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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 Ib - Psoriasis; BRIEF: This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F [Anti-IL-17A/F] Nanobody). ; DRUG USED: ALX-0761; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Human Serum Albumin (HSA), IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Chronic plaque psoriasis for at least 6 months before screening - Greater than or equal to (>=) 10% of BSA with plaques - Psoriasis Area and Severity Index (PASI) >=12 - Static Physicians Global Assessment (sPGA) >=3 (where scores range from 0 [clear of disease] to 5 [severe disease]) at the screening and baseline visits - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigators opinion constitutes a risk or a contraindication for the subjects participation in the trial or that could interfere with the trial objectives, conduct or evaluation - Currently having a form of non-plaque psoriasis as specified in the protocol - Drug induced psoriasis - Biological treatments as specified in the protocol, within 3 months prior to Day 1 - Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1 - Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol - Use of aspirin as defined in the protocol - Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1 - Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol - Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Number of Subjects With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Ocular Surface Disease; BRIEF: To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications. ; DRUG USED: Pro-Ocular; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Glia, LLC; CRITERIA: Inclusion Criteria: 1. Male or female of any race, at least 18 years of age at Visit 1 Screening. 2. Has provided verbal and written informed consent. 3. Be able and willing to follow instructions, including participation in all study assessments and visits. 4. Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime. 5. Suffers from at least two of the symptoms in the GLIA™ Glaucoma Medication Ocular Side Effect Symptoms Questionnaire at a severity of 2 (moderate) or more. 6. If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period. Exclusion Criteria: 1. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as corneal opacities and scars, dystrophies, epithelial scarring, infections, blood clots, etc. 2. Best corrected visual acuity (BCVA) at baseline <20/200. 3. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subjects participation in the study. 4. A woman who is pregnant, nursing an infant, or planning a pregnancy. 5. Has a known adverse reaction and/or sensitivity to the study drug or its components. 6. Routine use (more than twice a week) of a chlorinated swimming pool. 7. Unwilling or unable to cease using the following medications during the study period: Topical ocular cyclosporine (e.g. Restasis®), anti-histamines, antipsychotics, or eye gels. 8. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1. ; PRIMARY OUTCOME: Glaucoma medication ocular side effect symptoms; SECONDARY OUTCOME 1: Glaucoma medication ocular side effect signs[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Ambulant Children; BRIEF: The primary objective of Parts 1 and 2 of the study were to establish the histologic effects of givinostat administered chronically at the selected daily dose. The secondary objectives of Parts 1 and 2 of the study were as follows: - To establish the effects of givinostat administered chronically at the selected daily dose on functional parameters, such as the 6-Minute Walk Test (6MWT), North Star Ambulatory Assessment (NSAA), and performance of upper limb (PUL) - To establish the safety and tolerability of givinostat administered chronically at the selected daily dose in children with Duchenne muscular dystrophy (DMD) - To explore the effects of givinostat administered chronically at the selected daily dose on parameters such as magnetic resonance imaging (MRI) and biomarkers - To explore the acceptability/palatability of the oral suspension - To explore whether the effects of givinostat on disease progression may be related to the type of DMD mutation. The primary objective of the Extension of the study was to evaluate the safety and tolerability of long-term administration of givinostat administered chronically at the selected daily dose in children with DMD. The secondary objectives of the Extensions were: - To establish the effects of givinostat administered chronically at the selected daily dose on muscular functional parameters, such as the 6MWT, NSAA, and PUL (Extensions 1, 2, and 3) - To explore the effects of givinostat administered chronically at the selected daily dose on parameters such as MRI (Extension 1) - To collect information related to 2 biomarkers, latent Transforming growth factor β (TGFβ) binding protein 4 (LTBP4) and osteopontin genotype (at the beginning of Extension 2 only) - To collect information related to time to wheelchair and how much time the children spend in wheelchair (Extension 3 - only for the children who were not able to complete the 6MWT) ; DRUG USED: Givinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Histone Deacetylase (HDAC); THERAPY: Monotherapy; LEAD SPONSOR: Italfarmaco; CRITERIA: Inclusion Criteria: 1. Male children aged 7 to <11 years with an immunohistochemical and molecular diagnosis of DMD. 2. A parent/guardian and child can comply with all study evaluations/procedures and return for all study activities. 3. Able to complete the 2 screening 6MWTs with a minimal distance of at least 250 m each. In addition, the results of these tests must be within ±30 m of each other. 4. On a stable dose of systemic corticosteroids for at least 6 months. 5. At least 6 months worth of data on the 6MWT (this will be the historical 6MWT). From the moment of the historical 6MWT assessment(s), the child must not have received any compound that could potentially affect the 6MWT, with the exception of the stable steroid treatment. 6. Parent/guardian has signed the informed consent form and child has assented to be in the study (if applicable). Exclusion Criteria: 1. Initiation of systemic corticosteroid therapy within 6 months prior to the start of study drug or change in systemic corticosteroid therapy (e.g., initiation, change in type of drug, dose modification not related to body weight change, schedule modification, interruption, discontinuation, or re initiation) within 6 months prior to the start of study drug. 2. Use of any pharmacologic treatment, other than corticosteroids, that might have an effect on muscle strength since the time of the historical 6MWT and in any case within 3 months prior to the start of study treatment (e.g., growth hormone). Vitamin D, calcium, and integrators will be allowed. 3. Surgery that might have an effect on muscle strength or function within 3 months before study entry or planned surgery at any time during the study. 4. Exposure to another investigational drug since the time of the historical 6MWT and in any case within 3 months prior to the start of study treatment. 5. History of participation in gene therapy, cell-based therapy or oligonucleotide therapy. 6. Presence of other clinically significant disease that in the opinion of the investigator places the child in unacceptable risk for an adverse outcome or that could affect study results. 7. Symptomatic cardiomyopathy or heart failure. If child has a left ventricular ejection fraction <45% at screening, the investigator should discuss inclusion of child in the study with the medical monitor. 8. Inadequate hematological function 9. Absolute neutrophil count: <1.5 x 109/L 10. Platelets: <100 x 109/L 11. Current or history of liver disease or impairment, including but not limited to an elevated total bilirubin. 12. Inadequate renal function, as defined by serum creatinine >2 x the upper limit of normal. 13. Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus at screening 14. A baseline QTc >450 msec, (as the mean of 3 consecutive readings 5 minutes apart) or history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome). 15. Psychiatric illness/social situations rendering the potential child unable to understand and comply with the study protocol. ; PRIMARY OUTCOME: Change From Baseline to Part 2 in the Value of Muscle Fiber Area (MFA) % Comparing the Histology Biopsies Before and After 12 Months of Treatment With Givinostat.; SECONDARY OUTCOME 1: Change From Baseline to End of Study in Cross Sectional Area (CSA)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - PROACTIVE; BRIEF: This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD). ; DRUG USED: AMG 714; DRUG CLASS: Biologic; INDICATION: Celiac Disease; TARGET: IL-15 (Interleukin-15)/IL-15 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Provention Bio, Inc.; CRITERIA: Inclusion Criteria: - A diagnosis of celiac disease by intestinal biopsy - Following a GFD for at least 12 consecutive months - Must have detectable (above the lower limit of detection) serum celiac-related antibodies - Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8) - Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas. - Body weight between 35 and 120 kg Exclusion Criteria: - Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation - Diagnosis of any chronic, active GI disease other than celiac disease - Presence of any active infection - Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA - Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening - Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug - History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subjects participation and follow-up in the clinical trial or put the subject at unnecessary risk - Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding ; PRIMARY OUTCOME: Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire; SECONDARY OUTCOME 1: Effect of treatment with PRV-015 on other measures of disease activity[/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-CORAL; BRIEF: This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype (GT) 1, 4 or 6 infection. The primary hypothesis is that the percentage of participants receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to the historical reference rate of 73%. ; DRUG USED: Zepatier; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection - Meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment - Is abstinent or uses acceptable method(s) of contraception Exclusion Criteria: - Has evidence of decompensated liver disease - Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV) - Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC - Has a clinically-relevant drug or alcohol abuse within 12 months of screening - Is pregnant or breast-feeding - Has any condition or abnormality that might confound the results of the trial or pose an additional risk to the participant ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (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 I/II - C26004; BRIEF: The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian participants with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl Cyclase C (GCC). ; DRUG USED: MLN0264; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Antibody-drug Conjugate (ADC), Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Has Diagnosis of GI carcinoma with Immunohistochemistry/ Immunohistochemical (IHC) evidence of expression of GCC protein (H-score of 10 or greater), for which standard treatment is no longer effective or does not offer curative or life-prolonging potential. - Has completed prior chemotherapy, immunotherapy or radiation therapy at least 4 weeks prior to enrollment (except for Avastin [bevacizumab] for which at least 8 weeks from its last administration should elapse prior to enrollment). - Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the stomach or gastroesophageal junction with IHC evidence of expression of GCC indicated by an H-score of 10 or greater. - Has completed prior chemotherapy, immunotherapy or radiation therapy at least 4 weeks prior to enrollment. - Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. - Has Eastern Cooperative Oncology Group performance status of 0 or 1 (within 14 days prior to enrollment). - Females must be 1-year postmenopausal, or even if surgically sterile, agree to use other acceptable forms of birth control. - Has adequate organ and hematological function. - Has resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Exclusion Criteria: - Has Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent. - Female participants who are in the lactation period, even if they discontinue breastfeeding, or have a positive pregnancy test during the Screening period. - Has uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months prior to enrollment. - Has treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing Torsades de Pointes that cannot be discontinued or switched to a different medication prior to starting study drug. - Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically -significant, or repeated baseline prolongation of the rate-corrected QT interval millisecond (msec) of electrocardiograph (QTc). - Ongoing or clinically significant active infection. - Has signs of peripheral neuropathy. - Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment. - Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug. - Has any preexisting medical condition of sufficient severity to prevent full compliance with the study. - Has past or concurrent history of neoplasm other than GI carcinoma (phase 1) or gastric adenocarcinoma (phase 2), except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri. - Known diagnosis of human immunodeficiency virus (HIV) infection. - Has asymptomatic brain metastases. - Has an alcohol or substance abuse disorder. - Has positive test for hepatitis B surface antigen. - History of hypersensitivity to any ingredient of MLN0264. ; PRIMARY OUTCOME: Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Phase 1- Number of Participants With Antitherapeutic Antibodies (ATAs)[/INST]No</s>

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

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - ATTCK-20-2; BRIEF: This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and efficacy of an autologous T-cell product expressing ACTR in combination with rituximab in subjects with refractory or relapsed CD20+ B-cell lymphoma. ; DRUG USED: ACTR087; DRUG CLASS: Biologic; INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Cluster of Differentiation 20 (CD20), Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: Cogent Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Signed written informed consent obtained prior to study procedures - Histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: - DLBCL, regardless of cell of origin or underlying molecular genetics - MCL - PMBCL - Gr3b-FL - TH-FL - Biopsy-confirmed CD20+ expression of the underlying malignancy by immunohistochemical staining or flow cytometry between the most recent dose of an anti-CD20 monoclonal antibody (mAb) and study enrollment - At least 1 measurable lesion on imaging. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy - Must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following: - biopsy-proven refractory disease after frontline chemo-immunotherapy - relapse within 1 year from frontline chemo-immunotherapy and ineligible for autologous hematopoietic stem cell transplant (auto-HSCT) - For subjects with DLBCL, PMBCL, and Gr3b-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT - For subjects with TH-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT. At least 1 prior regimen with an anti-CD20 mAb in combination with chemotherapy is required following documented transformation - For subjects with MCL (confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization (FISH) or PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable) - Karnofsky performance scale ≥ 60% - Life expectancy of at least 6 months - ANC > 1000/µL - Platelet count > 50,000/µL - For women of childbearing potential (defined as physiologically capable of becoming pregnant), agreement to use of highly effective contraception for at least 1 year following ACTR087 infusion. For men with partners of childbearing potential, agreement to use effective barrier contraception for at least 1 year following ACTR087 infusion Exclusion Criteria: - Known active central nervous system (CNS) involvement by malignancy. Subjects with prior CNS involvement with their lymphoma must have completed effective treatment of their CNS disease at least 3 months prior to enrollment with no evidence of disease clinically and at least stable findings on relevant CNS imaging - Prior treatment as follows: - alemtuzumab within 6 months of enrollment - fludarabine, cladribine, or clofarabine within 3 months of enrollment - external beam radiation within 2 weeks of enrollment - mAb (including rituximab) within 2 weeks of enrollment - other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment - experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy - Serum creatinine ≥ 1.5 X age-adjusted upper limits of normal (ULN) - Pulse oximetry < 92% on room air - Direct bilirubin ≥ 3.0 mg/dL (50 mmol/L) - Alanine transaminase (ALT) ≥ 3 times the ULN, unless determined to be directly due to lymphoma. - Aspartate transaminase (AST) ≥ 3 times the ULN, unless determined to be directly due to lymphoma - Class III or IV heart failure as defined by the New York Heart Association (NYHA), history of cardiac angioplasty or stenting, documented myocardial infarction or unstable angina within 6 months prior to enrollment, cardiac ejection fraction of < 45%, or other clinically significant cardiac disease - Clinical history of, prior diagnosis of, or overt evidence of autoimmune disease, regardless of severity - Clinically significant active infection, in the judgment of the investigator - Pregnancy (negative serum pregnancy test to be obtained within 6 days prior to enrollment for subjects of childbearing potential) - Breastfeeding - Primary immunodeficiency - Seropositive for Human Immunodeficiency Virus (HIV) 1 or HIV 2, or positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody - Will need or has needed active treatment of a second malignancy within the prior 3 years before enrollment, other than FL, non-melanoma skin cancers, localized prostate cancer treated with curative intent, or cervical carcinoma in situ - Is unable to receive any of the agents used in this study due a history of severe immediate hypersensitivity reaction (e.g. hypersensitivity to dimethyl sulfoxide (DMSO)) - History of prior allogeneic HSCT - History of Richters transformation from CLL - Prior infusion of a genetically modified therapy ; PRIMARY OUTCOME: Safety as assessed by dose limiting toxicities (DLTs); SECONDARY OUTCOME 1: Overall response rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Toripalimab; BRIEF: An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of APG-1387 in combination with toripalimab. A phase II study of 3 cohorts will be included. ; DRUG USED: APG-1387; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: IAPs (Inhibitor of apoptosis proteins); THERAPY: Combination; LEAD SPONSOR: Ascentage Pharma Group Inc.; CRITERIA: Inclusion Criteria: 1. Histopathologically confirmed advanced solid tumors 1. For phase II CRC group only: Patients with histologically confirmed microsatellite stable (detected by immunohistochemistry, PCR or NGS methods) advanced colorectal cancer. 2. For phase II NPC group only: Patients with histologically or cytologically confirmed advanced NPC. 3. For phase II NSCLC group only: Patients with histologically confirmed or cytologically confirmed advanced non-small cell lung cancer together with wild-type EGFR/ALK/ROS1 (first or second-generation sequencing results are allowed). 2. Patients who have failed standard antitumor therapy. 3. At least one evaluable lesion according to RECIST 1.1 criteria. 4. Age greater than 18 years, both men and women. 5. ECOG: 0 to 1. 6. Expected survival ≥ 3 months. 7. The function of vital organs meets the following criteria (no blood components and cell growth factors are allowed 2 weeks before the start of study treatment): 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; 2. Platelets ≥ 100 × 10^9/L; 3. Hemoglobin ≥ 90 g/L; 4. Serum albumin ≥ 30 g/L; 5. Total bilirubin ≤ 1.5 x the upper limit of normal(ULN), ALT and AST ≤ 2.5 x ULN; if there is liver metastasis, ALT and AST ≤ 5 x ULN; 6. Serum creatinine ≤ 1.5 x ULN ; or if Serum creatinine >1.5 x UL, 24-hour creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); 8. Patients with asymptomatic brain metastases (not requiring pharmacological control) or brain metastases that have been stable for more than 28 days after treatment. 9. Patients must have recovered to Grade 1 or less from adverse reactions resulting from prior antineoplastic therapy (except alopecia and sensory neuropathy not exceeding Grade 2). 10. Males, women of childbearing potential (postmenopausal women who must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners voluntarily use contraception deemed effective by the investigator during treatment and for at least three months after the last dose of study drug. 11. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures. 12. Patients must be voluntary and able to complete study procedures and follow-up examinations. Exclusion Criteria: 1. Cytotoxic chemotherapy, radiation therapy, surgery (except minor surgery), anticancer therapy with hormone therapy (except hormone for hypothyroidism or estrogen replacement therapy (ERT)), or any clinical study treatment within 28 days prior to the first dose of study drug; or clinically significant tumor embolism or tumor lysis syndrome (TLS). 2. Immunotherapy, biologic therapy or anti-TNFa therapy within 28 days or 5 half-lives (whichever is shorter) prior to receiving the first dose of study drug. 3. Patients who have received targeted therapy within 28 days prior to first dose of study drug. 4. Prior treatment with anti PD-1, anti PD-L1, or anti PD-L2 agents (Phase II CRC cohort only). 5. Patients have an immunodeficiency diagnosis or are receiving chronic systemic steroid therapy (daily dose of more than 10 mg prednisone equivalent) or any form of immunosuppressive therapy 7 days prior to the first dose of trial treatment. 6. Patients have any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, decreased thyroid function (can be included if hormone replacement therapy is effective); patients with vitiligo or asthma that has been completely relieved in childhood and does not require any intervention after adulthood can be included, and patients with asthma requiring bronchodilators for medical intervention cannot be included. 7. Patient has an active infection or unexplained fever > 38.5。C within 2 weeks prior to the first dose (subjects may be enrolled due to tumor generated fever as judged by the investigator). 8. Any evidence of a past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or clinically active interstitial lung disease. 9. Hepatic decompensation. 10. Evidence of any severe or uncontrolled systemic disease; various chronic active infections such as hepatitis B (evidence of hepatitis activity such as HBV-DNA ≥ 104 copies/mL or 2000 IU/mL), hepatitis C, and HIV. 11. Any of the following cardiac criteria: Mean QTc> 470 msec at rest during screening; Any clinically important abnormality in rhythm, conduction, or morphology of the resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block); Congenital long QT syndrome or family history of long QT syndrome. 12. Uncontrolled hypertension (requiring 2 or more medications to control blood pressure); Unstable cardiac pain; Angina pectoris within 3 months of study entry; Congestive heart failure (NYHA class II or higher); Previous myocardial infarction (NSTEMI or STEMI) within 6 months of study entry; Serious cardiac arrhythmia requiring medical attention; Serious hepatic, renal, gastrointestinal, or metabolic disease. 13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to APG-1387 or toripalimab or their constituents. 14. Have received a live vaccine within 28 days prior to the first dose of investigational product. Live vaccines include but are not limited to the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin vaccine (BCG) and typhoid. Injectable seasonal influenza vaccines are usually inactivated viral vaccines and are therefore allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. 15. Patients who have not sufficiently recovered after surgical treatment as judged by the investigator. Patients with major surgery within 28 days prior to the first dose of study drug and minor surgery within 7 days prior to the start of the study. 16. Pregnant or lactating female patients. 17. The subject has other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness) requiring concomitant treatment, severe abnormalities in laboratory tests, family or social factors, conditions that may affect the safety of the subject or the collection of trial data, etc. ; PRIMARY OUTCOME: Recommended Phase 2 dose(RP2D) (Applicable for: phase I stage in various solid tumor types).; SECONDARY OUTCOME 1: Overall Response (Applicable for: phase I stage in various solid tumor types)[/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-05-35 - Acute Otitis Media; BRIEF: The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes. ; DRUG USED: Vigadexa; DRUG CLASS: Non-NME; INDICATION: Ear Infections (Antibacterial); TARGET: Glucocorticoid Receptor (GR), Topoisomerase II (DNA gyrase) and IV; THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - 6 months to 12 years old - Ear tubes in one or both ears - Ear drainage visible by the parent / guardian - Ear drainage less than 21 days - Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube - Patient may not have non-tube otorrhea - Patient may not have had otic surgery other than tube placement in the last year - Patient may not be a menarchal female - Diabetic patients are not eligible - Patient may not have any disease or condition that would negatively affect the conduct of the study - Patient may not require any other systemic antimicrobial therapy during the study - Patient must meet certain medication washouts to be eligible - Analgesic use (other than acetaminophen) is not allowed - Patient may not be pre-disposed to neurosensory hearing loss - Other protocol-defined inclusion criteria may apply Exclusion Criteria: - Age related - Other protocol-defined exclusion criteria may apply ; PRIMARY OUTCOME: Clinical cure rate at the test of cure visit as determined by the investigator; SECONDARY OUTCOME 1: Time to cessation of otorrhea[/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 - MCP-103-303 (1); BRIEF: The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder. ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ironwood Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings - Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests - Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs - Patient demonstrates continued chronic constipation through Pretreatment Period - Patient is compliant with IVRS Exclusion Criteria: - Patient has history of loose or watery stools - Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) - Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility - Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments ; PRIMARY OUTCOME: Complete Spontaneous Bowel Movement (CSBM) Overall Responder; SECONDARY OUTCOME 1: 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Males; BRIEF: An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231 ; DRUG USED: Cimlanod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Guanylate Cyclase (sGC), Ryanodine Receptor (RyRs), Sarcoplasmic reticulum Ca2+-ATPase (SERCA); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Signed Informed Consent - Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests - Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2. Exclusion Criteria: - History of chronic illness - Chronic headaches - Recurrent dizziness - Personal or family history of heart disease - Personal history of bleeding diathesis Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]); SECONDARY OUTCOME 1: Incidence of adverse events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - PICASSO AD; BRIEF: A Randomized, Double-blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the Effects of BPN14770 in Patients with Early Alzheimers Disease ; DRUG USED: BPN14770; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: Tetra Discovery Partners; CRITERIA: Inclusion Criteria: 1. Males or females between the ages of 55 and 85 years with a clinical diagnosis of early stage AD, defined according to the following criteria assessed during Screening and at Baseline : 1. Clinical Dementia Rating (CDR) score of 0.5 or 1, with Memory Box score of 0.5 or greater 2. MMSE score of 20 or greater 3. RBANS DMI score ≤ 85 Note: PET imaging for amyloid is not required for diagnosis, which will be made on clinical grounds. 2. Currently receiving a stable (at least 2 months) dose regimen of donepezil or another cholinesterase inhibitor for treatment of Alzheimers disease. Doses of these drugs may not be changed during the trial. Note: Memantine is not permitted during the trial and must be discontinued at least 3 weeks prior to Baseline. 3. Modified Hachinski Ischemia score < 4. 4. Body mass index (BMI) < 38 kg/m2, inclusive, and body weight of >48 kg (105 pounds) at screening. 5. Female subjects must be at least two years post-menopausal (subjected reported menopausal status), surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to first study drug administration), or willing to either (1) utilize hormonal contraception plus one barrier method or (2) use two barrier methods of contraception (e.g. diaphragm and spermicide) from initial screening until one month after taking the final dose. An intrauterine device (IUD) is considered a barrier method of contraception in this study. Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to first study drug administration, or use at least one barrier method of birth control). 6. Able to understand and comply with the study procedures, voluntarily agree to participate in this study, and provide written informed consent prior to start of any study-specific procedures. 7. All subjects must have a caregiver who is willing and able to ensure compliance with study medications, visits, and study procedures. Exclusion Criteria: 1. Any medical or neurological condition (other than early stage AD) that might be a contributing cause to the subjects cognitive impairment. 2. History of stroke or multiple (>3 discreet episodes) Transient Ischemic Attacks (TIAs), severe head trauma with cognitive sequelae, uncontrolled seizures, or unexplained prolonged loss of consciousness (> 1 minute) during the past year. 3. Clinically significant major psychiatric illness during the past 6 months. 4. History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities during the past year. 5. Clinically significant liver or renal disease. 6. Clinically significant abnormality, in the Investigators judgment, in hematology, chemistry, or urinalysis. 7. Positive serology results for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV). 8. Abnormal liver function test at the Screening Visit (aspartate aminotransferase or alanine aminotransferase >2 × the upper limit of normal [ULN], or total bilirubin >1.7 × ULN, based on appropriate age and gender normal values). Subjects may be re-screened once. 9. Marked hypotension (systolic blood pressure [BP] ˂90 mmHg or diastolic BP ˂50 mmHg) or hypertension (systolic BP ˃160 mmHg or diastolic BP ˃100 mmHg) based on sitting values. O ut-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline. 10. Marked bradycardia (heart rate ˂45 beats per minute [bpm]) or tachycardia (heart rate ˃115 bpm) based on supine ECG values. Out-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline. 11. Clinically important conduction abnormalities on ECG, or evidence or history of long QT syndrome based on supine ECG values obtained at Screening. Out-of-range results may be repeated once and eligibility confirmed at Baseline. 12. Active gastric or duodenal ulcers or other diseases of the gastrointestinal tract that could interfere with absorption of study drug. Note: Subjects with a history of appendectomy or cholecystectomy may be enrolled. 13. Active acute or chronic infectious diseases that would interfere with subjects participation in the study. 14. Unable to discontinue centrally active medications (other than cholinesterase inhibitors), including memantine, psychotropic drugs other than SSRIs (which must have been stable for 2 months and remain stable throughout the study), sedative antihistamines or other centrally active medications with potential cognitive effects (e.g., CNS-penetrant beta blockers). 15. Unable to discontinue moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or other cytochromes at least 14 days prior to the first dose of study drug. A complete listing of such inhibitors or inducers may be found in http://medicine.iupui.edu/clinpharm/ddis/main-table (Other prescription or non-prescription drugs such as antihypertensive or cholesterol lowering agents are allowed, if, in the Investigators judgement, they would not interfere with the study medication or the cognitive testing.) 16. A suicidal ideation intensity score of 3 or higher per screening Columbia Suicide Severity Rating Scale (CSSRS) assessment on Day 1 (Baseline) and/or any suicidal behavior within the past 28 days. 17. History of chronic alcohol or other substance abuse, including marijuana, within the previous year prior to the Screening visit (per the current edition of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: DSM-5), or regular (daily) consumption of alcohol exceeding two bottles of beer, or the equivalent amount of other forms of alcohol (1 serving = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits). 18. Inability or unwillingness to comply with the protocol, including performing the cognitive function tests, or likely inability to complete the study. 19. Participation in other clinical studies involving investigational drug within the previous 30 days prior to the Screening Visit. 20. Donation of blood within 4 weeks, or blood products within 2 weeks, prior to first study drug administration. 21. History of clinically significant drug allergy that includes symptoms such as shortness of breath, rash, or edema. 22. Clinically significant B12 deficiency within 12 months prior to Visit 1 (Screening). Participants on stable replacement therapy for a minimum of 3 consecutive months immediately prior to Visit 1 (Screening) may be included ; PRIMARY OUTCOME: Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI); SECONDARY OUTCOME 1: Repeatable Battery for the Assessment of Neurological Status (RBANS) total score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Infants (Aged 2-24 Months); BRIEF: Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age. ; DRUG USED: MEDI-534; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Human Parainfluenza virus (HPIV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: - Male or female whose age on the day of randomization falls within one of the two age groups: 6 to less than (<) 24 months (more than [>] 6 months of age and not yet reached their 2nd year birthday), Cohorts 1 and 2 2 months (+/- 4 weeks), Cohorts 3, 4, and 5 - Cohorts 1 and 2 only: Subject is seronegative to both Respiratory Syncytial Virus (RSV) and human Parainfluenza Virus Type 3 (hPIV3) at Screening - Subject whose gestational age was greater than or equal to (>=) 36 weeks - Subject is in general good health with normal growth (that is, body weight greater than (>) third percentile per world health organization [WHO] simplified weight-per-age field tables - Subjects legal representative is available by telephone - Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subjects legal representative - Subjects legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator - Subject is available to complete the follow-up period 1-year after receipt of the first dose of study vaccine - Subjects legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol. Exclusion Criteria: - Any fever (>=100.4 degrees Fahrenheit [>=38.0 degrees Celsius], regardless of route) or lower respiratory illness within 7 days prior to randomization - Moderate or severe nasal congestion that in the investigators opinion could interfere with intranasal delivery of study vaccine - Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization - Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications for the systemic treatment of common childhood symptoms (that is, pain relievers, decongestants or cough suppressants) are permitted according to the judgment of the investigator - Any current or expected receipt of immunosuppressive agents including steroids (>=2 milligram per kilogram [mg/kg] per day of prednisone or its equivalent, or >=20 milligram per day [mg/day] if the subject weighs >10 kilogram [kg], given daily or on alternate days for >=14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for >=30 days; the use of topical steroids is permitted according to the judgment of the investigator - History of receipt of blood transfusion or expected receipt through the protocol-specified blood collection at 28 days after final study dosing - History of receipt of immunoglobulin products or expected receipt through the protocol-specified blood collection at 28 days after final study dosing - Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after final study dosing - Receipt of any live virus vaccine (excluding oral polio vaccine and rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose - Receipt of any inactivated (that is, non-live) vaccine or oral polio vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose - Known or suspected immunodeficiency, including human immunodeficiency virus (HIV) infection - Expected to be living in the same home or enrolled in the same classroom at day care with infants <6 months within 28 days after each dose - Living in a household with another child who is concurrently enrolled in a study of a live viral vaccine (including this study) - Expected contact with a pregnant caregiver within 28 days after each dose - A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after any study vaccine dose - Expected household contact within 28 days after each dose with a health care provider for immunocompromised subjects or who is a day care provider for infants under the age of 6 months - History of allergic reaction to any component of the study vaccine - Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject - Known or suspected active or chronic hepatitis infection - History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation for respiratory illness (excludes elective mechanical ventilation during surgery for subjects in Cohorts 1 and 2) - Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study - Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation. ; PRIMARY OUTCOME: Number of Participants With Solicited Symptoms After Dose 1; SECONDARY OUTCOME 1: Number of Participants Who Shed Vaccine-Type Virus[/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 - Renal Insufficiency; BRIEF: The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study. ; DRUG USED: BHQ880; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Dickkopf-1 (DKK-1) , WNT Signaling Pathway; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Confirmed diagnosis of multiple myeloma 2. Life expectancy of more than 6 months in the absence of intervention 3. Must not have received previous or be receiving current antimyeloma therapies 4. Renal insufficiency 5. Recovered from the effects of any prior surgery or radiotherapy Exclusion Criteria: 1. Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry 2. Pagets disease of bone or uncorrected hyperparathyroidism 3. Impaired cardiac function 4. Known HIV, known active hepatitis B, or known or suspected hepatitis C infection 5. Pregnant or nursing (lactating) women, 6. Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone; SECONDARY OUTCOME 1: safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Chondrosarcoma; BRIEF: IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma. ; DRUG USED: Saridegib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bone Cancer; TARGET: Hedgehog Signaling Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Infinity Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - At least 18 years of age at the time of signing informed consent. - Pathologically diagnosed conventional chondrosarcoma. Patients must have tumor sample(s) available or provide tumor samples from a new biopsy - Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon - At least 1 radiologically measurable target lesion per RECIST 1.1. - Patients must have documented radiographic progression of disease within the 6-month period prior to screening. (MRI or CT Scan) - Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1. - Life expectancy of at least 3 months - All women of child-bearing potential (WCBP), all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug. - Ability to adhere to the study visit schedule and all protocol requirements. - Voluntarily signed an informed consent form. Exclusion Criteria: - Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer. - Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug. - Prior treatment with a Hedgehog pathway inhibitor - Medically significant surgical procedures or significant traumatic injury within 28 days before Day 1. - Inadequate hematologic function defined by: - Hemoglobin <8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding). - Inadequate hepatic function defined by: - Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN). - Total bilirubin >1.5 x ULN (with the exception of patients with Gilberts disease). - Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis. - Inadequate renal function defined by serum creatinine >1.5 x ULN - Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months. - Presence of active infection or systemic use of antibiotics within 72 hours of treatment. - Significant co-morbid condition or disease, which in the judgment of the Investigator, would place the patient at undue risk or interfere with the study. Examples include, but are not limited to sepsis and recent significant traumatic injury. - Known human immunodeficiency virus (HIV) positivity. - Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 or placebo capsules. - Pregnant or lactating women. - Current administration of the medications or foods which are known to be moderate or strong inhibitors of CYP3A4 activity ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Comparison of Time To Progression (TTP)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Vigabatrin; BRIEF: The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment of infants newly diagnosed with Infantile Spasms (IS). ; DRUG USED: Cannabidiol (INSYS); DRUG CLASS: New Molecular Entity (NME); INDICATION: Infantile Spasms (West Syndrome; Epilepsy); TARGET: Cannabinoid reuptake/Endocannabinoid system, Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor, GPR55, Serotonin 5-HT1A receptor; THERAPY: Combination; LEAD SPONSOR: Radius Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Parent(s)/caregiver(s) fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements. 2. Clinical diagnosis of Infantile Spasms, confirmed by video-EEG (including at least one cluster of electroclinical spasms [≥3 in any 10-minute epoch] and hypsarrythmia) obtained during the Screening Period and read by a central reader. 3. General good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on physical and neurological examinations, medical history, and clinical laboratory values completed during the Screening Visit). 4. In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and able to comply with the study procedures and visit schedules. Exclusion Criteria: 1. Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigators Brochure for Cannabidiol Oral Solution) to be an unsuitable candidate to receive the study drug. 2. Known or suspected allergy to cannabidiol. 3. History of an allergic reaction or a known or suspected sensitivity to any substance that is contained in the investigational product formulation. 4. Use of any cannabidiol/cannabis product within 30 days of study entry. 5. Participant is diagnosed or suspected of having tuberous sclerosis. 6. Participant has received treatment with either vigabatrin, ACTH, or high-dose steroids previously. 7. Previous or concomitant therapy with felbamate, clobazam, valproic acid, or the ketogenic diet. 8. Participant currently on any disallowed CYP3A4-related medication (phenytoin, fluvoxamine, carbamazepine, and St. Johns Wort). 9. Previously received any investigational drug or device or investigational therapy within 30 days before Screening. 10. Clinically significant abnormal laboratory values, including: liver function tests (LFTs) such as albumin, direct bilirubin, total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN). The investigator may deem the participant eligible if he or she judges the laboratory values to be not clinically significant. ; PRIMARY OUTCOME: Percentage of Participants Considered Complete Responders; SECONDARY OUTCOME 1: Percentage of Participants With Resolution of Infantile Spasms[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - B-Cell Malignancies; BRIEF: This study evaluated the safety, tolerability, pharmacokinetic profile and efficacy of BGB-3111 in participants with B-cell lymphoid malignancies. ; DRUG USED: Brukinsa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Waldenstrom Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: BeiGene; CRITERIA: Inclusion Criteria: 1. Aged ≥ 18 years, voluntarily consented to the study. 2. WHO classification defined B-lymphoid malignancy, with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma. 3. Requirement for treatment in the opinion of the investigator. 4. Disease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10^9/L and platelets ≥ 50 x 10^9/L; participants with neutrophils < 1.0 x 10^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10^9/L. 7. Adequate renal function, as defined by creatinine clearance of ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection). 8. Adequate liver function, as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN), and bilirubin ≤ 1.5 x ULN (unless documented Gilberts syndrome). 9. International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN. 10. Female participants of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug. 11. Male participants must not donate sperm from initial study drug administration, until 90 days after drug discontinuation. Exclusion Criteria: 1. Current central nervous system (CNS) involvement by disease 2. Current histologically transformed disease. 3. Prior Brutons tyrosine kinase (BTK) inhibitor treatment. 4. Allogeneic stem cell transplantation within 6 months, or has active graft-versus-host disease (GVHD) requiring ongoing immunosuppression. 5. Receipt of the following treatment prior to first dose of zanubrutinib: corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2 weeks, monoclonal antibody within 4 weeks. 6. Not recovered from toxicity of any prior chemotherapy to grade ≤ 1. 7. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent. 8. Uncontrolled systemic infection requiring parenteral anti-microbial therapy. 9. Major surgery in the past 4 weeks. 10. Known HIV, or active hepatitis B or hepatitis C infection (detected positive by PCR). 11. Cardiovascular disease resulting in New York Heart Association function status of ≥ 3. 12. Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigators opinion would adversely impact on his/her participating in the study. 13. Inability to comply with study procedures. 14. On medications which are cytochrome P450 (CYP) 3A inhibitors. ; PRIMARY OUTCOME: Part 1 and Part 2: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib[/INST]Yes</s>

<s>[INST]<<SYS>>Predict 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 Topotecan; BRIEF: The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer. ; DRUG USED: Karenitecin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: BioNumerik Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Age ≥ 18 years - Confirmed diagnosis of stage III or IV epithelial ovarian cancer - Have cancer that is resistant to platinum/taxane-based chemotherapy regimens - Have measurable, progressive disease - Have an ECOG PS ≤ 2 Exclusion Criteria: - Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry. - Have a life expectancy < 3 months - Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins). - Received prior treatment with any platinum agent other than cisplatin or carboplatin. - Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined). ; PRIMARY OUTCOME: Progression Free Survival; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 132-02; BRIEF: A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE. ; DRUG USED: RSLV-132; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Immune System, Interferon-alpha (IFNa), RNA; THERAPY: Monotherapy; LEAD SPONSOR: Resolve Therapeutics; CRITERIA: Inclusion Criteria: - Stable SLE with no anticipated change in medications for the next 60 days Exclusion Criteria: - Other biologic drugs ; PRIMARY OUTCOME: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0; 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 I - 16026A (EU); BRIEF: The purpose of this study is to determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimers disease. ; DRUG USED: Lu AF20513; DRUG CLASS: Vaccine; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Main Inclusion Criteria: - The patient has a diagnosis of probable Alzheimers Disease (AD) consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) criteria - The patient has a pattern of antibodies in cerebrospinal fluid (CSF) consistent with an amyloid plaque load - The patient is a man or a woman, and between ≥60 and ≤85 years of age - The patient has an MRI (performed within 3 months before screening) with results consistent with the diagnosis of probable AD - The patient has a mild severity of dementia - The patient has a knowledgeable and reliable caregiver who will be available and able to: accompany the patient to all clinical visits, monitor IRE after each immunization, and participate with the patient at all phone visits during the study AD - Patients must have completed Part A before being eligible for continued immunisations in Part B Main Exclusion Criteria: - The patient has evidence of mixed etiology of dementia (i.e. absence of other neurodegenerative, neuroinflammatory or cerebrovascular disease, or another neurological, mental or systemic disease or condition likely contributing to cognitive decline) - The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et lEnseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia - The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-5-TR) Axis I disorder other than AD; including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress disorder and/or cognitive disorder not otherwise specified, (note: patients may be included if treated with a stable dose of antidepressants for at least 2 months and not fulfilling DSM-5-TR criteria for depression at Screening) - The patients eligibility MRI scan (1.5T) shows findings that correspond to more than 4 brain micro haemorrhages - The patient has extensive white matter lesions as shown on the screening MRI scan (1.5T) Other protocol-defined inclusion and exclusion criteria do apply ; PRIMARY OUTCOME: Safety and tolerability assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests, vital signs; 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 - BRIGHT; BRIEF: The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkins lymphoma (NHL) or mantle cell lymphoma (MCL). ; 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: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Key Inclusion Criteria: - Histopathologic confirmation of one of the following cluster of differentiation antigen 20 positive (CD20+) B-cell non-Hodgkins lymphomas (tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review): - follicular lymphoma (NCI CTCAE grade 1 or 2) - immunoplasmacytoma/immunocytoma (Waldenstroms macroglobulinemia) - splenic marginal zone B-cell lymphoma - extra-nodal marginal zone lymphoma of mucosa-associated lymphoid tumor (MALT) type - nodal marginal zone B-cell lymphoma - mantle cell lymphoma - Meets one of the following need-for-treatment criteria (with the exception of mantle cell lymphoma for which treatment is indicated): - presence of at least one of the following B-symptoms: 1. fever (>38ºC) of unclear etiology 2. night sweats 3. weight loss of greater than 10% within the prior 6 months - large tumor mass (bulky disease) - presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma-induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites - hyperviscosity syndrome due to monoclonal gammopathy - CD20+ B cells in lymph node biopsy or other lymphoma pathology specimen. - No prior treatment (patients on watch and wait may enter the study if a recent biopsy [obtained within the last 6 months] is available) - Adequate hematologic function (unless abnormalities related to lymphoma infiltration of the bone marrow or hypersplenism due to lymphoma) as follows: - hemoglobin of >= 10.0 g/dL - absolute neutrophil count (ANC) >=1.5*10^9/L - platelet count >=100*10^9/L - Bidimensionally measurable disease (field not previously radiated) - Able to provide written informed consent - Eastern Cooperative Oncology Group (ECOG) Performance Status <=2 - Estimated life expectancy >=6 months - Serum creatinine of <=2.0 mg/dL or creatinine clearance >=50 mL/min - Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5*upper limit of normal (ULN), and alkaline phosphatase and total bilirubin within normal limits - Left ventricular ejection fraction (LVEF) >= 50% by multiple gated acquisition scan (MUGA) or cardiac echocardiogram (ECHO), prior for any patient to be treated with R-CHOP - A medically accepted method of contraception to be used by women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal) - Men capable of producing offspring and not surgically sterile must practice abstinence or use a barrier method of birth control. Key Exclusion Criteria: - Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicular lymphoma - Transformed disease (bone marrow blasts are permitted; however, transformed disease indicating leukemic involvement is not permitted) - Central nervous system (CNS) lymphomatous involvement or leptomeningeal lymphoma - Prior radiation for NHL, except for a single course of locally delimited radiation therapy with a radiation field not exceeding 2 adjacent lymph node regions - Active malignancy, other than NHL, within the past 3 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer following definitive treatment - New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiograph (ECG) evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months (prior to study entry, ECG abnormalities at screening must be documented by the investigator as not medically relevant) - Known human immunodeficiency virus (HIV) positivity - Active hepatitis B or hepatitis C infection (hepatitis B surface antigen testing required) - Women who are pregnant or lactating - Corticosteroids for treatment of lymphoma within 28 days of study entry Chronically administered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications are permitted - Any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to receive therapy - Any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data - Any other investigational agent within 28 days of study entry - Known hypersensitivity to bendamustine, mannitol, or other study-related drugs - Ann Arbor stage I disease. ; PRIMARY OUTCOME: Percentage of Participants With Complete Response (CR) at End of Treatment Period; SECONDARY OUTCOME 1: Percentage of Participants With Overall Response at End of Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EMPhASIS; BRIEF: This is a Phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of 2 once-daily oral doses of IMU-838 (vidofludimus calcium), a small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), 30 mg/day and 45 mg/day in the main study, cohort 1 (and 10 mg/day for the patients in the cohort 2 substudy), in patients with RRMS and evidence of active disease. The trial consists of a screening period, a blinded 24-week main treatment period, and an optional initially blinded, then open-label extended treatment period of up to 9.5 years. About 40 centers are planned to participate in Romania, Bulgaria, Ukraine, and Poland; potential additional centers in Hungary and Croatia were not used. The study started with 195 patients in the main group (cohort 1) planned to be randomized 1:1:1 to treatment with 30 mg/day or 45 mg/day IMU-838, or placebo (65 patients each) in the main treatment period. During the extended treatment period, patients were initially re-randomized so that patients previously on placebo were re-randomized 1:1 to treatment with 30 g/day or 45 mg/day IMU-838, all other patients were re-randomized to the same treatment they previously received. With approval of Protocol Version 3.0, a sub-study patient group (cohort 2) has been added with up to 60 patients, randomized to placebo or 10 mg IMU-838 for 24 weeks after which the option is available to continue into the extended treatment period and the recommended dose of 30 mg/day. However, based on discussion between investigator and patient 45 mg/day IMU-838/day may also be used. ; DRUG USED: IMU-838; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Dihydroorotate Dehydrogenase (DHODH), DNA synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Immunic AG; CRITERIA: Inclusion criteria for the main treatment period 1. Male or female patient (age ≥18 to 55 years, inclusive) 2. Diagnosis of RRMS according to the revised McDonald criteria (2017) Note: The diagnosis of MS (including dissemination in time) must have been established before the patient is screened for the trial. 3. Disease activity evidenced - by either at least 2 relapses in the last 24 months, or at least 1 relapse in the last 12 months before randomization (relapses must have been assessed and documented by a physician in the patient files), AND - ≥1 documented Gd+ MS-related brain lesion, in the last 6 months before informed consent (date of MRI examination as well as copy of MRI report or representative image has to be available and accessible as patient source data at the study site) 4. Expanded Disability Status Scale (EDSS) score between 0 and 4.0 (inclusive) at Screening Visit 1 5. Female patients - must be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening Visit 1) or post menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or - if of child-bearing potential, must have a negative pregnancy test at Screening Visit 1 (blood test) and before the first IMP intake (Day 0 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (see below) together with a barrier method between trial consent and 30 days after the last intake of the of the IMP. Highly effective forms of birth control are those with a failure rate less than 1% per year and include: - oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation - oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation - intrauterine device or intrauterine hormone-releasing system - bilateral tubal occlusion - vasectomized partner (i.e. the patients male partner underwent effective surgical sterilization before the female patient entered the clinical trial and is the sole sexual partner of the female patient during the clinical trial) - sexual abstinence (acceptable only if it is the patients usual form of birth control/lifestyle choice; periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods] and withdrawal are no acceptable methods of contraception) Barrier methods of contraception include: - Condom - Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository 6. Male patients must agree not to father a child or to donate sperm starting at Screening Visit 1, throughout the clinical trial and for 30 days after the last intake of the IMP. Male patients must also - abstain from sexual intercourse with a female partner (acceptable only if it is the patients usual form of birth control/lifestyle choice), or - use adequate barrier contraception during treatment with the IMP and until at least 30 days after the last intake of the IMP, and - if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 5 - if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP 7. Willingness and ability to comply with the protocol 8. Written informed consent given prior to any trial-related procedure Inclusion criteria for optional extended treatment period 1. Completed 24 weeks of main treatment 2. Baseline MRI and Week 24 MRI, as well as 2 additional post-dose MRIs Continuation criteria for optional extended treatment period 1. In case the initial Week 24 MRI was not evaluated at least partially assessable, availability of a repeated Week 24 MRI 2. Week 24 MRI (initial or repeated one, if applicable) evaluated at least partially assessable Exclusion criteria MS-related exclusion criteria 1. Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis 2. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from these 3. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or MOG-associated encephalomyelitis (i.e. presence of anti-NMO [aquaporin-4] antibodies or anti-MOG-antibodies) 4. MS types other than RRMS 5. Any MRI finding, atypical for MS, including but not limited to a longitudinally extensive spinal cord lesion 6. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease) 7. An MS relapse within 30 days before Screening Visit 1 and/or during the screening period (until Day 0) Therapy exclusion criteria 8. Any previous or current use of the following MS treatments: monoclonal antibodies (natalizumab, alemtuzumab, daclizumab, ocrelizumab, anti-CD4, rituximab or belimumab, including their biosimilars), total lymphoid irradiation, bone marrow transplantation, stem cell transplantation, or any use of DHODH inhibitors, including teriflunomide (Aubagio™) or leflunomide (Arava™) 9. Any use of the following MS treatments within 12 months before the date of informed consent: any cytokine (other than interferon) or anti-cytokine therapy, intravenous immunoglobulin, mitoxantrone, cytotoxic or immunosuppressive therapy (including, but not limited to azathioprine and cyclophosphamide, excluding only systemic corticosteroids or adrenocorticotrophic hormone [ACTH]), tofacitinib, methotrexate, mycophenolate mofetil, mycophenolate sodium, fingolimod, any calcineurin inhibitors (e.g. tacrolimus, cyclosporine, or pimecrolimus) 10. Any use of the following MS treatments within 30 days before the date of informed consent: interferon-β, glatiramer acetate, dimethyl fumarate and plasmapheresis 11. Within 30 days before the baseline MRI: Use of systemic corticosteroids (intravenous or oral) or ACTH 12. Use of the following concomitant medications is prohibited at Screening Visit 1 and throughout the duration of the trial: - any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid - treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafinib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib - any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogs - use of rosuvastatin at daily doses higher than 10 mg 13. Use of any investigational product within 8 weeks or 5 x the respective half-life before the date of informed consent, whichever is longer, and throughout the duration of the trial Immune response exclusion criteria 14. Conditions negatively affecting the immune response such as previous organ transplant 15. Clinically significantly low lymphocyte and/or neutrophil count (Common Terminology Criteria for AEs Grade of 2 or higher), i.e. - lymphocyte count <800/mm³ (0.8 x 109/L), and/or - neutrophil count <1,500/mm³ (1.5 x 109/L) 16. History of chronic systemic infections within 6 months before the date of informed consent, including but not limited to tuberculosis, human immunodeficiency virus (HIV), hepatitis B or C 17. Positive IFNγ release assay for Mycobacterium tuberculosis at Screening Visit 1 18. Positive hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (HBcAb), positive HCV-antibody (HCV-Ab) and/or HIV-antigen-antibody test at Screening Visit 1 19. Any live vaccinations within 30 days before the date of informed consent except for the influenza vaccine Other medical history and concomitant disease exclusion criteria 20. Presence of the following laboratory values at Screening Visit 1: - platelet count <100,000/mm³ (<100 109/L) - serum creatinine >1.5 x ULN - total bilirubin, ALT, or GGT >1.5 x ULN - Serum uric acid levels at Screening Visit 1 >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL) - indirect (unconjugated) bilirubin >1.2 x ULN (i.e. >1.1 mg/dL) 21. Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis, including hereditary hyperoxaluria or hereditary hyperuricemia 22. History or clinical diagnosis of gout 23. Renal impairment defined as estimated glomerular filtration rate ≤60 mL/min/1.73m² 24. Known or suspected Gilbert syndrome 25. Diagnosis or suspected liver function impairment which may cause fluctuating liver function tests during this trial, as assessed by the investigator 26. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (New York Heart Association [NYHA] class 3 or 4) Note: NYHA class 3: Cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. NYHA class 4: Cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. 27. Clinically relevant, severe pulmonary diseases, uncontrolled hypertension, or poorly controlled diabetes 28. Concurrent malignancy or prior malignancy within the previous 10 years except for the following: adequately-treated non-melanoma skin cancer and adequately-treated cervical cancer 29. History or presence of any major medical or psychiatric illness (such as severe depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the patient or could affect adherence with the trial protocol 30. Epilepsy or seizures not adequately controlled by treatment 31. Any other substantial medical condition that in the opinion of the investigator could create undue risk to the patient or could affect adherence with the trial protocol General exclusion criteria 32. Current or past (within 12 months of Screening Visit 1) alcohol or drug abuse 33. Any condition that would prevent the patient from undergoing an MRI scan, including: - claustrophobic conditions - unable to receive Gd-based MRI-contrast agents due to history of hypersensitivity to Gd based contrast agents, or severe renal insufficiency - presence of metallic implants incompatible with brain MRI 34. Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to understand the patient information and informed consent form 35. Pregnant or breastfeeding 36. An employee of an investigator or sponsor or an immediate relative of an investigator 37. Patients institutionalized due to judicial or administrative order Exclusion criteria for optional extended treatment period 1. Any ongoing, clinically significant (as assessed by the investigator) treatment-emergent (started after intake of IMP) AE or laboratory abnormality (including blood chemistry and urinalysis) 2. Significant treatment or trial non-compliance during the main treatment period (as assessed by the investigator), and/or inability or unwillingness to follow instructions by trial personnel 3. Treatment compliance <70% during the main treatment period 4. Significant protocol deviations during the main treatment period that are assessed by the investigator to negatively affect further patient cooperation in this trial ; PRIMARY OUTCOME: Difference Between 45 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions; SECONDARY OUTCOME 1: Difference Between 30 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Plasma/Pulmonary PK (IV); BRIEF: Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and alveolar macrophages represent an ideal estimate of concentrations at the site of infection and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial concentrations via BAL is not routine in clinical practice due to its complex methodology and poor patient tolerability. This study will evaluate intrapulmonary and plasma pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate the single dose PK profiles. Part B is optional and will only be conducted if necessary. Each part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be dosed initially; cohorts 5 and 6 are optional and will only be dosed if additional time-points are necessary to adequately model the pulmonary pharmacokinetic profile. ; DRUG USED: GSK2140944; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Gram-Negative Bacteria, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, vital signs, electrocardiograms (ECGs), physical examination, and laboratory tests. A participant with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included if in the Investigators judgement the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent. A female participant is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. To confirm post-menopausal status, a blood sample for simultaneous follicle stimulating hormone (FSH) > 40 milli-international units per milliliter (MlU/ml) and estradiol < 40 picrograms (pg)/ml (<147 picromoles/Liter [pmol/L]) is confirmatory. Male participant with female partners of child-bearing potential must agree to use one of the contraception methods listed as per protocol. This criterion must be followed from the time of the first dose of study medication until the final follow-up visit. - Body weight >= 50 kg and Body mass index (BMI) within the range 19 - 31Kilograms/meter^2(kg/m^2) (inclusive). - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: - Contraindications to bronchoalveolar lavage including hypercapnia >50 millimeters of mercury (mm Hg), known or suspected intolerability to medications necessary for bronchoscopy, refractory hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the last 6 months, heart failure, and severe hemostatic alterations. - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening or positive Human Immunodeficiency Virus (HIV) antibody. - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Any clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator may place the participant at an unacceptable risk as a participant in this trial or may interfere with the absorption, distribution, metabolism or excretion of drugs. - A positive urine test for drugs of abuse or alcohol (or alcohol breath test) at screening. - A screening urinalysis positive for protein or glucose (greater than trace findings of protein or glucose). - A serum creatinine value that is out of the normal range, or an increase of 0.2 milligrams/decilitre (mg/dL) (or 15.25 micromoles/Liters [µmol/L]) in serum creatinine value between screening and Day -1 visit. - History of photosensitivity to quinolones. - Unwillingness to commit to avoid excessive exposure to sunlight (or exposure whilst on a tanning bed) which would cause a sunburn reaction from first dose up to and including the follow-up visit. - History of drug abuse within 6 months of the study or a history of smoking or use of nicotine containing products within 3 months of screening, or a positive urine cotinine indicative of smoking at screening. - History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits. - The participant has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. - Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, or use of St. Johns Wort within 14 days prior to the first dose of study medication. By exception, the volunteer may take paracetamol or acetaminophen (<=2 grams/day) up to 48 hours prior to the first dose of study medication. However, the Investigator and GSK study team can review medication on a case by case basis to determine if its use would compromise participant safety or interfere with the study procedures or data interpretation. - History of sensitivity to any of the study medications, including GSK2140944 and those that may be used in association with the BAL procedure, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. - Donation of blood in excess of 500 mL within 12 weeks prior to dosing. - History of tendon rupture. - History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinical research unit uses heparin to maintain intravenous cannula patency). - Consumption of red wine, pomegranate, seville oranges, grapefruit or grapefruit juice, pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices containing such products from 7 days prior to the first dose of study medication. - Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart Rate, Males <40 and >100 Beat Per Minute (bpm), females <50 and >100 bpm; PR interval <120 and >220 msec; QRS duration <70 and >100 msec; A QT interval corrected for heart rate using the Bazetts formula (QTcB) or Single QT duration corrected for heart rate by Fridericias formula (QTcF) interval >450 msec. Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). A participant has Bundle Branch Block. Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome), sinus pauses>3 seconds, non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats) or any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety of the individual participant. ; PRIMARY OUTCOME: Pulmonary pharmacokinetics of GSK2140944 following intravenous single-dose administration.; SECONDARY OUTCOME 1: Characterisation of the safety profile of GSK2140944 with adverse events (AEs) following intravenous single-dose administration[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Japan; BRIEF: The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation. ; DRUG USED: Durezol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Sirion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time) - Patients showing an anterior chamber cell score of not less than 2 at a day after surgery - Patients aged 20 years or over, irrespective of genders (it is eligible for enrollment when patients age attains the criterion on the day of consent obtainment) Exclusion Criteria: - Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs; - Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded) - Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs; - Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery); - Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids; - Patients who underwent sub-conjunctival injection or sub-Tenon capsule injection of corticosteroids; - Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations; - Patients who underwent gas tamponade at the surgery; - Patients with endogenous uveitis; - Patients having corneal epithelial detachment or corneal ulcer in the target eye; - Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye; - Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents; - Patients showing IOP not less than 25 mmHg a day after surgery; - Patients who have allergy to corticosteroid drugs; - Patients who are required to wear contact lens during the study period; - Patients who are scheduled to undergo surgery of the opposite eye during the study period; - Patients who are pregnant or may be pregnant or lactating; - Patients who have participated in other clinical studies within 3 months. ; PRIMARY OUTCOME: The changes in anterior chamber cell score at day 14 after start of instillation from the baseline level (differences from the baseline score) were compared between the 2 treatment groups.; SECONDARY OUTCOME 1: The changes in anterior chamber cell score at days 3 and 7 after start of instillation were compared between the 2 treatment groups.[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Chronic Migraines ; BRIEF: The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs. ; DRUG USED: Vyepti; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Alder Biopharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year - During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary - Headache eDiary was completed on at least 22 of the 28 days prior to randomization Exclusion Criteria: - Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome) or any pain syndrome that requires regular analgesia - Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. - History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine - Unable to differentiate migraine from other headaches - Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening. - Have any clinically significant concurrent medical condition - Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial) - Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway ; PRIMARY OUTCOME: 75% Migraine Responder Rate; SECONDARY OUTCOME 1: 50% Migraine Responder Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GRAND-307 (Asia Pacific); BRIEF: The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults with type 2 diabetes mellitus (T2DM). ; DRUG USED: Fasiglifam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GPR40 (FFAR1, free fatty acid receptor 1); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. 2. The patient or, when applicable, the patients legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Male or female, aged at least 18 years or over the legal age of consent in countries where that is greater than 18 years, with a historical diagnosis of T2DM. 4. Has an HbA1c of 7.0% to 10.0%, inclusive at screening, and has been treated with diet and exercise for at least 3 months. 5. Has a body mass index (BMI) of ≤45 kg/m^2 at screening. 6. Patients regularly using, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medication is allowed at the discretion of the investigator. 7. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose of study drug. 8. Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete subject diaries. Exclusion Criteria: 1. Is unable to understand the official language (verbal or written) of the country for which a certified translation of the approved informed consent is available. 2. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress. 3. Has hemoglobin a level ≤12 g/dL (≤120 g/L) (males) and ≤10 g/dL (≤100 g/L) (females) at the Screening Visit. 4. Has a history of any hemoglobinopathy that may affect determination of HbA1c. 5. Donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study. 6. Has systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening or Baseline (If the patient meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after initial measurement and decision will be made based on the second measurement). 7. Had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram, cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening. 8. Has a serum creatinine level of ≥1.5 mg/dL (males) and ≥1.4 mg/dL (females) and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m^2 at Screening. 9. Has uncontrolled thyroid disease. 10. Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening. 11. Has a history or treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery. 12. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x the upper limit of normal range (ULN) at Screening. 13. Has a total bilirubin level greater than the ULN at Screening. Exception: if a patient has documented Gilberts Syndrome, they will be allowed with an elevated bilirubin level per the investigators discretion. 14. Has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). 15. If a patient has no known history of HBV infection, then a HBV Screening test panel should be done. If the test is positive and there is clinical manifestation of active infection per Investigators diagnosis, then the patient should be excluded. In addition, if the patient is considered to need antiviral treatment, the patient should be excluded. (If the test results indicate only an hepatitis B surface antigen (HBsAg) carrier without any clinical manifestation of active infection, and no antiviral treatment is needed, then the patient could be enrolled provided all other criteria are met.) 16. Has a history of cancer that has been in remission for <5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed. 17. Has received any investigational compound within 30 days prior to Screening or has received >7 days of any antidiabetic agent within 3 months prior to Screening. 18. Has received TAK-875 in a previous clinical study. 19. Has a history of hypersensitivity, allergies or has had an anaphylactic reaction(s) to any component of TAK-875. 20. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 2 years prior to Screening. 21. Received excluded medications prior to Screening or is expected to receive excluded medications. 22. If female, is pregnant (confirmed by laboratory testing, ie, serum/urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. 23. If male, intends to donate sperm during the course of this study or for 30 days after final study medication dose. 24. Has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the subject according to the protocol. ; PRIMARY OUTCOME: Change From Baseline in HbA1c at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With HbA1c <7% 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 I/IIa - w/Nivolumab; BRIEF: The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread. ; DRUG USED: BMS-986207; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: TIGIT; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization Exclusion Criteria: - Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll - Other active malignancy requiring concurrent intervention - Uncontrolled or significant cardiovascular disease - Active, known, or suspected autoimmune disease - NSCLC without prior treatment in the advanced or metastatic setting (Part 2C) Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Incidence of Adverse Events (AEs); SECONDARY OUTCOME 1: Objective response rate (ORR)[/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 Ib/II - w/Paclitaxel (GOG); BRIEF: The purpose of this study is to estimate the maximum tolerated doses (MTD) of CRLX101 when administered in combination with weekly paclitaxel in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer. Determine through pharmacokinetic evaluation(sometimes described as what the body does to a drug, refers to the movement of drug into, through and out of the body-the time and course of its absorption, bioavailability, distribution, metabolism, and excretion) whether or not the disposition of paclitaxel is affected by the concurrent administration of CRLX101. ; DRUG USED: NLG207; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Hypoxia Inducible Factor-1 alpha (HIF-1a), Topoisomerase I (Topo-I); THERAPY: Combination; LEAD SPONSOR: NewLink Genetics Corporation; CRITERIA: Inclusion Criteria: 1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report. 2. Patient must have measurable disease or detectable (non-measurable) disease: Measurable disease will be defined by RECIST 1.1. 3. Patients must have adequate bone marrow, renal, hepatic, and neurologic functions 4. Patients should be free of active infection requiring parenteral antibiotics. 5. Any other prior therapy directed at the malignant tumor, including chemotherapy, bevacizumab or other biologic or targeted agents and immunologic agents, must be discontinued at least 21 days (three weeks) prior to registration. 6. Any prior radiation therapy must be discontinued at least four weeks prior to registration. 7. Major surgery within 28 days (four weeks) prior to registration. 8. Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease. 9. Patients must have a GOG performance status of 0 or 1. 10. Patients who will be enrolled under protocol amendment # 2 must have previously received bevacizumab, either discontinued due to intolerability, or progressed after at least 2 cycles of bevacizumab Exclusion Criteria: 1. Patients who have had previous treatment with: - CRLX101 or with any topoisomerase I therapy; - Weekly paclitaxel for recurrent or persistent disease. 2. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin, are excluded if: - There is any evidence of other malignancy being present within the last three years; - Previous cancer treatment contraindicates this protocol therapy. 3. Patients with known active hepatitis or HIV. 4. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first dose of study drug. 5. Patients with clinically significant cardiovascular disease. 6. Patients with serous non-healing wound, ulcer, or bone fracture. 7. Patients with active bleeding or pathologic conditions that carry high risk of bleeding 8. Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition. 9. Patients with active infection requiring parenteral antibiotics. ; PRIMARY OUTCOME: 1. To estimate the maximum tolerated doses (MTD) of CRLX101 when administered in combination with weekly paclitaxel in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.; SECONDARY OUTCOME 1: Comparison of pharmacokinetic perimeters including max concentration (Cmax), time to maximum concentration (Tmax), AUC, elimination half-life for CRLX101 and paclitaxel[/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 - Entecavir-Treated Patients; BRIEF: This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection. ; DRUG USED: RG7795; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Toll-like receptor 7 (TLR7); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Chronic hepatitis B infection - Positive test for HBsAg for more than 6 months prior to randomization - HBsAg titer greater than or equal to (>/=) 250 international units per milliliter (IU/mL) at Screening - Treatment with any nucleoside/nucleotide analogue for >/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization - HBV DNA less than (<) 90 IU/mL for at least the preceding 6 months - HBeAg positive at randomization and for at least 6 months prior to randomization Exclusion Criteria: - Pregnant or lactating women - Documented history of HBV genotype D - History or other evidence of bleeding from esophageal varices - History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease - Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) - Documented history of hepatitis D infection - History of or suspicion of hepatocellular carcinoma - History of immunologically mediated disease - History of organ transplantation - History of thyroid disease - Significant acute infection ; PRIMARY OUTCOME: Safety: Percentage of Participants with Adverse Events; SECONDARY OUTCOME 1: Pharmacodynamics: Peripheral Blood Levels of Interferon (IFN)-Alpha in QOD Dosing Cohorts[/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 - Fludarabine Refractory CLL (1); BRIEF: Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days). ; DRUG USED: Fodosine; DRUG CLASS: Non-NME; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Purine Nucleoside Phosphorylase (PNP); THERAPY: Monotherapy; LEAD SPONSOR: BioCryst Pharmaceuticals; CRITERIA: Inclusion Criteria: - Ages 18 years and older - Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria - Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy - Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen. - ECOG performance status of 0, 1, 2 or 3 - Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after - All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug. Exclusion Criteria: - Pregnant or nursing - Unable or unwilling to sign consent - Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy - Active serious infections that are not controlled by antibiotics - ECOG performance status 4 - Inadequate renal function: creatinine 2.0 or more unless related to the disease - Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease - Known positive test for HIV - Patients with known hepatitis B and/or hepatitis C active infection ; PRIMARY OUTCOME: Response rate after 2 cyclesof forodesine therapy.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PORTRAY; BRIEF: To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells. ; DRUG USED: ASP7317; DRUG CLASS: Biologic; INDICATION: Dry Age-Related Macular Degeneration (Dry AMD)/Geographic Atrophy (Ophthalmology); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Institute for Regenerative Medicine; CRITERIA: Inclusion Criteria: - Geographic atrophy (GA) secondary to AMD with no evidence of prior to active choroidal neovascularization (CNV) in the study eye. - BCVA in the study eye must be between 4 and 58 Early Treatment of Diabetic Retinopathy Study (EDTRS) letters (20/800 to 20/80; 0.025-0.25) - Subjects must be willing to take IMT and willing to discontinue any medication that has a known strong interaction with tacrolimus or mycophenolate mofetil (MMF) Exclusion Criteria: - Macular atrophy due to causes other than AMD - Other sight-threatening ocular disease - Current or prior history of optic neuropathy, retinal dystrophy, retinitis pigmentosa, chorioretinitis, vasoocclusive disease, retinal vascular disease or retinal degenerative disease OTHER than AMD - History of uveitis - History of allergic reaction to sulfa drugs - Solid organ or bone marrow transplant recipient - History of malignancy within the previous 5 years (except for BCC (basal cell carcinoma), SCC (squamous cell carcinoma) or in-situ cervical) - History of myocardial infarction with past 12 months - History of clinically significant cardiac dysrhythmia - History of diabetes mellitus, bowel disease, tuberculosis - Prior treatment for non-exudative AMD - Intraocular, refractive or cataract surgery in the last 12 weeks - Prior retinal surgery, vitrectomy, macular laser photocoagulation, external beam radiation therapy, transpupillary thermotherapy, glaucoma filtration surgery or corneal surgery (except cataract surgery) - Receipt of gene transfer of cell transplant therapy in a prior clinical trial - Participation in any other interventional clinical trial within the last 12 weeks ; PRIMARY OUTCOME: Number of subjects with evidence of graft failure or rejection.; SECONDARY OUTCOME 1: Change in area of geographic atrophy by Optical coherence tomography[/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 - A2310 (Pediatric Severe Plaque); BRIEF: This was a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years were enrolled, of which at least 30 were 6 years to <12 years old. Subjects were enrolled at approximately 70 study sites worldwide. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Must be 6 to less than 18 years of age at the time of randomization - Plaque-type psoriasis history for at least 3 months. Severe plaque-type psoriasis meeting all of the following three criteria: - PASI score of 20 or greater, - Investigators Global Assessment (IGA) score of 4 - Total body surface area (BSA) affected of 10% or greater. - Patient being regarded by the investigator to be a candidate for systemic therapy because of: 1. inadequate control of symptoms with topical treatment, or 2. failure to respond to or tolerate previous systemic treatment and/or UV therapy Exclusion criteria - Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) at randomization. - Current drug-induced psoriasis. - Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor. - Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy - History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis. - History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. - Pregnant or nursing (lactating) women. - Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Number and Percentage of Participants Achieving a 75% Improvement From Baseline in PASI Score at Week 12; SECONDARY OUTCOME 1: Number and Percentage of Participants Achieving a 90% Improvement From Baseline in PASI Score 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 III - AURIGA (MMY3021); BRIEF: The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT). ; DRUG USED: Darzalex Faspro; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Cluster of Differentiation 38 (CD38); THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Must have newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT on the date of randomization - Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization - Must have archived bone marrow samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction) or have existing results on the index multiple myeloma clone based on Adaptive Biotechnologies next generation sequencing (NGS)-based minimal residual disease (MRD) assay. Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by NGS. If an existing result on index myeloma clone is available from Adaptive Biotechnologies NGS-based MRD assay, as part of institutional procedures, an archived bone marrow sample is not required as long as Adaptive Biotechnologies is able to retrieve historical results on the index myeloma clone form the clinical database. Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of -80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow aspirate clot sections (block or slides) for MRD assessment: (i) A formalin fixed paraffin embedded (FFPE) block of bone marrow aspirate clot, or slides (preferably 5, if available), 5 micrometer each, of non-decalcified bone marrow, or; (ii) Slides (preferably 5, if available), bone marrow aspirate smear; (iii) Please note, bone marrow core sections are not acceptable samples for analysis; (iv) In exceptional circumstances when index myeloma clone cannot be identified from the archived bone marrow sample, a post-transplant sample can be used to identify myeloma clone with permission from the sponsor - Must have residual disease as defined by detectable MRD (Adaptive Biotechnologies NGS based MRD assay) - Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Exclusion Criteria: - A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease before the of date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsors medical monitor, is considered cured with minimal risk of recurrence within 3 years - Must not have progressed on multiple myeloma (MM) therapy at any time prior to screening - Have had prior treatment/therapy with: (a) Daratumumab or any other anti-cluster of differentiation 38 (CD38) therapies, (b) Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management, or (c) Plasmapheresis within 28 days of randomization - Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma - Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%) of predicted normal - Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification - Have any of the following: (a) Known history of seropositivity for human immunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; (c) Seropositive for hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy) ; PRIMARY OUTCOME: Percentage of Participants with Minimal Residual Disease (MRD) Negative Status as determined by NGS; SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ultraVIOLET; BRIEF: Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective treatment of RVVC than other oral antifungal medications. This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part of the study is a 2-week induction phase for the treatment of the patients current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (VT-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period. ; DRUG USED: Oteseconazole; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fungal Infections - Non-Systemic; TARGET: Cytochrome p450; THERAPY: Monotherapy; LEAD SPONSOR: Mycovia Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - 3 or more episodes of acute VVC in the past 12 months - Positive KOH test - Total vulvovaginal signs and symptoms score of ≥3 at screening visit - Total vulvovaginal signs and symptoms score of <3 at Day 14 - Must be able to swallow pills Exclusion Criteria: - Presence or a history of another vaginal or vulvar condition(s) - Evidence of major organ system disease - History of cervical cancer - Poorly controlled diabetes mellitus - Pregnant - Recent use of topical or systemic antifungal or antibacterial drugs - Recent use of immunosuppressive or systemic corticosteroid therapies ; PRIMARY OUTCOME: Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population; 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 I/II - ZN-c3-001 (w/Talazoparib/Pembrolizumab); BRIEF: This is a Phase 1 open-label, multicenter study of ZN-c3 monotherapy which consists of Dose Escalation, a Food Effect Cohort, and Dose Expansion. ; DRUG USED: ZN-c3; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Wee1 Inhibitor ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc; CRITERIA: Major Eligibility Criteria: 1. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 3. Adequate hematologic and organ function. 4. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception and for 6 months and 90 days, respectively, after the last dose of ZN-c3. Dose Escalation Inclusion Criteria: 1. Subjects must have a solid tumor with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies). 2. Measurable or evaluable disease per RECIST version 1.1. Food Effect Cohort Inclusion Criteria: 1. Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available. 2. Subjects must have no relevant dietary restrictions, and be willing to consume a high-calorie, high-fat breakfast and other standard meals provided during the study. Dose Expansion Inclusion Criteria: 1. Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria. 2. Recurrent or persistent USC or locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways. Major Exclusion Criteria: 1. Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3. 2. Prior therapy with a WEE1 inhibitor. 3. A serious illness or medical condition(s). 4. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation). 5. Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to C1D1. 6. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. 7. 12-lead ECG demonstrating a corrected QT interval using Fridericias formula (QTcF) of >480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. 8. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP). ; PRIMARY OUTCOME: Dose Escalation; SECONDARY OUTCOME 1: Dose Escalation, Food Effect cohort & Dose Expansion[/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 - CEES (Pediatric); BRIEF: This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design. ; DRUG USED: Jornay PM; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Ironshore Pharmaceuticals and Development, Inc; CRITERIA: Inclusion Criteria: - Male and female children (6-12 years at study entry) - Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) - Able to swallow treatment capsules - Available for entire study period - Provision of informed consent (from the parent[s] and/or legal representative[s]) and assent (from the subject) - Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy test (and will be given specific instructions for avoiding pregnancy during trial). Exclusion Criteria: - Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease - Presence of any significant physical or organ abnormality - Any illness during the 4 weeks before this study - Comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder) - Known history of severe asthma (in the opinion of the investigator) unless deemed currently controlled - Known history of severe allergic reaction to MPH - Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa, bulimia or current diagnosis or family history of Tourettes disorder - Subject who are severely underweight or overweight (in the opinion of the Investigator) - Any clinical laboratory value outside of the acceptable ranges, unless deemed NCS significant per the Investigator - Positive history for hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) - Positive screening for illicit drug use, and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject - Use of prescription medications (except ADHD medications) within 7 days and over-the-counter medications (except birth control) within the 3 days preceding study enrollment, unless deemed acceptable by the Investigator and Clinical or Medical Monitor - Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment - Current suicidal ideation or history of suicidality determined as a significant finding on the C-SSRS by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children). ; PRIMARY OUTCOME: SKAMP; 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 - 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 II ; BRIEF: The purpose of this study is to determine whether patients with advanced cancers who receive AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain; improved mood; and decreased fatigue. For the first three weeks, some patients receive AVR118, and others receive placebo (an injection expected to have no benefits). After three weeks, all patients will be offered the opportunity to take injections of AVR118. ; DRUG USED: EOM613; DRUG CLASS: Biologic; INDICATION: Cachexia / Weight Loss; TARGET: Immune System, Platelet-derived growth factor (PDGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Advanced Viral Research Corp; CRITERIA: Inclusion Criteria: - · Histologically confirmed malignancy (excluding central nervous - system malignancy) - · Not a candidate for, or refuses, curative anti-neoplastic therapy. - · Between the ages of 18 and 80. - · Symptoms of advanced cancer (loss of appetite, fatigue, weakness, - malaise) that are not attributed to anemia, concomitant illnesses, or - obstruction or loss of organ function. - · Karnofsky performance status of ³40%, _<_ 80%. - · Normal cognition, interpreted as a Mini-Mental State Score of at - least 20. - · Life expectancy of >4 months. - · Decrease in weight of at least 5% over the preceding 6 months, with - no weight gain over the most recent 30 days - · Pretreatment laboratory data within 7 days of enrollment (if - screening labs are done within 3 days of Day 1, they need not be - repeated on Day 1). - ¨ Hemoglobin >8.5 g/dL on no, or on stable doses (hematocrit stable - within 1 gram and dose stable for one month) of Epogen or similar - medication. - ¨ Absolute neutrophil count (ANC) ³1,500/mm^3 . - ¨ Platelets ³50,000/mm^3 . - ¨ Total bilirubin £1.5 the upper limit of normal (ULN). - ¨ ALT and AST £2.5 times the ULN, or, if the patient has liver - metastases, £5 times the ULN. - ¨ Creatinine £1.5 mg/dL. - ¨ Fasting blood sugar -<1.2 x ULN - ¨ Normal T3, T4, TSH - · Voluntary written informed consent before performance of any - study-related procedure that is not part of normal medical care. - · Ability to self-administer subcutaneous medication, or to have an - assistant who can administer the study medication according to the - protocol. - · Female patient is post-menopausal, surgically sterilized, or willing - to use acceptable methods of birth control (i.e., a hormonal - contraceptive, intra-uterine device, diaphragm with spermicide, or - condom with spermicide, or abstinence) for the duration of the study. - · Male patient agrees to use an acceptable barrier method for - contraception during the study. - · If on an antidepressant, the dose must have been stabilized for at - least 60 days Exclusion Criteria: - · Received immunotherapy, radiation therapy or experimental therapy - within three weeks. - · Receiving chemotherapy other than third-line, single agent therapy; - permitted third-line, single agent dose must be stable for at least - one month. - · Diabetes requiring insulin or oral hypoglycemic agents. - · Mechanical reason to be unable to eat, or is reasonably expected to - develop an obstruction during the next eight weeks - · Myocardial infarction within six months of enrollment. - · Uncontrolled brain metastases or central nervous system disease. - · Major surgery within four weeks of enrollment. - · Severe allergies to milk or milk products. ; 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 II - TG001 (Canada); BRIEF: Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy. The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass. ; DRUG USED: ToleroMune - Grass; DRUG CLASS: Vaccine; INDICATION: Allergic Rhinitis; TARGET: Immune System, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Circassia Limited; CRITERIA: Inclusion Criteria: - Male or female, aged 18-65 years - Minimum 2 year history of rhinoconjunctivitis on exposure to grass - Positive skin prick test to whole grass allergen - LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response - Positive CPT to whole grass allergen with a score ≥4 Exclusion Criteria: - Subjects with a history of asthma - Subjects with an FEV1 <80% of predicted - Subjects with a rye grass specific IgE >100 kU/L - Subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter > 50 mm - Subjects who score >1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT - Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillisers or psychoactive drugs - History of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) ; PRIMARY OUTCOME: Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis; SECONDARY OUTCOME 1: Area of Late Phase Skin Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CR106478 (UK); BRIEF: The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants. ; DRUG USED: MVA-BN Filo/Ad26.ZEBOV; DRUG CLASS: Vaccine; INDICATION: Ebola; TARGET: Ebola Virus, Marburg virus; THERAPY: Monotherapy; LEAD SPONSOR: Crucell Holland BV; CRITERIA: Inclusion Criteria: - Must be healthy on the basis of physical examination, medical history, and the investigators clinical judgment - Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening, a negative urine pregnancy test immediately prior to each study vaccine administration, and practice adequate birth control measures from 28 days before the prime vaccination until at least 3 months after the boost vaccination as specified in the study protocol. If not heterosexually active at screening, must agree to practice adequate birth control measures if they become heterosexually active during their participation in the study (from screening onwards until at least 3 months after the boost vaccination). Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from screening onwards until at least 3 months after the boost vaccination - Women of non-childbearing potential, defined as postmenopausal (>45 years of age with amenorrhea for ≥2 years or any age with amenorrhea for ≥6 months and serum follicle-stimulating hormone [FSH] >40 mIU/mL) or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), are not required to use the birth control methods as specified in the study protocol - A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a double-barrier method of birth control, such as either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. In case the female partner is using an adequate method of birth control, a single-barrier method of birth control for the male subject is acceptable. Men must also agree not to donate sperm from screening onwards until at least 3 months after the boost vaccination - Must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Exclusion Criteria: - Has been vaccinated with a candidate Ebola vaccine - Has been diagnosed with Ebola disease or exposed to Ebola including travel to West Africa in the last 12 months. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone - Has received any Ad26- or MVA-based candidate vaccine in the past - Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg or aminoglycosides - A woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in the study or within 3 months after the boost vaccination - History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone; thyroidectomy, or thyroid disease requiring medication during the last 12 months; uncontrolled hypertension as defined in the study protocol; or, major psychiatric illness and/or substance abuse problems during the past 12 months that in the opinion of the investigator would preclude participation ; PRIMARY OUTCOME: Number of participants with adverse events; SECONDARY OUTCOME 1: Immune responses to the study vaccine regimens as measured by a virus neutralization assay[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - NIAID; BRIEF: This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults. Optional Substudy: This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg. ; DRUG USED: mRNA-1273; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: A subject must meet all of the following criteria to be eligible to participate in this study: 1. Provides written informed consent prior to initiation of any study procedures. 2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Male or non-pregnant female, >/= to 18 years of age at time of enrollment. 5. Body Mass Index (BMI) 18.0-35.0 kg/m^2, inclusive (< 56 years of age), at screening; BMI 18.0-30.0 kg/m^2, inclusive (>/= 56 years of age), at screening. 6. Women of childbearing potential* must agree to use or have practiced true abstinence** or use at least one acceptable primary form of contraception.***, **** Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship). - Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement). - True abstinence is 100% of time no sexual intercourse (males penis enters the females vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). - Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subjects first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products. - Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination. 7. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination. 8. Male subjects of childbearing potential*: use of condoms to ensure effective contraception with a female partner of childbearing potential from first vaccination until 60 days after the last vaccination. *Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy. 9. Male subjects agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination. 10. In good health.* *As determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of subjects. Chronic medical diagnoses/conditions should be stable for the last 60 days (no hospitalizations, emergency room (ER), or urgent care for condition or need for supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 60 days before enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the participating site principal investigator (PI) or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination. 11. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 12. Pulse no greater than 100 beats per minute. 13. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive. 14. Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), Lipase, prothrombin time (PT), and partial thromboplastin time (PTT)) are within acceptable normal reference ranges at the clinical laboratory being used. 15. Must agree to have samples stored for secondary research. 16. Agrees to adhere to Lifestyle Considerations throughout study duration. 17. Must agree to refrain from donating blood or plasma during the study (outside of this study). Leukapheresis Inclusion Criteria: A subject must meet all of the following criteria to be eligible for leukapheresis: 1. Written informed consent for leukapheresis is provided. 2. Weight >/= 110 pounds. 3. Screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed. 4. Negative urine or serum pregnancy test within 48 hours of the leukapheresis procedure for women of childbearing potential. 5. Adequate bilateral antecubital venous access. 6. No use of blood thinners, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the leukapheresis procedure. 7. Enrolled in cohorts 2, 3, 5, 10, or 11, and possibly cohort 6, if enrolled, and completed the two-dose vaccination series. Optional Substudy Inclusion Criteria: 1. Enrolled in the main study and received both the first and second mRNA-1273 vaccinations. 2. Provides written informed consent for the third mRNA-1273 vaccination. 3. Agrees to the collection of venous blood per substudy. 4. Must agree to have samples stored for secondary research. 5. Women of childbearing potential have had a negative urine pregnancy test within 24 hours before the third mRNA-1273 vaccination. 6. Women of childbearing potential* must agree to use or have practiced true abstinence** or use at least one acceptable primary form of contraception.***/**** - Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure® placement). - True abstinence is 100% of time no sexual intercourse (males penis enters the females vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). - Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subjects first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products. ****Must use at least one acceptable primary form of contraception for at least 30 days prior to the third mRNA-1273 vaccination and for at least 30 days after the third mRNA-1273 vaccination. Exclusion Criteria: A subject who meets any of the following criteria will be excluded from participation in this study: 1. Positive pregnancy test either at screening or just prior to each vaccine administration. 2. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. 3. Has any medical disease or condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation.* *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subjects successful completion of this trial. 4. Presence of self-reported or medically documented significant medical or psychiatric condition(s).* *Significant medical or psychiatric conditions include but are not limited to: Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics. Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia. Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinsons disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimers disease). Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis. An immunodeficiency of any cause. Chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2. 5. Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 6. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening. 7. Has participated in another investigational study involving any investigational product* within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration. *study drug, biologic or device 8. Currently enrolled in or plans to participate in another clinical trial with an investigational agent* that will be received during the study-reporting period.** *Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. **13 months after the first vaccination. 9. Has previously participated in an investigational study involving lipid nanoparticles (LNPs) (a component of the investigational vaccine assessed in this trial). 10. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. 11. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.* *Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted. 12. Anticipating the need for immunosuppressive treatment within the next 6 months. 13. Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study. 14. Has any blood dyscrasias or significant disorder of coagulation. 15. Has any chronic liver disease, including fatty liver. 16. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration. 17. Has a positive test result for drugs of abuse at screening or before the first vaccine administration. If cannabis is the only detected drug, inclusion is permitted. 18. Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region). 19. Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 20. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 21. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study. 22. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration. 23. History of COVID-19 diagnosis. 24. On current treatment with investigational agents for prophylaxis of COVID-19. 25. Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the investigator or necessary to manage a chronic condition. 26. Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after the last vaccination. 27. Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. 28. Non-ambulatory. 29. For subjects >/= 56 years of age, history of chronic smoking within the prior year. 30. For subjects >/= 56 years of age, current smoking or vaping. 31. For subjects >/= 56 years of age, individuals currently working with high risk of exposure to SARS-CoV-2 (e.g., active health care workers with direct patient contact, emergency response personnel). Optional Substudy Exclusion Criteria: 1. Anaphylaxis or other systemic hypersensitivity reaction following a mRNA-1273 or any other vaccination. 2. Immediate allergic reaction of any severity after mRNA-1273 or any of its components.* *Including polyethylene glycol (PEG) 3. Immediate allergic reaction of any severity to polysorbate.* *Due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG 4. History of an SAE judged related to mRNA-1273 vaccine. 5. Female subject who is breastfeeding or plans to breastfeed from the time of the third mRNA-1273 vaccination through 30 days after the third mRNA-1273 vaccination. 6. Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/=38.0°C (100.4°F)], within 72 hours prior to the third mRNA-1273 vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the substudy. 7. Has received any approved, authorized or investigational COVID-19 vaccine outside of this trial. 8. Any clinically significant medical condition that, in the opinion of the investigator, poses an additional risk to the subject from vaccination. 9. History of documented COVID-19 infection. 10. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes substudy participation. 11. Received or plans to receive a licensed vaccine, other than a COVID-19 vaccine, within 2 weeks before or after the third mRNA-1273 vaccination. ; PRIMARY OUTCOME: Frequency of Any Medically-attended Adverse Events (MAAEs); SECONDARY OUTCOME 1: Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers. ; DRUG USED: Tagrisso; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1, Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 3. In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291. Exclusion Criteria: 1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator. 2. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing. 3. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class. ; PRIMARY OUTCOME: Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax); SECONDARY OUTCOME 1: Pharmacokinetics of AZD9291 and its metabolites by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 2008-ALS-I; BRIEF: A Phase I, single center, prospective, non-randomized, open label, safety/efficacy study of the infusion of autologous bone marrow-derived stem cells, in 6 patients with Amyotrophic Lateral Sclerosis according to established criteria (1), (2) with a moderate to severe diagnosis of ALS according to the World Federation of Neurology El Escorial criteria. The primary purpose of this study is to evaluate safety of the infusion procedure, as assessed by absence of complications at the site of infusion or the appearance of new neurologic deficit not attributed to the natural progression of the disease. Secondary outcomes will include a)neurological evidence of trends toward a slowing down of the decline of the forced vital capacity (FVC) (3) and of the functional rating scale (ALS-FRS) scores, as assessed at 3-month intervals, b)evidence of a decline of the maximum voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z (4) scores and c)patient evaluation that the treatment was effective and consider the possibility of a new cell product stem cell infusion. Subjects who fulfill inclusion/exclusion criteria and sign informed consent will undergo an aspiration of bone marrow from the iliac crest for preparation of the cellular product. The day of infusion, the investigational product will be injected into the patients intrathecal space. After cell infusion patients will be followed at WK 2, MN 1, MN 2, MN 6 and a long-term followup at MN 12 in the clinic and/or office. Electromyographic (EMG) studies, Forced vital capacity (FVC), functional rating scale (FRS) and maximum voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z scores will have been used to assess the status of the disease before (historical record acceptable if done within three months of Screening Visit) and during the 12-month study period after cell infusion. ; DRUG USED: Autologous combination stem cell therapy; DRUG CLASS: Biologic; INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: TCA Cellular Therapy; CRITERIA: Inclusion Criteria: 1. Adult male and female subjects > 18 years of age. 2. Good understanding of the protocol and willingness to consent. 3. Moderate to severe Diagnosis of ALS according to the World Federation of Neurology El Escorial criteria. 4. Vital capacity at least 50% predicted value for gender, height and age. 5. More than 6 and less than 36 months of evolution of the disease. 6. Hematocrit greater than 30 % prior to bone marrow aspiration. 7. Platelet count greater than 100 Thousand/uL at screening. 8. INR less than or equal to 1.5. Exclusion Criteria: 1. Any concurrent illness, which affects the bone marrow. 2. Any concomitant medication that affects the bone marrow. 3. Previous stem cell therapy. 4. Any lymphoproliferative disease. 5. Riluzole with 4 weeks of study entry and at any time during the study. 6. Hemophiliacs or subjects with bleeding disorders. 7. Known hypersensitivity to fetal bovine serum 8. HIV infection. 9. Serum creatinine > 3.0 in subjects not on hemodialysis. 10. Skin infection at the infusion site or systemic infection 11. Current smoker. 12. Active drug or alcohol addiction 13. Pregnant, planning to become pregnant or not on accepted birth control method if subject is of child bearing potential. 14. Subjects that are breast feeding. 15. Any condition that the Principal Investigator considers would render the subject unfit for the study. ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Efficacy[/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 - ECLIPSE (w/Cyclophosphamide/GVAX Pancreas); BRIEF: Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma ; DRUG USED: CRS-207; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Immune System, Mesothelin; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Aduro Biotech, Inc.; CRITERIA: Inclusion Criteria: - Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required, mixed histology is not allowed; subjects must have metastatic disease - 2nd line, 3rd line or greater - At least 18 years of age - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Anticipated life expectancy >12 weeks - For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. A barrier method of contraception must be employed by all subjects (male and female), regardless of other methods. - Have adequate organ function as defined by specified laboratory values Exclusion Criteria: - Allergy to both penicillin & sulfa or suspected hypersensitivity to granulocyte-macrophage colony stimulating factor (GM-CSF), dimethyl sulfoxide, fetal bovine serum, trypsin, yeast, glycerol or other component of the therapy options - Known history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment - Have any evidence of hepatic cirrhosis or clinical or radiographic ascites - Have prosthetic heart valves, major implant or device placed in the last 12 months or history of infection with implant/device that cannot be easily removed - Rapidly progressing disease - Clinically significant and/or malignant pleural effusion - Received prior GVAX pancreas vaccine or CRS-207 - Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia - Infection with HIV or hepatitis B or C at screening - Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis - Pregnant or breastfeeding - Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen - Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patients ability to comply with study visits and procedures ; PRIMARY OUTCOME: Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set); SECONDARY OUTCOME 1: Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Chronic Liver Disease (201); BRIEF: Primary objectives: To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation. To assess the safety and tolerability of GRI-0621 at these two doses. Secondary objectives: To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a second marker of liver inflammation. To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from baseline measured at the different trial time points. To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or apoptosis. To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo. To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic liver disease. Exploratory objectives: To assess the effect, if any, that the investigational product may have on serum triglyceride levels. ; DRUG USED: GRI-0621; DRUG CLASS: Non-NME; INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: NKT Cells; THERAPY: Monotherapy; LEAD SPONSOR: GRI Bio, Inc.; CRITERIA: Inclusion Criteria: A participant will be eligible for participation in the trial if all of the following inclusion criteria are met: 1. Completion of the written informed consent process for trial participation prior to all trial-related procedures, including HIV testing. 2. Male or female participants aged 18 to 65 years. 3. Female participants of child-bearing potential must practice an effective method of birth control from four weeks prior to randomization and agree to continue this until 6 months after the completion of the end-of-trial follow-up visit. Effective birth control must include two methods, one of which must be a barrier method. Female participants are considered not to be of child-bearing potential if they are post-menopausal (12 months of spontaneous amenorrhoea with an appropriate clinical profile, or 6 months of spontaneous amenorrhoea with local laboratory serum follicle-stimulating hormone [FSH] levels in keeping with post-menopause) or surgically sterile (after bilateral oophorectomy, hysterectomy or salpingectomy). For the purpose of this trial any participant who has had a tubal ligation will not be considered surgically sterile due to the teratogenic nature of this class of chemical entities. 4. Female participants of child-bearing potential must have negative serum and urine pregnancy tests at screening and randomization respectively. 5. History of chronic liver disease [CLD] as a result of viral hepatitis, alcoholic steatohepatitis [ASH] or non-alcoholic steatohepatitis [NASH]. 6. Evidence of viral hepatitis, ASH or NASH as described beneath: - Viral Hepatitis: - Hepatitis C virus [HCV] infection as confirmed by the presence of HCV RNA (determined by PCR) and no other cause of liver disease or - Hepatitis B virus [HBV] infection as confirmed by the presence of HBV DNA > 104 copies/ml (determined by the Roche COBA TaqMan HBV DNA assay) and no other cause for liver disease or - Hepatitis C and B co-infection (as defined above) OR - ASH: - Findings and history consistent with the diagnosis of ASH in the opinion of the investigator OR - NASH: - Absence of viral hepatitis and - A history of no or minimal alcohol use and - Findings and history consistent with the diagnosis of NASH in the opinion of the investigator 7. Body Mass Index (BMI) of 18 to 39kg/m2. 8. Weight ≥ 45kg 9. ALT > 1.5 x ULN but less than 10 x ULN on two occasions during the screening period (Day -28 to Day -1). The second occasion must be between Day -7 and Day -1. 10. An ability to communicate well with the investigator and to understand and comply with the requirements of the trial. 11. Agree to stay in contact with the trial site for the duration of the trial, provide updated contact information as necessary. Exclusion Criteria: A participant will not be eligible for trial participation if any of the following exclusion criteria are met: 1. Use of any other investigational drug within 30 days or five half-lives (whichever is longer) of the first dose of GRI-0621. 2. Current pregnancy or lactation. 3. A history of anaphylaxis or severe hypersensitivity to any drugs. 4. A known hypersensitivity to any component of the investigational product or to any other retinoids. 5. ALT or AST > 10 x ULN on any occasion during the screening period (Day -28 to Day -1) 6. ALT or AST known to have been > 10 X ULN on any occasion during the 2 months prior to screening. 7. Any of the following laboratory abnormalities at screening: - Serum creatinine > 1.5 x ULN - Hemoglobin < 10.0 g/L - Platelets < 75 x 109/L - White cell count < 3.0 x 109/L. 8. Known hypothyroidism requiring treatment or laboratory results suggestive of hypothyroidism at screening (thyroxine [T4] < LLN and thyroid-stimulating hormone [TSH] > ULN). 9. Any clinically significant ECG abnormalities. 10. Current or recent (during the 3 months prior to screening) or required treatment for tuberculosis infection. 11. A history of any malignancy (other than treated localized basal cell carcinoma of the skin) in the last 5 years. 12. A history or known presence of osteoporosis. 13. A history of arthritic conditions requiring treatment with symptom- or disease-modifying drugs for > 4 weeks. 14. A history of atopic dermatitis. 15. History or presence of decompensated liver disease 16. Previous histological evidence of hepatic fibrosis stage > 3. 17. The presence of any acute disorder that could further compromise the hepato-biliary system including but not limited to acute infectious or alcoholic hepatitis, acute pancreatitis, biliary obstruction and cholecystitis. 18. History or presence of hepatocellular carcinoma, hepatic abscess, biliary obstruction or portal vein thrombosis as confirmed by ultrasound, CT or MRI scans. 19. A history of severe gastro-intestinal bleeding requiring blood transfusion therapy (packed cells or whole blood). 20. Any surgical or medical condition other than CLD which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the participant or the objectives of the trial including but not limited to inflammatory bowel disease, major gastro-intestinal surgery (e.g. gastrectomy, gastroenterostomy or bowel resection) or pancreatic injury. 21. A history of hemachromatosis, Wilsons disease, alpha-1-antitrypsin deficiency or celiac disease. 22. Previous organ or hematopoietic transplantation. 23. HIV infection confirmed by a positive HIV test result. 24. Any other medical condition which, in the opinion of the investigator, could affect the participants health during trial participation or could compromise his/her ability to participate in the trial. This includes but is not limited to significant cardiovascular, respiratory, renal, neurological, hematological, immunological, endocrinological or metabolic disorders. 25. Any psychiatric or mental disorder which could limit the validity of the informed consent or the participants ability to comply with the protocol requirements. 26. A history of drug abuse during the 12 months prior to screening, or evidence of such abuse as indicated by urine testing for drugs of abuse at screening that, in the opinion of the investigator, may be indicative of potential participant adherence issues during the course of the trial. 27. In the opinion of the investigator, the participant is not reliable to participate in the trial. ; PRIMARY OUTCOME: Change in serum ALT levels from Day 0 (baseline) to Day 28; SECONDARY OUTCOME 1: Change in serum AST levels from Day 0 (baseline) to 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 - vs. Travatan; BRIEF: The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension. ; DRUG USED: Izba; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension. - Qualifying intraocular pressure at both eligibility visits. - Understand and sign an informed consent form. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control. - Severe central visual field loss in either eye. - Chronic, recurrent or severe inflammatory eye disease. - Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen). - Any abnormality preventing reliable applanation tonometry. - Hypersensitivity to prostaglandin analogs or to any component of the study medications. - Therapy with another investigational agent within 30 days prior to the Screening Visit. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ISLE-1; BRIEF: This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c). ; DRUG USED: HDV-L; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Diasome Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Men and women ≥ 18 yrs. of age 2. Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months 3. Body Mass Index (BMI) ≤ 35 Kg/m2 4. Basal insulin includes insulin Glargine or insulin Detemir 5. Patient should be using bolus insulin defined as 2 to 4 doses of regular human insulin or rapid-acting analog at meals 6. HbA1c ≥ 7.0% and ≤ 10.5% 7. Fasting C-peptide ≤ 0.5 pmol/mL 8. Willingness to adhere to protocol and perform all required tests 9. Willing and able to review and sign the Informed Consent Form. 10. If child bearing age, must use acceptable form of birth control (ligation, 2 forms of birth control) 11. Willing to wear CGM devices and complete diaries. Exclusion Criteria: 1. Total daily insulin dose ≥ 1.5 IU/kg/day. 2. History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that effect HbA1c measurements 3. Evidence of serious complications of diabetes (eg, Symptomatic autonomic neuropathy) 4. Patients who are selected to but are unwilling or unable to participate in the MRI evaluation subset. (These patients may still participate in the non-MRI subset). 5. Significant cardiovascular dysfunction or history within 12 months of Screening, eg, congestive heart failure (New York Heart Association Class III or IV), or clinically significant arrhythmia, myocardial infarction, cardiac surgery; history of valvular heart disease including mild or greater aortic insufficiency, or moderate or greater mitral insufficiency; recurrent syncope, transient ischemic attacks, or cerebrovascular accident 6. Impaired liver function with elevated enzymes > 50% above the normal range at Screening. Patients with elevated liver enzymes may have the test repeated only at Visit 2 on a case-by-case basis at the request of the PI. 7. Creatinine level > 2 mg/dL for men, and > 1.8 mg/dL for women at Screening. 8. Patient on low carbohydrate diet, such as Atkins Diet 9. History of Adrenal supplementation within 3 years of Screening. 10. History of unawareness or SEVERE recurrent hypoglycemia, defined as a patient who is unaware of symptoms of hypoglycemia, or due to autonomic dysfunction, has no inherent warnings of hypoglycemia, and therefore requires outside assistance to rectify any episodes of hypoglycemia 11. Patients treated with systemic corticosteroids (Sporadic use of inhaled, intraarticular, and topical corticosteroids is not considered systemic). 12. Patients with triglyceride levels ≥500 mg/dL at Screening. 13. Patients with a history of cancer within the past 5 years, excluding basal or squamous cell carcinoma localized to the skin. 14. Epilepsy or other physical or medical conditions which could result in non-compliance with the study. 15. Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study 16. Unwilling to discontinue use of an insulin pump for the duration of the study. 17. Women who are pregnant, nursing, or planning to become pregnant during the course of the study. 18. Patients on NPH as their basal insulin. 19. Positive history of hepatitis A (within 12 months of Screening), or a positive history of hepatitis B, hepatitis C, or HIV at Screening. 20. History of drug addiction and/or alcohol abuse within 12 months of Screening. ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Change in fasting blood glucose glucose levels[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MSK10-134; BRIEF: Study of a Wilms Tumor-1 (WT1) vaccine to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth. ; DRUG USED: Zeltherva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mesothelioma; TARGET: Immune System, Wilms Tumor Protein 1 (WT1); THERAPY: Monotherapy; LEAD SPONSOR: Sellas Life Sciences Group; CRITERIA: Inclusion Criteria: - Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution. - Positive immunohistochemical staining for WT-1 (greater than 10% of cells). - Completion of multimodality therapy. This must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy. - 4-12 weeks since completion of combined modality therapy. - Age > or = to 18 years - Karnofsky performance status > or = to 70% - Hematologic parameters: Absolute neutrophil count > or = to 1000/mcL, Platelets > or = to 50K/mcL. - Biochemical parameters: Total bilirubin < or = to 2.0 mg/dl, AST and ALT < or = to 2.5 x upper limits of normal, Creatinine < or = to 2.0 mg/dl. Exclusion Criteria: - Pregnant or lactating women. - Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments. - Patients with a serious unstable medical illness or another active cancer. - Patients taking systemic corticosteroids. - Patients with an immunodeficiency syndrome. ; PRIMARY OUTCOME: To assess the 1-year progression free survival in patients; SECONDARY OUTCOME 1: To confirm the immunogenicity of the WT-1 analog peptide vaccine[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I (Advanced Cancer); BRIEF: The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have. In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma. ; DRUG USED: LY3023414; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, PI3K/AKT pathway; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Parts A, A2 & B1: Participants must have pathological evidence of a diagnosis of advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy - Part B2: Participants must have advanced, recurrent, or metastatic breast cancer that is refractory to aromatase inhibitors (AI) with either disease recurrence or disease progression; must be hormone receptor positive (HR+) and human epidermal growth factor receptor 2 (HER2)-negative; must be of postmenopausal status or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist - Part B3 only: Participants must have malignant pleural or peritoneal mesothelioma - Part B4 only: Participants must have malignant pleural or peritoneal mesothelioma and appropriate candidate for treatment with cisplatin/pemetrexed; no prior systemic chemotherapy - Part B5 only: Participants must have histologically confirmed diagnosis of B-cell iNHL, with histological subtype; prior treatment with ≥2 prior chemotherapy- or immunotherapy-based regimens for iNHL - Part B6 only: Participants must have squamous NSCLC; documented evidence of an activating molecular aberration of the PI3K/mTOR pathway - Parts B2, B3 & B6 only: Must have adequate tumor tissue sample from archival biopsy available, or willingness to undergo a fresh tumor biopsy - Parts B3, B4, B5 & B6: No previous treatment with any PI3K and/or mTOR inhibitor - Part B7: Must have a diagnosis of HR+ and HER2- breast cancer; have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease; no previous treatment or currently receiving 1 of the following treatments for locoregionally recurrent or metastatic breast cancer (chemotherapy, endocrine therapy, CDK4/6 inhibitor, and PI3K and/or mTOR inhibitor) - Measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1), modified RECIST or Revised Response Criteria for Malignant Lymphoma - Have adequate organ function, including: Absolute neutrophil count (ANC) at least 1.5 x 109/Liter (L), platelets at least 100 x 109/L, and hemoglobin at least 8 grams/deciliter (g/dL); bilirubin no more than 1.5 times upper limits of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 2.0 times upper limits of normal; Serum creatinine no more than 1.5 times upper limits of normal or calculated creatinine clearance >45 milliliters/minute (mL/min) - Have a performance status of at least 1 on the Eastern Cooperative Oncology Group (ECOG) scale and life expectancy >6 months - Have discontinued all previous cancer therapies (except nonsteroidal aromatase inhibitors for participants in Part B2), and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half lives prior to study enrollment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days - Are able to swallow capsules Exclusion Criteria: - Have serious preexisting medical conditions - Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). - Have known acute or chronic leukemia or current hematologic malignancies (except iNHL for patients in Part B5) that, in the judgment of the investigator and sponsor, may affect the interpretation of results - Have an active fungal, bacterial, and/or known viral infection - Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results (Part B only) - Part B1 only: No concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) or midazolam - Intolerance to any previous treatment with any phosphatidylinositol-3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor. - Participants with active alcohol abuse, as determined by the investigator - Have a history of New York Heart Association (NYHA) Class ≥3, unstable angina, or myocardial infarction (MI) in 6 months prior to study drug administration - Have QT corrected interval of >450 milliseconds (msec) on screening electrocardiogram (ECG) - Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus. - Part B only: Hypersensitivity to study drugs given in combination with LY3023414 ; PRIMARY OUTCOME: Recommended Phase 2 dose; SECONDARY OUTCOME 1: Pharmacokinetics: Maximum concentration (Cmax)[/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 - KRYSTAL-12; BRIEF: This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation. ; DRUG USED: Adagrasib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: KRas; THERAPY: Monotherapy; LEAD SPONSOR: Mirati Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. - Candidacy to receive treatment with docetaxel. Crossover Inclusion Criteria: - Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR - ECOG performance status 0-2 Exclusion Criteria: - Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib). - Active brain metastases. Crossover Exclusion Criteria: - Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study. ; PRIMARY OUTCOME: Progression-free Survival (PFS); 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 Ib - Stage III/IV Intratumoral; BRIEF: The purpose of this study is to test the safety of an investigational combination drug/immunotherapy for the treatment of Stage III/IV melanoma. ; DRUG USED: ZIN-CTI-001; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: IL-12 (Interleukin-12) and IL-12 receptor; THERAPY: Combination; LEAD SPONSOR: Alaunos Therapeutics; CRITERIA: Inclusion Criteria: 1. Males or females of all races ≥ 18 years of age and ≤ 75 years of age; 2. Unresectable Stage III C (in transit) or Stage IV melanoma (M1a, M1b, M1c with LDH ≤ 2x ULN), arising from primary cutaneous, mucosal, or subungual melanoma of any tumor thickness or from an unknown primary site; 3. A minimum of 2-3 accessible nonvisceral lesions (longest diameter ≤3 cm) or palpable tumor-involved lymph nodes (longest diameter ≤5 cm) for intratumoral injections (INXN-3001) and biopsies; 4. ECOG performance status of 0 or 1; 5. Patients without visible brain metastases as assessed by contrast-enhanced MRI scan within 6 weeks prior to receiving study treatment; 6. Adequate baseline hematological and organ function, assessed by laboratory values within 42 days (6 weeks) prior to study entry and prior to repeat treatment cycles with INXN-1001 as follows: hemoglobin ≥ 10 g/L, granulocytes > 2500/mm3, lymphocytes > 1000/ mm3, platelets > 100,000/ mm3, serum creatinine < 1.5 x ULN, AST, ALT, alkaline phosphatase < 2.5 x ULN, LDH ≤ 2 x ULN, serum bilirubin < 1.5 x ULN, absolute neutrophils > 500/ mm3; 7. An expected survival of at least approximately 6 months in the opinion of the investigator (as assessed mainly by performance status); 8. Females must be post-menopausal or surgically sterile or practice effective contraception; Men who are not surgically sterile and whose partners are not post-menopausal or surgically sterile must practice effective contraception; 9. Normal coagulation parameters as measured by PT/PTT; 10. Signed, IRB-approved voluntary written informed consent. Exclusion Criteria: 1. Active, acute viral, bacterial, or fungal infections requiring specific therapy; 2. HIV-infection due to concerns about ability to mount an effective immune response; 3. Active autoimmune disease requiring steroids (>10 mg prednisolone or comparable) or other immunosuppressive therapy; 4. Patients with detectable brain metastases at the time of screening (or within 6 weeks prior to receiving study treatment), as assessed by contrast-enhanced MRI scans; 5. Patients with one or more lesion(s) > 3cm (LD) or palpable, tumor-involved lymph node(s) >5 cm (LD); 6. Patients with a hemoglobin of < 10 g/L; 7. Presence of Stage IV visceral metastases or other distant metastases if LDH >2 x ULN; 8. Patients who have previously been treated with INXN-3001 and INXN-1001; 9. Recipients of organ allografts; 10. Other concurrent, clinically active malignant disease, with the exception of other cancers of the skin; 11. Less than 30 days (before the first dose of study medication) have elapsed since the completion of prior chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any first line therapy; 12. Clinically significant cerebrovascular disease; 13. History of or concurrent severe cardiac insufficiency (New York Heart Association Class III or IV) or coronary artery disease; 14. QTc interval of >470 ms on screening; 15. Inability to measure the QT interval due to conduction abnormalities such as Bundle Branch Block (left or right) or persistent cardiac arrhythmia e.g. atrial fibrillation, or cardiac pacemaker; 16. Long QT syndrome or family history of sudden cardiac death in young family members; 17. Concomitant use of medication known to affect ventricular repolarization; 18. Cardiac comorbidity such as a left ventricular ejection fraction <45%, myocardial infarction, persistent angina, or cardiac surgery within 3 months prior to enrollment; 19. Uncontrollable hypertension (>150 mm Hg systolic or >100 mm Hg diastolic); 20. Acute medical conditions such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk; 21. History of or current bleeding or uncorrected clotting disorders; 22. Concurrent immunosuppressive therapy such as corticosteroids (>10mg prednisolone or comparable) and cyclosporin A; 23. Concurrent investigational treatments, or treatment with any investigational treatment within the past 30 days (prior to the first dose of study medication); 24. Concurrent medications that are metabolized by the CYP 3A4 pathway; 25. Females who are lactating or pregnant; 26. A Body Mass Index (BMI) greater than or equal to 40 kg/m2; aa. Patients who have a history of hypersensitivity that may relate to any component of the product, e.g. to benzoic acid that might be related to INXN-1001, which contains two benzene rings; bb. Any medical or psychiatric condition which, in the opinion of the investigator, would unacceptably reduce the safety or delivery of the proposed treatment, or would preclude obtaining voluntary informed consent. ; PRIMARY OUTCOME: Physical examinations, vital signs, serum chemistry, urinalysis, hematology, adverse events, and objective response rate, as assessed by diagnostic CT scans; SECONDARY OUTCOME 1: PK of oral Activator Ligand, Immunologic responses, particularly frequency of CTLs and Tregs and hIL-12 and other cytokine levels in injected target tumor(s) and in peripheral blood, Efficacy.[/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 - Colonoscopy (US); BRIEF: A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons. ; DRUG USED: ByFavo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Paion UK Ltd.; CRITERIA: Inclusion Criteria: - Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example). - American Society of Anesthesiologists Score 1 through 3 - Body mass index ≤40 kg/m2. - For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed). - Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure. - Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy. Exclusion Criteria: - Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated. - Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity). - Chronic use of opioids for any indication. - Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline. - Lactating female patients. - Patients with positive drugs of abuse screen or a positive serum ethanol at baseline. - Patient with a history of drug or ethanol abuse within the past 2 years. - Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period. - Participation in any previous clinical trial with remimazolam. - Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason). ; PRIMARY OUTCOME: Success Rates of the Procedure; SECONDARY OUTCOME 1: Time to Start of Procedure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Acute Treatment - 13267A (Europe/South Africa); BRIEF: The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x) - The patient has a MADRS total score >=26 - The patient has a CGI-S score >=4 - The patient has had the current episode of MDE for >3 months Exclusion Criteria: - Any current anxiety psychiatric disorder as defined in the DSM-IV TR - Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR - Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR - Use of any psychoactive medication 2 weeks prior to screening and during the study - The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.; SECONDARY OUTCOME 1: Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 201; BRIEF: Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris ; DRUG USED: IDP-120; DRUG CLASS: Non-NME; INDICATION: Acne; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Key Inclusion Criteria: - Male or female at least 9 years of age and older; - Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit) - Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit. - Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing. - If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup. Key Exclusion Criteria: - Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study. - Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis. - Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. - Subjects with a facial beard or mustache that could interfere with the study assessments. ; PRIMARY OUTCOME: Percent of subjects achieving clear or almost clear on the Evaluators Global Severity Score.; 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 Ib/II - CIRLL Study; BRIEF: This is Phase 1b/2 study to investigate the safety and effectiveness of the investigational drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR 1) that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell signaling that cause leukemia and lymphoma cells to grow and survive. ROR1 is rarely found on healthy cells. ; DRUG USED: Cirmtuzumab; DRUG CLASS: Biologic; INDICATION: Mantle Cell Lymphoma - NHL; TARGET: ROR-1/NTRKR1; THERAPY: Combination; LEAD SPONSOR: Oncternal Therapeutics, Inc; CRITERIA: Inclusion Criteria: 1. Men and women of age ≥18 years. 2. ECOG performance status of 0, 1, or 2 3. Histological diagnosis of CLL/SLL, MCL or MZL (including splenic,nodal and extranodal subtypes) as documented in medical records (pathology reports and slides or blocks should be available for review or additional testing). 4. MCL has been previously treated and has relapsed after or progressed during prior therapy. CLL/SLL may have been previously treated or are treatment naïve but now require therapy. MZL has been previously treated and has relapsed after or progressed during at least one prior anti-CD20 -based therapy 5. A medically appropriate candidate for ibrutinib treatment (based on the judgement of the clinical investigator). 6. Patients who have received prior BTK inhibitor therapy are eligible, unless they demonstrated primary or acquired resistance to a BTK inhibitor or experienced a serious or severe adverse event attributed to BTK inhibitor therapy. 7. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 non-biopsied, non-irradiated lesion that measures >1.5 cm in the longest dimension [LD] and ≥1.0 cm in the longest perpendicular dimension [LPD] as assessed by computed tomography [CT] or magnetic resonance imaging [MRI]). 8. Current medical need for therapy due to disease-related symptoms, lymphadenopathy, organomegaly, extranodal organ involvement, or progressive disease. 9. Completion of all previous therapy (including any Bcl-2 or PI3K inhibitor therapy, surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week (or ≥3 half-lives of the previous drug) before the start of study therapy. 10. All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before the start of study therapy (with the exceptions of alopecia, or neurotoxicity [Grade 1 or 2 permitted], or selected laboratory parameters [Grade 1 or Grade 2 permitted with exceptions as noted below]). 11. Adequate bone marrow function: 1. Absolute neutrophil count (ANC) ≥1.0 × 109/L. 2. Platelet count ≥50 × 109/L. 3. Hemoglobin ≥8.0 g/dL maintained for ≥1 week from any prior transfusion. 12. Adequate hepatic profile: 1. Serum alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN). 2. Serum aspartate aminotransferase (AST) ≤3 × ULN. 3. Serum bilirubin ≤1.5 × ULN unless elevated due to Gilbert syndrome. 13. Adequate renal function: 1. Estimated creatinine clearance (eClCR) >30 mL/minute (with eClCR to be calculated by the Cockcroft-Gault formula [see Appendix 12.2]), or 2. Measured creatinine clearance >30 mL/minute (as assessed with a 24-hour urine collection). 14. Adequate coagulation profile: 1. Prothrombin time (PT) ≤1.5 × ULN. 2. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN. 15. Negative viral serology: 1. Negative human immunodeficiency virus (HIV) antibody. 2. Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or undetectable hepatitis B (HBV) deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (PCR) testing. 3. Negative hepatitis C virus (HCV) antibody or negative HCV RNA by quantitative PCR. 16. For female patients of childbearing potential, a negative urine or serum pregnancy test prior to the start of study therapy. 17. For female patients of childbearing potential, willingness to use a highly effective method of contraception from the start of the screening period until ≥3 months after the last dose of cirmtuzumab and ≥1 month after the last dose of ibrutinib, whichever is later. Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone [FSH] levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin [βHCG]); or is menopausal (age ≥50 years with amenorrhea for ≥6 months). 18. For male patients who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use an effective method of contraception from the start of study therapy until ≥3 months after the last dose of cirmtuzumab and ≥3 months after the last dose of ibrutinib, whichever is later and to refrain from sperm donation from the start of study therapy until ≥3 months after administration of the final dose of either of the study drugs. Note: A male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. 19. In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patients cancer. 20. Willingness and ability of the patient to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. 21. Evidence of a personally signed informed consent indicating that the patient is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation. Exclusion Criteria: 1. Known histological transformation to an aggressive lymphoma (ie, Richter transformation). 2. Known central nervous system malignancy. 3. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results. 4. Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy. 5. Significant screening ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation/flutter, left bundle branch block, 2nd-degree atrioventricular (AV) block type II, 3rd-degree AV block, or Grade ≥2 bradycardia. 6. Gastrointestinal disease (eg, gastric or intestinal bypass surgery, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, bowel obstruction) that might interfere with drug absorption or with interpretation of gastrointestinal AEs. 7. Contraindication for ibrutinib use because of bleeding diathesis. 8. Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of study therapy. Note: Patients with localized fungal infections of skin or nails are not precluded from participation. 9. In patients with prior hematopoietic progenitor cell transplantation, evidence of ongoing graft-versus-host disease (GVHD). 10. Pregnancy or breastfeeding. 11. Major surgery within 4 weeks before the start of study therapy. 12. Prior solid organ transplantation. 13. Prior anti-ROR1 therapy within 12 weeks prior to the start of study therapy. 14. Use of a moderate or strong inhibitor or inducer of cytochrome P450 (CYP) 3A4 within 7 days prior to the expected start of ibrutinib therapy. 15. Concurrent participation in another therapeutic or imaging clinical trial. 16. Any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a subjects ability to provide informed consent, adversely affect the subjects ability to cooperate and participate in the study, or compromise the interpretation of study results. ; PRIMARY OUTCOME: Part 1:To determine the Recommended dosing regimen (RDR) of cirmtuzumab within the tested dose range in combination of ibrutinib; SECONDARY OUTCOME 1: Part 3: Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.03[/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 - Mild Cognitive Impairment/Dementia; BRIEF: This is a Phase 2 study to evaluate safety and efficacy in participants with Mild Cognitive Impairment due to Alzheimers Disease/Prodromal Alzheimers Disease (referred to as MCI/Prodromal) and mild to moderate dementia due to Alzheimers Disease (referred to as mild to moderate AD). This study will have a Core Phase and an Extension Phase. ; DRUG USED: Elenbecestat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Beta-secretase (BACE); THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion criteria: Participants must meet all of the following criteria to be included in this study: 1. Meets the core clinical research criteria of the National Institute on Aging-Alzheimers Association (NIA-AA) for MCI due to AD (which is consistent with Prodromal AD) or AD dementia and is staged or classified as either MCI or mild to moderate dementia. 2. Amyloid positive Positron Emission Tomography (PET) image based on centralized PET scan reading. 3. Male or female, age 50 to 85 years, inclusive at time of consent. 4. Must have an identified caregiver or informant who is willing and able to provide follow-up information on the participant throughout the course of the study. 5. If receiving an Acetylcholinesterase Inhibitor (AChEI) or memantine, must have been on a stable dose for at least 12 weeks before the Baseline cognitive assessments, with no plans for dose adjustment in the foreseeable future. Treatment-naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs or memantine at the time of entry into the study. 6. Must have been on stable doses of all other permitted chronically used concomitant medications (that is, not related to their cognitive decline) for at least 4 weeks before randomization. Exclusion criteria: Participants who meet any of the following criteria will be excluded from this study: 1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participants AD pathology, including any co-morbidities such as cerebrovascular disease, detected by medical history, neurological examination, or magnetic resonance imaging (MRI). 2. History of transient ischemic attacks or stroke within 12 months of Screening. 3. History of epilepsy. 4. Evidence of depression on a rating scale at Screening or any psychiatric diagnosis or symptoms, (example, hallucinations, major depression, etc.) that could confound the diagnosis or could interfere with study assessments or procedures. This includes suicidal ideation or suicidal behavior within 6 months prior to Screening, or hospitalization or treatment for suicidal behavior in the past 5 years. 5. Abnormally low serum vitamin B12. 6. Thyroid stimulating hormone above the normal range. This applies to all participants regardless of whether or not they are taking thyroid supplements. 7. Participants with liver disease (hepatic impairment), at Screening or Baseline. Participant with Gilberts syndrome need not be excluded. 8. Not able to have a MRI, PET scanning, or cerebrospinal fluid (CSF) collection by Lumbar Puncture (LP). 9. Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately. 10. History of immunodeficiency disorders. 11. Participants with chronic viral hepatitis. 12. History of Tuberculosis (TB). Participants with no history of TB will be tested for previous TB exposure and a positive test will be exclusionary. 13. History of ophthalmic shingles or ocular Herpes Simplex Virus (HSV) infection. 14. Any live vaccine in the 3 months or any active infection within the last 4 weeks before study drug administration (that is, randomization). 15. Any chronic inflammatory disease that is not adequately controlled or requires immunosuppressive or immunomodulatory therapy. 16. T helper cell, cytotoxic T cell, or B cell absolute counts below normal. 17. Immunoglobulin (Ig) IgG, IgA, or IgM levels below normal at Screening or Baseline, unless both the Investigator and the Medical Monitor agree that the finding is not clinically significant. 18. Clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests at Screening or Baseline. 19. Exclusionary cardiac factors include: prolonged QT interval greater than 450 millisecond from Electrocardiograms (ECGs); history of risk factors for torsade de pointes or the use of concomitant medications that prolong the QT/corrected QT interval (QTc); left bundle branch block; persistent low or high heart rate; persistent low or high blood pressure; history of cardiac arrhythmias; other clinically significant ECG abnormalities. 20. Type 1 or Type 2 diabetes mellitus that is not well controlled. 21. Malignant neoplasms within 5 years before Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer that did not require systemic therapy; these do not exclude the participant). 22. Medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) that are not stably controlled, or which, in the opinion of the investigator(s), could affect the participants safety or interfere with the study assessments. 23. Hypopigmentation conditions (example, albinism and vitiligo). 24. Known or suspected history of drug or alcohol dependency or abuse within 2 years, current use of recreational drugs or a positive urine drug test. 25. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. 26. Participation in any other interventional clinical study related to cognitive impairment within 6 months before Screening unless it can be documented that the participant was in a placebo treatment arm. 27. Currently enrolled in another clinical study or used any investigational drug or device within 60 days or 5 half-lives of the investigational medication (whichever is longer) proceeding informed consent. 28. Hypersensitivity to the study drug or any of the excipients or to other Beta Secretase Cleaving Enzyme (BACE) inhibitors, or to the PET tracer, or components of its formulation. 29. Females who are lactating or pregnant. Females of childbearing potential who do not agree to adhere to the protocol specified methods for avoiding pregnancy. 30. Males who do not meet the protocol requirements for avoiding their partners becoming pregnant. Sperm donation is not permitted. ; PRIMARY OUTCOME: Core Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - w/Fludarabine and Cyclophosphamide (NCI); BRIEF: Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with B cell lymphomas or leukemias that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-cluster of differentiation 19 (CD19) incorporated in the retrovirus. Objective: The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-CD19 cells) cause tumors to shrink. Eligibility: - Adults age 18-70 with B cell lymphomas or leukemias expressing the CD19 molecule. Design: Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-CD19 cells. Leukapheresis is a common procedure, which removes only the white blood cells from the patient. Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy and the anti-CD19 cells. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days. ; DRUG USED: Yescarta; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: - INCLUSION CRITERIA: 1. Patient must have a cluster of differentiation 19 (CD19)-expressing B-cell lymphoma. Patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma must have measurable disease after at least two prior chemotherapy regimens one of which must have contained doxorubicin and rituximab. 2. Confirmation of diagnosis of B-cell malignancy and positivity for CD19 confirmed by the Laboratory of Pathology of the National Cancer Institute (NCI). The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patient. Immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood, fine needle aspirates and bone marrow samples. 3. Patients must have indications for treatment for their B-cell malignancy at the time of enrollment on this trial. 4. Greater than or equal to 18 years of age and less than or equal to age 70. 5. Willing to sign a durable power of attorney. 6. Able to understand and sign the Informed Consent Document. 7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Life expectancy of greater than three months. 9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment. 10. Women of child bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus. 11. Serology: - Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune -competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.). - Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative. If hepatitis C antibody test is positive. Then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. 12. Hematology: - Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim. - Platelet count greater than or equal to 50,000/mm^3. - Hemoglobin greater than 8.0 g/dl. - Lymphocyte count less than or equal to 4,000/ mm^3 13. Chemistry: - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 5 times the upper limit of normal. - Serum creatinine less than or equal to 1.6 mg/dl - Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilberts Syndrome who must have a total bilirubin less than 3.0 mg/dl 14. More than three weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patient toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 15. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram. EXCLUSION CRITERIA: 1. Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression. 2. Patients that have active hemolytic anemia. 3. Patients with active brain metastases, or with a history of any central nervous system (CNS) metastases or cerebrospinal fluid malignant cells. Note: patients who are asymptomatic but are found to have malignant cells in the cerebrospinal fluid (CSF) on lumbar puncture prior to treatment will be considered eligible. 4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant. 5. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. 6. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 7. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 8. Concurrent systemic steroid therapy. 9. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 10. History of allogeneic stem cell transplantation 11. Patients with cardiac atrial or cardiac ventricular lymphoma involvement. Screening Evaluation: Within 4 weeks prior to starting the chemotherapy regimen: 1. Complete history and physical examination, including, weight and vital signs, noting in detail the exact size and location of any lesions that exist. (Note: patient history may be obtained within 8 weeks.) 2. Chest x-ray 3. Electrocardiography (EKG) 4. Baseline computed tomography (CT) of the chest, abdomen and pelvis, positron emission tomography (PET) scan, and brain magnetic resonance imaging (MRI) to evaluate the status of disease. Additional scans and x-rays may be performed if clinically indicated based on patient signs and symptoms. 5. HIV antibody titer and Hepatitis B surface antigen (HbsAG) determination, and anti HCV, (Note: May be performed within 3 months of the chemotherapy start date). 6. Anti cytomegalovirus (CMV) antibody titer, herpes simplex virus (HSV) serology, and Epstein-Barr virus (EBV) panel (Note: patients who are known to be positive for any of the above do not need to be retested; may be performed within 3 months of chemotherapy start date) 7. Patients with a left ventricular ejection fraction (LVEF) of less than or equal to 55% will not proceed to treatment (Note: may be performed within 8 weeks of treatment). 8. Cluster of differentiation 19 (CD19) staining of malignant cells by immunohistochemistry or flow cytometry (testing is permitted to be conducted at any time prior to this point). 9. All patients must have a T cells, B cells, and natural killer cells (TBNK) for Peripheral blood cluster of differentiation 3 (CD3) count and CD19#. 10. Patients with a history of leptomeningeal disease, or signs/symptoms suggestive of leptomeningeal involvement, or with symptoms of central nervous system malignancy such as new onset severe headaches, neck stiffness, or any focal neurologic findings on physical exam will have lumbar puncture for examination of cerebral spinal fluid. 11. Patients may undergo lumbar puncture (LP) for flow cytometry of the CSF in order to assess the presence of CD19 positive lymphocytes for potential correlation with neurologic toxicity. Patients who have no neurologic symptoms at the time of LP will be eligible for enrollment regardless of the results of the flow cytometry. Within 14 days prior to starting the chemotherapy regimen: 12. Chem 20: (Sodium (Na), Potassium (K), Chloride (Cl), Total carbon dioxide (CO2) (bicarbonate), Creatinine, Glucose, Urea nitrogen (BUN), Albumin, Calcium total, Magnesium total (Mg), Inorganic Phosphorus, Alkaline Phosphatase, ALT/glutamic pyruvic transaminase (GPT), AST/glutamic oxaloacetic (GOT), Total Bilirubin, Direct Bilirubin, lactate hydrogenase (LD), Total Protein, Total creatine kinase (CK), Uric Acid) 13. Thyroid panel 14. Complete blood count (CBC) with differential and platelet count 15. Prothrombin time (PT)/partial thromboplastin time (PTT) 16. Urinalysis and culture, if indicated Within 7 days prior to starting the chemotherapy regimen: 17. Beta-human chorionic gonadotropin (βHCG) pregnancy test (serum or urine) on all women of child-bearing potential 18. ECOG performance status of 0 or 1 ; PRIMARY OUTCOME: Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma; SECONDARY OUTCOME 1: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).[/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 - MARIANNE (w/Pertuzumab; HER2+ MBC); BRIEF: This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult participants >/=18 years of age - HER2-positive breast cancer - Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent. - Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - Adequate organ function as determined by laboratory results Exclusion Criteria: - History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease - An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis - Hormone therapy <7 days prior to randomization - Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization - Prior trastuzumab emtansine or pertuzumab therapy ; PRIMARY OUTCOME: Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment; SECONDARY OUTCOME 1: Percentage of Participants Who Died Prior to Clinical Cutoff[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - B7471004 (> 65 y/o, w/SIIV); BRIEF: Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately ; DRUG USED: Prevnar 20; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female participants ≥65 years of age at the time of consent - Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease - Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination. Exclusion Criteria: - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) - Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation. - Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation. -- Serious chronic disorder, that in the investigators opinion would make the participant inappropriate for entry into the study - Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results ; PRIMARY OUTCOME: Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC; SECONDARY OUTCOME 1: Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD (IV); BRIEF: F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile. ; DRUG USED: Olorofim; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fungal Infections - Systemic; TARGET: Dihydroorotate Dehydrogenase (DHODH); THERAPY: Monotherapy; LEAD SPONSOR: F2G Biotech GmbH; CRITERIA: Inclusion Criteria: 1. Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-90 kg inclusive 2. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable) 3. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions Exclusion Criteria: 1. Male subjects who are not, or whose partners are not willing to use appropriate contraception (such as a condom) with established use of oral, injected or implanted hormonal contraceptive, intrauterine device or diaphragm with spermicide for three months after the last dose 2. Subjects who have received any prescribed systemic or topical medication within 14 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety 3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of dosing with study drug (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety 4. Subjects who have received any medications, including St Johns Wort, known to chronically alter drug absorption or elimination processes within 30 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety 5. Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months ; PRIMARY OUTCOME: Number of Subjects With Adverse Events; SECONDARY OUTCOME 1: Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - VALO-2; BRIEF: VALO-2 is a multicenter, open-label extension (OLE) study enrolling patients with genotyped keratin mutations KRT6A, KRT6B and KRT16 who were previously treated with investigational PTX-022 during the VALO study. The purpose of the OLE study is to investigate long term exposure to investigational PTX-022 and evaluate safety and efficacy data. A sub-study is included to evaluate safety and efficacy of patients with genotyped keratin mutations of KRT6C and KRT17 not previously treated with investigational PTX-022. ; DRUG USED: PTX-022; DRUG CLASS: Non-NME; INDICATION: Dermatology; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Palvella Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Adult patients 18 years or older, - Previously completed the VALO protocol, or VALO-2 K6C/17 sub-study, and received meaningful benefit from investigational PTX-022 as determined by the clinician. Key Exclusion Criteria: - Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022 ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events; SECONDARY OUTCOME 1: Patient Global Assessment of Activities Scale[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MMY-3001 (w/Velcade); BRIEF: The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy. ; DRUG USED: Doxil; DRUG CLASS: Non-NME; INDICATION: Multiple Myeloma (MM); TARGET: DNA, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Patients with multiple myeloma who have received at least 1 prior therapy and who have either responded and later had progressive disease or have progressed during their first therapy (primary refractory) are eligible for the study - Patients who may have received prior doxorubicin but not more than a cumulative dose of 240 milligram per meter square (mg/m^2) doxorubicin, DOXIL, or the equivalent amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin) - Must have normal cardiac function, as evidenced by a left LVEF within institutional normal limits. Exclusion Criteria: - History of treatment with VELCADE or progressive disease while receiving an anthracycline-containing regimen - No change in disease status during initial therapy - No treatment for malignancy within past 5 yrs (other than multiple myeloma) or progressive disease while receiving anthracycline-containing regimen - Non-secretory disease - Myocardial infarct within past 6 months - No major surgery in past 30 days. ; PRIMARY OUTCOME: Time to Progression (TTP); 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 I - Healthy Subjects; BRIEF: This is a 6-part study to evaluate the safety, tolerability, and PK of MEDI7219 in healthy subjects. Parts A, B, C & E are the single-dose parts of the study. Parts D & F are the multiple ascending dose (MAD) parts of the study. The starting dose and formulation for Parts D & F will be selected from data emerging from Parts A, B and E. Enrollment of approximately 198 subjects is anticipated. ; DRUG USED: MEDI7219; DRUG CLASS: Unknown; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: - Healthy volunteers age 18-55 years - BMI 18-32 kg/m2 - Females not of childbearing potential - Able and willing to adhere to the protocol - Must provide written informed consent Exclusion Criteria: - Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product - Abnormal lab values, physical exam, vital signs - Positive drug or alcohol screen. - Current enrollment in another clinical study or enrollment within the past 3 months - Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing - Abnormal ECG - Positive Hepatitis B, Hepatitis C or HIV test - Positive Drug or Alcohol screen - Current smokers or those who have smoked within the last 12 months - Recent plasma or blood donation - Evidence of current SARS-CoV-2 infection (Part E Cohort 5 and Part F Cohort 2 only) ; PRIMARY OUTCOME: Number of subjects with Adverse Events as a measure of safety and tolerability of MEDI7219; SECONDARY OUTCOME 1: Pharmacokinetics of MEDI7219: Cmax[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 18452A; BRIEF: The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug. ; DRUG USED: Lu AG06479; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neurology - Other; TARGET: Monoacylglycerol lipase (MGLL); THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit. Other in- and exclusion criteria may apply ; PRIMARY OUTCOME: Number of participants with treatment emergent adverse events (Safety and Tolerability); SECONDARY OUTCOME 1: AUC (0-inf) of Lu AG06479[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - ENB-002-08 - Infants; BRIEF: This clinical trial studies the safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP. ; DRUG USED: Strensiq; DRUG CLASS: Biologic; INDICATION: Hypophosphatasia; TARGET: Tissue-nonspecific alkaline phosphatase (TNSALP); THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Legal guardian(s) must provide informed consent prior to any study procedures - Documented diagnosis of severe HPP as indicated by: - Total serum alkaline phosphatase at least 3 standard deviations (SD) below the mean for age - Plasma pyridoxal 5-phosphate (PLP) at least 4 times the upper limit of normal - Radiographic evidence of HPP (hypophosphatasia), characterized by: - Flared and frayed metaphyses - Severe, generalized osteopenia - Widened growth plates - One or more HPP-related findings: - History or presence of: - Non-traumatic post-natal fracture - Delayed fracture healing - History of elevated serum calcium - Functional craniosynostosis with decreased head circumference growth - Nephrocalcinosis - Respiratory compromise - Rachitic chest deformity and/or vitamin B6 dependent seizures - Failure to thrive - Onset of symptoms prior to 6 months of age - Age ≤ 36 months - Otherwise medically stable (patient may be on ventilatory support) - Legal guardian(s) must be willing to comply with the study Exclusion Criteria: - History of sensitivity to any of the constituents of the study drug - Current or prior clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, infectious, urologic, pulmonary, neurologic, dermatologic, renal condition and/or other major disease which, in the opinion of the investigator, precludes study participation - Treatment with an investigational drug within 1 month prior to the start of study drug administration - Current enrollment in any other study involving an investigational new drug, device or treatment for HPP (e.g., bone marrow transplantation) - Low serum calcium, phosphate or 25(OH) vitamin D - Current evidence of a treatable form of rickets - Prior treatment with bisphosphonate ; PRIMARY OUTCOME: Change in Rickets Severity From Baseline to Week 24, Based on Assessment of Skeletal Radiographs Using Radiologic Global Impression of Change (RGI-C); SECONDARY OUTCOME 1: Maximum Serum Concentration of Asfotase Alfa (Cmax)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Biomarker Study (MDACC); BRIEF: The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical markers in the blood and/or tissue that may be related to a reaction to study treatment. The safety of the study treatments will also be studied. ; DRUG USED: Cixutumumab; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types II and III according to the World Health Organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. Patients with skin squamous cell carcinomas of the head and neck region will also be included in this study. 2. There is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. No anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. If a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization. 3. Prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months. 4. The patient has a fasting serum glucose < 130 mg/dL and HbA1C < 7.0%. Patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition. 5. The patient has adequate renal function, defined by serum creatinine </= 1.5 x the institutional upper limit of normal (ULN), or creatinine clearance >/=60 mL/min for patients with creatinine levels above the ULN. 6. Because the teratogenicity of cetuximab and IMC-A12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 7. The patient is age >/= 18 years. 8. The patient or the patients legally authorized representative has the ability to understand and the willingness to sign a written informed consent document. 9. ECOG performance status of 0-2. Exclusion Criteria: 1. Patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation. 2. Patients receiving concomitant radiation. 3. Prior treatment with an agent targeted at the insulin-like growth factor-1 receptor. 4. History of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or IMC-A12. 5. Pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded). 6. Patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s). ; PRIMARY OUTCOME: AKT Modulation; SECONDARY OUTCOME 1: Number of Participants With Objective Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - OPTI-1; BRIEF: Multi-center, open-label, multiple dose safety, tolerability and efficacy study ; DRUG USED: HDV-L; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Diasome Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female of age 18 to 65 years, inclusive. 2. If female of child-bearing potential, must agree for the duration of the study. to use adequate contraceptive measures, such as, intra-uterine device [IUD], oral or injectable contraceptives, or barrier method plus spermicide. 3. Has at Screening been diagnosed as T1DM for at least 12 months. 4. Has at Screening C-peptide ≤0.8 ng/mL (single retest allowed). 5. Has at Screening been on treatment with rapid analog insulin for the previous six (6) months. 6. Has at Screening willingness to use continuous glucose monitoring (CGM) technology throughout study. 7. Is, for the duration of the study, willing to use insulin lispro as the only analog bolus insulin and insulin degludec as the only basal insulin. 8. Has at Screening a BMI ≥18.0 kg/m2 and ≤33.0 kg/m2. 9. Has at Screening HbA1c ≥6.5% and ≤8.5%. Exclusion Criteria: 1. Has known or suspected allergy to any component of any of the study drugs in this trial. 2. Is, at Screening, pregnant or breast-feeding, or intends to become pregnant at any time during the duration of the study. 3. Has, at Screening, as judged by the Site Investigator, a history or current evidence of any of the following complications of diabetes: proliferative retinopathy or maculopathy, severe neuropathy (in particular, autonomic neuropathy), symptomatic gastroparesis. 4. Is, at Screening, judged by the Site Investigator to have a current addiction to alcohol or substances of abuse. 5. Is, at Screening, using one or more drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia (e.g., beta blockers, systemic corticosteroids at pharmacologic doses, cancer chemotherapies.). 6. Has at Screening any of the following findings, unless approved by both the Site Investigator and the Medical Monitor: - Uncontrolled hypertension, defined as diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the sitting position; - History of or findings on EKG of cardiac arrhythmia or conduction defect; - Clinically significant abnormalities on Screening laboratory studies 7. Has, within one (1) month prior to Screening, used either oral anti-diabetic medication or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.). 8. Has, within one (1) month prior to Screening, received any investigational drug. 9. Has, within two (2) months prior to Screening, used an insulin pump delivery system. 10. Has, within three (3) months prior to Screening, smoked tobacco or used any smokeless tobacco or nicotine delivery system (inhaled, oral or buccal). 11. Has at Screening, as judged by the Site Investigator, any condition (intrinsic or extrinsic) that could reasonably be expected to interfere with trial participation, confound evaluation of the data, or pose additional risk to adhering to the study protocol. Examples of such conditions include but are not limited to: - Clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems; - History of such an illness or disease - Diminished mental capacity, psychological or behavioral dysfunction, unwilling or resistant to protocol requirements, language barriers ; PRIMARY OUTCOME: Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period; 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 I - Healthy (CL-0001); BRIEF: The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and female subjects. This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous doses and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF); explore a potential gender difference in safety, tolerability and pk of single intravenous dose and single sc doses administrations of ASP6294 as well as determine the maximum tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294. Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc. ; DRUG USED: ASP6294; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Europe B.V.; CRITERIA: Inclusion Criteria: - Subject has a body mass index range of 18.5 - 30.0 kg/m2, inclusive, and the subject weighs at least 50 kg (at screening). - Female subject must either: - Be of non-childbearing potential: Post-menopausal (defined as at least 1 year without any menses) prior to screening, or Documented surgically sterile - Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 120 days after final study drug administration; Must have a negative pregnancy test at screening and day -1; And, if heterosexually active, agree to consistently use 2 forms of birth control starting at screening and throughout the clinical study period and for 120 days after final study drug administration. - Female subject must agree not to breastfeed starting at screening and throughout the clinical study period, and for 120 days after final study drug administration. - Female subject must not donate ova starting at screening and throughout the clinical study period, and for 120 days after final study drug administration. - Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective form of birth control† in combination with a barrier method starting at screening and throughout the clinical study period and for 120 days after final study drug administration. - Male subject must not donate sperm starting at screening and throughout the clinical study period and for 120 days after final study drug administration. - Subject agrees not to participate in another interventional study during participation in the present study, defined as signing the informed consent form until completion of the last study visit. Exclusion Criteria: - Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening. - Subject has a known or suspected hypersensitivity to ASP6294 or any components of the formulation used. - Subject has been exposed to a biological drug within the last 6 months prior to screening. - Subject has a history of allergic or anaphylactic reaction to a biological drug. - Subject has been diagnosed with osteoarthritis (OA) or has a history of rapidly progressive OA. - Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal (ULN) at day-1. In such a case, the assessment may be repeated once. - Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). - Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (including orthostatic hypotension and autonomic neuropathy), dermatologic, psychiatric, renal and/or other major disease or malignancy, as judged by the investigator. - Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1 (admission day). - Subject has any clinically significant abnormality following the investigators review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or day -1. - Subject has a mean pulse < 40 or > 90 beats per minute; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (vital sign measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) at screening and day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate measurement can be taken. - Subject has a mean corrected QT interval using Fridericias formula (QTcF) of > 430 ms for males and > 450 ms for females at screening and day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken (admission day). - Subject uses any prescribed or nonprescribed drugs (including vitamins, natural and herbal remedies, e.g. St. Johns Wort) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day) or the use of contraceptives or hormone replacement therapy. - Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit. - Subject has a history of drinking more than 21 units (male subjects) or 14 units (female subjects) of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit or the subject tests positive for alcohol or drugs of abuse at screening or day-1 (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinoids, cocaine, and opiates). - Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit. - Subject uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit regularly. - Subject has experienced significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission to the clinical unit. - Subject has a positive serology test for hepatitis B surface antigen, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies, hepatitis B core antibodies, or antibodies to human immunodeficiency virus types 1 and 2. - Subject participated in any clinical study or has been treated with any investigational drugs within 3 months prior to screening. - Subject has any condition which, in the investigators opinion, makes the subject unsuitable for study participation, such as phobias for intravenous or subcutaneous needles/injections. - Subject is an employee of the Astellas Group or a contract research organization. ; PRIMARY OUTCOME: Safety of ASP6294 as assessed by Nature, frequency and severity of Adverse Events (AEs); SECONDARY OUTCOME 1: Pharmacokinetics of ASP6294: AUClast[/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 Ib - NFC1-GREAT; BRIEF: This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral administration of NFC-1 and to evaluate safety and tolerability and to obtain evidence for the effect of NFC-1 on ADHD severity and global functioning during and following four weeks of continuous treatment. Exploratory analyses will be performed to assess effect size of specific mGluR-network genes on ADHD based on responsiveness of patients to NFC-1. This study will be conducted at a single clinical site, the Jefferson University Hospital PKU (Philadelphia, PA). ; DRUG USED: AEVI-001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Metabotropic Glutamate Receptor 8 (mGluR8) , Metabotropic Glutamate Receptor subtype 1 (mGluR1), Metabotropic Glutamate Receptor subtype 3 (mGluR3), Metabotropic Glutamate Receptor subtype 5 (mGluR5), Metabotropic Glutamate Receptor subtype 7 (mGluR7); THERAPY: Monotherapy; LEAD SPONSOR: Aevi Genomic Medicine, LLC, a Cerecor company; CRITERIA: Inclusion Criteria: 1. Patients weight is within 5th to 95th percentile for age 2. Patient has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and the Vanderbilt ADHD Rating Scale score (Parent or Teacher) > 16 at baseline with or without conventional ADHD therapy 3. Patient has been genotyped (CAP/CLIA certified) to determine whether there are disruptive mutations in genes within the mGluR-network 4. Patient has been a non-smoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months 5. Patient is judged to be in good health, other than having ADHD, based on medical history, physical examination, vital signs measurements, and laboratory safety tests performed at the screening visit and/or prior to administration of study drug 6. Female patients of reproductive potential will have a negative urine β-hCG test at screening and prior to drug administration. If sexually active, female participant agrees to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of study drug and throughout the study. Acceptable methods of birth control are abstinence, or 2 of the following: intrauterine device (IUD), diaphragm, spermicides, cervical cap, contraceptive sponge, and condoms 7. Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the screening visit and/or prior to administration of study drug 8. Parent/legal guardian and patient understand the study procedures and agrees to the patients participation in the study as indicated by parental/legal guardian signature on the patient consent form and patient signature on assent form Exclusion Criteria: 1. Patient or parent/legal guardian is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of screening visit or during the conduct of the study. Subjects with prior diagnosis of co-morbid major psychiatric disorders (i.e. aside from ADHD), including major depression, bipolar disease, Tourette syndrome, schizophrenia, autism spectrum disorder or pervasive development disorder, severe anxiety disorders 2. Patient has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the patient by their participation in the study 3. Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Patients with a history of uncomplicated kidney stones may be enrolled in the study at the discretion of the investigator 4. Patient has a history of stroke, chronic seizures, or major neurological disorder 5. Patient is pregnant or a nursing mother 6. Patient has a history of extreme psychological aversion to blood draws that in the opinion of the investigator or parents would result in compromising the study conduct. Patient has a history of extreme physiologic difficulty in venous access that in the opinion of the investigator and parents would result in compromising the study conduct 7. Patient has a history of inability to swallow whole unadulterated pills, which in the opinion of the investigator or parents would result in compromising the study conduct 8. Patient has a systolic or diastolic blood pressure ≥ the 95th percentile for his/her age 9. Patient consumes any alcoholic beverages 10. Patient consumes excessive amounts of caffeine, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day 11. Patient has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription of non-prescription drugs or food 12. Patient is currently a regular user (including recreational use) of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse within approximately 3 years 13. Patient has had surgery, lost more than 5cc/kg of blood, or participated in another investigational drug trial within 4 weeks prior to the screening visit. 14. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease 1. AST/SGOT > 2.0 times the upper limit of normal 2. ALT/SGPT > 2.0 times the upper limit of normal 3. Total bilirubin > 2.0 times the upper limit of normal 4. Hemoglobin < 9 gm/dL 5. White blood cell count < 1,000/ mm3 6. Platelet count < 100,000/mm3 15. Any investigational drug use within 30 days prior to enrollment ; PRIMARY OUTCOME: Assessing the safety and tolerability of NFC-1 at each dose level based on assessment of adverse events and other safety measurements including vital signs, electrocardiogram, laboratory safety tests.; SECONDARY OUTCOME 1: The change in Vanderbilt scores during and following 4-week treatment with NFC-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 I - Food Effect Study; BRIEF: To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers ; DRUG USED: Remoxy; DRUG CLASS: Non-NME; INDICATION: Chronic Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Pain Therapeutics; CRITERIA: Inclusion Criteria: - Healthy male and/or female subjects between 18 and 55 years of age (inclusive). Exclusion Criteria: - Evidence or history of clinically significant disease - Positive urine drug test ; PRIMARY OUTCOME: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]; SECONDARY OUTCOME 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK/PD Euglycemic Clamp; BRIEF: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes. ; DRUG USED: FIAsp; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 1 diabetes mellitus for more than 12 months - Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months - Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: - Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start - Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) - Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period ; PRIMARY OUTCOME: Area under the glucose infusion rate curve; SECONDARY OUTCOME 1: Area under the glucose infusion rate curve[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DUAL VIII (vs. Insulin Glargine Therapy); BRIEF: This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics. ; DRUG USED: Xultophy; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age greater than or equal to 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes mellitus - HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis - Body mass index greater than or equal to 20 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes - Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record) Exclusion Criteria: - Screening calcitonin greater than or equal to 50 ng/L - Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening - Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of pancreatitis (acute or chronic) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening - Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids) ; PRIMARY OUTCOME: Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification; SECONDARY OUTCOME 1: Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Mild-to-Moderate (Korea); BRIEF: 1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimers disease 2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change. 3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimers disease 4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimers disease. ; DRUG USED: Chantix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Nicotinic Acetylcholine Receptor - a4ß2 subtype &lt;br&gt;(a4ß2 nAChR), Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Males or females, age 55-85 - Diagnosis of probable Alzheimers disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV) - Mini-mental status exam score of 14-26 inclusive - Rosen-Modified Hachinski Ischemia Score of < or = 4 Exclusion Criteria: - Diagnosis or history of other dementia or neurodegenerative disorders - Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease - Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms ; PRIMARY OUTCOME: Alzheimers Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6; SECONDARY OUTCOME 1: Alzheimers Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3[/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 - Study 2207; BRIEF: The study is a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects. ; DRUG USED: Iscalimab; DRUG CLASS: Biologic; INDICATION: Diabetes Mellitus, Type I; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Written informed consent, and if needed assent from the child on the trial, must be obtained before any assessment is performed. 2. Males and females aged between 6 and 21 years (inclusive, and enrolled in stages) at screening. 3. Body weight range from 20 to 125 kg (inclusive). 4. Evidence of one or more type 1 diabetes autoantibody(ies) against: glutamic acid decarboxylase (anti-GAD), protein tyrosine, phosphatase-like protein (anti-IA-2); zinc transporter 8 (anti-ZnT8); islet cell (cytoplasmic) (anti-ICA) at screening or baseline in the central laboratory OR historical clinical record of one or more of the T1DM diabetes autoantibodies. As part of the historical record insulin autoantibodies (IAA) may have been used as part of the autoantibody panel but the blood sample must have been obtained prior to or within one week of starting exogenous insulin treatment. 5. Able to receive first dose of study drug within 56 days of diagnosis of T1DM (which may be extended to within 100 days of diagnosis in the event a screening assessment needs to be confirmed or vaccine administered). 6. Peak stimulated C-peptide levels ≥0.2 nmol/L (0.6 ng/mL) following standard liquid mixed meal tolerance test (MMTT), to be conducted when the subject is metabolically stable, at least 2 weeks from diagnosis and within 56 days prior to randomization (or within 100 days of diagnosis in the event a screening assessment needs to be confirmed or vaccine is required). 7. Study participants are to complete all recommended immunizations with live, attenuated vaccine at least eight weeks prior and killed, inactivated vaccine at least two weeks prior to first dose with study drug and in accordance with local immunization guidelines. In the event a subject has not had all vaccinations recommended according to local guidance, the screening period may be extended beyond 56 days to allow these vaccinations to be administered, but first dose of study drug must be administered within 100 days of diagnosis of T1DM. 8. Must be willing to comply with the standard of care for diabetes management. 9. A negative pregnancy test at screening is required for all sexually mature female subjects prior to participation in the study. 10. Subject and/or guardian must be able to communicate well with the investigator, to understand and comply with the requirements of the study. Exclusion Criteria: 1. Diabetes forms other than auto immune type 1 such as maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), acquired diabetes (secondary to medications or surgery), type 2 diabetes by judgement of the investigator. 2. Diabetic ketoacidosis within 2 weeks of the baseline MMTT test. 3. Polyglandular auto immune disease, Addisons disease, pernicious anemia, celiac sprue. Note: Investigators are not mandated to test for Celiac disease (also known as Sprue). Patients suspected of having Celiac disease should be tested for the presence of disease, as part of good medical care, as treatment would differ. Treated, stable Hashimotos thyroiditis is not exclusionary. 4. Any of the following abnormal laboratory values at screening: total white blood cell count (WBC) outside the range of 1,500-15,000/mm3 (1.5-15.0 x 109/L), neutrophil count (<1500/mm3) (<1.5 X 109 / L), lymphocyte count <500/mm3 (<0.5 X 109 / L), hemoglobin (Hgb) <8.0 g/dL, platelets <100,000/mm3 (<100 x 109/L) 5. History of immunodeficiency disorders, such as HyperIgM syndrome; history of recurrent infections suggestive of immunodeficiency disorders. 6. History of or active coagulation disorder with increased thromboembolic risk; a PTT and PT/ INR below lower limit of normal prior to inclusion. 7. Tuberculosis infection assessed by positive QuantiFERON TB-Gold test (QFT) at screening. Subjects with a positive QFT test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then anti tuberculosis treatment must have been initiated and maintained according to local country guidelines. 8. Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test, at screening, excludes a subject. Subjects with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded. 9. Positive human immune virus HIV test (ELISA and Western Blot) at screening. 10. Evidence of EBV, CMV, HSV, and/or SARS-CoV-2 infection by viral load above laboratory upper limit of normal or only positive IgM serology in the absence of positive IgG at screening. Rescreening is permitted in persistently asymptomatic or postsymptomatic subjects, but study drug must be able to be administered within 100 days of diagnosis of T1D. 11. Major dental work (e.g. tooth extractions or dental surgery with access to dental pulp) within 8 days of first dose; febrile illness within 48 hrs of first dose. 12. Use of other investigational drugs or use of immunosuppressive agents at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations. 13. History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study. Multiple and recurring allergies refer to known allergies to the investigational compound, to immunoglobulin based therapies, or to multiple drug classes. Dust mites, hay fever, and similar environmental allergies are not exclusionary. 14. History of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody. 15. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases. 16. Active serious psychiatric disorders (diagnosed or treated by a psychiatrist), such as eating disorders and psychosis or history thereof. 17. Any complicating medical issues or clinically abnormal laboratory results that may cause an increased safety risk to the subject as judged by the investigator. 18. Ongoing, and up to 2 weeks prior to screening, use of medications that may affect glucose control (e.g, systemic steroids, thiazides, beta blockers). A short course of oral steroids <10 days if medically required is permissible with sponsor notification. 19. History of drug abuse, nicotine or harmful alcohol use within 12 months prior to first dose, or evidence (as determined by the investigators) of such abuse at screening. For example, harmful alcohol use in adults is defined as five or more drinks per day for 5 or more days in the past 30 days. Harmful alcohol use by adolescents (age 13-18 years) is to be determined by the investigator, based on local culture and laws. Any alcohol use by children (age 6-12) is a disqualifier. Harmful cannabinoid use is difficult to define universally and the determination of abuse will be made by the Investigator based on local culture and law. 20. Taking medications prohibited by the protocol 21. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 22. Women of child-bearing potential, defined as all women, who are sexually active, physiologically capable of becoming pregnant (e.g. menstruating), unless they are using highly effective methods of contraception during dosing and for 14 weeks after stopping the investigational drug. Highly effective contraception methods include: - Total abstinence from heterosexual intercourse (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to first dose. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. - Male sterilization in the sexual partner of female study participant (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject. - Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. - In case of use of oral contraception, women should be stable on the same pill for a minimum of 3 months prior to first dose. ; PRIMARY OUTCOME: Proportion of subjects with adverse events (AE)/serious adverse events (SAE) in treatment groups.; SECONDARY OUTCOME 1: Free CFZ533 plasma concentration.[/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 - CFTR Gating Mutation (Pediatric, KLIMB Study); BRIEF: The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will further explore the efficacy of long-term ivacaftor treatment in this population of patients with CF. ; DRUG USED: Kalydeco; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria (Ivacaftor Arm): 1. Completed the last study visit of the treatment period of the previous study (NCT01705145) 2. Hematology, serum chemistry, and vital signs results on Day 1 with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator 3. As judged by the investigator, parent or legal guardian must be able to understand protocol requirements, restrictions, and instructions and the parent or legal guardian should be able to ensure that the subject assents to participation in the study to the degree the subject can assent, and that the subject will comply with and is likely to complete the study as planned Inclusion Criteria (Observational Arm): 1. Subjects who completed their assigned study drug treatment in the previous study (NCT01705145) and elected not to enroll in the ivacaftor arm and subjects who prematurely discontinued treatment in the previous study and received at least 1 dose of study drug treatment in the previous study will be eligible for enrollment in the observational arm. Exclusion Criteria (Ivacaftor Arm): 1. Subjects who prematurely discontinued from the previous study 2. History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject 3. Subjects with a history of study treatment intolerance as observed in their previous study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject 4. Subjects receiving commercially-available ivacaftor treatment 5. Subject was unable to complete an adequate slit-lamp examination at the last ophthalmologic examination in the previous study Exclusion Criteria: (Observational Arm) 1. Subjects receiving ivacaftor treatment will not be eligible for enrollment in the observational arm. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 024 and 025 ext.; BRIEF: This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks. ; DRUG USED: Encenicline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: FORUM Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025 - Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures - Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025 - No clinically significant change in the judgment of the investigator in the subjects medical status during study EVP-6124-024 or EVP-6124-025 - In the judgment of the investigator, extension treatment is in the best interest of the subject - Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method]) - Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible Exclusion Criteria: - Significant risk of suicidal or violent behavior in the judgment of the investigator - Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation - Any condition that would make the subject in the judgment of the investigator unsuitable for the study - Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study ; PRIMARY OUTCOME: Safety of 2 fixed doses of EVP-6124 for up to 52 weeks in subjects with Alzheimers disease who complete study EVP-6124-024 or EVP-6124-025; SECONDARY OUTCOME 1: Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PIK3CA Mutations; BRIEF: This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene ; DRUG USED: Piqray; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: p110 alpha/PIK3CA, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit Only patients who have confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant) - Availability of a representative formalin fixed paraffin embedded tumor tissue sample - At least one measurable or non-measurable lesion - Age ≥ 18 years - World Health Organization (WHO) Performance Status ≤ 2 - Good organ (hepatic, kidney, BM) function at screening/baseline visit Exclusion Criteria: - Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed). - Prior treatment with PI3K, AKT or mTOR inhibitor and failure to benefit - Patient with peripheral neuropathy NCI-CTC Grade ≥ 3 - Patient with diarrhea NCI-CTC Grade ≥ 2 - Patient with acute or chronic pancreatitis - Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug. - Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus - Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Incidence rate of dose limiting toxicities (DLT).; SECONDARY OUTCOME 1: Overall safety and tolerability of BYL719 as single agent and in combination with fulvestrant[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RADIANCE (Phase II/III Part B); BRIEF: This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record. The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS). ; DRUG USED: Zeposia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria - Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline Exclusion Criteria: - Primary progressive multiple sclerosis ; PRIMARY OUTCOME: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24; SECONDARY OUTCOME 1: Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Dose Escalation; BRIEF: To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of Oprozomib To explore the anti-tumor activity of Oprozomib in this patient population including the overall response rate (ORR), the duration of responses (DOR), the progression-free survival (PFS) and time to progression (TTP) To define the pharmacodynamics (PDn) of Oprozomib. ; DRUG USED: Oprozomib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Proteasome; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Disease Related - Histologically confirmed advanced solid tumor that is refractory or recurrent after standard treatments. - At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computed tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigators opinion, evaluable disease can be reliably and consistently followed, the patient may be eligible upon approval by the Onyx Therapeutics, Inc., Medical Monitor. - Demographic - Males and females ≥ 18 years of age - Life expectancy of more than three months - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 - Laboratory - Adequate hepatic function, with bilirubin ≤ 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) ≤ 3 times ULN or ≤ 5 times ULN in the presence of hepatic tumor involvement - Absolute neutrophil count (ANC) ≥ 1500/mm3, hemoglobin ≥ 8 g/dL, and platelet count ≥ 100,000/ mm3 1. Screening platelet count must be independent of platelet transfusions for at least one week 2. Screening ANC must be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least one week and of pegylated G-CSF for at least two weeks 3. Patients may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines - Calculated or measured creatinine clearance of ≥ 30 mL/min; calculation using a generally accepted formula such as that of Cockcroft and Gault: CrCl = [(140 - Age) × Mass (kg) / (72 × Creatinine mg/dL)], multiply by 0.85 if female - Ethical / Other - Written informed consent in accordance with federal, local, and institutional guidelines - Female patients of childbearing potential must have a negative serum or urine pregnancy test within three days of the first dose and agree to use dual methods of contraception during the study and for one month following the last dose of study drug. Post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for one month following the last dose if sexually active with a female of childbearing potential. Exclusion Criteria: - Disease Related - Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within four weeks prior to first dose of Oprozomib or six weeks for antibody therapy - Radiation therapy or immunotherapy within three weeks prior to first dose; localized radiation therapy within one week prior to first dose Patients with brain metastases (patients with prior brain metastases are permitted, but must have completed treatment and have no evidence of active CNS disease for at least three months prior to first dose) - Prior treatment with a proteasome inhibitor - Concurrent Conditions - Major surgery within three weeks prior to first dose - Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, or conduction abnormalities. Conduction system abnormalities not clinically warranting intervention are allowed. - Myocardial infarction within three months prior to first dose - Active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose - HIV infection (HIV seropositive) - Active hepatitis A, B, or C infection - Peripheral neuropathy of Grade ≥ 3 or Grade 2 with pain at the time of the first dose - Patients with pleural effusions requiring repeat thoracentesis or ascites requiring repeat paracentesis - Prior Oprozomib therapy - Hypersensitivity to Oprozomib or any of its components - Ethical / Other - Female patients who are pregnant or lactating - Psychiatric or medical conditions that in the opinion of the Investigator could interfere with treatment ; PRIMARY OUTCOME: Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Overall response rate (ORR), duration of responses (DOR), progression-free survival (PFS), and time to progression (TTP)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Cemiplimab; BRIEF: This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent. ; DRUG USED: BNT111; DRUG CLASS: Vaccine; INDICATION: Melanoma; TARGET: Immune System, Melanoma antigen-encoding gene (MAGE), NY-ESO-1 (Cancer-testis antigen), Tyrosinase; THERAPY: Combination; LEAD SPONSOR: BioNTech SE; CRITERIA: Inclusion Criteria: - Patients must sign the written informed consent form (ICF) before any screening procedure. - Patients must be aged ≥ 18 years on the date of signing the informed consent. - Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the trial. - Patients must have histologically confirmed unresectable Stage III or IV (metastatic) cutaneous melanoma and measurable disease by RECIST 1.1. - Patients must have confirmed disease progression on/after an approved anti-PD-1/PD-L1 regimen for melanoma as defined by RECIST 1.1. 1. Previous exposure to approved anti-PD-1/PD-L1 containing regimen for at least 12 consecutive weeks and 2. Current radiological progression to be confirmed by two scans 4 to 12 weeks apart. If progression is accompanied by new symptoms, or deterioration of performance status not attributed to toxicity, one scan is sufficient and 3. Inclusion into this trial must be within 6 months of confirmation of disease progression on anti-PD-1/PD-L1 treatment, regardless of any intervening therapy. - Patients should have received at least one but no more than five lines of prior therapy for advanced disease. - Patients must be able to tolerate additional anti-PD-1/PD-L1 therapy (i.e., did not permanently discontinue anti-PD-1/PD-L1 therapy due to toxicity). - Patients must have known B-Raf proto-oncogene (BRAF) mutation status. - Patients with BRAF V600-positive tumor(s) should have received prior treatment with a BRAF inhibitor (alone or in combination with a mitogen-activated protein kinase kinase [MEK] inhibitor). - Note: Considering the possible negative impact of a prior BRAF/MEK therapy on immune system targeting therapies, patients with BRAF V600-positive tumors with no clinically significant tumor-related symptoms or evidence of rapid PD may be eligible for participation. This should be based on investigator assessment AND provided they are ineligible for, intolerant to, or have refused BRAF V600 mutation targeted therapy after receiving the information on possible other therapies including BRAF/MEK inhibitor-based therapy during the informed consent process. - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. - Adequate bone marrow function, as defined by hematological parameters (as defined in the protocol). - Patients must have serum lactate dehydrogenase (LDH) ≤ upper limit of normal (ULN). - Patient should have adequate hepatic function, as defined in the protocol. - Patient should have adequate kidney function, assessed by the estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation. - Patient should be stable with adequate coagulation, as defined in the protocol. - Patients must provide the following biopsy samples: 1. All patients: must provide a tumor tissue sample (formalin fixed paraffin-embedded [FFPE] blocks/slides) from a fresh biopsy collected before Visit C1D1, or archival tissue. The archival tissue can be an FFPE block (not older than 3 years) or freshly cut slides (special storage conditions and immediate shipment to specialty lab are required), preferably derived from advanced disease stage. 2. Patients at selected trial sites: After additional consent, patients must be amenable to pre-treatment and on-treatment peripheral blood mononuclear cell (PBMC) sampling and optional biopsy. If amenable, patients should provide a PBMC sample and optionally a biopsy which contains tumor tissue after failure/stop of last prior trial treatment. - Women of childbearing potential (WOCBP) must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at screening. Patients that are postmenopausal or permanently sterilized can be considered as not having reproductive potential. Female patients of reproductive potential must agree to use highly effective contraception during and for 6 months after the last trial drug administration. - WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial starting at screening, during the trial and for 6 months after receiving the last trial treatment. - A man who is sexually active with a WOCBP and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the trial and for 6 months after receiving the last trial treatment. Exclusion Criteria: - Patients must not be pregnant or breastfeeding. - Patients must not have history of uveal, acral, or mucosal melanoma. - Patients must have no ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may pose a risk for irAEs. - Note: Patients with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included. - Patients must have no known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T cell-negative severe combined immunodeficiency [SCID]) or combined T and B cell immunodeficiencies (e.g., T and -B negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency). - Patients with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are not eligible. - Patients must have no uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed. 1. Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable anti-viral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards. 2. Patients with known hepatitis B virus (HBV) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction (PCR) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of trial treatment. 3. Patients who are known hepatitis C virus (HCV) antibody positive who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted. 4. Patients with HIV or hepatitis must have their disease reviewed by the specialist (e.g., infectious disease specialist or hepatologist) managing this disease prior to commencing and throughout the duration of their participation in the trial. - Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis, progression or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, non-invasive, superficial bladder cancer or breast ductal carcinoma in situ). - Current use or use within 3 months prior to trial enrollment of systemic immune suppression including: 1. use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed); patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible, 2. other clinically relevant systemic immune suppression. - Treatment with other anti-cancer therapy including chemotherapy, radiotherapy, investigational, or biological cancer therapy within 3 weeks prior to the first dose of trial treatment (6 weeks for nitrosureas). Adjuvant hormonotherapy used for breast cancer in long term remission is allowed. - Current evidence of ongoing National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade > 1 toxicity of prior therapies before the start of treatment, with the exception of hair loss, hearing loss, Grade 2 peripheral neuropathy, or laboratory abnormalities not considered clinical significant per investigators discretion, and those Grade 2 toxicities listed as permitted in other eligibility criteria. - Patients who have a local infection (e.g., cellulitis, abscess) or systemic infection (e. g., pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of trial treatment. - Patients who have had a splenectomy. - Patients who have had major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, have not fully recovered from surgery, or have a surgery planned during the time of trial participation. - Current evidence of new or growing brain or spinal metastases during screening. Patients with leptomeningeal disease are excluded. Patients with known brain or spinal metastases may be eligible if they: 1. had radiotherapy or another appropriate therapy for the brain or spinal bone metastases, 2. have no neurological symptoms that can be attributed to the current brain lesions, 3. have stable brain or spinal disease on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before randomization (confirmed by stable lesions on two scans at least 4 weeks apart, the second scan can be carried out during screening), 4. do not require steroid therapy within 14 days before the first dose of trial treatment, 5. spinal bone metastases are allowed, unless imminent fracture or cord compression is anticipated. - History or current evidence of significant cardiovascular disease including, but not limited to: 1. angina pectoris requiring anti-anginal medication, uncontrolled cardiac arrhythmia(s), severe conduction abnormality, or clinically significant valvular disease, 2. QTc (F) prolongation > 480 ms, 3. arterial thrombosis or pulmonary embolism within ≤ 6 months before the start of treatment, 4. myocardial infarction within ≤ 6 months before the start of treatment, 5. pericarditis (any NCI-CTCAE grade), pericardial effusion (NCI-CTCAE Grade ≥ 2), non-malignant pleural effusion (NCI-CTCAE Grade ≥ 2) or malignant pleural effusion (NCI-CTCAE Grade ≥ 3) within ≤ 6 months before the start of treatment, 6. Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria Class ≥ II within ≤ 6 months before the start of treatment. - Patients who have received a live vaccine within 28 days of planned start of trial therapy. - Known hypersensitivity to the active substances or to any of the excipients. - Presence of a severe concurrent illness or other condition (e.g., psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol. - Prior treatment with BNT111 and/or with cemiplimab. Inclusion criteria for entering add-on therapy - Patients must have confirmed disease progression on monotherapy in Arm 2 or 3 of the trial. 1. An initial radiological progression needs to be verified by BICR. 2. Radiological progression to be confirmed by two scans 4 to 12 weeks apart unless initial progression is accompanied by new symptoms, or deterioration of PS not attributed to toxicity, in which case one scan is sufficient. - Patients must sign a new ICF to continue with add-on therapy. Informed consent must be documented before any add-on-specific procedure is performed. - WOCBP must have a negative serum (beta-hCG) at baseline. Patients that are postmenopausal or permanently sterilized can be considered as not having reproductive potential. - Female patients of reproductive potential must agree to use adequate contraception during and for 6 months after the last trial drug administration. - WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial starting at screening, during the trial and for 6 months after receiving the last trial treatment. - A man who is sexually active with a WOCBP and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the trial and for 6 months after receiving the last trial treatment. Exclusion criteria for entering add-on therapy - Prior toxicity related to trial medication should have resolved to NCI-CTCAE v5.0 Grade ≤ 1 before the start of add-on treatment and may not have led to permanent discontinuation. - The time between confirmed PD on monotherapy and start of add-on therapy shall not exceed 6 weeks. - Current evidence of new or growing brain or spinal metastases at baseline (lesions that remained stable during initial treatment are allowed). - Systemic immune suppression: 1. use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed); patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible, 2. other clinically relevant systemic immune suppression. - Presence of cardiovascular, renal, hepatic or any other disease that in the investigators opinion, may increase the risks associated with trial participation or require treatments that may interfere with the conduct of the trial or the interpretation of trial results. ; PRIMARY OUTCOME: Objective response rate (ORR) - Arm: BNT111 + cemiplimab; SECONDARY OUTCOME 1: Objective response rate - Arm: BNT111 monotherapy and Arm: Cemiplimab monotherapy[/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 - vs. Jadenu or Exjade; BRIEF: This study is a multicenter, open-label, two-period crossover design that evaluates the safety, tolerability, pharmacokinetics and preliminary evidence of iron chelating activity of DST-0509 as compared to Jadenu and Exjade in transfusion-dependent thalassemia patients with transfusional iron overload, requiring iron chelation therapy and demonstrating an inadequate response to Jadenu or Exjade for greater than 3 months duration. Up to 36 patients will be evaluated (18 in each treatment arm), however, the balanced randomization may enroll fewer patients based on recruitment status. ; DRUG USED: DST-0509; DRUG CLASS: Non-NME; INDICATION: Iron Overload; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: DisperSol Technologies, LLC; CRITERIA: Inclusion Criteria: 1. Written informed consent or assent as appropriate obtained prior to any study-related procedure being performed; 2. Patients at least 8 years of age or older at the time of consent or assent; 3. Patient with TDT syndrome and iron overload currently receiving iron chelation therapy with Jadenu or Exjade and demonstrating inadequate response assessed with serum ferritin and LIC; 4. At least 8 or more blood transfusions in the past year; 5. Survival expected of >12 months; 6. Patient previously on dual iron chelation therapy will be transfered to iron chelation monotherapy ,stable dosing with Jadenu or Exjade for ≥1month prior to screening and receiving doses in the maximal dose range per day (e.g., Jadenu: >21 mg/kg or Exjade: >30 mg/kg, with specific doses in these ranges prescribed at the physicians discretion); 7. Serum ferritin levels that are persistently >800 mcg/L determined by 2 separate assessments during screening over the previous 2-4 weeks prior to study treatment and not showing a decreasing trend over these weeks OR, an LIC of >5 mg Fe/g dw measured by MRI in the 52 weeks prior to study entry, OR clearly identified as a poor responder in medical records within 3 months prior to the study 8. Compliant with chelation therapy in the 3 months prior to enrollment in the opinion of the Investigator; has taken at least 75% of medication prescribed on a regular basis was taken (Investigator enquiry into patient prescription refill records, preferably 3 months if available, SICT scores); and 1. Willing to comply with chelation therapy for the duration of the study; 2. The determination of compliance is at the discretion of the investigator. 9. Agree not to use other anti-chelating agents concurrently; 10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1; 11. Women of childbearing potential (WOCBP) must use an adequate method of birth control (double barrier, e.g. hormonal control and barrier contraception) at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug; 12. Male patients whose partners are WOCBP must use an adequate method of birth control (double barrier control) at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug; and 13. Patient is willing and able to comply with all protocol required visits and assessments. Exclusion Criteria: 1. Females of childbearing potential not on an adequate method of birth control, or who are pregnant or lactating; 2. History of non-compliance with chelation therapy (determined by the investigator). 3. Known history of human immunodeficiency virus (HIV) 4. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or other known active viral hepatitis; 5. Screening blood counts as follows: 1. Absolute neutrophil count < 1,000/μL 2. Platelets < 50,000/μL 3. Hemoglobin < 7 g/dL (transfusion support is permitted); 6. Screening chemistry values as follows: 1. Alanine aminotransferase (ALT) and aspartate transaminase (AST) > 3 × upper limit of the normal reference range (ULN) 2. Total bilirubin > 5 × ULN 3. Creatinine > 1.5 × ULN 4. Urine protein/creatinine ratio (UPCR) > 0.5 mg/mg 5. Albumin < 2.8 g/dL; 7. History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening; 8. History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer; 9. In the opinion of the Investigator, evidence of major inflammatory disease that would affect ferritin levels within 14 days prior to the start of study medication; 10. Major surgery within 30 days prior to the start of study medication; 11. Serious persistent infection within 14 days prior to the start of study medication; 12. Serious concurrent medical condition including central nervous system (CNS) disorders; 13. Requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents, or has used such treatment in the past 10 days before study entry (use of prednisone or equivalent <10 mg/day orally or use of inhaled corticosteroids or topical steroids is permitted); 14. Previous history of difficulty swallowing oral medications; 15. Any condition that, in the opinion of the Investigator, would impair the patients ability to comply with study procedures or study medication; or 16. Concomitant treatment with medications described in Section Prohibited Medications. Patients who screen fail for out-of-protocol laboratory values may be re-screened at the Investigators discretion provided that more than 30 days have passed since their previous screening. Up to three re-screenings will be permitted. ; PRIMARY OUTCOME: diarrhea %; SECONDARY OUTCOME 1: Area Under the Curve (AUC), mg*h/L[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - SHIELD; BRIEF: The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery. ; DRUG USED: SB-030; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral Arterial Disease (PAD); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Symic Vascular; CRITERIA: Inclusion Criteria: - Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s) - Rutherford Clinical Category 1-4 (claudication or critical limb ischemia) - Lesions are ≥70% stenosis by visual estimate - A patent inflow artery free from significant lesion - At least one patent native outflow artery to the ankle Exclusion Criteria: - History of haemorrhagic stroke within 3 months of screening - History of myocardial infarction, thrombolysis or angina within 2 weeks of screening - Renal failure or chronic kidney disease - Severe calcification that renders the lesion undilatable ; PRIMARY OUTCOME: Incidence of treatment-emergent adverse events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Itch Control; BRIEF: The purpose of this study is to test whether VLY-686 can prevent or reduce the itch and dermatological reaction observed after healthy volunteers are injected with Substance P in comparison with placebo. ; DRUG USED: Tradipitant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pruritus; TARGET: Neurokinin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Males 18 - 45 years of age, inclusive; - Non-smokers, per medical history, or ex-smokers for a period of ≥1 year; - Subjects with Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2 (BMI = weight (kg)/ [height (m)]2); - Vital signs (in sitting position after 3 minutes of rest) which are within the ranges shown below (inclusive): - Body temperature between 35.4-37.8 °C; - Systolic blood pressure between 91-130 mmHg; - Diastolic blood pressure between 51-90 mmHg; - Pulse rate between 50-100 bpm; - Respiratory rate between 10-20 breaths per minute; - Ability and acceptance to provide written informed consent; - Willing and able to comply with study requirements and restrictions; - Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, clinical laboratory tests and urinalysis. Exclusion Criteria: - Past or present history of atopy (atopic dermatitis problems, urticaria, asthma or allergic rhinitis) with no ascertained intolerance to histamine; - Past or present skin disease; - Lesions or any skin changes in the forearms in the month prior to the Screening Visit; - History of neurological diseases; - Past or present pain-related diseases such as cluster headaches, migraine, or back pain; - Treatment with all topical cream and ointments including cosmetics applied on the forearm in the 10 days prior to the screening visit; - Participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study; - Exposure (within 2 weeks of the Baseline Visit) to any prescription medication or over-the-counter medication including dietary supplements and/or herbal remedies, except those listed on Section 8.2; - Exposure (within 4 weeks of the Screening Visit) to any antihistamines, anxiolytics, antidepressants, pain killers including triptanes, neuroleptics, or sleep medications; - Treatment with any medication known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 days preceding the Screening Visit; - Administration of medications containing corticosteroids or adrenocorticotropic hormone in the three months prior to the Screening Visit; - Electrocardiogram reading considered outside the normal limits by the investigator (e.g. abnormally prolonged QTc corrected by Fridericias method > 450 msec in males, on ECG tracing). The following conduction abnormalities may confound QTc analysis and should be avoided if possible: PR > 220 msec, 2nd or 3rd degree AV block, intraventricular conduction delay with QRS > 120 msec, left branch bundle block, right branch bundle block or Wolff-Parkinson-White syndrome; - Blood donation in the last 3 months or donation of at least 1500 mL blood (including this study) within the last year; - History of liver disease and/or positive for one or more of the following serological results: - A positive hepatitis C antibody test (anti-HCV); - A positive hepatitis B surface antigen (HBsAg); - A positive HIV test result ; - Not willing to sign the informed consent or not able to understand completely the study objectives or risks; - Clinically relevant abnormalities in clinical lab or physical assessments performed at the screening visit; - Lack of sensitivity to Substance P and histamine or sensitivity to saline at the Screening Visit; - Any other sound medical reason as determined by the clinical Investigator. - Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>2 drinks/day for males, defined according to USDA Dietary Guidelines 2010), caffeine (>5 cups coffee/tea/day), smokers; - Diet: abnormal diets (<1600 or >3500 calories/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians. ; PRIMARY OUTCOME: Itch severity score on the Verbal Rating Scale; SECONDARY OUTCOME 1: Dose response of VLY-686 and reduction of itch severity[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - HVTN111; BRIEF: The purpose of this study is to evaluate the safety and immune response to an HIV clade C DNA vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults. ; DRUG USED: HIV Vaccine (GlaxoSmithKline); DRUG CLASS: Vaccine; INDICATION: HIV Prevention; TARGET: Human Immunodeficiency Virus (HIV) , Immune System; THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: General and Demographic Criteria - Age of 18 to 40 years - Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study - Ability and willingness to provide informed consent - Assessment of understanding: volunteer demonstrates understanding of this study; provides answers to a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly - Agrees not to enroll in another study of an investigational research agent - Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: - Willingness to receive HIV test results - Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. - Assessed by the clinic staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values: Hemogram/Complete blood count (CBC) - Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male - White blood cell count = 3,300 to 12,000 cells/mm^3 - Total lymphocyte count ≥ 800 cells/mm^3 - Remaining differential either within institutional normal range or with site physician approval - Platelets = 125,000 to 550,000/mm^3 Chemistry - Chemistry panel: ALT, AST, and ALP < 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal. Virology - Negative HIV-1 and -2 blood test: Sites may use locally available assays that have been approved by HVTN Laboratory Operations. - Negative Hepatitis B surface antigen (HBsAg) - Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine - Normal urine: - Negative urine glucose, and - Negative or trace urine protein, and - Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range). Reproductive Status - Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. Reproductive status: A volunteer who was born female must: - Agree to consistently use effective contraception (Appendix B) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. - Effective contraception is defined as using 1 of the following methods: - Condoms (male or female), or - Diaphragm or cervical cap, - PLUS 1 of the following methods: - Intrauterine device (IUD), - Hormonal contraception (in accordance with applicable national contraception guidelines), - Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity after vasectomy); or - Any other contraceptive method approved by the HVTN 111 PSRT - Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; - Or be sexually abstinent. Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit Other Volunteers 21 years of age and older who were born female consenting to provide cervical samples: pap smear within the 3 years prior to enrollment, with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance); for those 21 years and older that have not had a pap smear within the last 3 years prior to enrollment, must be willing to undergo a pap smear with the result reported as normal or ASCUS prior to sample collection. Exclusion Criteria: General - Blood products received within 120 days before first vaccination - Investigational research agents received within 30 days before first vaccination - Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, current smoker, known hyperlipidemia - Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 111 study - Pregnant or breastfeeding Vaccines and other Injections - HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 111 PSRT will determine eligibility on a case-by-case basis. - Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 111 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 111 PSRT on a case-by-case basis. - Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever) - Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) - Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System - Immunosuppressive medications received within 168 days before first vaccination. (Not excluded from participation: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment. - Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) - Immunoglobulin received within 60 days before first vaccination - Autoimmune disease - Immunodeficiency Clinically significant medical conditions - Untreated or incompletely treated syphilis infection - Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: - A process that would affect the immune response, - A process that would require medication that affects the immune response, - Any contraindication to repeated injections or blood draws, - A condition that requires active medical intervention or monitoring to avert grave danger to the volunteers health or well-being during the study period, - A condition or process for which signs or symptoms could be confused with reactions to vaccine, or - Any condition specifically listed among the exclusion criteria below. - Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteers ability to give informed consent - Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years. - Current anti-tuberculosis (TB) prophylaxis or therapy - Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who: - Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or - Uses moderate/high dose inhaled corticosteroids, or - In the past year has either of the following: - Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids; - Needed emergency care, urgent care, hospitalization, or intubation for asthma. - Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.) - Thyroidectomy, or thyroid disease requiring medication during the last 12 months - Hypertension: - If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic at enrollment. - If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment. - Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) - Malignancy (Not excluded: Volunteer who has had malignancy excised surgically and who, in the investigators estimation, has a reasonable assurance of sustained cure. or who is unlikely to experience recurrence of malignancy during the period of the study) - Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. - Asplenia: any condition resulting in the absence of a functional spleen - History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. ; PRIMARY OUTCOME: Frequency of severe local and systemic reactogenicity signs and symptoms (pain, tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Dose Ranging; BRIEF: The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD. ; DRUG USED: Darotropium; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - A signed and dated written informed consent prior to study participation. - Male or female adults. A female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or child-bearing potential, has a negative pregnancy test at Visit 1/Visit 1A, and agrees to one of the protocol-specified acceptable contraceptive methods used consistently and correctly (i.e. according to the approved product label and the instructions of the physician for the duration of the study - Screening through follow-up contact) - 40 to 80 years of age at Visit 1 - An established clinical history of COPD - Current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years 1. - A post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 and a post-albuterol/salbutamol FEV1 of ≥35 and ≤70% of predicted normal values Exclusion Criteria: Subjects meeting any of the following criteria must not be enrolled in the study: - Women who are pregnant or lactating. - A current diagnosis of asthma. - Known respiratory disorders other than COPD including but not limited to α-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease. - Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy) - Clinically significant Chest X-ray or computed tomography (CT) scan abnormalities within 6 months prior to Visit 1 that are not believed to be due to COPD. - Use of oral corticosteroids or antibiotics for COPD within 6 weeks prior to Visit 1. - Hospitalization for COPD or pneumonia within 3 months prior to Visit 1. - Use of antibiotics for a lower respiratory tract infection within 30 days prior to Visit 1. - Clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities. - An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in active medical problem. - Positive for Hepatitis B or Hepatitis C at Visit 1. - A current malignancy or previous history of cancer in remission for <5 years prior to Visit 1 - A history of allergy or hypersensitivity to ipratropium, tiotropium, or atropine and any of their derivatives, lactose/milk protein or magnesium stearate. - Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholingeric. - Medically unable to withhold albuterol/salbutamol for 6 hours prior to spirometry testing at each study visit or to withhold ipratropium (if applicable) for the 6-hour period prior to the first 3 study visits (ipratropium cannot be used after Visit 3). - Additional Medications: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications) - Use of inhaled corticosteroids at a dose greater than 1000 mcg/day of fluticasone propionate or equivalent within 30 days prior to Visit 1. - Use of long-term oxygen therapy (LTOT) or supplemental oxygen required for greater than 12 hours a day. Oxygen use as needed is not exclusionary. - Clinically significant sleep apnea that requires continuous positive airway pressure (CPAP) - Use of regular nebulized therapy - Use of nocturnal positive pressure or non-invasive positive pressure ventilation (NIPPV) - Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. - An investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the above who is involved in this study - History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study. - Use of GSK233705B in previous studies. ; PRIMARY OUTCOME: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29; SECONDARY OUTCOME 1: Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - 403 - w/Doxorubicin; BRIEF: The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma. ; DRUG USED: Evofosfamide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sarcoma; TARGET: DNA; THERAPY: Combination; LEAD SPONSOR: Threshold Pharmaceuticals; CRITERIA: Inclusion Criteria All Subjects: - At least 18 years of age - Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigators IRB/Ethics Committee - Pathologically confirmed diagnosis of soft tissue sarcoma of the following subtypes: - Synovial sarcoma - High grade fibrosarcoma - Unclassified, undifferentiated sarcoma - Liposarcoma - Leiomyosarcoma (excluding GIST) - Angiosarcoma (excluding Kaposis sarcoma) - Pleomorphic sarcoma/malignant fibrous histiocytoma - Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate; subjects in the dose escalation cohorts must have progressed since their most recent systemic therapy - Recovered from reversible toxicities of prior therapy - Evaluable disease by RECIST criteria (at least one target or non-target lesion for dose escalation cohorts; at least 1 target lesion for dose expansion cohort) - ECOG performance status of 0 or 1 - Life expectancy of at least 3 months - Acceptable liver function: - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN - Acceptable renal function: - Serum creatinine within normal limits - Acceptable hematologic status (without hematologic support): - ANC ≥ 1500 cells/μL - Platelet count ≥ 100,000/μL - Hemoglobin ≥ 9.0 g/dL - Acceptable cardiac function: - Normal 12-lead ECG (clinically insignificant abnormalities permitted) - LVEF normal by MUGA or echocardiogram - Urinalysis: No clinically significant abnormalities - All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose Exclusion Criteria Prior therapy: - Dose escalation cohort: Prior treatment with more than 2 myelosuppressive cytotoxic chemotherapy regimens - Expanded cohort: Prior systemic therapy for advanced disease (neoadjuvant and adjuvant permitted) - Low grade tumors according to standard grading systems (eg AJCC Grade 1 and 2) - Prior therapy with ifosfamide or cyclophosphamide - Prior therapy with an anthracycline or anthracenedione - Prior mediastinal/cardiac radiotherapy - Current use of drugs with known cardiotoxicity or known interactions with doxorubicin (see product label) - Anticancer treatment with radiation therapy, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), immunotherapy, hormones or other antitumor therapies within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C) - Significant cardiac dysfunction: - Any history of congestive heart failure - Any history of transmural myocardial infarction - Uncontrolled arrhythmias within the past 6 months - Angina pectoris requiring antianginal medication within the past 6 months - Clinically significant valvular heart disease - Poorly controlled hypertension within the last 6 months - Seizure disorders requiring anticonvulsant therapy - Known brain metastases (unless previously treated and well controlled for a period of ≥ 3 months) Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years - Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia - Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery - Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy - Prior therapy with an hypoxic cytotoxin - Subjects who participated in an investigational drug or device study within 28 days prior to study entry - Known infection with HIV, hepatitis B, or hepatitis C - Subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to TH-302 - Females who are pregnant or breast-feeding - Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study - Unwillingness or inability to comply with the study protocol for any reason ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Advanced CRPC; BRIEF: This Phase 2 Open-label Study examines the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib (eFT508) in Patients with advanced CRPC. An Open-label Study Examining the Effect of tomivosertib (eFT508) in Patients with Advanced Castrate-resistant Prostate Cancer (CRPC) ; DRUG USED: eFT508; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: MNK1/MNK2; THERAPY: Monotherapy; LEAD SPONSOR: Effector Therapeutics; CRITERIA: Inclusion Criteria: - Men ≥18 years. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - Histologically or cytologically confirmed (by clinical site) adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. - Ongoing androgen deprivation therapy with a GnRH analog or bilateral orchiectomy (surgical or medical castration). - Serum testosterone ≤1.73 nmol/L (50 ng/dL) at screening. - PSA progression on treatment with abiraterone and/or enzalutamide and/or apalutamide. PSA progression is defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. PSA value at the screening visit should be ≥2 ng/mL. Patients may also have: - Soft tissue disease progression defined by iRECIST/RECIST 1.1 - Bone disease - Patients receiving bisphosphonate/receptor activator of nuclear factor kappa-Β ligand (RANKL) therapy must have been on stable doses for ≥ 4 weeks before the start of study therapy. - Completion of all previous therapy for the treatment of cancer ≥4 weeks before the start of study therapy. - All acute toxic effects of any prior anti-tumor therapy resolved to Grade ≤1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted], neurotoxicity [Grade 1 or 2 permitted], or bone marrow parameters [Grade 1 or 2 permitted with exceptions as noted below]). - Adequate bone marrow function: - Absolute neutrophil count (ANC) ≥1.0 x 109/L - Platelet count ≥75 x 109/L - Hemoglobin ≥80 g/L (8.0 g/dL or 4.9 mmol/L) - Adequate hepatic function: - Serum alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN), ≤ 5 x ULN in the presence of liver metastases - Serum aspartate aminotransferase (AST) ≤3 x ULN, ≤5 x ULN in presence of liver metastases - Serum bilirubin ≤1.5 x ULN (unless due to Gilberts syndrome or hemolysis ≤3 x ULN) - Adequate renal function: -Serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥30 mL/min using Cockcroft Gault equation (Appendix 13.4) - For male patients who can father a child and are having intercourse with females of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of study therapy and for ≥30 days following the last dose of study medication or to abstain from sexual intercourse for at least this period of time, and willingness to refrain from sperm donation from the start of study therapy to ≥90 days following the last dose of study drug. - Estimated life expectancy >12 weeks. - Willingness to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests and biopsies, other study procedures, and study restrictions. Note: Psychological, social, familial, or geographical factors that might preclude adequate study participation should be considered. - Evidence of a personally signed informed consent indicating that the patient is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation. Exclusion Criteria: - History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ≥2 years. - Rapidly progressive, clinically unstable central nervous system malignancy. Note: Central nervous system imaging is only required in patients with known or suspected central nervous system malignancy. - Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism within 6 months before the start of study therapy; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; unstable angina; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg), or history of congenital prolonged QT syndrome. - Significant screening electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, left bundle-branch block, 2nd-degree atrioventricular (AV) block type II, 3rd-degree AV block, Grade ≥2 bradycardia, or QTcF ≥470 msec. - Symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable. - Patients with gastrointestinal disorders likely to interfere with absorption of study medication. - Major surgery within 4 weeks before the start of study therapy. - Prior treatment with chemotherapy within 3 weeks or at least 4 half-lives, whichever is longer, before the start of study therapy. - Prior therapy with any known inhibitor of MNK-1 or MNK-2. - Treatment with 5-alpha reductase inhibitors within 4 weeks of enrollment. - Prior flutamide treatment within 4 weeks before the start of study therapy and evidence of withdrawal response. - Bicalutamide or nilutamide within 6 weeks before the start of study therapy and evidence of withdrawal response. - Enzalutamide or abiraterone or apalutamid within 4 weeks before the start of study therapy. a. Steroids given in conjunction with abiraterone must be washed out for at least 2 weeks prior to Cycle 1 Day 1 unless the investigator chooses to maintain at a dose of ≤10 mg/day prednisone or equivalent. - Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto). - Current use of immunosuppressive medication at the time of randomization, EXCEPT for the following: 1. intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection); 2. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent; 3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication). - Use of a potent inhibitor or inducer of cytochrome P450 (CYP) 3A4 within 7 days before the start of study therapy or expected requirement for use of a CYP3A4 inhibitor or inducer during study therapy (Appendix 13.5). - Concurrent participation in another therapeutic clinical trial. - Any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patients ability to sign informed consent, adversely affect the patients ability to cooperate and participate in the study, or compromise the interpretation of study results. ; PRIMARY OUTCOME: Anti-tumor response as defined by a patient achieving either of the following outcomes:; SECONDARY OUTCOME 1: PSA progression-free survival from start of study therapy until the date PSA progression is first observed.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Temozolomide; BRIEF: The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a currently approved drug). An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the safety and tolerability of TPI 287 both alone and in combination with temozolomide, and look to establish a safe dose of this agent. The study will also look at the tumors response to these drugs, but this is not the primary objective of this study. TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in three different animal species. TPI 287 has been tested in humans in four clinical trials, and approximately 100 subjects with various types of cancers have received the drug. All of these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a pediatric population before this study. Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently published study. Preclinical studies of TPI in combination with temozolomide have shown at minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in combination is suggested by these two drugs showing even greater activity when used together. ; DRUG USED: TPI-287; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET); TARGET: Microtubules (Tubulin); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Giselle Sholler; CRITERIA: Inclusion Criteria: - Patients must have histologically proven neuroblastoma and confirmation of refractory or recurrent disease or medulloblastoma with histologic confirmation at diagnosis or at the time of recurrence/progression - Patients must be age >12 months and diagnosed before the age of 21 - Life expectancy must be more than 3 months - If measurable disease, this must be demonstrated by residual abnormal tissue at a primary or metastatic site measuring more than 1 cm in any dimension by standardized imaging (CT or MRI). For patients with neuroblastoma who only have skeletal disease, there must be at least two persisting skeletal foci on meta-iodobenzylguanidine (MIBG) follow-up scans - Current disease state must be one for which there is currently no known curative therapy - Lansky Play Score must be more than 30 and/or ECOG performance status must be 0 to 2 - For patients with medulloblastoma receiving steroids, the dose must be stable (i.e. not increasing) for at least one week before starting study - Patients without bone marrow metastases must have an ANC > 750/μl and platelet count >50,000/μl - Adequate liver function must be demonstrated, defined as: - Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND - SGPT (ALT) < 10 x upper limit of normal (ULN) for age - No other significant organ toxicity defined as > Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events version 3 (NCI-CTCAE V3.0 (http://ctep.cancer.gov/forms/CTCAEv3.pdf)) - A negative urine pregnancy test is required for female participants of child bearing potential (≥13 years of age or after the onset of menses) - Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (the pill), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these can not be used, contraceptive foam with a condom is recommended - Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines - Patients may have received microtubulin inhibitors and/or temozolomide during previous therapies Exclusion Criteria: - Patients who have received any chemotherapy administered within the last 21 days - Patients who have received radiotherapy within the last 30 days - Patients who have received myeloablative therapy within the previous 3 months - Patients receiving anti-tumor therapy for their disease or any investigational drug concurrently - Patients with serious infection or a life-threatening illness (unrelated to tumor) that is > Grade 2 (NCI CTCAE V3.0), or active, serious infections requiring parenteral antibiotic therapy within 4 weeks prior to screening - Any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a patients ability to sign or the legal guardians ability to sign the informed consent, and patients ability to cooperate and participate in the study - Patients with known hypersensitivity to any of the components of the drugs to be administered on study - Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study ; PRIMARY OUTCOME: Number of Participants With Adverse Events as a Measure of Safety and Tolerability; SECONDARY OUTCOME 1: Tmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MAJESTY (Primary Membranous Nephropathy); BRIEF: This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN). ; DRUG USED: Gazyva; DRUG CLASS: Biologic; INDICATION: Nephrotic Syndrome; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening - Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening - eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening - Other inclusion criteria may apply Exclusion Criteria: - Participants with a secondary cause of MN - Pregnancy or breastfeeding - Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization - Severe renal impairment, including the need for dialysis or renal replacement therapy - Type 1 or 2 diabetes mellitus - Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening - Significant or uncontrolled medical disease which, in the investigators opinion, would preclude participant participation - Known active infection of any kind or recent major episode of infection - Major surgery requiring hospitalization within the 4 weeks prior to screening - Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening - Intolerance or contraindication to study therapies - Other exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants who Achieve a Complete Remission (CR) at Week 104; SECONDARY OUTCOME 1: Percentage of Participants who Achieve an Overall Remission at Week 104[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy volunteers. The secondary objectives of the study are to estimate the PK parameters of single ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses of BIIB063. ; DRUG USED: BIIB063; DRUG CLASS: Biologic; INDICATION: Sjogrens Syndrome; TARGET: CD40 Ligand (CD40L) / gp39; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - All male subjects and all female subjects of childbearing potential must practice at least 1 highly effective method of contraception (i.e., contraceptive measure with a failure rate of <1% per year; estrogen-containing contraceptives are prohibited) during the study and be willing and able to continue contraception for 4 months after being dosed with study treatment. Male subjects must also be willing to refrain from sperm donation for at least 4 months after the last dose of study treatment. Male subjects must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study. - Must have a body mass index between 18 and 30 kg/m2, inclusive. - Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG. Key Exclusion Criteria: - History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]). - History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator. - Personal or family history of cardiovascular disease under the age of 50 years, inherited disorder of coagulation (e.g., Factor V Leiden, protein C or S deficiency), or anti-phospholipid Ab syndrome (APS). - History of meningococcal vaccination or meningococcal meningitis, or history of hypersensitivity to single components of meningococcal vaccines (including MENVEO), any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine. - History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test - Personal history of thromboembolic events - Treatment with any prescription or over-the-counter medication within 14 days prior to randomization (excluding vitamins, dietary supplements, herbal preparations, progestin-only birth control, and paracetamol up to 4 g/day for no more than 5 consecutive days). - Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months - Current enrollment or a plan to enroll in any other drug, biologic or device clinical study, or treatment with an investigational drug or approved therapy for investigational use within 3 months - Blood donation (1 unit or more) within 3 months prior to randomization. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)[/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 - B7541002; BRIEF: The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis. ; DRUG USED: PF-06480605; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: TNF superfamily member 15 (TNFSF15); THERAPY: Monotherapy; LEAD SPONSOR: Telavant, Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects between ≥ 18 and ≤ 75 years of age at the time of informed consent - Male subjects able to father children and female subjects of childbearing potential must agree to use two highly effective methods of contraception throughout the study and until the Week 26 visit - Diagnosis of ulcerative colitis for ≥ 4 months - Subjects with moderate to severe active ulcerative colitis as defined by screening colonoscopy with total Mayo score of ≥ 6, with rectal bleeding subscore of ≥ 1, and an endoscopic subscore of ≥ 2 on the Mayo - Active disease beyond the rectum (> 15 cm of active disease at the screening colonoscopy) - Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for ulcerative colitis such as: Steroids; Immunosuppressants (AZA, 6-MP, or MTX); Anti -TNF inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab). - Subjects currently receiving the following treatment are eligible provided they have been on stable doses of Oral 5-ASA or sulfasalazine for at least 4 weeks prior to baseline; oral corticosteroids stable dose for at least 2 weeks prior to baseline; 6-MP or AZA stable dose for 8 weeks prior to baseline. Exclusion Criteria: - Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohns Disease. Subjects with clinical findings suggestive of Crohns disease (eg, fistulae, granulomas on biopsy) are also excluded. - Subjects with colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known colonic stricture, history of colonic or small bowel stoma, history of colonic or small bowel obstruction or resection - Presence of active enteric infections (positive stool culture and sensitivity) - Known history of HIV based on documented history with positive serological test, or positive HIV serologic test at screening - Presence of a transplanted organ - Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence); - Acute coronary syndrome (eg., myocardial infarction, unstable angina pectoris); - Any history of cerebrovascular disease within 24 weeks before screening; - Subject with current or a history of QT prolongation - Class III or Class IV heart failure - Prior evidence of liver injury or toxicity due to methotrexate - Abnormality in hematology and/or chemistry profiles during screening (as detailed in the protocol) - Subjects receiving the following therapies within the designated time period: - > 9 mg/day of oral budesonide or >20 mg/day prednisone or equivalent within 2 weeks prior to baseline - IV, IM (parenteral), or topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline - Biologics including anti-TNF inhibitors as described: Infliximab, Adalimumab, or Golimumab within 8 weeks prior to baseline - Anti-integrin inhibitors (eg, vedolizumab) within 12 weeks prior to baseline - Other investigational procedures or products, or live attenuated vaccine within 30 days prior to baseline. - Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events; SECONDARY OUTCOME 1: Percentage of Participants Achieving Remission at Week 14 - Full Analysis Set[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Hyperuricemia (JP); BRIEF: This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo. ; DRUG USED: RDEA3170; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gout; TARGET: URAT1 (urate trans-porter 1, SLC22A12/Solute carrier family 22, member 12); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Subject meets any of the following criteria and with sUA ≤10.0 mg/dL: 1. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout; 2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome); 3. sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications. Exclusion Criteria: - Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit. - Subject has a history or suspicion of kidney stones. - Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula - Subject is receiving strong or moderate CYP3A inhibitors ; PRIMARY OUTCOME: Percent Changes of Serum Uric Acid Levels From Baseline Levels; SECONDARY OUTCOME 1: Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - IFN-Free w/ABT-450/Ritonavir/RBV (PILOT); BRIEF: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection. ; DRUG USED: ABT-072; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C. - Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV. - Treatment naïve male or female between the ages of 18 and 65. - Females must be postmenopausal for at least 2 years or surgically sterile. - Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection. - Body mass index 18 to < 35 kg/m^2 . Exclusion Criteria: - Significant sensitivity to any drug. - Use of herbal supplements within 2 weeks prior to study drug dosing. - Positive screen for certain drugs or alcohol. - Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody. - Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing. - Prior treatment with any investigational or commercially available anti-hepatitis C virus agents. - Abnormal laboratory tests. - Cirrhosis or extensive bridging fibrosis. - History of cardiac disease. ; PRIMARY OUTCOME: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12; SECONDARY OUTCOME 1: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)[/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 - SILVER (Study 11); BRIEF: The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD). PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA. ; DRUG USED: Seroquel XR; DRUG CLASS: Non-NME; INDICATION: Generalized Anxiety Disorder (GAD); TARGET: Alpha Adrenergic Receptors, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Male or female aged 18 to 65 years; - A diagnosis of generalized anxiety disorder; - Absence of current episode of major depression. Exclusion Criteria: - The presence or history of schizophrenia and other psychotic disorders; - Hypertension; - A current diagnosis of cancer, unless in remission for at least 5 years ; PRIMARY OUTCOME: To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).; SECONDARY OUTCOME 1: To evaluate efficacy by evaluating response rate.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - RESOLUTE; BRIEF: The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts. ; DRUG USED: SPK-3006; DRUG CLASS: Biologic; INDICATION: Pompe Disease; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Spark Therapeutics; CRITERIA: Inclusion Criteria: - Provide written informed consent; - Males and Females ≥18 years of age with late-onset Pompe disease; - Received ERT for at least the previous 24 months - Have clinically moderate, late-onset Pompe disease characteristics; - Agree to use reliable contraception. Exclusion Criteria: - Active hepatitis B and/or C; - Significant underlying liver disease; - Human immunodeficiency virus (HIV) infection; - Prior hypersensitivity to rhGAA; - Pre-existing anti-AAV neutralizing antibody titers; - High titer antibody responses to rhGAA; - Requires any invasive ventilation or requires noninvasive ventilation while awake and upright; - Received any prior vector or gene transfer agent; - Active malignancy (except non-melanoma skin cancer); - History of liver cancer; - Pregnant or nursing women; - Any evidence of active infection at the time of SPK-3006 infusion. ; PRIMARY OUTCOME: Number of adverse and serious adverse events (AEs/SAEs), including clinically significant abnormal laboratory values.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - University of Pennsylvania; BRIEF: A phase 0, exploratory study of the pharmacodynamics of a single intratumoral dose of IMCgp100, a monoclonal T cell receptor anti-CD3 scFv fusion protein, in subjects with advanced unresectable melanoma to assess the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Six patients will be enrolled to complete the study over approximately 12-15 months. ; DRUG USED: Tebentafusp; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cluster of Differentiation 3 (CD3), gp100, HLA-A, Immune System, Major Histocompatibility Complex (MHC), T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: University of Pennsylvania; CRITERIA: Inclusion Criteria: - 1. Histologically confirmed diagnosis of melanoma, with advanced unresectable disease not currently requiring immediate treatment and/or in a window between treatments. - 2. Two or more cutaneous or subcutaneous melanoma metastatic lesions 7-15 mm in at least one dimension and amenable to subsequent biopsy. - 3. Age 18 years - 4. ECOG performance status 0-2 - 5. Able to understand and to provide written informed consent and willingness to comply with all protocol requirements; - 6. Female patients who are not be of childbearing potential as documented by medical history (e.g., tubal ligation or hysterectomy), or be post menopausal with a minimum 1 year without menses or have a negative serum beta human chorionic gonadotropin (HGC) pregnancy test within 48 hours prior to receiving the intratumoral injection and agree to use an acceptable form of birth control, defined as abstinence or use of an intrauterine device (IUD), oral contraceptive, barrier and spermicide, or hormonal implant throughout the study period; - 7. Male patients who must agree to use an acceptable form of birth control throughout the study period. - 8. Adequate organ system function as evidenced by laboratory values: -Absolute neutrophil count (ANC) greater than or equal to 1.0 X 109/L -Hemoglobin greater than or equal to 9 g/dL -Platelets greater than or equal to 75 X 109/L -Total bilirubin less than or equal to 1.5 mg/dL -AST and ALT less than or equal to 2.5 X ULN ( 2.5 X ULN in the presence of liver metastasis.) -Creatinine less than or equal to 2 mg/dL -TSH within normal limits -INR/PT and PTT less than or equal to 1.3 X ULN Exclusion Criteria: - 1. Receive any chemotherapy, immunotherapy, radiation therapy, or other investigational agents (agents part of a research protocol or not approved by the FDA) within 2 weeks prior to injection. A minimum of 14 days is required between last therapy and injection on this study. In addition, any clinically significant drug-related toxicity should have recovered to grade 1 or less (excluding alopecia) - 2. Patients without cutaneous or subcutaneous metastatic lesions; - 3. Cutaneous metastases that have received prior local therapy, such as radiation or isolated limb perfusion. - 4. Pregnancy or breastfeeding - 5. History of autoimmune disease (excluding vitiligo or controlled thyroid disease) or immunodeficiency. - 6. Current treatment with steroids (inhaled, topical or systemic) or other immunosuppressive medications within 2 weeks of injection; - 7. Active uncontrolled infection; - 8. Known HIV positivity; - 9. Uncontrollable seizures; - 10. Known delayed wound healing; - 11. Full dose anticoagulation with heparin, warfarin, or any other anticoagulant within 2 weeks of injection ; - 12. History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting, stroke or TIA within the past 24 weeks.; - 13. Known hypersensitivity of IMCgp100 or any of its components (ie, Tween) ; - 14. Class II, III, or IV heart failure as defined by the New York Heart Association; - 15. Any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. - 16. Any other condition that in the investigators opinion would jeopardize compliance with the protocol ; ; PRIMARY OUTCOME: Adverse Events as a Measure of Safety and Tolerability; SECONDARY OUTCOME 1: Adverse events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Pediatric IBS-C (Ages 7-17); BRIEF: The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C. ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Patient weighs at least 18 kg (39.7 lbs) - Patient meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening Visit, the patient experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time: - a) Improvement with defecation - b) Onset associated with a change in frequency of stool - c) Onset associated with a change in form (appearance) of stool - Patient meets modified Rome III criteria for child/adolescent Functional Constipation (FC): For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, patient meets 1 or more of the following: - a) History of retentive posturing or excessive volitional stool retention - b) History of painful or hard bowel movements (BMs) - c) Presence of a large fecal mass in the rectum - d) History of large diameter stools that may obstruct the toilet - Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine - Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM - Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit Exclusion Criteria: - Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization - Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses - Patient has required manual disimpaction anytime prior to randomization or disimpaction during in-patient hospitalization within one year prior to randomization - Patient is unable to tolerate the placebo during rhe Screening Period ; PRIMARY OUTCOME: Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period; SECONDARY OUTCOME 1: Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ILLUMINATE-206 (w/Nivolumab + Ipilimumab); BRIEF: A Phase 2 study intended to see efficacy of tilsotolimod in combination with immunotherapy drugs ipilimumab and nivolumab in different solid tumors. ; DRUG USED: Tilsotolimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: Toll-like receptor 9 (TLR9); THERAPY: Combination; LEAD SPONSOR: Idera Pharmaceuticals, Inc.; CRITERIA: Main Inclusion Criteria: 1. Subject must be willing and able to sign the informed consent and comply with study protocol. 2. Must be ≥ 18 years of age (males and females). 3. ≥ 1 lesion accessible for i.t. injection and biopsy(ies). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 minimum life expectancy ≥ 4 months. 5. Adequate baseline organ function as defined by: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/mm3) 2. Platelet count ≥ 100 x 109/L (100,000/mm3) 3. Hemoglobin ≥ 9.0 g/dL (5.59 mmol/L) 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance of ≥ 40 mL/minute (measured or calculated using the Cockroft-Gault formula) 5. Aspartate aminotransferase (AST) ≤ 3 x ULN, alanine aminotransferase (ALT) ≤ 3 x ULN; AST/ALT < 5 ULN if liver involvement 6. ≤ 1.5 x ULN, except in subjects with Gilberts syndrome who must have a total bilirubin ≤ 3 mg/dL 6. Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to use effective contraception methods as defined in the clinical study protocol. 7. For any subjects who received prior approved/investigational i.t. anti-cancer treatments, the studys Medical Monitor must be consulted before enrollment. Inclusion Criteria ( MSS CRC IO Naïve) 1. Histologically confirmed advanced, metastatic, or progressive MSS CRC based on either an analysis of tissue from a prior biopsy or based on tissue from a new biopsy. Subjects microsatellite/MMR status should be known. 2. Received two prior lines of therapy for advanced or metastatic CRC including fluoropyrimidine-, oxaliplatin-, and irinotecan-based regimens. Subjects who relapse within 6 months of adjuvant chemotherapy composed of oxaliplatin and a fluoropyrimidine will have their adjuvant therapy count as one prior regimen. 3. Documentation of radiologic progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 during or after previous chemotherapy. Subjects documented clinical progression may be eligible and must be discussed with the medical monitor to determine eligibility. Main Exclusion Criteria: 1. Subject must have completed or completely discontinued any previous cancer-related treatments before enrollment with necessary windows and wash out periods as defined in the clinical study protocol. 2. History of interstitial lung disease, pneumonitis, known or suspected autoimmune diseases (unless for specific diseases as defined in protocol) or human immunodeficiency virus (HIV) infection. 3. Prior therapy with TLR9 agonist, excluding topical agents. 4. Known hypersensitivity to any study drug component. 5. Treatment with botanical preparations (e.g. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to treatment. 6. Known or suspected autoimmune diseases. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to be enrolled. Subject with a requirement of systemic steroids > 10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study treatment. 7. Subject with another primary malignancy that has not been in remission for at least 3 years except for non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate specific antigen, cervical carcinoma in situ on biopsy, or thyroid cancer (except anaplastic). 8. Active systemic infections requiring antibiotics. 9. Active Hepatitis A, B or C infections. 10. Known diagnosis of human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally. 11. Women who are breast feeding or pregnant. 12. Prior anaphylactic or other severe infusion reaction associated with human antibody administration that cannot be managed by standard supportive measurements. 13. Presence of known central nervous system (CNS), meningeal, or epidural metastatic disease.However, subjects with known brain metastases are allowed if brain metastases are stable for≥ 4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved at baseline, no radiological evidence of progression, and steroid requirement of prednisone ≤ 10 mg/day or equivalent. 14. Subject with unstable and impaired cardiac function or clinically significant cardiac disease per Investigators clinical judgment. 15. Has received live attenuated vaccine 30 days before first study dose. Any live attenuated vaccine [e.g., varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella (MMR)] during treatment and until 100 days post last dose will be prohibited. Exclusion Criteria (MSS CRC IO Naïve): 1. Prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed cell death ligand-1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor in an approved or experimental setting. 2. Subjects with BRAF V600E mutations. 3. Subjects with a history of immune-mediated colitis. 4. Subjects who received three or more lines of therapy for advanced or metastatic CRC ; PRIMARY OUTCOME: Demonstrate the efficacy of intratumoral tilsotolimod in combination with ipilimumab and nivolumab for each cohort; SECONDARY OUTCOME 1: Safety and tolerability of the combination of tilsotolimod with nivolumab and ipilimumab[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - REPRISE ; BRIEF: The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD) ; DRUG USED: Jynarque; DRUG CLASS: Non-NME; INDICATION: Polycystic Kidney Disease; TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or eGFR between 25-44 mL/min/1.73m2 (if aged 56 to <66) - Tolvaptan naïve - Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history Exclusion Criteria: - Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Investigational medicinal product (IMP) - Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP - Need for chronic diuretic use - Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease - Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury - Contraindications to required trial assessments - Medical history or medical findings inconsistent with safety or compliance with trial assessments ; PRIMARY OUTCOME: The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.; SECONDARY OUTCOME 1: Mean Annualized Slope of eGFR Change[/INST]Yes</s>