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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - CD-002; BRIEF: Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms. ; DRUG USED: DFD-07; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion: 1. Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian. 2. Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study. 3. Subjects must have 5 or more AK lesions that are non-hypertrophic and non-hyperkeratotic, contained within a single contiguous approximately 5 cm x 5 cm (25 cm2) region of face and/or scalp. 4. Subjects must be 18 years of age or older. Male and female subjects can be enrolled. 5. Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment. A female is considered of childbearing potential unless she is: 1. postmenopausal for at least 12 months prior to study product administration; 2. without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to study product administration. Reliable methods of contraception are: 1. hormonal methods or intrauterine device in use more than 90 days prior to study product administration; or 2. barrier methods plus spermicide in use at least 14 days prior to study product administration. 3. partner has had a vasectomy at least 3 months previous to study product administration. 4. Essure Exception: Sexually inactive female subjects of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigators discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception. 6. Subjects must agree not to use any product on the treatment area during the entire course of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated make-up. Subjects should continue to use these Investigator-approved products for the duration of the study and should avoid any changes in these consumer products. 7. Subjects must be willing to comply with sun avoidance measures for the face including use of Investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use. 8. Subjects must be in good general health as determined by the Investigator and supported by the medical history, and normal or not clinically significant abnormal vital signs (blood pressure and pulse rate). Subjects are eligible if: - Systolic blood pressure (BP) < 160 and > 85 mmHg - Diastolic BP < 100 and > 50 mmHg Exclusion: 1. Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drugs (NSAID) or any component of the formulation of the study medication, including a history of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDs. 2. Known or suspected allergy to sulfonamides. 3. Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease. 4. Recent (within 6 months) or planned coronary artery bypass graft surgery. 5. Significant history (within the past year) of alcohol or drug abuse. 6. Participation in any clinical research study within 30 days of the Baseline Visit. 7. Concomitant use of cosmetics or other topical drug products on or near the selected treatment area, except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup. 8. Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 2 weeks and within 2 cm of the selected treatment area. 9. Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis, atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism). 10. Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit. 11. Females who are pregnant or lactating or planning to become pregnant during the study period. ; PRIMARY OUTCOME: Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks; SECONDARY OUTCOME 1: Proportion of Subjects With Partial Clearance at Week 16[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ESTABLISH 2 (IV to Oral); BRIEF: This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration. Approximately 100 to 140 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment. ; DRUG USED: Sivextro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: - Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI. - Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections Exclusion Criteria: - Uncomplicated skin infections - Severe sepsis or septic shock - ABSSSI solely due to gram-negative pathogens ; PRIMARY OUTCOME: The Early Clinical Response Rate; SECONDARY OUTCOME 1: Clinical Response at the End of Therapy Visit[/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 - Japan; BRIEF: The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint. ; DRUG USED: Ciprofloxacin DPI; DRUG CLASS: Non-NME; INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Topoisomerase II (DNA gyrase) and IV; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older. - Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.) - The following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia or secondary infection of chronic respiratory disease - Severe pneumonia - Community-acquired pneumonia: PORT score III, IV or V - Hospital-acquired pneumonia [HAP]-Group B and with a low risk for multidrug-resistant pathogens - Patients with [HAP]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa - Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who dont respond to or have a poor response to other antimicrobials over 3days treatment.2 - Secondary infection of chronic respiratory disease - Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease - Hospitalized patients with secondary infection of chronic respiratory disease with a poor response to other antimicrobials Note: The patients should be limited to secondary infection of chronic respiratory disease patients who dont respond to or have a poor response to other antimicrobials over 3days treatment. Exclusion Criteria: - Creatinine clearance (Ccr) ≤ 30 mL/min or nephrotic syndrome - Patient with chronic treatment of immunosuppressive drug - Decompensated congestive heart failure - Subject who received more than 24 hours of an antibacterial drug for the current infection - Patient who requires Intensive Care Unit (ICU) management [In case subjects who dont correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded] - Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease - Lung abscess, or empyema - Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis - Known or suspected bacteremia secondary to Staphylococcus aureus - Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia - Infection that necessitates the use of a concomitant antibacterial agent in addition to study medication [excluding subjects with concomitant use of long-term, low-dose macrolide for chronic respiratory diseases, sulbactam sodium/ampicillin sodium (Unasyn-S) and clindamycin (Dalacin-S)] - Known bronchial obstruction or a history of post-obstructive pneumonia - Known primary lung cancer ; PRIMARY OUTCOME: Safety variables will be summarized using descriptive statistics based on adverse events collection; SECONDARY OUTCOME 1: Clinical response rate based on resolution of signs and symptoms[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACES 255; BRIEF: This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participants self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participants medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ. ; DRUG USED: Aripiprazole/Escitalopram; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration - Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period - Participants with a Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline Visit for the Prospective Treatment Phase Exclusion Criteria: - Lack of prior treatment with an antidepressant during the current depressive episode - Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode - Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode - Participants with epilepsy or significant history of seizure disorders - Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder - Participants who have received electroconvulsive therapy (ECT) in the last 10 years ; PRIMARY OUTCOME: Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14); SECONDARY OUTCOME 1: Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Velcade + dexamethasone; BRIEF: This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when added to the combination of bortezomib and dexamethasone in multiple myeloma patients who have relapsed on a prior bortezomib treatment regimen. ; DRUG USED: Perifosine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: AEterna Zentaris; CRITERIA: Inclusion Criteria: - Patient was previously diagnosed with multiple myeloma based on standard diagnostic criteria. - Patients must have relapsed (progressed > 60 days) after their last dose of bortezomib-based therapy. In addition, patients may be relapsed or refractory to other non-bortezomib-based therapies. - Patient has received at least 1 but not more than 4 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen. - Patients must have adequate organ and marrow function. Exclusion Criteria: - Patients must not be refractory to any bortezomib-containing regimen. - History of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine), bortezomib or dexamethasone or any of their components. - Prior treatment with perifosine or an investigational proteasome inhibitor. - Chemotherapy or other therapy experimental or proven that is or may be active against myeloma within two weeks (14 days) prior to Cycle 1 Day 1. ; PRIMARY OUTCOME: Determine the PFS (progression free survival) in patients with multiple myeloma, treated with perifosine, bortezomib and dexamethasone compared to patients treated with placebo, bortezomib and dexamethasone; SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - VITAL (Children); BRIEF: This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years. ; DRUG USED: Kanuma; DRUG CLASS: Biologic; INDICATION: Lysosomal Acid Lipase Deficiency ; TARGET: Cholesterol/Cholesteryl Ester, Triglycerides; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Participants parent or legal guardian provided written informed consent/permission prior to any study procedures. - Male or female child with documented decreased LAL activity relative to the normal range of the laboratory performing the assay or documented result of molecular genetic testing (2 mutations) confirming a diagnosis. - Growth failure with onset before 6 months of age. Exclusion Criteria: - Clinically important concurrent disease or comorbidities. - Had received an investigational product other than sebelipase alfa within 14 days prior to the first dose. - Participant was older than 24 months of age. - Myeloablative preparation, or other systemic pre-transplant conditioning, for hematopoietic stem cell or liver transplant. - Previous hematopoietic stem cell or liver transplant. - Known hypersensitivity to eggs. ; PRIMARY OUTCOME: Percentage Of Participants In The Primary Efficacy Analysis Set (PES) Surviving To 12 Months Of Age; SECONDARY OUTCOME 1: Percentage Of Participants Surviving Beyond 12 Months Of Age[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ES-SCLC; BRIEF: This is a randomized, multi-center, open-label study of approximately 24 months duration (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in combination with carboplatin and etoposide versus carboplatin and etoposide alone in chemotherapy-naive patients with extensive-stage small cell lung cancer. ; DRUG USED: Obatoclax mesylate; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Combination; LEAD SPONSOR: Cephalon; CRITERIA: Inclusion Criteria: - The patient has histologic or cytologic confirmation (upon local review) of small cell lung cancer (SCLC). - The patient has extensive-stage small cell lung cancer (ES-SCLC), as defined by National Comprehensive Cancer Network (NCCN) guidelines. - The patient has measurable disease as assessed by Response Evaluation Criteria Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). - The patient has not received any prior chemotherapy, biological agent, or investigational drug for SCLC. - The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - The patient is 18 years of age or older at the time informed consent is obtained. - The patient must be accessible for study treatment and follow-up. Patients enrolled in this study must be treated at participating study centers for all 3 days of study drug administration in either treatment group. - The patient has normal organ function. - Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to study enrollment. Women of childbearing potential and men with partners of childbearing potential must use a highly effective method of contraception throughout the entire study and up to 8 weeks after the last dose of any study drug (including obatoclax maintenance). Effective contraception or birth control is defined as those with a low failure rate (less than 1% per year) when used consistently and correctly. - Women must not be breastfeeding. - Written informed consent is obtained. - Patients with asymptomatic brain metastases may be enrolled and if clinically indicated, may be treated with steroids to be tapered as tolerated by the patient. Patients with symptomatic brain metastases will be eligible for the study after they have received therapeutic whole brain irradiation (WBI), which must be completed at least 7 days before the day of first treatment with study drugs. Since these patients will also be treated with steroids it is recommended that steroids be tapered as clinically indicated and tolerated by the patient. The use of chronic, low-dose steroids is not contraindicated for these patients (or any other patients). Stereotactic radiation will be allowed for 1 to 3 brain metastatic lesions that meet appropriate criteria for that procedure; however, this must be discussed with the study monitor prior to consideration for enrollment into this study. - The patient must be willing and able to comply with study restrictions and to remain at the study center for the required duration during the study period and willing to return to the study center for the follow-up evaluation as specified in this protocol. Exclusion Criteria: - The patient has had any prior systemic therapy for ES-SCLC other than radiation therapy or surgery. - The patient has a history of prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell or squamous cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy and is deemed by his or her treating physician to be at low risk for recurrence for 5 years. - The patient has a history of hypersensitivity or allergic reactions attributed to components of the obatoclax mesylate formulation (ie, polysorbate 20 and polyethylene glycol [PEG] 300) or to carboplatin or etoposide. - The patient currently has leptomeningeal disease or paraneoplastic syndromes. - The patient has uncontrolled intercurrent illness including, but not limited to, symptomatic neurologic illness; active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness that would limit compliance with study requirements. - The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study but will be monitored for safety.) - The patient has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus (HCV Ab) or a known positive history of antibodies to human immunodeficiency virus (HIV) and is receiving combination antiretroviral therapy. ; PRIMARY OUTCOME: Overall survival (OS): Time to Death; 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 - COUPLE; BRIEF: The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction. ; DRUG USED: Priligy; DRUG CLASS: New Molecular Entity (NME); INDICATION: Premature Ejaculation; TARGET: Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Clinical diagnosis of erectile dysfunction (ED), International Index of Erectile Function (IIEF) score >=21 at screening and baseline, and receiving treatment with a stable regimen of a phosphodiesterase 5 (PDE 5) inhibitor (ie, sildenafil, vardenafil, or tadalafil) for the treatment of ED for at least 3 months before screening - Study participant in a stable, monogamous sexual relationship with the same woman for at least 6 months before screening and plan to maintain this relationship for the duration of the study - Study participant medically stable (ie, in good general health) on the basis of physical examination, medical history, vital signs, 12 lead ECG, and clinical laboratory tests performed at screening Exclusion Criteria: - History suggestive of syncope (a condition characterized by a loss of consciousness) - History of medical events such as surgical interventions or neurologic conditions (eg, multiple sclerosis), trauma, or infections that are associated with the development of symptoms of premature ejaculation (PE) and considered a potential cause of PE - Current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder, or alcoholism - Known allergy, hypersensitivity, or intolerance to selective serotonin reuptake inhibitors (SSRIs) or selective noradrenaline reuptake inhibitors (SNRIs) - Taken another investigational drug (or vaccine) within 30 days or used an investigational medical device within 6 months before screening, or enrolled in another investigational study ; PRIMARY OUTCOME: The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12; SECONDARY OUTCOME 1: The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Carboplatin and Paclitaxel (Current or Former Smokers); BRIEF: The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigators choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer. ; DRUG USED: Veliparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Subject must be ≥ 18 years of age with life expectancy > 12 weeks. - Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers. - Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening. - Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Exclusion Criteria: - Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). - Subject has a known hypersensitivity to platinum compounds. - Subject has peripheral neuropathy ≥ grade 2. - Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement. - Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC. ; PRIMARY OUTCOME: Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup; SECONDARY OUTCOME 1: Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup[/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 - OPTIMRETREAT; BRIEF: The objective of this study is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on progression free survival (PFS). ; DRUG USED: Velcade; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Monotherapy; LEAD SPONSOR: Janssen-Cilag International NV; CRITERIA: Inclusion Criteria: - Have received a bortezomib containing regimen in one of the previous line(s) of therapy and have shown at least PR to the previous bortezomib therapy. - Have relapsed / progressed multiple myeloma following 1 or 2 previous lines of therapy as defined in the protocol. - Have measurable secretory multiple myeloma: measurable disease for secretory multiple myeloma is defined by at least one of the following measurements: serum M protein greater than or equal to 1 g/dL (≥10g/L], urine M-protein of ≥200 mg/24 hours. - Have an ECOG performance status of ≤2. - Have a life expectancy estimated at screening of ≥6 months. Exclusion Criteria: - Has received more than 2 previous lines of therapy for multiple myeloma or has received no previous bortezomib-containing regimen. - Has been refractory to bortezomib, defined as either having progressed during bortezomib therapy or relapsed/progressed within 6 months after the last dose of bortezomib. - Has oligosecretory or nonsecretory multiple myeloma. - Has a history of a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. - Has peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE), version 4.0. ; PRIMARY OUTCOME: Effect of optimized retreatment followed by prolonged therapy versus standard retreatment on Progression Free Survival (PFS); SECONDARY OUTCOME 1: Overall Response Rate (ORR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - First-Line (China); BRIEF: This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer. ; DRUG USED: Anlotinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Fibroblast Growth Factor (FGF), Tyrosine Kinases, VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; CRITERIA: Inclusion Criteria: - 1. Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion. 2. EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks. 4. Has not received systemic anti-tumor treatment for advanced disease. 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization. 7. Understood and signed an informed consent form. Exclusion Criteria: - 1.Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab. 3. Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1. 7. Has any severe and / or uncontrolled diseases. 8. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists. 9.Has received surgery, or unhealed wounds within 4 weeks before the first administration. 10. Has hemoptysis within 28 days before randomization. 11. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear. 12. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism. 13. Has psychotropic substances abuse or a mental disorder. 14. Have a history of immunodeficiency. 15. Has received allogeneic organ transplantation, hematopoietic stem cell transplantation or bone marrow transplantation. 16. Has other malignancy. 17.Has participated in other anticancer drug clinical trials within 4 weeks. 18.According to the judgement of the researchers, there are other factors that may lead to the termination of the study. ; PRIMARY OUTCOME: Progression free survival (PFS); SECONDARY OUTCOME 1: Overall response rate (ORR) assessed by Independent Review Committee (IRC)[/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 - 14865A; BRIEF: To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms. ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Post-Traumatic Stress Disorder (PTSD); TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI). - The patient has a Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at Screening and Baseline Visits. - The reported duration of the PTSD is at least 3 months. Exclusion Criteria: - The index traumatic event that led to development of PTSD took place more than 15 years before screening. - The patient has a severe personality disorder that in the investigators opinion may interfere with the conduct of the study. - The patient is at significant suicidal risk. Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: PTSD Symptoms Using CAPS-2 Total Score; SECONDARY OUTCOME 1: Global Clinical Impression Severity of Illness (CGI-S) 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 - ATLAS; BRIEF: This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250. ; DRUG USED: Abilify Maintena; DRUG CLASS: Non-NME; INDICATION: Bipolar Disorder; 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: - Completed participation in Trial 31-08-250 - De novo subjects not participating in Trial 31-08-250 - Subjects who are able to provide written informed consent. - Male and female subjects 18 years of age or older at time of informed consent - Subjects who, in the investigators judgment, require chronic treatment with an antipsychotic medication for their bipolar I disorder and would benefit from extended treatment with a long-acting injectable formulation - Subjects who have a recurrence of mood episode or exacerbations of mood symptoms when they are not receiving treatment for their bipolar I disorder or are noncompliant with treatment for their bipolar I disorder - Have an outpatient status Exclusion Criteria: - Experienced 9 or more mood episodes within the past year - A current manic episode with a duration of > 2 years - Currently meet DSM-IV-TR criteria for substance abuse or substance dependence; this includes the abuse of alcohol and benzodiazepines, but excludes the use of caffeine and/or nicotine - Hypothyroidism or hyperthyroidism, unless condition has been stabilized - Diagnosed with epilepsy or a history of seizures - Known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones - Sexually active women of childbearing potential and sexually active men who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during this trial and for 180 days following the last dose of trial medication - Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug) - Risk of committing suicide - Abnormal laboratory test results, vital signs and ECG results - Participated in any clinical trial other than Trial 250 with an investigational agent within the 30 days prior to screening - Had electroconvulsive therapy (ECT) treatment during the current episode or within 3 months - Subjects who have not met criteria for stabilization for 4 consecutive weeks ; PRIMARY OUTCOME: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Percentage of Participants Who Remained Stable at End of Treatment in Phase C[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MERCURY 3 (EU); BRIEF: The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure ; DRUG USED: Rocklatan; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Prostaglandin F receptor (FP)/PGF2 alpha receptor , Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Must be 18 years of age or older. 2. Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable). 3. Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators. 4. Medicated intraocular pressure ≥ 17 mmHg in at least one eye and < 28mmHg in both eyes at screening visit. 5. Unmedicated (post-washout) IOP >20mmHg in at least one eye and < 36mmHg in both eyes at 2 qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP >17mmHg in at least one eye and < 36mmHg in both eyes at 10:00 and 16:00 hours. Note: For purposes of determining eligibility of subjects to be enrolled, the non-integral IOP mean number will be used. Any non-integral mean IOP number should not be rounded. If only one eye qualifies at the second qualification visit it MUST be the same eye that qualified on the first visit and this will be the study eye for the duration of the study. 6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye). 7. Be able and willing to give signed informed consent and follow study instruction. 8. Women must be either of non-childbearing potential, or women with childbearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study. 9. Women of childbearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception during the study and for 3 months after the last dose of study medication. 10. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use an effective form of contraception from time of randomization and for 3 months following the last dose of study medication. 11. In France, a subject will be eligible for inclusion in this study only if either affiliated to or as a beneficiary of a social security number. Exclusion Criteria: Ophthalmic: 1. Clinically significant ocular disease (e.g., corneal edema, uveitis, or severe keratoconjunctivitis sicca) which might interfere with interpretation of the study efficacy endpoints or with safety assessments, including subjects with glaucomatous damage so severe that washout of ocular hypotensive medications for 4 weeks or longer if needed is not judged safe as it would put the subject at risk for further vision loss. 2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles i.e. Grade 2 Shaffer (Chan 1981) or less extreme narrow angle with complete or partial closure. Note: Previous laser peripheral iridotomy is NOT acceptable. 3. Intraocular pressure ≥ 36mmHg (unmedicated) in either eye (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication. However, subjects currently taking 2 fixed dose combination products are excluded. 4. Treatment-naïve subjects. 5. Prior treatment with GANFORT® topical eye drops where the subjects IOP did not achieve the target IOP and was considered either a therapeutic failure or to have insufficient response. Subjects currently (immediately prior to screening visit) being treated with GANFORT® are excluded from the study. 6. Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride) or to fluorescein. 7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye. 8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty). 9. Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening. 10. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, current evidence or history of herpes simplex or zoster keratitis in either eye at screening. 11. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications which must have been the same medication for 30 days prior to screening (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study), as prescribed by the Investigator. 12. Mean central corneal thickness greater than 620μm at screening. 13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus). Systemic: 14. Clinically significant abnormalities in laboratory tests at screening. 15. Known hypersensitivity or contraindication to GANFORT® (Appendix 3 Marketed Product Medication Information Section 4.3) and to β-adrenoceptor antagonists (e.g. Chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third-degree heart block or congestive heart failure, cardiac failure, cardiac shock and severe diabetes). 16. Clinically significant systemic disease which might interfere with the study. 17. Participation in any investigational study within 30 days prior to screening. 18. Systemic medication including corticosteroid containing drugs that could have a substantial effect on IOP which HAVE NOT been maintained at a consistent dose and regime within 30 days prior to screening, and are anticipated to change in dose and/or regime during the study. 19. Use of topical steroid containing medications on the face or in or around the eyes will exclude the subject (see Section 5.6 Concomitant Medications). 20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable and highly effective form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal (1 year without menses with appropriate clinical profile, e.g. age appropriate, > 45 years in the absence of HRT. In questionable cases the subject must have FSH value > 40mIU/mL and an estradiol value < 40pg/mL (< 140pmol/L)) or three months post-surgical sterilization. 21. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent (e.g. hospitalized persons in coma), persons deprived of liberty (prisoners from jails), or persons subject to psychiatric care. ; PRIMARY OUTCOME: Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry; 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 - w/ Ivacaftor; BRIEF: The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation ; DRUG USED: Orkambi; 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: - Homozygous for the F508del-CFTR mutation; historical genotype must be documented in the participants source documents. - Percent predicted FEV1 <40 of adjusted for age, sex, and height at Screening Exclusion Criteria: - Participant currently receiving invasive mechanical ventilation. - 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 participant - Any clinically significant laboratory abnormalities at screening that would interfere with the study assessments or pose an undue risk for the subject - A 12-lead electrocardiograms (ECG) demonstrating QTcF >450 msec at Screening - History of solid organ or hematological transplantation - History of alcohol or drug abuse in the past year - Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening. - Use of strong inhibitors, moderate inducers, or strong inducers of CYP3A - Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at Screening and Day 1. - Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements - Use of beta blockers or the equivalent at Screening. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Up 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 - Pediatric; BRIEF: The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517) plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s) associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s) not previously tolerated due to vomiting. The primary hypothesis is that a single dose of fosaprepitant in combination with ondansetron provides superior control of CINV compared to ondansetron alone as measured by the percentage of participants with a Complete Response (no vomiting, no retching, and no use of rescue medications) in the delayed phase (>24 to 120 hours) following initiation of emetogneic chemotherapy in Cycle 1. ; DRUG USED: Emend (IV); DRUG CLASS: Non-NME; INDICATION: Chemotherapy Induced Nausea and Vomiting (CINV); TARGET: Neurokinin Receptor; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Is 0 (at least 37 weeks gestation) to 17 years of age at time of randomization - Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age) - Has a predicted life expectancy ≥3 months - Is receiving chemotherapeutic agent(s) associated with moderate or high risk of emetogenicity, or a chemotherapy regimen not previously tolerated due to vomiting - Has a preexisting functional central venous catheter available for study drug administration - Is male OR is female who is not of reproductive potential OR is female who is of reproductive potential and agrees to avoid becoming pregnant in the 28 days prior to receiving study drug, while receiving study drug and for at least 30 days after last dose of study drug Exclusion Criteria: - Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1 - Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study) - Will be receiving stem cell rescue therapy in conjunction with study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant/placebo for fosaprepitant - Has received or will receive total body irradiation of radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period (120 hours following initiation of chemotherapy) - Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy except for single doses of midazolam, temazepam or triazolam - Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen - Is currently taking, or has taken within 48 hours of Treatment Day 1 the following drugs with antiemetic properties: 5-hydroxytryptamine 3 (5-HT3) antagonists (e.g., ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorpenzine), scopolamine (this is not an exhaustive list) - Is or has an immediate family member who is investigational site or sponsor staff directly involved with this study - Is currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence - Is mentally incapacitated or has a significant emotional or psychiatric disorder - Is pregnant or breast feeding - Is allergic to fosaprepitant, aprepitant (MK-0869), ondansetron, or any other 5-HT3 antagonist - Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation - Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy - Has ever participated in a previous study of aprepitant or fosaprepitant or has taken an investigational drug with the last 4 weeks. ; PRIMARY OUTCOME: Percentage of Participants Who Experienced a Complete Response During the Delayed Phase (>24 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1; SECONDARY OUTCOME 1: Percentage of Participants Who Experienced a Complete Response During the Acute Phase (0 to 24 Hours Post Initiation of Chemotherapy) in Cycle 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 - United Kingdom; BRIEF: This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active rheumatoid arthritis (RA) and an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (anti-TNF) agent. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously once a week for 52 weeks. ; DRUG USED: Actemra (Subcutaneous); DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria - Participants who have an inadequate response to current non-biologic DMARD therapy or the first anti-TNF agent (in monotherapy or in combination with MTX or other non-biologic DMARDs). Inadequate response to anti-TNF treatment is defined as DAS28 score improvement of less than 1.2 or participants achieving a DAS28 score improvement of 1.2 but not achieving low disease activity (current DAS28-ESR above 3.2) according to a treat-to-target strategy and have not been previously exposed to treatment with tocilizumab. Inadequate response to non-biologic DMARD therapy will be assessed according to local guidelines and the participants will need to be eligible for biologic therapy according to local guidelines - Oral corticosteroids (≤10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to recommended dose) are permitted if on stable dose regimen for greater than or equal to [≥] 4 weeks prior to baseline - Permitted non-biologic DMARDs are allowed if on stable dose for at least 4 weeks prior to baseline - Receiving treatment on an outpatient basis, not including tocilizumab - Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol during the study and for at least 3 months following the last dose of tocilizumab Exclusion Criteria: - Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline - Rheumatic autoimmune disease other than RA - Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16 - Prior history of or current inflammatory joint disease other than RA - Exposure to tocilizumab either intravenous or SC at any time prior to baseline - Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening - Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline - History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies - Known active current or history of recurrent infections - Major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening - Active tuberculosis (TB) requiring treatment within the previous 3 years - Positive for hepatitis B or hepatitis C virus infection - Primary or secondary immunodeficiency (history of or currently active) - Pregnant or lactating women - Inadequate hematologic, renal or liver function ; PRIMARY OUTCOME: Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2; SECONDARY OUTCOME 1: Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HEC2 (Oral); BRIEF: This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles. ; DRUG USED: Varubi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chemotherapy Induced Nausea and Vomiting (CINV); TARGET: Neurokinin Receptor; THERAPY: Combination; LEAD SPONSOR: Tesaro, Inc.; CRITERIA: Inclusion Criteria: - 18 years of age or older, of either gender, and of any race - Has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2) - Karnofsky performance score of ≥60 - Predicted life expectancy of ≥4 months - Adequate bone marrow, kidney, and liver function Exclusion Criteria: - Contraindication to cisplatin, granisetron, or dexamethasone - Is pregnant or breast feeding - Has previously received cisplatin or subject is planning to receive multiple days of cisplatin in a single cycle - Has taken the following agents within the last 48 hours 5-HT3 antagonists,Phenothiazines,Benzamides,Domperidone,Cannabinoids,NK1 antagonist, Benzodiazepines - Scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 4 or above (Hesketh Scale) from Day 2 through Day 6, except on Day 1. - Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6 - Has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes, pemetrexed) - Symptomatic primary or metastatic CNS disease. - Has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting. - Has vomited and/or has had dry heaves/retching within 24 hours prior to the start of cisplatin-based chemotherapy on Day 1 in Cycle 1. ; PRIMARY OUTCOME: No Emetic Episodes and No Rescue Medication; SECONDARY OUTCOME 1: Acute Phase Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IFN-Free w/ABT-267/ABT-450/Ritonavir (Follow-Up); BRIEF: A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725) M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845). ; DRUG USED: Exviera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND. - The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years. - The subject must voluntarily sign and date the informed consent form. - Subject completed the post-treatment period of an eligible prior study. Exclusion Criteria: - The investigator considers the subject unsuitable for the study for any reasons. - Receipt of any investigational product from Day 1 and while enrolled in this study. ; PRIMARY OUTCOME: Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection; SECONDARY OUTCOME 1: Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RENEW (CMI); BRIEF: The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia. ; DRUG USED: OLOGO; DRUG CLASS: Biologic; INDICATION: Angina; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Lisata Therapeutics, Inc.; CRITERIA: Main Inclusion Criteria: - Male or female participants who are 21 to 80 years of age at the time of signing the informed consent. - Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina. - Participants without control of their angina symptoms in spite of maximal tolerated doses of anti-angina drugs. Participants must be on optimal therapy for their angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form. - Participants with obstructive coronary disease unsuitable for conventional revascularization due to unsuitable anatomy or comorbidity as determined at the site and confirmed by an independent adjudication committee. - Participants must have evidence of inducible myocardial ischemia. - Participants must experience angina episodes. - Participants must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization. - If female of childbearing potential, subject must not be pregnant and agree to employ adequate birth control measures for the duration of the study. Main Exclusion Criteria: - Cardiovascular hospitalization within 60 days prior to potential study enrollment. Participant has had a successful or partially successful coronary artery bypass graft (CABG) within 6 months or PCTA within 60 days of potential study enrollment. - Participant has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure within 180 days of potential study enrollment. - Participant has documented stroke or transient ischemic attacks (TIAs) within 60 days of potential study enrollment. - Participant has a history of moderate to severe aortic stenosis; or severe aortic insufficiency; or severe mitral stenosis; or severe mitral insufficiency. - Participant has a prosthetic aortic valve or a mechanical mitral valve replacement. - Participant has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses. - Participants with cancer are excluded with the following exceptions: - Subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are not excluded. - Participants that have been cancer free for >= 5 years as determined by their oncologist are not excluded. Subjects with a prior history of stem cell transplant for cancer are excluded no matter how long they have been cancer-free. - Participants with a history of leukemia or other bone marrow disease. - Participant has sickle cell disease or sickle cell trait. - Participants with proliferative retinopathy. - Participants with Hb A1c > 9%. - Participant has platelet counts >10% above the upper limit of normal (ULN) or platelet counts < 70,000. - Participant has a hematocrit < 30% prior to potential study enrollment. - Participant has a serum creatinine > 2.5 mg/dL prior to potential study enrollment. - Participant tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant. - Participant has a known contraindication to Neupogen (filgrastim) or G-CSF. - Participant was previously enrolled in an active treatment group of cell therapy trials for cardiovascular disease including any phase of CD34+ stem cell trials. - Left ventricular (LV) thickness of < 7 mm in the target areas of injection as measured by during a 2-D echocardiogram (ECHO). - Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that would prohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection. - Bleeding diathesis with an INR > 1.8 when not receiving anti-thrombotic therapy. - Hepatic dysfunction as evidenced by elevated AST or ALT levels > 2.5 x ULN. - Any previous transplant requiring immunosuppression. - Disease state requiring chronic immunosuppression. ; PRIMARY OUTCOME: Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol; SECONDARY OUTCOME 1: Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TAK-491CLD-303; BRIEF: The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in participants with moderate to severe hypertension. ; DRUG USED: Edarbyclor; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Na/Cl transporter - Thiazide-sensitive; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg. 2. Females of childbearing potential who are sexually active agree to routinely use adequate contraception from Screening through 30 days after the last administered study drug dose. 3. Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant. 4. Is willing to discontinue current antihypertensive medications on Day -21 or Day -28 if the participant is on amlodipine or chlorthalidone. Exclusion Criteria: 1. Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on Day -1. 2. Has a baseline 24-hour ambulatory blood pressure monitoring reading of insufficient quality. 3. Works a night (third) shift. 4. Has an upper arm circumference less than 24 cm or greater than 42 cm. 5. Has secondary hypertension of any etiology. 6. Has a recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. 7. Has clinically significant cardiac conduction defects. 8. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 9. Has severe renal dysfunction or disease. 10. Has known or suspected unilateral or bilateral renal artery stenosis. 11. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. 12. Has poorly-controlled diabetes mellitus at Screening. 13. Has hypokalemia or hyperkalemia. 14. Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice. 15. Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol. 16. Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds. 17. Has a history of drug abuse or a history of alcohol abuse within the past 2 years. ; PRIMARY OUTCOME: Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.; SECONDARY OUTCOME 1: Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.[/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 - TDE-HF-302; BRIEF: This was an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil was commercially available to treat PH associated with HFpEF or the study was discontinued by the Sponsor. The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March 2020. Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed. ; DRUG USED: Orenitram; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: 1. The subject participated in Study TDE-HF-301, remained on study drug, was compliant with study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of that study. Exclusion Criteria: 1. The subject was pregnant or lactating. 2. The subject was prematurely discontinued from Study TDE-HF-301 for any reason. 3. The subject developed a concurrent illness or condition during Study TDE-HF-301, which, in the opinion of the Investigator, represented a risk to the subjects overall health if they enrolled in this study. ; PRIMARY OUTCOME: Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301; 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 - 301 (EMU); BRIEF: This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity. ; DRUG USED: Nayzilam; DRUG CLASS: Non-NME; INDICATION: Seizure Disorders (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma S.P.R.L.; CRITERIA: Inclusion Criteria: - Subject has been admitted to the institutions EMU for seizure characterization or pre-surgical evaluation, or such admission is planned within 28 days - Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive) - Subject has an established diagnosis of partial or generalized epilepsy Exclusion Criteria: - Subject has history of status epilepticus in the 6 months prior to Screening - Subject has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months - Subject has respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen - Subject has acute narrow-angle glaucoma - Subject is receiving chronic benzodiazepine treatment (defined as an average of ≥ 4 administrations per week) and cannot safely withdraw from such treatment within the washout period prior to treatment ; PRIMARY OUTCOME: Number of Participants That Were Seizure-free; SECONDARY OUTCOME 1: Time to First Seizure Following Treatment (TFSFT)[/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 - Induction and Maintenance; BRIEF: The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase. ; DRUG USED: Andecaliximab; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: MMP (metalloproteinase); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Ulcerative Colitis (UC) confirmed on endoscopy - Moderately to severely active UC (Mayo Score 6-12) - May be receiving oral 5-aminosalicylate (ASA), oral corticosteroid, azathioprine, 6-mercaptopurine (MP), or methotrexate - Treatment failure with at least one of the following agents received: corticosteroids, immunomodulators, tumor necrosis factor-alpha (TNFα) antagonists, vedolizumab Key Exclusion Criteria: - Diagnose of Crohns disease or indeterminate colitis - Pregnant or lactating females - Any chronic medical condition (including, but not limited to cardiac or pulmonary disease, alcohol or drug abuse) - Exhibit severe UC / clinically significant active infection - History of malignancy in the last 5 years Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8; SECONDARY OUTCOME 1: For Cohort 1, Percentage of Participants With MCS Remission at Week 8[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PB-06-001; BRIEF: Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system. This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line. ; DRUG USED: Elelyso; DRUG CLASS: Biologic; INDICATION: Gauchers Disease; TARGET: Glucocerebroside (glucosylceramide); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Males and females, 18 years or older - Confirmed enzymatic diagnosis of Gaucher disease - Splenomegaly defined as greater than eight times the expected volume (measured volume divided by estimated volume (0.2% of body weight)] as determined by MRI volumetric analysis - Female patients of child-bearing potential who agree to use a medically acceptable method of contraception - Thrombocytopenia (defined as platelet counts below the lower limit of normal) and/or anemia (defined by hemoglobin level at least 1 g/dL below normal range according to sex and age). - Patients who have not received ERT in the past or patients whoc have not received ERT in the past 12 months and have a negative anti-glucocerebrosidase antibody test. - Patients who have not received substrate reduction therapy (SRT) in the past 12 months. - Ability to provide a written informed consent. Exclusion Criteria: - Currently taking another experimental drug for any condition - Pregnant or nursing - Presence of HIV and/or, HBsAg and/or hepatitis C infections - Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease. - Previous anaphylactoid reaction to Cerezyme® or Ceredase®. - History of allergy to carrots. ; PRIMARY OUTCOME: Change From Baseline in Spleen Volume Measured by MRI.; SECONDARY OUTCOME 1: Change From Baseline in Liver Volume[/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 305; BRIEF: A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting. ; DRUG USED: Dasotraline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: - 1. Subject is 6 - 12 years old, inclusive at screening and randomization. 2. At least one of the subjects parents/legal guardians must give written informed consent, including privacy authorization, prior to study participation. The subject will provide informed assent prior to study participation. 3. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) at screening established by a comprehensive psychiatric evaluation that reviews DSM-5 criteria and confirmed using the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) at screening. 4. Subject is currently on a treatment regimen of a methylphenidate formulation within the approved labeled dose range for ADHD for at least 6 weeks prior to Day -7 with the same dose level for at least 1 week immediately prior to Day -7. Note: if any doses of methylphenidate were missed during the week prior to Day-7, the subjects eligibility will be discussed with the Medical Monitor. 5. In the opinion of the investigator, methylphenidate well tolerated and clinically effective based on clinical assessment and informant interview, as well as, review of available medical records. Note: The ADHD Rating Scale Version IV - Home Version (modified for investigator administration) (ADHD-RS-IV HV) will be administered at Screening by the investigator to inform clinical evaluation. 6. Subject is male or a non-pregnant, non-lactating female. 7. Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age must have a negative serum pregnancy test at screening. 8. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must practice true abstinence (consistent with lifestyle) and must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control, from the time of informed consent/assent to at least 14 days after the last dose of the study drug has been taken. 9. Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical and neurological examinations, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis). Note: If any of the hematology, chemistry, or urinalysis results are not within the laboratorys reference range, then the subject can be included only if the investigator determines the deviations to be not clinically relevant. 10. Subject is within the 3rd to 97th percentile for gender specific body mass index (BMI)-for-age from the World Health Organization (WHO) growth charts and weighs at least 21 kg. 11. Subject must report a history of being able to swallow capsules. 12. Subject and subjects parent/legal guardian must be able to fully comprehend the informed consent/assent forms, understand and be willing and able to comply with all study procedures and visit schedule, and be able to communicate satisfactorily with the investigator and study coordinator. Exclusion Criteria: - 1. Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits. 2. Subject, on Day 1, has not demonstrated evidence of worsening of ADHD symptoms as measured by ADHD-RS-IV HV total score ≥ 26 and at least a 30% worsening in ADHD-RS-IV HV total score since the last assessment and following a minimum 72-hour washout from prior methylphenidate treatment. 3. Subject is currently being treated for ADHD with an amphetamine-based product, or has been treated with an amphetamine-based product in the 6 weeks prior to the start of screening. 4. Subject is currently being treated for ADHD with a non-methylphenidate product, or has been treated with a non-methylphenidate product in the 6 weeks prior to the start of screening. 5. Subject has failed 2 adequate courses (dose and duration) of stimulant or non-stimulant treatment for ADHD, as judged by the investigator. 6. Subject currently has a diagnosis of asthma that has required daily treatment with bronchodilators or nebulizer treatments in the 30 days prior to screening and/or who may require daily treatments with these agents over the course of the trial. Intermittent use of bronchodilators is not exclusionary. Subjects who have a history of requiring persistent asthma treatment should be discussed with the medical monitor prior to randomization. 7. Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (eg, malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the medical monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the medical monitor during screening. 8. Subject has a history or presence of abnormal ECGs, which in the investigators opinion is clinically significant. Screening site ECGs will be centrally over-read, and eligibility will be determined by the investigator based on the results of the over-read report. 9. Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourettes Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Note: Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment. 10. Subject has generalized anxiety disorder or panic disorder that has been the primary focus of treatment at any time during the 12 months prior to screening or that has required pharmacotherapy any time during the 6 months prior to screening. 11. Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood (eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is exclusionary. Subject taking anticonvulsants for seizure control currently or within the past 2 years is not eligible for study participation. 12. Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone (TSH) ≤ 0.8 x the lower limit of normal (LLN) or ≥ 1.25 x the upper limit of normal (ULN) for the reference laboratory. 13. Subject answers yes to Suicidal Ideation item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for any lifetime history on the C-SSRS Childrens Lifetime/Recent assessment at screening. 14. Subject has any history of attempted suicide or clinically significant suicidal ideation, in the opinion of the investigator. 15. Subject has a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions or has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulations. 16. Subject has history of intolerance (safety) or lack of efficacy to stimulants. 17. Subject has taken any antipsychotic medication within 6 months prior to screening. 18. Subject has taken any herbal and/or complementary treatments, eg, St. Johns Wort, within 7 days prior to Day 1. 19. Subject has taken any antidepressant medication (eg, bupropion, selective serotonin reuptake inhibitor [SSRI]/ serotonin norepinephrine reuptake inhibitor [SNRI], tricyclic, etc) within 7 days prior to Day 1. 20. Subject has taken any monoamine oxidase [MAO] inhibitor within 21 days prior to Day 1. 21. Subject is currently undergoing Cognitive Behavioral Therapy (CBT) for the treatment of ADHD, has initiated behavioral therapy (including school based interventions) less than 1 month prior to screening, or is receiving behavioral therapy and in the opinion of the investigator will not be able to follow a stable routine for the duration of the study. Note: Unavoidable changes in school-based interventions that occur during study participation will not be exclusionary, but should be documented by the investigator, to the extent possible. 22. Subject or subjects family anticipates a move outside the geographic range of investigative site during the study period, or plans extended travel inconsistent with the recommended visit interval during study duration. 23. Subject has history of, or current malignancy except for non-melanomatous skin cancer. 24. Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C antibody. 25. Subject is known to have tested positive for human immunodeficiency virus (HIV). 26. Subject has participated in a classroom study within 6 months prior to the start of screening or has participated in any other clinical study with an investigational drug/product within 90 days prior to the start of screening or is currently participating in another clinical trial. 27. Subject shows evidence of substance or alcohol use or is currently using tobacco or other nicotine-containing products, or has a positive urine drug screen (UDS) at screening. Note: Subjects with a positive UDS may be allowed to continue in the study, provided that the investigator determines that the positive test is as a result of taking medications as prescribed after consultation with the medical monitor. 28. Subject is taking any disallowed medications for chronic treatment. 29. Subject has previously been enrolled in a clinical trial of dasotraline (SEP-225289). 30. Subjects parent/legal guardian is an investigational site staff member or the relative of an investigational site staff member. 31. Subject is, in the opinion of the investigator, unsuitable in any other way to participate in this study. 32. Subjects sibling or family member living in the same household is participating in the same laboratory classroom cohort for this study. 33. Subject is unable to perform at the basic level of the standardized math test as defined in the laboratory classroom manual. ; PRIMARY OUTCOME: Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose); SECONDARY OUTCOME 1: Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)[/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 - AWARD-5 (vs. Sitagliptin, dose-finding); BRIEF: This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Diabetes mellitus, type 2, for at least 6 months - Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization. - Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of >8.0% to ≤9.5% - Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m^2), inclusive - Stable weight for 3 months prior to screening - Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method Exclusion Criteria: - Diabetes mellitus, type 1 - Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin - Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility - Use of medications to promote weight loss - Clinically-relevant cardiovascular event within 6 months prior to screening - Poorly controlled hypertension - Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease - Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels >3.0 times the upper limit of normal - Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance <60 milliliters per minute (mL/minute) - Uncontrolled diabetes, defined as >2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry. - Uncontrolled endocrine or autoimmune abnormality - History of a transplanted organ - Chronic use of systemic glucocorticoid therapy - Active or untreated malignancy - Use of central nervous system (CNS) stimulants ; PRIMARY OUTCOME: Glycosylated Hemoglobin (HbA1c) Change From Baseline; SECONDARY OUTCOME 1: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - P07057 (India); BRIEF: This study will investigate the efficacy and safety of the monophasic combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in healthy fertile Indian women. ; DRUG USED: Zoely; DRUG CLASS: New Molecular Entity (NME); INDICATION: Contraception; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion Criteria: - Sexually active and at risk for pregnancy - Of Indian descent, born in India, never emigrated out of India, with Indian home address - Body mass index (BMI) ≥17 and ≤35 kg/m^2 Exclusion Criteria: - Presence or history of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident - Presence or history of prodromi of a thrombosis - History of migraine with focal neurological symptoms - Diabetes mellitus with vascular involvement - Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis - Severe hypertension - Severe dyslipoproteinemia - Presence or history of pancreatitis associated with severe hypertriglyceridemia - Presence or history of severe hepatic disease - Undiagnosed vaginal bleeding - Known or suspected pregnancy - Currently breastfeeding or breastfeeding within 2 months of starting trial medication - Investigational drug use or participation in another clinical trial within 2 months of signing Informed Consent Form for current trial ; PRIMARY OUTCOME: Number of In-treatment Pregnancies; SECONDARY OUTCOME 1: Number of Participants Experiencing an Adverse Event (AE) or Serious AE[/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 - 322; BRIEF: This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is to help answer the following questions: - How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it? - Can supplemental SPD489 help patients who still have residual depression symptoms while taking an antidepressant? - How much SPD489 should be given to patients with depression who are also taking an antidepressant? - How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant? ; DRUG USED: Vyvanse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Combination; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Subject is able to provide written, personally signed, and dated informed consent to participate in the study. - Subject is between 18 and 65 years of age. - Subject has a primary diagnosis of non-psychotic MDD (single or recurrent). - Subject has a MADRS total score 24. - Subject who is female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test at the and agrees to comply with any applicable contraceptive requirements of the protocol. - Subject is able to swallow a capsule. Exclusion Criteria: - Subject whose current episode of MDD has not responded to an adequate treatment regimen with 2 or more approved single antidepressant agents. - Subject who has a lifetime history of treatment resistant depression. - Subject has a current co-morbid psychiatric disorder. Excluded are: any significant Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa. - Subject has been hospitalized (within the last 12 months) for their current MDD episode. - Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD). - Subject has a first degree relative that has been diagnosed with bipolar I disorder. - Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder - Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation. - Subject has a concurrent chronic or acute illness or unstable medical condition. - Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a 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. - Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. - Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit. - Subject has a known family history of sudden cardiac death or ventricular arrhythmia. - Subject has glaucoma. - Subject has a history of moderate to severe hypertension. - Current use of any other medications (including over-the-counter [OTC], herbal or homeopathic preparations) that have central nervous system effects. - Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3 months prior. - The subject has a known or suspected intolerance, hypersensitivity, or contraindications to their assigned antidepressant treatments (escitalopram oxalate, sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl). - Subject has a positive urine drug result. - Subject has a body mass index (BMI) of <18.5 or >40. - Subject is female and is pregnant or nursing. ; PRIMARY OUTCOME: Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks; SECONDARY OUTCOME 1: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 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 - RP-001 (River Plate); BRIEF: The study is designed to assess the safety and efficacy of Vismed®, a special eye drop containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being compared to another eye drop, identical in composition except that it does not contain the active ingredient, sodium hyaluronate. This eye drop is designed as the vehicle. Some subjects are to receive Vismed® treatment, while others are to receive the vehicle; the assignment of subjects to receive either Vismed or vehicle is to be random. The two-week treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®. ; DRUG USED: AL-2354A; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Hyaluronic acid; THERAPY: Monotherapy; LEAD SPONSOR: Lantibio; CRITERIA: Inclusion Criteria: - Male and female adults aged 18 years and over. - Subjects should have at least a 3-month documented history of dry eye in both eyes diagnosed as dry eye syndrome, keratoconjunctivitis sicca (KCS), or due to Sjögren syndrome (immune exocrinopathy). - Subjects must agree to discontinue all artificial tears from Screening through the duration of the treatment period (Screening to Day 14). - Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening. - Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study. - Subjects must provide signed informed consent prior to participation in any study-related procedures. Exclusion Criteria: - Pregnancy or lactation. - Females of childbearing potential who are not using systemic contraception, are not postmenopausal (≥ 1 year), or are not surgically sterilized. - Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening. - Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication. - Any active inflammation of the eye not due to KCS (eg, iritis, scleritis, etc.). - Participation in any other clinical trial within 30 days prior to Screening. - Prior participation in a previous clinical trial of Vismed®. ; PRIMARY OUTCOME: staining of the cornea and conjunctiva; SECONDARY OUTCOME 1: staining of the cornea and conjunctiva[/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 - 14568 (Japan) ; BRIEF: The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) Exclusion Criteria: - Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT - More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization - Calculated creatinine clearance (CLCR) < 30 mL/min - Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk - Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin - Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg ; PRIMARY OUTCOME: Number of participants with newly onset of symptomatic venous thromboembolism (VTE); SECONDARY OUTCOME 1: Number of participants with improvement in thrombotic burden[/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 - 005 (SHaRCS); BRIEF: The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL). ; DRUG USED: NB-001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Herpes Simplex Virus (HSV) (Antiviral); TARGET: Herpes Simplex Virus (HSV); THERAPY: Monotherapy; LEAD SPONSOR: NanoBio Corporation; CRITERIA: Inclusion Criteria: - A healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigators discretion) be included in the study. - Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months; - Have the majority of their cold sore recurrences preceded by a well defined history of prodromal symptoms. Exclusion Criteria: - Subjects with severe chronic illness - Received (within the last 6 months) or receiving chemotherapy; - Significant skin disease on the face - Previously received herpes vaccine; - Active alcohol or drug abuse; - Prior randomization into any NanoBio study; - Known allergies to topical creams, ointments or other topical medications. ; PRIMARY OUTCOME: Time of Healing of the primary lesion complex; SECONDARY OUTCOME 1: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.[/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 - LINC-4; BRIEF: The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushings disease who are candidates for medical therapy. ; DRUG USED: Isturisa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cushings Syndrome; TARGET: Aldosterone synthase (CYP11B2); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key inclusion criteria: - Confirmed Cushings Disease (CD) that is persistent or recurrent as evidenced by all of the following criteria being met (i.e., a, b and c): 1. mUFC > 1.3 x ULN (Mean of three 24-hour urine samples collected preferably on 3 consecutive days, during screening after washout of prior medical therapy for CD (if applicable), confirmed by the central laboratory and available before Day 1), with ≥2 of the individual UFC values being > 1.3 x ULN. 2. Morning plasma Adrenocorticotropic hormone (ACTH) above Lower Limit of Normal 3. Confirmation (based on medical history) of pituitary source of excess ACTH as defined by any one or more of the following three criteria: i. Histopathologic confirmation of an ACTH-staining adenoma in patients who have had prior pituitary surgery. OR ii. Magnetic resonance imaging (MRI) confirmation of pituitary adenoma > 6 mm OR iii. Bilateral inferior petrosal sinus sampling (BIPSS) with either corticotropic-releasing hormone (CRH) or desmopressin (DDAVP) stimulation for patients with a tumor ≤ 6mm. The criteria for a confirmatory BIPSS test are any of the following: Pre-dose central to peripheral ACTH gradient > 2; Post-dose central to peripheral ACTH gradient > 3 after either CRH or DDAVP stimulation - Patients that received glucocorticoid replacement therapy must have discontinued such therapy for at least seven days or 5 half-lives prior to screening, whichever is longer. - Patients with de novo CD can be included only if they are not considered candidates for surgery (e.g., poor surgical candidates due to co-morbidities, inoperable tumors, patients who refuse to have surgical treatment, or surgical treatment is not available). Key exclusion criteria: - Patients with pseudo-Cushings syndrome. This may be diagnosed by a normal late night salivary cortisol value collected during the screening period and after washout of prior CD medication. - Patients with risk factors for QT corrected (QTc) prolongation or Torsade de Pointes, including: patients with a baseline QT corrected (Fridericia QT formula) (QTcF) > 450 ms for males and QTcF > 460 ms for females; personal or family history of long QT syndrome; concomitant medications known to prolong the QT interval; patients with hypokalemia, hypocalcaemia, or hypomagnesaemia, if not corrected before pre-dose Day 1. - Patients likely to require adrenalectomy, pituitary surgery, or radiation therapy during the placebo-controlled period (Weeks 1-12) for the treatment of severe hypercortisolism or pituitary tumor growth causing compression of the optic chiasm. - Patients with compression of the optic chiasm due to a macroadenoma or patients at high risk of compression of the optic chiasm (tumor within 2 mm of optic chiasm). - Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1, AIP). - Patients with Cushings syndrome due to ectopic ACTH secretion or ACTH independent (adrenal) Cushings syndrome. Pregnant or nursing (lactating) women. 8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after completion of dosing. Highly effective contraception methods include: A. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. B. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study drug. In case of bilateral oophorectomy, documentation is required (e.g. operative report, pelvic ultrasound or other reliable imaging method). C. Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject. D. Combination of any two of the following (a+b or a+c, or b+c): 1. Use of oral*, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. *In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study drug. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential. ; PRIMARY OUTCOME: Percentage of Randomized Participants With a Complete Response; SECONDARY OUTCOME 1: Percentage of Participants With mUFC ≤ ULN at Week 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 - BIA-2093-301; BRIEF: This was a phase III 4-part study in multiple centres. Part I was a 26-week parallel-group, randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks double-blind titration, 12 weeks maintenance, and 4 weeks tapering off). After completing the baseline period, patients were randomised in a 1:1:1:1 ratio to 1 of 3 ESL dose levels or to placebo. Part II was a 1-year open-label extension for patients who had completed Part I. The starting dose was 800 mg once daily and could be titrated up or down at 400-mg intervals between 400 and 1200 mg. Part III was an additional 1-year open-label extension for patients who had completed Part II, had participated in the post-Part II study extension, which allowed patients to continue treatment with ESL, or had continued to take ESL in a compassionate use program. ESL starting doses were the same as received at the end of Part II, during post-Part II study extension, or under compassionate use, and could be titrated up or down at 400-mg intervals between 400 and 1200 mg once daily. Part IV was a study extension to allow patients to continue ESL treatment after the end of Part III until marketing authorisation or discontinuation of clinical development. ; DRUG USED: Aptiom; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Bial - Portela C S.A.; CRITERIA: Inclusion Criteria: - written informed consent signed by patient - aged 18 years or more - documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening - at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified) - excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests - post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method) Exclusion Criteria: - only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented - primarily generalised epilepsy - known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening - seizures of psychogenic origin within the last 2 years - history of schizophrenia or suicide attempt - currently on or with exposure to felbamate or oxcarbazepine more within one month of screening - using benzodiazepines on more than on an occasional basis (except when used chronically as AED) - previous use of ESL or participation in a clinical study with ESL - known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances - history of abuse of alcohol, drugs or medications within the last 2 years - uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder - second or third-degree atrioventricular blockade not corrected with a pacemaker - relevant clinical laboratory abnormalities ; PRIMARY OUTCOME: Part I: Seizure Frequency; 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 - Maintenance - IFM 2005-02; BRIEF: Maintenance treatment of myeloma. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: University Hospital, Toulouse; CRITERIA: Inclusion Criteria: - No signs of progression after transplant - Effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males) - No active severe infection - Satisfactory restoration of the haematological parameters defined by: PN >1,000/mm3 and Platelets > 75,000/mm3 - Bilirubin < 35 umol/l and GOT/GPT/PAL<3N - Creatinine < 160 umol/l. ; PRIMARY OUTCOME: Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.; SECONDARY OUTCOME 1: Assess the impact of Revlimid® on the post-transplant complete response rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IND3-08-04b; BRIEF: The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain. ; DRUG USED: Tivorbex; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Iroko Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - Patient is male or female between 18 and 65 years of age - For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control - Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures - Patient must be willing to stay at the study site ≥ 72 hours Exclusion Criteria: - Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs - Patient has a current disease or history of a disease that will impact the study or the patients well-being - Patient has used or intends to use any of the medications that are prohibited by the protocol - Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test - Patient has taken another investigational drug within 30 days prior to screening ; PRIMARY OUTCOME: The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48); SECONDARY OUTCOME 1: VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ADVANCE; BRIEF: The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability. ; DRUG USED: Plegridy; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Interferon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005) - Must have an EDSS score between 0.0 and 5.0. - Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months Key Exclusion Criteria: - Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease - Pregnant or nursing women - Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Annualized Relapse Rate (ARR) at 1 Year; SECONDARY OUTCOME 1: Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year[/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 - HAROSA I (Sleep Apnea); BRIEF: Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product. ; DRUG USED: Wakix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Excessive Sleepiness Associated with Medical Conditions; TARGET: Histamine H3 Receptor (HRH3); THERAPY: Monotherapy; LEAD SPONSOR: Bioprojet; CRITERIA: Inclusion Criteria: - patients with OSA treated by nCPAP but still complaining with EDS - ESS score > or = 12 Exclusion Criteria: - patient suffering from insomnia without OSA - co-existing narcolepsy - patient with sleep debt not due to OSA - acute or chronic severe disease ; PRIMARY OUTCOME: ESS change (Epworth Sleepiness Scale); 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 - SALT Ext. ; BRIEF: This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states. ; DRUG USED: Samsca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyponatremia; TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: 1. Age greater than or equal to 18 years. 2. Ability to provide informed consent or assent. 3. Prior successful participation in a tolvaptan hyponatremia trial termination with evidence of continued need or desire for therapy. Exclusion Criteria: - A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient. - Hyponatremia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy. - Hyponatremia due to reversible medical condition or therapy - Conditions associated with an independent imminent risk of morbidity and mortality - Conditions which confound the assessment of endpoints. ; PRIMARY OUTCOME: Participants With Adverse Events (AEs); SECONDARY OUTCOME 1: Mean Change From Baseline in Serum Sodium 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 - HZ-CA-304; BRIEF: The purpose of this study is to evaluate the safety of long-term treatment with HZT-501. ; DRUG USED: Duexis; DRUG CLASS: Non-NME; INDICATION: Arthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Histamine H2 Receptor (HRH2); THERAPY: Monotherapy; LEAD SPONSOR: Horizon Pharma Ireland, Ltd., Dublin Ireland; CRITERIA: Inclusion Criteria: - Expected to continue to require daily administration of an NSAID for at least the coming 6 months. - Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303 Exclusion Criteria: - Subject didnt meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303 - Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303 - Malignant Disease of the gastrointestinal tract - Erosive esophagitis - Clinically significant cardiac, renal or hepatic disease - Uncontrolled diabetes - Positive pregnancy test on Study Day 0 - Please note that there are other additional criteria. The study center will determine if you meet all of the criteria. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FREEDOM-1 HBL; BRIEF: An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day ; DRUG USED: ITCA 650; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Intarcia Therapeutics; CRITERIA: Inclusion Criteria: - Men or women age 18 to 80 years with type 2 diabetes - On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs - HbA1c >10.0% and ≤12.0% Exclusion Criteria: - Prior treatment with any GLP-1 receptor agonist - History of hypersensitivity to exenatide or liraglutide - FPG >300 mg/dL - History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2 - Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months - history of pancreatitis ; PRIMARY OUTCOME: Change in HbA1c between Week 39 and Day 0; 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 IIIb - LIRA-LIXI; BRIEF: This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM). ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - 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 - Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening - HbA1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive) - Body Mass Index (BMI) equal to or above 20 kg/m^2 Exclusion Criteria: - Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law or practice) - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness - History of chronic pancreatitis or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 per Modification of Diet in Renal Disease (MDRD) formula - Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening - Heart failure, New York Heart Association (NYHA) class IV - Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg) - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) ; PRIMARY OUTCOME: Change in Glycosylated Haemoglobin (HbA1c) From Baseline; SECONDARY OUTCOME 1: Change in Fasting Plasma Glucose (FPG) 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 - Agitation in Acute Patients; BRIEF: This pilot trial in Finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first visits on days 1, 2, 4 or 5 and 7 ± 1. ; DRUG USED: Seroquel XR; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha Adrenergic Receptors, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to DSM-IV diagnostic criteria), Positive and Negative Symptoms Scale (PANSS) ≥ 65, CGI ≥ 4 Exclusion Criteria: - Pregnancy or lactation - In-patients/hospitalized > 7 days before enrollment - Known intolerance or lack of response to quetiapine fumarate or risperidone, as judged by the investigator ; PRIMARY OUTCOME: Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks); SECONDARY OUTCOME 1: Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 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 - ENGAGE (Early AD); BRIEF: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI]. ; DRUG USED: Aduhelm; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have: - A Clinical Dementia Rating (CDR)-Global Score of 0.5. - Objective evidence of cognitive impairment at screening - An MMSE score between 24 and 30 (inclusive) - Must have a positive amyloid Positron Emission Tomography (PET) scan - Must consent to apolipoprotein E (ApoE) genotyping - If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1 - Must have a reliable informant or caregiver Key Exclusion Criteria: - Any medical or neurological condition (other than Alzheimers Disease) that might be a contributing cause of the subjects cognitive impairment - Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year - Clinically significant unstable psychiatric illness in past 6 months - History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening - Indication of impaired renal or liver function - Have human immunodeficiency virus (HIV) infection - Have a significant systematic illness or infection in past 30 days - Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities - Any contraindications to brain magnetic resonance imaging (MRI) or PET scans - Alcohol or substance abuse in past 1 year - Taking blood thinners (except for aspirin at a prophylactic dose or less) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78; SECONDARY OUTCOME 1: Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78[/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 - STELLAR 4 (F4 Fibrosis); BRIEF: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH. ; DRUG USED: Selonsertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Apoptosis Signal Regulating Kinase 1 (ASK1); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader - Has the following laboratory parameters at the screening visit, as determined by the central laboratory: - Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN) - Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation - HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to be resulted) - International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation - Platelet count ≥ 100,000/μL Key Exclusion Criteria: - Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding - Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic anti-coagulation - Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation - Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology. - History of liver transplantation - Current or history of hepatocellular carcinoma (HCC) Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH; SECONDARY OUTCOME 1: Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240[/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 - MORA (EU); BRIEF: This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens. Approximately 810 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 3 groups. ; DRUG USED: Plenvu; DRUG CLASS: Non-NME; INDICATION: Colon Cleansing/Laxatives; TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Norgine; CRITERIA: Inclusion Criteria: - Patients must provide written informed consent. - Male and female outpatients and inpatients aged: ≥18 to ≤85 years undergoing a screening, surveillance or diagnostic colonoscopy. - Females of child-bearing potential must have a negative pregnancy test at Screening and at Visit 2 and must be practising one of the following methods of birth control and agree to continue with the regimen throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): Oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; Intrauterine device in combination with a condom; Double barrier method (condom* and occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository). - Willing and able to complete the entire study and to comply with instructions. Exclusion Criteria: - Patients with past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. - Patients with ongoing severe acute Inflammatory Bowel Disease. - Patients who have had previous significant gastrointestinal surgeries, including colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning colostomy, Hartmanns procedure and de-functioning ileostomy or other similar surgeries involving structure and function of the small or large colon. - Regular use of laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation. - Patients with active intestinal bleeding episodes or with a clinically significant low hemoglobin level <9 g/dL for women and <11 g/dL for men at screening. - Known glucose-6-phosphate dehydrogenase (G6PD) deficiency. - Known phenylketonuria. - Known hypersensitivity to polyethylene glycols, ascorbic acid and sulfates (not including sulfa-based products) or any other component of the study drug or comparator - Past history within the last 12 months or evidence of any on-going clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias). - History of uncontrolled hypertension with systolic blood pressure >170 mmHg and diastolic blood pressure >100 mmHg. - Patients with cardiac insufficiency NYHA grades III or IV. - Patients with severe renal insufficiency (i.e. with GFR, <30 mL/min/1.73m2). - Patient with serum albumin <3.4 g/dL. - Patients with liver disease of grades B and C according to the Child Pugh classification. - Patients suffering from dehydration at screening as evaluated by the Investigator from physical examination and laboratory investigations. - Patients with clinically significant electrolyte abnormalities, whether pre-existing or noted at screening, such as hypernatremia, hyponatremia, hyperphosphatemia, hypermagnesemia, hypokalemia, hypocalcaemia dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors. - Patients with any other clinically significant hematological parameters including coagulation profile at screening. - Patients with impaired consciousness that might predispose them to pulmonary aspiration. - Patients undergoing colonoscopy for foreign body removal and/or decompression. - Patients who are pregnant or lactating, or intending to become pregnant during the study. - Clinically relevant findings on physical examination based on the Investigators judgment. - History of drug or alcohol abuse within the 12 months prior to dosing. - Concurrent participation in an investigational drug or device study or participation within three months of study entry. - Patients who are ordered to live in an institution on court or authority order ; PRIMARY OUTCOME: Number of Patients With Successful Bowel Cleansing (Overall Colon); SECONDARY OUTCOME 1: Adenoma Detection Rate (Colon Ascendens)[/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 - PB-06-002 - Switchover from Cerezyme; BRIEF: This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy. ; DRUG USED: Elelyso; DRUG CLASS: Biologic; INDICATION: Gauchers Disease; TARGET: Glucocerebroside (glucosylceramide); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Males and females, 2 years or older - Confirmed diagnosis of Gaucher disease by the enzymatic activity assay - Stable Gaucher disease - Treatment with imiglucerase (Cerezyme®) for at least 2 years and on a stable maintenance regimen (dose and regimen unchanged, except for situation of drug shortage) for at least the last six months - Able to provide written informed consent Exclusion Criteria: - Currently taking another experimental drug for any condition - History of allergy to carrots - History of allergy to beta lactam antibiotics - Previous infusion reaction suspected to be allergic in nature to Cerezyme® or Ceredase® or receiving premedication to prevent infusion reactions - Presence of HIV and/or HBsAg and/or hepatitis C infection - Presence of unresolved anemia due to iron, folic acid or vitamin B12 deficiency - Presence of any significant comorbidity that could confound the interpretation of the clinical response to taliglucerase alfa - Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patients compliance with the requirements of the study ; PRIMARY OUTCOME: Hemoglobin; 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 - 01-05-TL-491-006; BRIEF: This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension. ; DRUG USED: Edarbi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1); THERAPY: Combination; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria 1. Diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to 119 mm Hg. For diabetic subjects and subjects with chronic kidney disease, diastolic blood pressure must be greater than or equal to 85 mm Hg and less than or equal to109 mm Hg). 2. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating. 3. Clinical laboratory evaluations within the reference range for or deemed not clinically significant by the investigator. Exclusion Criteria 1. Systolic blood pressure greater than 185 mm Hg. 2. Expected to take angiotensin II receptor blockers other than the study drug. 3. Taking more than 2 antihypertensive agents. 4. Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or sulfonamide-derived compounds. 5. Recent history of major cardiovascular event. 6. History of moderate to severe heart failure or hypertensive encephalopathy. 7. Clinically significant cardiac conduction defects. 8. Secondary hypertension of any etiology. 9. Known or suspected unilateral or bilateral renal artery stenosis. 10. Severe renal dysfunction or disease. 11. History of drug abuse or a history of alcohol abuse within the past 2 years. 12. Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.. 13. Uncontrolled diabetes mellitus. 14. Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice. 15. Serum potassium level of greater than the upper limit of normal. 16. Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to enrollment. 17. Any other serious disease or condition. 18. Randomized in a previous azilsartan medoxomil study. ; PRIMARY OUTCOME: Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.; SECONDARY OUTCOME 1: Change From Baseline in Sitting Clinic Systolic Blood Pressure - 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 - ATHENA - MO19391 (HER2-); BRIEF: This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - patients, >=18 years of age; - HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting; - candidates for chemotherapy. Exclusion Criteria: - previous chemotherapy for metastatic or locally recurrent breast cancer; - concomitant hormonal therapy for metastatic or locally recurrent disease; - concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease; - previous radiotherapy for treatment of metastatic disease; - evidence of CNS metastases. ; PRIMARY OUTCOME: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs); SECONDARY OUTCOME 1: Percentage of Participants With Disease Progression[/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 - HONOR (Military PTSD); BRIEF: This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety. ; DRUG USED: Tonmya; DRUG CLASS: Non-NME; INDICATION: Post-Traumatic Stress Disorder (PTSD); TARGET: Alpha 2 Adrenergic Receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Tonix Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female between 18 and 75 years of age, who have served in any branch of the military. - Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5. - Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related. - Willing to refrain from use of all other formulations of cyclobenzaprine. - Willing and able to refrain from antidepressants and other excluded medications. - Capable of reading and understanding English and able to provide written informed consent. - If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study. - Willing and able to comply with all protocol-specified requirements. Exclusion Criteria: - Increased risk of suicide, based on the investigators judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol. - Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history. - Severe depressive symptoms at screening or baseline. - Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigators opinion. - Use of antidepressant medication within 2 months of baseline. - Female patients who are pregnant or lactating. - History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients. - Seizure disorder. - Patients with a body mass index (BMI) > 45. - Has received any other investigational drug within 30 days before Screening. - Previous participation in any other study with TNX-102 SL. - Family member of investigative staff. ; PRIMARY OUTCOME: Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.; SECONDARY OUTCOME 1: Clinical Global Impression - Improvement from Initiation of Treatment (CGI-I) score after 12 weeks of treatment.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - P05751; BRIEF: This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo. ; DRUG USED: Ragwitek; DRUG CLASS: Biologic; INDICATION: Allergic Rhinitis; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: ALK-Abelló A/S; CRITERIA: Inclusion Criteria: - Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma - Must have a positive skin prick test response to Ambrosia artemisiifolia - Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value - Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor - Females of child-bearing potential must agree to use medically accepted methods of contraception Exclusion Criteria: - Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months - Received an immunosuppressive treatment within 3 months - History of anaphylaxis with cardio-respiratory symptoms. - History of chronic urticaria or angioedema - Current severe atopic dermatitis - Female subject who is breastfeeding, pregnant, or intending to become pregnant - Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years - History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine - Unable to or will not comply with the use of self-injectable epinephrine - Participating in any other clinical trial ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events (AEs); SECONDARY OUTCOME 1: Number of Participants Reporting Oral Pruritus.[/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 - Israel ; BRIEF: A multi-center, open-label single-arm study to evaluate the efficacy and safety of tocilizumab administered as a single, weekly injection in adults with rheumatoid arthritis. Combination therapy with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) was permitted. ; DRUG USED: Actemra (Subcutaneous); DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adults >/= 18 years of age - Diagnosis of active rheumatoid arthritis (RA) according to the revised (1987) American College of Rheumatology (ACR) criteria or European League Against Rheumatism (EULAR)/ACR (2010) criteria - Previously treated with the following: three non-biologic DMARDs, and not treated with any biologic agent OR one biologic agent (alone or in combination with non-biologic DMARDs), and discontinued that agent for a reason - Oral corticosteroids (</= 10 mg/day prednisone or equivalent), non-steroidal anti-inflammatory drug (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for >/= 4 weeks prior to Baseline - Use of effective contraception throughout the study as defined by protocol; female patients of childbearing potential must not be pregnant Exclusion Criteria: - Presence of serious, uncontrolled, clinically significant medical conditions - History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal (GI) disease that might predispose to perforation - Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections - Any infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening - Clinically significant findings on lab tests and/or hepatitis B or C, or human immunodeficiency virus (HIV) screenings - Active tuberculosis (TB) requiring treatments within the previous 3 years - Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years - History of alcohol, drug, or chemical abuse within 1 year prior to Screening - Neuropathies or other conditions that might interfere with pain evaluation - Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline - Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Feltys syndrome). Secondary Sjögrens syndrome with RA is permitted - Functional Class IV as defined by the ACR Classification of Functional Status in-Rheumatoid Arthritis - Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16 - Prior history of current inflammatory joint disease other than RA - Exposure to tocilizumab (either IV or subcutaneous administration) at any time prior to Baseline - Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening - Previous treatment with any cell-depleting therapies, including investigational agents approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation - Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline - Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline ; PRIMARY OUTCOME: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity; SECONDARY OUTCOME 1: Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest (AESIs)[/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; BRIEF: This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720. ; 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; CRITERIA: Inclusion Criteria: - 18-65 years of age, must have relapsing MS Exclusion Criteria: - Patients with a type of MS that is not relapsing - Patients with history of chronic immune disease - Patients with a history of certain cancers - Diabetic patients with certain eye disorders - Patients who are on certain immunosuppressive medications or heart medications - Patients with certain heart conditions - Patients with certain lung conditions Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS; SECONDARY OUTCOME 1: Incidence of macular edema[/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. Sevelamer Hydrochloride; BRIEF: Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb. The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride. ; DRUG USED: Alpharen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Ineos Healthcare Limited; CRITERIA: Inclusion Criteria: Subjects will be considered eligible for entry in the study if they meet all of the following criteria. 1. Male or female, aged > 18 years. 2. Able to comply with the study procedures and medication. 3. Written informed consent given. 4. On a stable haemodialysis regimen (at least 3x per week) for ≥12 weeks prior to screening. 5. (a) Subject receiving phosphate binder medication(s) at screening, must have been on a stable regimen (dose and medication) for at least 1 month prior to screening and will remain on this regimen until entry into the washout period OR (b)Subject (i) is not currently receiving any phosphate binding medication at screening (or medication likely to act as a phosphate binder) and (ii) must not have done so for at least one month and (iii) has sustained hyperphosphataemia. 6. Willing to abstain from taking any phosphate binder or oral magnesium-, oral aluminium- or oral iron-containing products and preparations other than the study medication. 7. If required to take >6000 mg/day of fermagate, the subject will be willing to have at least three meals per day. Specifically, for randomisation and inclusion into the treatment period, the following criterion must be fulfilled: 8. Has a serum phosphate value of ≥1.94 mmol/L (≥6.0 mg/dL) within the 2 to 4 week washout period or above 3.0 mmol/L (9.3 mg/dL) at any time during washout. Exclusion Criteria: Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria. 1. Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit. 2. Previous experience of fermagate treatment. 3. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator. 4. Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn. 5. Laboratory findings at screening which, in the opinion of the investigator, are clinically significant for this subject population. 6. A screen serum magnesium concentration of >1.25 mmol/L (>3.0 mg/dL). 7. A known history of haemochromatosis. 8. Subjects receiving either tetracycline or lithium treatment. 9. A serum ferritin level of ≥1000 ng/mL. 10. Non-elective hospitalisation in the 4 weeks prior to screening. 11. Female subjects who are of childbearing potential and who are neither surgically sterilised nor using reliable contraceptive methods (hormonal, barrier methods or intrauterine device) or who are lactating or pregnant. 12. Current hypophosphataemia at screening (last 2 consecutive phosphate values of <0.7 mmol/L [<2.2 mg/dL]). 13. Known history of colorectal malignancy, familial polyposis coli and/or strong family history (in 2 or more first degree relatives) of these terms. 14. A QTcF interval of >560 ms at screen. 15. Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens at screen. 16. Current clinically significant intestinal motility disorder. 17. Bowel obstruction with current or previous use of sevelamer HCl. 18. Known intolerance to sevelamer HCl or any excipients of fermagate or Renagel medication. 19. Subjects with inflammatory bowel disease that, in the investigators opinion, is poorly controlled. ; PRIMARY OUTCOME: Control or not the level of serum phosphate; SECONDARY OUTCOME 1: Change from baseline in mean serum phosphate[/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 - ENDEAR (TNBC); BRIEF: The purpose of this study is to evaluate and compare the clinical benefit and safety of treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic, diagnostic-positive, triple-negative breast cancer (TNBC). ; DRUG USED: Xtandi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Androgen receptors; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Adult women and men at least 18 years of age and willing and able to provide informed consent. - Has advanced TNBC: - TNBC is defined as staining by immunohistochemistry (IHC) < 1% or Allred score < 2 for estrogen receptor (ER) and progesterone receptor (PgR), and 0 or 1+ by IHC for human epidermal growth factor receptor 2 (HER2) or negative for gene amplification (average HER2 copy number < 4 signals/cell; HER2:CEP17 ratio < 2.0). - Advanced disease is defined as locally advanced or metastatic disease not amenable to curative intent surgery or radiotherapy. - Has diagnostic-positive status as determined by a central diagnostic testing laboratory. - Received 0 or 1 prior line of systemic therapy in the advanced disease setting. - Patients who received 1 prior line of therapy for locally advanced or metastatic TNBC must have objective disease progression as assessed by the investigator. - Has measurable and/or disease that is not measurable but is evaluable using RECIST 1.1 (eg, bone metastases, pathologic lymph nodes, or skin lesions). - Patients with nonmeasurable and nonevaluable TNBC (eg, malignant effusions or bone marrow as the only manifestations of disease) are not eligible for enrollment. - Patients with metastatic disease limited to the bone must have disease adequately visualized by computed tomography (CT) with bone windows, magnetic resonance imaging (MRI), or x-ray. - Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and a life expectancy of at least 3 months from randomization. Exclusion Criteria: - Received a taxane regimen ≥ 28 days in duration in the advanced disease setting. - Prior taxane therapy for neoadjuvant and/or adjuvant disease is permitted. - A single dose of a taxane given as part of an every-3-weeks regimen is permitted. - Two doses of a taxane given as part of a once-weekly regimen is permitted. - Had a disease-free interval of ≤ 12 months from the last dose of taxane when used as part of adjuvant therapy for patients who did not receive prior therapy for locally advanced or metastatic breast cancer. - Has history of or known central nervous system (CNS) metastasis or active leptomeningeal disease; brain imaging is required for all patients during screening. - Received any anticancer agent (commercially available or investigational) within 14 days before randomization. - Received treatment with any of the following medications within 14 days before randomization: - Estrogens, including hormone replacement therapy - Androgens (eg, testosterone, dehydroepiandrosterone) - Systemic radionuclides (eg, samarium, strontium) - Had major surgery within 4 weeks before randomization. - Has a history of another invasive cancer within 3 years before randomization, with the exception of fully treated cancers with a remote probability of recurrence. - Has a history of a seizure condition or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma). - Has known hypersensitivity to any of the enzalutamide/placebo capsule components. - Had a hypersensitivity reaction to Cremophor EL (polyoxyethylated castor oil) or a drug formulated in Cremophor EL, such as paclitaxel, unless successfully treated and rechallenged with appropriate premedications. ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CARAVAGGIO; BRIEF: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study ; DRUG USED: Eliquis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Fadoi Foundation, Italy; CRITERIA: Inclusion Criteria: - Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery; - Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia); - Signed and dated informed consent of the patient, available before the start of any specific trial procedure. Exclusion Criteria: - age <18 years; - ECOG Performance Status III or IV; - life expectancy of less than 6 months; Related to anticoagulant treatment: - administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; - 3 or more doses of a vitamin K antagonist before randomization; - thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode; - indication for anticoagulant treatment for a disease other than the index VTE episode; Related to bleeding risk: - thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy; - active bleeding or a high risk of bleeding contraindicating anticoagulant treatment; - recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery - hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10^9/L or history of heparin induced thrombocytopenia; - creatinine clearance < 30 ml /min based on the Cockcroft Gault equation; - acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range; - uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite antihypertensive treatment); - concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein; Standard criteria: - bacterial endocarditis; - hypersensitivity to the active substance or to any of the excipients of study drug; - patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system; - childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; - any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study. ; PRIMARY OUTCOME: Recurrent venous thromboembolism; 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 - Add-on to Metformin; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise. ; DRUG USED: Ranexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Late Sodium Current; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Documented history of T2DM - Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening - Body mass index (BMI) 25 to 45 kg/m^2, inclusive, at Screening - HbA1c within specified ranges at Screening and at the end of the Qualifying Period based on current metformin dose - C-peptide ≥ 0.8 ng/mL at Screening - Fasting serum glucose (FSG) ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period Exclusion Criteria: - Type 1 diabetes mellitus - History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma - History of severe hypoglycemia - Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening - History of congestive heart failure - Corrected QT interval (QTc) > 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or individuals who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone) - Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening - Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL - Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization - Treatment with chronic insulin within 24 weeks prior to Screening (except for one temporary period of daily insulin injections no longer than 7 days) - Treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization - Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization - Treatment with simvastatin or lovastatin at a dose > 20 mg or > 40 mg daily, respectively, within 14 days prior to randomization ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Fasting Serum Glucose 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 - ERC-245; BRIEF: The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women. ; DRUG USED: Intrarosa; DRUG CLASS: Non-NME; INDICATION: Female Sexual Arousal Disorder; TARGET: Androgen receptors, Estrogen; THERAPY: Monotherapy; LEAD SPONSOR: EndoCeutics Inc.; CRITERIA: Inclusion Criteria (main criteria): - Postmenopausal women (hysterectomized or not). - Women between 40 and 80 years of age. - Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months. - Diagnosis of HSDD confirmed by a qualified clinician. - Willing to participate in the study and sign an informed consent. Exclusion Criteria (main criteria): - Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity. - Taking drugs which could be responsible for HSDD. - Severe medical condition which can explain the loss of sexual desire. - The administration of any investigational drug within 30 days of screening visit. - Clinically significant abnormal serum biochemistry, urinalysis or hematology. ; PRIMARY OUTCOME: Sexual desire; SECONDARY OUTCOME 1: Satisfying sexual events (SSEs)[/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 - inTandem2 (Europe); BRIEF: This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy. ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participant who gave written informed consent to participate in the study in accordance with local regulations. - Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent. - Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). - Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol. - At the Screening Visit, A1C was between 7.0% to 11.0%. - Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test. Exclusion Criteria: - Use of antidiabetic agent other than insulin or insulin analog at the time of screening. - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening. - Chronic systemic corticosteroid use. - Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in A1C at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) 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 - Post Renal Transplant; BRIEF: Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant. ; DRUG USED: Sensipar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperparathyroidism (Secondary); TARGET: Calcium-Sensing Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose - May be the first kidney transplant or a repeat kidney transplant. - Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening. - Men or women ≥ 18 years at the start of Screening (ie, time of informed consent). - Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period. - iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2). Exclusion Criteria: - Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet). - Anticipated parathyroidectomy within 6 to12 months after Randomization. - Ongoing therapy with bisphosphonates or use within 6 months prior to Screening. - Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening. - Ongoing use of calcium supplements or use within 30 days prior to Screening. - Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening. - Ongoing use of a thiazide diuretic. - Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication. - Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy. ; PRIMARY OUTCOME: Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP); SECONDARY OUTCOME 1: Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck[/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 - AZALEA (Open-Label Safety); BRIEF: This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema. ; DRUG USED: Xipere; DRUG CLASS: Non-NME; INDICATION: Uveitis (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Clearside Biomedical, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior) - ETDRS BCVA score of ≥ 5 letters read in the study eye Exclusion Criteria: - Any active ocular disease or infection in the study eye other than uveitis - Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications. - Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study - Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline. ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: Mean Intraocular Pressure in the Study Eye[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DIAS-3; BRIEF: The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms. ; DRUG USED: Desmoteplase; DRUG CLASS: Biologic; INDICATION: Ischemic Stroke; TARGET: Plasminogen; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - Diagnosis of acute ischemic stroke - Informed consent - Age between 18 and 85 years - Treatment can be initiated within 3-9 hours after the onset of stroke symptoms - NIHSS Score of 4-24 - Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries Exclusion Criteria: - Pre-stroke mRS >1 - Previous exposure to desmoteplase - Extensive early infarction on MRI or CT in any affected area - Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm - Internal carotid artery occlusion on the side of the stroke lesion - Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time - Treatment with oral anticoagulants and a prolonged prothrombin time - Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted - Treatment with a thrombolytic agent within the past 72 hours ; PRIMARY OUTCOME: Modified Rankin Scale Score; SECONDARY OUTCOME 1: National Institutes of Health Stroke Scale (NIHSS) 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 - SPIRE-FH; BRIEF: This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C. ; DRUG USED: Bococizumab; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Treated with a statin. - Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL. - High or very high risk of incurring a cardiovascular event. - Heterozygous familial hypercholesterolemia. Exclusion Criteria: - Pregnant or breastfeeding females. - Cardiovascular or cerebrovascular event of procedures during the past 30 days. - Congestive heart failure NYHA class IV. - Poorly controlled hypertension. ; PRIMARY OUTCOME: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12; SECONDARY OUTCOME 1: Percent Change From Baseline in Total Cholesterol (TC) at Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ARVI; BRIEF: A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment. The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI. ; DRUG USED: XC-8; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Histamine Receptors (unspecified) ; THERAPY: Monotherapy; LEAD SPONSOR: PHARMENTERPRISES LLC; CRITERIA: Inclusion Criteria: 1. Men and women aged 18 to 45 years (inclusively). 2. Clinically diagnosed influenza or other acute or moderate ARVI based on the patients body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs. 3. Uncomplicated course of ARVI or influenza. 4. The onset of symptoms no more than 36h prior to the inclusion into the study. 5. Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period. 6. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol. 7. Signed Informant Consent Form. Exclusion Criteria: The patient will be deemed ineligible for the study meeting any of the following criteria: 1. Complicated course of influenza or ARVI (including the presence / development of bacterial infection). 2. Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action. 3. Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis). 4. Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs). 5. Infectious diseases during the last week before including into the study. 6. History of bronchial asthma. 7. History of increased convulsive activity. 8. Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patients prognosis, and make him/her ineligible for the clinical study). 9. History of oncological diseases, HIV, tuberculosis. 10. Hypersensitivity to excipients of the XC8. 11. Diabetes mellitus, lactose intolerance, lactase deficiency. 12. Drug or alcohol abuse. 13. Participation in any other clinical trial in the last 90 days. 14. Pregnancy or lactation. 15. Military or prison populations. 16. Impossibility or inability to comply with the study procedures. 17. A member of the investigators family or other person interested in the results of the study 18. Abnormal laboratory results, which, according to the study doctor, interfere with the patients inclusion in the study. 19. History of renal insufficiency. 20. Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01. - ; PRIMARY OUTCOME: Time to sustained improvement in clinical symptoms; SECONDARY OUTCOME 1: Body temperature below 37°C without further elevation[/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; BRIEF: This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma. ; DRUG USED: Gleevec; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), PPAR gamma; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Signed informed consent prior to initiation of any study procedure. - Patients >= 18 years of age. - Histological confirmed diagnosis of glioblastoma multiforme / astrocytoma World Health Organization (WHO) grade IV by a reference pathologist - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2. - Adequate hepatic, renal and bone marrow function as defined by the following: total bilirubin < 1.5 x Upper Limit of Normal (ULN), ALT and AST < 2.5 x ULN, creatinine < 1.5 x ULN, absolute neutrophil count > 1.5 x109/L, platelets > 100 x109/L and hemoglobin > 10 g/dL. - Female patients of childbearing potential with a negative pregnancy test within 7 days of initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential who agree to employ an effective barrier method of birth control throughout the study, and for up to 3 months following discontinuation of study drug. - Life expectancy of >3 months. - MRI available every 6 weeks for disease management - No intercerebral inflammation - Irradiation therapy 54 to 62 gy finished or less according to national standard - Chemotherapy at least 1 temozolomide containing regimen finished, no established chemotherapy regiment available and progression under chemotherapy or in between 6 months following the last chemotherapy. - Leucocytes > 2.500/µl, to be controlled once a week - Thrombocytes > 80.000/µl, to be controlled once a week - Ensured compliance - Patients who had a second or third resection after disease progression cannot be included earlier than 2 weeks following the resection. MRI should be performed not later than 72 h post operation. If patients are to be included later than 4 weeks after the resection, a new baseline MRI must be performed. Exclusion Criteria: - Female patients who are pregnant or breast-feeding. - Patients who have been treated with any investigational agent(s) within 28 days of the first day of administration of study drug. - Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina or Grade 3 or 4 cardiac problems as defined by the New York Heart Association Criteria. - Patients with other malignant disorders. - Patient with acute or known chronic liver disease (i.e., chronic active hepatitis, cirrhosis). - Patients who are known to be HIV positive (no specific tests are required for confirmation of eligibility). - Expected incompliance according to treatment, treatment diary and examination schedule - Not confirmed histological diagnosis glioblastoma multiforme/astrocytoma WHO grade IV - Other drugs with potential cytostatic main or side effect - No or inadequate chemotherapy or irradiation therapy - Patients without hematological recovery after previous chemotherapy who have been treated with Chemotherapy within 28 days of the first day of administration of study drug. Other protocol-specific inclusion /exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Progression Free Survival (PFS) During the Study Duration; SECONDARY OUTCOME 1: Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations[/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 - 30025 - 52 Weeks (subcutaneous dosing); BRIEF: The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy. ; 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: - Written informed consent is obtained. - The participant is male or female, 12 years of age and older, with a diagnosis of asthma. - The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol. - The participant has required an inhaled corticosteroid. - The participant has required an additional asthma controller medication besides inhaled corticosteroids. - The participant has a history of asthma exacerbation. - The participant must be willing and able to comply with study restrictions, perform requisite procedures and 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. - Additional criteria may apply, please contact the investigator for more information Exclusion Criteria: - The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patients safety. - The participant has another confounding underlying lung disorder - The participant has a known hypereosinophilic syndrome. - The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers. - The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study. - The participant is a current smoker or has a smoking history. - The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer. - The participant was previously exposed to reslizumab. - The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV). - The participant has current or suspected drug and alcohol abuse. - The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening. - The participant has a history of allergic reaction or hypersensitivity to any component of the study drug. - Additional criteria may apply, please contact the investigator for more information ; PRIMARY OUTCOME: Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment; SECONDARY OUTCOME 1: Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EKL001 (Korea); BRIEF: The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD). ; DRUG USED: Tudorza Pressair; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Daewoong Pharmaceutical Co. LTD.; CRITERIA: Inclusion Criteria: - A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value. - Current or former cigarette smokers with a smoking history of at least 10 pack-years. Exclusion Criteria: - History or current diagnosis of asthma - Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1 - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. - Patients with any clinically significant respiratory conditions other than COPD ; PRIMARY OUTCOME: Change from baseline to Week 12 in morning predose (trough) FEV1; SECONDARY OUTCOME 1: Change from baseline to Week 12 in peak FEV1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RESTORE (NVS); BRIEF: CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema. CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis; CRITERIA: Inclusion Criteria: - Visual acuity impairment - Diabetic macular edema in at least one eye - Type 1 or type 2 diabetes mellitus - Medication for the diabetes treatment must be stable for the last 3 months Exclusion Criteria: - Patients with uncontrolled systemic or ocular diseases - Laser photocoagulation in the study eye for the last 3 months - Any history of any intraocular surgery in the study eye within the past 3 months - Blood pressure > 160/100 mmHg Extension Inclusion Criteria: -Completion of the Core Study ; PRIMARY OUTCOME: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12; SECONDARY OUTCOME 1: Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DURATION-NEO-2 (vs. Sitagliptin); BRIEF: To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus. ; DRUG USED: Bydureon BCise; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - At least 18 years old - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.1% to 11.0%, inclusive, at screening - Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening - Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening - Body mass index of <45 kg/m2 at screening - Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening) Exclusion Criteria: - History of pancreatitis or triglycerides >=500 mg/dL - Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either - History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min - Active cardiovascular disease - Presence or history of severe congestive heart failure - Central nervous system disease, including epilepsy - Liver disease - History of severe gastrointestinal diseases - Clinically significant malignant disease - Repeated severe hypoglycemia within the last 6 months - Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog - Any DPP-4 inhibitor within 3 months prior screening ; PRIMARY OUTCOME: Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28; SECONDARY OUTCOME 1: Percentage of Subjects Achieving HbA1c <7% at Week 28[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TREAT 1 (80 mg); BRIEF: Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy. ; DRUG USED: Acapodene - ADT; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: GTx; CRITERIA: Inclusion Criteria: To be eligible for participation in this study, subjects must meet all of the following criteria (minor deviations may be discussed with the medical monitor for possible inclusions): - Give voluntary, signed informed consent in accordance with institutional policies - Be male, aged ≥ 50 years - Have histologically documented prostate cancer. Subjects with metastatic prostate cancer may still be considered for the study as long as they are not disqualified by other inclusion/exclusion criteria and there is a reasonable expectation that their medical condition will not interfere with the objectives of the study and that adequate follow-up and compliance with the study protocol can be achieved for the full 24-month duration of the study. - Have been on: - ADT treatment (either luteinizing hormone-releasing agonist [LHRHa] or orchiectomy) for at least 6 months; Or - Intermittent LHRHa for at least the preceding 12 months is acceptable, but subjects must be maintained on uninterrupted treatment for the duration of this study once they are randomized into the study. - Be aged ≥ 70 years or have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry: - Hologic BMD (g/cm2): L1-L4 - 0.926; Femoral neck - 0.717 - Lunar BMD (g/cm2): L1-L4 - 1.050; Femoral neck - 0.840 - Serum prostate-specific antigen (PSA) ≤ 4 ng/mL - Have a Zubrod performance status ≤ 1 - Subject weight < 300 lbs (weight limitation of DEXA equipment) - Agree to complete a daily diary of medication intake and to provide tablet containers for accurate counts - Agree to use an effective method of contraception, if the partner is of childbearing age, while on study - Have adequate bone marrow, liver and renal function: - White blood cell (WBC) count ≥ 3,000/mm3; - Platelet count ≥ 100,000/mm3; - Bilirubin ≤ 1.5 mg/dL; - AST and ALT < 2x upper limit of normal; - Serum creatinine ≤ 2.0 mg%. Exclusion Criteria: Subjects with any of the following will not be eligible for enrollment: - Taking bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH), Forteo® (teriparatide), calcitonin, or oral glucocorticoids within 45 days of randomization - Have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic and lumbar spine (at least eight evaluable vertebrae in the range T4 to L4) [for example, severe scoliosis, or sequelae of orthopedic procedures or other surgery] - Have > 4 vertebral fragility fractures - Have any history of other carcinomas within the last 5 years (except nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of recurrence which will not be excluded). NOTE: Patients with cancers other than nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of tumor recurrence for at least 5 years after definitive treatment will not be excluded from this study. - Have Pagets disease of bone - Have active systemic viral, bacterial or fungal infections requiring treatment - Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol for the full 24-month duration of the study - Received treatment with other investigational agents within 30 days prior to randomization - Taking finasteride (e.g., Proscar®), dutasteride (e.g., Avodart®), Danocrine® (danazol) or testosterone-like supplements, such as dehydroepiandrosterone (DHEA) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study] - Taking herbal medicine or dietary supplements for prostate health, such as PC SPES and saw palmetto (also known as Serenoa repens) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study]. Lycopene and selenium are not prohibited and no washout is required. - Have a history of thromboembolic disease including deep vein thrombosis or pulmonary embolus - Have a history of chronic hepatitis or cirrhosis - Have received prior treatment with toremifene ; PRIMARY OUTCOME: Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine; SECONDARY OUTCOME 1: Percentage of subjects with at least one new or worsening vertebral fracture at 24 months[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OPTIMYST (351); BRIEF: Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. ; DRUG USED: Myobloc; DRUG CLASS: Biologic; INDICATION: Neurology - Other; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinsons Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications. - Able to read and provide written informed consent before enrollment into the study, or the subjects caregiver (Legally Authorized Representative) can provide written informed consent. - Male or female, 18 to 85 years of age (inclusive). - Minimum unstimulated salivary flow rate of 0.2 g/min at screening - Minimum Investigators Drooling Frequency and Severity Scale (DFSS) score of 4 at screening. - Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis Exclusion Criteria: - A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate. - Respiratory forced vital capacity (FVC) of <20% of predicted - Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening - Subjects should be excluded if, in the Investigators opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subjects participation is complete). - Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function - Prior salivary gland surgery - Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary - Evidence of any clinically significant neurologic disease - Pregnancy or lactation - Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation. - Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening. - Current infection at the sialorrhea treatment injection site(s) - History of drug or alcohol abuse currently or within the previous 6 months - Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study ; PRIMARY OUTCOME: Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - nmDMD (US) Ext.; BRIEF: The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren [PTC124-GD-020-DMD {NCT01826487}]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study. This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued. ; DRUG USED: Translarna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: RNA translation; THERAPY: Monotherapy; LEAD SPONSOR: PTC Therapeutics; CRITERIA: Inclusion Criteria: - Completion of study treatment in the previous Phase 3, double-blind study (PTC124-GD-020-DMD). - Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. Note: If the study candidate is considered a child under local regulation, a parent or legal guardian must provide written consent prior to initiation of study screening procedures and the study candidate may be required to provide written assent. The rules of the responsible Institutional Review Board/Independent Ethic Committee (IRB/IEC) regarding whether 1 or both parents must provide consent and the appropriate ages for obtaining consent and assent from the participant should be followed. - In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the period of study drug administration and 6-week follow-up period. - Willingness and ability to comply with scheduled visits, ataluren administration plan, study procedures, laboratory tests, and study restrictions. Exclusion Criteria: - Known hypersensitivity to any of the ingredients or excipients of the study drug (Litesse® UltraTM [refined polydextrose], polyethylene glycol 3350, Lutrol® micro F127 [poloxamer 407], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla, Cab-O-Sil® M5P [colloidal silica], and magnesium stearate). - Ongoing participation in any other therapeutic clinical trial. - Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigators opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change From Baseline in 6MWD at Week 144[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SIRROUND-LTE; BRIEF: The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003 - Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study - Signed an informed consent form (ICF) for pharmacogenetics research (how a persons genes may affect a drugs effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study Exclusion Criteria: - Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003 - Is pregnant - Has active diverticulitis - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Percentage of Participants With Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils[/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 - US-014; BRIEF: This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinsons Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinsons medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinsons disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group. ; DRUG USED: Nourianz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Adenosine A2a Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Hakko Kirin Pharma, Inc.; CRITERIA: Inclusion Criteria: - 30 years of age or older. - UK Parkinsons Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD - PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale. - On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit - Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization - Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization - Documented end-of-dose wearing-off and levodopa-induced dyskinesia - Have an average of two hours of OFF time per day Exclusion Criteria: - Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion. - Subject who have had neurosurgical operation for PD - Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers - Subjects who smoke > 5 cigarettes/day ; PRIMARY OUTCOME: Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12; SECONDARY OUTCOME 1: Total Hours of ON Time Per Day Without Troublesome Dyskinesia[/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 - GTI1503; BRIEF: Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) who complete the entire study. This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC 20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20% weekly doses). A total of 52 doses of IGSC 20% will be administered with a final follow-up visit 1 week after the last dose at Week 53. Subjects/caregivers will be trained on self-administration of IGSC 20% by the clinical site personnel. ; DRUG USED: Xembify; DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Grifols Therapeutics LLC; CRITERIA: Inclusion Criteria: - Pre-existing diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy - No serious bacterial infection within the 3 months prior to Screening and has no serious bacterial infections (SBIs) up to the time of the Baseline Visit - Currently on IgG replacement therapy (stable regimen [dose and dosing interval] via IV or SC infusion) for ≥ 3 consecutive months at a dosage of at least 200 mg/kg per infusion - Documented (within previous 3 months) of an IgG trough level of ≥ 500 mg/dL on current IgG replacement therapy regimen - Screening/pre-Baseline trough IgG levels must be ≥ 500 mg/dL. Exclusion Criteria: - Known serious adverse reaction to immunoglobulin or any severe anaphylactic reaction to blood or any blood-derived product - History of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study - Isolated IgG subclass deficiency, isolated specific antibody deficiency disorder, or transient hypogammaglobulinemia of infancy - Nephrotic syndrome, and/or a history of acute renal failure, and/or severe renal impairment, and/or is on dialysis - Known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection - History of (year prior to Screening or 2 episodes in lifetime) or current diagnosis of deep venous thrombosis or thromboembolism (e.g., myocardial infarction, cerebrovascular accident, or transient ischemic attack) - Acquired medical condition known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/μL [1.0 x 10^9/L]), or human immunodeficiency virus infection/acquired immune deficiency syndrome - HIV positive by nucleic acid amplification technology based on a Screening blood sample - Uncontrolled arterial hypertension (adult subjects: systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) - Receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents, (b) immunomodulators, (c) long-term systemic corticosteroids defined as daily dose > 1 mg of prednisone equivalent/kg/day for > 30 days Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a subject. Inhaled or topical corticosteroids are allowed. ; PRIMARY OUTCOME: Rate of Serious Bacterial Infection (SBI) Per Participant Per Year; SECONDARY OUTCOME 1: Mean Trough Total IgG Concentration[/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 - Expanded Access Program; BRIEF: The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including both previously treated and untreated patients. ; DRUG USED: Dacogen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: DNA Methyltransferase (DNMT); THERAPY: Monotherapy; LEAD SPONSOR: Janssen-Cilag Farmaceutica Ltda.; CRITERIA: Inclusion Criteria: - Must have a diagnosis of MDS (de novo / primary or secondary) of all FAB subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups - Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2 - Adequate hepatic and renal function as measured by the following pre-treatment laboratory criteria within 21 days of starting treatment with Decitabine (laboratory measure of liver function no more than 2.5 times the upper limit of normal, laboratory measure of total bilirubin and serum creatinine no more than 1.5 times the upper limit of normal) - Female patients must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study - Have a negative serum or urine pregnancy test at screening - Male subjects should be advised not father a child while on or within 2 months of completion of Decitabine therapy Exclusion Criteria: - Have a diagnosis of AML (>20% bone marrow blasts) or other progressive malignant disease - has previously been treated with Azacitidine or Decitabine - Have uncontrolled heart disease or uncontrolled congestive heart failure - Have uncontrolled restrictive or obstructive pulmonary disease - Have active viral or bacterial infection - Have known positive serology for HIV - Have a mental illness or any other condition that could prevent full cooperation with the treatment and monitoring requirements of the study - Have known hypersensitivity to any of the excipients of decitabine - Are pregnant or breast-feeding ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RESET (Study 3203, N24HSWD); BRIEF: The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder. ; DRUG USED: Hetlioz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-24 Hour Sleep Wake Disorder (Non-24); TARGET: Melatonin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Ability and acceptance to provide informed consent; 2. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and must have a negative pregnancy test at the screening and baseline visits; Note: Women using hormonal methods of birth control must use an additional method of birth control during the study and for one month after the last dose. 3. Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study; 4. Diagnosis of N24HSWD in a previous clinical trial as measured by a tau value of > 24.1 and the lower bound of the 95% CI is > 24. Exclusion Criteria: 1. History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder, that is not being successfully treated or has not been resolved and that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures; 2. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists; 3. History of drug or alcohol abuse as defined in DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening and/or regular consumption of alcoholic drinks (> 2 drinks/day or > 14 drinks/week); a. Note: A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol or - 12-ounces of beer - 8-ounces of malt liquor - 5-ounces of wine - 1.5-ounces or a shot of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey); 4. Subject is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt within the past year or any other suicidal behavior within the past year; 5. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable; 6. Subjects who have estimated creatinine clearance (CLcr; based on the Cockcroft-Gault equation) ≤ to 55 mL/min; 7. Clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings at screening as determined by the clinical investigator; 8. Indication of impaired liver function (values for AST, ALT or bilirubin > 2 times Upper Limit of Normal); 9. Pregnant or lactating females; 10. A positive test for drugs of abuse at the screening visit; Note: A positive drug screen at Visit 1 needs to be discussed with the medical monitor and will be evaluated on a case-by-case basis. 11. Smoke more than 10 cigarettes/day; 12. Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study; 13. Unwilling or unable to follow the medication restrictions described in Section 8.2., or unwilling or unable to sufficiently wash-out from use of a restricted medication 14. Unable to perform calls to the study IVR system to report questionnaire results; 15. Any other sound medical reason as determined by the clinical investigator; 16. Legal incompetence or limited legal competence, detainment in an institution for official or legal reasons. ; PRIMARY OUTCOME: Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.; SECONDARY OUTCOME 1: Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD[/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 - LIBERTY AD CAFE; BRIEF: The main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral Cyclosporine A (CSA), or when this treatment is currently not medically advisable. The secondary objective is to assess the safety and tolerability of 2 dose regimens of dupilumab compared to placebo, administered with concomitant TCS, in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable. ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female, 18 years or older 2. Severe, Chronic AD, (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]) for whom treatment with potent TCS is indicated 3. EASI score ≥20 at the screening and baseline visits 4. IGA score ≥3 (on the 0 to 4 IGA scale) at the screening and baseline visits 5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits 6. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with TCS 7. Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit 8. Documented history by a physician of either: 1. No prior CSA exposure and not currently a candidate for CSA treatment due to: - medical contraindications (eg, uncontrolled hypertension on medication), or - use of prohibited concomitant medications (eg, statins, digoxin, macrolide, antibiotics, barbiturates, anti-seizure, nonsteroidal anti-inflammatory drugs, diuretics, angiotensin-converting-enzyme inhibitors, St Johns Wort, etc), or - increased susceptibility to CSA-induced renal damage (elevated creatinine) and liver damage (elevated function tests), or - increased risk of serious infections, or - hypersensitivity to CSA active substance or excipients OR 2. Previously exposed to CSA, and CSA treatment should not be continued or restarted due to: - intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function tests, uncontrolled hypertension, paraesthesia, headache, nausea, hypertrichosis, etc), or - inadequate response to CSA (defined as flare of AD on CSA tapering after a maximum of 6 weeks of high dose [5 mg/kg/day] to maintenance dose [2 to 3 mg/kg/day] or a flare after a minimum of 3 months on maintenance dose). Flare is defined as increase in signs and/or symptoms leading to escalation of therapy, which can be an increase in dose, a switch to a higher-potency class of TCS, or the start of another systemic non-steroidal immunosuppressive drug or - requirement for CSA at doses >5 mg/kg/day, or duration beyond those specified in the prescribing information (>1 year) Exclusion Criteria: 1. Participation in a prior dupilumab clinical study 2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the screening visit 3. Hypersensitivity and/or intolerance to corticosteroids or to any other ingredients contained in the TCS product used in the study 4. Systemic CSA, systemic corticosteroids, or phototherapy within 4 weeks prior to screening, and azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors within 8 weeks prior to screening 5. Treatment with TCI within 1 week before the screening visit 6. Treatment with biologics as follows: - Any cell-depleting agents including but not limited to rituximab: within 6 months before the screening visit, or until lymphocyte count returns to normal, whichever is longer - Other biologics: within 5 half-lives (if known) or 16 weeks prior to the screening visit, whichever is longer 7. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit 8. Treatment with a live (attenuated) vaccine within 12 weeks before the screening 9. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the screening or superficial skin infections within 1 week before the screening visit. NOTE: patients may be rescreened no sooner than 2 weeks after infection resolves 10. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, Listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment 11. Presence of any 1 of the following TB criteria: 1. A positive tuberculin skin test at the screening visit 2. A positive blood QuantiFERON®-TB or T-Spot test at the screening visit 3. Chest x-ray (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior TB infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non-caseating granulomata. NOTE: Any of these 3 TB tests will be performed on a country-by-country basis according to local guidelines only if required by regulatory authorities or ethics boards. 12. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening 13. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab), or hepatitis C antibody (HCV Ab) at the screening visit ; PRIMARY OUTCOME: Percentage of Participants With Eczema Area and Severity Index (EASI) 75 (≥75% Improvement From Baseline) at Week 16; SECONDARY OUTCOME 1: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - REAKT; BRIEF: Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI. ; DRUG USED: Reltecimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: Cluster of Differentiation 28 (CD28) /ICOS and B7RP-1 Pathway, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Atox Bio Ltd; CRITERIA: Inclusion Criteria: 1. Has either suspected or documented diagnosis of abdominal sepsis requiring treatment with parenteral antibiotics and planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures within 24 hours of evaluation by medical personnel. Recommended surgical or interventional radiologic procedures be performed with 12 hours of evaluation by medical personnel. 2. Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria established either upon presentation to medical care in those patients with suspected abdominal sepsis or in those patients in whom the initial diagnosis of AKI is established during the 48 hour period from the suspected diagnosis of abdominal sepsis. 3. Study medication must be administered within 6 hours of confirmation of onset of Stage 2 or 3 AKI as established at the study site, under the following criteria: - After the decision is made by the attending surgeon at the study site for a surgical or interventional radiology procedure for the abdominal infection OR - After confirmed diagnosis of abdominal infection has been established by a surgical or interventional radiology procedure Exclusion Criteria: 1. Has known prior history of chronic kidney disease (CKD( with a documented estimated GFR (eGFR) < 30 mL/min • Exception: Patients with history of CKD but no available prior eGFR who have documented normal kidney size on ultrasound or computed tomography evaluation (performed within 90 days of screening) will be eligible 2. Patients receiving renal replacment therapy (RRT) for CKD 3. . Previously diagnosed with documented AKI in the last 30 days 4. Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the time of AKI diagnosis 5. Patient is not expected to survive throughout 28 days of study due to significant underlying medical condition 6. Any concurrent medical condition, which in the opinion of the Investigator, may compromise the safety of the patient or the objectives of the study or the patient will not benefit from treatment such as: - Congestive heart failure (CHF) {New York Heart Association (NYHA) class III-IV} - Severe chronic obstructive pulmonary disease (COPD) {GOLD - Global Initiative for Chronic Obstructive Lung Disease - stage IV. or chronic hypoxemia) - Liver dysfunction {Childs-Pugh class C} - Primary or acquired immunodeficiency or immunosuppression due to treatment with immunosuppressive medications - Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes - Neutropenia < 1,000 cells/mm3 not due to the underlying infection - Receiving or about to receive chemotherapy or biologic anti-cancer treatment, - Hematological and lymphatic malignancies in the last 5 years 7. Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis; 8. Pregnant or lactating women 9. Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device ; PRIMARY OUTCOME: Freedom From Durable Loss of Renal Function at Day 28; SECONDARY OUTCOME 1: Freedom From Durable Loss of Renal Function at Day 14[/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 - CREATE-1 (CRPS); BRIEF: This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I. ; DRUG USED: AXS-02; DRUG CLASS: Non-NME; INDICATION: Pain Indications; TARGET: Mevalonate pathway , Osteoclast; THERAPY: Monotherapy; LEAD SPONSOR: Axsome Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Male or female of at least 18 years of age - Recently confirmed diagnosis of CRPS-1 (Budapest criteria) - Average pain intensity score of ≥ 5 (based on an 11-point scale [0 - 10]) - Willing and able to provide written informed consent Key Exclusion Criteria: - Received chronic opioid therapy within 4 weeks - Received a sympathetic nerve block within 3 weeks - Active litigation or a pending workers compensation decision - Any other clinically significant medical or pain condition (eg, Parkinsons disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigators judgment interfere with the subjects ability to participate in the study ; PRIMARY OUTCOME: Change in patient reported pain intensity; SECONDARY OUTCOME 1: Change in Brief Pain Inventory (BPI) Pain 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 - w/Carboplatin/Paclitaxel (307); BRIEF: This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. ; DRUG USED: Camrelizumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Jiangsu HengRui Medicine Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) and clinical stage IV 2. has not received prior systemic treatment for metastatic NSCLC. 3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status 4. Has archived Tumor tissue samples 5. Subject must have a measurable target lesion based on RECIST v1.1 . 6. Has adequate organ function. 7. Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug. 8. Subjects should be voluntarily participate in clinical studies and informed consent should be signed. Exclusion Criteria: 1. active brain metastases and meningeal metastasis 2. uncontrollable tumor-related pain 3. massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage; 4. radiotherapy to lung that is >30 Gy within 24 weeks before the first dose, 5. imaging (CT or MRI) showed that the tumor invading the large vessels 6. Known EGFR/ALK mutation. 7. subjects with any known or suspected autoimmune diseases 8. subjects with known or suspected interstitial pneumonia; 9. Subjects with severe cardiovascular and cerebrovascular diseases 10. arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months; 11. female subjects who are pregnant or lactation or who plan to be pregnant during the study period; 12. positive HIV test; 13. active hepatitis B 14. evidence of active TB infection within 1 year before first dose; 15. severe infection occurred within 4 weeks before the first dose 16. patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month 17. subjects who is on systemic immunogenic agents; 18. a history of severe allergic reactions to other monoclonal antibodies/fusion proteins; 19. History of severe allergic reactions to carboplatin or paclitaxel or their preventive drugs; ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Progression-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - S187.3.003 (Study 001, 002 LT Safety); BRIEF: Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel. ; DRUG USED: Duopa; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Aromatic L-amino acid decarboxylase (AADC), Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Idiopathic Parkinsons disease (PD) according to United Kingdon Parkinsons Disease Society (UKPDS) Brain Bank Criteria - Levodopa-responsive with severe motor fluctuations - Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study Exclusion Criteria: - Patients with medically relevant abnormal findings (labs, electrocardiogram [ECG], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387) ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs; SECONDARY OUTCOME 1: Change From Baseline in Average Daily Off Time at Endpoint[/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 - POINT; BRIEF: This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®). ; DRUG USED: Ponvory; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Actelion; CRITERIA: Inclusion Criteria: - Signed informed consent prior to initiation of any study-mandated procedure. - Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception - Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses). - Ongoing treatment with DMF for at least 6 months prior to screening - Active disease after at least 3 months of DMF treatment - Ambulatory and with an EDSS score between 0 and 6.0 (inclusive). Exclusion Criteria: - Lactating or pregnant women and women intending to become pregnant during the study. - Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS). - Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment. - Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. ; PRIMARY OUTCOME: Annualized Confirmed Relapse Rate (ARR); SECONDARY OUTCOME 1: Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96[/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 2 Ext. Study; BRIEF: This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohns disease (CD) and to gather long-term safety and tolerability data in this population. Participants were allowed to enroll in the study if they participated in and successfully completed Study M06-806 (NCT00409682) through Week 52. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Participant must have successfully enrolled in and completed Study M06-806 through Week 52. - Participant must have been a responder at any time point during the M06-806 study (defined as having achieved at least a 15-point reduction in the Pediatric Crohns Disease Activity Index (PCDAI) from Baseline). - If female, participants who were sexually active and of child-bearing potential were to be practicing an approved method of birth control throughout the study and for 150 days after study drug administration. Examples of approved methods of birth control included the following: 1. Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD) 2. Oral, parenteral or intravaginal contraceptives 3. A vasectomized partner - Participant of legal age, parent or legal guardian, as required, voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form, after the nature of the study was explained and the participant of legal age, participants parent, or legal guardian, as required, had the opportunity to ask questions. Participants were to be included in all discussions, and if required, their signature on an assent form was to be obtained. - Parent or legal guardian of participant who was not of legal age, as required, must have been willing to actively supervise storage and administration of study drug and to ensure that the time of each dose was accurately recorded in the participants diary. - Participants of legal age, must have been willing to actively store, administer, and accurately record study drug administration in the participant diary. - Participant was judged to be in acceptable medical condition, as determined by the Principal Investigator based upon results of clinical and laboratory evaluations done throughout the preceding Crohns disease study M06-806. Exclusion Criteria: - For any reason, the participant was considered by the Investigator to be an unsuitable candidate for continuing therapy in the M06-807 study. - Participant had abnormal laboratory or other test results that in the opinion of the Investigator would make the participant unsuitable to participate in this study. - History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix. - History of listeriosis, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus (HIV) infection, any immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB (receiving treatment or not receiving treatment). Ongoing severe infections such as sepsis and opportunistic infections were exclusionary. - Participant with known, symptomatic obstructive strictures. - Participant who was planning surgical bowel resection at any time point while enrolled in the study. - Participant who had short bowel syndrome as determined by the Investigator. - Participant who was receiving total parenteral nutrition (TPN). - Participant who was unwilling to discontinue growth hormone prior to the first dose of open-label study drug at the Baseline visit of M06-807. - Female participant who was pregnant or currently breastfeeding. - Participant with a history of clinically significant drug or alcohol abuse in the last year. - Participant with a poorly controlled medical condition such as: uncontrolled diabetes, recurrent infections, unstable ischemic heart disease, moderate to severe heart failure, recent cerebrovascular accidents or any other condition which, in the opinion of the Investigator or the Sponsor, would put the participant at risk by participation in the protocol. - Participant with any prior exposure to Tysabri (natalizumab). - Participant with a known hypersensitivity to the excipients of adalimumab as stated in the label. - Participant with a previous history of dysplasia of the gastrointestinal tract. ; PRIMARY OUTCOME: Number of Participants Who Achieved Pediatric Crohns Disease Activity Index (PCDAI) Clinical Remission Over Time; SECONDARY OUTCOME 1: Number of Participants Who Were in Crohns Disease Activity Index (CDAI) Clinical Remission Over Time[/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 - EMS0815; BRIEF: Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia. ; DRUG USED: Valsartan/Rosuvastatin FDC; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Angiotensin II Receptor Type 1 (AT1), HMG CoA Reductase (HMGR); THERAPY: Monotherapy; LEAD SPONSOR: EMS; CRITERIA: Inclusion Criteria: - Participants of both sexes aged between 18 and 65 years; - Participants diagnosed with uncontrolled hypertension; - Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis; - Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) . Exclusion Criteria: - Participants with a previous diagnosis of familial hypercholesterolemia (homozygous); - Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE); - participants with isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis; - research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL; - participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg; - research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg in orthostatic position in relation to the sitting position); - History of congestive heart failure (CHF) functional class III or IV (NYHA);; - any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants; - Creatine phosphokinase (CPK) levels above the established laboratory normal range; - Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range; - Body mass index (BMI) ≥35 kg / m²; - Immunocompromised participants (eg .: malignancies, patients with Acquired Immunodeficiency Syndrome etc); - Chronic use of drugs that may interact with the drugs of the study; - Patients on concomitant lipid-lowering therapy; - History hypersensitivity to the active ingredients used in the study; - Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception; - History of alcohol abuse or illicit drug use; - Adherence to uniformization medication <80%; - Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it; ; PRIMARY OUTCOME: Reduction of systemic blood pressure measured between the first visit and last visit.; SECONDARY OUTCOME 1: Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the 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 - RESOLVE 3 (Ext); BRIEF: Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240). Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator. Exclusion Criteria: Subject answers yes to Suicidal Ideation Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305). Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property. ; PRIMARY OUTCOME: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores[/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 - INROADS (Walking Impairment); BRIEF: This study assessed the efficacy and safety of ADS-5102 (at daily doses of 137 mg or 274 mg) compared with placebo in MS patients with walking impairment. ; DRUG USED: Gocovri; DRUG CLASS: Non-NME; INDICATION: Multiple Sclerosis (MS); TARGET: Dopamine, NMDA Glutamate Receptor, Norepinephrine (Noradrenaline); THERAPY: Monotherapy; LEAD SPONSOR: Adamas Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Signed a current IRB-approved informed consent form - Male or female subjects between 18 and 70 years of age, inclusive, at the time of Screening - Confirmed diagnosis of MS according to the 2017 McDonald criteria - Current medication regimen must be stable for at least 30 days prior to screening, and subject must be willing to continue the same dosing regimen for the duration of study participation - Maximum Expanded Disability Status Scale (EDSS) score during screening of 6.5 - Stable physical activity level (inclusive of prescribed physical therapy) for at least 30 days prior to screening and willing to continue without change for the duration of study participation - A score on each of two completed screening T25FW tests between 8 and 45 seconds, inclusive Exclusion Criteria: - Documented inability to tolerate amantadine - Clinically significant MS relapse with onset less than 30 days prior to screening - Receipt of dalfampridine (or any 4-aminopyridine or 2,4-diaminopyridine preparation) or amantadine within 30 days prior to screening - History of seizures within 3 years prior to screening - History of hallucinations (visual, auditory, or any other type) within 3 years prior to screening - History of bipolar disorder, schizophrenia, or psychosis, regardless of treatment - For subjects with a history of major depressive disorder, the presence of active depressive symptoms that, in the opinion of the investigator, would affect the subjects ability to complete study assessments, or which would not be in the subjects best interest to participate in the study - Presence of orthostatic hypotension at screening: a decrease in systolic blood pressure (at least 20 mm Hg) or diastolic blood pressure (at least 10 mm Hg) within 3 minutes of the subject standing up, compared to pressures obtained while sitting - If female, is pregnant or lactating - If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from screening through at least 4 weeks after the completion of study treatment. If a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment. - Treatment with an investigational drug or device within 30 days prior to screening - Treatment with an investigational biologic within 6 months or 5 half-lives, whichever is longer, prior to screening ; PRIMARY OUTCOME: Timed 25 Foot Walk (T25FW, Feet/Second): the Proportion of Subjects With a ≥ 20% Increase in Walking Speed (Measured by T25FW) From Baseline at Week 16 (Responder Analysis); SECONDARY OUTCOME 1: Timed 25 Foot Walk: Change From Baseline at Week 16[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DYNAGITO; BRIEF: The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD. ; DRUG USED: Stiolto Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Male or female patients, 40 years of age or older. - Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1 - Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization. - Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1. - Current or ex-smokers with a smoking history of more than 10 pack years. Exclusion criteria: - Significant disease other than COPD. - Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.) - Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma - A diagnosis of thyrotoxicosis - A history of myocardial infarction within 6 months of screening visit. - Life-threatening cardiac arrhythmia. - Known active tuberculosis. - Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed). - A history of cystic fibrosis. - Clinically relevant bronchiectasis. - Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening - A history of significant alcohol or drug abuse in the opinion of the investigator. - Patients who have undergone thoracotomy with pulmonary resection - Patients being treated with oral or patch ß-adrenergics. - Patients being treated with oral corticosteroid medication at unstable doses - Patients being treated with antibiotics for any reasons within 4 weeks of screening visit - Patients being treated with PDE4 inhibitors within 3 months of screening visit - Patients who have taken an investigational drug within one month or six half-lives - Pregnant or nursing women. - Women of childbearing potential not using a highly effective method of birth control. ; PRIMARY OUTCOME: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.; SECONDARY OUTCOME 1: Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - AAVance; BRIEF: MPS IIIA is predominantly a central nervous system disease causing cognitive disability, progressive loss of acquired skills, behavioral and sleep disturbance. LYS-SAF302 is a gene therapy which is intended to deliver a functional copy of the SGSH gene to the brain. This is a phase 2-3 study to assess the efficacy in improving or stabilizing the neurodevelopmental state of MPS IIIA patients. ; DRUG USED: LYS-SAF302; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis IIIA (MPS IIIA; Sanfilippo A Syndrome); TARGET: Heparan-N-sulfatase (N-sulphoglucosamine sulphohydrolase, sulfamidase), N-sulfo-D-glucosamine; THERAPY: Monotherapy; LEAD SPONSOR: LYSOGENE; CRITERIA: Inclusion Criteria: - Documented MPS IIIA diagnosis based on genotyping confirming the SGSH gene mutations - Cognitive DQ score on BSID-III: 50% and above Exclusion Criteria: - Homozygous for the S298P mutation or non-classical severe form of MPS IIIA, based on investigators judgement. - Participation in another gene or cell therapy clinical trial. - Past use of SGSH enzyme replacement therapy for a period exceeding 3 months. A washout period of at least 2 months is required prior to screening. - Current participation in a clinical trial of another investigational medicinal product. - History of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following surgery. - Any condition that would contraindicate treatment with immunosuppressants such as tacrolimus, mycophenolate mofetil or steroids. ; PRIMARY OUTCOME: Change from baseline in development quotient (DQ), compared to regression reported in natural history studies; SECONDARY OUTCOME 1: Change from baseline in the total adaptive behavior composite standard score as measured by the expanded interview Vineland Adaptive Behavior Scales (VABS-II)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 063-020 (Classroom Setting - Adults); BRIEF: This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults ; DRUG USED: Adhansia XR; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Purdue Pharma, Canada; CRITERIA: Inclusion Criteria: 1. Males or females 18 to 60 years of age 2. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional 3. Subject is willing and able to comply with all the protocol requirements. Exclusion Criteria: 1. Primary and/or comorbid psychiatric diagnosis other than ADHD 2. Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug; 3. Has used any investigational drug within 30 days of the screening visit; ; PRIMARY OUTCOME: Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit; 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 - IMAGINE 6 (26 Weeks); BRIEF: The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: - Change in participants overall blood sugar control - The rate of night time low blood sugar episodes - The number of participants that reach blood sugar targets without low night time blood sugar episodes - The total number of low blood sugar episodes reported ; 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 had type 2 diabetes mellitus for at least 1 year, not treated with insulin - Have been receiving 2 or more OAMs for at least 3 months prior to the study - Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening - Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2) - Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug Exclusion Criteria: - Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions) - Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening - For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations - Are taking, or have taken within the 90 days before screening, prescription or over-the-counter medications to promote weight loss - Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening - Have cardiac disease with functional status that is New York Heart Association Class III or IV - Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) [177 millimoles per liter (mmol/L)] - Have obvious clinical signs or symptoms of liver disease [excluding nonalcoholic fatty liver disease (NAFLD)], acute or chronic hepatitis, nonalcoholic steatohepatitis (NASH), or elevated liver enzyme measurements - Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c - Have active or untreated cancer, have been in remission from clinically significant cancer(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 - Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening - Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening - Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigators opinion - Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening ; PRIMARY OUTCOME: Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic 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 - 1VIT14037; BRIEF: This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subjects participation in the study will be for approximately 1 year from Day 0. ; DRUG USED: Injectafer; DRUG CLASS: Non-NME; INDICATION: Restless Leg Syndrome (RLS); TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: American Regent, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female subjects ≥18 years of age, willing and able to give informed consent to the study. 2. RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria must be met: 1. An urge (distressing need) to move the legs usually associated with painful or uncomfortable sensations in the legs. The urge to move may be present without the uncomfortable sensations. The arms or other body parts may be involved in addition to the legs. 2. The urge to move or unpleasant sensations are worse or exclusively present at rest or inactivity, such as lying down or sitting. 3. The urge to move or unpleasant sensations are partially/temporarily relieved with walking or moving the legs. 4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. When symptoms are severe, the worsening at night may not be noticeable but must have been previously present. 3. Subjects should be on monotherapy for RLS. Treatment should be stable for at least 8 weeks prior to screening (See approved RLS Therapies/Regimen in Appendix III). 4. A score ≥15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing. 5. Subjects on anti-depressants and sleep medications must be on a stable dose for at least 6 months. 6. Subject has regular sleep hours between 9 pm and 9 am. 7. Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide with barrier, intrauterine device, or partner sterility. Exclusion Criteria: 1. RLS 2° to other disease or injury. 2. Disorders that require treatment with the same medications used for RLS include: peripheral neuropathy and neurodegenerative disorders (i.e. Parkinsons Disease or Dementia). 3. Stage 4 - 5 CKD, subjects on dialysis or anticipated to start dialysis while participating in this study. 4. Any pain related (e.g., frequent muscle cramps, myalgia, fibromyalgia) or sleep related disorders (e.g. sleep apnea, unless on stable Continuous Positive Airway Pressure [CPAP]) which may confound the outcome measures. 5. Subjects with multiple sclerosis. 6. History of neuroleptic akathisia. 7. Parenteral iron use within 6 weeks prior to screening. 8. History of >10 blood transfusions in the past 2 years. 9. Anticipated need for blood transfusion during the study. 10. Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose). 11. Previously randomized to Injectafer® (FCM or VIT-45) in a clinical trial. 12. Current, active or acute or chronic infection other than viral upper respiratory tract infection 13. Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years). 14. Pregnant or lactating women. 15. Seizure disorder currently being treated with medication. 16. Baseline ferritin ≥300 ng/mL. 17. Baseline TSAT ≥45%. 18. History of hemochromatosis, hemosiderosis, or other iron storage disorders. 19. AST or ALT greater than 2 times the upper limit of normal (ULN). 20. Hemoglobin greater than the ULN. 21. Known positive hepatitis B antigen (HBsAg), unless positive test can be attributed to receipt of hepatitis B vaccination in childhood or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal). 22. Known positive HIV-1/HIV-2 antibodies (anti-HIV). 23. Received an investigational drug within 30 days before randomization. 24. Chronic alcohol or drug abuse within the past 6 months. 25. Any other pre-existing laboratory abnormality, medical condition or disease, which per the investigator may put the subject at risk if they participate in the study. 26. Subject unable or unwilling to comply with the study requirements. ; PRIMARY OUTCOME: International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42; SECONDARY OUTCOME 1: Clinical Global Impression-Improvement (CGI-S) by Subject[/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 - FUTURE 5; BRIEF: The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each). - Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening. - Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis. - Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24. - Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24. - Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52. - Subjects on MTX must be on folic acid supplementation at randomization. - Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed. - Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor. - Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization Exclusion Criteria: Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics. - Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. - Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization. - Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved). - Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents - Other protocol-defined exclusion criteria do apply ; PRIMARY OUTCOME: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16; SECONDARY OUTCOME 1: Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))[/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 - GARNET; BRIEF: This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV). ; DRUG USED: Exviera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Chronic HCV infection at Screening. 2. Screening laboratory result indicating HCV genotype 1b infection. 3. Treatment-naïve and non-cirrhotic. Exclusion Criteria: 1. HCV genotype or subtype other than GT1b. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test. 3. Any current or past clinical evidence of cirrhosis. 4. Screening laboratory analyses that shows abnormal results. 5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study. ; PRIMARY OUTCOME: Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-Treatment Virologic Failure During Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EU; BRIEF: A Phase III, multicentre, randomised, double blind, placebo-controlled study in subjects having anal fissure (AF) with AF-related pain. Subjects will undertake a 1-week screening period to provide baseline data and for assessment of eligibility. At the Baseline visit (Week 0), eligible subjects (having an average Numerical Rating Scale (NRS) score of >4 for worst pain associated with or following defaecation) will be randomised on a 1:1:1 basis to one of the three treatment groups. Subjects will receive diltiazem hydrochloride 2% cream or diltiazem hydrochloride 4% cream or placebo cream. Study treatment will be applied in and around the anus, three times daily, for up to 8 weeks. Following the Week 0 Visit, subjects will be contacted by telephone during Week 1 to ensure adequate compliance with study treatment, to ensure that study drug is being tolerated and that any concomitant medications are used at a level consistent with that prior to randomisation. Subjects will return to the clinic for safety and efficacy assessments at Weeks 2, 4, and 8 and receive a follow-up telephone call at Week 12, following cessation of therapy. Concomitant laxatives and stool softeners will be permitted, as needed, during the entire study period (screening and treatment) to ensure that constipation or passage of hard stools does not confound evaluation or improvement of the condition. Fibre supplements will be allowed but should be continued at the baseline level. Instructions on the use of the Interactive Voice Response System (IVRS) diary will be issued to subjects to record fissure-related pain (NRS) and bowel symptoms daily during the 1-week screening period, to confirm eligibility and post-randomisation to record worst anal pain associated with or following defaecation (NRS) and daily overall AF-related pain (NRS). A record of the number of times the subject has defaecated, laxative and analgesic usage will also be made as well as the number of applications of study treatment, any changes to concurrent medications and any Adverse Events (AEs). In addition, at some or all study visits, subjects will record the Patients Global Impression of Improvement (PGI-I) on a 7 point Likert scale, complete a Short Form 36 (SF-36) quality of life questionnaire and will undergo examination of their AF. Routine blood samples will be taken and the Skin Irritation Score (SIS) recorded for safety evaluations. Subjects may receive permitted medications for pain per Entry Criteria, but these should remain stable, where possible, up to the Week 8 Visit. Introduction of any new medication for AF will not be permitted unless the Investigator deems rescue intervention necessary. A subject will be deemed a treatment failure if rescue intervention is required and will have to be withdrawn from the study. Any subject leaving the study following randomisation for any reason will be asked to complete the Early Withdrawal Visit. This includes subjects who withdraw due to the development of AEs or intolerance, as well as subjects who require rescue intervention. These subjects will return for safety follow-up visits at their previously scheduled follow-up assessment appointments. If complete healing has occurred at the 2 or 4 Week visits, (i.e. prior to the end of the 8-week treatment period), subjects will be asked to continue applying the medication for the full 8 week course, up to the final assessment. Following the Week 8 visit (or Early Withdrawal Visit), subjects will be followed up for a further 4 weeks (following cessation of study medication) to note any AEs. All routine blood analyses (haematology and biochemistry) and plasma levels of diltiazem and of its principal metabolites will be analysed by central laboratories. ; DRUG USED: Dolizem; DRUG CLASS: Non-NME; INDICATION: Chronic Pain; TARGET: Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: S.L.A. Pharma AG; CRITERIA: Inclusion Criteria: - • Must give written informed consent. - Male or female subjects, from 18 years of age. - Subjects with at least a 4 week history of painful AF, prior to screening, where AF-related pain associated with, or following, defaecation is experienced at least twice a week for the 4 weeks prior to Screening with an average of ≥ 3 on an 11-point NRS (Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable). - Subjects with an average of ≥4 on an 11-point NRS during the screening phase for worst anal pain associated with, or following, defaecation for the most recent 3 days on which the subject has defaecated. - Subjects with evidence of a circumscribed fissure, with induration at the edges. - Willing to stop all other concomitant topical preparations applied perianally prior to commencing study treatment, and throughout the study. - Willingness and ability to use the IVRS diary. Exclusion Criteria: - Subjects unwilling to have examination of AF. - Subjects with acute AF (i.e. duration of symptoms less than 4 weeks prior to screening, and/or no induration of fissure edges). - More than 1 AF. - Subjects who have had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region. - Subjects who have had sub-fissure injection of botulinum toxin in the 3 months prior to screening, or have used glyceryl trinitrate (GTN) ointment for >1 week in the 4 weeks prior to the screening visit. - Subjects with AF associated with other conditions (drug-induced [e.g. nicorandil], trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or malignancy). - Subjects with cardiovascular disease (including those diagnosed by the screening ECG): history of reduced left ventricular function, bradycardia, 1st degree atrioventricular (AV) block or prolonged P-R interval (>0.2 seconds/ >200 milliseconds). - Subjects with known hypersensitivity to diltiazem. - Subjects who have previously received therapy with diltiazem hydrochloride cream or other topical calcium channel blockers. - Subjects taking medications prohibited by the protocol. - Subjects who have taken experimental agents must have been discontinued at least 8 weeks prior to screening, or for a period equivalent to 5 half-lives (t1/2) of the agent (whichever is longer); - Subjects who have or have undergone the following gastrointestinal disorders or procedures: - Inflammatory bowel disease. - Chronic faecal incontinence. - History of chronic constipation or constipation in the 4 weeks prior to the screening phase (defined as 2 or less defaecations per week; associated with straining/passage of hard stools). - Anal abscess. - A history of radiation therapy to the pelvis. - Fixed anal stenosis/fibrosis. - Subjects with a history of neoplastic disease within 5 years (except for basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin). - Subjects with a clinically significant history of renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers), or haematological illness. - Subjects with any laboratory tests considered clinically significant at screening. - Subjects with planned elective or other treatment requiring hospitalisation, during the study, booked before entry into the study - Subjects who will be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason; - Women of childbearing potential unless surgically sterile or using adequate contraception (IUD, oral or depot contraceptive, or barrier plus spermicide). Women using oral contraception must have started using it at least 2 months prior to enrolment. - Women who are pregnant or breastfeeding. ; PRIMARY OUTCOME: Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation for Week 4 (for the 7 Treatment Days Immediately Preceding the Week 4 Visit).; SECONDARY OUTCOME 1: Patients Global Impression of Improvement (PGI-I)[/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 - RE-SONATE (Secondary Prevention); BRIEF: The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA). ; DRUG USED: Pradaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study. 2. Written informed consent Exclusion criteria: 1. Younger then 18 years of age 2. Indication for VKA other than DVT and/or PE 3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued 4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN 5. Creatinine clearance < 30 ml/min 6. Acute bacterial endocarditis 7. Active bleeding or high risk for bleeding. 8. Uncontrolled hypertension (investigators judgement) 9. Intake of another experimental drug within the 30 days prior to randomization into the study 10. Life expectancy <6 months 11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding ; PRIMARY OUTCOME: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period; SECONDARY OUTCOME 1: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - dHACM; BRIEF: Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis ; DRUG USED: AmnioFix; DRUG CLASS: Biologic; INDICATION: Orthopedic Disorder; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: MiMedx Group, Inc.; CRITERIA: Inclusion Criteria: 1. Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator 2. VAS Pain scale of ≥ 45 mm at randomization 3. Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities: - RICE - Stretching exercises - NSAIDs - Orthotics 4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities 5. BMI ≤ 40 kg/m2 6. Age ≥ 21 years and < 80 7. Ability to sign Informed Consent and Release of Medical Information Forms Exclusion Criteria: 1. Prior surgery or trauma to the affected site 2. Subjects requiring bilateral plantar fasciitis treatment at time of enrollment 3. Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months 4. Has diabetes either Type I or Type II 5. Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiters syndrome, rheumatoid arthritis, etc. 6. The presence of comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to: - Calcaneal stress fracture - Nerve entrapment syndrome (Baxter Nerve Syndrome) - Fat pad atrophy - Acute traumatic rupture of the plantar fascia - Calcaneal tumor - Tarsal tunnel syndrome - Significant bone deformity of the foot that may interfere with the study 7. Affected site exhibits clinical signs and symptoms of infection 8. Known allergy or known sensitivity to Aminoglycosides, such as Gentamicin sulfate or Streptomycin sulfate 9. Clinically significant abnormal laboratory tests at baseline, including CBC, PT/PTT/INR, liver function and creatinine, as determined by the investigator 10. Patients who are non-ambulatory 11. History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study 12. Prior radiation at the site 13. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment 14. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) 15. History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator 16. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) 17. Workers compensation patients ; PRIMARY OUTCOME: 20% improvement over baseline Visual Analog Scale for Pain; SECONDARY OUTCOME 1: 20% improvement in Foot Function Index-Revised (FFI-R) score from baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Evaporative-009; BRIEF: The objectives of this study are twofold - To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) - To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE ; DRUG USED: AGN-195263; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Male, 18 years of age or older, at the screening (day -51) visit OR - Females, who are naturally postmenopausal (permanent cessation of menstrual periods for at least 12 consecutive months) or are permanently sterilized (ie, eg, tubal occlusion, hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) at the screening (day -51) visit - In at least 1 eye, all of the following objective measures of evaporative dry eye (EDE) must be present at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits - Tear film break-up time (TBUT) ≥ 2 seconds and ≤ 7 seconds - Corneal sodium fluorescein staining score ≥ 1 and ≤ 4 (Oxford scheme) - Anesthetized Schirmers tear test score ≥ 10 mm after 5 minutes - At the standardization (day -21) and baseline (day 1) visits, patients must have: - Ocular Surface Disease Index© (OSDI) score > 12 (0 to 100 scale) - Overall ocular discomfort score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe) - Ocular burning score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe) - Blurred vision score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe) - In at least 1 eye, a lower lid margin meibum quality global assessment score ≥ 1 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits - In at least 1 eye, the number of lower lid margin expressible meibomian glands must be ≥ 3 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits - Use of an artificial tear product or lid hygiene (ie, warm compress, lid massage, lid scrub) for the treatment of dry eye disease, EDE or meibomian gland disease within 1 year of the standardization (day -21) visit Exclusion Criteria: - Male patients with a history of, known, or suspected prostate cancer - Male patients with a prostate-specific antigen (PSA) level ≥ 4 μg/L - Female patients with a history of known or suspected breast, cervical, ovarian, or uterine cancer - Female patient who is of child-bearing potential - At standardization (day -21) and / or baseline (day 1) visits, a lower lid margin meibum quality global assessment score of non-expressible (NE) in either eye - Patients who are currently or have used hormone replacement therapy or estrogen and /or progesterone based products (including herbal and nutritional supplements) within 90 days of the standardization (day -21) visit or anticipated use during the study - Patients who are currently using or have used any androgen or anti-androgen treatment (including herbal and nutritional supplements), within 90 days of the standardization (day -21) visit or anticipated use during the study - Patients who are currently using or have used any hair growth product within 90 days of the standardization (day -21) visit or anticipated use during the study - Patients who are currently using or have used corticosteroids administered via any route within 30 days prior to the standardization (day -21) visit, or any anticipated use via any route of administration prior to the month 6 visit - Patients who are currently using or have used oral or topical macrolides, tetracycline, tetracycline derivative drugs (including doxycycline and minocycline), retinoids (eg, isotretinoin), or calcineurin inhibitors (ie, RESTASIS®, Ikervis®) within 60 days of the standardization (day -21) visit, or anticipated use prior to the month 6 visit ; PRIMARY OUTCOME: Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe); SECONDARY OUTCOME 1: Change From Baseline in Tearfilm Break Up Time (TBUT)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Adults and Elderly ; BRIEF: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in adults (18 to 60 years of age) and in the elderly (over 60 years of age). ; DRUG USED: Fluarix Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject prior to performing any study specific procedure. - A male or female aged 18 years or above at the time of vaccination. - Healthy subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study. - 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 treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day -29 to Day 0), or planned use during the study period. - Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. - Administration of long-acting immune-modifying drugs (e.g. rituximab, infliximab, etc.) within 6 months before study start, or planned administration during the study. - Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study vaccination and during the entire study period. - Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. - Administration of an influenza vaccine within the 6 months preceding the study start or planned use of such vaccines during the study period.. - 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 vaccine/product (pharmaceutical product or device). - Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥ 38.0°C/100.4°F, measured by any means. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. - Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilised or clinically serious. - History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. - History of Guillain-Barré syndrome. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex. - History of severe adverse reaction to a previous influenza vaccination. - Anaphylaxis following the administration of vaccine(s). - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions. ; PRIMARY OUTCOME: Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.; SECONDARY OUTCOME 1: Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EVERHEART; BRIEF: The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation. ; DRUG USED: Zortress; DRUG CLASS: New Molecular Entity (NME); INDICATION: Heart Transplant Rejection; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Male or female cardiac transplant candidates 18-65 years of age undergoing primary heart transplantation. - Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization Exclusion criteria: - Patients who are recipients of multiple solid organ transplants - Patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive; - Presence of Donor/Recipients serological mismatch for Hepatitis B or C; - Recipients of organ from donors positive for Hepatitis B-surface antigen; - Panel Reactive Antibodies (cytotoxicity method) > 30%. - Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group; SECONDARY OUTCOME 1: Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group[/INST]Yes</s>