosimilar; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Gan and Lee Pharmaceuticals, USA; CRITERIA: Inclusion Criteria: 1. Male or nonpregnant, non-lactating female subjects between the ages of 18 and 75 years, inclusive. 2. Female subjects of child-bearing potential, willing to use contraceptive method(s), agreed by the Investigator, to prevent pregnancy during the study. 3. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before initiating any study related procedures. 4. Ability to understand and fully comply with all study procedures and restrictions. 5. A confirmed diagnosis of T1DM and who have been on an approved basal-bolus insulin regimen for at least 6 months prior to Screening. The type or brand of insulins should not have changed in the 6 months before Screening. 6. Do not expect to change the brand or type of their basal insulin during the study. 7. C-peptide ≤ 1.0 ng/mL 8. HbA1c ≤ 10.0% 9. Body mass index (BMI) ≥ 19 kg/m2 and ≤ 35 kg/m2 10. Adherence to a prudent diet and exercise regimen recommended by the medical provider in accordance with local standard of care or American Diabetes Association recommendations, and willingness to maintain this regimen consistently for the duration of the study. Exclusion Criteria: 1. Participation in another clinical study within 30 days or 5 half-lives of last dose of experimental medication before Screening, whichever is longer. 2. Previous use of Gan & Lee Insulin Lispro Injection. 3. Use of insulin neutral protamine hagedorn or insulin detemir within 6 months prior to study entry. 4. Current or expected use of an insulin pump or use of continuous glucose measurement to monitor blood glucose during the study. 5. Diabetic ketoacidosis (DKA) within 6 months before Screening. 6. Brittle T1DM within 1 year before Screening, defined as more than 2 hospitalizations related to diabetes mellitus (excluding hospitalizations for diagnostic purposes), and/or severe hypoglycemia for which the subject experiences severe cognitive impairment requiring external assistance for recovery. 7. Renal replacement therapy required or with an estimated (or measured) glomerular filtration rate < 15 mL/min (Modification of Diet in Renal Disease calculation). 8. Any clinically significant cardiovascular (CV) or cerebrovascular event, e.g., myocardial infarction (MI), acute coronary syndrome (ACS), recent revascularization (including coronary artery bypass graft procedures [CABG], percutaneous coronary intervention [PCI]), transient ischemic attack (TIA), or hemorrhagic or ischemic stroke within 3 months before Screening. 9. History of congestive heart failure defined as New York Heart Association (NYHA) Stage III or IV. 10. Inadequately controlled or unstable hypertension as defined by a systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and/or Randomization. 11. Inadequately controlled thyroid disease, as reflected by abnormal TSH and free T4 values. (Hypothyroid or hyperthyroid conditions should be resolved or stabilized before Screening according to local standard of care). 12. Any clinically significant (in the opinion of the Investigator) hematology, chemistry, or urinalysis test results at Screening, including any liver function test > 3X of the upper limit of normal (ULN) or bilirubin > 1.5X of the ULN (subjects with elevated bilirubin due to Gilbert syndrome are eligible to participate, if such tests were performed in the past). 13. Autonomic neuropathy resulting in a diagnosis of gastroparesis. 14. Hemoglobin < 12 g/dL for males or < 11 g/dL for females at Screening. 15. Hospitalization within the 14 days before Screening, or planned hospitalization at any time during the study. 16. Newly prescribed or high-dose (60 mg/day prednisone or equivalent) treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents due to disorders of the immunological system, such as rheumatoid arthritis, psoriasis, spondyloarthritis, and asthma, within 60 days before Screening (Medications under following scenario are allowed: chronically administered oral, inhaled, topical, or intra-articular corticosteroids at a stable dosage; stable therapy with disease modifying agents [e.g., methotrexate, sulfasalazine]; disease is inactive [e.g., remission, well controlled stable phase]; and no significant changes in treatment scheme are expected). 17. History of human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infections. 18. Any unresolved infection or a history of active infection within 30 days before screening other than mild viral illness (as judged by the Investigator). 19. Current use of other medications for diabetes treatment, such as dipeptidyl peptidase 4 inhibitors (DPP4i), glucagon-like peptide 1 receptor agonists (GLP1-R), or sodium glucose cotransporter 2 inhibitors (SGLT2i) (See Appendix 1 [Section 16.1] for a list of prohibited medications). 20. A history of alcohol use of more than two drinks a day on average for the last year, or a history of alcohol or substance abuse within 2 years before Screening. 21. Previous (within 3 months before Screening) or anticipated treatment with interferons. 22. History of malignancy (except for treated non-melanoma skin cancer and treated cervical adenocarcinoma in situ) within 5 years before Screening 23. Receiving blood transfusion or undergoing plasmapheresis within 6 months before Screening. 24. History of splenectomy. 25. Intolerance or history of hypersensitivity to insulin lispro or any excipient of the study drugs. 26. Any other clinically significant medical or psychiatric condition, or one requiring further evaluation that in the opinion of the Investigator could interfere with conduct of the study or interpretation of the data. ; PRIMARY OUTCOME: Treatment developed AIAs or important increase in AIA titers; SECONDARY OUTCOME 1: Percentage of subjects with negative AIA at baseline who develop positive AIA after baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Two Dose Schedule (Ages 9-14); BRIEF: This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females. ; DRUG USED: Cervarix; DRUG CLASS: Vaccine; INDICATION: Human papillomavirus (HPV) Prevention (Antiviral, Vaccines); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol - A female between, and including, 9 and 25 years of age at the time of the first vaccination - Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form - Healthy subjects - Female subjects of non-childbearing potential may be enrolled in the study - Female subjects of childbearing potential may be enrolled in the 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 vaccination period and up to two months after the last study vaccine dose Exclusion Criteria: - Pregnant or breastfeeding - A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose - Previous vaccination against HPV or planned administration of another HPV vaccine during the study - Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian. - Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines - Cancer or autoimmune disease under treatment - Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window - 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 - Previous administration of MPL or AS04 adjuvant. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period - Any confirmed or suspected immunosuppressive or immunodeficient condition - Family history of congenital or hereditary immunodeficiency - Major congenital defects or serious chronic illness - 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 - Acute disease and/or fever at the time of enrolment ; PRIMARY OUTCOME: Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7; SECONDARY OUTCOME 1: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 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 - vs. PP1M; BRIEF: The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M. ; DRUG USED: Invega Trinza; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator - A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120 - Signed informed consent - Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control - Men must agree to use a double-barrier method of birth control - Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria: - A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis - Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc) - A diagnosis of substance dependence within 6 months before screening - History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia - Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness - Clinically significant findings in biochemistry, hematology, ECG or urinalysis results - Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase; SECONDARY OUTCOME 1: Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OA Safety Study (vs. NSAIDs); BRIEF: The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees. ; DRUG USED: Tanezumab; DRUG CLASS: Biologic; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Nerve growth factor (NGF)/receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader - Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period - WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening - Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study - Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements Exclusion Criteria: - Subjects exceeding protocol defined BMI or body weight limits - History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments - Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer - A history of osteonecrosis or osteoporotic fracture - History of significant trauma or surgery to a knee, hip or shoulder within the previous year - Planned surgical procedure during the duration of the study - Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain - Signs or symptoms of carpal tunnel syndrome in the year prior to Screening - Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required - Contraindications to magnetic resonance imaging - History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated - History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated - Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period - History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision - Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol - Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities - History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy - History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder - History of known alcohol, analgesic or drug abuse within 2 years of Screening - Previous exposure to exogenous NGF or to an anti-NGF antibody - History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein - Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening - Evidence of protocol defined orthostatic hypotension at Screening - Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening - Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits - Presence of drugs of abuse in screening urine toxicology panel - Positive hepatitis B, hepatitis C or HIV test results indicative of current infection - Participation in other investigational drug studies within protocol defined time limits - Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study ; PRIMARY OUTCOME: Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome; SECONDARY OUTCOME 1: Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome[/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 - OneStep-2; BRIEF: The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers. ; DRUG USED: Locilex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Foot and Other Ulcers; TARGET: Bacteria-miscellaneous, Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Dipexium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Diabetes mellitus. 2. Male or female at least 18 years old. 3. Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent. 4. Subject is to be treated on an outpatient basis. 5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement. 6. Localized mild infection of the ulcer. 7. The diagnosis of mild infection must be confirmed immediately following debridement at Baseline. 8. Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot. Exclusion Criteria: 1. IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement. 2. IDSA-defined severe infection, including systemic toxicity or metabolic instability. 3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware. 4. > 1 infected foot ulcer. 5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment. 6. Subject has received a systemic antibiotic within 48 hours prior to Screening. 7. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer. 8. Bone or joint involvement is suspected based on clinical examination or plain X-ray. 9. Clinically significant peripheral arterial disease requiring vascular intervention. 10. Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home. ; PRIMARY OUTCOME: Number of Participants With Clinical Response; SECONDARY OUTCOME 1: Number of Participants With Microbiological 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 - CADHUM; BRIEF: This is a study that invites adults with Crohns disease and have been responding well to Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance medications in Crohns disease, particularly when in remission. Patients want to know that they truly need to take a medication, yet they dont want to have flares. The purpose of this study is to see that if we monitor the patient, along with looking at changes in their stool samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks, or add as-needed dosing only, and keep them in remission. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Peter Higgins; CRITERIA: Inclusion Criteria: 1. Men or women 18 years of age or older at the time of informed consent. 2. Crohns disease confirmed by endoscopy with biopsies. 3. On maintenance Adalimumab at a dose of 40 mg SC q 2 weeks without concomitant immunosuppressive therapy. 4. Must be in clinical remission (CDAI <150) at the baseline/randomization (Week 0) visit and biologic remission (both CRP <0.8 and FCP <167)at Week 0. 5. Prior medication for Crohns disease may include one of the following and must have been stopped with wash out periods: Methotrexate, Azathioprine, 6-Mercaptopurine, Tacrolimus, Steroids. 6. Negative for TB, Hepatitis B-negative, and negative stool for Clostridium difficile. Exclusion Criteria 1. Unable to consent for themselves. 2. Are prisoners, students or employees of the investigators, or mentally incapacitated. 3. Are unwilling to complete this 48 week study, provide stool samples throughout, or unwilling to undergo multiple venipunctures. 4. Have a current infection with Clostridium difficile, clinically-significant intestinal stricture, history of allergy, or adverse reaction, to Adalimumab, history of sensitivity to latex. 5. Are currently using steroids or systemic immunomodulators (MTX, AZA, 6-MP, or Tacrolimus), or have used another biologic medication in the past 12 weeks other than Adalimumab, or have current or past use of Kineret® (Anakinra) or Tysabri® (natalizumab). 6. Have received any live bacterial or viral vaccinations ≤ 12 weeks prior to Week 0 and must not receive 12 months after study as well as BCG vaccination 7. Are known to have congestive heart failure. 8. Have a history of, or ongoing chronic or recurrent infectious disease, including but not limited to chronic renal, chest infection (i.e. bronchiectasis) or urinary tract infection (i.e. recurrent pyelonephritis) or open, draining, or infected skin wounds or ulcers. 9. Have evidence of current clinically active and important infection. 10. Have or ever had a non-tuberculous mycobacterium infection or serious opportunistic infection (i.e. cytomegalovirus, Pneumocystis carinii, aspergillosis). 11. Are known to be infected with HIV, Hepatitis B, or Hepatitis C. 12. Have severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. 13. Have a known history of lymphoproliferative disease including lymphoma. Have a history of certain malignancies within five years of screening. ; PRIMARY OUTCOME: Percent Time in Remission (PTIR) in PRNLOAD vs. Placebo arms; SECONDARY OUTCOME 1: Percent Time in Remission MAINT vs. PRNLOAD[/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 - OPTIMIST-2 (w/Sofosbuvir) (Cirrhotic; GT1); BRIEF: The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced. ; DRUG USED: Olysio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Janssen Infectious Diseases BVBA; CRITERIA: Inclusion Criteria: - Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening). - HCV ribonucleic acid (RNA) greater than 10,000 IU/mL at screening - Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin - Participants must have an hepatic imaging procedure (ultrasound, computerized tomography scan or magnetic resonance imaging scan) within 6 months prior to the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma - Participant must be willing and able to comply with the protocol requirements - Participants with liver cirrhosis Exclusion Criteria: - Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy) - Infection/co-infection with HCV non-genotype 1 - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening) - Co-infection with hepatitis B virus (hepatitis B-surface-antigen positive) - Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection ; PRIMARY OUTCOME: Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT); SECONDARY OUTCOME 1: Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)[/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 206; BRIEF: Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia. ; DRUG USED: Collategene; DRUG CLASS: Biologic; INDICATION: Peripheral Arterial Disease (PAD); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: AnGes USA, Inc.; CRITERIA: Inclusion Criteria: 1. Subjects with CLI (Severe Rutherford 4 and Rutherford 5) who have: - No option for revascularization by endovascular intervention or surgical bypass or - Poor option (high risk) for revascularization by surgery and no option for an endovascular intervention (see Section 3.1 Study Population for full definition for appropriate inclusions). 2. Subjects 40-90 years of either gender who have signed an informed consent form either directly or through a legally authorized representative. 3. Subjects currently are taking a statin and an anti-platelet agent (e.g., clopidogrel, ticlopidine, aspirin, etc.) for 2 weeks or more prior to Day 0 as part of their standard of care, unless contraindicated. Subjects for whom these agents are contraindicated will have the reason for contraindication recorded in their case report form (CRF). 4. If female, the subjects must not be of child bearing potential, e.g., post-menopausal or surgically sterile. 5. If a male subject is of reproductive potential, he must agree to use an accepted and effective (barrier) form of birth control starting with the first dose of study product and continue for 12 weeks from the last dose of study product. This applies to both courses of treatment. 6. Subjects with a previous medical history of myocardial infarction and/or stroke should have adequate management of risk factors to prevent secondary occurrence. (See Section 4.2 Medical History for guidelines on appropriate secondary prevention.) 7. Subjects should have the ability to understand the requirements of the protocol and agree to return for the required study visits, assessments and follow up. - The index leg will be the leg with the greater severity of CLI disease. Entry requirements apply to the index leg. The index leg may also be referred to as the treated leg or affected leg in the text of this protocol or other study documents. If the subject has two legs that have the same Rutherford classification (severe Rutherford 4 or Rutherford 5) and are both eligible for treatment, the leg with greater disease severity (based on more extensive necrosis or more extensive/deeper ulceration(s), difference in ABI (ankle brachial index) or TBI (toe brachial index) ≥ 0.1, and/or more extensive vascular disease based on the angiogram) will be chosen as the index leg. If there is no clinical, hemodynamic or angiographic or other evidence to determine which leg has greater disease severity, the subject will be excluded from the study. - These entry criteria will be enforced (prior to randomization) by the Sponsor, as well as an Entry Committee who will review all relevant clinical data including but not limited to medical illness, CLI status, the findings of an angiogram, ulcer photographs and measurements and hemodynamic data. Exclusion Criteria: 1. Subjects whose CLI status is unstable (spontaneous marked improvement or marked worsening during the screening period) or who have excessive tissue necrosis that is unlikely to benefit from medication, or those poor option subjects requiring immediate revascularization by surgery. Stability of the CLI status will be confirmed by the Principal Investigator prior to randomization and retrospectively reviewed by the Adjudication Committee. 2. Subjects who may require a major amputation (amputation at or above the ankle) within 4 weeks of Day 0 (± 4 weeks of Day 0). 3. Subjects with ulcers with exposure of tendons, osteomyelitis or uncontrolled infection or with the largest ulcer that is greater than 20 cm2 in area (>10 cm2 area if on the heel). 4. Subjects with purely neuropathic, or with venous ulcers. 5. Subjects in Rutherford 6 class. 6. Subjects who have had revascularization by surgery or angioplasty within 3 months, unless the procedure has failed based on the anatomy or the hemodynamic measurements. 7. Subjects with a diagnosis of Buergers disease (Thrombo-angiitis Obliterans). 8. Subjects currently receiving immunosuppressive, chemo or radiation therapy. 9. Evidence or history of malignant neoplasm (clinical, laboratory or imaging) except for successfully excised basal cell or squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had successful tumor resection or radio-chemotherapy of breast cancer more than 10 years prior to inclusion in the study, and with no recurrence, may be enrolled in the study. Subjects, who had successful tumor resection or radio-chemotherapy of all other tumor types and have been in remission for more than 5 years prior to inclusion in the study, and with no recurrence, may be enrolled in the study. A dermatological exam will have ruled out any skin cancer. 10. Subjects who have proliferative retinopathy, or moderate or severe non-proliferative retinopathy, from any cause (ETDRS Score > 35), clinically significant macular oedema or previous panretinal photocoagulation therapy (Results from the Early Treatment Diabetic Retinopathy Study. Ophthalmology May 1991 Supplement 98: 823-833). 11. Females of child-bearing potential defined as subjects that are not surgically sterile or post-menopausal. 12. Subjects with severe renal disease defined as significant renal dysfunction evidenced by an estimated creatinine clearance of <30 mL/minute (calculated using the Cockcroft Gault formula), or receiving chronic hemodialysis therapy. 13. Any co-morbid condition likely to interfere with assessment of safety or efficacy endpoints, acute cardiovascular events (i.e., CVA (cardiovascular accident), MI (myocardial infarction), etc.) within 3 months of treatment, or any disease that in the opinion of the Investigator may result in subject mortality in less than 3 months. 14. Subjects with known liver disease (e.g., hepatitis B or C or cirrhosis of the liver). 15. A subject with HIV, AIDS, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohns disease, etc). 16. Subjects who have a significant psychiatric disorder or mental disability that could interfere with the subjects ability to provide informed consent or comply with study procedures. 17. Subjects with a current, uncorrected history of alcohol or substance abuse. 18. Diabetic subjects with an uncorrected HbA1c > 9.0% during the screening period. 19. Subjects that have been administered rhPDGF (e.g, becaplermin) or other growth factors locally within one month of randomization. 20. Subjects who have received another investigational drug within 30 days of randomization or have previously received any gene transfer therapy within 3 years of entering the study. ; PRIMARY OUTCOME: Major Amputation or Revascularization (of the Index Leg), All-cause Death, and Incidence of Stroke and Myocardial Infarction (MI); 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 - University of Ferrara; BRIEF: Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy, can be equally controlled by guidelines recommended regular bid treatment with long acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended treatment). ; DRUG USED: Symbicort; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Combination; LEAD SPONSOR: Università degli Studi di Ferrara; CRITERIA: Inclusion Criteria: - Male or female out-patient aged from 18 years to 65 years - Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2006 guidelines - Post-bronchodilator forced expiratory volume (FEV1) at least 80% of the predicted - Either positive methacholine challenge test (PC20 FEV1< 4mg/ml or PD20 FEV1<0.8 mg) or positive response to the reversibility test in the last year - Asthma either not adequately controlled with low-dose (≤500 mcg beclomethasone or equivalent) inhaled corticosteroids (ICS) or controlled by bid inhaled combination of low-dose ICS/long acting beta-2 agonists (LABA) - A co-operative attitude and ability to be trained to correctly use the dry powder inhalator and to complete the diary cards - Written informed consent obtained Exclusion Criteria: - Inability to carry out pulmonary function testing - Moderate severe asthma associated with reduced lung function - History of near-fatal asthma and/or admission intensive care unit because of asthma - 3 or more courses of oral corticosteroids or hospitalization for asthma during the previous year - Diagnosis of COPD as defined by the GOLD guidelines - Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 8 weeks - Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years - History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias - Diabetes mellitis - Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months - Abnormal ECG - Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases - Malignancy - Any chronic diseases with prognosis < 2 years - Pregnant or lactating females or not able to exclude pregnancy during the study period - History of alcohol or drug abuse - Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use - Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients - Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study - Patients who received any investigational new drug within the last 12 weeks - Patients who have been previously enrolled in this study ; PRIMARY OUTCOME: comparison between groups of the relative risk for treatment failure; SECONDARY OUTCOME 1: number of treatment failures[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - UNCOVER-A; BRIEF: The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization - At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization - Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization - Candidate for phototherapy and/or systemic therapy - Men must agree to use a reliable method of birth control during the study - Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Exclusion Criteria: - Pustular, erythrodermic, and/or guttate forms of psoriasis - History of drug-induced psoriasis - Clinically significant flare of psoriasis during the 12 weeks prior to randomization - Concurrent or recent use of any biologic agent - Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization - Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study - Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab - Serious disorder or illness other than plaque psoriasis - Serious infection within the last 3 months - Breastfeeding or nursing (lactating) women ; PRIMARY OUTCOME: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device; SECONDARY OUTCOME 1: PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)[/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 - GOLDEN-3; BRIEF: This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines. ; DRUG USED: Lonhala Magnair; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sunovion Respiratory Development Inc.; CRITERIA: Inclusion Criteria: 1. Male or female patients age ≥ 40 years, inclusive 2. A clinical diagnosis of COPD according to the GOLD 2014 guidelines 3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent) 4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1) 5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1) 6. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005) 7. Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, eg, condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence 8. Willing and able to provide written informed consent 9. Willing and able to attend all study visits and adhere to all study assessments and procedures Exclusion Criteria: 1. Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject 2. Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease). 3. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1) 4. Use of daily oxygen therapy > 12 hours per day 5. Respiratory tract infection within 6 weeks prior to Screening (Visit 1) 6. Use of oral, intravenous, or intramuscular steroids within 3 months prior to Screening (Visit 1) 7. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin 8. Prolonged QTcF (> 450 msec for males and > 470 msec for females) during Screening (Visit 1) as determined from the report provided by the central laboratory, or history of long QT syndrome 9. History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months. 10. History of narrow angle glaucoma 11. History of hypersensitivity or intolerance to aerosol medications 12. Recent documented history (within the previous 3 months) of substance abuse 13. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator 14. Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study 15. Previously received SUN-101 (active treatment; formerly known as EP-101). 16. Contraindicated for treatment with, or having a history of reactions/hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines ; PRIMARY OUTCOME: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12; SECONDARY OUTCOME 1: Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Sexual Function; BRIEF: Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function as well as subject satisfaction with hair growth and quality of life in men with AGA. This study will consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks, and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of double-blind, placebo controlled treatment and 24 weeks of open-label treatment with dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a change in erectile function at the end of treatment. ; DRUG USED: Avodart; DRUG CLASS: New Molecular Entity (NME); INDICATION: Androgenetic Alopecia; TARGET: steroid 5a-reductase; THERAPY: Monotherapy; LEAD SPONSOR: Stiefel, a GSK Company; CRITERIA: Inclusion Criteria: - Subject agrees to participate in the study and has signed and dated the informed consent form prior to the initiation of any study-related activities. - AGA classified utilizing the Norwood-Hamilton classification. - Men 18 to 50 years old, inclusively. - Fluent and literate in local language with the ability to comprehend and record information on the International Index of Erectile Function, Hair Growth Satisfaction Scale, and DLQI questionnaires. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%). - Have been in a stable heterosexual relationship during the last 6 months prior to screening and expect to maintain that relationship throughout the study. - Must be sexually active: a man is considered sexually active if he has engaged in sexual intercourse (at least once) during the 4 weeks prior to screening. - Men with a female partner of childbearing potential must agree to avoid exposure of his partner to semen by using a condom. Use of a condom must be from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e., a total of 4.5 months) to allow clearance of any residual drug in the semen after the last dose of study treatment. - Willing to comply with study requirements. Exclusion Criteria: - Current or pre-existing sexual dysfunction as determined by: History of erectile dysfunction defined as the consistent inability to achieve or maintain an erection sufficient to permit satisfactory sexual intercourse. Score of ≤25 on the erectile function domain (IIEF-EF) of the IIEF at screening or at the baseline visit. - Evidence of hypogonadism. - Have a communicable skin or sexually-transmitted disease, or any rash or lesions on the penis or in the surrounding area (as reported by subject and evaluated by investigator). - Serum prostate-specific antigen (PSA) >2.0 ng/mL at screening. - Serum creatinine >1.5xULN at screening. - Unstable liver disease (chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria). - History of malignancy (including prostate cancer) within the past 5 years, except basal cell or squamous cell carcinoma of the skin. - History of prostate cancer before the age of 50 years in a first degree relative. - History of breast cancer or clinical breast examination suggestive of malignancy. - Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening; and uncontrolled diabetes or peptic ulcer disease that is uncontrolled by medical management. - History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could, in the opinion of the investigator or the medical monitor, interfere with the subjects safety, obtaining informed consent, or compliance with study procedures.Note: the investigator may consult with the GSK medical monitor if a condition could interfere with the subjects safety. - Global scalp hair thinning, including occipital areas. - Scarring of the scalp, including prior hair transplant or scalp reduction, or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., tinea infection, non-androgenetic-cause of alopecia, psoriatic dermatitis or other psoriatic lesions, or uncontrolled seborrheic dermatitis). - History of hair transplantation at any time to correct AGA or use of hair weaving within 6 months prior to screening. - History or evidence of hair loss other than AGA (e.g., due to an auto-immune, endocrine, mechanical or infectious process, or secondary to a scalp dermatological disorder). - Use of any cosmetic product aimed at improving or correcting the signs of hair loss (e.g., scalp preparations with claims aiming at improved hair growth) within 2 weeks prior to screening. - Use of light or laser treatments on the scalp (e.g., light emitting diode [LED] lamps) within 3 months prior to screening. - Hypersensitivity to any 5-alpha reductase inhibitor (5-ARI) or its components or excipients or drugs chemically related to the study treatment. - Use of dutasteride within 10 months prior to screening or use of finasteride within 6 months prior to screening. - Previous use of systemic cytotoxic agents. - Use of glucocorticoids (inhaled glucocorticoids are allowed; topical corticosteroids are allowed provided that they are not used on the scalp) within 3 months prior to screening. - Use of the following prior to Baseline (within 1 week for topical products; within 1 week or 5 half-lives, whichever is longer, for systemic treatments): Phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); Minoxidil (oral or topical); Carpronium chloride; Systemic drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, and bicalutamide); Topical or systemic estrogen or progesterone; Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens); Drugs potentially causing hypertrichosis or telogen effluvium (e.g., valproic acid); Anabolic steroids; - Participation in any study of an investigational or marketed drug (within 5 half lives of drug) or device that may affect hair growth or sexual function prior to screening for this study. Note: Subject must not participate in any other drug or device studies during the course of this study. ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period; SECONDARY OUTCOME 1: Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - STEADFAST; BRIEF: The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreichs Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients. ; DRUG USED: Actimmune; DRUG CLASS: Biologic; INDICATION: Friedreichs Ataxia; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Horizon Pharma Ireland, Ltd., Dublin Ireland; CRITERIA: Inclusion Criteria: - Written informed consent and child assent, if applicable. - FA confirmed by genetic testing with two expanded guanine-adenine-adenine (GAA) repeats. - FA functional stage of >1 to <5 and ability to walk 25 feet with or without an assistive device. - Male or female subject between the ages of 10 and 25 years, inclusive. - If female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. Female subjects of child-bearing potential must have a negative serum pregnancy test result at Screening, a negative urine pregnancy test result at Baseline, and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug. Exclusion Criteria: - Any unstable illness that in the investigators opinion precludes participation in the study. - Use of any investigational product within 30 days prior to randomization. - A history of substance abuse. - Presence of clinically significant cardiac disease (as determined by the investigator based on electrocardiogram [ECG] and echocardiogram results at Screening). Specifically, an ejection fraction of <40% or a prolonged QT interval (>50% of cycle duration) will result in exclusion. If the investigator notes any other clinically significant abnormalities on the ECG or echocardiogram, the subject may be eligible if they are provided clearance from a cardiologist. - History of hypersensitivity to interferon (IFN)-ɣ or E. coli-derived products. - Presence of moderate or severe renal disease (estimated creatinine clearance <50 mL/min) or hepatic disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2x the upper limit of normal) as evidenced by laboratory results at Screening. - Clinically significant abnormal white blood cell count, hemoglobin, or platelet count as evidenced by laboratory test results at Screening. ; PRIMARY OUTCOME: Change From Baseline to Week 26 in the Friedreichs Ataxia Rating Scale (FARS)-mNeuro Score; SECONDARY OUTCOME 1: Change From Baseline to Week 26 in Activities of Daily Living (ADL) 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 - PC4; BRIEF: This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer. ; DRUG USED: G17DT; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: gastrin1-17 (G17), Immune System, Protein synthesis; THERAPY: Combination; LEAD SPONSOR: Cancer Advances Inc.; CRITERIA: Inclusion criteria: - Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection - Life expectancy of at least 3 months - Functional status by Karnofsky Index of at least 70 Exclusion criteria: - Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy - Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease - Immunodeficiency - Bone marrow transplant within past year - Brain metastasis ; PRIMARY OUTCOME: Survival; SECONDARY OUTCOME 1: Number of Participants with Serious and Non-Serious Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Atosiban; BRIEF: The primary objective of this study is to demonstrate the superiority of retosiban to prolong pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is based on the hypothesis that prolonging the time to delivery in the absence of harm may benefit the newborn, particularly in women who experience spontaneous preterm labor at early gestational ages (GA). This study is designed to test this hypothesis through a direct comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks gestation in preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of any one subjects (maternal or neonatal) participation in the study will be variable and dependent on GA at study entry and the date of delivery. ; DRUG USED: Retosiban; DRUG CLASS: New Molecular Entity (NME); INDICATION: Preterm Labor; TARGET: Oxytocin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Signed and dated written informed consent is required prior to a subjects participation in the study and the performance of any protocol specific procedures. Adolescents aged 12 to 17 years must provide written agreement to participate in the study in accordance with applicable regulatory and country or state requirements. Subjects will also be asked to sign a release for medical records at the time of consenting to allow access to both the maternal and neonatal records including information about delivery and infant care as well as information collected prior to the consent having been signed. - Females aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm labor (Note: This protocol includes pregnant adolescents, aged 12 to 17 years, as appropriate, based on national or local regulations.). - Gestational age between 24^0/7 and 33^6/7 weeks as determined by known fertilization date, either in vitro fertilization or intrauterine insemination, last menstrual period confirmed by the earliest ultrasound prior to 24^0/7 weeks gestation, or the earliest ultrasound alone prior to 24^0/7 weeks gestation, whichever is the most accurate method available for each subject. In situations where prenatal ultrasound records are not available at the time the subject presents, the investigator will make every effort to obtain these records (either via computer records, directly from the subjects primary care obstetrician, or via telephone). However, in cases in which these records are not readily available (e.g., off hours, holiday), it is within the investigators discretion to use GA based on a verbal history from the subject with the intent of getting confirmation from the medical records as soon as possible. - Subjects must be diagnosed with preterm labor according to both of the following criteria: Regular uterine contractions at a rate of >=4 contractions of at least 30 seconds duration during a 30-minute interval confirmed by tocodynamometry AND at least 1 of the following: Cervical dilation >=2 centimeter (cm) and <=4 cm by digital cervical examination or If <2 cm dilation by digital cervical examination, a cervical change consisting of an increase of at least 25% effacement or 1 cm dilation - Treatment naïve subjects and subjects not adequately responding to tocolytics other than atosiban (e.g., transfers from other care units) during their current episode of preterm labor may be eligible for the study. Historical failure of a tocolytic treatment in a previous episode of preterm labor is not a required inclusion criterion. Tocolytic failure is defined by progressive cervical changes or continuing uterine contractions. Exclusion Criteria: - Fever with a temperature greater than 100.4°fahrenheit (F) (38°Celcius [C]) for more than 1 hour or >=101°F (38.3°C) in the 24 hours prior to the start of study treatment. - Women with maternal-fetal conditions that potentially necessitate the need for delivery, such as pre-eclampsia or fetal compromise - A fetus with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety (e.g., nonreassuring fetal status, intrauterine growth restriction, major congenital anomaly). - Preterm premature rupture of membranes - Women with any confirmed or suspected contraindication to prolongation of pregnancy, such as placental abruption, chorioamnionitis, or placenta previa - Evidence of polyhydramnios (amniotic fluid index [AFI] >25 cm) or oligohydramnios (AFI <5 cm). - Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes, such as uncontrolled hypertension, uncontrolled diabetes (if known, history of glycosylated hemoglobin >8% at any time during pregnancy), or compromise the safety of the subject, such as underlying cardiovascular disorder (specifically ischemic cardiac disease, congenital heart disease, pulmonary hypertension, valvular heart disease, arrhythmias, and cardiomyopathy). - Women with a history of substance abuse or urine drug screen findings suggestive of substance abuse that may either be implicated as the cause of preterm labor (e.g., abuse of cocaine or methamphetamines) or have the potential to complicate the pregnancy outcome (e.g., alcohol abuse or opioid addiction). - Women with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety. - Women with documented active hepatitis B or hepatitis C viral infection, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - History of sensitivity to the IPs or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK)/PPD medical monitor, contraindicates their participation. ; PRIMARY OUTCOME: Time to Delivery From the Start of Investigational Product (IP) Administration; SECONDARY OUTCOME 1: Number of Participants With Births Prior to 37 0/7 Weeks Gestation[/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 - SI04010; BRIEF: A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks. ; DRUG USED: Rapaflo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Benign Prostatic Hyperplasia (BPH); TARGET: Alpha 1 Adrenergic Receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Watson Pharmaceuticals; CRITERIA: Inclusion Criteria: - Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH. Exclusion Criteria: - Medical conditions that would confound the efficacy evaluation. - Medical conditions in which it would be unsafe to use an alpha-blocker. - The use of concomitant drugs that would confound the efficacy evaluation. - The use of concomitant drugs that would be unsafe with this alpha-blocker. ; PRIMARY OUTCOME: Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks; SECONDARY OUTCOME 1: Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GETGOAL-O (w/Basal Insulin and/or Oral Antidiabetic); BRIEF: Primary objective: - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen. Main secondary objective: - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects). Other secondary objectives: - To assess the effect of lixisenatide compared to placebo after 24-week treatment on: - Fasting plasma glucose (FPG); - During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion; - 7-point Self-monitored plasma glucose (SMPG) profile; - Body weight; - Change in total daily dose of basal insulin (if taken); - Percentage of participants requiring rescue therapy - Safety and tolerability; - To assess lixisenatide pharmacokinetic profile; - To assess anti-lixisenatide antibody development. ; DRUG USED: Adlyxin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Older participants, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen. - Signed written informed consent. Exclusion criteria: - At screening HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older participants and that this was the responsibility of the investigator to include the participant based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia). - At screening participants on both basal insulin and sulfonylurea or basal insulin and meglitinides. - At screening FPG >250 mg/dL (>13.9 mmol/L). - Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit. - Type 2 diabetes mellitus diagnosed less than 1 year prior to screening. - Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening. - Treatment within the 3 months preceding the screening with other anti-diabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea (except glibenclamide >10mg, gliclazide >160mg), meglitinides (except repaglinide >6mg), pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population. - Participants who had been on an approved or an investigational Glucagon-like peptide 1 (GLP-1) medication (exenatide, liraglutide, lixisenatide or others). - History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening. - BMI <22 or >40 kg/m^2. - Malnutrition assessed clinically by the investigator or any sub-investigator and by Mini-Nutritional Assessment-Short Form (MNA-SF) score <12 in countries (the judgment of the investigator prevails on questionnaires scores). - Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by Mini Mental State Examination (MMSE) score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that affected the participants ability to participate in the study. - Participant who had a glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease (MDRD) formula <30ml/min/1.73m^2). - Participant with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment. - Laboratory findings at the time of screening: - Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times ULN - Calcitonin >20 pg/mL (5.9 pmol/L). - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) and not controlled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening. - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. - Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposed to medullary thyroid cancer (e.g., multiple endocrine neoplasia syndromes). The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Absolute Change in HbA1c From Baseline to Week 24; SECONDARY OUTCOME 1: Change in 2-Hour PPG From Baseline to 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 - SPD489-336 (Long-term Safety); BRIEF: The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable. ; DRUG USED: Vyvanse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Combination; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - 18 to 65 years of age - Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject) - Fixed home/place of residence and can be reached by telephone - On a stable dose of antipsychotic medications - Able to swallow capsules Exclusion Criteria: - -Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products - Treated with clozapine in past 30 days - Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence - History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourettes Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinsons disease, or intracranial lesions - Uncontrolled hypertension - History of thyroid disorder that has not been stabilized on thyroid medication - Glaucoma - Pregnant or nursing - Subject has received an investigational product or participated in a clinical study within 30 days ; PRIMARY OUTCOME: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks; SECONDARY OUTCOME 1: Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 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 - A0081185; BRIEF: The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance. ; DRUG USED: Lyrica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Restless Leg Syndrome (RLS); TARGET: Voltage-gated calcium channels; THERAPY: Monotherapy; LEAD SPONSOR: Pfizers Upjohn has merged with Mylan to form Viatris Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS). - RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months. - PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs. Exclusion Criteria: - Secondary RLS. - Daytime RLS symptoms requiring treatment. - Primary sleep disorder. - Sleep apnea. - Night or shift work. - Concurrent medical disorder that could interfere with efficacy assessment or present a safety concern. - Pregnant or lactating women. - Women of child-bearing potential not using acceptable method of birth control. - Use of prohibited medication. ; PRIMARY OUTCOME: Wake After Sleep Onset (WASO); SECONDARY OUTCOME 1: Periodic Limb Movement Arousal Index (PLMAI)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Dacarbazine; BRIEF: The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma. ; DRUG USED: Masitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: AB Science; CRITERIA: Main inclusion criteria include: - Patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4 melanoma - Patient with detectable c-Kit JM mutation (mutation in exon 9, 11 or 13) confirmed by DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma). - Patient not previously treated for melanoma (first-line) Main exclusion criteria include: - Pregnant, or nursing female patient - Patient with active brain metastases. - Prior treatment with a tyrosine kinase c-Kit inhibitor ; PRIMARY OUTCOME: Objective Response Rate; SECONDARY OUTCOME 1: 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 - 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 - SUNRISE 1 (Age 55+); BRIEF: This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder. ; DRUG USED: Dayvigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Insomnia; TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria 1. Male age 65 years or older or female age 55 years or older at the time of informed consent 2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for Insomnia Disorder, as follows: - Complains of dissatisfaction with nighttime sleep, in the form of difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep (Note that if the complaint is limited to difficulty initiating sleep, the participant is not eligible) - Frequency of complaint ≥ 3 times per week - Duration of complaint ≥ 3 months - Associated with complaint of daytime impairment 3. History of subjective wake after sleep onset (sWASO) typically ≥ 60 minutes on at least 3 nights per week in the previous 4 weeks 4. Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours 5. Reports habitual bedtime, defined as the time the participant attempts to sleep, between 21:00 and 24:00 and habitual waketime between 05:00 and 09:00 6. Insomnia Severity Index (ISI) score ≥ 13 7. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary before the second screening visit 8. Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary 9. Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary 10. Objective (polysomnography [PSG]) evidence of insomnia as follows: a) Wake after sleep onset (WASO) average ≥ 60 minutes on the 2 consecutive PSGs, with neither night < 45 minutes 11. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night 12. Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participants participation in the study Exclusion Criteria 1. A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows: 1. STOPBang score ≥5 2. International Restless Legs Scale score ≥16 3. Epworth Sleepiness Scale score >15 (scores of 11 to 15 require excessive daytime sleepiness to be recorded in participants Medical History) 2. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy 3. On the Munich Parasomnia Scale (MUPS), endorsed the item that corresponds to a history of sleep-eating or reports a history of sleep-related violent behavior, sleep-driving, or symptoms of another parasomnia that in the investigators opinion make the participant unsuitable for the study 4. Apnea-Hypopnea Index > 15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the second screening visit 5. Beck Depression Inventory - II (BDI-II) score >19 at Screening 6. Beck Anxiety Index (BAI) score >15 at Screening 7. Habitually naps during the day more than 3 times per week 8. Is a female of childbearing potential Note: All females will be considered to be of childbearing potential unless they are postmenopausal (defined as amenorrheic for at least 12 consecutive months, and are postmenopausal without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). 9. Excessive caffeine use that in the opinion of the investigator contributes to the participants insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study. 10. History of drug or alcohol dependency or abuse within approximately the previous 2 years 11. Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males), or unwilling to limit alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3 hours before bedtime for the duration of his/her participation in the study 12. Known to be positive for human immunodeficiency virus 13. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening 14. A prolonged QT/QTcF interval (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF interval >450 ms) 15. Current evidence of clinically significant disease (e.g., cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; gastrointestinal; severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 years other than adequately treated basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessments, including the ability to perform tasks on the cognitive performance assessment battery (PAB). Participants for whom a sedating drug would be contraindicated for safety reasons because of the participants occupation or activities are also excluded. 16. Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night 17. Any history of a medical or psychiatric condition that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessment, including the ability to perform the PAB. 18. Any suicidal ideation with intent with or without a plan, at the time of or within 6 months before the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) administration during the Prerandomization Phase (i.e., answering Yes to questions 4 or 5 on the Suicidal Ideation section of the eC-SSRS) 19. Any suicidal behavior in the past 10 years (per the Suicidal Behavior section of the eC-SSRS) 20. Scheduled for surgery during the study 21. Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half lives, whichever is longer, before the first dose of study medication (Run-in Period). 22. Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 1 week or 5 half-lives, whichever is longer, before the first dose of study medication (Run-in Period) 23. Failed treatment with suvorexant (Belsomra®) (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator 24. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel across more than 3 time zones during the study 25. A positive drug test at Screening, Run-In, or Baseline, or unwilling to refrain from use of recreational drugs during the study 26. Hypersensitivity to lemborexant or zolpidem or to their excipients 27. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5× the half-life, whichever is longer preceding informed consent 28. Previously participated in any clinical trial of lemborexant ; PRIMARY OUTCOME: Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30; SECONDARY OUTCOME 1: Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30[/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 - Colonoscopy (US); BRIEF: A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons. ; DRUG USED: ByFavo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Paion UK Ltd.; CRITERIA: Inclusion Criteria: - Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example). - American Society of Anesthesiologists Score 1 through 3 - Body mass index ≤40 kg/m2. - For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed). - Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure. - Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy. Exclusion Criteria: - Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated. - Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity). - Chronic use of opioids for any indication. - Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline. - Lactating female patients. - Patients with positive drugs of abuse screen or a positive serum ethanol at baseline. - Patient with a history of drug or ethanol abuse within the past 2 years. - Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period. - Participation in any previous clinical trial with remimazolam. - Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason). ; PRIMARY OUTCOME: Success Rates of the Procedure; SECONDARY OUTCOME 1: Time to Start of Procedure[/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 - ALLEGRO; BRIEF: Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). ; DRUG USED: Nerventra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Aryl hydrocarbon receptor (AhR); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: 1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846], with a relapsing-remitting disease course. 2. Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.5. 3. Subjects must be in a stable neurological condition and free of corticosteroid treatment [intravenous (iv), intramuscular (im) and/or per os (po)] 30 days prior to screening (month -1). 4. Subjects must have had experienced one of the following: - At least one documented relapse in the 12 months prior to screening - At least two documented relapses in the 24 months prior to screening - One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening. 5. Subjects must be between 18 and 55 years of age, inclusive. 6. Subjects must have disease duration of at least 6 months (from the first symptom) prior to screening. 7. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partners vasectomy or double-barrier method (condom or diaphragm with spermicide). 8. Subjects must be able to sign and date a written informed consent prior to entering the study 9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study. Exclusion Criteria: 1. Subjects with progressive forms of MS 2. An onset of relapse, unstable neurological condition or any treatment with corticosteroids [intravenous (iv), intramuscular (im) and/or per os (po)] or ACTH between month -1 (screening) and 0 (baseline). 3. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. 4. Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit. 5. Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod. 6. Previous treatment with glatiramer acetate (Copaxone®) Interferon-β (either 1a or 1b) or IVIG within 2 months prior to screening visit. 7. Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit. 8. Previous total body irradiation or total lymphoid irradiation. 9. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. 10. A known history of tuberculosis. 11. Acute infection two weeks prior to baseline visit. 12. Major trauma or surgery two weeks prior to baseline 13. A history of vascular thrombosis (excluding catheter-site superficial venous thrombophlebitis). 14. A carrier state of factor V Leiden mutation (either homo- or heterozygous) as disclosed at screening. 15. Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody as disclosed at screening visit. 16. Use of potent inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine) see detailed list in Appendix 5 17. Use of amiodarone within 2 years prior to screening visit. 18. Pregnancy or breastfeeding. 19. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include: - A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol. - A gastrointestinal disorder that may affect the absorption of study medication. - Renal or metabolic diseases. - Any form of chronic liver disease, including known non-alcoholic steatohepatitis. - A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin - A QTC interval (obtained from either 2 ECG recordings at screening or from the mean value calculated from 3 measurements at baseline visit) which is >450msec. - A family history of Long- QT syndrome. - A history of drug and/or alcohol abuse. - Major psychiatric disorder. 20. A known history of sensitivity to Gd. 21. Inability to successfully undergo MRI scanning. 22. Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate. Exclusion Criteria: 1. Subjects who suffer from any form of progressive MS. 2. Any condition which the investigator feels may interfere with participation in the study. 3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, 4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening 5. Previous treatment with immunomodulators within two months prior to screening 6. Pregnancy or breastfeeding. ; PRIMARY OUTCOME: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period; SECONDARY OUTCOME 1: Composite Endpoint: Sum of the Number of T1 Gadolinium (Gd)-Enhanced Lesions on T1-Weighted MRI Images[/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 - 136 (Japan); BRIEF: This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks. ; DRUG USED: Janumet; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK), Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Type 2 Diabetes Mellitus (T2DM) - Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or - Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and < 10.0% Exclusion Criteria: - Type 1 diabetes mellitus, - Secondary diabetes mellitus, or - Gestational diabetes mellitus ; PRIMARY OUTCOME: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CF301 - EU/Australia; BRIEF: The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment. ; DRUG USED: Bronchitol; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Pharmaxis; CRITERIA: Main Inclusion Criteria: - Written informed consent - Confirmed diagnosis of cystic fibrosis - Aged > 6 years - FEV1 >30 % and < 90% predicted - Able to perform all the techniques necessary to measure lung function Main Exclusion Criteria: - Terminally ill or listed for lung transplantation - Had a lung transplant - Using nebulised hypertonic saline - Significant episode of haemoptysis (>60 mL) in the three months prior to enrolment - Recent myocardial infarction or cerebral vascular accident - Breast feeding or pregnant, or plan to become pregnant while in the study participating in another investigative drug study, parallel to, or within 4 weeks of study entry - Allergy or intolerance to mannitol - Using beta blockers - Have a condition or be in a situation which in the Investigators opinion may put the subject at significant risk, may confound results or may interfere significantly with the patients participation in the study ; PRIMARY OUTCOME: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control; SECONDARY OUTCOME 1: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF on existing RhDNase treatment compared to control. (key objective)[/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 - BIA-2093-307; BRIEF: The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase. ; DRUG USED: Aptiom; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Bial - Portela C S.A.; CRITERIA: Inclusion Criteria: - Male and female outpatients aged 18 years or older. Female subjects are of nonchildbearing potential, defined as surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or at least 2 years postmenopausal (spontaneous amenorrhea for at least 24 months before Visit 1), or if of childbearing potential, subjects agree to use a medically acceptable nonhormonal method of contraception. - Diagnosis of Type 1 or Type 2 diabetes mellitus. - Pain due to bilateral peripheral polyneuropathy caused by Type 1 or Type 2 diabetes mellitus. - Have stable glycemic control, as assessed by the investigator, and have glycosylated hemoglobin proportion of less or equal than 11% before randomization. - A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days). - Compliance with patient diary completion. - If not used to treat DNP, subjects are permitted to take nonsteroidal anti inflammatory drugs and selective serotonin reuptake inhibitors if they were kept on a stable dose for 1 month prior to Screening and are foreseen to remain stable throughout the study. - Competent and able to freely give own informed consent. - Female subjects of childbearing potential, who are not currently breastfeeding, must have a negative serum pregnancy test at Visit 1. Exclusion Criteria: - Historical exposure to drugs known to cause neuropathy. - Significant skin lesions (active infection, ulcer, etc). - Peripheral vascular disease with a history of amputation, except amputation of toes. - Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications. - Subjects who previously participated in a clinical study with ESL. - Major psychiatric disorders. - Serious or unstable disease that could compromise participation cause hospitalization during the study. - Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator. - Subjects taking the following drug classes and individual drugs are excluded: benzodiazepines (except short half life sleep agents), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletine, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants, tricyclic antidepressants, and serotonin norepinephrine reuptake inhibitors. These drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide. - Relevant clinical laboratory abnormality that, in the investigators opinion, can compromise the subjects safety. - History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine. - Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry. - History of recurrent epileptic seizures except febrile seizures. - History of severe gastroparesis or gastric bypass surgery. - Neurolytic treatment for DNP. - Injected anesthetics or steroid use within 30 days of Visit 1. - Malignancy within past 2 years. - History of chronic hepatitis B or C within the past 3 months or human immunodeficiency virus infection. ; PRIMARY OUTCOME: Change From Baseline to Endpoint in Mean Pain; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HIMALAYAS; BRIEF: The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD. ; 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: FibroGen; CRITERIA: Inclusion Criteria: - Participant has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines. - Receiving HD or PD for ESRD for a minimum of 2 weeks and a maximum of 4 months, prior to randomization. - Hemodialysis access consisting of an arteriovenous (AV) fistula, AV graft, or tunnelled (permanent) catheter; or PD catheter in use. - Mean of the two most recent predialysis Hb values during the Screening Period, obtained at least 2 days apart, must be ≤ 10.0 g/dL, with a difference of ≤ 1.3 g/dL between the highest and the lowest values. The last Hb value must be drawn within 10 days prior to randomization. - Ferritin ≥ 100 nanograms (ng)/milliliter (mL) (≥ 220 picomoles (pmol)/L); participants with ferritin level < 100 ng/mL(<220 pmol/L) during screening, qualify after receiving iron supplement (per local standard of care), without the need to retest ferritin prior to randomization. - Transferrin saturation ≥ 20%; participants with TSAT level < 20% during screening, qualify after receiving iron supplement (per local standard of care), without the need to retest TSAT prior to randomization. - Serum folate level, performed within 8 weeks prior to randomization ≥ lower limit of normal (LLN); participants with serum folate level < LLN during screening, qualify after receiving folate supplement (per local standard of care), without the need to retest folate prior to randomization. - Serum vitamin B12 level, performed within 8 weeks prior to randomization ≥ LLN; participants with vitamin B12 level < LLN during screening, qualify after receiving B12 supplement (per local standard of care), without the need to retest B12 prior to randomization. - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 * upper limit of normal (ULN), and total bilirubin ≤ 1.5 * ULN. - Body weight up to 160 kg (HD participants: dry weight). Exclusion Criteria: - Total duration of prior effective ESA use must be ≤3 weeks within the preceding 12 weeks at the time informed consent is obtained. Specific dosing guidance, depending on the type of ESAs, injected IV or SC within 12 weeks prior to start of screening are as follows: i) Short-acting ESAs (EPO-alfa or equivalents) - IV: Up to 9 doses, last EPO dose must be ≥2 days prior to start of screening; SC: Up to 3 doses, last EPO dose must be ≥1 week (7 days) prior to start of screening ii) Darbepoetin - IV: Up to 3 doses, last darbepoetin dose must be ≥1 week (7 days) prior to start of screening; SC: Up to 2 doses, last darbepoetin dose must be ≥2 weeks (14 days) prior to start of screening iii) Continuous erythropoietin receptor activator (CERA) IV and SC: Up to 2 doses; last CERA dose must be ≥2 weeks (14 days) prior to start of screening - Intravenous iron: there is no restriction regarding IV iron use during screening, provided it is administered in accordance with local SOC. - Red blood cell transfusion within 4 weeks prior to randomization. - Active, clinically significant infection that could be manifested by white blood cell (WBC) count > ULN, and/or fever, in conjunction with clinical signs or symptoms of infection at the time of randomization. - History of chronic liver disease (for example, chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver). - New York Heart Association Class III or IV congestive heart failure at screening. - Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event within a major vessel (excluding vascular dialysis access) (for example, deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization. - Uncontrolled hypertension, in the opinion of the Investigator, (for example, that requires a change in anti-hypertensive medication) within 2 weeks prior to randomization. - Renal imaging performed within 12 weeks prior to randomization indicative of a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category 2 or higher) of renal cell carcinoma. - 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. - Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab). - Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission. - Known, untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration, or retinal vein occlusion (participants who are already blind for the above reasons qualify to participate). - Known history of myelodysplastic syndrome or multiple myeloma. - 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). - Known hemosiderosis, hemochromatosis, coagulation disorder, or a hypercoagulable condition. - Organ transplant: participants with any of the following: 1. Experienced rejection of a transplanted organ within 6 months of transplantation 2. Currently on high doses of immunosuppressive therapy (per discretion of the Investigator) 3. Scheduled for organ transplantation. Note: being on a waiting list for kidney transplant is not exclusionary - Anticipated elective surgery, except for vascular access surgery or dialysis catheter placement, that is expected to lead to significant blood loss, or anticipated elective coronary revascularization. - Active or chronic gastrointestinal bleeding. - Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). - Use of iron-chelating agents within 4 weeks prior to randomization. - Known hypersensitivity reaction to any ESA. - Use of an investigational drug or treatment, participation in an investigational study, or presence of an expected carryover effect of an investigational treatment, within 4 weeks prior to randomization. - Anticipated use of dapsone or androgens at any dose amount or chronic use of acetaminophen or paracetamol > 2.0 g/day during the study. - History of alcohol or drug abuse within 6 months prior to randomization. - Females of childbearing potential, unless using contraception as detailed in the protocol; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use contraception. - Pregnant or breastfeeding females. - Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this study, may confound efficacy or safety assessment, or may interfere with study participation. ; PRIMARY OUTCOME: US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population); SECONDARY OUTCOME 1: US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EAGLE (+/-Tremelimumab); BRIEF: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population. ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; 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: - Age ≥18 years; - Written informed consent obtained from the patient/legal representative; - Histologically or cytologically confirmed recurrent or metastatic SCCHN; - Tumor progression or recurrence during or after only one palliative systemic treatment regimen for recurrent or metastatic disease that must have contained a platinum agent OR progression within 6 months of the last dose of platinum given as part of multimodality therapy with curative intent; - Confirmed PD-L1-positive or -negative SCCHN by the Ventana PD-L1 SP263 IHC assay; - WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; At least 1 measurable lesion, - Not previously irradiated; - No prior exposure to immune-mediated therapy; - Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Exclusion Criteria: - Histologically or cytologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck; - Received more than 1 palliative systemic regimen for recurrent or metastatic disease; -Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment; - Receipt of any investigational anticancer therapy within 28 days or 5 half-lives; - Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment; - Major surgical procedure within 28 days prior to the first dose of Investigational Product; - Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion; - Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product; - History of allogeneic organ transplantation; - Active or prior documented autoimmune or inflammatory disorders; - Uncontrolled intercurrent illness; - Patients with a history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis; - Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericias Correction; - History of active primary immunodeficiency; - Active tuberculosis; - Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV); - Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product; - Pregnant or breast-feeding female patients; - Known allergy or hypersensitivity to Investigational Product ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Overall Survival (OS) in PD-L1 Negative 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 - ORACLE MS (Early MS); BRIEF: A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS. ; DRUG USED: Mavenclad; DRUG CLASS: Non-NME; INDICATION: Multiple Sclerosis (MS); TARGET: Ribonucleotide Reductase (RNR); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Male or female between 18 and 55 years old, inclusive - Weighed between 40 to 120 kilogram (kg), inclusive - Participant has experienced a single, first clinical event suggestive of MS within 75 days prior to the Screening visit, (clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic - Participant has at least two clinically silent lesions on the T2-weighted MRI scan, at screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid or periventricular or infratentorial on screening MRI - Participant has EDSS 0 - 5.0 at Screening - Participant has no medical history or evidence of latent tuberculosis infection (LTBI) or active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or a comparable sensitive test according to local regulations/guidelines (if the Mantoux test is not available), and/or a chest X-ray - Participant has normal hematological parameters at Screening, as defined by the central laboratory that performed all the assessments - If female, she must: - be neither pregnant nor breast-feeding, nor attempting to conceive and - use a highly effective method of contraception throughout the entire duration of the study and for 90 days following completion of the last dose of study medication. A highly effective method of contraception is defined as those which result in a low failure rate (that is less than 1 percent per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner, or - be post-menopausal or surgically sterilized (Note: for Danish sites only, participants should use a hormonal contraceptive or intrauterine device for the duration of the trial) - Male participants must be willing to use contraception to avoid impregnating partners throughout the study, and for 90 days following the last dose of study medication - Be willing and able to comply with study procedures for the duration of the study - Participant has to provide written informed consent voluntarily, including, for United states of America (USA), participant authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care - Participant has refused any treatment already available for clinically isolated syndrome (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial Treatment Period of this study Exclusion Criteria: - Participant has a diagnosis of MS (per McDonald criteria, 2005) - Participant has any other disease that could better explain the participants signs and symptoms - Participant has complete transverse myelitis or bilateral optic neuritis - Participant using or has used any other approved MS disease modifying drug (DMD) - Participant has used any investigational drug or undergone an experimental procedure within 12 weeks prior to Study day 1 - Participant received oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days after the oral or systemic corticosteroids or ACTH treatment. In case this interfered with MRI timing the screening period could be extended accordingly. - Participant has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit of normal - Participant suffered from current autoimmune disease other than MS - Participant suffered from psychiatric illness (including history of, or concurrent, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the participant or could affect compliance with the study protocol - Participant suffered from major medical illness such as cardiac (for example angina, congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic, metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease that would preclude the administration of oral cladribine - Participant has a history of seizures not adequately controlled by medications - Participant has a known allergy to cladribine, interferon-beta, the excipient(s) of the study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA) - Participant has any renal condition that would preclude the administration of gadolinium (for example acute or chronic severe renal insufficiency (glomerular filtration rate [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2]) - Participant has a history of chronic or clinically significant hematological abnormalities - Participant has a history of active or chronic infectious disease or any disease that compromises immune function (for example human immunodeficiency virus positive [HIV+], human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection [LTBI] or TB, insulin-dependent diabetes). - Participant has previously been screened in this study (signed an informed consent) and then withdrawn - Participant has received any immunomodulatory or immunosuppressive therapy) at any time prior to Study Day 1, including, but not limited to, the following products: any interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4 [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy - Participant has received experimental MS treatment - Participant has a history of alcohol or drug abuse - Participant has intolerance or any contraindication to both paracetamol (acetaminophen) and ibuprofen - Participant has inability to administer subcutaneous injections either by self or by caregiver - Participant has prior or current malignancy (with the exception of in situ basal or squamous cell skin cancer surgically removed without recurrence for at least five years) - Participant has a positive stool hemoccult test at Screening ; PRIMARY OUTCOME: ITP: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS; SECONDARY OUTCOME 1: ITP: Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS[/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 - 001; BRIEF: This research study is being done to compare the safety and effectiveness of GDC 695 (test drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to establish that these two drugs work better than placebo in the treatment of actinic keratosis. ; DRUG USED: GDC 695; DRUG CLASS: Non-NME; INDICATION: Actinic Keratoses; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Balmoral Medical company; CRITERIA: Inclusion Criteria: - Has provided written informed consent. - Immunocompetent male and/or non-pregnant female, 18 years of age or older. - Willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. - Clinical diagnosis of actinic keratosis. - In good general health and free of any disease state or physical condition. - Women, must be post-menopausal, surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1). Exclusion Criteria: - Women who are pregnant, breastfeeding, or are planning to become pregnant or breastfeed during the study. - Is currently enrolled in another investigational drug or device study or has used an investigational drug or investigational device within 30 days prior to the Baseline Visit (Day 1). - Has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study. - Is immunosuppressed (e.g., human immunodeficiency virus [ HIV], systemic malignancy, graft host disease, etc.) or is taking medications that suppress the immune system. - Has experienced an unsuccessful outcome from previous topical diclofenac sodium therapy. - Has a history of sensitivity to any of the ingredients in the test articles or other excipients in the test or reference drug. - Has signs or symptoms consistent with the aspirin (ASA) triad. - Has used topical medications: corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >2%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, aminolevulinic acid (ALA) or prescription retinoids (e.g., tazarotene, adapalene, tretinoin), over-the-counter (OTC) products labeled as scrubs of any kind which are used to smooth the skin (as they contain some form of exfoliant such as nut shells, coffee grounds, polymer particles, etc.) within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit. - Has had cryodestruction or chemodestruction, curettage, photodynamic therapy (PDT), surgical excision, or other treatments for AK within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit. - Has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within one month prior to the Baseline Visit. - Has used oral isotretinoin within six months prior to the Baseline Visit. - Has used chemical peels, including but not limited to alphahydroxy acid, betahydroxy acid, bichloroacetic acid, trichloroacetic acid, and phenol within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit. - Has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, ultraviolet B (UVB) therapy, ALA-PDT, or dermabrasion within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit. - Has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or bald scalp). - Has active gastrointestinal ulceration or bleeding or has a history of gastrointestinal bleeds due to use of aspirin or other NSAIDs. - Has severe renal or hepatic impairment. - Has any condition which, in the investigators opinion, could interfere with the evaluation of the test drugs or that could make it unsafe or preclude the subjects ability to fully participate in this research study. ; PRIMARY OUTCOME: Number of Subjects With Complete Clearance of AK Lesions; 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 - HARRIER (vs. Aflibercept (Study 2)); BRIEF: The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye. ; DRUG USED: Beovu; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Key Inclusion Criteria: - Provide written informed consent; - Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening; - Total area of CNV > 50% of the total lesion area in the study eye at Screening; - Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening; - Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. Key Exclusion Criteria: - Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline; - Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis ≥ 50% of the total lesion in the study eye at Screening; - Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at Screening; - Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time; - Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline; - Pregnant or nursing women; women of child-bearing potential; - Stroke or myocardial infarction in the 6-month period prior to Baseline. ; PRIMARY OUTCOME: Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye; SECONDARY OUTCOME 1: Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - 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 - AUGMENT; BRIEF: The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo. ; DRUG USED: Duaklir Pressair; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Male or female patients at least 40 years of age - Current or former cigarette smoker with a cigarette smoking history of at least 10 pack-years - A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the GOLD guidelines and stable airway obstruction. Patients had to have a postbronchodilator FEV1/FVC ratio < 70% at Visit 1 (GOLD, 2010) - Post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of predicted value. FEV1 was measured at the Screening Visit (Visit 1) 10 to 15 minutes after inhalation of albuterol/salbutamol. Predicted normal used for calculation purposes were based on National Health and Nutrition Examination Survey III predicted values (Hankinson et al, 1999) - Able to perform acceptable and repeatable pulmonary function testing for FEV1 according to ATS/ERS criteria (Miller et al, 2005) at Screening Visit (Visit 1) and throughout their participation in the trial - Negative serum β-human chorionic gonadotropin pregnancy test at Visit 1 and must have been using hormonal contraceptives or a barrier method plus a spermicidal agent; otherwise at least 1-year postmenopausal or surgically sterile, defined as having a hysterectomy or tubal ligation (applied to female patients only) - Judged by the Principal Investigator to be in otherwise good stable health based on medical history, physical examination, ECGs, and routine laboratory data evaluations - Patients previously randomized in an aclidinium monotherapy trial were permitted as long as it had been at least 6 months since the completion of their previous trial participation - Able to understand the study procedures and be willing to participate in the study as indicated by signing the informed consent Exclusion Criteria: - Hospitalization for an acute COPD exacerbation within 3 months before Visit 1 - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. Patients who developed a respiratory tract infection or COPD exacerbation during the washout or run-in period were discontinued from the study before randomization - Any clinically significant respiratory conditions other than COPD, including active tuberculosis, history of interstitial lung disease, pulmonary thromboembolic disease, history of α1-antitrypsin deficiency, pulmonary resection, lung volume surgery, or any other thoracic surgery during the past 12 months, history of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener syndrome), post organ transplantation, or expected to require thoracotomy or other lung surgery during the study - Clinical history suggesting that the patient had asthma as opposed to COPD (Study Physician was to be contacted to discuss eligibility, if necessary) - Chronic use of oxygen therapy ≥ 15 hours/day - Body mass index(BMI) ≥ 40 kg/m2 - Patients who intended to start a pulmonary rehabilitation program during the trial were excluded, as well as those who finished or started it within 3 months prior to Screening Visit - Clinically significant cardiovascular conditions including: myocardial infarction within the previous 6 months; newly diagnosed arrhythmia within the previous 3 months; unstable angina; unstable arrhythmia that had required changes in pharmacological therapy or other intervention within the previous 6 months; the presence of an automated implantable cardioverter-defibrillator; history of thoracic surgery within the past year before screening; hospitalization within the previous 12 months for heart failure of New York Heart Association functional class III (marked limitation of physical activity and only comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea), or class IV (unable to carry out any physical activity without discomfort) (Criteria Committee of the New York Heart Association criteria, 1994) - Any uncontrolled infection that may have placed the patient at risk resulting from human immunodeficiency virus, active hepatitis and/or patients with diagnosed active tuberculosis - QTcB > 470 msec in the resting ECGs performed at Screening (Visit 1), as indicated in the centralized ECG vendor generated report. Patients who were on a stable dose of medication that may prolong the QTc, but had a documented, stable, and normal QTc, could have been considered - QTcB > 470 msec in the resting ECGs performed before randomization at Visit 2, as indicated in the paper tracing generated by the Sponsor-provided ECG equipment - Clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters other than QTc, or in the physical examination or vital signs at Visit 1 except for those related to COPD - History of drug or alcohol abuse within the previous 5 years - Any other serious or uncontrolled physical or mental condition/disease that, as judged by the Investigator, could have placed the patient at higher risk derived from his/her participation in the study, could have confounded the results of the study, or would be likely to have prevented the patient from complying with the requirements of the study or completing the study. If there was a history of such disease, but the condition had been stable for more than 1 year and was judged by the Investigator not to interfere with the patients participation in the study, the patient may have been included, with the documented approval of the Study Physician - History of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) or a history of acute urinary retention, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or narrow-angle glaucoma. (Note: Patients who had well controlled, stable, asymptomatic benign prostatic hyperplasia were not to be excluded) - Sitting, resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 100 mm Hg at Visit 1 and Visit 2 - Unable to use a multidose dry-powder inhaler or a pressurized metered-dose inhaler - Treatment with any other investigational product within 30 days (or 6 half-lives, whichever was longer) before Visit 1 - Previous participation in a clinical trial with aclidinium bromide in an FDC therapy - Pregnant or breastfeeding - Current diagnosis of cancer (present in the patient) other than basal or squamous cell skin cancer. Patients who had a history of cancer must have been cleared before Visit 1 (Screening) on a case-by-case basis - Patients who did not maintain regular day/night, waking/sleeping cycles (eg, night shift workers) - Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication (Appendix III of the protocol, which can be found in Appendix 16.1.1 of this report) - Patients who were unlikely to be compliant with study requirements (eg, take their medication, complete their electronic diaries, attend clinic at the required times) - Patients who were employees or relatives of employees of the investigative study center, FRI, Almirall, SA, or Pharmaceutical Product Development (PPD, Inc.) - Patients who had any other conditions that, in the Investigators opinion, might have indicated the patient to be unsuitable for the study or supported excluding the patient from the study ; PRIMARY OUTCOME: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1); SECONDARY OUTCOME 1: Change in Transition Dyspnea Index (TDI) Focal Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HALLMARK-Dual - w/Asunaprevir (GT 1b); BRIEF: The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive. ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and females, ≥ 18 years of age - HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive - HCV RNA ≥ 10,000 IU/mL - Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg) - Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population) Exclusion Criteria: - Prior treatment of HCV with HCV direct acting antiviral (DAA) - Evidence of a medical condition contributing to chronic liver disease other than HCV - Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy - Diagnosed or suspected hepatocellular carcinoma or other malignancies - Uncontrolled diabetes or hypertension ; PRIMARY OUTCOME: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive; SECONDARY OUTCOME 1: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R[/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-PED-01; BRIEF: This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate). ; DRUG USED: Velphoro; DRUG CLASS: Non-NME; INDICATION: Hyperphosphatemia; TARGET: Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Vifor Fresenius Medical Care Renal Pharma; CRITERIA: Inclusion Criteria: 1. Subjects 0 to <18 years at time of consent. 2. Subjects with hyperphosphataemia 3. Subjects ≥1 year with CKD Stages 4-5 defined by a glomerular filtration rate <30 mL/min/1.73 m2 or with CKD Stage 5D receiving adequate maintenance haemodialysis (HD) or peritoneal dialysis (PD) for at least 2 months prior to screening. 4. Subjects <1 year must have CKD. 5. Appropriate written informed consent and, where appropriate/required assent, have been provided. Exclusion Criteria: 1. Subjects with hypercalcaemia at screening 2. Subjects with intact parathyroid hormone (iPTH) levels >700 pg/mL at screening. 3. Subjects who are PB naïve who weigh <5 kg at screening. Subjects receiving stable doses of PBs who weigh <6 kg at screening 4. Subjects requiring feeding tube sizes ≤6 FR (French catheter scale). 5. Subjects with history of major gastrointestinal surgery or significant gastrointestinal disorders. 6. Subjects with hypocalcaemia (serum total corrected calcium <1.9 mmol/L; <7.6 mg/dL) at screening. 7. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding. 8. Subject has a significant medical condition(s) ; PRIMARY OUTCOME: Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group; SECONDARY OUTCOME 1: Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra 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 III - FSS-AS-301; BRIEF: The primary objective of this study was to evaluate the efficacy of fluticasone propionate multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years of age and older with persistent asthma. Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants performed spirometry at every visit. Each participant was given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by the investigational center personnel. ; DRUG USED: AirDuo RespiClick; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: 1. Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of 40 to 85% of their predicted normal value. 2. Current Asthma Therapy: Patients must have a short-acting β2-agonist (for rescue use) for a minimum of 8 weeks before the Screening Visit (SV) and a low-dose inhaled corticosteroid (ICS). The low-dose ICS may be either as ICS monotherapy or as an ICS/long-acting beta agonist (LABA) combination. The ICS component of the patients asthma therapy should be stable for a minimum of 1 months before providing consent. 3. Reversibility of Disease: Patients must have at least 15% reversibility (all patients) and at least a 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol at the SV. Note: Patients who do not qualify for the study due to failure to meet reversibility will be permitted to perform a retest once within 7 days. 4. Patients must provide written informed consent/assent. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written assent form must be signed and dated by the patient (if applicable). Note: Age requirements are as specified by local regulations. 5. Outpatient >= 12 years of age on the date of consent/assent. In countries where the local regulations permit enrollment of adult patients only, patients must be 18 years of age and older. 6. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institutes of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days. 7. The patient is able to perform acceptable and repeatable spirometry. 8. The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter. 9. The patient is able to use a MDI device without a spacer device and a MDPI device. 10. The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before the SV and before all treatment visits. 11. The patient/parent/legal guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements. 12. SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol for the duration of the study. 13. Female patients may not be pregnant, breastfeeding, or attempting to become pregnant. - other criteria may apply, please contact the investigator for more information Exclusion Criteria: 1. A history of a life-threatening asthma exacerbation (an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures). 2. The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study. 3. The patient has participated as a randomized patient in any investigational drug study within 30 days of the SV. 4. The patient has previously participated as a randomized patient in a study of Fp MDPI or FS MDPI. 5. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose). 6. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV. 7. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV. 8. The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco). 9. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV. 10. The patient has a history of alcohol or drug abuse within 2 years preceding the SV. 11. The patient 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. 12. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients on stable immunotherapy may be considered for inclusion. 13. The patient has used immunosuppressive medications within 4 weeks before the SV. 14. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications. 15. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study. 16. The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection. 17. The patient is either an employee or an immediate relative of an employee of the clinical investigational center. 18. A member of the patients household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened. 19. The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study. - other criteria may apply, please contact the investigator for more information ; PRIMARY OUTCOME: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 302 (Extension to 301); BRIEF: This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression >=6 months. ; DRUG USED: Galiximab; DRUG CLASS: Biologic; INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Combination; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP >=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC). - Bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension. - Acceptable hematologic, hepatic, and renal function. Key Exclusion Criteria: - Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study. - Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1. - Transfusion-dependent subjects. - Presence of central nervous system (CNS) lymphoma. - Histologic transformation. - Presence of pleural or peritoneal effusion with positive cytology for lymphoma. - Another primary malignancy requiring active treatment. - Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. - New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1. ; PRIMARY OUTCOME: Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies; SECONDARY OUTCOME 1: Pharmacokinetics[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - iLLUMINATE (w/Gazyva); BRIEF: The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Combination; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: Disease Related: 1. Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria. 2. Age 65 yrs and older OR if less than 65 years, must have at least one of the following criteria: - Cumulative Illness Rating Score (CIRS) >6 - Creatinine clearance estimated <70 mL/min using Cockcroft-Gault equation. - Del 17p by fluorescence in situ hybridization (FISH) or TP53 mutation by polymerase chain reaction (PCR) or Next Generation Sequencing 3. Active disease meeting at least 1 of the following IWCLL criteria for requiring treatment: - Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and thrombocytopenia - Massive, progressive, or symptomatic splenomegaly - Massive nodes (at least 10 cm longest diameter), or progressive or symptomatic lymphadenopathy. - Progressive lymphocytosis with an increase of more than 50 percent over a 2-month period or a lymphocyte doubling time (LDT) of <6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of <30,000/µL, LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded. - Autoimmune hemolytic anemia and/or immune thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy. - Autoimmune hemolytic anemia is defined by at least one marker of hemolysis (indirect bilirubin above the upper limit of normal (ULN) not due to liver disease, increased lactate dehydrogenase (above ULN) without alternative etiology, or increased absolute reticulocytosis (above ULN) or bone marrow erythropoiesis in the absence of bleeding AND at least one marker direct or indirect autoimmune mechanism (positive direct antiglobulin for immunoglobulin G [IgG] or C3d, cold agglutinins). - Immune thrombocytopenia is defined by platelets ≤100,000/µL and increased megakaryocytes on the bone marrow exam. - Constitutional symptoms, defined as one or more of the following disease-related symptoms or signs, documented in the patients record prior to randomization: - unintentional weight loss >10 percent within 6 months prior to screening. - significant fatigue (inability to work or perform usual activities). - fevers >100.5°F or 38.0°C for 2 or more weeks prior to screening without evidence of infection. - night sweats for more than 1 month prior to screening without evidence of infection. 4. Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node >1.5 cm in the longest diameter in a site that has not been previously irradiated. An irradiated lesion may be assessed for measurable disease only if there has been documented progression in that lesion since radiotherapy has ended. Laboratory 5. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening and randomization. 6. Adequate hepatic and renal function 7. Men and women ≥ 18 years of age. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: 1. Any prior treatment of CLL or SLL 2. Evidence of central nervous system (CNS) involvement with primary disease of CLL/SLL 3. History of other malignancies, except: - Malignancy treated with curative intent and with no known active disease present for ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. 4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura 5. Known or suspected history of Richters transformation. 6. Concurrent administration of >20mg/day of prednisone within 7 days of randomization unless indicated for prophylaxis or management of allergic reactions (eg, contrast) 7. Known hypersensitivity to one or more study drugs 8. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug. 9. Any uncontrolled active systemic infection or an infection requiring systemic treatment that was completed ≤ 7 days before randomization. 10. Known bleeding disorders or hemophilia. 11. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 12. Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV). 13. Major surgery within 4 weeks of randomization. 14. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigators opinion, could compromise the subjects safety or put the study outcomes at undue risk. 15. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization. 16. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. 17. Concomitant use of warfarin or other vitamin K antagonists. 18. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor. 19. Lactating or pregnant 20. Unwilling or unable to participate in all required study evaluations and procedures. 21. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations). ; PRIMARY OUTCOME: Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30; SECONDARY OUTCOME 1: Primary Analysis: PFS in High-Risk Sub-Population (del17p/TP53 Mutation/Del 11q) Based on IRC Assessment - Kaplan Meier Landmark Estimates at Month 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 - EGP-437-004 (Anterior Uveitis); BRIEF: The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis. ; DRUG USED: EGP-437; DRUG CLASS: Non-NME; INDICATION: Uveitis (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Eyegate Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an anterior chamber cell count of ≥ 11 cells - Receive, understand, and sign a copy of the written informed consent form - Be able to return for all study visits and willing to comply with all study-related instructions Exclusion Criteria: - Have uveitis of infectious etiology - Have active intermediate or posterior uveitis - Known positive HLA-B27 with a severe (4+) fibrinoid reaction - Have previous anterior segment uveitis episode in the study eye ≤ 4 weeks prior to baseline visit - Have used topical corticosteroid treatment in the study eye ≤ 48 hours prior to baseline visit - Have used oral corticosteroid within the past 14 days prior to baseline - Have received intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months prior to baseline visit - Currently using prescribed nonsteroidal anti-inflammatory agents (i.e., use of over-the-counter dosages is allowable) or prescribed immunosuppressive agents, unless the dose has been stable for the last six weeks and no change in dosing is anticipated for the duration of the study - Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications in the study eye - Be known steroid intraocular pressure responders in either eye - Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied - Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator - Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study - Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin, or Behçets disease - Have monocular or BCVA worse than 20/80 in the fellow eye - Have optic neuritis of any origin - Have clinically suspected or confirmed central nervous system or ocular lymphoma - Planning to undergo elective ocular surgery during the study - Have active hyphema, pars planitis, choroiditis, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage - Have severe/serious ocular pathology or medical condition which may preclude study completion - Have pacemaker and/or any other electrical sensitive support system - Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method - Have participated in another investigational device or drug study within 30 days of baseline visit - Have significant Fuchs Corneal Dystrophy ; PRIMARY OUTCOME: Proportion of patients with with ACC count of zero at Day 14; SECONDARY OUTCOME 1: Proportion of patients with ACC count of zero at Day 7[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AGREE; BRIEF: This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8 mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares. ; DRUG USED: Colcrys; DRUG CLASS: Non-NME; INDICATION: Gout; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Patients of either gender and of any race ≥18 years of age. 2. If female, patients must be postmenopausal as evidenced by lack of menses for ≥12 consecutive months. 3. Patients must present with a confirmed diagnosis of gout. 4. Patients must have experienced ≥2 acute gouty arthritic attacks in the 12 months prior to randomization. 5. Patients on urate lowering therapy must be on a stable dose and schedule with no changes in therapy for 4 weeks prior to randomization and expected to remain on a stable regimen during study participation. 6. Patients must be willing to adhere to the study schedule and the protocol requirements. 7. Patients must be willing and able to give written informed consent. A HIPAA and/or state privacy consent must also be signed. Exclusion Criteria: 1. Patients with acute polyarticular gout (>4 joints). 2. Patients who have experienced >2 acute gouty arthritic attacks per month, or >12 attacks overall, in the 6 months prior to randomization. 3. Patients with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion. 4. Patients with a history of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting within the previous 6 months prior to screening. 5. Patients with active myeloid leukemia, obstructive gastrointestinal cancer, or metastatic cancer. 6. Patients with chronic renal dysfunction (creatinine clearance <60 mL/min as estimated with the Cockcroft Gault formula). 7. Patients with chronic hepatic dysfunction. 8. Patients with a history of alcohol or substance abuse within the 12 months prior to randomization. 9. Patients who have any concomitant illness or other finding that, in the opinion of the Investigator, would confound the study data or place the patient at unacceptable risk if the patient were to participate in the study, or that would require frequent adjustments in concomitant medications during the course of the study. 10. Patients using systemic corticosteroid, cyclosporine, adalimumab, etanercept, infliximab, anakinra, abatacept, mycophenolate, azathioprine, anticoagulants (warfarin, heparin, low molecular weight heparin [LMWH], antithrombin agents, thrombin inhibitors, or selective Factor Xa inhibitors [note, use of aspirin ≤325 mg/day is allowed]), or chronic use of non steroidal anti inflammatory drugs (NSAIDs), acetaminophen, tramadol, and other analgesics such as opiates at screening 11. Use of any investigational drug within 30 days prior to randomization. 12. Patients currently participating in another research study or anticipated to enroll in such during participation in this study. 13. Patients for whom informed consent cannot be obtained. 14. Patients who have previously been randomized into this study and begun ingestion of study drug. ; PRIMARY OUTCOME: Responders; 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 - 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 - vs. Neostigmine/Glycopyrrolate ; BRIEF: This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate). ; DRUG USED: Bridion; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: Neuromuscular Blocking Agents ; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - American Society of Anesthesiologists (ASA) Class 1 or 2 or 3 - Scheduled to undergo an elective abdominal surgical procedure under general anesthesia; and: - expected to undergo neuromuscular relaxation with rocuronium for endotracheal intubation; and - expected to require at least one maintenance dose of rocuronium; and - expected to require active reversal of neuromuscular blockade; and - expected to require clinical or subjective neuromuscular monitoring only; and - expected to recover in the PACU - Arm that is accessible for measuring the TOF ratio in the PACU - Sexually active female patient of child-bearing potential must agree to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Exclusion Criteria: - Anatomical malformations that may lead to difficult intubation - Neuromuscular disorder(s) that may affect neuromuscular blockade and/or trial assessments - Dialysis-dependent or has or is suspected of having severe renal insufficiency - Significant hepatic dysfunction - Family history of malignant hyperthermia - Cardiac pacemaker - Allergy to study treatments or its/their excipients, to opioids / opiates, sugammadex, muscle relaxants or their excipients, or other medication(s) used during general anesthesia - Toremifene before or within 24 hours of study drug administration - Scheduled for an overnight stay (or >12 hours) in PACU - Expected transfer to an Intensive Care Unit after surgery - Pregnant, intention to become pregnant between randomization and the Day 30 pregnancy follow-up visit - Breast-feeding. - Investigational drug(s) within 30 days of randomization on this study - Participation in any other clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial - Participant or family member is among the personnel of the investigational or Sponsor staff directly involved with this trial ; PRIMARY OUTCOME: Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry; SECONDARY OUTCOME 1: Time From Start of Study Drug Administration to Operating Room Discharge-ready[/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 - AUX-CC-806; BRIEF: This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronies disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Enrollment will include all subjects who meet the eligibility criteria and who received placebo and completed one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804. ; DRUG USED: Xiaflex; DRUG CLASS: Biologic; INDICATION: Peyronies Disease; TARGET: Collagen; THERAPY: Monotherapy; LEAD SPONSOR: Endo Pharmaceuticals; CRITERIA: Inclusion Criteria: No subject should be enrolled until all eligibility criteria have been satisfied. Subjects who completed their participation in Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804 and received placebo in that study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must: 1. Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study 2. Be judged to be in good health, based upon the results of a medical history, physical examination,and laboratory profile 3. Have participated in Study AUX-CC-803 or Study AUX-CC-804, received placebo in that study,and completed that study 4. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution 5. Be able to read, complete and understand the various rating instruments in English. Exclusion Criteria: A subject will be excluded from study participation if he: 1. Has a penile curvature of less than 30° or greater than 90° at the screening visit 2. Has any of the following conditions: - Chordee in the presence or absence of hypospadias - Thrombosis of the dorsal penile artery and/or vein - Infiltration by a benign or malignant mass resulting in penile curvature - Infiltration by an infectious agent, such as lymphogranuloma venereum - Ventral curvature from any cause - Presence of an active sexually transmitted disease - Known active hepatitis B or C - Known immune deficiency disease or be positive for human immunodeficiency virus (HIV) 3. Has previously undergone surgery for Peyronies disease 4. Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subjects penile deformity after administration of prostaglandin E1 or trimix or another suitable injectable pharmacologic stimulant according to the standard practice at the investigators institution 5. Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or penile ultrasound that would prevent proper injection of study medication. Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque 6. Has an isolated hourglass deformity of the penis 7. Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque 8. Has previously received alternative medical therapies for Peyronies disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study 9. Has received alternative medical therapies for Peyronies disease administered by the oral (including, but not limited to, vitamin E [>500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, and pentoxifylline, ,) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study 10. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronies disease within the 6-month period before screening or plans to have ESWT at any time during the study 11. Has used any mechanical type device for correction of Peyronies disease within the 2-week period before screening or plans to use any these devices at any time during the study 12. Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study 13. Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors 14. Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant 15. Has uncontrolled hypertension, as determined by the investigator 16. Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigators opinion would make the subject unsuitable for enrollment in the study 17. Has received an investigational drug or treatment within 30 days before the first dose of study drug, except for placebo in Studies AUX-CC-803 or AUX-CC-804 18. Has a known systemic allergy to collagenase or any other excipient of AA4500 19. Has a known allergy to any concomitant medication required as per the protocol 20. Has received anticoagulant medication (except for ≤ 150 mg aspirin daily) during the 7 days before each dose of study drug 21. Has received any collagenase treatments within 30 days of the first dose of study drug 22. Has, at any time, received AA4500 for the treatment of Peyronies disease 23. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits ; PRIMARY OUTCOME: Percentage Change From Baseline in Penile Curvature; SECONDARY OUTCOME 1: Change From Baseline in the Severity of Peyronies Disease Symptoms Domain of the PDQ[/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 - MB102-137 - Asia; BRIEF: The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes. ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit - Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment Inclusion criteria for randomization: HbA1c ≥ 7.5 and ≤ 10.5% at Day -14 Exclusion Criteria: - Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment - History of diabetic ketoacidosis of hyperosmolar nonketotic coma - Clinically diagnosed Type 1 diabetes mellitus - Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV - Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg - History of unstable or rapidly progressing renal disease - History of severe hepatobiliary disease - Mallingancy within 5 years of the screening/enrollment visit ; PRIMARY OUTCOME: Adjusted Mean Change in HbA1c From Baseline to Week 24; SECONDARY OUTCOME 1: Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to 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 - CARE (vs. Colistin); BRIEF: This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP, VABP, complicated urinary tract infection (cUTI), or acute pyelonephritis (AP) due to CRE, not eligible for inclusion in the other cohort, were enrolled into a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic drug management (TDM) was used to help ensure that plazomicin exposures lie within an acceptable range of the target mean steady-state area under the curve (AUC). ; DRUG USED: Zemdri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Cell Membrane, Gram-Negative Bacteria, Protein synthesis; THERAPY: Combination; LEAD SPONSOR: Achaogen, Inc.; CRITERIA: Key Inclusion Criteria: - Cohort 1: APACHE II score between 15 and 30, inclusive; Cohort 2: BSI, HABP, VABP patients with an APACHE II score ≤30 (cUTI and AP patients do not need to have their APACHE II score calculated) - Positive culture that was collected ≤96 hours prior to randomization indicating a CRE infection, or a high likelihood of a CRE infection - Diagnosis of BSI as defined by at least one of the following: fever, hypothermia, new onset arterial hypotension, elevated total peripheral white blood cell (WBC) count, increased immature neutrophils (band forms), or leukopenia - Or, diagnosis of HABP defined as clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic-care facility, or acquired within 7 days after being discharged from a hospitalization of ≥3 days duration - Or, diagnosis of VABP defined by clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous mechanical ventilation - Or, diagnosis of cUTI or AP defined by clinical signs and symptoms consistent with cUTI or AP assessed within 24 hours prior to enrollment Key Exclusion Criteria: - Cohorts 1 and 2 BSI, HABP, and VABP patients: receipt of more than 72 hours of potentially effective antibacterial therapy; Cohort 2: cUTI and AP patients: receipt of any potentially effective antibacterial therapy in the 48 hours prior to enrollment - Cohort 1 only: knowledge that index CRE infection is resistant to colistin prior to randomization - Objective clinical evidence for any of the following clinical syndromes that necessitates study therapy for greater than 14 days: endovascular infection including endocarditis, osteomyelitis, prosthetic joint infection, meningitis and/or other central nervous system infections - Objective clinical evidence of infectious involvement of intravascular material potentially due to the study qualifying pathogen and not intended to be removed within 4 calendar days of the initial positive culture - HABP or VABP patients only: pulmonary disease that precludes evaluation of therapeutic response including known bronchial obstruction or a history of post-obstructive pneumonia, tracheobronchitis, primary lung cancer or malignancies metastatic to the lung, bronchiectasis, known or suspected active tuberculosis - cUTI or AP patients only: renal abscess, chronic bacterial prostatitis, orchitis or epididymitis, polycystic kidney disease, one functional kidney, vesicoureteral reflux, renal transplant, cystectomy or ileal loop surgery, fungal UTI or complete, permanent obstruction of the urinary tract - Patients in acute renal failure at the time of randomization - Patients receiving intermittent hemodialysis (IHD) at the time of screening - Pregnant or breastfeeding female patient ; PRIMARY OUTCOME: Percentage of Patients With All Cause Mortality (ACM) at Day 28 or Significant Disease-Related Complication (SDRC) in the Microbiological Modified Intent to Treat (mMITT) Population in Cohort 1; SECONDARY OUTCOME 1: Percentage of Patients With ACM at Day 28 in the mMITT Population in Cohort 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 - 112147 - US/Spain; BRIEF: This clinical trial aims to study the immunogenicity of GSK Biologicals influenza vaccine GSK2186877A in people aged 65 years or older. ; DRUG USED: GSK2186877A; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: All subjects must satisfy the following criteria at study entry: - Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse. - Written informed consent obtained from the subject. - Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study. Elderly adults: • A man or woman 65 year of age or older at the time of the first vaccination. Young adults: - Man or woman between the ages of 18 and 40 years, inclusive. - If the subject is female, she must be of non-childbearing potential or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period. - Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4. - Vaccination against influenza since February 2008 with a seasonal influenza vaccine. - Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic influenza vaccine. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - History of hypersensivity to a previous dose of influenza vaccine. - History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg or chicken protein. - Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests. - Acute disease at the time of enrolment. - Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. - Any medical conditions in which intramuscular injections are contraindicated. - Pregnant or lactating female. - Female of childbearing age planning to become pregnant or planning to discontinue contraceptive precautions. - Any medical condition that in the opinion of the investigator precludes the collection of blood volumes as required by the protocol. ; PRIMARY OUTCOME: The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers; SECONDARY OUTCOME 1: The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers[/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 - DUAL-1; BRIEF: The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers. Other objectives include: - the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. - the evaluation of the safety and tolerability of macitentan in these patients. - the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period. ; DRUG USED: Opsumit; DRUG CLASS: New Molecular Entity (NME); INDICATION: Scleroderma; TARGET: Endothelin Receptor Type A (EDNRA), Endothelin Receptor Type B (EDNRB); THERAPY: Monotherapy; LEAD SPONSOR: Actelion; CRITERIA: Inclusion Criteria : - Patients ≥ 18 years of age - Women of childbearing potential must use two reliable methods of contraception - Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR) - At least one visible, active ischemic digital ulcers (DU) at baseline - History of at least one additional recent active ischemic DU Exclusion Criteria : - DUs due to condition other than SSc - Symptomatic Pulmonary arterial hypertension (PAH) - Body mass index (BMI) < 18 kg/m^2 - Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x upper limit of the normal range (ULN) - Hemoglobin < 75% of the lower limit of the normal range - Systolic blood pressure < 95 mmHg or diastolic blood pressure < 50 mmHg - Severe malabsorption; any severe organ failure (e.g., lung, kidney), or any life-threatening condition. - Females who are pregnant or breastfeeding or plan to do so during the course of this study. - Substance or alcohol abuse or dependence, or tobacco use at any level. - Treatment with phosphodiesterase type-5 (PDE5) inhibitors. - Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period. - Patients on vasodilators, who have received treatment for less than 2 weeks prior to Screening or whose treatment has not been stable during this period. - Treatment with prostanoids within 3 months. - Treatment with disease modifying agents if present for less than 3 months prior to Screening or whose treatment has not been stable for at least 1 month prior to Screening. - Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent). - Treatment with ERAs within 3 months. - Systemic antibiotics to treat infected DU(s) within 4 weeks. ; PRIMARY OUTCOME: Incidence Rate of New Digital Ulcers (DUs) up to Week 16; SECONDARY OUTCOME 1: Percentage of Participants Without a New DU Up To 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 IIIb/IV - ASSESS; BRIEF: The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS ; 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: Inclusion criteria: - Written informed consent must be obtained before any assessment is performed - Male and female patients 18 to 65 years of age, inclusive. - Patients with RRMS, as defined by 2010 revised McDonald criteria. - Patients must be neurologically stable with no onset of relapse within 30 days of randomization - Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization. - Patients with an EDSS score of 0 to 6, inclusive, at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting. Exclusion criteria: - Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma) in the last 5 years that do not have confirmation of absence of a malignancy prior to randomization - Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogrens syndrome, Crohns disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency). - Patients who have been treated with: - High-dose intravenous (IV) immunoglobulin (Ig) within 4 weeks before randomization - Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization - Natalizumab within 2 months before randomization - Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab, ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous treatment with mitoxantrone within 6 months before randomization - Use of teriflunomide within 3.5 months prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done. In that case, plasma levels are required to be measured and be below 0.02 mg/L before randomization. No washout period is necessary for patients treated with dimethyl fumarate, interferon (IFN) beta, or glatiramer acetate. Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the Screening visit can continue drug intake up to the day before Day 1 of this study (i.e., there is no need for a washout period). - Patients who have been treated with systemic corticosteroids or adrenocorticotropic hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI) procedure. - Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin >9%) or with diabetic neuropathy. - Patients with a diagnosis of macular edema during Screening (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at Screening). - Patients with severe active bacterial, viral, or fungal infections. - Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at randomization. - Patients who have received any live or live-attenuated vaccines (including VZV, herpes simplex, or measles) within 1 month before randomization. - Patients who have received total lymphoid irradiation or bone marrow transplantation. - Patients with any unstable medical/psychiatric condition, as assessed by the primary treating physician at each site. - Patients who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure. ; PRIMARY OUTCOME: Confirmed Annualized Relapse Rate; SECONDARY OUTCOME 1: New or Newly Enlarging T2 Lesions[/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 - 72 mcg Dose; BRIEF: The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder. ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ironwood Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings - Patient has no clinically significant findings on a physical examination and clinical laboratory tests - Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis - Patient is compliant with daily interactive voice response system (IVRS) calls - Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization. Exclusion Criteria: - Patient has history of loose or watery stools - Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS) - Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility - Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments - Patient has Bristol Stool Form Scale score of 7 during Pretreatment period. ; PRIMARY OUTCOME: Percentage of 12-Week CSBM Overall Responders; SECONDARY OUTCOME 1: Change From Baseline in 12-Week CSBM Frequency Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IFN-Free w/ABT-450/Ritonavir/ABT-267 +/- RBV (PEARL-IV); BRIEF: The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis. ; DRUG USED: Exviera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile - Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening) - Subject has never received antiviral treatment for hepatitis C infection - No evidence of liver cirrhosis Exclusion Criteria: - Significant liver disease with any cause other than HCV as the primary cause - Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody - Positive screen for drugs or alcohol - Significant sensitivity to any drug - Use of contraindicated medications within 2 weeks of dosing - Abnormal laboratory tests ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses; SECONDARY OUTCOME 1: Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Forteo; BRIEF: The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis. ; DRUG USED: Bonsity; DRUG CLASS: Non-NME; INDICATION: Osteoporosis / Osteopenia; TARGET: Parathyroid Hormone Receptor (PTHR); THERAPY: Monotherapy; LEAD SPONSOR: Pfenex, Inc; CRITERIA: Inclusion Criteria: - If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women - If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men - Able to use the pen injection device correctly - Able to understand and sign the written Informed Consent Form (ICF) Exclusion Criteria: - Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening - Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara), including for investigational purposes - Immobility due to severe or chronically disabling conditions (e.g., stroke, Parkinsons disease, multiple sclerosis) - History of metabolic bone diseases other than osteoporosis - History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured) - History of Pagets disease of bone - History of prior external beam or implant radiation therapy involving the skeleton - Active urolithiasis or primary hyperparathyroidism ; PRIMARY OUTCOME: Blood levels of anti-drug antibody (ADA) against teriparatide; SECONDARY OUTCOME 1: Mean percentage change in lumbar-spine bone mineral density (BMD)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Lantus (003); BRIEF: The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantus™. ; DRUG USED: Lusduna Nexvue; DRUG CLASS: Biosimilar; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - T1DM For at least 1 year - is currently using or has been using prandial insulin for at least 4 weeks. Participants taking any type of basal insulin should require a total daily dose of >=10 units/day. For participants currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of >=10 units/day. - is male, or is female who is not of reproductive potential or if of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication Exclusion Criteria: - has had 1 or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months - history of ketoacidosis in the last 6 months - participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L]. - history of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients - used a formulation of insulin glargine other than Lantus™ - has received injectable incretin-based therapy within the past 8 weeks - on a weight loss program and not in the maintenance phase, or has started a weight loss medication within the past 8 weeks - has undergone bariatric surgery within the past 12 months - is likely to require treatment for 2 or more consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal, and topical corticosteroids are permitted) - has undergone a surgical procedure within the past 4 weeks or has planned major surgery during the study - has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder - has severe peripheral vascular disease - has high blood pressure - has chronic myopathy, or a progressive neurological or neuromuscular disorder - has active nephropathy - history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - has human immunodeficiency virus (HIV) - has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - history of malignancy in the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - history of melanoma, leukemia, lymphoma, or renal cell carcinoma - is currently being treated for hyperthyroidism or has been on a stable dose of thyroid hormone replacement therapy for <6 weeks - is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence - is pregnant or breast-feeding, or is expecting to conceive or donate eggs - has donated blood products or has had phlebotomy of >300 mL within the past 8 weeks or intends to donate blood products during the study - has poor mental function or works the night shift ; PRIMARY OUTCOME: Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in A1C at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ORCHID; BRIEF: ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment. ; DRUG USED: Hydroxychloroquine (NIH); DRUG CLASS: Non-NME; INDICATION: COVID-19 Treatment; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Massachusetts General Hospital; CRITERIA: Inclusion Criteria: 1. Age ≥18 years 2. Currently hospitalized or in an emergency department with anticipated hospitalization. 3. Symptoms of acute respiratory infection, defined as one or more of the following: 1. cough 2. fever (> 37.5° C / 99.5° F) 3. shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy). 4. sore throat 4. Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization. Exclusion Criteria: 1. Prisoner 2. Pregnancy 3. Breast feeding 4. Symptoms of acute respiratory infection for >10 days before randomization 5. >48 hours between meeting inclusion criteria and randomization 6. Seizure disorder 7. Porphyria cutanea tarda 8. Diagnosis of Long QT syndrome 9. QTc >500 ms on electrocardiogram within 72 hours prior to enrollment 10. Known allergy to hydroxychloroquine, chloroquine, or amodiaquine 11. Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol 12. Receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment 13. Inability to receive enteral medications 14. Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15 15. Previous enrollment in this trial 16. The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient ; PRIMARY OUTCOME: COVID Outcomes Scale Score on Study Day 15 (14 Days After Randomization); SECONDARY OUTCOME 1: COVID Ordinal Outcomes Scale on Study Day 3 (2 Days After Randomization)[/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 - EPIC Study; BRIEF: The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen. ; DRUG USED: Erbitux; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic. - Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer. - Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or uracil/tegafur [UFT]), for the first-line treatment of metastatic disease. Exclusion Criteria: - A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy - Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease - Known or documented brain metastases ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Progression Free Survival[/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 - SCARLET2; BRIEF: The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality. ; DRUG USED: ART-123; DRUG CLASS: Biologic; INDICATION: Sepsis and Septic Shock; TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Asahi Kasei Pharma America Corporation; CRITERIA: Inclusion Criteria: 1. Subjects must be receiving treatment in an ICU or in an acute care setting (e.g., Emergency Room, Recovery Room). 2. Subjects with either compelling evidence of infection OR clinical syndromes highly likely to be bacterial in origin, as follows (Please refer to Appendix B): 1. Compelling objective evidence of bacterial infection and a known site of infection: Objective evidence would be met with a grossly purulent site of infections, Gram stain evidence, confirming a bacterial pathogen from normally sterile fluids (blood, urine, cerebrospinal fluid (CSF), peritoneal fluid, etc.), having either: - White Blood Cell (WBC) count greater > 12,000/mm3 or < 4,000/mm3 or > 10% bands within 36 hours of randomization OR - Temperature <36°C or fever >38°C 2. Clinical syndromes highly likely to be bacterial in origin but not compelling - White Blood Cell (WBC) count greater > 12,000/mm3 or < 4,000/mm3 or > 10% bands within 36 hours of randomization AND - Temperature <36°C or fever >38°C 3. Current treatment with intravenous antibiotics for the acute bacterial infection (i.e. not prophylactic antibiotics) 4. Subjects with sepsis-associated organ dysfunction defined by at least one of the following: 1. Cardiovascular Dysfunction defined as requiring both adequate fluid resuscitation and vasopressors* to maintain Mean Arterial Pressure (MAP) greater than or equal to (≥) 65 mmHg (implies fluid resuscitation alone does not raise MAP to ≥ 65 mmHg), with onset time being the time of vasopressors are initiated (end of surgery if initiated in surgery), with adequate fluid resuscitation defined as: • Intravenous administration of at least 20 mL/kg crystalloid or 10 mL/kg colloid infusion within 6 hours. OR •Central Venous Pressure (CVP) of greater than (>) 8 mmHg or Pulmonary Artery Wedge Pressure (PAWP) of greater than (>) 12 mmHg. - If dopamine is the only vasopressor used, the infusion rate must be greater than (>) 5 μg/kg/min (i.e., must be prescribed to support cardio-pulmonary perfusion). If vasopressin is used, it must be given in conjunction with another vasopressor. 2. Respiratory Dysfunction is defined as the acute need for mechanical ventilation and PaO2/FiO2 ratio of <250 (or < 200 when lung is the site of infection) with onset time being time of intubation prior to first qualifying PaO2:FiO2 (if intubated for surgery and unable to extubate the qualifying time is the end of surgery), with mechanical ventilation defined as any type of ventilation administered via an endotracheal or nasotracheal tube. 5. Subjects with coagulopathy characterized by an INR >1.40 without other known etiology (e.g., anticoagulant therapy, chronic liver disease), and having an onset at the time of the first blood draw yielding a qualifying result (point of care device INR results must be confirmed by local laboratory). 6. Subjects with coagulopathy characterized by platelet count that meets any of the below criteria, and having an onset at the time of the first blood draw yielding a qualifying result. 1. ≥ 20,000/mm3 and ≤ 30,000/mm3 that upon retesting after platelet transfusion is > 30,000/mm3 (qualifying at the time of the first blood draw yielding a result ≥ 20,000/mm3 and ≤ 30,000/mm3) 2. > 30,000/mm3 to < 150,000/mm3 3. > 30% decrease in platelet count within 24 hours 7. First and last qualifying criteria of sepsis associated organ dysfunction (as defined in Inclusion #4), platelet count and INR occurring in ≤ 24 hours Exclusion Criteria: Candidates for the study will be excluded if ANY of the following criteria are present: 1. Subject or Authorized Representative is unable or unwilling to provide informed consent (as applicable per local and country regulations) 2. Subject is pregnant (positive serum or urine human Chorionic Gonadotropin (hCG)) or breastfeeding or intends to get pregnant within 28 days of enrolling into the study 3. Subject is < 18 years of age 4. Body weight ≥ 175 kg 5. Subject is unwilling to allow transfusion of blood or blood products 6. Presence of an advance directive to withhold life-sustaining treatment (except Cardiopulmonary Resuscitation), or likely to have life support withdrawn within 24 hours of consent 7. Subject has had previous treatment with ART-123 8. Platelet count < 20,000/ mm3 for any reason, or for platelet count ≥ 20,000/mm3 and ≤ 30,000/mm3 that upon retesting after platelet transfusion does not increase > 30,000/mm3 9. Elevated INR, leukopenia, or thrombocytopenia that is not due to sepsis, (e.g. patients treated by chemotherapy agent). Please refer to Appendix C as an example of agents known to cause myelosuppression that should be evaluated as the cause of potential leukopenia or thrombocytopenia 10. Inability to randomize patients in ≤ 12 hours after meeting Inclusion # 7 (onset time requirements for sepsis associated organ dysfunction, INR, and platelet count) 11. ≤ 8 hours remaining from the end of a major surgery having a high risk of post-operative bleeding and randomization (e.g. extensive intraabdominal or intrathoracic dissection, debridement of a large surface area of tissue, complications arising during surgery, problems with hemostasis during surgery, surgeries of long duration, surgeries with large estimated blood loss). • Ensures all randomized surgical subjects with a high risk of post-operative bleeding can be dosed no earlier than 12 hours post-operatively, as described in Section 2.6.3. (minimum 8 hour delay before randomization and 4 hour maximum time to dose after randomization) 12. Stroke within 3 months prior to consent, trauma or major surgery within 3 months prior to consent that may increase the risk of bleeding 13. Known bleeding diatheses or anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia, esophageal varices, arteriovenous malformation) 14. Gastrointestinal bleeding (e.g., melena, hematemesis) or genitourinary bleeding within 6 weeks prior to consent unless a corrective interventional procedure has been performed (i.e., therapeutic endoscopy), or there is evidence of complete resolution 15. Known thrombophilia or a history of deep-vein thrombosis or pulmonary embolism within 3 months prior to consent 16. Need for full dose anticoagulation therapy (other than IV unfractionated heparin discontinued > 12 hours prior to randomization), full dose or catheter directed thrombolysis, aspirin at a daily dose > 325 mg, long-acting antiplatelet drugs (e.g. clopidogrel, prasugrel, or ticagrelor), dual antiplatelet therapy, and doses of anticoagulants exceeding thromboprophylaxis doses within 72 hours prior to the first dose of study drug (see Appendix D for more detail) 17. Acute liver failure not due to sepsis, sepsis associated acute liver failure in any patient with a history of cirrhosis, Class C Chronic liver disease (Child-Pugh score of 10-15); (See Appendix E) 18. Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or Gram stain consistent with bacterial infection. Also, in the opinion of the investigator the subject is at increased risk for developing hemorrhagic pancreatitis over the duration of the study 19. Acute renal failure not due to sepsis or chronic renal failure requiring chronic RRT (Renal Replacement Therapy) 20. Imminent death or anticipated life expectancy < 90 days for any reason other than the acute sepsis 21. Participation in another research study involving an investigational agent within 30 days prior to consent, or projected study participation before the Day 29 assessment post randomization 22. Confirmed or suspected endocarditis, malaria, Pneumocystis jiroveci pneumonia, or viral infections associated with hemorrhage (e.g. dengue fever, lassa, ebola, Bolivian) during the current admission ; PRIMARY OUTCOME: 28 day; SECONDARY OUTCOME 1: 3 months[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EQUIP (OB-302); BRIEF: The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35. ; DRUG USED: Qsymia; DRUG CLASS: Non-NME; INDICATION: Obesity; TARGET: Dopamine, GABA-A Receptor, Norepinephrine (Noradrenaline); THERAPY: Monotherapy; LEAD SPONSOR: VIVUS LLC; CRITERIA: Inclusion Criteria: - Body mass index (BMI) ≥ 35 kg/m2 - Informed consent - 70 years of age or less - Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications - Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension - Fasting blood glucose level of ≤ 110 mg/dL Exclusion Criteria: - Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months - Clinically significant renal, hepatic or psychiatric disease - Unstable thyroid disease or replacement therapy - Nephrolithiasis - Obesity of known genetic or endocrine origin - Participation in a formal weight loss program or lifestyle intervention - History of glaucoma or intraocular pressure - Pregnancy or breastfeeding - Alcohol abuse - Smoking cessation within previous 3 months or plans to quit smoking during study - Eating disorders - Cholelithiasis within past 6 months - Excluded medications - Type 2 diabetes - Previous bariatric surgery - History of bipolar disorder or psychosis ; PRIMARY OUTCOME: Percent Weight Loss From Baseline to Week 56; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Orkambi-Experienced ; BRIEF: Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA). ; DRUG USED: Symdeko; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures. - Prior discontinuation of Orkambi, with at least 1 respiratory sign or symptom considered related to therapy. - Resolution or stabilization of qualifying event(s) >28 days prior to Screening. - Discontinuation of Orkambi therapy must have occurred within approximately 12 weeks from the first dose of Orkambi. - Homozygous for F508del mutation in the CFTR gene as documented in the subjects medical record. If genotype documentation is not available in the medical record, genotyping will be performed during screening. - FEV1 ≥25% and ≤90% of predicted normal for age, sex, and height. - Stable CF disease as judged by the investigator. - Other protocol defined inclusion criteria could apply. Exclusion Criteria: - History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. - Recent rapid or progressive deterioration in respiratory status. - Receiving continuous oxygen at >2L/min or on face-mask ventilation. - Any protocol-defined exclusionary laboratory values at Screening. - Child-Pugh Class B or C hepatic impairment. - An acute upper or lower respiratory infection, pulmonary exacerbation, or change in therapy for pulmonary disease within 28 days before Day 1. - Documentation of colonization with organisms associated with a more rapid decline in pulmonary status. - History of lung transplantation since most recent initiation of Orkambi. - History of alcohol or drug abuse in the past year as deemed by the investigator. - Participation in an investigational drug study or use of a CFTR modulator within 28 days or 5 terminal half-lives of the investigational drug or modulator (whichever is longer). - Use of restricted medications or foods within the specified window before the first dose of study drug, or an anticipated need or use of restricted medication or foods after the first dose of study drug. - Pregnant or nursing females: Females of child-bearing potential must have a negative pregnancy test at Screening and Day 1. - Other protocol defined exclusion criteria could apply. ; PRIMARY OUTCOME: Incidence of Respiratory Adverse Events of Special Interest (RAESIs); SECONDARY OUTCOME 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Day 28 and Day 56 Measurements[/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 301 (Bacterial Vaginosis); BRIEF: The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis. ; DRUG USED: Solosec; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Microbial DNA, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Symbiomix Therapeutics; CRITERIA: Inclusion Criteria: - Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in good general health - Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria: - Off-white (milky or gray), thin, homogeneous vaginal discharge - Vaginal pH ≥ 4.7 - Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount - A positive 10% KOH Whiff test - Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1) Exclusion Criteria: - Are pregnant, lactating, or planning to become pregnant during the study - Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1) - Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex - Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1) ; PRIMARY OUTCOME: Clinical Outcome Responder Rate; SECONDARY OUTCOME 1: Clinical Outcome Responder Rate (Interim Visit Only)[/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 - Onset 5; BRIEF: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes. ; DRUG USED: FIAsp; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age at least 18 years at the time of signing the informed consent - Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening - Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.) - HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening - Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening - Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial Exclusion Criteria: - 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 - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening - Any condition which, in the opinion of the Investigator, might jeopardise a Subjects safety or compliance with the protocol ; PRIMARY OUTCOME: Change in Glycosylated Haemoglobin (HbA1c); SECONDARY OUTCOME 1: Change From Baseline in 1-hour PPG Increment[/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 - SUNRISE (Controlled Re-Treatment); BRIEF: This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX). ; DRUG USED: Rituxan; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Signed informed consent form - Ability and willingness to comply with the requirements of the study protocol - Age 18-80 years - Diagnosis of RA for at least 6 months - Receiving treatment for RA on an outpatient basis - Documented moderate to severe active RA activity at screening and Day 1 - Documented inadequate response to previous or current treatment with one or more of the following: etanercept, infliximab, and/or adalimumab because of toxicity or inadequate efficacy - Use of MTX 10-25 mg/wk for ≥ 12 weeks prior to Day 1 at a stable dose for ≥ 4 weeks - Willingness to receive oral folic acid - If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to Day 1 - Use of one NSAID is permitted if the dose is stable for ≥ 2 weeks prior to Day 1 - For men and women of reproductive potential, willingness to use a reliable means of contraception for ≥ 30 days prior to Day 1 and for the study duration or the duration that the subjects peripheral CD19 B cells are depleted, whichever is longer Exclusion Criteria: - Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Secondary Sjogrens syndrome with RA is permitted. - History of or current inflammatory joint disease other than RA or other systemic rheumatic disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, or overlap syndrome) - History of deep space/tissue infection within 52 weeks prior to Day 1 - Diagnosis of juvenile idiopathic arthritis (JIA), juvenile rheumatoid arthritis (JRA), and/or RA before age 16 - Functional Class IV, as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement), within 12 weeks prior to Day 1 or planned within 48 weeks after Day 1 - Known hypersensitivity to any component of a humanized or murine monoclonal antibody - Receipt of any vaccination within 4 weeks prior to Day 1 - Significant cardiac or pulmonary disease, including obstructive pulmonary disease - Evidence of significant uncontrolled concomitant disease, such as, but not limited to nervous system, renal, hepatic, endocrine, or gastrointestinal disorders - Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease but excluding fungal infections of the nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1 - History of serious recurrent or chronic infection (a chest X-ray will be performed at screening if one has not been performed within 12 weeks of screening that showed no clinically significant abnormality) - History of or currently active primary or secondary immunodeficiency, including HIV infection - History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that has been excised and cured) - History of significant cytopenias or other bone marrow disorders - History of alcohol, drug, or chemical abuse within 24 weeks prior to Day 1 - Pregnancy or lactation - Neuropathies and neurovasculopathies that might interfere with pain evaluation - Poor peripheral venous access - Intolerance or contraindications to oral or IV corticosteroids - Positive hepatitis B surface antigen or hepatitis C antibody serology - For women of childbearing potential (including those who have had a tubal ligation), a positive serum pregnancy test at screening - Current use of any DMARD other than MTX - Concurrent treatment with any biologic agent - Treatment with any investigational agent within 4 weeks prior to Day 1 or five half-lives of the investigational drug (whichever is longer) - Any previous treatment with rituximab or other cell-depleting therapies, including CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti-CD11a, anti-CD22, anti-BLys/ BAFF, and other anti-CD20 agents - Previous treatment with a co-stimulation blocking agent, including abatacept - Previous treatment with an anti-<alpha> 4 integrin agent, including natalizumab - Previous treatment within 6 months of screening with IV & globulin or the Prosorba(R) Column - Intra-articular or parenteral corticosteroids within 4 weeks prior to Day 1 ; PRIMARY OUTCOME: Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline; SECONDARY OUTCOME 1: Retreated Subjects With American College of Rheumatology 50% (ACR50) Response and American College of Rheumatology 70% (ACR70) Response at Week 48 Relative to Baseline[/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 Treatment - 13267A (Europe/South Africa); BRIEF: The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x) - The patient has a MADRS total score >=26 - The patient has a CGI-S score >=4 - The patient has had the current episode of MDE for >3 months Exclusion Criteria: - Any current anxiety psychiatric disorder as defined in the DSM-IV TR - Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR - Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR - Use of any psychoactive medication 2 weeks prior to screening and during the study - The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.; SECONDARY OUTCOME 1: Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)[/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 - MEL3-12-02 (OA Knee or Hip); BRIEF: The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip. ; DRUG USED: Vivlodex; 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: - Primary diagnosis of Functional Class I-III OA of the hip or knee - Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for OA pain - Discontinued all analgesic therapy at Screening - For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control Exclusion Criteria: - History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam - Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip - Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease - Significant difficulties swallowing capsules or unable to tolerate oral medication - Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening ; PRIMARY OUTCOME: Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.; SECONDARY OUTCOME 1: Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ECOG 3200 (FOLFOX4); BRIEF: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced or metastatic colorectal cancer that has been previously treated. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Histologically confirmed adenocarcinoma of the colon or rectum - Advanced or metastatic disease - Must have received a fluoropyrimidine-based regimen and an irinotecan-based regimen, either alone or in combination, for advanced disease - May have relapsed within 6 months of adjuvant therapy with fluorouracil (5-FU) (or combination 5-FU and irinotecan) and progressed after single-agent irinotecan - Measurable disease - No known brain metastases - Performance status - ECOG 0-2 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of thrombotic or hemorrhagic disorders - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 5 times ULN - INR no greater than 1.5 - PTT no greater than ULN - Creatinine no greater than 1.5 times ULN - Proteinuria less than 1+ (i.e., 0 or trace) - Protein less than 500 mg by 24-hour urine collection - Proteinuria secondary to ureteral stents allowed - No proteinuria secondary to nephropathy - Controlled hypertension (less than 150/100 mm Hg) allowed if on a stable antihypertensive regimen - No prior myocardial infarction - No uncontrolled congestive heart failure - No unstable angina within the past 3 months - No serious nonhealing wound, ulcer, or bone fracture - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior bevacizumab - See Disease Characteristics - Recovered from prior chemotherapy - No prior oxaliplatin - At least 2 weeks since prior radiotherapy and recovered - At least 28 days since prior major surgical procedure - At least 10 days since prior aspirin dose of more than 325 mg/day - No concurrent therapeutic anticoagulation except prophylactic anticoagulation of venous access device - No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol) - No concurrent oral cryotherapy on day 1 of oxaliplatin administration ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Response defined using RECIST criteria[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3084 - 16 Weeks; BRIEF: The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1). ; DRUG USED: Cinqair; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion criteria: Patients are included in the study if all of the following criteria are met: - The patient is a man or woman, 18 through 65 years of age, with a diagnosis of asthma. - The patient has an ACQ score of at least 1.5. - At screening, the patient has airway reversibility of at least 12% to beta-agonist administration. - The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or equivalent). Patients baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening and continue without dosage changes throughout study. - Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test at screening (serum) and baseline (urine). - Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). - Written informed consent is obtained. - The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and serology. - The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: - The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis). - The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patients safety. - The patient has known hypereosinophilic syndrome (HES). - The patient is a current smoker (ie, has smoked within the last 6 months prior to screening). - The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin, interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry (randomization). - The patient is currently using or has used systemic corticosteroids (includes use of oral corticosteroids) within 30 days prior to the screening visit. - The patient is expected to be poorly compliant with study drug administration, study procedures, or visits. - The patient has any aggravating factors that are inadequately controlled, and thus would aggravate asthma symptoms (eg, gastroesophageal reflux disease). - The patient has participated in any investigative drug or device study within 30 days prior to screening. - The patient has participated in any investigative biologics study within 90 days prior to screening. - The patient has previously received reslizumab or other anti-hIL-5 mAbs (eg, mepolizumab). - The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.) - The patient has a current infection or disease that may preclude assessment of asthma. - The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency). - The patient is suspected of current drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. - The patient has presence of or suspected parasitic infestation/infection. - Patients may not have received any live attenuated vaccine within the 12-week period before study entry. ; PRIMARY OUTCOME: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set; SECONDARY OUTCOME 1: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - XSGP-303 (vs. Lilly Glucagon); BRIEF: This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen™ glucagon 1 mg during one period and Lilly Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 50 mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedure are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug. ; DRUG USED: Gvoke RTU Micro; DRUG CLASS: Non-NME; INDICATION: Hyperinsulinemia/Hypoglycemia; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Xeris Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Males and females diagnosed with type 1 diabetes mellitus for at least 24 months. 2. Current usage of daily insulin treatment that includes having an assigned correction factor for managing hyperglycemia. 3. Age 18-75 years, inclusive. 4. Random serum C-peptide concentration < 0.5 ng/mL. 5. Willingness to follow all study procedures, including attending all clinic visits. 6. Subject has provided informed consent as evidenced by a signed/dated informed consent form completed before any trial-related activities occur. Exclusion Criteria: 1. Pregnancy: For women of childbearing potential, there is a requirement for a negative urine pregnancy test and for agreement to use contraception throughout the study and for 7 days after the last dose of study glucagon. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. 2. Breastfeeding: Nursing mothers will be allowed into the study. However, breast feeding during the during inpatient study visits and for 48 hours after each dose of study drug is not allowed. 3. HbA1c >9.0% at Screening. 4. BMI > 40 kg/m2. 5. Renal insufficiency (serum creatinine greater than 3.0 mg/dL) or end-stage renal disease. requiring renal replacement therapy. 6. Serum ALT or AST equal to or greater than 3 times the upper limit of normal. 7. Hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL. 8. Hematocrit of less than or equal to 30%. 9. BP readings at Screening where SBP <90 or >150 mm Hg, and DBP <50 or >100 mm Hg. 10. Clinically significant ECG abnormalities. 11. Use of > 2.0 U/kg total insulin dose per day. 12. Inadequate venous access. 13. Congestive heart failure, NYHA class III or IV. 14. History of myocardial infarction, unstable angina, or revascularization within the past 6 months. 15. History of a cerebrovascular accident in past 6 months or with major neurological deficits. 16. Active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. History of breast cancer or malignant melanoma will be exclusionary. 17. Major surgical operation within 30 days prior to Screening. 18. Current seizure disorder (other than with suspect or documented hypoglycemia). 19. Current bleeding disorder, treatment with warfarin, or platelet count below 50 x 10e9 per liter. 20. History of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease). 21. History of insulinoma. 22. History of allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products or to any of the excipients (DMSO & trehalose) in the investigational formulation. 23. History of glycogen storage disease. 24. Subject tests positive for HIV, HCV or HBV infection (HBsAg+) at Screening. 25. Active substance or alcohol abuse (more than 21 drinks/wk. for males or 14 drinks/wk. for females). Subjects reporting active marijuana use or testing positive for tetrahydrocannabinol (THC) via rapid urine test will be allowed to participate in the study at the discretion of the Investigator. 26. Administration of glucagon within 28 days of Screening. 27. Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before Screening for the current study and during participation in the current study. 28. Any reason the Investigator deems exclusionary. ; PRIMARY OUTCOME: Number of Subjects With a Positive Glucose Response; SECONDARY OUTCOME 1: Time for Positive Glucose Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Spain; BRIEF: The main objective is to evaluate the effectiveness of the experimental drug to reduce plasma ammonia concentration at a dose that is safe and well tolerated. Ammonia usually rises significantly in the hours after gastrointestinal bleeding in patients with cirrhosis of the liver. This increase in the concentration of ammonia facilitates the development of hepatic encephalopathy. The study will be divided in two parts: Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to confirm the tolerance and safety of the dose of OP that is being proposed for the study according to the results of phase I and phase II studies in healthy subjects and stable outpatients with cirrhosis. Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group trial. Assignment of treatment will be done according to a list (one at each study site) of random numbers in blocks that will be concealed until the end of the study. The control group will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked. ; DRUG USED: MNK-6105 IV/MNK-6106 Oral; DRUG CLASS: New Molecular Entity (NME); INDICATION: Liver Failure / Cirrhosis; TARGET: Ammonia; THERAPY: Monotherapy; LEAD SPONSOR: Hospital Universitari Vall dHebron Research Institute; CRITERIA: Inclusion criteria - Cirrhosis of the liver; diagnosed by clinical, laboratory or radiological findings. - Upper gastrointestinal bleeding, as judged by clinical signs (hematemesis, melena, anemia) combined with endoscopic data. - Bleeding that has been active within 24 hours prior to inclusion; signs of activity are defined by the presence of blood in the gastrointestinal tract and symptoms attributable to bleeding (hypotension, tachycardia, etc.). - Age between 18 and 75 years. - Informed consent by the patient. In case of inability to provide informed consent due to impaired mental status secondary to hepatic encephalopathy the informed consent should be provided by the next of kin and should be confirmed by the patient when he/she recovers from hepatic encephalopathy. - Absence of exclusion criteria. Exclusion criteria - Terminal illness (e.g. advanced hepatocellular carcinoma). - Need for mechanical ventilation. - Renal impairment, defined by a creatinine > 1.5 mg/dl or need of hemodialysis. - Pregnant or breast-feeding. Pre-menopausal women capable of bearing children should be following a reliable method of birth control and should have a negative result in a pregnancy test prior to inclusion. - Known or suspected hypersensitivity or allergic reaction to ornithine or phenylacetate. - Use of medications known to interfere with the clearance of either ornithine and/or phenylacetate, such as antibiotics of the penicillin group and probenicid. - Use of medications that may induce hyperammonemia; such as haloperidol, valproic acid, and systemic corticosteroids. - History or known infection with human immunodeficiency virus (HIV). - Neurological comorbidities that impair mental status and do not allow to adequately assess the presence or outcome of hepatic encephalopathy. - The presence in the electrocardiogram of a QTcF >500 msec ; PRIMARY OUTCOME: Ammonia plasma concentration umol/L.; SECONDARY OUTCOME 1: Hepatic encephalopathy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GEMINI III; BRIEF: This study in patients with moderately to severely active Crohns disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission. ; DRUG USED: Entyvio; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Age 18 to 80 - Diagnosis of moderately to severely active Crohns disease - Crohns Disease involvement of the ileum and/or colon - Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol - May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol Exclusion Criteria - Evidence of abdominal abscess at the initial screening visit - Extensive colonic resection, subtotal or total colectomy - History of >3 small bowel resections or diagnosis of short bowel syndrome - Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine - Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol - Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection - Active or latent tuberculosis ; PRIMARY OUTCOME: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation; SECONDARY OUTCOME 1: Percentage of Participants in Clinical Remission at Week 6 in the Overall Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ARRIVE EU - 31-11-284; BRIEF: The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole. ; DRUG USED: Abilify Maintena; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to any protocol-required procedure. - Male and female subjects 18 to 65 years of age, inclusive - Current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and a history of the illness for at least 1 year (12 months) - Subjects who in the investigators judgment would benefit from extended treatment with a long-acting injectable formulation - Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior entering the study - Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase Subjects who have shown response to previous antipsychotic treatment. - Subjects who understand the nature of the trial and are able to follow the protocol requirements. Exclusion Criteria: - Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial. - Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial. - Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication. - Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones. - Subjects with a history of hypersensitivity to antipsychotic agents. - Subjects deemed intolerant of receiving injectable treatment. - Subjects who have received electroconvulsive therapy within the last 7 months prior to screening. - Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator. - Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. - Subjects requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the Informed Consent Form (ICF) or during the screening period. - Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 months) prior to screening. - Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening. - Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine. - Treatment with long-acting injectable antipsychotics in which the last dose was within 7 months prior to screening. - Subjects who have not been treated with oral antipsychotics for 7 months prior to screening. - Subjects who have a significant risk of committing suicide - Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial - Sexually active males and females who will not commit to utilizing birth control during the trial and for up to 180 days following the trial. - Abnormal laboratory or physical examination results indicating a condition which may interfere with the results of the study or pose a safety risk to the subject. - Subjects who have previously enrolled in an aripiprazole IM depot clinical study or who have participated in any clinical trial with an investigational agent within the past 30 days. ; PRIMARY OUTCOME: Comparison of Inpatient Psychiatric Hospitalization Rates; SECONDARY OUTCOME 1: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - R/R DLL3 (w/Dexamethasone); BRIEF: A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs). ; DRUG USED: Rova-T; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Antibody-drug Conjugate (ADC), Delta-like 3 (DLL3), DNA synthesis; THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Minimum life expectancy of at least 12 weeks. - Laboratory values meeting the criteria specified in the protocol. - Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen. - Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue. - Measurable disease as described per protocol. - In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids. Exclusion Criteria: - Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III - IV within 6 months prior to first dose of study drug. - Recent or on-going serious infection. - History of other invasive malignancy that has not been in remission for at least 3 years. - History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation. - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells. - Documented history of capillary leak syndrome. - Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis. ; PRIMARY OUTCOME: Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE; SECONDARY OUTCOME 1: Change in Participant Reported Outcome EORTC QLQC15-PAL[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PIONEER 10 (vs. Dulaglutide, Japanese Subjects); BRIEF: This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes. ; DRUG USED: Rybelsus; DRUG CLASS: Non-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 - Japanese male or female, age above or equal to 20 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening - HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive) - OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling 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 measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Any disorder, which in the investigators opinion might jeopardise subjects safety or compliance with the protocol - Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC) - History of pancreatitis (acute or chronic) - History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) - Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening and randomisation - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) - Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening - For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening - Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in situ carcinomas) - History of diabetic ketoacidosis ; PRIMARY OUTCOME: Number of Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change in HbA1c[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Safety Study (RFHE3002); BRIEF: This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past. ; DRUG USED: Xifaxan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatic Encephalopathy (HE); TARGET: Gram-Negative Bacteria, RNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Must sign an Informed Consent Form - In remission from past HE - Appropriate birth control measures - More than or equal to 18 years of age - Must be potential for benefit from treatment - Recent HE episodes - Capable and willing to comply with all study procedures - Participant has support network Exclusion Criteria: - Significant medical conditions or Investigator decision not to include the participant - Allergies to the study drug or similar drugs - Laboratory abnormalities - Recent participation in another clinical trial - Problems experienced in a previous HE trial - Pregnant or at risk of pregnancy - Recent alcohol consumption - Active or latent bacterial or viral Infections - Bowel issues - Recent Active Cancer - On a prohibited medication ; PRIMARY OUTCOME: Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event; SECONDARY OUTCOME 1: Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Fx-006 (Extension); BRIEF: This study is designed to determine the long-term safety and tolerability of Fx-1006A as well as the effects of Fx-1006A on clinical outcomes in patients with ATTR-PN. All patients who enroll in this extension study will receive once-daily oral 20 mg Fx-1006A for 12 months; therefore, patients randomized to placebo in Study Fx-005 will cross over to active drug (Fx-1006A 20 mg) during this study. However, patients and their families as well as clinical Investigators and their clinical site staff will remain blinded to the original Fx-005 treatment assignment. It is intended that there will be no interruption in study medication administration between the two studies. The majority of safety and clinical outcomes assessments will be identical to those evaluated in Study Fx-005. Additional assessments for this open-label extension study include 24-hour Holter monitoring and skin biopsy for IENF; patients will be required to provide written informed consent to participate in this open-label extension study prior to having these additional procedures performed. The values obtained from procedures and evaluations conducted during the Month 18 visit of Study Fx-005 will be used as the Baseline values for this open-label extension study. The Baseline assessments of IENF and Holter monitoring may be conducted at either day of the Month 18 visit days of Study Fx-005, but prior to the first Fx-1006A dose in this open-label extension study. Clinic Visits will be conducted at Week 6 (± 2 days), and Month 3 (± 1 week), Month 6 (± 2 weeks), and Month 12 (± 2 weeks). Monthly telephone contacts (± 1 week of the scheduled date) will be made during months in which no investigative site visits are scheduled (Months 2, 4, 5, 7, 8, 9, 10, and 11) for assessment of adverse events and concomitant medications. Neurological evaluation by NIS-LL will be performed at Months 6 and 12. The NIS-LL will be assessed by utilizing the average of two successive NIS-LL clinical assessment scores obtained at least 24 hours apart within a one week period for each study visit. A dedicated neurologist will be required to perform NIS-LL scoring across all time-points for each individual patient enrolled in the study. Quality of life utilizing the Norfolk QOL-DN will be assessed at Months 6 and 12 (based on the total score as well as the five individual domains of the questionnaire). QST (utilizing CASE IV), NCS, HRDB, mBMI, and echocardiography will be conducted at Months 6 and 12. Holter monitoring will be conducted at Baseline and Months 6 and 12. Biopsies for IENF will be obtained at Baseline only. Assessments of troponin I and NT-pro-BNP levels will be made at each study visit. Blood samples for pharmacokinetic assessments (Fx-1006A concentrations as well as calculated steady-state parameters) and pharmacodynamic assessments (TTR stabilization) will be collected at Week 6 and Months 6 and 12. Safety and tolerability will be assessed throughout the study. Vital signs, 12-lead ECG, blood and urine samples for clinical laboratory tests (serum chemistry, hematology, coagulation panel, urinalysis, and urine pregnancy testing), adverse events, and concomitant medications will be assessed at each study visit. Eye examinations (including fundal photography) will be conducted at Months 6 and 12. Abbreviated physical examinations will be conducted at Week 6, and Months 3 and 6, and a complete physical examination will be conducted at Month 12. All patients will be contacted by telephone 30 days (± 1 week) after the last dose of study medication for assessment of adverse events and concomitant medications. Patients who complete the Month 12 visit of this open-label study may be allowed to continue receiving Fx-1006A under a compassionate use program. Patients who discontinue from the study at any time after enrollment (i.e., early termination) will have final safety assessments performed at the time of discontinuation. Any patient discontinuing after the Month 6 visit will have all safety and clinical outcomes assessments scheduled for the Month 12 visit performed. ; DRUG USED: Vyndaqel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hereditary Transthyretin (hATTR) Amyloidosis With Polyneuropathy (Familial Amyloid Polyneuropathy); TARGET: Transthyretin (TTR); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: Male and non-pregnant female patients meeting all of the following criteria are eligible for enrollment in this study: - Patient has completed the Month 18 visit of Study Fx-005. - If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study. (A condom alone is not considered an acceptable method of birth control.) If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication. - Patient is, in the opinion of the investigator, willing and able to comply with the study medication regimen and all other study requirements. - Patient agrees not to participate in another investigational drug or device study while participating in this open-label extension study. Exclusion Criteria: Patients meeting any of the exclusion criteria will not be enrolled in the study: - Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted). - If female, patient is pregnant or breast feeding. - Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) >2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease. ; PRIMARY OUTCOME: Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6; SECONDARY OUTCOME 1: Change From Baseline in Neuropathy Impairment Score - Lower Limb (NIS-LL) Score at Month 6 and 12[/INST]Yes</s>