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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PA1302 (Long Term Study; Japan); BRIEF: The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia. ; DRUG USED: Velphoro; DRUG CLASS: Non-NME; INDICATION: Hyperphosphatemia; TARGET: Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Kissei Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Receiving stable maintenance hemodialysis 3 times a week. - Dialysis patients with hyperphosphatemia Exclusion Criteria: - Patients having history of a pronounced brain / cardiovascular disorder. - Patients having severe gastrointestinal disorders. - Patients having severe hepatic disorders. ; PRIMARY OUTCOME: Incidence of Adverse Events; SECONDARY OUTCOME 1: Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIa - XSGP-302; BRIEF: This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. Subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center (CRC) or comparable setting. ; DRUG USED: Gvoke RTU Micro; DRUG CLASS: Non-NME; INDICATION: Hyperinsulinemia/Hypoglycemia; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Xeris Pharmaceuticals; CRITERIA: Inclusion Criteria: - diagnosed with T1D for at least 6 months at Screening. - current usage of daily insulin treatment. Exclusion Criteria: - pregnant or nursing - renal insufficiency - hepatic synthetic insufficiency - aspartate or alanine aminotransferase > 3 times the upper limit of normal - hematocrit less than or equal to 30% - use of > 2.0 U/kg total insulin dose per day - inadequate venous access - current seizure disorder - history of pheochromocytoma or disorder with increased risk of pheochromocytoma - history of insulinoma - history of glycogen storage disease. - active use of alcohol or drugs of abuse - administration of glucagon within 14 days of the first treatment visit - participation in other studies involving an investigational drug or device within 30 days ; PRIMARY OUTCOME: Change in Plasma Glucose; SECONDARY OUTCOME 1: Time for Plasma Glucose to Increase by ≥25 mg/dL[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Chronic Stable Plaque Psoriasis; BRIEF: This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment. ; DRUG USED: Impoyz; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Promius Pharma, LLC; CRITERIA: Inclusion Criteria: 1. Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study. 2. Subject must be at least 18 years of age. 3. Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis. 4. Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas. 5. Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit. 6. 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 (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment. 7. Subject 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). Exclusion Criteria: 1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. 2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis). 3. Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters. 4. History of psoriasis unresponsive to biological or topical treatments. 5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. 6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept). 7. Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit. 8. Use within 60 days prior to the Baseline Visit of: 1) systemic or topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin). 9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed. 10. Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids. 11. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit. ; PRIMARY OUTCOME: Efficacy (Percentage of Subjects With Treatment Success); SECONDARY OUTCOME 1: The Percent Change in Body Surface Area of Psoriasis[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PSUMMIT I; BRIEF: The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis. ; DRUG USED: Stelara; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months - Have a diagnosis of active PsA at the time of entry into the study - If the participant is using methotrexate they should have started treatment at a dose not to exceed 25 milligram per week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate. Methotrexate route of administration and doses should be stable for at least 4 weeks prior to the first administration of study agent. If currently not using methotrexate, must have not received methotrexate for at least 4 weeks prior to the first administration of the study agent Exclusion Criteria: - Have other inflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease - Have used any therapeutic agent targeted at reducing interleukin (IL)-12 or IL-23, including but not limited to ustekinumab and briakinumab (ABT-874) - Have used any biologic agents that are targeted for reducing tumor necrosis factor-alpha, including but not limited to infliximab, etanercept, adalimumab, and golimumab - Have a medical history of latent or active granulomatous infection - Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years of the beginning of the study ; PRIMARY OUTCOME: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.; SECONDARY OUTCOME 1: Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - HERMIONE (HER2+); BRIEF: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physicians choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. ; DRUG USED: MM-302; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), DNA, DNA synthesis, HER2/neu or ErbB-2, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: Merrimack Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients must have histologically or cytologically confirmed invasive cancer of the breast - Patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent. - Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratory - Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. - Patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the LABC/MBC setting - Patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab) - ECOG Performance Status of 0 or 1 Exclusion Criteria: - Patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative - Subjects with central nervous system (CNS) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment - Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF) - Patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months - Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia) - Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity - Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy. ; PRIMARY OUTCOME: Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; SECONDARY OUTCOME 1: Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III; BRIEF: This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain. The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious. ; DRUG USED: Exalgo; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Mallinckrodt; CRITERIA: Inclusion Criteria 1. Patients must have been provided with written consent to participate in the study prior to any study procedures, and must understand that they are free to withdraw from the study at any time. 2. Patients who can speak, read, write, and understand English, and must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff. 3. Male and female patients aged 18-75 years, inclusive. 4. Documented diagnosis of moderate to severe chronic low back pain that must have been present 5. Patients who are classified as non-neuropathic (Class 1 and 2) or neuropathic (Class 3, 4, 5 and 6) of lower back pain based on the Quebec Task Force Classification of Spinal Disorders will be enrolled for this study. 6. Patients who require daily scheduled opioid analgesics for low back pain for at least 2 months prior to the screening visit. 7. Patients with a daily opioid requirement of ≥ 60 mg oral morphine equivalent (≥ 12 mg hydromorphone), but ≤ 320 mg morphine (≤ 64 mg hydromorphone) per day within the 2 months prior to the screening visit. 8. Patients who, in the Investigators opinion, are on a stable dose (≥ 2 weeks) of all prior analgesics (both opioid and non-opioid) prior to the screening visit. 9. Female subjects of childbearing potential including those who have had a tubal ligation surgery but excluding those who have not experienced a menstrual period for a minimum of 2 years, must have a negative serum pregnancy test at screening visit, and must consent to utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 1 week after the study is completed. Exclusion Criteria 1. Patients with an active diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, severe or progressive lower extremity weakness or numbness, bowel or bladder dysfunction as a result of cauda equina compression, diabetic amyotrophy, meningitis, diskitis, back pain because of secondary infection or tumor, or pain caused by a confirmed or suspected neoplasm. 2. Patients who have undergone a surgical procedure for back pain within 6 months prior to the screening visit. 3. Patients who have had nerve or plexus block, including epidural steroid injections or facet blocks, within 1 month prior to the screening visit. 4. Patients with any other chronic pain condition that, in the investigators opinion, would interfere with the assessment of low back pain (e.g., osteoarthritis, rheumatoid arthritis, postherpetic neuralgia, pain associated with diabetic neuropathy, migraine headaches requiring opioid therapy). 5. Patients who are involved in an active workmans compensation or insurance claim or disability claim or litigation related to back pain. 6. Patients who have by history used any illicit drugs of abuse, abused opioids or exhibited drug seeking behavior within 5 years prior to the screening visit. 7. Patients who have abused prescription medication or alcohol within 5 years prior to the screening visit. 8. Patients with a positive alcohol or drugs of abuse test 9. Women who are pregnant (as indicated by a positive result in a serum pregnancy test administered at screening visit), or breast feeding, or planning to breast feed within 30 days prior to the screening visit. 10. Patients who have demonstrated allergic reactions or hypersensitivity to opioids. 11. Patients who have had no bowel movement within three days, or bowel obstruction within 60 days, prior to the screening visit. 12. Patients with pre-existing severe narrowing of the gastrointestinal tract secondary to: prior gastrointestinal surgery (e.g., vagotomy, antrectomy, pyloroplasty, gastroplasty, gastrojejunostomy) or gastrointestinal disease resulting in impaired gastrointestinal function (e.g., paralytic ileus, gastroparesis, inflammatory bowel disease, short gut syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckel diverticulum) 13. Patients who have a major psychiatric condition (e.g., schizophrenia, major depression) or who have clinically significant anxiety or depression as defined by a Hospital Anxiety and Depression Scale(HADS) score greater than 10. 14. Patients who have received monoamine oxidase (MAO) inhibitors within 14 days prior to the screening visit. 15. Patients with clinically significant abnormal laboratory results in clinical chemistry, hematology or urinalysis including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) ≥ 3.0 times the upper limit of the reference range or a serum creatinine ≥ 2.0 mg/dL at screening. 16. Patients with a serious or unstable intercurrent illness. 17. Patients with a history of uncontrolled seizure disorder. 18. Patients with increased intracranial pressure, mental clouding of unknown etiology, coma, or hypotension. 19. Patients who have severe asthma, severe chronic obstructive pulmonary disease, or any other disorder that predisposes the patient to carbon dioxide retention or respiratory depression. 20. Patients who have taken any investigational drug within 30 days prior to the screening visit or are currently enrolled in another investigational drug study. ; PRIMARY OUTCOME: Change From Baseline to Week 12 in Mean Pain Intensity; 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 - 016 - Bacterial Vaginosis; BRIEF: The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV). After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30). ; DRUG USED: VivaGel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Cell Membrane, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Starpharma Pty Ltd; CRITERIA: Key eligibility criteria: - Post-menarchal females, aged 12 years or more - Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells - Nugent score of at least 4 - Otherwise healthy, as determined by medical history, physical examination - normal Pap smear at or documented within 24 months of screening ; PRIMARY OUTCOME: Number of Women With Clinical Cure at the End of Treatment Visit (EOT); SECONDARY OUTCOME 1: Number of Women With Nugent Cure at the EOT 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 IIIa - Ellipse; BRIEF: This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes. ; 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: - Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population Exclusion Criteria: - Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigators opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics ; PRIMARY OUTCOME: Change in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DAPA-HF; BRIEF: The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed informed consent prior to any study specific procedures - Male or female, aged ≥18 years - Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months - LVEF≤40% - Elevated NT-proBNP levels - Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines - eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1) Exclusion Criteria: - Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2 - Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment - Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization - Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device - Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization - HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease - Symptomatic bradycardia or second or third degree heart block without a pacemaker - Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization ; PRIMARY OUTCOME: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.; SECONDARY OUTCOME 1: Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SHIELD-2; BRIEF: A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohns disease. Efficacy will be assessed by the Crohns Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohns Disease (WPAI-CD) and disability. ; DRUG USED: Vercirnon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Crohns Disease; TARGET: Chemokine Receptor 9 (CCR9); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects achieving clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study - Written informed consent prior to any CCX114157 specific study procedures - Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of less than 1 percent - Stable doses of Crohns disease medications - Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose taper during the study Exclusion Criteria: - If female, is pregnant, has a positive pregnancy test or is breast-feeding - Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study. - Known or suspected fixed symptomatic small bowel stricture - Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period - Current sepsis or infections requiring intravenous antibiotic therapy for greater than 2 weeks - Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities ; PRIMARY OUTCOME: Percentage of Participants in Clinical Remission (Crohns Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period; SECONDARY OUTCOME 1: Percentage of Participants in Clinical Remission (CDAI Score <150 Points) and Not Taking Corticosteroids at Both Weeks 28 and 52 of the 52-week Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VIBRANT (BRVO); BRIEF: This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO. ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: The following inclusion criteria include, but are not limited to: 1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit 2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1 3. Provide signed informed consent Exclusion Criteria: The following exclusion criteria include, but are not limited to: 1. Current bilateral manifestation of BRVO 2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye 3. Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves) 4. Uncontrolled diabetes mellitus (DM) 5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye 6. Use of periocular corticosteroids in the study eye within 3 months before day 1 7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1 8. Previous administration of systemic anti-angiogenic medications 9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye ; PRIMARY OUTCOME: Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF; SECONDARY OUTCOME 1: Change From Baseline to Week 24 in BCVA Score - LOCF[/INST]Yes</s>

<s>[INST]<<SYS>>Predict 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. Pred (Anterior, Alcon); BRIEF: The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis. ; DRUG USED: Durezol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uveitis (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - Diagnosis of endogenous anterior uveitis in at least 1 eye. - The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye. - Age 2 years or older on day of consent. - Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study. - Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye. - Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug. - History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye. - History of steroid-induced elevation of intraocular pressure. - Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye. - History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye. - Corneal abrasion or ulceration in either eye. - Pregnancy or lactation. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14; SECONDARY OUTCOME 1: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TAILOR; BRIEF: The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients. ; DRUG USED: Tarceva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Fatebenefratelli and Ophthalmic Hospital; CRITERIA: Inclusion Criteria: - Age 18 years or older - Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study - Absence of EGFR mutations of exons 19 or 21 (randomization) - Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy - One prior platinum-based at adequate doses and taxane free regimen - Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated or non-measurable disease - ECOG-PS 0-2 - ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L - Bilirubin level either normal or <1.5xULN - AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present) - Serum creatinine <1.5xULN - Effective contraception for both, male and female pts, if the risk of conception exists - Recovery from all acute toxicities of prior therapies - Provision of written informed consent to the analysis of biological markers (registration) - Provision of written informed consent to enter the randomized part of the study (randomization) Exclusion Criteria: - Prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase - Prior chemotherapy with taxanes - Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity - Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study Known severe hypersensitivity to erlotinib or any of the excipients of this product - Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel - Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ - Unable to swallow tablets - Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded) - As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease) - As judged by the investigator, any inflammatory changes of the surface of the eye - Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study ; PRIMARY OUTCOME: Overall Survival; 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 - EMERGE (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 Scale - 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 - Bacterial Vaginosis Prevention (1); BRIEF: A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV. ; DRUG USED: VivaGel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Cell Membrane, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Starpharma Pty Ltd; CRITERIA: Inclusion Criteria: - Current active episode of BV (diagnosis defined as: At least 3 of the 4 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms) - History of recurrent BV (at least 3 episodes in previous year including current episode) - Using an effective method of contraception Exclusion Criteria: - Test positive for a sexually transmitted infection - Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment - Abnormal pelvic exam, including presence of other vaginal or urinary tract infections - Pregnancy ; PRIMARY OUTCOME: Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings; SECONDARY OUTCOME 1: Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KRISTINE (Neoadjuvant); BRIEF: This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period. Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically confirmed invasive breast cancer with a primary tumor size of greater than (>) 2 cm - HER2-positive breast cancer - Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive - Stage at presentation: cT2-cT4, cN0-cN3, cM0, according to American Joint Committee on Cancer (AJCC) staging system - Known hormone receptor status of the primary tumor - Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Baseline Left Ventricular Ejection Fraction (LVEF) >/= 55 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) - Effective contraception as defined by protocol Exclusion Criteria: - Stage IV (metastatic) breast cancer - Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer - Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer - Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes - Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy - History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years - Treatment with any investigational drug within 28 days prior to randomization - Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 - Any significant concurrent medical or surgical conditions or findings that would jeopardize the participants safety or ability to complete the study - Current pregnancy or breastfeeding ; PRIMARY OUTCOME: Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples; SECONDARY OUTCOME 1: Overall Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - BRIGHTER (Branch RVO); BRIEF: This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Written informed consent must be obtained before any study assessment is performed - Diagnosis of visual impairment exclusively due to ME secondary to BRVO - BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS) Exclusion Criteria: - Pregnant or nursing (lactating) women - Stroke or myocardial infarction less than 3 months before Screening - Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline. - Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye - Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye - Neovascularization of the iris or neovascular glaucoma in the study eye - Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline - Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye - Focal or grid laser photocoagulation within 4 months before Baseline in the study eye - Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye - Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye ; PRIMARY OUTCOME: Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO); SECONDARY OUTCOME 1: The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 332; BRIEF: This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic drugs (AED). ; DRUG USED: Fycompa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: AMPA-type glutamate receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion: 1. Clinical diagnosis of PGTC seizures (with or without other subtypes of primary generalized seizures) and experiencing greater than or equal to 3 PGTC seizures during the 8-week period prior to randomization 2. Have had a routine electroencephalogram (EEG) prior to or during the Baseline Period with electroencephalographic features consistent with primary generalized epilepsy; other concomitant anomaly should be explained by adequate past medical history 3. On a fixed dose of one to a maximum of three concomitant antiepileptic drugs (AEDs) for a minimum of 30 days prior to Baseline; only one inducer AED (i.e., carbamazepine, oxcarbazepine, or phenytoin) out of the maximum of two AEDs will be allowed 4. A vagal nerve stimulator (VNS) will be allowed, but it must have been implanted greater than or equal to 5 months prior to Baseline (stimulator parameters cannot be changed for 30 days prior to Baseline and for the duration of the study). 5. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years (for adults) and 5 years (for adolescents) that ruled out a progressive cause of epilepsy 6. A ketogenic diet will be allowed as long as the participant has been on this diet for 5 weeks prior to randomization Exclusion: 1. A history of status epilepticus that required hospitalization within 12 months prior to Baseline 2. Seizure clusters where individual seizures cannot be counted 3. A history of psychogenic seizures 4. Concomitant diagnosis of Partial Onset Seizures (POS) 5. Progressive neurological disease 6. Clinical diagnosis of Lennox-Gastaut syndrome 7. If felbamate is used as a concomitant AED, participants must be on felbamate for at least 2 years, with a stable dose for 60 days prior to Baseline. They must not have a history of white blood cell (WBC) count below less than or equal to 2500/microL (2.50 1E+09/L), platelets less than 100,000/microL, liver function tests (LFTs) greater than 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. 8. Concomitant use of vigabatrin: Participants who took vigabatrin in the past must be discontinued for approximately 5 months prior to Baseline, and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test 9. Concomitant use of barbiturates (except for seizure control indication) within 30 days prior to Baseline 10. Use of intermittent rescue benzodiazepines (i.e., one to two doses over a 24-hour period considered one-time rescue) two or more times within the 30 days prior to Baseline ; PRIMARY OUTCOME: Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study); SECONDARY OUTCOME 1: Median Percent Change in All Seizure Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ROV-BEM-2006-01; BRIEF: Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes and often causes lower-extremity amputation. The aim of this study is to evaluate the effect of bemiparin as treatment of diabetic foot ulcers. ; DRUG USED: Hibor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Foot and Other Ulcers; TARGET: HB-EGF (heparin-binding epidermal growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Rovi Pharmaceuticals Laboratories; CRITERIA: Inclusion Criteria: - Patients over 18 years old who have given their informed consent to participate in the study. - Patients with type I or II Diabetes Mellitus (ADA Criteria). - Presence of chronic neuropathic inframalleolar diabetic foot ulcer (starting at least 2 months before), grade I or II on Wagner Classification, without significant improvement (reduction of ulcer area > or = 25%) within the past 15 days prior to inclusion. - Ulcer size equal or bigger than 0.64 cm2 using the following formula: [Major axis] x [Minor axis] - Ankle-brachial index (ABI) > or = 0,7 Exclusion Criteria: - Patients with clinical symptoms of limb-threatening or life-threatening infection - Presence of bone exposure at the bottom of the ulcer and/or bone palpation by catheter and/or presence of radiological signs of pathological fractures and/or bone sequesters - Ankle-brachial index (ABI) <0,7 - Subjects with arterial calcification (ABI > 1,3) with negative tibial and foot pulse that for any cause the Toe/Arm index (T/A) cannot be measured by plethysmography (photoplethysmography or strain-gauge) - Subjects with arterial calcification (ABI > 1,3) with negative tibial and foot pulse and with T/A index < 0,55 measured by plethysmography (photoplethysmography or strain-gauge) - Patients with hematological disorders, organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms), severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg). - Patients with severe renal failure (creatinine clearance <30 ml/min) or hepatic insufficiency (AST and/or ALT values >5 times the normal value established by the reference ranges of the local hospital laboratory). - Patients with connective tissue disease - Acute bacterial endocarditis or slow endocarditis. - Patients with antithrombin deficit and C and S protein deficit. - Patients with HbA1C > 12%. - Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study. - Known hypersensitivity to LMWH, heparin or substances of porcine origin. - Patients with a history of heparin-induced thrombocytopenia. - Patients on treatment with anticoagulant therapy at inclusion time or in the past 15 days. - Patients on treatment with pentoxifiline at inclusion time or in the past 30 days. - Patients on treatment with systemic corticosteroid or immunosuppressive therapy at inclusion time or in the past 3 months. - Patients on treatment with beclapermin at inclusion time or in the past 15 days. - Patients that have suffered a revascularization or endovascular surgery two months prior to inclusion - Patients with a life expectancy less than 6 months. - Patients that cannot complete the scheduled follow-up visits or are not able to complete the study period. - Patients who are participating in another clinical trial or have done it in the past 30 days. ; PRIMARY OUTCOME: total healing with intact skin or a significant improvement defined as a reduction of ulcer area > or = 50% or one degree reduction on Wagner Classification.; SECONDARY OUTCOME 1: incidence of major bleeding and the incidence of adverse events.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Pediatric; BRIEF: The primary purpose of your childs participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it. ; DRUG USED: Edivoxetine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD based on Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL) prior to randomization. - Patients must have an Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score at least 1.5 standard deviations above the age/gender norm prior to randomization. They must have a Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) score greater than or equal to 4 at both the patients screening visit, prior to randomization. - Patients must have laboratory results; showing no clinically significant abnormalities. - Patients must be of normal intelligence, as assessed by the investigator. - Patients/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venous punctures and examinations required by the protocol. - Patients of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test. Exclusion Criteria: - Patients who weigh less than 18 kg or greater than 75 kg at screening and at randomization. - Female patients who are pregnant or who are breast-feeding. Patients who have a history of Bipolar I/ II, psychosis, or pervasive developmental disorder. - Patients who have current motor tics or a diagnosis of Tourettes Syndrome. - Patients with marked anxiety, tension, and agitation sufficient, to contraindicate treatment with extended-release methylphenidate. - Patients with a history of any seizure disorder, known electroencephalographic (EEG) abnormalities in the absence of seizures. - If the electrocardiogram (ECG) assessed at screening/prior to randomization shows an abnormality meeting one or more of the absolute exclusion criteria listed in the Pediatric ECG Alert Criteria must be excluded from the study. - Patients who, in the opinion of the investigator, are at serious suicidal risk. - Patients with a history of severe allergies to more than one class of medications, multiple adverse drug reactions, or known hypersensitivity to extended-release methylphenidate. - Patients with a history of alcohol or drug abuse within the past 3 months prior to, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse. - Patients who screen positive for drugs of abuse not prescribed by a physician cannot participate. Drug screen may be repeated at the discretion of the investigator, and the patient may be allowed to enter the study if the repeat screen is negative. All patients must have a negative drug screen before enrollment in the study. - Patients who have a medical condition that would increase sympathetic nervous system activity markedly, or who are taking a medication on a daily basis that has sympathomimetic activity are excluded. Such medications can be taken on an as-needed basis. - Patients with problems that would be exacerbated by increased norepinephrine tone, including a history of cardiovascular disease, thyroid dysfunction, glaucoma, urinary retention, or severe gastrointestinal narrowing. - Patients who, at any time during the study, are likely to need psychotropic medications apart from the drugs under study. - Patients who, at any time during the study, are likely to begin structured psychotherapy aimed at ADHD symptoms are excluded. Psychotherapy initiated at least 1 month prior to screening is acceptable. - Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior to randomization. - Patients with current or past history of clinically significant hypertension. - Patients who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug, or concurrently enrolled in any other type of medical research. - Patients who have participated in a prior study of LY2216684. ; PRIMARY OUTCOME: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8; SECONDARY OUTCOME 1: Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RIVER-PCI; BRIEF: This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. ; DRUG USED: Ranexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Coronary Artery Disease; TARGET: Late Sodium Current; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: 1. Written informed consent 2. Males and females aged 18 years and older 3. History of chronic angina defined as at least 2 episodes of anginal pain or discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which occurred on at least 2 separate days and at least 14 days prior to PCI (in the case of staged PCI procedures, at least 14 days prior to the first PCI in the series). Participants may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as any time prior to Randomization. 4. PCI for any indication (ACS or non-ACS). For the purposes of stratification at randomization, ACS will be defined as hospitalization for anginal pain or discomfort within the previous 24 hours to their hospitalization with any one (or more) of the following criteria: i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with myocardial infarction (MI), as reported by local laboratory and measured prior to index PCI ii. Electrocardiographic changes (including transient changes) comprising new or presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle Branch Block 5. Randomization within 14 days post-PCI. In the case of staged PCI procedures, randomization has to occur within 14 days of the last PCI in the series. Participants may be randomized starting on the day of PCI and anytime during the following 14 days. PCI is defined as an attempt to cross the lesion with a wire with the intention of performing revascularization. 6. Post-PCI (post the last PCI for staged procedures) evidence of incomplete revascularization defined as the presence of one or more visually estimated ≥ 50% stenoses in one or more coronary arteries with reference vessel diameter of at least 2.0 mm, whether in the target vessel or in a non-target vessel regardless of the presence or absence of coronary collaterals. In the case of a participant post-coronary artery bypass grafting (CABG), incomplete revascularization is defined as the presence of one or more visually estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft supplying an otherwise unrevascularized myocardial territory. 7. Clinically stable post-PCI. Participants randomized in-hospital on day of planned discharge or in clinic are considered stable. Participants randomized in-hospital prior to day of planned discharge must meet all of the following criteria: i. CK-MB < 3 times the upper limit of normal (ULN) at least 3 hours post-PCI, or if ≥ 3 times the ULN with evidence of decreasing CK-MB (decreased by at least 20% from the prior measurement) as reported by local laboratory. If CK-MB is not available, a participant must have evidence of normal or decreasing troponin levels (by at least 20% from the prior measurement) at least 3 hours post-PCI, as reported by local laboratory. ii. Systolic blood pressure ≥ 90 mm Hg and not receiving pressors or inotropes iii. No current requirement for an intra-aortic balloon pump (IABP) or any left ventricular assist device iv. No current requirement for intravenous (IV) nitroglycerin 8. Ability and willingness to comply with all study procedures during the course of the study 9. Females of childbearing potential must have a negative pregnancy test at Screening (unless surgically sterile or post-menopausal) and must agree to use highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug. Exclusion Criteria: 1. Any future planned revascularization (including staged procedures) or possible planned revascularization (ie, planned stress test to assess the imminent need for additional revascularization). Future planned stress tests for purposes of monitoring are permitted but strongly discouraged. Participants may be enrolled after the last PCI in the staged series or once a decision is made not to perform a follow up PCI, as long as Randomization occurs within 14 days from the last PCI. If a participant has had a stress test post-PCI and prior to Randomization and no further intervention is planned, the participant may be enrolled within 14 days from the last PCI. 2. Unrevascularized left main coronary artery stenosis ≥ 50%. Participants with a history of CABG to the left coronary system will be considered to have a revascularized left main if at least one graft is patent. 3. Major complication during or after the index PCI (in the case of staged PCI, the last in the series) including: i. Major bleeding (TIMI Bleeding classification or any bleeding requiring blood transfusion of ≥ 2 units of red blood cells) ii. Coronary perforation requiring treatment iii. Procedural complication requiring surgery (including CABG or peripheral vascular surgery) 4. Stroke within 90 days prior to Randomization, or any history of stroke with permanent major neurologic disability (eg, aphasia or significant motor dysfunction) 5. Cardiogenic shock within 90 days prior to Randomization (transient decreases in blood pressure without clinical sequelae are not considered to be cardiogenic shock) 6. New York Heart Association (NYHA) Class III or IV heart failure 7. Severe renal insufficiency as assessed by an estimated glomerular filtration rate < 30 mL/min/1.73m2 using the 4 variable modification of diet in renal disease (MDRD) equation per local laboratory (based on the last available measurement prior to Randomization, collected within 1 month prior to the index PCI [in the case of staged PCI, the last in the series]) 8. Liver cirrhosis 9. Use of Class Ia, Ic, or Class III antiarrhythmics, except for amiodarone 10. Current treatment with strong inhibitors of CYP3A 11. Current treatment with CYP3A4 inducers or P-gp inducers 12. Participants taking > 20 mg simvastatin daily or > 40 mg lovastatin daily who cannot reduce the dose to 20 mg once daily for simvastatin or 40 mg once daily for lovastatin, or who cannot switch to another statin 13. Participants taking greater than a total of 1000 mg daily of metformin who cannot reduce the dose to a maximum total of 1000 mg daily (additional anti-diabetic medications may be added as clinically indicated to allow participants to decrease their metformin dose and maintain glycemic control) 14. Previous treatment with ranolazine for > 7 consecutive days within 30 days prior to Randomization, or known hypersensitivity or intolerance to ranolazine or to any of the excipients 15. Participation in another investigational drug or investigational device study within 30 days prior to Randomization (participation in registries is allowed) 16. Women who are pregnant or breast feeding 17. Non-coronary artery disease comorbid conditions (eg, advanced malignancy, severe aortic stenosis) which are likely to result in death within 2 years of Randomization 18. Any condition that in the opinion of the investigator would preclude compliance with the study protocol ; PRIMARY OUTCOME: Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization; SECONDARY OUTCOME 1: Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death[/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 - Neonates; BRIEF: This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn. ; DRUG USED: Revatio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: Pfizers Upjohn has merged with Mylan to form Viatris Inc.; CRITERIA: Inclusion Criteria: - Neonates with persistent pulmonary hypertension of the newborn - Age <=96 hours and >=34 weeks gestational age - Oxygenation Index >15 and <60 - Concurrent treatment with inhaled nitric oxide and >=50% oxygen Exclusion Criteria: - Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation - Expected duration of mechanical ventilation <48 hours - Profound hypoxemia - Life-threatening or lethal congenital anomaly ; PRIMARY OUTCOME: Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure; SECONDARY OUTCOME 1: Time From Initiation of Intravenous (IV) Study Drug to Final Weaning of Mechanical Ventilation[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RADIANT; BRIEF: This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients. ; DRUG USED: Tarceva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: OSI Pharmaceuticals; CRITERIA: Inclusion Criteria: - Primary tissue from patients surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests - Patients may have up to 4 cycles of chemotherapy after surgery - Complete removal of the tumor by surgery - Able to start drug under the following timelines: - 6 months from the day of surgery for patients who get chemotherapy - 3 months from the day of surgery for those who do not get chemotherapy - Confirmed diagnosis of Stage IB-IIIA NSCLC - Patients must be accessible for follow-up visits Exclusion Criteria: - History of prior radiotherapy for NSCLC either before or after surgery - History of heart disease or uncontrolled heart arrhythmias within the previous year - History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug - History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years - Patients who have received chemotherapy for NSCLC before surgery - Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible. ; PRIMARY OUTCOME: Disease Free Survival (DFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HARMONY; BRIEF: The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment. ; DRUG USED: Nuplazid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dementia; TARGET: Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: ACADIA Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Meets criteria for All-cause Dementia according to NIA-AA guidelines 2. Meets clinical criteria for one of the following disorders: Dementia associated with Parkinsons disease, Dementia with Lewy bodies, Possible or probable Alzheimers disease, Frontotemporal degeneration spectrum disorders, Vascular dementia 3. Has an MMSE score ≥6 and ≤24 4. Has had psychotic symptoms for at least 2 months 5. Must be on a stable does of cholinesterase inhibitor or memantine, if applicable 6. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception for the duration of the study Exclusion Criteria: 1. Has psychotic symptoms that are primarily attributable to a condition other than dementia 2. Has had a recent major depressive episode 3. Has experienced suicidal ideation or behavior within 3 months prior to study enrollment 4. Has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition 5. Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke 6. Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or unexplained syncope 7. Has any of the following: greater than New York Heart Association (NYHA) Class 2 congestive heart failure, Grade 2 or greater angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an arrhythmia, an implantable cardiac defibrillator 8. Had a myocardial infarction within the last 6 months 9. Has a known personal or family history or symptoms of long QT syndrome 10. Has a significant unstable medical condition that could interfere with subjects ability to complete the study or comply with study procedures 11. Requires treatment with a medication or other substance that is prohibited by the protocol Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met. ; PRIMARY OUTCOME: Time From Randomization to Relapse in the Double-blind (DB) Period; SECONDARY OUTCOME 1: Time From Randomization to Discontinuation From the DB Period for Any Reason[/INST]Yes</s>

<s>[INST]<<SYS>>Predict 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 3202, N24HSWD) - Safety; BRIEF: The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with 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: - Ability and acceptance to provide informed consent; - No perception of light; - History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire - Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study; Exclusion Criteria: - Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment; - Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable; - 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 in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures; - History of intolerance and/or hypersensitivity to melatonin or melatonin agonists; - Smoke more than 10 cigarettes/day - Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial; - Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever was longer) of Baseline; - Use of melatonin or melatonin agonist; ; PRIMARY OUTCOME: Safety Evaluations; SECONDARY OUTCOME 1: Patient Global Impression of Change (PGI-C)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MOTION EXT; BRIEF: Parkinsons disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, extension trial, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinsons Disease. The principal objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation. ; DRUG USED: Xadago; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Calcium Channel, Dopamine Reuptake, Monoamine oxidase B (MAO-B), Sodium Channels; THERAPY: Combination; LEAD SPONSOR: Newron Pharmaceuticals SPA; CRITERIA: Inclusion Criteria: 1. The subject completed 24 weeks of Trial 27918. 2. The subject successfully completed all trial requirements in Trial 27918. 3. If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as: All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive. 4. Subject is willing and able to participate in the trial and has provided written, informed consent Exclusion Criteria: 1. If female, the subject is pregnant or lactating. 2. The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigators opinion. 3. The subject has shown clinically significant deterioration during participation in Trial 27918. 4. Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication. 5. The investigator deems it is not in the subjects best interest to participate to trial 27938 6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. ; PRIMARY OUTCOME: Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy; SECONDARY OUTCOME 1: Proportion of subjects requiring intervention[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Europe; BRIEF: The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer. ; DRUG USED: TG4010; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IL-2 (Interleukin-2), Immune System, Mucin 1 (MUC-1); THERAPY: Combination; LEAD SPONSOR: Transgene; CRITERIA: Inclusion Criteria: - Histologically confirmed non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma); - Histological documentation of MUC1 antigen expression on the primary tumor or on metastasis, as defined by a positive staining by immuno-histo-chemistry in at least 25% of the tumor cells in the conditions described in the technical documentation of the monoclonal antibody; - Patients will have stage IIIb wet (with pleural or pericardial effusion) or IV disease, with no prior systemic therapy for advanced disease except for adjuvant treatment. Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted; - At least one measurable lesion by Computed Tomography (CT-scanner) according to WHO criteria (lesion accurately measured in two dimensions with longest diameter equal or greater to 10 mm with spiral CT scan); - Adequate hematological, hepatic, and renal function: - Hemoglobin >= 10.0 g/dL; WBC >= 3.0x10e9/L including neutrophils >= 1.5x10e9/L and total lymphocytes count >= 0.5x10e9/L; platelets count >= 100x10e9/L; - Bilirubin =< 2x the upper limit of normal and serum transaminases =< 3x the upper limit of normal; - Glomerular Filtration Rate higher than 60 ml/mn according to Cockcroft formula; - Performance status 0 or 1 on the ECOG scale (Appendix 2); - Minimum estimated life expectancy of 4 months; - Written informed consent from patient. Exclusion Criteria: - Concomitant brain metastases. If previous brain metastases were treated, the absence of evolution is to be demonstrated by the MRI or scanner performed at baseline; - Prior history of other malignancy except basal cell carcinoma and intra-epithelial cervical cancer or other cancer with complete response since at least 5 years; - History of any form of systemic therapy for advanced non-small cell cancer of the lung except for (neo)adjuvant treatment; - Previous (within 4 weeks prior to day 1) or concomitant long term treatment with systemic steroids, immunosuppressive / immunomodulating drugs (e.g. Cyclosporine, corticoïds); - Positive serology for HIV or HCV; positive antigens for hepatitis B; - Serious concomitant medical disorder; - Major surgery within 4 weeks prior to day 1; - Patient with an organ allograft; - Allergy to eggs; - Participation in another experimental protocol during the study period, or within 4 weeks prior to day 1; - Pregnancy at the entry or women who are breast feeding; - Patient without adequate protection against pregnancy during the conduct of the study and for 3 months after the last injection of TG4010 and/or chemotherapy; - History of substance abuse; - Patient unable or unwilling to comply with the protocol requirements. ; PRIMARY OUTCOME: Progression free survival at 6 months; SECONDARY OUTCOME 1: Response Rate according to WHO criteria[/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 - TREND; BRIEF: This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Male or female patients, ≥50 years of age with signed informed consent before study procedures - Visual impairment predominantly due to nAMD. - Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography - Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT - BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320) Key Exclusion Criteria: - Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. - Stroke or myocardial infarction within 3 months prior to Screening. - Any active periocular or ocular infection or inflammation in both eyes. - Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity. - Presence of amblyopia or amaurosis in the fellow eye. - History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye. - History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening. - Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. ; PRIMARY OUTCOME: Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12; SECONDARY OUTCOME 1: Number of Visits Scheduled[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pulmonary Function (115805); BRIEF: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Signed and dated written informed consent - Male or females ≥ 40 years of age - Females must be post-menopausal or using a highly effective method for avoidance of pregnancy - Established clinical history of COPD by ATS/ERS definition - Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III) - Former or current smoker ≥10 pack years - A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following: - Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD) - Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD) - Previous stroke - Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional) - Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary) OR - Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker): - Current diagnosis of hypertension - Current diagnosis of hypercholesterolemia - Diabetes mellitus treated with pharmacotherapy Exclusion Criteria: - Current diagnosis of asthma - Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases - Lung volume reduction surgery within previous 12 months - Clinically significant abnormalities not due to COPD by chest X-ray or CT scan - Hospitalized for poorly controlled COPD within 12 weeks of Screening - Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician - Lower respiratory infection requiring antibiotics 6 weeks prior to Screening - A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period - An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization - An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization - An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects) - Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities - Carcinoma not in complete remission for at least 5 years - History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subjects participation will also be excluded - Known/suspected history of alcohol or drug abuse in the last 2 years - Women who are pregnant or lactating or plan to become pregnant - Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit - Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications) - Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day - Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study - Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments - Non-compliance or inability to comply with study procedures or scheduled visits - History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study - Affiliation with investigator site - Women who are pregnant or lactating or are planning on becoming pregnant during the study ; PRIMARY OUTCOME: Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84; SECONDARY OUTCOME 1: Time to Onset on Treatment Day 1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BET vs. BBT; BRIEF: The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control. ; DRUG USED: Byetta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start. - Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start: - Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or - Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start. - Have an HbA1C > 7.0% and ≤ 10.0%. - Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2. Exclusion Criteria: - Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label. - Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications). - Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week. - Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start. - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. - Have previously completed or been withdrawn from this study after enrollment. ; PRIMARY OUTCOME: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30; SECONDARY OUTCOME 1: Percentage of Participants Achieving HbA1C < 7.0%[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PCR3001 (w/Prednisone); BRIEF: The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC). ; DRUG USED: Zytiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Cytochrome P450c17; THERAPY: Combination; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Confirmed prostate cancer - Prostate cancer progression after previous chemotherapy as assessed by the investigator - Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel) - Serum testosterone of less than 50ng/dL (less than 2.0 nM) - Eastern Cooperative Oncology Group (ECOG) performance status of <=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities) Exclusion Criteria: - Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection) - Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests - Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg) - History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction - Known brain metastasis (ie, spread of cancer to the brain) ; 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 - PINETREE (Outpatient Population); BRIEF: The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting. ; DRUG USED: Veklury; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: RNA polymerase, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures - Either: - Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease) - Or aged ≥ 60 years - Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening - Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization - Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care) Key Exclusion Criteria: - Participation in any other clinical trial of an experimental treatment and prevention for COVID-19 - Prior hospitalization for COVID-19 - Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine - Requiring oxygen supplementation Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28; SECONDARY OUTCOME 1: Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Violet PETAL; BRIEF: A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants. ; DRUG USED: Orilissa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Endometriosis; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: 1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent. 2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening. 3. Agrees to use required birth control methods during the entire length of participation in the study. 4. Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1 Exclusion Criteria: 1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period. 2. Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary). 3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain. 4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy. 5. Subject has a history of osteoporosis or other metabolic bone disease. 6. Subject has a current history of undiagnosed abnormal genital bleeding. ; PRIMARY OUTCOME: Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS); SECONDARY OUTCOME 1: Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Bunionectomy Surgery; BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first metatarsal bunionectomy with osteotomy and internal fixation. ; DRUG USED: ELI-201; DRUG CLASS: Non-NME; INDICATION: Pain Indications; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Elite Laboratories, Inc; CRITERIA: Inclusion Criteria: 1. Complete the informed consent process as documented by a signed informed consent form (ICF). 2. Be in generally good health and classified as either PS-1 or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System. 3. Be male or female, age 18 to 75 years, inclusively at the time of screening. 4. Be scheduled for a primary, unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation (with no collateral procedures) 5. Female subjects are eligible only if all of the following apply: - Not pregnant (subjects of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening and a negative urine pregnancy test before surgery); - Not lactating; - Not planning to become pregnant within the duration of study; - Surgically sterile (bilateral tubal ligation or hysterectomy), or at least two years postmenopausal, or is practicing an acceptable form of birth control (defined as the use of an intrauterine device [IUD], a barrier method with spermicide, condoms, any form of hormonal contraceptives, partner with a vasectomy (surgery at least 6 weeks prior to start of surgery) or abstinence ) for at least 3 months prior to the screening visit and agrees to continue acceptable methods of contraception until one week following the last dose of ELI-200. 6. Be willing to complete the pain assessments and return to clinic as scheduled. 7. Subjects must experience postoperative pain (Day 1) that is at least moderate as measured by a NRS score ≥ 4 on a 0-10 NRS, less than 9 hours after discontinuing the nerve block. Exclusion Criteria: 1. Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study. 2. Have a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator. 3. Have had any type of gastric bypass surgery or have a gastric band. Have previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus. 4. Have a history of any medical condition or surgical procedure that would alter the absorption, distribution, metabolism or excretion of oxycodone or any opioid including but not limited to severe chronic diarrhea, chronic constipation, irritable bowel syndrome, or bowel resection. 5. Have a history of severe bronchial asthma, hypercarbia, or hypoxia (oxygen partial pressure [PO2] <92%) or any respiratory condition that, in the opinion of the investigator, makes the subject unsuitable for the study. Mild episodic asthma or exercised induced asthma will be allowed. 6. Have, in the opinion of the investigator, a clinically significant abnormality on their clinical laboratory values (urinalysis, hematology and chemistry) at screening. 7. Have glycosylated hemoglobin (2c) > 7%. 8. Have Addisons disease, benign prostatic hyperplasia, or kidney disease or other conditions as outlined in the Investigators Brochure or the Percocet and Oxycontin Package Inserts that are contraindicated for use. 9. Have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to Day -1 . 10. Have made a plasma donation within 7 days prior to Day -1. 11. Have a known allergy or hypersensitivity to any opioid analgesics, naltrexone, anesthetics (eg, propofol), acetaminophen, NSAIDs (eg, ibuprofen or naproxen, ketorolac) or any of the excipients 12. Have a known allergy or hypersensitivity to ropivacaine, Mepivacaine, Lidocaine or any related drug. 13. Have a history of significant intolerance (in the opinion of the investigator) or allergic hypersensitivity reaction to opioid use. 14. Not be willing to discontinue the prohibited medications, within the allotted time before surgery and throughout the duration of their participation in the study. 15. Have a history of substance(more than recreational use) or alcohol (more than 14 drinks in a week) abuse within 2 years before screening. 16. Have a positive drug screen or alcohol screen result. 17. Use of anti-coagulant agents (eg, Coumadin, heparin, etc) 18. Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit. 19. Have an active malignancy of any type, or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin). 20. Have dysphagia and/or cannot swallow study medication whole. 21. Use concurrent therapy that could interfere with the evaluation of efficacy or safety parameters in the opinion of the investigator. (eg, any drugs, in the investigators opinion, that may exert significant analgesic properties or act synergistically with oxycodone, morphine, ketorolac, acetaminophen or ibuprofen). 22. Have a history of seizures or history of serious head injury. 23. Must not be a member of a vulnerable population as defined by the Code of Federal Regulations Title 45, Part 46, Section 46.111(b), including but not limited to employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the Sponsor, or of the Clinical Research Organization. 24. Have previously participated in a clinical trial using (Oxycodone Hydrochloride Naltrexone Hydrochloride, 1.5 mg or Oxycodone Hydrochloride , Naltrexone Hydrochloride 3.0 mg ). 25. Have a history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study. Institutionalized subjects will not be eligible for participation. 26. Been exposed to any investigational agent within 30 days or five half-lives (whichever is longer) prior to check-in for Day 1, Period 1, or is scheduled to receive an investigational device or drug (other than test product) during the course of this study. Day -1 Exclusions: 1. Have taken any of the following drugs within the indicated times before surgery: - over-the-counter or prescription non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen [Advil®, Motrin®]), acetaminophen, or naproxen sodium (Anaprox®, Aleve®) within 24 hours; a daily dose of 81 mg of aspirin will be allowed (higher doses must be lowered to 81 mg a day by 72 hours prior to surgery). - naproxen sodium sustained-release (Naprelan®) within 72 hours - C-2 inhibitors (such as piroxicam or indomethacin) within 5 days - oxycodone-containing drugs and other analgesic drugs containing opioids within the past 14 days - immediate-release sedating antihistamines, tranquilizers, or hypnotics within at least 6 hours, or long-acting or sustained-released forms of these drugs within at least 7 days of Day -1 Day 1 Exclusion: 1. Have surgical complications (Day -1) that could compromise the safety of the subject or confound the results of the trial or any other reason that, in the opinion of the investigator, makes the subject unsuitable to participate. ; PRIMARY OUTCOME: Pain Intensity Measure for Oxycodone/Naltrexone (a); SECONDARY OUTCOME 1: Pain Intensity Measure for Oxycodone/Naltrexone (b)[/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 - CONCERTO-2 (TE, Japan, w/ PEG/RBV); BRIEF: The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy in Japan. ; DRUG USED: Olysio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Janssen Pharmaceutical K.K.; CRITERIA: Inclusion Criteria: - Participant must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10 IU/mL - Participant failed to respond to previous IFN-based therapy - Participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication. Exclusion Criteria: - Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV) - Diagnosed with hepatic cirrhosis or hepatic failure - A medical condition which is a contraindication to PegIFNα-2a or ribavirin therapy - History of, or any current medical condition which could impact the safety of the patient in the study ; PRIMARY OUTCOME: The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12); SECONDARY OUTCOME 1: The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 020 (Belgium, Germany, Netherlands) ; BRIEF: Primary objective To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men ; DRUG USED: Gardasil 9; DRUG CLASS: Vaccine; INDICATION: Human papillomavirus (HPV) Prevention (Antiviral, Vaccines); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment. - Subject is a man who has had no more than 5 lifetime female sexual partners. - Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results. - Subject, or subjects parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent. Exclusion Criteria: - Subject who has had sex with a male partner. - Subject has a history of HPV-related external genital lesions or HPV-related anal lesions - Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE - Subject has a history of severe allergic reaction that required medical intervention. - Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. - Subject is concurrently enrolled in clinical studies of investigational medicinal products. - Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study. - Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. - Subject has had a splenectomy. - Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies, intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response. - Subject has received any immune globulin product or blood-derived product within the 6 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study. - Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination. - Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo. - Subject has had a fever within the 24-hour period prior to the Day 1 vaccination. - Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subjects participation for the full duration of the study, such that it is not in the best interest of the subject to participate. - Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. - Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use. - Subject, or subjects parent or guardian, is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial. ; PRIMARY OUTCOME: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18; SECONDARY OUTCOME 1: GMTs to HPV Types 31/33/45/52/58[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - WC28325; BRIEF: This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks. ; DRUG USED: Aleglitazar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: PPAR alpha, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/=18 years of age - Diagnosis of diabetes mellitus, type 2 - Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening - HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit - Fasting plasma glucose </=240 mg/dL at pre-randomization visit - Agreement to maintain diet and exercise habits during the study Exclusion Criteria: - Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months - Any previous treatment with thiazolidinedione or a dual PPAR agonist - Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin) - Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening - Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening ; PRIMARY OUTCOME: Change from baseline in hemoglobin HbA1c; SECONDARY OUTCOME 1: Change in lipid profile[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BR vs. R-CHOP (StiL); BRIEF: The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS). ; DRUG USED: Treanda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: DNA, p53; THERAPY: Combination; LEAD SPONSOR: University of Giessen; CRITERIA: Inclusion Criteria: - Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities: - Follicular lymphoma grade 1 and 2 - Immunocytoma and lymphoplasmocytic lymphoma - Marginal zone lymphoma, nodal and generalised - Mantle cell lymphoma - lymphocytic lymphoma (CLL without leucaemic characteristics) - non-specified/classified lymphomas of low malignancy - No prior therapy with cytotoxics,interferon or monoclonal antibodies - Need for therapy, except mantle cell lymphomas - Stadium III or IV - Written informed consent - Performance status WHO 0-2 - Histology not older than 6 months Exclusion Criteria: - Patients not establishing all above mentioned prerequisites - Option of a primary, potential curative radiation therapy - Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions - Comorbidities excluding a study conform therapy: - heart attack during the last 6 months - severe, medicinal not adjustable hypertonia - severe functional defects of the heart (NYHA III or IV) - lung (WHO grade III or IV), liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma. ; PRIMARY OUTCOME: Progression free survival; SECONDARY OUTCOME 1: Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Ten 03; BRIEF: To primary efficacy variable is to assess the presence or absence of excessive blood loss during and after surgery. The secondary efficacy endpoints are as follows: 1. A subjective overall assessment by the investigator of FACTOR X in the control of bleeding during surgery. 2. The incidence of bleeding episodes during treatment with FACTOR X while the subject is at risk of post-operative bleeding, including location and duration. 3. Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion. 4. Assessment of FX:C and FX:Ag levels on each day post-surgery. 5. Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C (IU/kg body weight) administered to each subject to maintain haemostasis. 6. Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to each subject to maintain haemostasis. 7. Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered daily (day of surgery and each post-operative day) to maintain haemostasis. ; DRUG USED: Coagadex; DRUG CLASS: Biologic; INDICATION: Factor X (Stuart-Prower Factor) Deficiency; TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bio Products Laboratory; CRITERIA: Inclusion Criteria: - Subjects who are at least 12 years of age at date of written informed consent/assent. - Subjects who have given written informed consent or, for subjects aged 12-17 years (inclusive), have given written assent and whose parent/guardian has given written informed consent. - Subjects with hereditary mild to severe Factor X deficiency (<20% basal FX activity), including previously untreated subjects OR those currently treated with Fresh Frozen Plasma (FFP), Prothrombin Complex Concentrate (PCC) or factor IX/X concentrate by prophylaxis or on demand. - Subjects who are to undergo surgery in which the investigator believes a factor X concentrate will be required due to a prior history of unusual bleeding either spontaneously or after surgery or trauma in the absence of treatment with a factor X containing product. - Pregnant subjects undergoing obstetric delivery (including Caesarean surgery and vaginal delivery) may enter the study. Female subjects of child-bearing potential must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female subject is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study. Exclusion Criteria: - Subjects who are required or expected to take other factor X containing medications during or after surgery. - Subjects with a history of inhibitor development to FX or a detectable inhibitor to FX (≥0.6 BU) on the Nijmegen-Bethesda assay at screening. Obtaining a FX inhibitor result at screening is not mandatory if the subject is to undergo emergency surgery and the local laboratory is unable to perform the analyses prior to the surgical procedure. - Subjects with thrombocytopenia (platelets < 50 x 109/L). - Subjects who have clinically significant renal disease (creatinine >200µmol/L). - Subjects who have clinically significant liver disease (ALT levels greater than three times the upper limit of normal). - Subjects known to have other coagulopathy or thrombophilia. - Subjects who are currently participating or have participated in another trial within the last 30 days, with the exception of the BPL Factor X PK study (protocol number Ten01). - Female subjects who are lactating. - Subjects who have known or suspected hypersensitivity to the investigational medicinal product or its excipients. - Subjects known to have abused chemicals or drugs within the past 12 months. - Subjects with a history of unreliability or non-cooperation. ; PRIMARY OUTCOME: Clinical Estimation of Volume of Blood Loss During Surgery; SECONDARY OUTCOME 1: Incremental Recovery After Bolus Dose of FACTOR X[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUSTAIN; BRIEF: To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor ; DRUG USED: Tembexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cytomegalovirus (CMV) Infection (Antiviral); TARGET: DNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Chimerix; CRITERIA: Inclusion Criteria Subjects must have met all of the following criteria, as applicable, to be eligible to participate in this study: 1. Were male or female kidney transplant recipients who were ≥18 years of age (subject to local law/practice for clinical trial participation) and ≤14 days following their first or second renal allograft. 2. Were at high risk of cytomegalovirus (CMV) infection defined as CMV-seronegative recipients who have received an allograft from a CMV-seropositive donor. 3. Had an estimated glomerular filtration rate of >10 mL/min (Cockcraft-Gault equation) at screening based on local laboratory results. 4. Were CMV viremia negative (i.e., not detected) as measured by the desginated central virology laboratory using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test no more than 5 days prior to subject randomization, and at all prior assessments performed since transplant under local standard of care. 5. Were able to ingest, absorb, and tolerate tablets. 6. If male, was willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 52. 7. If female of childbearing potential, i.e., not post menopausal or surgically sterile, was willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 52. 8. Were willing and able to provide informed consent. 9. Were willing and able to participate in all required study activities for the entire duration of the study (i.e., through Week 52). Exclusion Criteria Subjects who met any of the following criteria were not eligible to participate in this study: 1. Weighed ≤50 kg (110 lbs) or ≥120 kg (265 lbs). 2. Were pregnant or breastfeeding or intended to conceive during the study period (i.e., through Week 52). 3. Received a stem cell transplant or a solid organ transplant other than a kidney transplant. 4. Had suspected CMV disease (either syndrome or tissue-invasive disease) or detectable CMV viremia by the central virology laboratory prior to the first dose of study drug. 5. Had a history of CMV disease (either syndrome or tissue-invasive disease) within 6 months prior to the first dose of study drug. 6. Had an absolute neutrophil count of <500 cells/μL, platelet count of <25,000/μL, or hemoglobin of <8 g/dL at screening. 7. Had hypersensitivity (not including renal dysfunction or an eye disorder) to valganciclovir (vGCV), ganciclovir (GCV), cidofovir (CDV) or to brincidofovir (BCV) or their excipients. 8. Received (or were anticipated to need treatment with) any of the following: - GCV, vGCV, foscarnet, intravenous CDV, or any other anti-CMV therapy (including CMV immune globulin, cell-based therapies, and investigational anti-CMV drugs, e.g., leflunomide, letermovir [previously AIC246], or maribavir) at any time posttransplant; - Any anti-CMV vaccine at any time; - Any other investigational drug within 14 days prior to the first dose of study drug (unless prior approval had been received from the Chimerix Medical Monitor or designee); or - Prior treatment with BCV at any time. [Note: An investigational drug was defined as any drug that is not approved for any indication by the FDA (or appropriate regulatory authority).] 9. Received acyclovir orally at >2000 mg total daily dose (TDD) or intravenously at >15 mg/kg TDD, valacyclovir at >3000 mg TDD on the first dose of study drug or were anticipated to receive any of these drugs at the doses described after the the first dose of study drug. 10. Were infected with HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV), had evidence of active viral replication within 6 months prior to screening, as demonstrated by detectable HIV or HCV RNA, or detectable HBV DNA in blood, plasma or serum. 11. Had severe vomiting, diarrhea, or malabsorption syndrome on or prior to the first dose of study drug. 12. Had gastrointestinal (GI) disease that would have, in the judgement of the investigator, precluded the subject form taking or absorbing oral medication (e.g., gastroparesis, diabetic autonomic neuropathy affecting the GI tract, clinically active Crohns disease, ischemic colitis, moderate or severe ulcerative colitis, small bowel resection, ileus, or any condition that was expected to require abdominal surgery during the course of study participation). 13. Had serum alanine aminotransferase or aspartate aminotransferase concentrations >5 x the upper limit of normal (ULN). 14. Had total serum bilirubin >2 x the ULN and direct bilirubin >1.5x the ULN. 15. Had moderate (Class B) to severe (Class C) hepatic dysfunction according to the Child-Pugh Turcotte scoring system. 16. Were receiving or would require digoxin or ketoconazole therapy (other than topical formulations) during the treatment phase of the study. 17. Had active malignancies (with the exception of basal cell carcinoma). 18. Had a serious psychiatric, medical disorder, including abnormal laboratory values, that would have, in the judgement of the investigator, put the subject at increased risk by participating in the study, or would have interfered with the conduct of the study. ; PRIMARY OUTCOME: The Incidence of CMV Disease; 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 - COMPOSE II (V9232); BRIEF: The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives. ; DRUG USED: Symproic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Opioid Induced Constipation (OIC); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Shionogi; CRITERIA: Inclusion Criteria: - Subjects aged 18 to 80 years inclusive at the time of informed consent - Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC) - Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate - Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration - Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary Exclusion Criteria: - Evidence of significant structural abnormalities of the gastrointestinal (GI) tract - Evidence of active medical diseases affecting bowel transit - History or presence of pelvic disorders that may be a cause of constipation - Surgery (except for minor procedures) within 60 days of Screening - History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction) - Subjects who have never taken laxatives for the treatment of OIC - History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of breast cancer - Current use of any prohibited medication including opioid antagonists, partial agonists, or mixed agonists/antagonists ; PRIMARY OUTCOME: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response; SECONDARY OUTCOME 1: Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Unity 2 w/Asunaprevir/BMS-791325; BRIEF: To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects. ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects chronically infected with HCV genotype 1 - Subjects with compensated cirrhosis - HCV RNA ≥ 10,000 IU/mL at screening - Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.) - Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir (ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA. Exclusion Criteria: - Subjects without cirrhosis - Liver or any other organ transplant - Current or known history of cancer within 5 years prior to screening - Documented or suspected hepatocellular carcinoma(HCC) - Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy ; PRIMARY OUTCOME: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12); SECONDARY OUTCOME 1: Proportion of treated subjects in each of the experienced arms with SVR12[/INST]Yes</s>

<s>[INST]<<SYS>>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 - MARVEL; BRIEF: This study injects a persons own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patients heart performance. ; DRUG USED: MyoCell; DRUG CLASS: Biologic; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Bioheart, Inc.; CRITERIA: Inclusion Criteria: Eligible patients must meet ALL of the following inclusion criteria during the screening/enrollment visit #1 and prior to being randomized into the study. Screening/enrollment visit #1 is defined to start the date the ICF is signed by the patient: 1. Chronic CHF, New York Heart Association (NYHA) Class II-IV; 2. Stable and on optimal medical management for greater or equal to 60 days as follows: 1. systolic and diastolic hypertension controlled in accordance with contemporary guidelines; 2. patient stabilized on maximum tolerated dose of beta blockers; 3. patient stabilized on maximum tolerated dose of angiotensin concerting enzyme (ACE) inhibitors; 4. patients intolerant of ACE inhibitors should be stabilized on angiotensin receptor blockers (ARB); 5. fluid control with diuretics and a salt restricted diet; 6. patients with sever symptoms of heart failure (Class III-IV) lacking contraindications to aldosterone antagonism and not on both ACE inhibitors and ARBs have been considered for such therapy. 3. Age 18-80; 4. Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35 percent by multiple gaited acquisition scan (MUGA); 5. Need or feasibility for revascularization has been ruled out by previous coronary angiogram or ruled out to the satisfaction of the investigator via previous conventional stress study completed within 1 year of screening. The need or feasibility for revascularization will be reassessed at screening using dobutamine stress echocardiography (DSE); 6. Defined region of mycardial dysfunction related to previous MI involving the anterior, later, posterior or inferior walls including the apical septum (excluding the basal septum) assessed by a large area of akinesia in the left ventricle (using DSE at screening); 7. B-type natriuretic peptide (BNP) or NT pro-BNP is above the upper limit of normal. Exclusion Criteria: 1. Non-pregnant women who are not postmenopausal, surgically sterile or not practicing an acceptable method of contraception. A female patient of child bearing potential, with a positive serum or urine pregnancy test at screening visit #1. Females refusing to exercise a reliable form of contraception; 2. Myocardial wall thickness of <6 mm (millimeters) in the akinetic myocardial region to be injected (using DSE at screening) 3. Inability to undergo a surgical biopsy of the skeletal muscle for culture of myoblasts, including any significant myopathy; 4. Patient will require revascularization within six months; 5. Patients on continuous or intermittent intravenous drug therapy; 6. Not fitted, or fitted within less than 90 days prior to screening visit #1, with an implantable cardioverter defibrillator (ICD); 7. Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screening visit #1; 8. Inability to perform a 6 minute walk test due to physical limitations other than HF including: 1. Severe peripheral vascular disease, including aortic aneurysms, leading to limited claudication; 2. Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise, dependence on chronic oral steroid therapy or previously requiring mechanical ventilation; 3. Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening visit #1; 9. MI, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening; 10. having undergone CABG surgery within 150 days prior to screening visit #1; 11. Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy; 12. Hemodynamically significant severe primary valvular heart disease, unless corrected by a properly functional prosthetic valve; 13. Prior aortic valve replacement; 14. Systolic blood pressure (supine) ≤90 mmHg; 15. Resting heart rate >100 bpm; 16. Severe uncontrolled HF including any evidence of severe fluid overload such as peripheral edema >+2 or rales ≥1/3 the lungs height, need for intravenous therapy for HF within 60 days of screening visit #1 or hospitalization for HF within 90 days of screening visit #1; 17. Patient scheduled to receive cardiac resynchronization therapy (CRT) during the study; 18. Expected to receive or received a cardiac transplant, surgical remodeling procedure, left ventricular assist device or cardiomyoplasty; 19. Six-minute walk test (6MWT) of >400 meters or Minnesota Living With Heart Failure (MLWHF) score of <20; 20. Hematocrit (HCT) concentration below 30% (males) or below 27% (females); 21. Serum creatinine greater than 2.5 mg/dL (milligrams per deciliter) or end stage renal disease; 22. Left ventricular mural thrombus; 23. Known sensitivity to gentamicin sulfate; or severe adverse reaction to nonionic radiocontrast agents; 24. Active infectious disease and/or known to have tested positive for human immunodeficiency virus (HIV), human t lymphotrophic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV); immunoglobulin M [IgM], and/or syphilis. If the panel includes antibodies to the HBV core antigen (HBV-cAg) and hepatitis B surface antigen (HBV-sAg), then an expert will be consulted as to patients eligibility based on the patients infectious status; 25. Patients have undergone enhanced external pulsation (EECP) tratment within the last 6 months; 26. Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy, or therapy with another investigational drug within 60 days of screening visit #1 or enrollment in any concurrent study that may confound the results of this study; 27. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate; 28. Any illness other than CHF which might reduce life expectancy to less than 1 year from screening visit #1; 29. Recent initiation of cardiac resynchronization therapy via placement of a bi-ventricular pacemaker or bi-ventricular AICD within 180 days of study enrollment; and 30 Unwilling and/or not able to give written informed consent. ; PRIMARY OUTCOME: 6-minute walk test; SECONDARY OUTCOME 1: Hospitalization occurrences[/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 - Behavioral Disturbances (BPSSD); BRIEF: The purpose of the study is to compare the effectiveness of an oral formulation of risperidone (an antipsychotic medication) to that of placebo for treating behavioral and psychological signs and symptoms in dementia (BPSSD), specifically aggression, delusions, and hallucinations, in patients with dementia. ; DRUG USED: Risperdal; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen-Cilag Pty Ltd; CRITERIA: Inclusion Criteria: - Dementia of the Alzheimers type with behavioral disturbance, vascular dementia with behavioral disturbance, or mixed dementia, as classified by DSM-IV (the Diagnostic and Statistical Manual of Mental Diseases, 4th edition) - a score >=4 on the FAST (Functional Assessment Staging, a diagnosis tool for determining the stage of dementia) and a score <=23 on the MMSE (Mini-Mental State Examination, a clinical measure used to evaluate cognition) - a BEHAVE-AD (Behavior Pathology in Alzheimers Disease Rating Scale) total score >=8, and a BEHAVE-AD global rating >=1 - patient must be living in an nursing home for >=1 month. Exclusion Criteria: - Patients with other medical or neurological conditions other than dementia in which cognition is diminished (for example, severe anemia, severe liver, heart, lung, and kidney malfunctions, Parkinsons disease) - diagnosis of depression within the 6 months before study entry, schizophrenia, bipolar affective disorder, or schizoaffective disorder - history of or moderate to severe tardive dyskinesia, (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs) - abnormal clinical laboratory test findings. ; PRIMARY OUTCOME: Change from baseline to the end of double-blind treatment in total aggression score of the CMAI (Cohen-Mansfield Agitation Inventory).; SECONDARY OUTCOME 1: Change from baseline to end of double-blind treatment in global and total BEHAVE-AD score, BEHAVE-AD cluster scores and in CMAI cluster scores, CGI, and in FAST MMSE; safety evaluations conducted throughout 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 - PSY102; BRIEF: The purpose of this research study is to gather scientific information about the effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of self-injurious behaviors when compared with the effectiveness and safety of placebo (inactive substance) in subjects with Lesch-Nyhan Disease. ; DRUG USED: Ecopipam; DRUG CLASS: Non-NME; INDICATION: Metabolic - General; TARGET: Dopamine 1 (D1) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Psyadon Pharma; CRITERIA: Inclusion Criteria: - Subjects must have classic LND as defined by (a) characteristic clinical syndrome (evidence of overproduction of uric acid, severe generalized dystonia, frequent and persistent self-injurious behavior (SIB), and cognitive impairment) and (b) laboratory confirmation for mutation of the HPRT gene or severe deficiency of the associated enzyme. - Subjects must have a minimum combined score of 20 on the Behavior Problems Inventory (BPI) SIB subscales for frequency and severity as assessed by the caregiver. - Subjects must have a minimum score of 4 on the Physicians Global Impression (PGI) severity scale. - Subject must be ≥ 6 years old. - Subjects must weigh > 10 kg. Exclusion Criteria: - Subjects who are currently treated with medications for seizures. - Subjects who are on neuroleptics or dopamine-depleting agents. - Subjects with impaired renal function as defined by a serum creatinine >1.5 mg/dL. ; PRIMARY OUTCOME: Behavior Problems Inventory - Self-Injurious Behavior Subscale; SECONDARY OUTCOME 1: Effect of Ecopipam Withdrawal and Maintenance[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - C-Early (RA0055A); BRIEF: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis. ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Combination; LEAD SPONSOR: UCB Pharma SA; CRITERIA: Inclusion Criteria: - Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit - Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP) - Active RA disease - DMARD-naïve - Subject is naïve to RA related biologics Exclusion Criteria: - A diagnosis of any other inflammatory Arthritis - History of infected joint prosthesis, or other significant infection and other serious medical condition - Known Tuberculosis (TB) disease or high risk of acquiring TB infection ; PRIMARY OUTCOME: Percentage of Subjects in Sustained Remission at Week 52; SECONDARY OUTCOME 1: Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Cardiac Stroke Volume; BRIEF: This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7 days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003 compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7 days) in subjects with moderate to severe COPD. ; DRUG USED: Bevespi Aerosphere; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pearl Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - At least 40 years of age and no older than 80 at Visit 1. - Women of non-child bearing potential,or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly from Screening until 14 days after final visit - Evidence of lung hyperinflation - Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) - Current or former smokers with a history of at least 10 pack-years of cigarette smoking. - Pre- and Post-bronchodilator FEV1/FVC ratio must be <0.70 - Post-bronchodilator FEV1 must be ≥30% to <65% predicted normal value, calculated using NHANES III reference equations. Exclusion Criteria: - Significant diseases or conditions other than COPD which, in the opinion of the Investigator, may put the patient at risk - Women who are pregnant or lactating or are planning to become pregnant during the course of the study - Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma or other active pulmonary disease - Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening - Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period - Subjects who have clinically significant uncontrolled hypertension. - Subjects with symptomatic prostatic hypertrophy that is clinically significant and not adequately controlled with appropriate therapy, in the opinion of the Investigator. - Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator. - Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney Disease Epidemiology Collaboration. (CKD-EPI) formula at Screening and on repeat testing prior to Visit 2. - Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Screening and on repeat testing prior to Visit 2 - Subjects who have cancer that has not been in complete remission for at least five years. - Subjects with a diagnosis of glaucoma, who in the opinion of the Investigator, have not been adequately treated. - Subjects with a clinically significant ECG - Subjects who were previously enrolled in any previous PT001, PT003, or PT005 study conducted or sponsored by Pearl. ; PRIMARY OUTCOME: Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVi) at 2-3 Hours Post-dose on Day 8; SECONDARY OUTCOME 1: Change From Baseline in Aortic Left Ventricular Stroke Volume (LVSV) at 2-3 Hours Post-dose on Day 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 - 09-032 (EU); BRIEF: This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union. ; DRUG USED: HP802-247; DRUG CLASS: Biologic; INDICATION: Chronic Venous Ulcers; TARGET: Fibrinogen (Coagulation Factor I), Fibroblasts, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Healthpoint; CRITERIA: Inclusion Criteria: - Provide informed consent. - Age ≥ 18 years and of either sex. - Willing to comply with protocol instructions, including allowing all study assessments. - Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2 - Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence. - Arterial supply adequacy confirmed - Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. - Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months). - Acceptable state of health and nutrition Exclusion Criteria: - History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B. - Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buergers disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication. - Therapy with another investigational agent within thirty (30) days of Screening, or during the study. - A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). - Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit. - Refusal of or inability to tolerate compression therapy. - Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit. - History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers). - Any prior exposure to HP802-247 or its vehicle. ; PRIMARY OUTCOME: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline; SECONDARY OUTCOME 1: Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period 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 - BOLERO 3 (HER2+; w/trastuzumab/vinorelbine); BRIEF: This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane. ; DRUG USED: Afinitor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent. - HER2+ status defined as IHC 3+ staining or in situ hybridization positive - Patients with resistance to trastuzumab - Prior taxane therapy - Patients with an ECOG performance status of 0 - 2 - Patients with measurable disease as per RECIST criteria - Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study; - Patients must meet laboratory criteria defined in the study within 21 days prior to randomization Exclusion Criteria: - Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer - More than three prior chemotherapy lines for advanced disease. - Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus - Peripheral neuropathy ≥ grade 2 at randomization - Active cardiac disease - History of cardiac dysfunction - Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer - Known hypersensitivity to any study medication - Breastfeeding or pregnant ; PRIMARY OUTCOME: Progressive-free Survival (PFS) Per Investigator Assessment; SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALLY 1 (w/Sofosbuvir/RBV; GT 1-6); BRIEF: This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients. ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications - Participants chronically infected with hepatitis C virus (HCV) Genotype 1, 2, 3, 4, 5, or 6 with HCV RNA viral load of ≥10,000 IU/mL at screening - Participants may be treatment-naïve or treatment-experienced - Cirrhotic participants must have cirrhosis confirmed by biopsy, Fibroscan or fibrotest and Aspartate aminotransferase platelet ratio index (APRI) criteria as outlined in the protocol - Post-transplant participants must be at least 3 months post-transplant with no evidence of moderate or severe rejection Exclusion Criteria: - History of multi-organ transplant, with the exception of dual transplantation of the liver/kidney, is prohibited - Current or known history of cancer (with the following exceptions: In situ carcinoma of the cervix, adequately treated basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma within Milan criteria for transplantation) within 5 years prior to screening - Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV (such as, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, or toxin exposures) - History of HIV infection or chronic hepatitis B virus (HBV) as documented by HBV serologies (e.g., HBsAg-seropositive). Participants with resolved HBV infection may participate (e.g., HBcAb-seropositive with concurrent HBsAg-seronegative) - Active hospitalization for decompensated liver disease ; PRIMARY OUTCOME: Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12); SECONDARY OUTCOME 1: Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 301 - Acutely Exacerbated Schizophrenia; BRIEF: The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis. ; DRUG USED: Caplyta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Intra-Cellular Therapies, Inc.; CRITERIA: Inclusion Criteria: - male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia - experiencing an acute exacerbation of psychosis Exclusion Criteria: - any subject unable to provide informed consent - any female subject who is pregnant or breast-feeding - any subject judged to be medically inappropriate for study participation ; PRIMARY OUTCOME: Positive and Negative Syndrome Scale Total Score; SECONDARY OUTCOME 1: Positive and Negative Syndrome Scale Subscales[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SAKURA 1; BRIEF: The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution. ; DRUG USED: Opsiria; DRUG CLASS: Non-NME; INDICATION: Uveitis (Ophthalmology); TARGET: FKBP12; THERAPY: Monotherapy; LEAD SPONSOR: Santen Inc.; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of active uveitis - 18 years of age or older - Sign informed consent - Meet best corrected ETDRS visual acuity Exclusion Criteria: - Uveitis of infectious etiology - Suspected/confirmed central nervous system or ocular lymphoma - Primary diagnosis of anterior uveitis - Uncontrolled glaucoma - Use of topical oculary medication - Implanted device - Significant ocular disease - Lens/media opacities or obscured ocular media - Intraocular surgery or treatments - Capsulotomy - Ocular or periocular infection - Pupillary dilation - History of herpetic infection - Toxoplasmosis or toxoplasmosis scar - Ocular malignancy - Allergy or hypersensitivity to study drug - Participation in other uveitis trial within 30 days - Monoclonal antibody treatment or biologic therapy - Any systemic condition/infection - Immunosuppressive therapy or immunocompromised - Malignancy remission - Females who are pregnant or lactating and females not using adequate contraceptives ; PRIMARY OUTCOME: The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5; SECONDARY OUTCOME 1: VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EPIC-E; BRIEF: The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC. ; DRUG USED: Vepoloxamer; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Mast Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Completed participation in study MST-188-01 (EPIC study) - Subject age 4 through 65 years - Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia - Subject requires hospitalization Exclusion Criteria: - Subject has acute chest syndrome - Subjects laboratory results indicate inadequate organ function - Subject is pregnant or nursing an infant - Subject had a painful crisis requiring hospitalization within the preceding 14 days - Subject has been transfused within the past 14 days - Subject has complications related to SCD ; PRIMARY OUTCOME: Safety as measured as the incidence of adverse events; SECONDARY OUTCOME 1: Rate of re-hospitalization for recurrence of VOC[/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 - ASPIRE - 31-07-246 (Maintenance); BRIEF: The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia. The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks. ; DRUG USED: Abilify Maintena; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by the Institutional Review Board/Institutional Ethics Committee [IRB/IEC]), prior to the initiation of any protocol-required procedures. - Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent. - Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR) criteria and a history of the illness for at least 3 years prior to screening. - Subjects who, in the investigators judgment, require chronic treatment with an antipsychotic medication. - Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete patient-reported outcomes measures; and who can be reliably rated on assessment scales. Exclusion Criteria: - Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. - Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine. - Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigators judgment. - Subjects who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine; or 2 positive drug screens for cocaine. - Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones; or hypersensitivity to antipsychotic agents. - Subjects with uncontrolled thyroid function abnormalities. - Subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments. - Subjects who are involuntary incarcerated. - Subjects who have used an investigational agent within 30 days of screening or prior participation in a clinical study with aripiprazole IM depot. - Subjects with clinically significant abnormalities in laboratory test results, vital signs, or ECG results; and subjects hospitalized for more than 30 days in the 90 days prior to Phase 1. - Subjects who fail to wash-out from prohibited concomitant medications, including the use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors [MAOI}), and mood stabilizers during screening and/or Phase 1. ; PRIMARY OUTCOME: Time to Exacerbation of Psychotic Symptoms/Impending Relapse; SECONDARY OUTCOME 1: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IGIV; BRIEF: Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetics Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD). ; DRUG USED: IVIG; DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Prometic Biotherapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Subject is male or female between the ages of 2 and 80 years at Screening. 2. Female subjects of childbearing potential must agree to employ adequate birth control measures, as determined by their IRB/IEC, for the duration of the study. 3. The subject must have one of the following three diagnoses (isolated PIDD of other types will be excluded): - Common variable immunodeficiency - X-linked agammaglobulinemia - Hyper-IgM syndrome and documented low IgG levels (<4.5 mg/mL [450 mg/dL]). 4. Subjects must have been treated with a stable dose of immune globulin administered intravenously (IGIV) or subcutaneously (IGSC) and has documented trough or steady state IgG levels of ≥ 5 mg/mL. Exclusion Criteria: 1. Subject has secondary immunodeficiency or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency; has known hypoalbuminemia (<3 gm/dL), protein-losing enteropathy, or nephrotic syndrome. 2. Subject has ever had a history of severe anaphylactic or anaphylactoid reaction to immunoglobulins or other blood products. 3. Subject has a known history of immunoglobulin A (IgA) deficiency and known anti-IgA antibodies, thrombotic event, such as deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, at any time. 4. Subject has received blood products except IGIV, IGSC, or albumin within the previous 12 months or has participated in another study (except for IGIV, IGSC studies) within the previous 4 weeks. 5. Subject has had cancer in the past 5 years, except for basal cell or squamous cell cancers of the skin. 6. Subject has had a documented active infection within 7 days prior to Screening, or subject is on continuous prophylactic antibiotics. 7. Subject is positive for human immunodeficiency virus (HIV)-1 or HIV-2, a positive hepatitis C virus (HCV) or hepatitis B virus (HBV). 8. Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the upper limit of normal (ULN). 9. Subject has serum creatinine >1.5 times the ULN or a severe chronic condition such as renal failure with proteinuria. 10. Subject has anemia with a hemoglobin level ≤8 g/dL. 11. Subject has severe neutropenia with neutrophil count ≤1000 per mmᴧ3 or has lymphopenia with <500 per/ mmᴧ3. 12. Subject is taking prednisone at a dose ≥0.15 mg/kg/day and receiving other immunosuppressive drugs or chemotherapy. 13. Subject has known atrial fibrillation requiring anticoagulant therapy; congestive heart failure (New York Heart Association Class III/IV); cardiomyopathy; or cardiac arrhythmia associated with thromboembolic events, unstable or advanced ischemic heart disease, or hyperviscosity. 14. Subject has known decreased Protein C and/or Protein S levels. 15. Subject is positive for antibodies to β2GPI and/or β2GPI DI at Screening. 16. Female subject who is pregnant, breast-feeding, or planning a pregnancy during the course of the study. 17. A history of epilepsy or multiple episodes of migraine (defined as at least one episode within 6 months of enrolment) not completely controlled by medication, or any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study in the Investigators opinion. ; PRIMARY OUTCOME: Annual Rate of Occurrence of Serious Bacterial Infections (SBI); SECONDARY OUTCOME 1: Trough Levels of IgG (Total) Prior to Each Prometic IGIV 10% Infusion[/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 (Malaysia); BRIEF: The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations. ; DRUG USED: Biokangtai Covid-19 Vaccine; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Shenzhen Kangtai Biological Products Co., LTD; CRITERIA: Inclusion Criteria: - Healthy residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms. - Be able to understand and comply with study requirements/ procedures. - Participants with negative results of SARS-CoV-2 Realtime-PCR (RT-PCR) detection. - For females or sex-partners of males at childbearing age: be willing to use birth control for 3 months after the 2nd dose. - For females of childbearing potential (Pausimenia ≤ 2 years ) must: have a negative urine or blood pregnancy test at screening - Axillary temperature < 37.3℃/99.1℉ when screening (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ). Exclusion Criteria: - Previous treatments for curing or preventing COVID-19 (including vaccination of various COVID-19 vaccines). - History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections. - History of allergy to any components of the candidate vaccine or severe allergic reactions to vaccine or medicine (including, but not limited to, allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrosis (Arthus reaction)). - Positive for HIV detection. - History or family history of convulsion, epilepsy, encephalopathy, and psychosis. - Active stage of malignancies, malignancies without adequate treatments, malignancies with potential risk for recurrence during the study. - Severe or uncontrolled cardiovascular, neurological, blood and lymphatic, kidney, liver, respiratory, metabolic and skeletal diseases. - Congenital or functional absence of spleen, complete or partial removal of spleen in any case. - Chronic administration (defined as ≥ 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the 1st vaccination (eg. corticosteroids, ≥ 0.5 mg/kg/day prednisone or equivalent; but, inhaled and topical steroids are allowed). - Planned administration/administration of a vaccine not foreseen by the study protocol less than 7 days before 1st dose of candidate vaccine for inactivated vaccines or 14 days before 1st dose of candidate vaccine for attenuated live vaccines. - Receipt of blood products and/or immunoglobulins within 3 months prior to enrollment or expected receipt during the study. - Donate or loss ≥ 450 ml of blood within 1 month prior to enrollment, or expected blood donation during the study. - Fever: axillary temperature ≥ 37.3℃/99.1℉ within the past 24 hours (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ). - Those who participated in other clinical trials 1 month prior to the enrollment or used any investigational or non-registered drug during the study period; Those who are unable to finish follow-up or fail in efficacy assessments. - Breastfeeding females should not be included. - Ineligible for the study based on the assessment of investigator. ; PRIMARY OUTCOME: Incidence density of symptomatic COVID-19 cases; SECONDARY OUTCOME 1: Incidence density of COVID-19 moderate cases and above[/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 - CARMEN CD 305 (Induction Therapy); BRIEF: The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohns Disease. ; DRUG USED: SHP647; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: MAdCAM-1 (Mucosal addressin cell adhesion molecule-1); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Participants must be between greater than or equal to (> =) 16 and less than or equal to (<=) 80 years of age; participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index >=16.5 kilogram per meter square (kg/m^2) - Participants must have active moderate to severe ileal (terminal ileum), ileocolic, or colonic CD at baseline (Visit 2) as defined by: 1. CDAI score between 220 and 450 (inclusive) AND 2. Meeting the following subscores in the 2 item PRO: i. Abdominal pain subscore >= 5 (average worst daily pain on the 11 point NRS) and abdominal pain subscore >= 2 (average daily pain on the 4-point abdominal pain variable of CDAI) over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) AND/OR ii. Average of the daily stool frequency subscore >=4 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) c. Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD >6 (SES CD >=4 for isolated ileitis) Note that the participant must be confirmed as meeting the CDAI score and PRO subscore requirements before a colonoscopy is done - Participants must have a documented diagnosis (endoscopic with histology) of CD for >=3 months before screening. Documented diagnosis is defined as: 1. A biopsy report in which the description of the histological findings is consistent with the CD diagnosis AND 2. A report documenting disease duration based upon prior colonoscopy Note: If a biopsy report is not available in the source document at the time of screening, a biopsy must be performed during the screening colonoscopy and the histology report should be consistent with the CD diagnosis. If the histology description does not support the CD diagnosis at this time point, the participant should not be randomized - Participants must be willing and able to undergo a colonoscopy during screening after all other inclusion criteria have been met - Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as sulfasalazine or mesalamine (5-aminosalicylic acid [5-ASA]), glucocorticoids, or immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) or anti-tumor necrosis factor (anti-TNF). Participants who have had an inadequate response to sulfasalazine or mesalamine should have also failed at least 1 other conventional treatment such as glucocorticoids - Participants receiving any treatment(s) for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time - Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use appropriate contraception (ie, highly effective methods for female and medically appropriate methods for male study participants, for the duration of the study Exclusion criteria: - Participants with indeterminate colitis, microscopic colitis, nonsteroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of UC - Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed) - Participants with past medical history or presence of toxic megacolon - Participants with presence of enterovesical (ie, between the bowel and urinary bladder) or enterovaginal fistulae - Participants with current symptomatic diverticulitis or diverticulosis - Participants with clinically significant obstructive colonic stricture, or who have a history of bowel surgery within 6 months before screening, or who are likely to require surgery for CD during the treatment period. Participants who have undergone previous colonic resection or ileocolectomy more than 6 months before screening must have at least 25 cm of colon remaining - Participants with past medical history of multiple small bowel resections resulting in clinically significant short bowel syndrome - Participants requiring total parenteral nutrition - Participants with past medical history of bowel surgery resulting in an existing or current stoma. Participants who had a j-pouch are excluded as a j-pouch could result in a stoma - Participants have had prior treatment with ontamalimab (formerly PF-00547659; SHP647) - Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients - Participants have received any nonbiologic treatment with immunomodulatory properties (other than AZA, 6-MP, or MTX) or continuous antibiotics (>2 weeks) for the treatment of CD within 30 days before baseline (Visit 2) - Participants have received anti-TNF treatment within 60 days before baseline (Visit 2) - Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline (Visit 2) - Participants have ever received anti-integrin/adhesion molecule treatment (eg, natalizumab,vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule) - Participants have received lymphocytes apheresis or selective monocyte granulocytes apheresis within 60 days before baseline (Visit 2) - Participants have received enteral nutrition treatment within 30 days before baseline (Visit 2) - Participants have received parenteral or rectal glucocorticoids or rectal 5-ASA within 14 days before screening colonoscopy - Participants have taken >20 milligram per day(mg/day) of prednisone, >9 mg/day of budesonide, or equivalent oral systemic corticosteroid dose within 14 days before baseline (Visit 2) or have taken >=40 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 6 weeks before baseline (Visit 2) - Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before screening (Visit 1) - Participants have received a live (attenuated) vaccine within 30 days before the baseline visit (Visit 2) - Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis (subjects with C. difficile infection at screening may be allowed retest after treatment), evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the subjects to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit (Visit 2) - Participants with abnormal chest x-ray or other imaging findings at screening (Visit 1), such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy (A chest x-ray, computed tomography scan, etc, performed up to 12 weeks before study entry [screening, Visit 1] may be used if available; documentation of the official reading must be located and available in the source documentation) - Participants with evidence of active or latent infection with Mycobacterium tuberculosis (TB) or participants with this history who have not completed a generally accepted full course of treatment before baseline (Visit 2) are excluded All other participants must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin test or interferon-gamma release assay (IGRA) performed - Participants who have no history of previously diagnosed active or latent TB are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >= 5 millimeter [mm] induration) or a positive IGRA (the latter to be tested at the sites local laboratory) during screening or within 12 weeks before screening If the IGRA cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor: 1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guérin vaccination but may be used for any participant Documentation of IGRA product used and the test result must be in the participants source documentation if performed locally Acceptable IGRA products include QuantiFERON-TB Gold Plus In-Tube Test 2. If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed In participants with no history of treated active or latent TB, a positive test on repeat will exclude the participantParticipants with a history of active or latent TB infection must follow instructions for Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met in this criterion 3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action) This consultation must be included in source documentation Results from a chest x-ray, taken within the 12 weeks before or during screening (Visit 1)must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist - Participants with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening - Participants with any unexplained symptoms suggestive of PML based on the targeted neurological assessment during the screening period - Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed - Participants with a significant concurrent medical condition at the time of screening (Visit 1) or baseline (Visit 2), including, but not limited to, the following: 1. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, GI [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [eg, Feltys syndrome], or local active infection/infectious illness) that, in the investigators judgment will substantially increase the risk to the subject if he or she participates in the study 2. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence) 3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening (Visit 1) 4. History of significant cerebrovascular disease within 24 weeks before screening (Visit 1) - Participants who have had significant trauma or major surgery within 4 weeks before the screening (Visit 1), or with any major elective surgery scheduled to occur during the study. - Participant with evidence of cirrhosis with or without decompensation (ie, esophageal varices, hepatic encephalopathy, portal hypertension, ascites) - Participant with primary sclerosing cholangitis - Participant with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) Note: if a subject tests negative for HBsAg, but positive for HBcAb, the subject would be considered eligible if no presence of hepatitis B virus (HBV) DNA is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in the central laboratory - Participant with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb] and HCV RNA) Note: Participant who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks prior to baseline]) - Participant with any of the following abnormalities in hematology and/or serum chemistry profiles during screening (Visit 1) Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the subjects clinical condition, may be repeated once during the screening period for confirmation results must be reviewed for eligibility prior to the screening colonoscopy procedure 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0 × the upper limit of normal (ULN) 2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the subject has a known documented history of Gilberts syndrome 3. Hemoglobin level less than or equal to(<=80) gram per liter(g/L) (8.0 g/deciliter[dL]) 4. Platelet count <=100× 10^9/L (100,000 cells/mm^3) or >=1000 × 10^9/L (1,000,000 cells/mm^3)* 5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3) 6. Absolute neutrophil count <2 × 10^9/L (2000 cells/mm^3) 7. Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 millilter per minute (mL/min)/173 meter square (m^2) based on the abbreviated Modification of Diet in RenalDisease Study Equation Note: if platelet count is <150,000 cells/mm3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified - Participant with known human immunodeficiency virus (HIV) infection based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the sites local laboratory in accordance with country requirements or tested at the central laboratory Note: A documented negative HIV test within 6 months of screening is acceptable and does not need to be repeated - With known human immunodeficiency virus (HIV) infection based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the sites local laboratory in accordance with country requirements or tested at the central laboratory. - Participants who have, or who have a history of (within 2 years before screening), serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of any kind including abuse of medicinal marijuana (cannabis) NOTE: The above Inclusion/Exclusion criteria are NOT exhaustive and other Inclusion/ Exclusion criteria as defined in the protocol may apply. ; PRIMARY OUTCOME: Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16; SECONDARY OUTCOME 1: Number of Participants With Clinical Remission Based on Crohns Disease Activity Index (CDAI) Score 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 - E14 (Paediatric; w/CKD stage 5 on dialysis); BRIEF: The Primary Objective of this study is to determine the initial starting doses of colestilan (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with Hyperphosphataemia. ; DRUG USED: BindRen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Bile Acids, Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Children aged 2 years to <18 years with CKD stage 5 on dialysis (haemodialysis or peritoneal dialysis) for at least one month - The subject has a documented diagnosis of hyperphosphataemia, as demonstrated by serum phosphorus(P) levels above the age-related upper limit of normal KDOQI Clinical Practice Guidelines for Nutrition in Children with CKD updated 2008) - The subject has been taking CBPB prior to enrolment into the study (i.e., prior to the screening visit) - The subject must have demonstrated serum P levels >1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the wash-out period (this must be demonstrated after stopping treatment with CBPB) - At the time of randomisation, the subject must have demonstrated an increase in serum P levels from his/her most recent P central laboratory measurement by at least 10% above the pre-wash-out level Exclusion Criteria: - The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices) - The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery) - The subject was treated with a combination of two or more phosphate binders within one month prior to screening - The subject cannot stop treatment (prescription or over-the counter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril - The subject is receiving immunosuppressant treatment for any medical condition at the time of randomisation or is expected to receive such treatment during the course of the study - The subject is considered unstable on his/her current treatment for CKD within one month prior to screening (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e., serum P and Ca levels]) ; PRIMARY OUTCOME: Mean absolute change in serum phosphorus; SECONDARY OUTCOME 1: Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value)[/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 - Affinity-1; BRIEF: Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin ; DRUG USED: Afrezza; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Mannkind Corporation; CRITERIA: Inclusion Criteria: - Men and women = 18 years of age - Clinical diagnosis of type 1 diabetes mellitus for at least 12 months - Body mass index (BMI) = 38 kg/m2 - Stable dose of basal/bolus insulin therapy for at least 3 months with an FPG consistently < 220 mg/dL: - HbA1c = 7.5% and = 10.0% - Fasting C-peptide = 0.30 pmol/mL - Subject willingness to not use CGM during the entire course of the trial - Nonsmoking (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding 6 months - Negative urine cotinine test, defined as = 100 ng/mL - Lung function tests: • Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted - Written informed consent Exclusion Criteria: - Total daily insulin dose = 2 IU/kg/day. History of insulin pump use within 3 months of Screening or use of continuous glucose monitoring within 6 weeks of Screening - History of inhaled insulin use in the previous 6 months - Two or more unexplained severe hypoglycemic episodes within 3 months of Screening or an episode of severe hypoglycemia between Visit 1 and Visit 2. Unexplained refers to episodes of severe hypoglycemia that are not related to a dosing error, lack of or a change in meal size, or related to additional/unanticipated exercise - Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 2 - Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the study, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure - History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements. - History of COPD, asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis), or use of any medications for these conditions - Any clinically significant radiological findings on screening chest x-ray - Active respiratory infection within 30 days before Screening (subject may return after 30 days from resolution for rescreening) - Major organ system diseases, including: ? Seizure disorder; systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine; cancer (other than excised cutaneous basal cell carcinoma) or any history of lung neoplasms - Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity; use of medications for weight loss (eg, sibutramine, orlistat) within 12 weeks of Screening; treatment with amiodarone within 12 weeks of Screening - Clinically significant abnormalities on screening laboratory evaluation or chest x-ray - Severe complications of diabetes, in the opinion of the PI, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant, or dialysis; nontraumatic amputations due to gangrene; or vascular claudication - Women who are pregnant, lactating, or planning to become pregnant during the clinical study period; women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for this study includes amenorrhea f - Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the PI, would make the subject an unsuitable candidate for participation in the study - Exposure to any investigational medications or devices within the previous 30 days before study entry - Unable to read or write, or unlikely to comprehend and follow the study protocol procedures; lack of compliance with medication or procedures that, in the PIs opinion, may affect the study data or subject safety and that precludes the subject from participation in the study; or any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical study or could limit the validity of the informed consent or impair the subject ; PRIMARY OUTCOME: Change From Baseline to Week 24 in HbA1c; SECONDARY OUTCOME 1: FEV1 Change 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 - FSS-AS-30003; BRIEF: This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma. ; DRUG USED: ArmonAir RespiClick; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - The participant has a diagnosis of asthma as defined by the National Institutes of Health (NIH). - The participant has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV). - The participants persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Participants currently on a short-acting β2-agonist (SABA) only, regimen or as needed (PRN), are not eligible. - The participant has demonstrated ≥10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol. - The participant (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device. - All participants must be able to replace their current SABA with albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) inhalation aerosol at the SV for use as needed for the duration of the study. - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: - The participant has a history of life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures. - The participant is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the participants last study-related visit. - The participant has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the investigational medicinal product (IMP) or rescue medication formulation (that is, lactose). - The participant has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (for example, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study. - The participant currently smokes or has a smoking history. The participant must not have used tobacco products within the past year (for example, cigarettes, cigars, chewing tobacco, or pipe tobacco). - The participant has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV. - The participant has used immunosuppressive medications within 30 days before the SV. - The participant has untreated oral candidiasis at the SV. Participants with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period. - The participant has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection. - The participant is an immediate relative of an employee of the clinical investigational center. - A member of the participants household is participating in the study at the same time. - Vulnerable participants (that is, people kept in detention) are excluded from participation. - Additional criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 020/CL (Moderate Acute UC) (ex-US); BRIEF: The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis. ; DRUG USED: COLAL-PRED; DRUG CLASS: Non-NME; INDICATION: Ulcerative Colitis (UC); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Alizyme; CRITERIA: Inclusion Criteria: - Endoscopically confirmed diagnosis of ulcerative colitis - Score of 6-10 on the Disease Activity Index (DAI) - Moderate to severe mucosal appearance Exclusion Criteria: - Previous colonic surgery - Other treatments for ulcerative colitis that have not been stabilised - Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure - History of tuberculosis ; PRIMARY OUTCOME: Disease activity index; SECONDARY OUTCOME 1: Simple clinical colitis activity index[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SIRROUND-H; BRIEF: The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate. ; 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: - Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening - Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline - Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate - Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent - C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening Exclusion Criteria: - Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept - Has ever used tofacitinib therapy or any other JAK inhibitor - Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration - Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable ; PRIMARY OUTCOME: Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission 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 - MAGELLAN-2; BRIEF: The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C virus (HCV) infection. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Male or female, at least 18 years of age at time of screening. - Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection. - Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or subject received a cadaveric or living donor kidney at least 3 months before screening. - Subjects must be documented as non-cirrhotic. - Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine. Exclusion Criteria: - Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. - Clinical history of fibrosing cholestatic hepatitis post-transplant. - Re-transplantation of the liver or kidney. - Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening. - History of post-transplant complications related to hepatic or renal vasculature. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-treatment Virologic Failure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SYNERGY; BRIEF: The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems. ; DRUG USED: Solifenacin/Mirabegron; DRUG CLASS: Non-NME; INDICATION: Overactive Bladder (OAB); TARGET: Beta-3 adrenergic receptor (ß3 adrenoceptor), Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Europe B.V.; CRITERIA: Inclusion Criteria: - Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; - Subject had symptoms of wet OAB (urinary frequency and urgency with incontinence) for at least 3 months; Exclusion Criteria: - Subject had significant PVR volume (> 150 mL); - Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinsons disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion. - Subject had an indwelling catheter or practices intermittent self catheterization. - Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis. - Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin. - Subject had moderate to severe hepatic impairment - Subject had severe renal impairment - Subject had a clinically significant abnormal ECG - Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. - Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia). - Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg. ; PRIMARY OUTCOME: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours; SECONDARY OUTCOME 1: Change From Baseline to EoT in Mean Volume Voided Per Micturition[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - P08034 - Pediatric GT1; BRIEF: This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC. ; DRUG USED: Victrelis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - CHC GT1 infection for at least 6 months with with HCV-RNA ≥10,000 IU/mL. - Treatment naive, non-cirrhotic participants will be eligible for inclusion in Study Part A - Non-cirrhotic subjects who failed previous (peg)interferon/ribavirin treatment for CHC and cirrhotics, whether treatment naive or treatment failure, will be eligible for inclusion in Study Part B - To participate in Study Part C, participants must have completed the required post-treatment follow-up in Study Part A or Part B - Weight ≥ 10 kg to ≤ 125 kg - Body surface area (BSA) ≥0.46 m^2 and ≤2.5 m^2 - Previous liver biopsy with histology consistent with chronic hepatitis C and no other etiology within 2 years of the screening visit - Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the screening visit or between the screening visit and Day 1 with no findings suspicious for hepatocellular carcinoma - Participant must be able to adhere to dose and visit schedules Exclusion Criteria: - Known co-infection with the the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive) - For Study Part A, participant received any prior hepatitis C treatment, including herbal remedies, with known hepatotoxicity - For Study Part B, participant received treatment with ribavirin within 90 days or any interferon alpha within 30 days prior to screening - For Study Part B, participant received previous treatment with a hepatitis C virus protease inhibitor (excepting participants in study P07614, Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1) - For Study Part B, participant required discontinuation of previous (peg)interferon/ribavirin therapy for an adverse event considered by the investigator to be related to (peg)interferon and/or ribavirin - For Study Part B, participant is currently taking any antiviral/immunomodulatory treatment for hepatitis C - Participant has taken any investigational drugs, except boceprevir - Participant has received any of the following medication(s) within 2 weeks prior to the Day 1 visit: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine) - Participation in any other clinical trial within 30 days of enrollment or intent to participate in another clinical trial during participation in the current study - Evidence of decompensated liver disease - Child Pugh score >6 (class B and C) - History of diabetes or hypertension or was born prior to 32 weeks of gestation and has clinically significant ocular examination findings - Pre-existing clinically significant psychiatric condition(s) - Clinical diagnosis of substance abuse - Any pre-existing medical condition that could interfere with participation in and completion of the study - Evidence of active or suspected malignancy - Females who are pregnant, nursing, or intend to become pregnant during the study period - Allergy or sensitivity to the investigational products or excipients ; PRIMARY OUTCOME: Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A; SECONDARY OUTCOME 1: Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RELATION (NVS, Adjunct to Laser); BRIEF: This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Visual acuity impairment caused by macular edema in at least one eye - Type 1 or type 2 diabetes mellitus - Stable medication of diabetes in past 3 month 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 Other protocol defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12; 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 - 200190; BRIEF: The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults aged 18 years and older. ; DRUG USED: FluLaval; 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. - A male or female 18 years of age and older at the time of the first vaccination. - Written informed consent obtained from the subject. - Healthy subjects or subjects with well-controlled chronic disease, 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. - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. - Female subjects of childbearing potential may be enrolled in 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 dose. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding the dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. - Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration during the study period. - Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period. - Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period. - Clinically or virologically confirmed influenza infection within the 6 months preceding the study vaccination. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required): - History of human immunodeficiency virus (HIV) infection, - Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. - Acute disease and/or fever at the time of enrollment. - Acute disease is defined as the presence of a short term, moderate or severe illness, with or without fever. - Fever is defined as temperature ≥ 38.0°C/100.4°F for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral. - Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. - Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. Uncontrolled is defined as: - Requiring institution of new medical or surgical treatment within one month prior to study enrollment, or - Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or - Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or - Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. - Subjects who participated in the registration trial [116664 (FLU Q-TIV-014)] for Fluviral™ 2012/2013 conducted in the 2012-2013 season. - Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder. - A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period. - Any known or suspected allergy to any constituent of Fluviral™ and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury. - A history of severe adverse reaction to a previous influenza vaccination. - Pregnant or lactating female. - 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. - Any condition which, in the opinion of the investigator, prevents the subject from participation in the study or would make the intramuscular injection unsafe. ; PRIMARY OUTCOME: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains; SECONDARY OUTCOME 1: Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SOLITAIRE-IV; BRIEF: This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia. ; DRUG USED: Solithera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Melinta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Male and female patients ≥ 18 years of age - An acute onset of at least 3 of the following signs and symptoms (new or worsening): 1. Cough 2. Production of purulent sputum 3. Shortness of breath (dyspnea) 4. Chest pain due to pneumonia - At least 1 of the following: 1. Fever 2. Hypothermia 3. Presence of pulmonary rales and/or evidence of pulmonary consolidation - PORT Risk Class II, III, or IV - Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study - Not received any systemic antibiotics during the prior 7 days Exclusion Criteria: - Ventilator-associated pneumonia - Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease - Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms - Fungal pneumonia - Pneumocystis jiroveci pneumonia - Aspiration pneumonia - Other non-infectious causes of pulmonary infiltrates - Primary or metastatic lung cancer - Cystic fibrosis - Active or suspected tuberculosis - HIV or myasthenia gravis ; PRIMARY OUTCOME: Early clinical response rate in the Intent to Treat (ITT) population.; SECONDARY OUTCOME 1: Early clinical response rate in the microITT population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EVCR-11196 (vs. Estrace Cream); BRIEF: The purpose of this study is to determine the therapeutic equivalence of Mylans estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment. ; DRUG USED: Estradiol Vaginal Cream; DRUG CLASS: Non-NME; INDICATION: Vaginal Atrophy; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Mylan Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: 1. Capable of providing informed consent. 2. Age: 40-70 years old. 3. Sex: Female 4. Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 5. Weight: At least 48 kg with all subjects having a Body Mass Index less than or equal to 38 kg/m2 but greater than or equal to 19 kg/m2. 6. Baseline evaluation requirements: - ≤5% superficial cells on vaginal smear cytology - Vaginal pH > 5.0 - At least one patient self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy (VVA) from the following list that is identified by the subject: - Vaginal dryness - Vaginal and/or vulvar irritation/itching - Dysuria - Vaginal pain associated with sexual activity - Vaginal bleeding associated with sexual activity (absence vs. presence) 7. All subjects should be judged to be eligible for participation in this study by the principal or sub-investigator physician during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include: 1. a normal or non-clinically significant physical examination, including vital signs 2. a normal or non-clinically significant pelvic examination that was consistent with hypoestrogenemia 3. a normal or non-clinically significant breast exam and mammogram 4. a normal or non-clinically significant ASCUS Papanicolaou (Pap) smear that is negative for HPV for subjects with an intact uterus and cervix 5. within normal limits or non-clinically significant laboratory evaluation results (unless otherwise noted in the exclusion criteria) for the following tests: - Serum Chemistry - Hematology - Coagulogram - Urinalysis 6. normal or non-clinically significant 12- Lead ECG. 7. negative urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine with the following exceptions: positive tests for amphetamines, barbiturates, benzodiazepines, or opiates may be allowed provided the subject has a valid prescription and is on a stable regimen that complies with Exclusion Criteria, Section 6.3.2. 8. negative urine cotinine test. 8. For women with an intact uterus, an endometrial thickness < 5 mm as determined by vaginal ultrasonography. 9. If warranted, other tests or examinations may be performed at the discretion of the Principal Investigator or responsible physician. 10. Ability to use applicator properly. Exclusion Criteria: 1. Institutionalized subjects will not be used. 2. Any contraindication to estrogen therapy. 3. Social Habits: 1. Use of any tobacco-containing products within 1 year of the start of the study. 2. Regular intake of more than 7 units of alcohol per week. 3. Beginning any new regimens of vitamins or herbal products within 7 days prior to the initial dose of the study medication. 4. Any recent, significant change in dietary or exercise habits. 5. History of drug and/or alcohol abuse within one year of start of study. 4. Medications: 1. Use of any new prescription or over-the-counter (OTC) medication regimens within fourteen (14) days prior to the initial dose of study medication (any necessary medication, unless otherwise noted in the exclusion criteria, for which dosing has been stabilized for a period of at least 14 days prior to initial dosing of study drug and is expected to remain stable for the entire study period is allowed, with the exception of acetaminophen, which may be administered as needed to treat minor adverse events). 2. Use of hormonal replacement therapies for the following time periods: - within 2 weeks of baseline assessment for vaginal therapy (rings, creams, gels) - within 4 weeks of baseline assessment for transdermal estrogen alone or estrogen/progestin therapy - within 8 weeks of baseline assessment for oral estrogen and/or progestin therapy or intrauterine progestin therapy - within 3 months of baseline assessments for progestin implants or estrogen alone injectable therapy - within 6 months of baseline assessments for estrogen pellet or progestin injectable therapy 3. A depot injection or implant of any drug within 3 months prior to administration of study medication. 4. Currently taking medication indicated for anticoagulation as a result of an excluded condition listed in #5 below. This includes but is not limited to warfarin, heparin, NSAIDs, clopidogrel, dabigatran, etc. 5. Diseases: 1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, urinary, musculoskeletal disease or malignancies unless under medical control and/or deemed not clinically significant by the Principal Investigator or Medical Sub-investigator. 2. Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or > 50% angiographic narrowing of coronary artery, thrombosis of deep veins and arteries, thromboembolic disorders, pulmonary embolism) or history of these conditions. 3. Coronary artery or cerebrovascular disease. 4. Current clinically significant liver or kidney dysfunction/disorders. 5. Current clinically significant gallbladder dysfunction/disorders. 6. Abnormal or clinically significant breast examination. Acceptable breast examination is defined as no masses or other findings identified that are suspicious of malignancy. 7. First degree family history of breast cancer. 8. Current non diet controlled diabetes mellitus or other clinically significant endocrinological disease. 9. Estrogen-dependent neoplasia 10. Postmenopausal uterine bleeding 11. Endometrial hyperplasia 12. Uncontrolled hypothyroidism 13. Urinalysis showing an ongoing clinically significant urinary tract infection that requires treatment. 14. Current clinically significant vaginal infection that requires treatment. 15. Known chronic lichen sclerosis 16. Acute illness at the time of either the pre-study medical evaluation or dosing. 17. History of allergy or hypersensitivity to estradiol, other related products, or any inactive ingredients. 18. Undiagnosed vaginal bleeding or history of significant risk factors for endometrial cancer. 19. Increased frequency or severity of headaches while on previous hormone or estrogen therapy. 20. History of psychiatric disorders occurring within the last 6 months that require hospitalization or medication. 21. Current hypercalcemia, hypocalcemia, and/or hypertriglyceridemia. 22. Clinically significant eye/visual abnormalities such as retinal vascular thrombosis, partial or complete loss of vision, proptosis, diplopia, papilledema, retinal vascular lesions. 6. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study. 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. 8. Sitting blood pressure higher than 150/90 mmHg at screening. 9. Baseline serum estradiol levels >30 pg/mL at screening. ; PRIMARY OUTCOME: Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence; SECONDARY OUTCOME 1: Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - REMISSION (Morocco); BRIEF: This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions). ; DRUG USED: Actemra (Intravenous) ; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/= 18 years of age - Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening) - Inadequate response to DMARDs - Body weight < 150 kg Exclusion Criteria: - Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment - Rheumatic autoimmune disease other than RA - American College of Rheumatology (ACR) functional class IV - Prior history of or current inflammatory joint disease other than RA - Previous treatment with any biologic drug that is used in the treatment of RA - Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline - Pregnant or lactating women - Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection ; PRIMARY OUTCOME: Percentage of Participants With Adverse Events; SECONDARY OUTCOME 1: Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study 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 - ENDURANCE-1 (GT-1); BRIEF: This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Male or female, at least 18 years of age at time of screening. - Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection. - Chronic HCV infection. - Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy). - Subjects must be non-cirrhotic. Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients: - HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening. OR - On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening. Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs. - Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. - Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. - Positive test result at Screening for hepatitis B surface antigen (HBsAg). - HCV genotype performed during screening indicating co-infection with more than one HCV genotype. - Chronic HIV type 2 (HIV-2) infection. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm; SECONDARY OUTCOME 1: Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - A303 (Ext.); BRIEF: Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep ; DRUG USED: Daridorexant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Insomnia; TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: - Signed informed consent prior to any study-mandated procedure (Visit 1). - Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104). - For woman of childbearing potential, the following is required: - Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies) - Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT. Exclusion Criteria: - Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subjects safety or interfere with the study assessments (Visit 1). - For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1). - Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT). ; PRIMARY OUTCOME: Total no. of Subjects With at Least One TEAE; 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 - PALLAS; BRIEF: Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death). ; DRUG USED: Multaq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atrial Fibrillation/Flutter; TARGET: Alpha Adrenergic Receptors, Beta Adrenergic Receptors, Calcium Channel, Potassium channels, Sodium Channels; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Permanent AF defined by the presence of all of the following criteria: - Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter; - Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization; - No evidence of sinus rhythm in the period between these two documentations of AF; - Decision of the patient and physician to allow AF to continue without further efforts to restore sinus rhythm. - At least one of the following risk criteria: - Coronary artery disease; - Prior stroke or Transient Ischemic Attack [TIA]; - Symptomatic heart failure; - Left ventricular ejection fraction [LVEF] less or equal to 0.40; - Peripheral arterial occlusive disease; - Aged 75 years or older with both hypertension and diabetes mellitus. Exclusion criteria: - Paroxysmal AF; - Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm; - Heart failure of New-York Heart Association [NYHA] class IV or recent unstable NYHA class III. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Overview of the Two Co-primary Outcomes; SECONDARY OUTCOME 1: Deaths[/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 - Severe Hemophilia ; BRIEF: The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs, thus supplementing the existing database to obtain approval of Wilate for the indication hemophilia A in the USA. ; DRUG USED: Wilate; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Octapharma; CRITERIA: Inclusion Criteria: 1. Severe hemophilia A (<1% FVIII:C) according to medical history 2. Male patients aged ≥12 years 3. Previous treatment with a FVIII concentrate for at least 150 exposure days (EDs) 4. Immunocompetence (CD4+ count >200/µL) 5. Good documentation of the historical bleeding rate (at least for the 6 months preceding study start) 6. Voluntarily given, fully informed written and signed consent obtained by the patient (or parent/legal guardian in case of adolescents) before any study-related procedures are conducted Whenever possible, the interval between the Screening Visit and the PK or Non-PK Visit should not exceed 30 days. If the 30-day interval is exceeded, determination of the CD4+ count is to be repeated and must be >200/µL for patients to be enrolled (i.e., exclusion criterion no. 4). Exclusion Criteria: 1. Any coagulation disorders other than hemophilia A 2. History of FVIII inhibitor activity (≥0.6 BU) or detectable FVIII inhibitory anti-bodies (≥0.6 BU using the Nijmegen modification of the Bethesda assay) at screening, as determined by the central laboratory 3. Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate transaminase [ASAT] levels >5 times of upper limit of normal, creatinine>120 µmol/L) 4. Patients receiving or scheduled to receive immunomodulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs 5. Treatment with any investigational medicinal product in another interventional clinical study currently or within 4 weeks before enrollment ; PRIMARY OUTCOME: Total Annualized Bleeding Rate (TABR); SECONDARY OUTCOME 1: Spontaneous Annualized Bleeding Rate (SABR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALIZE; BRIEF: This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1 - Weight of ≥40 kg - Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA) - Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50% predicted at Visit 1 or Visit 2. - Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR - Airway reversibility documented in the previous 12 months prior to Visit 1 - An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR - Any condition assessed by patient recall over the previous 2-4 weeks Exclusion Criteria: - Clinically important pulmonary disease other than asthma - Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine - Receipt of an influenza vaccine within 90 days prior to randomization - Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma - Acute illness or evidence of significant active infection or known influenza infection during the current flu season ; PRIMARY OUTCOME: Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12; SECONDARY OUTCOME 1: Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ACELARATE; BRIEF: The primary purpose of this study is to assess whether Acelarin (NUC-1031) is superior to gemcitabine in terms of overall survival for treatment of patients with metastatic pancreatic carcinoma. In addition disease progression, quality of life and comparative safety will be evaluated. Secondary objectives are to compare between the two treatment groups the following: - Progression Free Survival (PFS) - Radiological Response and disease control rate - Toxicity and safety - Quality of Life Additional, exploratory objectives are to discover and validate possible biomarkers to predict additional benefit of Acelarin (NUC-1031) over gemcitabine alone. ; DRUG USED: Acelarin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: DNA synthesis; THERAPY: Monotherapy; LEAD SPONSOR: The Clatterbridge Cancer Centre NHS Foundation Trust; CRITERIA: Inclusion Criteria: - Age ≥ 18 years. - Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas. - Metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected pancreatic cancer can be included. - Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment. - Unidimensionally measurable disease. - ECOG performance status 0, 1 or 2 where combination chemotherapy is not deemed appropriate or is declined by the patient. - Platelets ≥100 x 109/l; WBC ≥ 3 x 109/l; neutrophils ≥ 1.5 x 109/l at entry. - Documented life expectancy > 3 months. - Informed written consent. Exclusion Criteria: - Laboratory results: - Serum bilirubin ≥ 1.5x the upper limit of reference range (ULRR). - Haemoglobin < 10G/dl. - Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula). - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULN or > 5x ULN if judged by the investigator to be related to liver metastases. - Medical or psychiatric conditions compromising informed consent. - Intracerebral metastases or meningeal carcinomatosis. - Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigators opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. - Pregnancy or breast feeding. - Previous chemotherapy for locally advanced and metastatic disease. Adjuvant chemotherapy for resected pancreatic cancer will be permitted provided that chemotherapy was completed > 12 months previously. - Radiotherapy within the last 4 weeks prior to start of study treatment. - Concurrent malignancies or invasive cancers diagnosed within past 5 years except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer. - Hypersensitivity to gemcitabine or any of the excipients of gemcitabine or Acelarin (NUC-1031). - All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be from the list below, the other must be a condom* or abstaining from sexual intercourse, until six months after treatment has ended: - Combined (oestrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: either oral, intravaginal or transdermal. - Progesterone-only hormonal contraception associated with inhibition of ovulation: either oral, injectable or implantable. - Intra-uterine device (IUD) - Intra-uterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomised partner *Male or female condom with or without spermicide is not an acceptable method of contraception alone. ; PRIMARY OUTCOME: Number of participants that have survived throughout treatment and also into follow-up, as measured by the primary cause of death and date of death CRFs.; SECONDARY OUTCOME 1: Number of participants that survive progression-free and for how long, as assessed by 12-weekly CT scan assessments per RECIST v1.1 and end of study CRF to capture the reasons for coming off 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 - SPIRIT II; BRIEF: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer. ; DRUG USED: Targretin capsules; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Retinoid X receptors (RXRs); THERAPY: Combination; LEAD SPONSOR: Eisai Inc.; CRITERIA: Patients must have: - Pathologic (histologic or cytologic) confirmation of NSCLC - Stage IIIB with malignant pleural effusion or Stage IV disease - At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy - ECOG performance status 0 or 1 - Adequate organ system function - Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy). Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months) Patients must not have had: - Brain metastasis - Prior chemotherapy for NSCLC - Prior platinum-based chemotherapy for any indication ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MERIT - Selzentry/Combivir vs Sustiva/Combivir (Treatment-Naive); BRIEF: Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96. ; DRUG USED: Selzentry; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5); THERAPY: Combination; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities) - HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL - A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP) - Effective barrier contraception for WOCBP and males Exclusion Criteria: - Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy - Treatment for an active opportunistic infection, or unexplained temperature >38.5 degrees Celsius for 7 consecutive days - Prior treatment with efavirenz, zidovudine or lamivudine or with any other antiretroviral therapy for more than 14 days at any time - Active alcohol or substance abuse sufficient, in the Investigators judgment, to prevent adherence to study medication and/or follow up - Lactating women, or planned pregnancy during the trial period - Suspected primary (acute) HIV-1 infection - Previous therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 30 days prior to randomization or the expected need for such therapy during the study period - Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization - Significantly elevated liver enzymes or cirrhosis - Significant neutropenia, anemia or thrombocytopenia - Malabsorption or an inability to tolerate oral medications - Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease - Certain medications - Genotypic or phenotypic resistance to efavirenz, zidovudine or lamivudine - X4- or dual/mixed-tropic virus or repeated assay failure - Any other clinical condition that, in the Investigators judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy ; PRIMARY OUTCOME: Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KF7013-04; BRIEF: The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS). The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid 100 mg or placebo) over 10 days, and a Follow-up Period 1 until Week 26. At Week 26, participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52. Participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52. ; DRUG USED: Nerixia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Pain; TARGET: Osteoclast; THERAPY: Monotherapy; LEAD SPONSOR: Grünenthal GmbH; CRITERIA: Inclusion Criteria: - Informed consent signed. - Male or female participant at least 18 years of age at Visit 1. - A diagnosis of CRPS according to the clinical diagnostic criteria recommended by the International Association for the Study of Pain (IASP; Budapest clinical criteria), assessed at Visit 1. Signs and symptoms of CRPS must apply to an affected limb (arm or leg) and must demonstrate asymmetry with respect to the contralateral limb. The CRPS duration must be 2 years or less since onset of symptoms. - A baseline average pain intensity score of greater than or equal to 4 using an 11-point numerical rating scale (NRS), referring to the CRPS-affected limb (average of pain recorded over 7 days). The baseline average pain intensity score will be calculated automatically by the electronic diary, which must be checked prior to allocation at Visit 2. A participant who has not met average baseline pain intensity requirements (at least 4 average pain intensity ratings) due to lack of compliance with the electronic diary may be rescheduled for Visit 2 (1 time only), with appropriate re-training to ensure compliance with use of the electronic diary. - In stable treatment and follow-up therapy for CRPS for at least 1 month prior to allocation to treatment (Visit 2). Participants must have failed attempts with at least 2 available treatments for CRPS, 1 of which must have been a pharmacologic treatment. - Women of child-bearing potential must have a negative urine Beta-human chorionic gonadotropin (ß-HCG) pregnancy test at Visit 1 and must be using 2 forms of medically acceptable contraception, including at least 1 highly effective method of contraception with a low failure rate, defined as less than 1% per year, and a second medically acceptable method such as use of condoms with spermicide by their male partner. A barrier method alone is not acceptable. Highly effective methods of contraception must be used for at least 1 month prior to Visit 2 and for the duration of the trial. Male participants must use condom and spermicide during intercourse and must take care that the female sexual partner uses at least 1 additional method of contraception with a low failure rate defined as above, starting with Visit 2 until at least 4 weeks after the last Investigational medicinal product (IMP) infusion. - Participants must be able to communicate meaningfully, be able to differentiate with regard to location and intensity of the pain, and be able to answer the questions in the questionnaires used in this trial (assistance in filling out the questionnaires may be provided, if required due to motor or other physical impairment). Exclusion Criteria: - Evidence of renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2 using the 2009 Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation [Levey et al. 2009] or a urinary albumin to creatinine ratio [ACR] greater than 150 mg/g), based on central safety laboratory data obtained prior to Visit 2. Note: a single repeat laboratory test is allowed. - Serum calcium or magnesium outside of the central laboratorys reference range, based on central safety laboratory data obtained prior to Visit 2 (a single repeat laboratory test is allowed); a history of hypocalcemia or a metabolic disorder anticipated to increase risk for hypocalcemia (e.g., hypoparathyroidism); anticipated need for any new drug with known potential to cause hypocalcemia (e.g., aminoglycosides, new treatment with or dose adjustment of loop diuretics) during the trial. Participants on a stable dose of loop diuretics may receive treatment with IMP as long as no dosage increases in the diuretic medication are anticipated and calcium levels are in the reference range. - Vitamin D deficiency, defined as a 25(OH)D level less than 30 ng/mL (75 nmol/L), based on central safety laboratory data obtained prior to Visit 2 (up to 4 repeat laboratory tests are allowed). Participants with vitamin D deficiency should receive appropriate supplementation during the Enrollment Period. A vitamin D level of at least 30 ng/mL (75 nmol/L) must be documented prior to allocation to IMP. - Corrected QT interval (according to Fridericias formula; QTcF) greater than 470 ms (average of 3 Electrocardiogram (ECGs) obtained at Visit 1) according to central ECG reading facility evaluation or QTcF greater than 470 ms at pre-dose ECG at Visit 2 according to the investigators judgment; serum potassium outside the central laboratorys reference range at Visit 1(a single repeat laboratory test is allowed); clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or an indwelling pacemaker; evidence of complete left bundle branch block; complete atrioventricular block; history of Long QT Syndrome or a relative with this condition; or any history of or other known risk factor for torsade de pointes. - Participants receiving medications with a known risk of torsades de pointes within 7 days prior to allocation. Participants receiving selective serotonin re-uptake inhibitor antidepressants are eligible if the QT interval values do not meet the exclusion criteria, the medication was started at least 1 month prior to allocation, the dose is stable, and the dose is anticipated to remain stable throughout the trial. - Any prior use of a bisphosphonate for treatment of CRPS, any prior administration of a bisphosphonate within the previous year, anticipated requirement for treatment with a bisphosphonate for another condition such as osteoporosis during the trial, or administration of denosumab (Prolia®) or other bone turnover suppressing drugs within 6 months prior to Visit 1. - History of any allergic or hypersensitivity reaction to neridronic acid or other bisphosphonate, acetaminophen, or to vitamin D or calcium supplements. - Recent tooth extraction or other invasive dental procedure (within 3 months prior to Visit 1), unhealed or infected extraction site, or significant dental/periodontal disease that may pre-dispose to need for tooth extraction or other invasive dental procedures during the trial. Participants with indeterminate, suspicious or unreliable dental history, in the opinion of the investigator, must undergo a dental examination prior to receiving treatment. - Evidence of denture-related gum trauma or improperly fitting dentures causing injury. - Prior radiation therapy of the head or neck (within 1 year of Visit 1). - History of malignancy within 2 years prior to Visit 1, with the exception of basal cell carcinoma. - Use of nerve blocks, ketamine infusions, intravenous immunoglobulin, acupuncture, electromagnetic field treatment, or initiation/implementation of radiofrequency ablation or other sympathectomy procedures, or peripheral nerve stimulation within 6 weeks prior to Visit 1. - Evidence of current alcohol or drug abuse, or history of alcohol or drug abuse within 2 years of Visit 1, based on participant history and physical examination and according to the investigators judgment. - Any other severe medical condition, including severe depression, or any other severe mood disorder, that in the opinion of the investigator may affect efficacy or safety assessments or may compromise the participants safety during trial participation. - Women who are pregnant or breastfeeding. - Elevated aspartate aminotransferase or alanine aminotransferase greater than 2-fold upper limit of normal, based on central safety laboratory data obtained at Visit 1, or current evidence of chronic liver disease. Safety laboratory testing may be repeated prior to Visit 2, and participants will be allowed in the trial if results of 2 consecutive tests, at least 3 days apart, are less than or equal to 2-fold upper limit of normal. - Participation in another investigational drug trial within 3 months prior to Visit 1, or any previous trial involving neridronic acid, with the exception of participants participating in study KF7013-01 who were assigned to placebo and did not receive neridronic acid. - Participant is engaged in litigation related to their disability from CRPS in which monetary gain or loss (or other compensation) may affect their objective participation in the trial. - Participants taking forbidden concomitant medications/therapies or not being able to follow the rules of use of concomitant treatment. - Participants incapable of giving informed consent. Criteria to continue into Treatment Period B - A value of at least 4 on the pain intensity question (question number 29, GLOBAL07) of the Patient-Reported Outcomes Measurement Information System (PROMIS®) (PROMIS-29 profile) at Visit 11. - The following exclusion criteria are not met: - Evidence of renal impairment (eGFR less than 30 mL/min/1.73 m2 using the 2009 CKD-EPI creatinine equation [Levey et al. 2009] or a urinary ACR greater than 150 mg/g), based on central safety laboratory data obtained prior to Visit 11. A single repeat laboratory test is allowed. - Corrected QT interval (QTcF) greater than 470 ms (average of 3 ECGs obtained at Visit 10) according to the central ECG reading facility evaluation or QTcF greater than 470 ms at pre-dose ECG at Visit 11 according to the investigators judgment; serum potassium outside the central laboratorys reference range at Visit 10 (a single repeat laboratory test is allowed); clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or an indwelling pacemaker; evidence of complete left bundle branch block; complete atrioventricular block; any other known risk factor for torsade de pointes. - Participants receiving medications with a known risk of torsades de pointes within 7 days prior to re-allocation. - Participants taking forbidden concomitant medications/therapies or not being able to follow the rules of use of concomitant treatment. - Recent tooth extraction or other invasive dental procedure (within 3 months prior to Visit 11), unhealed or infected extraction site, or significant dental/periodontal disease that may pre-dispose to need for tooth extraction or other invasive dental procedures during the further course of the trial. - Serum calcium outside of the central laboratorys reference range, despite appropriate supplementation between Visit 10 and Visit 11, based on the last central safety laboratory data obtained prior to Visit 11. Two repeat laboratory tests are allowed. - Vitamin D deficiency prior to IMP re-allocation, defined as a 25(OH)D level less than 30 ng/mL (75 nmol/L), based on the last central safety laboratory data obtained prior to Visit 11, i.e., inability to normalize 25(OH)D levels to at least 30 ng/mL (75 nmol/L) despite appropriate supplementation between Visit 10 and Visit 11. Two repeat laboratory tests are allowed. - Elevated aspartate aminotransferase or alanine aminotransferase greater than 2-fold upper limit of normal, based on central safety laboratory data obtained at Visit 10, or current evidence of chronic liver disease. A single repeat laboratory test is allowed. - No other criterion for trial and/or IMP discontinuation is met. ; PRIMARY OUTCOME: Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary); SECONDARY OUTCOME 1: Change From Baseline to Week 26 in the Average Pain Intensity Recorded on the Tablet Computer[/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 - PCM306 (U.S.); BRIEF: Multi-center, prospective, randomized controlled clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer. The study will include criteria for evaluation, biopsy, eligibility, informed consent, subsequent management and decision making conducted based on data provided locally at each center that follow a set of standardized criteria. ; DRUG USED: Tookad; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Steba Biotech S.A.; CRITERIA: Inclusion Criteria: 1. Men 18 years or older. 2. Men who have chosen Active Surveillance as the treatment for their prostate cancer. 3. Patients who have had a multiparametric MRI of the prostate performed and have undergone transrectal systematic biopsy plus biopsy of any lesions (or areas) considered suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before signing consent. 4. Unilateral Grade Group 2 (Gleason grade 3+4=7) prostate cancer with a total length of Gleason pattern 4 no more than 2mm when measured in all systematic biopsy cores plus up to 1 core from each targeted biopsy lesion (if more than 1 core is taken from a given lesion the core with the longest length of pattern 4 will be included). Note: the presence and length of Grade Group 1 (Gleason score 3+3=6) cancer in the biopsy will not be considered when determining eligibility. 5. Prostate cancer clinical stage up to cT2a, N0/Nx, M0/Mx. 6. Prostate volume ≥20 mL and ≤80 mL 7. Serum PSA ≤10 ng/mL. 8. Patients with cT2a and PSA between 10 and 20 ng/mL will have appropriate imaging and work up to sufficiently exclude clinical evidence of bone metastases (e.g., bone scan, whole body MRI, PET scan, or equivalent). Patients with sites considered suspicious may be evaluated with confirmatory biopsy to determine eligibility. Patients with sites considered definite or consistent with bone metastases will be excluded. 9. Men who are sexually active with women of childbearing potential must use contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days after the VTP procedure. The individual methods of contraception may be determined in consultation with the investigator. 10. Signed Informed Consent Form. Exclusion Criteria: 1. Grade Group 3, 4 or 5 (≥ Gleason Score 4+3=7) cancer 2. In patients with Grade Group 2 cancers, a total length of Gleason pattern 4 more than 2mm when measured in all systematic biopsy cores plus up to 1 core from each targeted biopsy lesion (if more than 1 core is taken from a given lesion, include the mm of pattern 4 in the 1 core with the longest length of pattern 4) 3. Bilateral GG 2 cancer 4. MRI evidence of extracapsular extension of cancer (MRI read as definite, frank or gross ECE, or MRI lesion with >10mm capsular contact, in an area with biopsy proven cancer). 5. Seminal vesicle invasion on DRE or MRI (probable or consistent with) 6. Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan. 7. Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy) or chemotherapy; 8. Life expectancy less than 10 years; 9. Participation in another clinical study involving an investigational product that in the opinion of the investigator may interfere with the endpoints or investigational criteria of this study; 10. Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks, especially inability to understand and fulfill the health-related QOL questionnaire; 11. Any history of a definitively ablative procedure for benign prostatic disease, such as benign prostatic hyperplasia, including TURP, whether electrosurgical or thermal laser ablation; or high intensity frequency ultrasound (HIFU) or cryotherapy, for focal or total ablative therapy of the prostate. 12. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure such as: 1. Medical conditions that preclude the use of general anesthesia; 2. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of fistula formation; 3. Hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production within the previous 6 months; 4. Oral anticoagulant drugs that could not be withdrawn at least 5 days prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn at least 5 days prior to the VTP procedure and for at least 3 days after VTP; 5. Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) or blood disorders (upon clinician judgment); 6. A history of sun hypersensitivity or photosensitive dermatitis. 7. Any other condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the patient (e.g., cardiac or respiratory disease precluding general anesthesia, active urethral stricture disease). ; PRIMARY OUTCOME: Rate of objective progression; SECONDARY OUTCOME 1: Rate of conversion to radical local or systemic therapy[/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 - 302 (Adenoviral Conjunctivitis); BRIEF: The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis. ; DRUG USED: TAK-640; DRUG CLASS: Non-NME; INDICATION: Other Ophthalmological Indications (Ophthalmology); TARGET: Bacteria-miscellaneous, Glucocorticoid Receptor (GR), Microbial DNA, Viral Envelope; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria 1. An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable). 2. Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally-authorized representative(s) informed consent (and assent, if applicable) to participate in the study. 3. Participants of any age at Visit 1 (Note: Participants less than (<) 3 months of age at Visit 1 must have been full-term, that is greater than or equal to (>=) 37 weeks gestational age at birth). 4. Meet at least 1 of the 2 criteria below: a. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye; b. Have at least 2 of the following 5 criteria, based upon medical history and examination: i. Symptoms within the past 7 days consistent with acute upper respiratory tract infection (example: sore throat, cough, rhinorrhea, etc); ii. Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis; iii. Acute onset within the past 4 days of 1 or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity; iv. Enlarged periauricular lymph node(s); v. Presence of follicles on tarsal conjunctiva. Note: If the participant only meets Inclusion Criterion 4a (a positive AdenoPlus test in at least 1 eye), then the same eye must meet Inclusion Criterion 5. 5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye: Report presence of signs and/or symptoms of adenoviral conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1; Bulbar conjunctival injection: a grade of >=1 on 0-4 scale of Bulbar Conjunctival Injection Scale; Watery conjunctival discharge: a grade of >=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale. 6. Be willing to discontinue contact lens wear for the duration of the study. 7. Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the American Academy of Pediatrics (AAP) Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians. The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants < 2 months of age who have not yet developed this ability. Participants < 2 months will be enrolled at the discretion of the investigator. 8. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. Exclusion Criteria 1. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigators discretion. 2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. 3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. 4. Prior enrollment in a FST-100 or SHP640 clinical study. 5. Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site. 6. Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study. 7. Have a preplanned overnight hospitalization during the period of the study. 8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example: uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis. 9. Have presence of corneal subepithelial infiltrates at Visit 1. 10. Have active or history of ocular herpes. 11. Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-adenoviral ocular infection (example: bacterial, fungal, acanthamoebal, or other parasitic). Note: History or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary. 12. Neonates or infants (that is (ie,) participants < 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin. 13. Neonates or infants (ie, participants < 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes. 14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1). 15. Presence of any significant ophthalmic condition (example: retinopathy of prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables. 16. Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma, or be a glaucoma suspect. 17. Have any known clinically significant optic nerve defects. 18. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1. 19. Presence of significant, active condition in the posterior segment which requires invasive treatment (example: intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period. 20. Have used any topical ocular or systemic anti-virals or antibiotics within <= 7 days of enrollment. 21. Have used any topical ocular NSAIDs within <= 1 day of enrollment. 22. Have used any topical ophthalmic steroids in the last <= 14 days. 23. Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the peri-ocular area. 24. Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1. 25. Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study. 26. Have any significant ocular disease (example: Sjogrens syndrome) or any uncontrolled systemic disease or debilitating disease (example: cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per investigators discretion. 27. Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplantation. 28. Within 30 days prior to the first dose of investigational product: Have used an investigational product or device, or Have been enrolled in a clinical study (including vaccine studies) that, in the investigators opinion, may impact this Shire-sponsored study. ; PRIMARY OUTCOME: Percentage of Participants With Clinical Resolution on Day 6; SECONDARY OUTCOME 1: Percentage of Participants With Adenoviral Eradication on Day 6[/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 - 3074 (Adjunctive Ext; Depression); BRIEF: The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder. ; DRUG USED: Nuvigil; DRUG CLASS: Non-NME; INDICATION: Bipolar Disorder; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Cephalon; CRITERIA: Key Inclusion Criteria: - The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder. - The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression. - During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met: 1. The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation. 2. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine. 3. The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s). 4. The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator. - The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment. Key Exclusion Criteria: - The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study. - The patient has psychotic symptoms or had psychosis during the double-blind study. - The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. - The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study. - The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation. ; PRIMARY OUTCOME: Participants With Treatment-Emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)[/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 - IB1001-04; BRIEF: To evaluate the safety (acute adverse effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding and control of hemorrhaging during prophylaxis of IB1001 in subjects with hemophilia B. ; DRUG USED: Ixinity; DRUG CLASS: Biologic; INDICATION: Hemophilia B; TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Cangene Corporation; CRITERIA: Inclusion Criteria: 1. Age of at least 12 years 2. Body Mass Index of ≤ 29, with a minimum body weight of 40 kg 3. Written Institutional Review Board (IRB)/ Ethics Committee (EC)-approved informed consent form (ICF) 4. Willingness to make the required study visits, and follow instructions while enrolled in the study (up to 12 months) 5. Severe (factor IX activity ≤2 U/dL) hemophilia B patients with a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months or in the event the subject is on prophylaxis, a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months prior to being placed on prophylaxis 6. Subjects must be on prophylaxis or switch to a prophylaxis regimen for the duration of the PK and Treatment/Continuation Phase of the study 7. Previously treated patients with a minimum of 150 exposure days to a factor IX preparation 8. Willingness to adhere to the 5-day washout of any factor IX replacement therapy prior to PK evaluations 9. Immunocompetent (CD4 count >400/mm3) and not receiving immune modulating or chemotherapeutic agents 10. Platelet count at least 150,000/mm3 11. Liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤2 times the upper limit of the normal range 12. Total bilirubin ≤1.5 times the upper limit of the normal range 13. Renal function: serum creatinine ≤1.25 times the upper limit of the normal range 14. Hemoglobin ≥7 g/dL at the time of the blood draw Exclusion Criteria: 1. History of factor IX inhibitor ≥0.6 BU (Bethesda units) 2. Existence of another coagulation disorder 3. Evidence of thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC) 4. Use of an investigational drug within 30 days prior to study entry 5. Previous use of IB1001 6. Use of medications that could impact hemostasis, such as aspirin 7. Hypersensitivity to the active substance or to any of the excipients in the investigational products 8. Known allergic reaction to hamster proteins 9. History of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol 10. History of adverse reaction to either plasma-derived factor IX or recombinant factor IX that interfered with the subjects ability to treat bleeding episodes with a factor IX product ; PRIMARY OUTCOME: Number of study subjects with adverse events; SECONDARY OUTCOME 1: Number of bleeding episodes divided by number of months of observation[/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 - OMC-SXB-7 ext. (Canada); BRIEF: This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner. ; DRUG USED: Xyrem; DRUG CLASS: New Molecular Entity (NME); INDICATION: Narcolepsy; TARGET: GABA Receptors, GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial - Signed and dated an informed consent ; PRIMARY OUTCOME: Adverse Experiences; 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 - Treatment Naive; BRIEF: The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and symptoms of radiographic AxSpA. ; DRUG USED: Stelara; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met - Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of greater than or equal to (>=4) and a visual analog scale (VAS) score for total back pain of >=4, each on a scale of 0 to 10 - Participants with elevated high sensitivity C-reactive protein (hsCRP) level of >=0.300 milligram per deciliter (mg/dL) at Screening - If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics for AS, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. If currently not using NSAIDs or other analgesics for AS, must not have received NSAIDs or other analgesics for AS for at least 2 weeks prior to the first administration of the study agent - A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Week 0 before randomization Exclusion Criteria: - Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease - Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent - Participants who have received any prior biologic therapy, including but not limited to anti-TNF alpha agents, tocilizumab, alefacept, efalizumab, natalizumab, abatacept, anakinra, ustekinumab, tidrakizumab or other anti-interleukin (IL) 23 biologics, brodalumab, secukinumab, ixekizumab, and B-cell depleting therapies - Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine - Participant who have received leflunomide within 3 months prior to the first administration of study agent (irrespective of undergoing a drug elimination procedure), or have received leflunomide within 12 months prior to the first administration of study agent and have not undergone a drug elimination procedure ; PRIMARY OUTCOME: Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 20 Response 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 - SAKK 41/06 (Switzerland); BRIEF: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab as maintenance therapy is more effective than observation in treating patients with colorectal cancer. PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in treating patients who have undergone first-line therapy for metastatic colorectal cancer. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Swiss Group for Clinical Cancer Research; CRITERIA: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic colorectal cancer - Received prior first-line chemotherapy with oral or intravenous fluoropyrimidine alone or in combination with irinotecan or oxaliplatin - Chemotherapy must have been given in combination with a standard dose of bevacizumab for 16-24 weeks as part of first-line treatment for metastatic colorectal cancer - Stable disease, partial response, or complete response after completion of first-line treatment as documented by abdominal and thoracic CT scan, MRI, or x-ray within the past 21 days - No clinical symptoms or history of CNS metastases - No imaging required in asymptomatic patients PATIENT CHARACTERISTICS: - WHO performance status 0-1 - Serum creatinine < 2.0 mg/dL or 177 μmol/L - Proteinuria < 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 12 months after completion of study therapy - Must have basic health insurance with a Swiss health insurance company - Patients must be compliant and in geographic proximity to allow proper staging and follow-up - No medical reason that prohibits further bevacizumab treatment, including any of the following: - Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg) or clinically significant (i.e., active) cardiovascular disease - Serious non-healing wound, active peptic ulcer, or non-healing bone fracture - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months - History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding - No serious underlying medical condition that, in the judgment of the investigator, could further impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes) - No psychiatric disorder that would preclude patient understanding of study-related topics or giving informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 4 weeks since prior bevacizumab - No prior anti-EGFR treatment (e.g., cetuximab) during first-line therapy - No anticipation of concurrent major surgery (e.g., resection) or ablation of metastases - No concurrent elective major surgery - No concurrent daily aspirin exceeding 325 mg/day or clopidogrel exceeding 75 mg/day - Lower doses of the drugs noted above, or non-steroidal anti-inflammatory drugs with activity on platelets and gastric mucosa, or dipyridamole are allowed if given at a stable dose for ≥ 2 weeks prior to study entry - No other concurrent experimental drugs or anticancer therapy ; PRIMARY OUTCOME: Time to progression (TTP); SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1024 (Department of Veterans Affairs); BRIEF: The main objective of this study is to investigate the effectiveness of lofexidine in reducing withdrawal symptoms among subjects undergoing opiate detoxification. Currently, lofexidine is the most commonly used non-opiate medication for detoxification from opiates in the United Kingdom (UK). There is no non-opiate medication approved by the Food and Drug Administration (FDA) for the same indication in the United States (US). The only medications currently approved by the FDA for opiate detoxification are methadone and buprenorphine. These medications, however, have the potential to be abused. Lofexidine, on the other hand, offers a unique advantage for opiate detoxification because it is not addicting, is easy to use, and has a favorable safety profile. ; DRUG USED: Lucemyra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Substance Use Disorder; TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: US Department of Veterans Affairs; CRITERIA: Inclusion Criteria: Potential subjects must: 1. Be at least 18 years of age. 2. Have current dependence, according to SCID criteria, on any opioid with a half-life similar to heroin or morphine, including Vicodin, Lortab, or Lorcet, Percocet, Percodan, Tylox, or Hydrocodone (by any route of administration), or oxycodone (oxycodone and oxycodone time-released formulation when crushed and snorted, injected or swallowed after chewing). 3. Be seeking treatment for opiate dependence. 4. Have a score greater than or equal to 2 on the Objective Opiate Withdrawal Scale-Handelsman (OOWS) immediately prior to admission. 5. Have reported use of heroin, morphine, or any opioid with a half-life similar to heroin or morphine, for at least 21 of the past 30 days. 6. Have urine toxicology screen positive for opiates and negative for methadone or buprenorphine. 7. If female and of child bearing potential, agree to use of one of the following methods of birth control: 1. oral contraceptives 2. patch 3. barrier (diaphragm, sponge or condom) plus spermicidal preparations 4. intrauterine contraceptive system 5. levonorgestrel implant 6. medroxyprogesterone acetate contraceptive injection 7. complete abstinence from sexual intercourse 8. hormonal vaginal contraceptive ring 9. surgical sterilization or partner sterile (must have documented proof) 8. Have completed the ASI during screening and all other assessments (SOWS-Gossop OOWS, and MCGI) during the baseline period. 9. Be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures and pass the study consent quiz with 100% accuracy (if necessary, quiz may be administered more than one time). Exclusion Criteria: Potential subjects must not: 1. Be female subjects who are pregnant or lactating. 2. Have self-reported use of methadone or buprenorphine in the past 14 days. 3. Have serious medical illnesses including, but not limited to: 1. Seizures, or those who have received anticonvulsant therapy during the past 5 years. 2. Pancreatic disease such as insulin-dependent diabetes. 3. Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 5 times the upper limit of normal. 4. Gastrointestinal or renal disease, which would significantly impair absorption, metabolism or excretion of study drug, or would require medication or medical treatment. 4. Have a psychiatric disorder, as assessed by the SCID, including but not limited to dementia or any disorder that, in the opinion of the study physician requires ongoing treatment that would make study participation unsafe or which would make treatment compliance difficult. 5. Have self-reported AIDS. 6. Have an abnormal cardiovascular exam prior to randomization, including any of the following: 1. Clinically significant abnormal ECG (e.g., second or third degree heart block, uncontrolled arrhythmia, or QTc interval > 450 msec for males, and > 470 msec for females). 2. Heart rate less than 45 bpm or symptomatic bradycardia. 3. Systolic blood pressure < 90 mm Hg or symptomatic hypotension (diastolic blood pressure < 60 mm Hg). 4. Blood pressure > 160/100 mm Hg. 5. Prior history of myocardial infarction. 7. Have clinically significant abnormal laboratory values. 8. Require any of the following medications currently or within the past 4 weeks: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics (excluding those listed in inclusion criteria #2 above), anticonvulsants, antihypertensives, antiarrhythmics, antiretroviral, and cholesterol lowering medications. Nicotine replacement therapy (patch, inhaler, gum, or nasal spray) for nicotine-dependent subjects are allowed. 9. Have current dependence (by SCID criteria) on ; PRIMARY OUTCOME: SOWS-Gossop score on Day 3 during the treatment phase & time-to-dropout for the subjects in the two treatment groups. during the treatment phase.; 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 - B7471006 (<u>></u> 65 y/o); BRIEF: This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination ; DRUG USED: Prevnar 20; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria 1. Male or female adults 65 years of age or greater. 2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. 3. Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception. 4. Male or female adults who meet 1 of the following: 1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to 5 years prior to vaccination in the study, and no prior 13vPnC vaccination (Cohort A). 2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B). 3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C). Exclusion Criteria 1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigators opinion, excludes the subject from participating in the study. 2. History of microbiologically proven invasive disease caused by S pneumoniae. ; PRIMARY OUTCOME: Percentage of Participants With Local Reactions Within 10 Days After Vaccination; SECONDARY OUTCOME 1: Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Intradermal (18-64yrs); BRIEF: The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus. Primary Objective: - To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination. Secondary Objectives: - To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain. - To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID. - To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status. - To describe the safety profile for subjects who receive QIV-ID and TIV-ID. Observational Objectives: - To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined - To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined. ; DRUG USED: Fluzone Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: - Aged 18 through 64 years on the day of inclusion - Informed consent form (ICF) has been signed and dated - Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: - Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) - Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure - Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination - Vaccination against influenza in the past 6 months - Receipt of immune globulins, blood or blood-derived products in the past 3 months - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances - History of thrombocytopenia - Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily - Current alcohol abuse or drug addiction - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion - Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial - Personal or family history of Guillain-Barré Syndrome - Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years. ; PRIMARY OUTCOME: Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route; SECONDARY OUTCOME 1: Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Relapse Prevention; BRIEF: The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia. ; DRUG USED: Invega Trinza; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Patients with schizophrenia for more than 1 year - A total score in the Positive and Negative Syndrome Scale (PANSS) < 120 - Signed informed consent - Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control - Men must agree to use a double-barrier method of birth control - Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria: - A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis - Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc) - A diagnosis of substance dependence within 6 months before screening - History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia - Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness - Clinically significant findings in biochemistry, hematology, ECG or urinalysis results - Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Time to Relapse During the Double-Blind Phase; SECONDARY OUTCOME 1: Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase[/INST]Yes</s>

<s>[INST]<<SYS>>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 - GESTURE; BRIEF: Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months prior to randomization and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigators Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area - Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy Exclusion Criteria: - Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis) - Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium) - Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply. - Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor - Use of any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer - Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy - History of hypersensitivity to constituents of the study treatment ; PRIMARY OUTCOME: Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment; SECONDARY OUTCOME 1: Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TWiTCH (Childrens Hospital Medical Center, Cincinnati); BRIEF: The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the risk of primary stroke. For the alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have a mean TCD velocity similar to that observed with transfusion prophylaxis. ; DRUG USED: Pedroxa; DRUG CLASS: Non-NME; INDICATION: Sickle Cell Anemia; TARGET: Fetal hemoglobin; THERAPY: Monotherapy; LEAD SPONSOR: Childrens Hospital Medical Center, Cincinnati; CRITERIA: Inclusion Criteria: 1. Pediatric subjects with severe forms of sickle cell anemia (HbSS, HbSβ0 thalassemia,HbSOArab) 2. Age range of 4.0-15.99 years, inclusive, at the time of enrollment 3. Documented index (pre-treatment) abnormally high TCD Velocity by Transcranial Doppler ultrasonography. An abnormally high index TCD is defined as TCD V greater than or equal to 200 cm/sec, or abnormally high TCDi V greater than or equal to185cm/sec, or TCD maximum V greater than or equal to 250 cm/sec. 4. At least 12 months of chronic monthly erythrocyte transfusions since the index abnormal TCD examination 5. Adequate monthly erythrocyte transfusions with average HbS less than or equal to 45% (the upper limit of the established academic community standard) for the past 6 months before enrollment 6. Parent or guardian willing and able to provide informed consent with verbal or written assent from the child 7. Ability to comply with study related treatments, evaluations, and follow-up Exclusion Criteria: 1. Completed overt clinical stroke or TIA 2. Inability to obtain TCD velocities due to anatomical abnormalities such as a) Inadequate bone windows b) Previous revascularization procedures (e.g., EDAS) 3. Known severe vasculopathy or moya-moya disease on brain MRA 4. Inability to receive or tolerate chronic red blood cell (RBC) transfusion therapy, due to any of the following: a) Multiple RBC alloantibodies making cross-matching difficult or impossible b) RBC autoantibodies making cross-matching difficult or impossible c) Religious objection to transfusions that preclude their chronic use d) Non-compliance with transfusions over the past 6 months before enrollment (temporary exclusion) 5. Inability to take or tolerate daily oral hydroxyurea, including a) Known allergy to hydroxyurea therapy b) Positive serology to HIV infection c) Malignancy d) Current lactation e) Previous stem cell transplant or other myelosuppressive therapy 6. Clinical and laboratory evidence of hypersplenism (temporary exclusions): a) Palpable splenomegaly greater than 5cm below the left costal margin AND b) Transfusion requirement greater than 250 mL/kg over the previous 12 months 7. Abnormal laboratory values at initial evaluation (temporary exclusions): a) Pre-transfusion hemoglobin concentration less than 8.0 gm/dL b) WBC count less than 3.0 x 10^9/L c) Absolute neutrophil count (ANC) less than 1.5 x 10^9/L d) Platelet count less than 100 x 10^9/L e) Serum creatinine more than twice the upper limit for age OR greater than or equal to 1.0 mg/dL 8. Current participation in other therapeutic clinical trials 9. Current use of other therapeutic agents for sickle cell disease (e.g., arginine, decitabine, magnesium). Subjects must have been off hydroxyurea for at least 3- months prior to enrollment. 10. Any condition or chronic illness, such as a positive tuberculin (PPD) test, which in the opinion of the CI makes participation ill-advised. 11. Inability or unwillingness to complete required screening and exit studies, including TCD ultrasonography, brain MRI/MRA, liver MRI and blood tests. 12. A sibling enrolled in TWiTCH 13. Pregnancy or unwillingness to use a medically acceptable form of contraception if sexually active (male OR female). ; PRIMARY OUTCOME: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side; SECONDARY OUTCOME 1: TCD Time-averaged Mean Velocity on the Non-index Side[/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 - IDEAL; BRIEF: The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimers Disease. ; DRUG USED: Exelon Patch; DRUG CLASS: Non-NME; INDICATION: Alzheimers Disease (AD); TARGET: Cholinesterases; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Diagnosis of dementia of the Alzheimers type - Males, and females who are surgically sterile or one year postmenopausal - A primary caregiver willing to accept responsibility for supervising the treatment Exclusion Criteria: - Any condition (other than Alzheimers) that could explain patients dementia - An advanced, severe or unstable disease that may put the patient at special risk - Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease ; PRIMARY OUTCOME: Change in cognition from baseline at week 24; SECONDARY OUTCOME 1: Change from baseline at week 24 in activities of daily living[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - B7471008 (18-49 y/o); BRIEF: This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC. ; DRUG USED: Prevnar 20; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Male or female adults ≥18 and <50 years of age. 2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. 3. Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children. Exclusion Criteria: 1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigators opinion, excludes the subject from participating in the study. 3. History of microbiologically proven invasive disease caused by S pneumoniae. 4. Pregnant female subjects or breastfeeding female subjects (known or suspected). ; PRIMARY OUTCOME: Percentage of Participants With Local Reactions Within 10 Days After Vaccination; SECONDARY OUTCOME 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DIC3-08-06; BRIEF: The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip. ; DRUG USED: Zorvolex; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Iroko Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - Male or female ≥ [greater than or equal to] 40 years of age - If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety - Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain - Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening Exclusion Criteria: - Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac - Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip - Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease - Has significant difficulties swallowing capsules or is unable to tolerate oral medication ; PRIMARY OUTCOME: Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TRANSFORM-3 (Elderly); BRIEF: The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo. ; DRUG USED: Spravato; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - At the time of signing the informed consent form (ICF), participant must be a man or woman 65 years of age or older - At the start of the Screening/prospective observational Phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) [if single-episode MDD, the duration must be greater than or equal to (>=) 2 years] or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI) - At the start of the Screening/Prospective observational Phase, participant must have an Inventory of Depressive Symptomatology-Clinician rated (IDS-C30) total score of greater than or equal to (>=) 31 - At the start of the Screening/Prospective observational Phase, participants must have had nonresponse (less than or equal to 25% improvement) to >=1 but less than or equal to (<=) 8 oral antidepressant treatments taken at adequate dosage and for adequate duration, as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and documented records by medical and pharmacy/prescription records, or a letter from the treating physician, for the current episode of depression - Participant must be taking one of the oral antidepressant treatment with nonresponse that is documented on the MGH-ATRQ at the start of the screening/prospective observational phase - The participants current major depressive episode, depression symptom severity (Week 1 MADRS total score greater than or equal to 24 required) and treatment response to antidepressant treatments used in the current depressive episode (retrospectively assessed) must be confirmed for participation in a clinical study based on a Site-Independent Qualification Assessment - Participant must be medically stable on the basis of clinical laboratory tests performed in the screening/prospective observational phase Exclusion Criteria: - The participants depressive symptoms have previously demonstrated nonresponse to: Esketamine or ketamine in the current major depressive episode per clinical judgment, or all of the 4 oral antidepressant treatment options available for the double-blind induction Phase (Duloxetine, Escitalopram, Sertraline, and Venlafaxine extended release [XR]) in the current major depressive episode (based on MGH-ATRQ), or an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral ECT - Participants who has received vagal nerve stimulation (VNS) or who has received deep brain stimulation (DBS) in the current episode of depression - Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current episode only), intellectual disability ( intellectual disability [DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319]), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder - Participant has homicidal ideation/intent, per the Investigators clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the Screening/prospective observational Phase, per the Investigators clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS) and also includes history of suicidal behavior within the past year prior to start of the screening/prospective observational phase - Participant has a history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder\ - Participant has a Mini Mental State Examination (MMSE) < 25 or <22 for those participants with less than an equivalent of high school education - Participant has neurodegenerative disorder (eg, Alzheimers Disease, Vascular dementia, Parkinsons disease with clinical evidence of cognitive impairment) or evidence of mild cognitive impairment (MCI) - Participant has a history of uncontrolled hypertension; current or past history of significant pulmonary insufficiency/condition;clinically significant ECG abnormalities; current or past history of seizures; clinically significant cardiovascular disorders including cerebral and cardiac vascular disease ; PRIMARY OUTCOME: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CP-00001; BRIEF: The proposed single-dose study aims to evaluate the product design clinical performance of the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination Product, in adult Subjects previously diagnosed with mild to advanced heart failure. The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the sc2Wear Furosemide Pump adhered to the body using medical grade adhesive. The objectives of this study are: - To demonstrate that the to-be-marketed drug-device combination product performs as intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area - To assess safety and local tolerance of the drug-device combination product ; DRUG USED: Furoscix; DRUG CLASS: Non-NME; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Na-K-Cl cotransporter (NKCC2); THERAPY: Monotherapy; LEAD SPONSOR: scPharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Male and female Subjects ≥18 years of age 3. New York Heart Association (NYHA) Class II-IV Heart Failure. 4. In the opinion of the Investigator, able to participate in the study. 5. If Subject is on oral diuretic, willing to suspend the oral furosemide or other loop diuretic treatment on the day of treatment (use of oral diuretic within 8 hours of start of treatment is not permitted). 6. If Subject has significant body hair on the abdomen, willing to clip or shave the area where the device will be placed prior to treatment. 7. Has the ability to understand the requirements of the study, and is willing to comply with all study procedures. Exclusion Criteria: 1. Contraindication to furosemide. 2. History of chronic skin conditions requiring medical therapy. 3. Skin reaction to medical adhesives or history of poor skin adherence of adhesives. 4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc. 5. Diabetic patients currently using an insulin pump and/or interstitial glucose monitors. 6. Clinically significant abnormalities at Screening in safety laboratory tests. 7. Hypokalemia - Potassium of < 3.6 mmol/L. 8. Systolic BP (SBP) < 90 mm Hg. 9. Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment. 10. History of major abdominal surgery affecting the site of device placement. 11. Participation in another trial, within 30 days prior to Screening. 12. History of hepatitis B, hepatitis C, or HIV 13. Evidence of current or recent alcohol abuse. 14. Female Subject who is pregnant or lactating. 15. Any surgical or medical condition that -in the opinion of the Investigator - may interfere with participation in the study or that may affect the outcome of the study. ; PRIMARY OUTCOME: Absence of Major Product Failure; SECONDARY OUTCOME 1: Local Pain Tolerance[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SWAP; BRIEF: This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm^2 rivastigmine patch formulation in patients with probable Alzheimers Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period. ; DRUG USED: Exelon Patch; DRUG CLASS: Non-NME; INDICATION: Alzheimers Disease (AD); TARGET: Cholinesterases; THERAPY: Monotherapy; LEAD SPONSOR: Novartis; CRITERIA: Inclusion Criteria: - Be at least 50 years of age; - Have a diagnosis of probable Alzheimers Disease; - Have an MMSE score of > or = 10 and < or = 24; - Must have a caregiver who is able to attend all study visits; - Have received continuous treatment with donepezil for at least 6 months prior to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months. Exclusion Criteria: - Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk; - Have a history of malignancy of any organ system, treated or untreated, within the past 5 years; - Have a history within the past year or current diagnosis of cerebrovascular disease; - Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months; - Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease); - Digestive problems related to peptic ulcer; - Urinary obstruction or current severe urinary tract infection; - Abnormal thyroid function tests; - Low folate or Vitamin B12; - Have a disability that may prevent the patient from completing all study requirements; - Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch; Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study; SECONDARY OUTCOME 1: Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SP584; BRIEF: This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial. The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period. Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination. ; DRUG USED: Toviaz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Overactive Bladder (OAB); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Overactive bladder syndrome Exclusion Criteria: - Less than 8 micturitions in 24 hours ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]Yes</s>

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