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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ATG FRES; BRIEF: Paediatric patients affected by haematological malignancies and eligible to undergo HSCT from an unrelated volunteer will be stratified according to the degree of compatibility with their donor, the source of haematopoietic stem cells employed (BM vs. PB) and the disease phase (good vs. poor prognosis). In particular, on the basis of compatibility with their donor, patients will be allocated to 2 different arms: those transplanted from an unrelated donor either perfectly matched or with a single allelic disparity at one of the HLA loci (i.e. A, B, C, and DrB1) vs. those transplanted from an unrelated donor either with 2 allelic disparities or with an antigenic disparity at the HLA loci (i.e. A, B, C, and DrB1). Patients enrolled in the study will be randomized to receive ATG (Fresenius) at a dosage of either 30 mg/Kg (10 mg/Kg on days -4, -3 and -2) or 15 mg/Kg (5 mg/Kg on days -4, -3 and -2). Good prognosis patients are defined as follows: ALL in 1st CR; ALL in 2nd CR belonging to S2 group; AML in 1st CR, AML in 2nd CR and relapsed more than 6 months after stopping therapy; NHL in 2nd CR; Ph+ CML in 1st CP; refractory cytopenia. Poor prognosis patients are defined as follows: ALL in 2nd CR belonging to the S3-S4 group; ALL in ≥ 3rd CR; AML in 2nd CR and relapsed less than 6 months after stop therapy; secondary AML; NHL in 3rd CR; Ph+ CML in 2nd CP, as well as in AP; RAEB, RAEB-t, JMML. ; DRUG USED: Grafalon; DRUG CLASS: Biologic; INDICATION: Bone Marrow and Stem Cell Transplant - Graft vs. Host Disease (GVHD) Prophylaxis; TARGET: T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: IRCCS Policlinico S. Matteo; CRITERIA: Inclusion Criteria: - Unrelated donor selected using high-resolution molecular typing of HLA-A, B, C and DrB1 loci, perfectly matched or with a single allelic disparity at one of the HLA loci or with 2 allelic disparities and with an antigenic disparity at the HLA loci; - Age comprised between 0 and 19 years; - Life-expectancy of at least 2 months; - Use of G-CSF mobilized PB- or BM-derived haematopoietic stem cells Exclusion Criteria: - Unrelated donor selected using high-resolution molecular typing of HLA-A, B, C and DrB1 loci, with more than one antigenic disparity or more than 2 allelic disparities at the HLA loci; - Previous allogeneic HSCT; - Cord blood as source of haematopoietic stem cells; - Previous treatment with rabbit ATG in the last 3 months before HSCT; - History of allergic reactions to rabbit ATG; - Absence of written informed consent. ; PRIMARY OUTCOME: incidence and severity of acute GVHD; SECONDARY OUTCOME 1: • incidence of chronic GVHD •relapse rate •TRM •EFS •incidence of infection[/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 - Partners PrEP; BRIEF: Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples. ; DRUG USED: Truvada; DRUG CLASS: Non-NME; INDICATION: HIV Prevention; TARGET: Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: University of Washington; CRITERIA: Inclusion Criteria for HIV-1 uninfected partner: - Partner within an HIV-1 discordant heterosexual relationship - One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant - Plan to remain in the relationship for the duration of the study period - Adequate renal, hepatic & hematologic function - Negative Hepatitis B surface antigen test - Willing and able to provide written informed consent & locator information Exclusion Criteria for HIV-1 uninfected partner: - Current pregnancy, or planning to become pregnant during the study period - Currently breastfeeding - Concurrent enrollment in another HIV-1 vaccine or prevention trial - Receiving ongoing antiretroviral therapy - Repeated positive urine dipstick tests for glycosuria or proteinuria - Active and serious infections - History of pathological bone fractures not related to trauma Inclusion Criteria for HIV-1 infected partner: - Partner within an HIV-1 discordant heterosexual relationship - One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant - HIV-1 infected based on positive EIA - No history of any clinical AIDS-defining diagnoses - Plan to remain in the relationship for the duration of the study period - Willing and able to provide written informed consent & locator information Exclusion Criteria for HIV-1 infected partner: - Current use of antiretroviral therapy - Concurrent enrollment in another HIV-1 treatment trial ; PRIMARY OUTCOME: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants; SECONDARY OUTCOME 1: Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.[/INST]Yes</s>

<s>[INST]<<SYS>>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/IIa - F508del-CFTR Mutation; BRIEF: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation. ; DRUG USED: N6022; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: S-Nitrosoglutathione reductase (GSNOR); THERAPY: Monotherapy; LEAD SPONSOR: Nivalis Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Homozygous for F508del-CFTR gene - Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis - Body weight ≥ 40 kg - FEV1 ≥ 40% predicted - Oxygen saturation ≥ 90% breathing ambient air - Hematology and clinical chemistry of blood and urine results with no clinically significant abnormalities that would interfere with the study assessments - Negative pregnancy test for women of child bearing potential - Sexually active subjects of child bearing potential willing to follow contraception requirements Exclusion Criteria: - Previous enrollment in another cohort for this study. - Any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment within 4 weeks of Study Day 1. - Any change in chronic therapies for CF lung disease within 4 weeks of Study Day 1. - Blood hemoglobin <10 g/dL at screening. - Serum albumin <2.5 g/dL at screening. - Abnormal liver function defined as ≥ 3 x upper limit of normal (ULN) in three or more of the following: AST, ALT, GGT, ALP, total bilirubin at screening. - History of abnormal renal function (creatinine clearance < 50 mL/min using Cockcroft-Gault equation) within a year at screening. - History, including the screening assessment, of ventricular tachycardia or other ventricular arrhythmias. - History, including the screening assessment, of prolonged QT and/or QTcF interval (> 450 msec). - History of solid organ or hematological transplantation. - Intranasal medication changes within 14 days prior to Study Day 1 - Required Use of continuous (24 hr/d) or nocturnal supplemental oxygen. - Concomitant use of any inhibitors or inducers of CYP3A4. ; PRIMARY OUTCOME: Safety and Tolerability; SECONDARY OUTCOME 1: Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - MAB-N003; BRIEF: The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14. ; DRUG USED: Pagibaximab; DRUG CLASS: Biologic; INDICATION: Staphylococcal Vaccines and Other Staphylococcus-Specific Agents (Antibacterial); TARGET: Bacteria-miscellaneous, Staphylococcus, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Biosynexus Incorporated; CRITERIA: Inclusion Criteria: Patients must meet all of the following criteria at the time of first infusion (Day 0): 1. 48-120 hours of age, inclusive 2. Birth weight of 700-1300 grams 3. Inpatient in a Neonatal Intensive Care Unit 4. Written informed consent obtained from the parent(s) or legal guardian Multiple gestations: 1. Siblings from multiple gestations may be enrolled if they each meet the entry criteria 2. No more than 4 subjects in any birth weight cohort may be siblings Exclusion Criteria: Patients may have none of the following at the first dose: 1. Survival not expected for at least 1 week after infusion 2. Clinically overt systemic infection, as determined by history, physical examination, and positive culture from a normally sterile site. (Infuse only when infant clinically stable and cultures negative for 48 hours. If being evaluated for sepsis, decision to infuse may be deferred as allowed by protocol infusion window. Infusions outside of protocol window must be approved by Sponsor.) 3. Severe congenital anomalies or genetic disorders that are likely to be fatal or that may interfere with drug distribution or metabolism, as determined by history and/or physical examination, and including but not limited to: i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly 4. Known or suspected hepatic or renal insufficiency 5. Clinically uncontrolled seizures 6. Immunodeficiency other than due to prematurity 7. A history of standard immune globulin administration prior to first study drug infusion (excluding Hepatitis B Immune Globulin, HBIG) 8. Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products 9. Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study; including enrollment in another investigational study for a product under an IRB-approved protocol 10. Expectation that the patient will not be able to be followed for the duration of the study 11. Mother with serology positive for hepatitis B surface antigen ; PRIMARY OUTCOME: Safety and pharmacokinetics; SECONDARY OUTCOME 1: Pharmacodynamics, sepsis/bloodstream infection[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - COG-ADVL1014 w/ cyclophosphamide (Pediatric) ; BRIEF: This phase I trial studies the side effects and the best dose of viral therapy in treating young patients with solid tumors that have come back or that have not responded to standard therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off a virus called wild-type reovirus. The virus causes cells with this weakness to die, and may therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a drug used in chemotherapy that stops tumor cells from dividing and causes them to die. Giving wild-type reovirus together with cyclophosphamide may kill more tumor cells. ; DRUG USED: Pelareorep; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Oncolytic Virus Therapy, Ras; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients with relapsed or refractory solid tumors, with the exception of central nervous system (CNS) tumors and lymphomas, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse - Patients must have either measurable or evaluable disease - Patients current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life - Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score - Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and immunizations - Must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea) - At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair - At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair - At least 6 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines - At least 3 half-lives of the antibody after the last dose of a monoclonal antibody - >= 2 weeks for local palliative radiation therapy (XRT) (small port); >= 24 weeks must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation - No evidence of active graft vs host disease and >= 12 weeks must have elapsed since stem cell transplant or infusion - Patients must not have received any previous viral-based anti-neoplastic therapies - Viral immunizations, including influenza, may not have been administered within 7 days prior to enrollment; Note: patients may not receive any viral immunizations after enrolling on study until 28 days post their last planned REOLYSIN infusion - Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 - Platelet count >= 100,000/mm^3 (transfusion independent (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) - Patients with known bone marrow metastatic disease will be eligible for study but not evaluable for hematologic toxicity (maximum of one per cohort); such patients must meet the blood counts above (may receive transfusions provided they are not be known to be refractory to red cell or platelet transfusion); if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR serum creatinine based on age and/or gender as follows: - 0.8 mg/dL (3 to < 6 years of age) - 1.0 mg/dL (6 to < 10 years of age) - 1.2 mg/dL (10 to < 13 years of age) - 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age) - 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age) - Bilirubin (sum of conjugated plus unconjugated) =< 1.5 x upper limit of normal (ULN) for age - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L - Serum albumin >= 2 g/dL - Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by gated radionuclide study - Normal pulmonary function tests (PFTs) (including diffusion capacity of carbon monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen); for patients who do not have respiratory symptoms, full PFTs are NOT required - Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled - Nervous system disorders National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v. 4) resulting from prior therapy must be =< grade 2 - All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines Exclusion Criteria: - Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method - Patients who have an uncontrolled infection are not eligible - Patients with chronic diarrhea, urinary incontinence during the day or at night, or patients who are not completely toilet trained will not be eligible - Patients will be excluded if they have household contacts who are pregnant, immunosuppressed or infants less than 3 months of age; household contacts are defined as anyone living with the patient during the isolation period of the treatment cycles - Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible - Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are excluded due to risk of viral infectivity of REOLYSIN; therefore, patients with a pre-existent infection are not eligible - Patients who are currently receiving other anti-cancer agents are not eligible - Patients who are currently receiving another investigational drug are not eligible - Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post transplant are not eligible for this trial - Patients must not have received corticosteroids, immune modulators or antiviral therapy for 7 days prior to enrollment and must not have an anticipated need for any of these therapies, intravenous immune globulin (IVIG) must not have been administered within 2 weeks prior to enrollment - Patients should avoid taking acetaminophen with REOLYSIN; whenever suitable, physicians should utilize alternative medications - Patients with known germline mutations affecting Ras activation (e.g. NF-1, Cardio-facial-cutaneous syndrome, Noonan syndrome, Costello syndrome) will be excluded from enrollment - Patients with known metastatic CNS disease involvement are excluded - Patients with primary CNS tumors are excluded ; PRIMARY OUTCOME: Maximum-tolerated dose (MTD), defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT), graded using the NCI CTCAE v. 4.0; SECONDARY OUTCOME 1: Time course of viral clearance of wild-type reovirus[/INST]Yes</s>

<s>[INST]<<SYS>>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; BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts ; DRUG USED: Prezalumab; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Cluster of Differentiation 28 (CD28) /ICOS and B7RP-1 Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Diagnosis of SLE with positive ANA - Stable disease with no change in SLE therapy within the previous 30 days - BMI from 18 to 38 kg/m2 Exclusion Criteria: - Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization - Evidence of renal disease or liver disease - Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis - Prior administration of any other biologic that primarily targets the immune system ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: Pharmacokinetic profile of AMG 557 including Tmax, AUClast and 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 II - 100 (Pediatric); BRIEF: The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT). ; DRUG USED: Sensipar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperparathyroidism (Secondary); TARGET: Calcium-Sensing Receptor; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion criteria: - Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment) - Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing - Screening corrected calcium from the central laboratory: - ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years - ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years - Serum phosphorus from the central laboratory: - ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year - ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years - SHPT not due to vitamin D deficiency, per investigator assessment - Dry weight ≥ 7 kg at the time of screening Exclusion criterion: - History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval - Corrected QT interval (QTc) > 500 ms, using Bazetts formula - QTc ≥ 450 to ≤ 500 ms, using Bazetts formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist - Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole) - Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol) ; PRIMARY OUTCOME: Percentage of Participants With Hypocalcemia; SECONDARY OUTCOME 1: Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb/IV - CheckMate 511 - w/Ipilimumab; BRIEF: The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma Exclusion Criteria: - Subjects with active brain metastases or leptomeningeal metastases - Subjects with ocular melanoma - Subjects with active, known or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Onychomycosis; BRIEF: Onychomycosis is a fungal infection that affects fingernails and/or toenails. The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails. ; DRUG USED: MOB-015; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fungal Infections - Non-Systemic; TARGET: Squalene Epoxidase (Fungal); THERAPY: Monotherapy; LEAD SPONSOR: Moberg Pharma AB; CRITERIA: Inclusion Criteria: 1. Male or female 2. 18 - 70 years 3. DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization) 4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes) 5. Signed written informed consent Exclusion Criteria: 1. Proximal subungual onychomycosis 2. DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm) 3. Spike of onychomycosis extending to eponychium of the target nail 4. Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail 5. Other conditions than DSO known to cause abnormal nail appearance 6. Topical antifungal treatment of the nails within 1 month before screening 7. Systemic use of antifungal treatment within 3 months before screening 8. Signs of severe peripheral circulatory insufficiency 9. Immunosuppression 10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening 11. Known allergy to any of the tested treatment products 12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1) 13. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who : - are pregnant or nursing - are not surgically sterile - are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine ; PRIMARY OUTCOME: Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.; SECONDARY OUTCOME 1: Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ESCAPE-2; BRIEF: The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or placebo. ; DRUG USED: Cleviprex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: The Medicines Company; CRITERIA: Pre-randomization Inclusion Criteria: - Provide written informed consent before initiation of any study-related procedures. - Be at least 18 years of age - Be scheduled for cardiac surgery (including Coronary Artery Bypass Grafting [CABG], Off Pump Coronary Artery Bypass [OPCAB], Minimally Invasive Direct Coronary Artery Bypass [MIDCAB] surgery, and/or valve replacement/repair procedures) Pre-randomization Exclusion Criteria: - Women of child-bearing potential (unless they have a negative pregnancy test) - Recent cerebrovascular accident (within 3 months before randomization) - Known intolerance to calcium channel blockers - Allergy to soybean oil or egg lecithin (components of the lipid vehicle) - Pre-existing left bundle branch block or permanent ventricular pacing - Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial. - Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study Post-randomization Inclusion Criteria: - Expected to survive beyond 24 hours post-surgical procedure - No surgical complications or conditions, present or anticipated, that preclude them from inclusion in a double blind, placebo-controlled study - Determined to be hypertensive (SBP > 140 mm Hg) within 4 hours of arrival in a postoperative setting - It is the investigators intent to lower the patients SBP by a minimum of 15% from its baseline value ; PRIMARY OUTCOME: Incidence of bailout during 30-minute treatment period; SECONDARY OUTCOME 1: Median time to target SBP lowering effect (defined as a reduction by 15% or more)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACP-103-020; BRIEF: The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinsons disease psychosis (PDP). ; DRUG USED: Nuplazid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Serotonin 5-HT2A receptor; THERAPY: Combination; LEAD SPONSOR: ACADIA Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - A clinical diagnosis of Parkinsons disease with a minimum duration of 1 year - Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening - Psychotic symptoms must have developed after Parkinsons disease diagnosis was established - Subjects that are on anti-Parkinsons medication must be on a stable dose for 1 month prior to Study Day 1 (Baseline) and during the trial - Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial - The subject is willing and able to provide consent - Caregiver is willing and able to accompany the subject to all visits - Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment Exclusion Criteria: - Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinsons disease including, but not limited to, schizophrenia or bipolar disorder - Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinsons disease - Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder - Subject has had a myocardial infarction in last six months - Subject has any surgery planned during the screening, treatment or follow-up periods Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria). ; PRIMARY OUTCOME: Antipsychotic Efficacy; SECONDARY OUTCOME 1: Motor Symptoms Change From Baseline (Negative = Improvement)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Inadequate Control Candesartan Cilexetil Mono; BRIEF: This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone. Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone. Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks. ; DRUG USED: BAY 98-7106; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: - Inclusion Criteria: - Male and female subjects 18 years or older are eligible. - At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP (mean seated systolic blood pressure) of >/= 160 mmHg and < 200 mmHg, and 24 hours MASBP (mean ambulatory systolic blood pressure) >/= 130 mmHg; those subjects treated with antihypertensive medication are to have MSSBP >/= 150 mmHg and < 200 mmHg as measured by a calibrated electronic BP measuring device - At Visit 3,subject must have MSSBP >/= 140 mmHg before randomization. - Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active. This applies since signing of the IC (informed consent)form until the last study drug administration. - Exclusion Criteria: - Mean seated systolic blood pressure (MSSBP) >/= 200 mmHg and/or mean seated diastolic blood pressure (MSDBP) >/= 120 mm/Hg - Mean seated diastolic blood pressure (MSDBP) < 60 mm/Hg - Differences greater than 20 mmHg for systolic blood pressure (SBP) and 10 mmHg for diastolic blood pressure (DBP) are present on 3 consecutive blood pressure readings at visit 0 - Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc. - Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA]) within the previous 12 months - History of hypertensive retinopathy - known Keith-Wagener Grade III or IV. Any history of heart failure, New York Heart Association (NYHA) classification III or IV - Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0 - Clinically significant cardiac valvular disease - Subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study. - Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by glycosylated hemoglobin HbA1C of greater than 9% on visit 0 ; PRIMARY OUTCOME: Change in mean seated systolic blood pressure (MSSBP).; SECONDARY OUTCOME 1: Change in mean seated diastolic blood pressure (MSDBP).[/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 - CHARMS; BRIEF: Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life and if the immune system is weakened, like after a transplant, they can cause life threatening infections. Patients enrolled on this study will have had an infection with one or more of the following viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), BK virus, JC virus, adenovirus or HHV6 (Human Herpes Virus 6). Investigators want to see if they can use a kind of white blood cell called T cells to treat infections of these viruses after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated multivirus-specific T cells (VSTs) from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen multivirus-specific T cells from healthy donors to treat virus infections after bone marrow transplant and now have improved the production method to make it safer and target more viruses. In this study, investigators want to find out if they can use these banked VSTs to fight infections caused by the viruses mentioned above. ; DRUG USED: Viralym-M; DRUG CLASS: Biologic; INDICATION: Antiviral - Other Treatments; TARGET: Epstein Barr Virus (EBV), Human Cytomegalovirus (HCMV), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: AlloVir; CRITERIA: Inclusion Criteria: For Initial VSTs and subsequent infusions: patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus, EBV, BK virus and/or HHV6 infection/disease persistent or recurrent despite 14 days of standard therapy OR after failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy. Patients with persistent JC virus infection will be eligible as well. 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood. 2. Treatment of the following persistent or relapsed infections despite standard therapy; 1. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir. - CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination. - CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx. - Failure of antiviral therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy. 2. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function. - Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx. - Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or nasopharynx. - Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy. 3. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor. - EBV infection: defined as Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR,Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood. - Failure of therapy is defined as: Increase or less than 50% response at sites of disease for EBV lymphoma OR, Increase or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease after 1st dose of rituximab. 4. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined. Cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy. In small trials leflunomide had activity against BK virus, therefore we will consider this agent an acceptable alternative to cidofovir, given the absence of a clear first line option. - BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine. - BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids and symptoms of disease including, but not limited to persistent microscopic or macroscopic hematuria or detectable BK virus in more than one site. - Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) or worsening hematuria after 7 days of antiviral therapy. 5. HHV6: Treatment of persistent HHV6 infection or disease despite antiviral treatment with ganciclovir, cidofovir and foscarnet. No clear standard treatment is defined. Ganciclovir, cidofovir and foscarnet all have variable in vitro activity against HHV-6, and may have a role in treating HHV-6-associated disease - therefore antiviral treatment with one or more of these agents will we acceptable initial therapy. - HHV6 virus infection is defined as the presence of elevated HHV-6 levels as detected by PCR or positive culture in one site such as CSF or blood. - HHV6 disease is defined as defined as the presence of HHV6 detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of HHV6 encephalitis OR detectable HHV6 by PCR or culture in more than one site. - Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy. 6. JC virus: Treatment of progressive or persistent JC virus infection or disease without suitable alternative treatment option. Pepmixes specific for antigens on adenovirus, EBV, CMV, HHV6 and BK virus are used to generate our multivirus-specific VSTs. No pepmix specific for the rare JC virus is used for generation of these CTLs, however given the high homology (>90%) between JC and BK and the fact that BK virus-specific T cells targeting VP1 and Large T (as targeted in our multivirus VSTs) have been administered to treat JCV-PML, resulting in viral clearance from the cerebrospinal fluid it is likely that our VSTs are efficacious against JC virus. Given the current lack of treatment options for JC virus infection or reactivation after HSCT and the risk of progression to JML, which is almost uniformly fatal, and the apparent activity of BK virus-directed T cells against JC virus infected cells, we propose including patients with progressive or persistent JC virus on this study, unless a suitable alternative therapy is available. - JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood. - JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by PCR or culture in more than one site. 3. Patients with multiple CMV, EBV, Adenovirus, HHV6 and BK virus infections are eligible given that each infection is persistent despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll. 4. Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent). 5. HgB>8.0 6. Pulse oximetry of > 90% on room air 7. Available multivirus-specific VSTs 8. Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen). 9. Written informed consent and/or signed assent line from patient, parent or guardian. Exclusion Criteria: 1. Patients receiving ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment. 2. Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 3. Patients who are less than 28 days removed from their allogeneic hematopoietic stem cell transplant or who have received donor lymphocyte infusions (DLI) within 28 days. 4. Patients with active acute GVHD grades II-IV. 5. Active and uncontrolled relapse of malignancy ; PRIMARY OUTCOME: Number of Patients Where a Suitable VST Line Could be Found; SECONDARY OUTCOME 1: Number of Participants With a Viral Response at 42 Days[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GRADUATE-2; BRIEF: This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose. ; DRUG USED: Gantenerumab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Key Inclusion criteria: - Meets National Institute on Aging/Alzheimers Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment) - Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid PET scan - Demonstrated abnormal memory function - MMSE score greater than or equal to 22 (≥ 22) - Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0 - Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study - If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening and until randomization - For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods Key Exclusion criteria: - Any evidence of a condition other than AD that may affect cognition - History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder - History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function - History or presence of clinically evident cerebrovascular disease - History or presence of posterior reversible encephalopathy syndrome - History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack - History of severe, clinically significant CNS trauma - History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition - Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae - History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits - At risk for suicide in the opinion of the investigator - Alcohol and/or substance abuse or dependants in past 2 years - Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities - Any contraindications to brain MRI - Unstable or clinically significant cardiovascular, kidney or liver disease - Uncontrolled hypertension - Unstable or clinically significant cardiovascular disease - Abnormal thyroid function - Patients with evidence of folic acid deficiency Exclusion for Open-Label Extension (OLE): - Discontinued from study treatment during the double-blind treatment period - Received any other investigational medication during the double-blind treatment period or after the end of double-blind treatment - Participation in the OLE deemed inappropriate by the investigator - Presence of ARIA-E findings at the Week 116 MRI scan ; PRIMARY OUTCOME: Change From Baseline to Week 116 in Global Outcome, as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SOB); SECONDARY OUTCOME 1: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) 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 Ib - CATCH (w/Cabazitaxel, Duke); BRIEF: The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC). ; DRUG USED: TASQ; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Angiogenesis, Migration inhibitory factor-related protein 14 (MRP14)/S100A9; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Andrew J. Armstrong, MD; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features; 2. At least 18 years of age when signing the Informed Consent; 3. Presence of metastatic disease on bone scan or CT/MRI imaging; 4. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration); 5. For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial; 6. Serum testosterone level < 50 ng/dL at the Screening Visit; 7. Progressive disease on or following docetaxel-based chemotherapy with medical or surgical castration. Patients who are intolerant of docetaxel are also allowed. Disease progression for study entry is defined as one or more of the following three criteria: 1) PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL); 2) Soft tissue disease progression defined by RECIST 1.1; 3) Bone metastatic disease progression defined by one or more new lesions on bone scan that are not clinically consistent with tumor flare; 8. No more than three prior chemotherapy regimens with at least one regimen containing docetaxel (unless intolerant as per # 7 above); 9. Karnofsky Performance Status of >70; 10. Estimated life expectancy of at least three months; 11. Able to swallow the study drug and comply with study requirements; 12. Willing and able to give informed consent. Exclusion Criteria: 1. Subjects > 80 years old (dose escalation phase only, due to lower clearance in elderly patients); 2. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment; 3. Metastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed provided follow up imaging documents stability of epidural disease); 4. Absolute neutrophil count < 1,200/μL, platelet count < 100,000/μL, and hemoglobin <9 g/dL at the Screening Visit; (NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening Visit) 5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal at the Screening Visit; 6. Creatinine > 1.5 x ULN at the Screening visit; 7. History of another malignancy within the previous 3 years other than non-melanomatous skin cancer or non-invasive bladder cancer treated with curative intent; 8. Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide, MDV3100), 5-α reductase inhibitors (finasteride, dutasteride), estrogens (ie DES), sipuleucel-T, or chemotherapy within 28 days of Day 1 visit or plans to initiate treatment with any of these treatments during the study; 9. Use of herbal products that may decrease PSA levels or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of Day 1 visit; 10. Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 11. Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 28 days prior to Day 1 Visit. For abiraterone acetate or TAK700, 14 days washout is needed. 12. Ongoing treatment with sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range (Appendix 3). 13. Ongoing treatment with CYP3A4 substrates with narrow therapeutic range (Appendix 3). 14. Radiation therapy within 2 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of Day 1 visit; 15. Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery; 16. Structurally unstable bone lesions suggesting impending fracture; 17. Clinically significant cardiovascular disease including:myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure, Diagnosed or suspected congenital long QT syndrome; significant ventricular arrhythmias, Prolonged corrected QT interval by the Fridericia or Bazett correction formula, History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Hypotension (systolic blood pressure < 86 mMHg or bradycardia with a heart rate < 50 beats per minute on any ECG taken at the Screening or Day 1 visit; Uncontrolled hypertension; TIA or stroke/CVA within 6 months of Day 1 visit; Rest limb claudication or ischemia within 6 months of Day 1 visit 18. Use of an investigational agent within four weeks of Day 1 visit or plans to initiate treatment with an investigational agent during the study; 19. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months); 20. Major surgery within four weeks prior to Day 1 visit. 21. Presence of NCI CTC grade >1 peripheral neuropathy 22. History of pancreatitis 23. Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host). 24. Chronic hepatitis B or C with advanced, decompensated hepatic disease, or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study). 25. Documented prior disease progression on tasquinimod - ; PRIMARY OUTCOME: Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level; SECONDARY OUTCOME 1: Evaluation of progression free survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PROTECT-2 (Maintenance, EU); BRIEF: The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC) ; DRUG USED: LT-02; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: Cell Membrane, Phosphatidylcholine; THERAPY: Combination; LEAD SPONSOR: Dr. Falk Pharma GmbH; CRITERIA: Major Inclusion Criteria: - Signed informed consent - Men or women, 18 to 70 years of age - Historically confirmed diagnosis of UC by endoscopy and histology - Patients being in clinical and endoscopical remission at baseline - Negative pregnancy test in females of childbearing potential at baseline visit Major Exclusion Criteria: - Crohns disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis - Toxic megacolon or fulminant colitis - Colon resection - Malabsorption syndromes - Celiac disease - Bleeding hemorrhoids - Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding - History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack - Any severe concomitant renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patients compliance or the interpretation of the results - Any relevant known systemic disease (e.g., AIDS, active tuberculosis) - Severe co-morbidity substantially reducing life expectancy - History of cancer in the last five years - Abnormal hepatic function at screening visit, liver cirrhosis - Abnormal renal function at screening visit - Patients with known hypersensitivity to soy - Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine) - Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization - Treatment with methotrexate within last 6 weeks prior to randomization - Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization - Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization - Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02 - Existing or intended pregnancy or breast-feeding ; PRIMARY OUTCOME: Percentage of patients who are relapse-free and are not a treatment failure; SECONDARY OUTCOME 1: Mean change from baseline in the total mDAI[/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 - PATENCY-1; BRIEF: This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF. ; DRUG USED: Vonapanitase; DRUG CLASS: Biologic; INDICATION: End-Stage Renal Disease (ESRD); TARGET: Elastin; THERAPY: Monotherapy; LEAD SPONSOR: Proteon Therapeutics; CRITERIA: Inclusion Criteria: 1. Age of at least 18 years. 2. Life expectancy of at least 6 months. 3. Diagnosis of Chronic Kidney Disease (CKD). 4. Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible. 5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team. 6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB). 7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device. Exclusion Criteria: 1. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ. 2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. 3. Previous treatment with PRT 201. 4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent. ; PRIMARY OUTCOME: Time to AVF Primary Unassisted Patency; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I; BRIEF: This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors. ; DRUG USED: ABT-806; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive. - Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent. - Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. - Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. - Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) . Exclusion Criteria: - Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort. - Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806. - Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806. - Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806. - Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher. ; PRIMARY OUTCOME: Safety (Number of subjects with adverse events and/or dose-limiting toxicities); SECONDARY OUTCOME 1: Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - INCB 18424-204; BRIEF: A phase 2 study to find out if the drug ruxolitinib Phosphate Cream is safe and has beneficial effects in people who have alopecia areata (partial or complete hair loss) when applied to the skin. ; DRUG USED: Opzelura; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alopecia Areata; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of AA - Duration and extent of current episode of AA - Evidence of active hair loss Exclusion Criteria: - Evidence of diffuse, spontaneous terminal hair regrowth - Receipt of treatment known to potentially affect the course of AA within last month ; PRIMARY OUTCOME: Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).; SECONDARY OUTCOME 1: Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.[/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 - MSC-NTF-002 (Israel); BRIEF: The study will evaluate the safety, tolerability and therapeutic effects of transplantation of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS). ; DRUG USED: NurOwn; DRUG CLASS: Biologic; INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Brainstorm-Cell Therapeutics; CRITERIA: Inclusion Criteria: 1. Patient must fulfill El Escorial criteria (APPENDIX 2) for definite or probable ALS (sporadic and not familial) 2. Participants, either men or non pregnant women are between 20 and 75 years of age. 3. The patient is mentally intact and psychologically stable 4. Patients will be with an ALS-FRS-R scale (APPENDIX 3) of at least 30 and disease duration of less than 2 years. 5. Patient has sufficiently bulky muscles. 6. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure. Exclusion Criteria: 1. Patient has a positive test for HBV, HCV or HIV. 2. Patient has high protein in the CSF (Protein > 70 mg/ml). 3. Patient has lymphocytosis in the CSF (lymphocytes > 5/ml). 4. Patient is positive for anti-GM1 antibodies. 5. Patient has significant conduction blocks or slow nerve conduction velocities (a reduction of more than 30%) confirmed by nerve conduction velocity - EMG studies. 6. The patient is a respiratory dependent patient. 7. Patients with renal failure (Cr > 2 mg/dl). 8. Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit). 9. Patients suffering from significant cardiac disease, malignant disease or any other disease that may risk the patient or interfere with the ability to interpret the results 10. Patient with active infections. 11. Participation in another clinical trial within 1 month prior to start of this study. 12. Patient has not been treated previously with any cellular therapy. 13. Subject unwilling or unable to comply with the requirements of the protocol. ; PRIMARY OUTCOME: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF); SECONDARY OUTCOME 1: Changes in the progression rate of the disease as evidenced by changes in the ALS functional rating scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 001 (NIAID); BRIEF: This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate the safety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lung function in patients that were hospitalized for severe COVID-19-related illness and continue to experience post-acute respiratory complications associated with Long-COVID after discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo. ; DRUG USED: BIO 300; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Humanetics Corporation; CRITERIA: Inclusion Criteria: 1. Age ≥ 18 2. Patients hospitalized for COVID-19-related complications ready to be discharged and those within 365 days of discharge (even if the patient was referred to subacute or acute respiratory rehabilitation after discharge) 3. Radiographic signs of lung injury after standard treatment of COVID-19 such as, ground glass opacity, consolidation, or fibrotic shadows at screening 4. Able to perform a PFT and have a DLCO <70% of predicted at screening 5. Able to perform a 6-minute walk test 6. Blood routine, liver and kidney function test values are within the controllable range 1. Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and bilirubin < 1.5X ULN for the reference lab 2. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation 3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x10^9 / L and platelets ≥ 100x10^9 / L 7. Female patients of childbearing potential must have a negative pregnancy test at screening 8. Female patients of childbearing potential and male participants with female sexual partners of childbearing potential must agree to use an effective method of non-estrogen-based contraception (e.g., condom and a diaphragm, condom and intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and progesterone mini-pill) during the 12-week portion of the study that they are receiving study medication and for 30 days following the last dose of study medication, or to abstain from sexual intercourse during these time periods. Women who have been off estrogen contraceptives for a minimum of 5 days prior to the first scheduled day of study intervention dosing are eligible. A woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as no menstrual periods for 12 consecutive months 9. Ability of the patient or the patients legal representative to read and provide written informed consent Exclusion Criteria: 1. Severe background disease like severe cardiac or pulmonary insufficiency (WHO grade III or IV), severe liver and kidney diseases, severe COPD, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated 2. Severe asthma on chronic therapy with biologics or steroids. 3. Prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages I or II) breast cancer 4. D-dimer levels of >2,000 ng/mL at screening 5. Use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing 6. Use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing 7. Use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing 8. An active infection or infection with a fever ≥ 38.5°C within 3 days of the first scheduled day of study intervention dosing 9. Poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of Screening; history of congestive heart failure (NYHA Class III or IV); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. QTc with Fridericias correction that is unmeasurable, or ≥480 msec on screening ECG. The average QTc from the screening ECG (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. Patients taking any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes (www.crediblemeds.org) are not eligible if QTc ≥460 msec 12. Patients who have undergone thoracotomy within 4 weeks of Day 1 of protocol therapy 13. Patients that have a known allergy to any of the placebo components 14. Psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. Pregnancy or currently on estrogen-based contraceptives 16. Women who are breastfeeding 17. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participants ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. ; PRIMARY OUTCOME: Change in DLCO; SECONDARY OUTCOME 1: Change in 6 Minute Walk Test[/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 - MP-8 (Veterans); BRIEF: This study is designed to provide information on whether therapy (talk therapy) combined with the drug MDMA is safe and helpful for subjects with posttraumatic stress disorder (PTSD). The study will compare the effects of a low, a medium and a full dose of MDMA on symptoms of PTSD in 24 veterans, firefighters or police officers. MDMA dose will be assigned at random, and the investigators and the subject will not know the dose given. The researchers will also investigate depression symptoms. The researchers believe that the full dose of MDMA will produce a greater reduction in PTSD symptoms than the two lower doses. ; DRUG USED: Midomafetamine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Post-Traumatic Stress Disorder (PTSD); TARGET: Trace Amine Associated Receptor 1 (TAAR1); THERAPY: Monotherapy; LEAD SPONSOR: MAPS Public Benefit Corporation; CRITERIA: Inclusion Criteria: - Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service; - Have a CAPS score showing moderate to severe PTSD symptoms; - Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy. - Are at least 18 years old; - Must be generally healthy; - Must sign a medical release for the investigators to communicate directly with their therapist and doctors; - Are willing to refrain from taking any psychiatric medications during the study period; - Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session; - Willing to remain overnight at the study site; - Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session; - Are willing to be contacted via telephone for all necessary telephone contacts; - Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control; - Must provide a contact in the event of a participant becoming suicidal; - Are proficient in speaking and reading English; - Agree to have all clinic visit sessions recorded to audio and video - Agree not to participate in any other interventional clinical trials during the duration of this study. Exclusion Criteria: 5.3.2 Exclusion Criteria: - Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control; - Weigh less than 48 kg; - Are abusing illegal drugs; - Are unable to give adequate informed consent; - Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary. - Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the s ; PRIMARY OUTCOME: Baseline Clinician-Administered PTSD Scale (CAPS-IV) Total Score; SECONDARY OUTCOME 1: Change in Global Assessment of Function (GAF) From Baseline to Primary Endpoint[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - A4091017 - Add on to Diclofenac SR; BRIEF: The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy. ; DRUG USED: Tanezumab; DRUG CLASS: Biologic; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Nerve growth factor (NGF)/receptor; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence X-ray grade equal to, or greater than, 2. - Patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen. - Pain and function levels as required by the protocol at Screening and Baseline. - Willing to discontinue all non-study pain medications throughout the study except as permitted per protocol. - Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: - Pregnant women. - BMI greater than 39. - History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Pagets disease or tumors. - Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA. - Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening. - Diagnosis or TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities. - History, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder. - At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 150 micro-mol/L in men or 133 micro-mol/L in women. - Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening. - Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen). ; PRIMARY OUTCOME: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16; SECONDARY OUTCOME 1: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MK-0431-403; BRIEF: This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment. ; DRUG USED: Januvia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion criteria - Type 2 diabetes mellitus. - On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%. - Capable of using a liraglutide pen device. Exclusion criteria - History of Type 1 Diabetes mellitus. - Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening. - Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder. - Impaired liver function. - Impaired kidney function. - History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study. - History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment. - Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study. - Participation in another study with an investigational drug or device within 12 weeks prior to screening. - History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site. - Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks. - Surgery within the prior 4 weeks or major surgery planned during the study. - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). - User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption. ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (A1C); SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - IX-0102; BRIEF: The purpose of this study is to compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men. ; DRUG USED: IX-01; DRUG CLASS: New Molecular Entity (NME); INDICATION: Premature Ejaculation; TARGET: Oxytocin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ixchelsis Limited; CRITERIA: Inclusion Criteria: - A body mass index (Quetelet index) in the range 18-30 kilograms/meters squared (kg/m2) - Body Mass Index = weight [kg] divided by (height [m])2 - Total body weight greater than (>)50 kg at screening - Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial - Participants and their partners must be willing to use adequate forms of contraception and to comply with the contraception requirements during the trial and for 4 months after the last dose of medication - Willingness to give written consent to have data entered into The Over Volunteering Prevention System Exclusion Criteria: - Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment, including: - Lipid and/or liver function test results >1.25 x Upper Limit of Normal (ULN) or other clinical laboratory blood biochemistry test results outside the normal reference range unless discussed and approved by sponsor - International normalised ratio (INR) of >1.2 or a platelet count < 150 x 109/Liter - History of unexplained syncope - Family history of unexplained sudden death, or sudden death due to long QT syndrome - Fridericia Correction Formula (QTcF) interval >450 milliseconds (msec) at screening - Bundle branch block and other conduction abnormalities, other than mild first degree atrio-ventricular block - Irregular rhythms other than sinus arrhythmia or occasional supraventricular ectopic beats - T-wave configuration of insufficient quality for determination of QT interval, as assessed by the investigator - Presence of acute or chronic illness or history of chronic illness sufficient to invalidate participation in the trial - Impaired gastrointestinal, endocrine, thyroid, hepatic, cardiovascular, respiratory, haematological, renal or neurological function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness - Surgery (for example (e.g.) stomach bypass) or medical condition that might affect absorption, metabolism or elimination of medicines - Any skin condition, abnormality of the lumbar spine, medical or surgical condition that would preclude lumbar puncture (e.g. coagulopathy, local or systemic infection, left ventricular outflow obstruction, aortic stenosis, previous back surgery) - Presence or history of severe adverse reaction to any drug - Use of any prescription or over-the-counter medicine during the 14 days before the first dose of trial medication, or intention to use any medicine during the trial, with the exception of short courses of medication considered by the investigator not to interfere with the safety of the participant or the integrity of the trial data (such as acetaminophen (paracetamol)) - Current use of any herbal remedy or nutritional supplement, or intention to use any such product during the study - Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months. - Previous participation in this trial or any other clinical trial of an oxytocin receptor antagonist - Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 5 cigarettes daily - Blood pressure and heart rate in supine position at the screening examination outside the ranges 100-130 millimeters of mercury (mm Hg) systolic, 60-90 mm Hg diastolic; heart rate 50-100 beats/minute. Measurements must be made in duplicate, and all values must fall within the acceptable ranges - Possibility that the participant will not cooperate with the requirements of the protocol - Evidence of drug abuse on urine testing - Positive test for hepatitis B, hepatitis C, Human Immunodeficiency Virus 1 (HIV1) or Human Immunodeficiency Virus 2 (HIV2) - Loss of more than 400 mL blood during the 3 months before the trial, e.g. as a blood donor - Objection by General Practitioner (GP), on medical grounds, to participant entering trial - Employee of the investigator site or any company involved in sponsoring, organizing or conducting the trial, or immediate family of the employee ; PRIMARY OUTCOME: Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity; SECONDARY OUTCOME 1: Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious 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 - 2000; BRIEF: The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate. ; DRUG USED: Ozoralizumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Ablynx, a Sanofi company; CRITERIA: Inclusion Criteria: - Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly). Exclusion Criteria: - Any significant health problem other than rheumatoid arthritis - Any clinically significant laboratory abnormalities - Any prior use of B cell-depleting therapy ; PRIMARY OUTCOME: American College of Rheumatology (ACR) 20 response at week 16; SECONDARY OUTCOME 1: Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Safety/PK (China); BRIEF: AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010 in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation. ; DRUG USED: Abivertinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), T790M EGFR, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: Hangzhou ACEA Pharmaceutical Research Co., Ltd.; CRITERIA: Inclusion Criteria - phase 1: 1. Patients of either gender, aged from 18 years older to 75. 2. Histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC. 3. At least one measurable disease by CT or MRI, according to RECIST Version 1.1. 4. Failed to the treatment of EGFRTKI with definite state of T790M, or harbored T790M mutation without the treatment of EGFRTKI. 5. Offer biopsy sample to central lab if failed or without the treatment of EGFRTKI. 6. Adequate hematological and physiological functions of heart, lung, liver, and kidney according to definitions given in Appendix D. 7. Any prior treatment (including chemotherapy, radiotherapy, biotherapy and other clinical medicine) must be completed over 28 days or 5 half-lives from the screening. 8. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1. 9. NSCLC patients with asymptomatic brain metastasis or drug-controllable brain metastasis. 10. Life expectancy of at least 3 months. 11. Patients should cooperate with investigator to observe adverse events and efficacy. 12. Without other anticancer therapy. 13. Women without pregnancy or breastfeeding. 14. Adequate function of blood coagulation (INR≤1.5) 15. Signed consent on an Independent Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation. Exclusion Criteria - Phase 1: 1. No pathology confirmation. 2. HCV positive, active hepatitis B. 3. History of interstitial lung disease related to prior EGFR inhibitor therapy. 4. Positive to HIV antibody or other immunodeficiency disease or organ transplantation. 5. Residue toxicity related to prior therapies > grade 1. 6. BUN or Cr > 1.5 × upper limits of normal. 7. ALT or AST > 2.5 × upper limits of normal, total bilirubin> 1.5 × upper limits of normal. 8. Fever (temperature>38℃ or any uncontrolled active infections. 9. Patients received high-dose glucocorticoid or any other immunosuppression within 1 month. 10. Any severe or uncontrolled disease, such as mental, neurologic, cardiovascular, respiratory diseases. 11. Patients with symptomatic and untreated brain metastasis. 12. Patients with organic heart disease, cardiac insufficiency, >2 degree heart block, experienced myocardial infarction in 6 months. Abnormal PR, QT, QRS interval (defined as: 12 lead electrocardiogram QT interval correlated to Bazetts (QTcB)>450ms (male) or >470ms (female), PR>240ms, QRS>110ms). 13. Patients receiving medication known to prolong QT interval. 14. Past history of major surgery in 14 days prior to enrollment. 15. Pregnant or lactating women. 16. Any other reasons for the investigator to consider the patient should not participate in the study. Inclusion Criteria - Phase 2: 1. Patients of either gender, aged from 18 years older to 75. 2. Histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC. 3. At least one measurable disease by CT or MRI, according to RECIST Version 1.1. 4. Failed to the treatment of EGFR-TKI and harbored T790M mutation. 5. Offer biopsy sample to central lab if failed or without the treatment of EGFRTKI. 6. Patients failed the treatment of EGFR-TKI should be treated with only one kind of medicine. Patients with arbored T790M mutation should be treated with only one kind of medicine or never be treated. 7. Comply with the results of laboratory testing. 8. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1 and no deterioration in 2 weeks. 9. Life expectancy of more than 12 weeks. 10. Patients should cooperate with investigator to observe adverse events and efficacy. 11. Women without pregnancy. 12. Signed consent on an Independent Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation. Exclusion Criteria - Phase 2: 1. Acute and chronic hepatitis C, active hepatitis B (including positive HBsAg and/or HBeAg; HBcAb and/or positive HBeAb and positive HBV DNA), hepatitis E Virus IgM antibody positive. 2. History of interstitial lung disease related to prior EGFR inhibitor therapy. 3. Positive to HIV antibody or other immunodeficiency disease or organ transplantation. 4. Fever (temperature>38℃ or any uncontrolled active infections. 5. Patients received high-dose glucocorticoid or any other immunosuppression within 1 month. 6. Any severe or uncontrolled disease, such as mental, neurologic, cardiovascular, respiratory diseases. 7. ECG showed abnormal rhythm, conduction and form, such as complete left bundle branch block, >2 degree heart block, PR interval >250ms, experienced myocardial infarction in 6 months. Risks leading to prolonged QT interval or arrhythmia, such as heart failure, hypokalemia, congenital long QT, long QT family history or sudden death under 40 years old in first degree relatives (12 lead electrocardiogram QT interval correlated to Bazetts (QTcB) > 450ms. 8. Prior history of malignancies other than NSCLC (except cured malignancy such as removed basal-cell carcinoma and carcinoma in situ) within 5 years. 9. Patients with CNS metastasis (except asymptomatic CNS metastasis with stable radiography in 4 weeks and no long-term use of corticosteroid. CNS metastasis focuses ≤2, maximum diameter of focus <10mm) 10. Radiation field covered more than 30% bone marrow within 4 weeks of enrollment. 11. Lab test of 1ml plasma prove treatment of AZD9291. 12. Patients already received treatment of this research or quite the treatment of this research. Patients treated with 3rd generation of EGFR-TKI (AZD9291, AC0010, BPI-15086, CO-1686, HM61713). 13. Past history of major surgery in 14 days prior to enrollment. 14. Pregnant or lactating women. 15. Patients with uncontrolled pleural effusion and/or pericardial effusion. 16. Any other reasons for the investigator to consider the patient should not participate in the study ; PRIMARY OUTCOME: ORR(Objective Response Rate); SECONDARY OUTCOME 1: DoR (Duration of 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 I - SAD/MAD (Israel); BRIEF: The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the proposal trial described below. ; DRUG USED: BL-1021; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuropathic Pain; TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: BioLineRx, Ltd.; CRITERIA: The inclusion criteria for both parts 1 and 2 of the study are: - Ability to provide written informed consent - Healthy male between 18 and 45 years of age, inclusive - BMI of 18-30, inclusive - Negative urinary drugs of abuse screen within 21 days of start of study - No significant abnormal blood hematology and biochemistry tests according to the opinion of the principal investigator - Only subjects with a known (pre-study) CYP2D6 genotype will be enrolled. - No concomitant medications (prescription, OTC, vitamins, dietary supplements) within 7 days prior to administration of study medication - Non-smoking (by declaration) for a period of at least 6 months prior to enrolment - Ability to adhere to the visit schedule and protocol requirements and be available to complete the study - No significant abnormalities in physical examination Exclusion criteria for both parts 1 and 2 of the study are: - Evidence or history of significant concomitant disease (including mental, CNS-related, renal, hepatic, cardiovascular, pulmonary disease, or other) - Prior or current history of cancer, except for cured basal cell carcinoma of the skin - History of significant abnormalities in ECG, including QT prolongation - History of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm (especially melanoma), or any other clinically significant medical disorder, which in the Investigators judgment contraindicate administration of the study medications - Use of another investigational medication/treatment in the past 30 days - History of drug or alcohol abuse - Significant abnormalities in screening physical examination - Significant abnormalities in clinical laboratory parameters (hematology, biochemistry, serology, urinalysis) - History of gastrointestinal disorder likely to influence drug absorption - Consumption of Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic/tetracyclic antidepressants within 90 days prior to Day 0 - Consumption of drugs that may potentially inhibit or induce liver cytochrome P450 activity within 3 weeks prior to Day 0 - Subjects who are either extensive-extensive metabolizers (i.e. carriers of multiple CYP2D6 gene copies) or poor metabolizers of CYP 2D6 will be excluded. - Any acute medical situation (e.g. acute infection) within 48 hours of Day 0, which is considered of significance by the Principal Investigator - Unusual diet - Sero-positive HIV, HBSAg or HCV - Donation of 450ml or more blood within the previous 12 weeks - Probability of undertaking intense physical activity throughout the study duration (Single Dose: Day 0 - Day 8, Multiple Dose: Day 0 - Day 14) - Any condition, which in the opinion of the Principal Investigator would place the subject at risk or influence the conduct of the study or interpretation of results - Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function) - Subjects who, in the judgment of the investigators, are likely to be non-compliant or uncooperative or unwilling to sign a consent form ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: Mean change from baseline in vital signs[/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/Ipilimumab; BRIEF: Ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4, and GVAX have demonstrated anti-tumor activity in prostate cancer. Pre-clinical studies with this combination have demonstrated potent synergy. The purpose of this study is to investigate, using a phase-I 3+3 dose escalation design followed by an expansion cohort, the safety and efficacy of combined treatment with GVAX and ipilimumab in castration-resistant metastatic prostate cancer (CRPC) patients. ; DRUG USED: GVAX Prostate Cancer Vaccine; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Stem Cells/Other Cell Therapies; THERAPY: Combination; LEAD SPONSOR: Amsterdam UMC, location VUmc; CRITERIA: Inclusion Criteria: - Males age 18-80 years - Histologic diagnosis of adenocarcinoma of the prostate - Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy - Detectable metastases by bone scan, CT scan or MRI - Two consecutive rising PSA values obtained at least two weeks apart and both obtained at least 4-6 weeks after discontinuation of hormone therapy. Second PSA value must be > 5.0 ng/mL. LHRH agonist should not be discontinued. - Testosterone < 50 ng/dL. Must have had orchiectomy or is currently receiving an LHRH agonist. - WBC > 3.0 x 109/L, ANC > 1.5 x 109/L, hemoglobin > 6.2 mmol/L, and platelets > 100 x 109/L - Serum creatinine < 177 umol/L Bilirubin < 1.5 times the upper limit of normal AST < 3 times the upper limit of normal - ECOG performance status 0-2 - Life expectancy of at least 6 months - If sexually active, willing to use barrier contraception during the treatment phase of the protocol - The ability to understand and willingness to sign a written informed consent Exclusion Criteria: - Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer - Bone pain severe enough to require routine narcotic analgesia use - Clinical evidence of brain metastases or history of brain metastases - Seropositive for HIV, Hepatitis B antigen positive and/or Hepatitis C viremic - Prior chemotherapy or immunotherapy for prostate cancer - Radiation therapy within 4 weeks of the first treatment - Surgery within 4 weeks of the first treatment. Must have recovered from all side effects. - Flutamide within 4 weeks of the first treatment Megesterol acetate (Megace), finasteride (Proscar), bicalutamide (Casodex),nilutamide, aminoglutethimide, ketoconazole or diethylstilbestrol within 6 weeks of the first treatment. - Systemic corticosteroid use within 4 weeks of the first treatment - History of autoimmune disease - History of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission or any other cancer that has been in complete remission for at least 5 years ; PRIMARY OUTCOME: Number of patients with adverse events; SECONDARY OUTCOME 1: number of patients that have a tumor/PSA 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 - BALTIC (Platinum Refractory); BRIEF: Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy. ; DRUG USED: AZD1775; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Tyrosine Kinases, Wee1 Inhibitor ; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria (applicable to all arms) - Adults with histologically or cytologically documented ED SCLC who have demonstrated progressive disease either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum based-chemotherapy (platinum resistant) and have not received further treatment. - Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. - At least 1 lesion, not previously irradiated, that can be accurately measured at baseline (per RECIST v 1.1 guidelines) - Life expectancy of at least 8 weeks. - WHO/ ECOG PS of 0-1 at enrollment. Inclusion criteria (Arm A specific) - Body weight >30 kg. - No prior exposure to immune mediated therapy, excluding therapeutic anticancer vaccines. Inclusion criteria (Arm B specific) • Able and willing to swallow oral medication. Inclusion criteria (Arm C specific) • Able and willing to swallow oral medication. Exclusion criteria (applicable to all arms): - Participation in another clinical study, major surgery, radiation therapy within 28 days. - Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results. - Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. - History of another primary malignancy, leptomeningeal carcinomatosis or spinal cord compression. Exclusion criteria (Arm A specific) - Active autoimmune disease, including a paraneoplastic syndrome. - Active or prior documented autoimmune or inflammatory disorders. - Any unresolved toxicity (CTCAE Grade >2) from previous anticancer therapy. - Active infection including tuberculosis, HIV, Hepatitis B or C. Exclusion criteria (Arm B specific) - Prior exposure to any WEE1 inhibitors. - Products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4. Co-administration of rosuvastatin, atorvastatin, simvastatin and lovastatin, aprepitant or fosaprepitant or any herbal preparations. Grapefruit and Seville oranges should be avoided while taking AZD1775. - Any known hypersensitivity or contraindication to IP or CBDP. - QTcF > 470 msec or congenital long QT syndrome. - Any current or within 6 months cardiac diseases NYHA ≥ Class 2: unstable angina pectoris, congestive heart failure, acute MI, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias. - A recent history of Torsades de pointes. Exclusion criteria (Arm C specific) - Cytotoxic chemotherapy within 21 days of Cycle 1 Day 1 is not permitted - Previous treatment with a PARP inhibitor (including olaparib) or ATR inhibitor - Concomitant use of known strong CYP3A inhibitors and moderate CYP3A inhibitors - Concomitant use of known strong and moderate CYP3A inducers - Persisting (> 4 weeks) severe pancytopenia due to previous therapy - Cardiac dysfunction - Refractory nausea and vomitting, chronic gastrointenstinal diseases or previous significant bowel resection - Patients with uncontrolled seizures - Intenstinal obstruction or CTCAE grade 3 or grade 4 GI bleeding within 4 weeks before dosing ; PRIMARY OUTCOME: Number of Participants With Overall Response; SECONDARY OUTCOME 1: Duration of Response (DoR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CLR_09_12; BRIEF: A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM. ; DRUG USED: Xelpros; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharma Advanced Research Company Limited; CRITERIA: Inclusion Criteria: - Men and women aged ≥ 18 years. - Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG). - Unmedicated IOP ≥ 22 mmHg in one or both eyes. - Given informed consent. - Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test. Exclusion Criteria: - Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator). - Intraocular conventional surgery or laser surgery within the past six months. - Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months. - Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy. - Ocular trauma within the past 3 months. - Progressive retinal or optic nerve disease apart from glaucoma. - Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye. - Any abnormality preventing stable applanation tonometry. - Use of contact lens for the duration of the study. - Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber. - Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe. - Clinically significant systemic disease which might interfere with the study. - History of non-compliance to medical regimens or unwilling to comply with the study protocol. - Participation in another clinical study within the last thirty (30) days. ; PRIMARY OUTCOME: Change in Intraocular Pressure From Baseline to Week 12; 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 - 16-hour test; BRIEF: The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model. ; DRUG USED: Pazeo; DRUG CLASS: Non-NME; INDICATION: Allergic Conjunctivitis (Ophthalmology); TARGET: Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions. - Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1. - History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1. - Positive bilateral CAC response at Visit 1 and Visit 2. - Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Known history or presence of persistent dry eye syndrome, or currently requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes. - Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes. - Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1. - Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study. - Any contraindications or hypersensitivities to the use of the study medication or their components. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Mean Ocular Itching at Onset of Action; SECONDARY OUTCOME 1: Mean Conjunctival Redness at Onset of Action[/INST]Yes</s>

<s>[INST]<<SYS>>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/EGF816 (CTNO155X2101); BRIEF: The purpose of this first in human (FIH) trial is to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications. ; DRUG USED: TNO155; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PTPN11/SHP-2; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements. 2. Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria. 3. Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or is appropriate. 4. ECOG (Eastern cooperative oncology group) performance status ≤2 Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib): 5. Patients must be screened for Hepatitis B virus and Hepatitis C virus Exclusion Criteria: 1. Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLCs) 2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. 3. Any medical condition that would, in the investigators judgment, prevent the patients participation in the clinical study due to safety concerns or compliance with clinical study procedures. 4. Clinically significant cardiac disease. 5. Active diarrhea or inflammatory bowel disease 6. Insufficient bone marrow function 7. Insufficient hepatic and renal function. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib): 8. Patients with a known history of human immunodeficiency virus (HIV) seropositivity. 9. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry. 10. Patients who have undergone a bone marrow or solid organ transplant 11. Patients with a history or presence of interstitial lung disease or interstitial pneumonitis 12. Bullous and exfoliative skin disorders at screening of any grade 13. Presence of clinically significant ophthalmological abnormalities that might increase the risk of corneal epithelial injury ; PRIMARY OUTCOME: Number of participants with adverse events; 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 - High Risk MDS (MD Anderson); BRIEF: This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ; DRUG USED: Vyxeos; DRUG CLASS: Non-NME; INDICATION: Myelodysplastic Syndrome (MDS); TARGET: DNA polymerase, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: - Diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO) - Patients are either not eligible for or choose not to proceed with a stem cell transplant at the time of enrollment - MDS and CMML classified by International Prognostic Scoring System (IPSS) as intermediate-2/high risk with excess blasts > 5%, or with 10-19% bone marrow blasts - No response following at least 4 cycles of therapy or relapse after initial CR, partial response (PR), or HI or progression after any number of cycles of either azacitidine, decitabine, guadecitabine or ASTX727 (oral decitabine) as single agents or in combination with other investigational agents - Patient (or patients legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study - Total bilirubin < 3 mg/dL (will allow less than 5 x upper limit of normal [ULN] if Gilberts at investigators discretion) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x ULN - Serum creatinine clearance > 30 mL/min and no end/stage renal disease - Hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient Exclusion Criteria: - New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50 by echocardiogram or multigated acquisition (MUGA) scan - History of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias - Uncontrolled infection not adequately responding to appropriate antibiotics - Female patients who are pregnant or lactating - Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study - Female patients with reproductive potential who have a positive urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening - Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment) - Prior cumulative anthracycline exposure of > 550 mg/m^2 daunorubicin or equivalent, or > 400 mg/m^2 in patients who received radiation therapy to the mediastinum ; PRIMARY OUTCOME: Incidence of adverse events (dose-escalation stage); 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 - Escalating Multiple Doses (Healthy/Elderly/Osteoarthritis); BRIEF: The purpose of the study is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days. ; DRUG USED: PF-05089771; DRUG CLASS: New Molecular Entity (NME); INDICATION: Postsurgical Pain; TARGET: Sodium Channel Nav1.7 (SCN9A); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive. - elderly cohort : healthy male and/or female subjects of 65 and 74 years, - cohort 3: subjects with osteoarthritis of the knee: Male or female subjects not of child bearing potential between the ages of 18 and 75 years inclusive at the time of entering the study. Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). - Any condition possibly affecting drug absorption (eg, gastrectomy). - A positive urine drug screen. - History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. - Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. - 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subjects eligibility. - Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. - As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor. - Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing. - History of sensitivity to heparin or heparin-induced thrombocytopenia. - Unwilling or unable to comply with the Lifestyle guidelines described in this protocol. - Other severe 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 and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. for cohort 3: Evidence of relapse or recurrence of clinically significant endocrine, metabolic, pulmonary, hepatic, osteo-mio-artricular, gastrointestinal, cardiovascular, renal, , psychiatric or neurological disease, or neurological disease less than 28 days prior to screening. Symptomatic OA of the hip ipsilateral to index knee which the patient considers more painful than the knee. History of diseases other than OA that may involve the index knee in the last 12 months prior to screening, including but not limited to: inflammatory joint diseases (i.e rehumatoid arthritis and gout), calcium crystal diseases, bursitis, tendinitis, tumors and cysts, ligament injuries, bone fractures, post-infective pathologies; widespread chronic pain conditions (ie, fibromyalgia) and neuropathic disorders. ; PRIMARY OUTCOME: Number of participants with adverse events as a measure of safety and tolerability of PF-05089771; SECONDARY OUTCOME 1: AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ADACCESS; BRIEF: The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis. ; DRUG USED: Hyrimoz; DRUG CLASS: Biosimilar; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Sandoz; CRITERIA: Inclusion Criteria: - Men or women at least 18 years of age at time of screening - Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization - Moderate to severe psoriasis as defined at baseline by: - PASI score of 12 or greater - Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and, - Body Surface Area affected by plaque-type psoriasis of 10% or greater - Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator. Exclusion Criteria: - Forms of psoriasis other than chronic plaque-type - Drug-induced psoriasis - Ongoing use of prohibited psoriasis treatments - Previous exposure to adalimumab - Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab Other In-/Exclusion criteria may apply ; PRIMARY OUTCOME: PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab; SECONDARY OUTCOME 1: Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Bupropion/Warfarin; BRIEF: This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin. ; DRUG USED: Odomzo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Hedgehog Signaling Pathway; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Adults - Patients with cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists or patients with locally advanced or metastatic basal cell carcinoma who are not amendable or eligible for standard therapy. - Protocol-defined renal , liver and bone marrow function Exclusion Criteria: - CNS (Central Nervous System) tumors as well as history of brain metastases - Systemic anticancer treatment (including biologic therapy/antibodies) within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies). - Radiation therapy within 4 weeks before first dose - Investigational agents within 4 weeks before start of study therapy - Patients with known allergy/hypersensitivity to warfarin or bupropion and/or related compounds - Patients with a history of/or active bleeding disorders - Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed. - Patients receiving treatment with bupropion. - Patients who have neuromuscular disorders that are associated with elevated CK (Creatine phosphokinase) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). - Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C (testing is not mandatory for study entry) - Patients currently receiving systemic corticosteroids Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Pharmacokinetics (PK) parameter AUClast for S- and R-warfarin; SECONDARY OUTCOME 1: effects of LDE225 on the pharmacodynamic activity of warfarin[/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 - CL-0021 (IBS-c) (Japan); BRIEF: This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome. ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month during the 3 months before screening examination associated with at least 2 out of the following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a change in frequency of stool; and (3) Onset associated with a change in form (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before the screening examination period. - Patients with ≥25% of stools hard or lumpy (with each bowel movement occurring without antidiarrheal, laxative, suppository or enema) and <25% of them loose (mushy) or watery during the 3 months before the screening examination. - Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of IBS symptom and had no organic changes. Exclusion Criteria: - Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine - Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function - Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort - Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the Severity Criteria for Drug Adverse Reaction and judged to be clinically significant ; PRIMARY OUTCOME: Global assessment of relief of IBS symptoms Responder; SECONDARY OUTCOME 1: SBM (Spontaneous Bowel Movement) Responder[/INST]Yes</s>

<s>[INST]<<SYS>>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 - 1001 (Australia); BRIEF: This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine. ; DRUG USED: CTP-692; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Concert Pharmaceuticals; CRITERIA: Inclusion Criteria: - Must give written and informed consent and any authorizations required by local law. - Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive Exclusion Criteria: - Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug - Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody - History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions - Positive drug or alcohol test at screening or prior to the first dose of study drug ; PRIMARY OUTCOME: The number of AEs in participants as a measure of safety and tolerability.; 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 - TREND; BRIEF: This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Male or female patients, ≥50 years of age with signed informed consent before study procedures - Visual impairment predominantly due to nAMD. - Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography - Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT - BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320) Key Exclusion Criteria: - Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. - Stroke or myocardial infarction within 3 months prior to Screening. - Any active periocular or ocular infection or inflammation in both eyes. - Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity. - Presence of amblyopia or amaurosis in the fellow eye. - History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye. - History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening. - Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. ; PRIMARY OUTCOME: Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12; SECONDARY OUTCOME 1: Number of Visits Scheduled[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Colorectal Surgery; BRIEF: The purpose of this Phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, placebo-controlled study. ; DRUG USED: VVZ-149; DRUG CLASS: New Molecular Entity (NME); INDICATION: Postsurgical Pain; TARGET: Glycine Neurotransmitter Transporter (GlyT-2), Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vivozon, Inc.; CRITERIA: Inclusion Criteria: 1. Men and women age between 18-70, inclusive. 2. Pain intensity (NRS) ≥4 at initial post-operative measurement in PACU. 3. Subjects undergoing planned laparoscopic colorectal surgery. 4. Ability to provide written informed consent. 5. Ability to understand study procedures and communicate clearly with the investigator and staff. 6. American Society of Anesthesiologists (ASA) risk class of I to III. Exclusion Criteria: < Surgical Factors > 1. Emergency or unplanned surgery. 2. Repeat operation (e.g., previous surgery within 30 days for same condition). 3. Cancer-related condition causing preoperative pain in site of surgery. < Subject Characteristics > 4. Women with childbearing potential (Women age 18-55 must undergo pregnancy test). 5. Women who are pregnant or breastfeeding. 6. Chronic pain diagnosis (e.g., ongoing pain at baseline with NRS ≥ 4/10). 7. Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, anxiety, or depression) Subjects who take stable doses (same dose >30 days) of antidepressants and anti-anxiety drugs may be included. 8. Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS). < Drug, Alcohol, and Pharmacological Considerations > 9. Renal or hepatic impairment. 10. History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening (TICS alcohol/drug screen will be performed at Screening). 11. Ongoing or recent (within 30 days prior to surgery) use of steroids, opioids, or antipsychotics. 12. Alcohol consumption within 24 hours of surgery. 13. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 24 hours of surgery. 14. Use of herbal agents or nutraceuticals (i.e., chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. Johns wort, or valerian) within 7 days prior to surgery. < Anesthetic and Other Exclusion Considerations > 15. Use of neuraxial or regional anesthesia related to the surgery. 16. Use of local anesthetic wound infiltration > 20 ml of 1% lidocaine 17. Use of ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery. 18. Subjects with known allergies to hydromorphone. 19. Subjects who received another investigational drug within 30 days of scheduled surgery. 20. Subjects who have long PR (>200 msec) or prolonged QTc (> 450 msec) at Screening or on an EKG done immediately prior to dosing. ; PRIMARY OUTCOME: Sum of Pain Intensity Difference over 8-hours post-dose (SPID8); SECONDARY OUTCOME 1: Difference of Opioid Consumption between Study 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 II - CP003; BRIEF: Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will evaluate the safety and tolerability of multiple doses of Cat-PAD in controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation Test. ; DRUG USED: Cat-SPIRE; 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. - A history of controlled asthma as defined in GINA (2007) on exposure to cats for at least 1 year - Asthma controlled with:Inhaled salbutamol (Cohort 1), Inhaled corticosteroid (Cohort 2), Inhaled corticosteroid plus a long acting β2agonist (LABA) (Cohort 3) Treatment for asthma must have been stable (drug(s), dose, frequency) for at least 3 months. - A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) on exposure to cats for at least 1 year. - Subjects who provide written informed consent. - Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control. - A LPSR to cat allergen eight hours after intradermal injection of greater than 25mm diameter. - Positive CPT with a score ≥4. - The subject must be willing and able to comply with the study requirements. - If the subject is female and of childbearing potential she must practice an acceptable form of contraception, and produce a negative urine pregnancy test on the Screening Visit. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal. Exclusion Criteria - Subjects with asthma falling under GINA (2007) definitions partly controlled and uncontrolled - Subjects with a requirement for more than 1000 µg beclomethasone (or equivalent) per day for the treatment of asthma. - A history of anaphylaxis to cat allergen. - Subjects with a cat specific IgE >100 kU/L. - Subjects with an FEV1 <80% of normal - Subjects with an acute phase skin response to cat allergen with a wheal diameter > 30mm. - Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the baseline/post-treatment challenge (PTC) and the dosing periods outside the respective pollen season. - Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy. - Subjects who have completed or are undergoing ongoing treatment with anti-IgE-antibody. - Use of the therapies listed in Section 5.9.2 at any time during the study will make the subject ineligible for the study. - The subject has unacceptable symptoms in the 3 days without loratadine prior to the screening visit. - Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). - Subjects being treated with beta-blockers. - Have symptoms of a clinically relevant illness in the Investigators opinion, within 6 weeks prior to Screening Visit. - Female subjects who are pregnant, lactating or planning a pregnancy during the study. - Have any clinically relevant abnormalities detected on physical examination. - 12-lead ECG or vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) that are outside normal limits, unless the abnormality is considered not to be of clinical relevance by the Investigator. - Laboratory values (haematology, biochemistry, urine tests) that are outside the normal ranges, unless the abnormality is considered not to be of clinical relevance by the Investigator. - Significant history of alcohol or drug abuse. - History of immunopathological diseases. - Positive test for hepatitis B, hepatitis C or HIV at screening. - Previously randomised into this study or have received Cat-PAD (or a prototype thereof) previously. - Have a history of severe drug allergy or anaphylactic reaction to food. - Planned travel outside the study area for a substantial portion of the study period. - Have received treatment with an investigational drug within 6 months prior to study screening or have participated in a study with a new formulation of a marketed drug one month prior to study screening. - Are unable to communicate or to understand the requirements of the study, or any psychiatric disorder, which would impair communication between the subject and the Investigator thereby interfering with the informed consent procedure or the gathering of study data. - A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subjects ability to participate in the study. - Subjects with a known allergy to thioglycerol. - Subjects who have a dependent relationship (e.g. employees or family members) with either the Sponsor or Investigator ; PRIMARY OUTCOME: Safety and tolerability of multiple intradermal injections of Cat-PAD in cat allergic subjects with controlled asthma; SECONDARY OUTCOME 1: Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Relapsing; BRIEF: Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: - To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures - To evaluate the safety and tolerability of SAR441344 - To evaluate pharmacokinetics of SAR441344 ; DRUG USED: SAR441344; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: CD40 Ligand (CD40L) / gp39; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. - The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria. - The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening. - Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening. - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Capable of giving signed informed consent. Exclusion criteria: - The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS. - The participant has conditions or situations that would adversely affect participation in this study. - The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study. - History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment. - Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule. - The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment. - The participant has taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit. - The participant has an EDSS score >5.5 at the first screening visit. - The participant has had a relapse in the 30 days prior to randomization. - Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission. - Abnormal laboratory test(s) at Screening. - Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention. - Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions; SECONDARY OUTCOME 1: Number of new or enlarging T2 lesions[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CR108062; BRIEF: The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults. ; DRUG USED: MVA-BN Filo/Ad26.ZEBOV; DRUG CLASS: Vaccine; INDICATION: Ebola; TARGET: Ebola Virus, Marburg virus; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Vaccines & Prevention B.V.; CRITERIA: Inclusion Criteria: - Participant must be healthy in the Investigators clinical judgment on the basis of medical history, physical examination and vital signs performed at Screening - Participant must be healthy on the basis of clinical laboratory tests and electrocardiogram (ECG) (only in participants >50 years) performed at Screening. If the results of the laboratory screening tests and ECG are outside the institutional normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study - A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin [beta-hCG] pregnancy test at Screening and a negative urine [beta-hCG] pregnancy test immediately prior to each study vaccine administration - A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to dose 1 vaccination until at least 3 months after the dose 2 vaccination, unless a vasectomy was performed more than 1 year prior to Screening - Participant must pass the test of understanding (TOU) - Additional Inclusion Criteria for HIV-infected participants a) participants must have a positive HIV-1 and/or -2 serology test within 6 months of screening, including the day of screening; b) participants must have a Screening CD4+ cell count >200 cells/microliter (mcL); c) in part 1, all participants must be on a stable highly active antiretroviral therapy (HAART) regimen for 4 weeks prior to Screening, in part 2 participants with screening CD4+ cell count <350 cells/mcL must also be on a stable HAART regimen for 4 weeks prior to Screening Exclusion Criteria: - Has received any candidate Ebola vaccine - Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to epidemic Ebola areas less than 1 month prior to Screening - Has received any experimental candidate Ad26- or MVA-based vaccine in the past or received any other investigational drug or investigational vaccine or used an invasive investigational medical device within 3 months prior to Screening - Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products - Presence of significant conditions (eg, history of seizure disorders, (auto)immune disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis treatment, other systemic infections) or clinically significant findings during screening of medical history, ECG (only in participants >50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the participants (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events; SECONDARY OUTCOME 1: Number of Participants With Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 2005; BRIEF: To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia. ; DRUG USED: NYX-2925; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibromyalgia; TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Aptinyx; CRITERIA: Inclusion criteria: - Informed consent - Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening and reports at least moderate pain over the last week - Stable protocol allowed medication and other therapies during the study - Agrees to use highly effective birth control during the study - Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study Exclusion Criteria: - Pain due to other conditions or diseases that would complicate participation in the study or pain reporting - Current or historical serious medical conditions - Prior participation in NYX-2925 clinical trial ; PRIMARY OUTCOME: Change in the Mean Numerical Rating Scale (NRS) Score; SECONDARY OUTCOME 1: Number of Subjects Much Improved or Very Much Improved on the Patient Global Impression of Change (PGI-C) 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 - X-TRA; BRIEF: A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stroke Prevention in Atrial Fibrillation (SPAF); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Men or women aged >/= 18 years - Hemodynamically stable nonvalvular AF or atrial flutter - LA/LAA thrombus documented at baseline by transesophageal echocardiography (TEE) up to 72 hours prior to start of study medication - vitamin K antagonist(s) (VKA)/ new oral anticoagulant(s) (NOAC)-naïve or untreated within 1 month prior to signing of the informed consent form - VKA pretreated but under ineffective INR levels(<2.0,documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks - Women of childbearing potential and men must agree to use adequate contraception when sexually active Exclusion Criteria: - Transient Ischemic Attack within 3 days prior to study inclusion - Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug - Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion - Acute myocardial infarction within the last 14 days prior to study inclusion - Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, Intracardiac tumor, known left ventricular or aortic thrombus - Active bleeding or high risk for bleeding contraindicating anticoagulant therapy - Concomitant drugs/therapies: Indication for anticoagulant therapy for a condition other than nonvalvular AF or atrial flutter (eg, venous thromboembolism). Concomitant use of anticoagulant drugs, including VKA, or factor IIa or factor Xa inhibitors. Chronic aspirin therapy >100 mg or dual antiplatelet therapy. Concomitant use of strong inhibitors of both cytochrome P450 (CYP) 3A4 and P glycoprotein (P-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents-ketoconazole, itraconazole, voriconazole, and posaconazole-if used systemically - Concomitant conditions: Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding. Hypersensitivity to investigational treatment. Calculated creatinine clearance (CrCl) < 15 mL/minute at the screening visit. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk. Any severe condition that would limit life expectancy to less than 3 months (eg, advanced malignancy, etc.). Planned invasive procedure with potential for uncontrolled bleeding or increased risk of stroke, including major surgery, cardiac catheterization, or cardioversion prior to the end-of-treatment TEE. Inability to take oral medication. Ongoing drug addiction or alcohol abuse ; PRIMARY OUTCOME: The percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatment; SECONDARY OUTCOME 1: Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 843 (BID); BRIEF: The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) ; DRUG USED: Lotemax SM; DRUG CLASS: Non-NME; INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Bausch & Lomb Incorporated; CRITERIA: Inclusion Criteria: Visit 1 (Screening Visit) - Be willing and able to comply with all treatment and follow-up/study procedures. - Be a candidate for routine, uncomplicated cataract surgery. Visit 3 (Postoperative Day 1) - Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye. - Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye. Exclusion Criteria: - Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study. - Have known hypersensitivity or contraindication to the study drug(s) or their components. ; PRIMARY OUTCOME: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells; SECONDARY OUTCOME 1: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 20050159 - MDS; BRIEF: The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim. ; DRUG USED: Nplate; DRUG CLASS: Biologic; INDICATION: Thrombocytopenia; TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Diagnosis of MDS using the World Health Organization classification - Low or Intermediate-1 risk MDS using the International Prognostic Scoring System (IPSS) - The mean of two platelet counts taken during the screening period must be ≤ 50 x 10^9/L, with no individual count > 55 x 10^9/L (The mean platelet counts of 5 subjects enrolled at the maximum tolerated dose (MTD) must be ≤ 20 x 10^9/L). Standard of care platelet assessments taken prior to Informed Consent may be used as 1 of the 2 counts taken within 3 weeks prior to study day 1. - Must be ≥ 18 years of age at the time of obtaining informed consent - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of screening - Adequate Liver Function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilberts Disease), alanine aminotransferase (ALT) ≤ 3 times the laboratory normal range, and aspartate aminotransferase (AST) ≤ 3 times the laboratory normal range - A serum creatinine concentration ≤ 2 mg/dL (≤ 176.6 µmol/L) - Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1) Exclusion Criteria: - Currently receiving any treatment for MDS other than transfusions and erythropoietic growth factors. If granulocyte growth factors are currently being received, they cannot be used on or after study day 1 - Clinically significant bleeding within 2 weeks prior to screening (eg, gastrointestinal (GI) bleeds, intracranial hemorrhage) - Prior malignancy (other than controlled prostate cancer, in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years before screening - Prior history of bone marrow transplantation - Persistent peripheral blood monocytosis (≥ 3 months with an absolute monocyte count > 1,000/µL) - Unstable angina, congestive heart failure (New York Heart Association [NYHA] > class II), uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction - Received Anti-Thymocyte Globuline (ATG) within 6 months of screening - Received hypomethylating agents, immunomodulating agents, histone deacetylase inhibitors, cyclosporine or mycophenolate within 6 weeks of screening - Received interleukin (IL)-11 (oprelvekin) within 4 weeks before screening - Concurrent use of granulocyte growth factors (i.e. granulocyte-colony stimulating factor [G-CSF; Neupogen, Granocyte], pegfilgrastim [Neulasta], granulocyte macrophage-colony stimulating factor [GM-CSF; Leukine, Prokine, Sargramostim]) - Have ever previously received recombinant thrombopoietin (rTPO), pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), eltrombopag, or romiplostim - Less than 4 weeks since receipt of any therapeutic drug or device that is not Food and Drug Administration (FDA) approved for any indication - Other investigational procedures are excluded - History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year - History of venous thrombosis that currently requires anti-coagulation therapy - Untreated B12 or folate deficiency - Subject is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test) or is breast feeding - Subject is not using adequate contraceptive precautions - Subject has known hypersensitivity to any recombinant E coli-derived product - Subject previously has enrolled in this study - Subject will not be available for follow-up assessment - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures ; PRIMARY OUTCOME: Part A: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Part A: Number of Participants With a Complete or Major Platelet Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FAST 1; BRIEF: The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE). ; DRUG USED: Firazyr; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hereditary Angioedema (HAE); TARGET: Bradykinin B2 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Age above 18 years; - Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor [C1-INH] deficiency); - Current edema be in the cutaneous, abdominal and/or laryngeal areas; - Current edema be moderate to severe according to the investigators Symptom Score. Exclusion Criteria: - Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE); - Participation in a clinical trial of another investigational medicinal product (IMP) within the past month; - Treatment with any pain medication since onset of the current edema attack; - Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack; - Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril); - Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination; - Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial; - Pregnancy and/or breast-feeding. ; PRIMARY OUTCOME: Time to Onset of Symptom Relief (TOSR); SECONDARY OUTCOME 1: Time to Regression (Start of Improvement) According to Patient[/INST]Yes</s>

<s>[INST]<<SYS>>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 - MDX010-21; BRIEF: Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment. ; DRUG USED: Yervoy; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Histologic diagnosis of adenocarcinoma of the prostate - Metastatic prostate cancer (positive bone scan or measurable disease) - Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured. - Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression. - Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products. - Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required. - Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment. - No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer). - Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. Exclusion Criteria: - Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use. - History of severe hypersensitivity reactions to drugs formulated with polysorbate 80. - Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo. - Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody. - Active infection requiring therapy. - Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable. ; PRIMARY OUTCOME: Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants; SECONDARY OUTCOME 1: Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EMERALD; BRIEF: The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much potassium in the blood). Another purpose of the study is to evaluate the safety and tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia. ; DRUG USED: Veltassa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperkalemia; TARGET: Potassium; THERAPY: Monotherapy; LEAD SPONSOR: Vifor Pharma, Inc.; CRITERIA: Inclusion Criteria: - Written assent (when applicable) and written informed consent by a legally authorized representative provided prior to participation in the study - Age 2 - <18 years old - CKD defined by the estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m2, including renal transplant subjects, based on local creatinine measurement at screening - Two potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days - In the opinion of the study doctor, is expected to require treatment for hyperkalemia for at least 6 month - If taking any renin-angiotensin-aldosterone system inhibitors (RAASi) beta blockers or diuretic medications, must be on a stable dose for at least 28 days prior to Screening - Negative pregnancy test in females of child-bearing potential Exclusion Criteria: - Pseudohyperkalemia due to hemolysis or to abnormally high numbers of platelets (>500,000/mm3), leukocytes (>70,000/mm3), or erythrocytes (hematocrit >55%) at Screening based on results obtained locally - Evidence of potassium-related electrocardiogram (ECG) changes at Screening - Any of the following kidney conditions: maintenance hemodialysis or peritoneal dialysis, renal artery stenosis, and acute kidney injury or a history of acute renal insufficiency in the past 3 months - Severe disorder of stomach or intestines including surgery that could affect gastrointestinal transit of the drug - Increased liver enzymes (ALT, AST > 3 times upper limit of normal) at Screening - Active cancer, currently on cancer treatment or history of cancer in the past 2 years (except for non-melanoma skin cancer) - Heart or liver transplant, or anticipated need for transplant during the study treatment period including a scheduled kidney transplant recipient. (Note: patients currently on a kidney transplant wait list are not excluded unless there is an identified donor). - Alcohol abuse or substance use disorder within 1 year of Screening - Subjects currently being treated with or having taken any one of the following medications (includes resins) in the 7 days prior to Screening: sodium or calcium polystyrene sulfonate, drospirenone - Use of certain medications that can affect blood potassium levels if doses have not been stable for at least 14 days prior to Screening or if doses are anticipated to change during the 14-day PD / Dose Finding Phase - Use of investigational product within 30 days of screening or within 5 half-lives, whichever is longer - Known hypersensitivity to patiromer or its components - In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or potentially affect the quality of the data ; PRIMARY OUTCOME: Change in Serum Potassium Levels; SECONDARY OUTCOME 1: Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L[/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 - DESTINY-Breast04 (HER2-low); BRIEF: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants cancer: - Cannot be removed by an operation - Has spread to other parts of the body ; DRUG USED: Enhertu; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo, Inc.; CRITERIA: Inclusion Criteria: - Is the age of majority in their country - Has pathologically documented breast cancer that: 1. Is unresectable or metastatic 2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) 3. Is HR-positive or HR-negative 4. Has progressed on, and would no longer benefit from, endocrine therapy 5. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting 6. Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines) - Has documented radiologic progression (during or after most recent treatment) - Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for: 1. assessment of HER2 status 2. assessment of post-treatment status - Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1 - Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions - Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels) Exclusion Criteria: - Is ineligible for all options in the physicians choice arm - Has breast cancer ever assessed with high-HER2 expression - Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate - Has uncontrolled or significant cardiovascular disease - Has spinal cord compression or clinically active central nervous system metastases - Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening - Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study ; PRIMARY OUTCOME: Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer; SECONDARY OUTCOME 1: Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status[/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 - LOWR 4; BRIEF: A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically infected with hepatitis delta virus (HDV) ; DRUG USED: Zokinvy; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis D (HDV) (Antiviral); TARGET: Farnesyl transferase; THERAPY: Monotherapy; LEAD SPONSOR: Eiger BioPharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Male or female, 18 to 65 years of age, inclusive 2. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6 months duration and detectable HDV ribonucleic acid (RNA) by quantitative polymerase chain reaction (qPCR) at study entry 3. Liver biopsy demonstrating evidence of chronic hepatitis 4. Willingness to practice appropriate contraception Key Exclusion Criteria: 1. Previous use of lonafarnib 2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) 3. Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have Gilberts disease 4. Decompensated liver disease or cirrhosis, history of bleeding esophageal varices, ascites, or hepatic encephalopathy 5. Serum creatinine concentration ≥1.5 times upper limit of normal (ULN) 6. Evidence of another form of viral hepatitis (not including hepatitis B virus or HCV) or another form of liver disease 7. Evidence of hepatocellular carcinoma 8. Use of alfa interferon, either interferon alfa-2a or interferon alfa-2b, or peginterferon alfa-2a within 2 months before the start of screening 9. Concomitant use of any of the following: 1. Medications or foods that are known moderate or strong inducers or inhibitors of CYP3A4 or CYP2C19 2. Drugs known to prolong the PR interval or QT interval of the electrocardiogram 3. Receipt of systemic immunosuppressive therapy within the 3 months before start of screening 4. Statins, due to inhibition of mevalonate synthesis, which reduces protein prenylation 5. Medications contraindicated in the prescribing information for ritonavir ; PRIMARY OUTCOME: Change From Baseline to Week 24 in Mean Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) Titer; SECONDARY OUTCOME 1: Number of Patients With 1 Log Reduction From Baseline by Timepoint[/INST]Yes</s>

<s>[INST]<<SYS>>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 - STARS (Angelman Syndrome); BRIEF: The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory efficacy outcome measures will be investigated. ; DRUG USED: OV101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Angelman Syndrome; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ovid Therapeutics Inc.; CRITERIA: Inclusion Criteria 1. Age 13- 49 years 2. Diagnosis of Angelman syndrome 3. Receiving a stable regimen of concomitant medications for at least 4 weeks prior to Baseline, and able to maintain these throughout the duration of the study 4. Has a caregiver capable of providing informed consent on behalf of the subject and able to attend scheduled study visits 5. Able to ingest study medication 6. Caregivers must agree not to post any subject or study information on social media Exclusion Criteria 1. Unable to perform the study related safety and exploratory efficacy assessments, such as motor function 2. Poorly controlled seizure activity 3. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study 4. Pregnancy or women of child-bearing potential who are not using and acceptable method of contraception 5. Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon, and cannabinoid derivatives, or any other use of any investigational agent, device, and/or investigational procedure 4 weeks prior to Baseline and during the study 6. Allergy to OV101 or any excipients 7. At increased risk of harming self and/or others based on investigator assessment 8. Any condition or reason that in the opinion of the investigator makes the subject unsuitable for enrollment 9. Inability of subject or caregiver to comply with study requirements Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Incidence of Adverse Events in Placebo and Active Treatment Groups; 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 - LAC-MD-32; BRIEF: The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD). ; DRUG USED: Duaklir Pressair; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years - A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction. Exclusion Criteria: - Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1 - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1. - Patients with any clinically significant respiratory conditions other than COPD - Clinical history that suggests that the patient has asthma as opposed to COPD - Chronic use of oxygen therapy ≥ 15 hours/day - Patients with clinically significant cardiovascular conditions - Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis - Patients with a history of hypersensitivity reaction to inhaled anticholinergics, - Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above - Current diagnosis of cancer other than basal or squamous cell skin cancer ; PRIMARY OUTCOME: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE); SECONDARY OUTCOME 1: Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - TR701-120; BRIEF: This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a single IV (Part A) or oral suspension (Part B) administration to hospitalized participants ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4, respectively). ; DRUG USED: Sivextro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity; - Weight >5th percentile and <95th percentile based on age; - Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations; - Females must be premenarchal, abstinent, or practicing an effective method of birth control; Exclusion Criteria: - History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results; - Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease; - History of drug allergy or hypersensitivity to oxazolidinones; - Pregnant or breast feeding; - Significant blood loss within 60 days prior to study start; - Any acute or chronic condition that would limit the participants ability to complete and/or participate in this clinical study. - Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug. - Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug. - Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study. ; PRIMARY OUTCOME: Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug); SECONDARY OUTCOME 1: Number of Participants Who Experienced at Least One Adverse Event[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - L-PLUS 2; BRIEF: The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo for the treatment of thrombocytopenia in patients with chronic liver disease who are undergoing elective invasive procedures. ; DRUG USED: Mulpleta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thrombocytopenia; TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: Shionogi; CRITERIA: Inclusion Criteria: 1. Able to understand the study and comply with all study procedures. 2. Willing to provide written informed consent prior to Screening. 3. Male or female. 4. 18 years of age or older at the time of signing informed consent. 5. Platelet count < 50 × 10^9/L at baseline on Day 1 prior to randomization. 6. Undergoing an elective invasive procedure. 7. In the opinion of the investigator, able to meet study requirements. 8. Male patients who are sterile or who agree to use an appropriate method of contraception (including use of a condom with spermicide) from Screening to completion of the Post-treatment Period. 9. Female patients who are not postmenopausal or surgically sterile need to agree to use a highly effective contraception (including contraceptive implant, injectable contraceptive, combination hormonal contraceptive [including vaginal rings], intrauterine contraceptive device or vasectomised partner) from Screening to completion of the Post-treatment Period. Barrier method with or without spermicide, double barrier contraception and oral contraceptive pill are insufficient methods on their own. Exclusion Criteria: 1. Any of the following diseases: - hematopoietic tumor - aplastic anemia - myelodysplastic syndrome - myelofibrosis - congenital thrombocytopenia - drug-induced thrombocytopenia - generalized infection requiring treatment except for viral liver disease - immune thrombocytopenia. 2. History of splenectomy. 3. History of liver transplantation. 4. Any of the following at Screening: - hepatic encephalopathy uncontrolled by drugs - ascites uncontrolled by drugs. 5. Portal vein tumor embolism. 6. Known to be positive for the human immunodeficiency virus. 7. Past or present thrombosis or prothrombotic condition (e.g., cerebral infarction, myocardial infarction, angina pectoris, coronary artery stent placement, angioplasty, coronary artery bypass grafting, congestive heart failure [New York Heart Association Grade III/IV], arrhythmia known to increase the risk of thromboembolic events [atrial fibrillation], pulmonary thromboembolism, deep vein thrombosis, or disseminated intravascular coagulation syndrome). 8. History or evidence of any of the following diseases: - congenital thrombotic disease (eg, antithrombin deficiency, protein C deficiency, protein S deficiency, or coagulation factor [Factor V Leiden] mutation) - acquired thrombotic disease (eg, antiphospholipid antibody syndrome, paroxysmal nocturnal hemoglobinuria, hyperhomocysteinemia, or increased factor VIII) - Budd Chiari syndrome. 9. Portal vein thrombosis based on ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) within 28 days prior to randomization or a history of portal vein thrombosis. 10. Absence of hepatopetal blood flow in the main trunk of the portal vein as demonstrated by Doppler ultrasonography within 28 days prior to randomization. 11. History or evidence of disease associated with a risk of bleeding (e.g., coagulation factor deficiency or von Willebrand factor deficiency). 12. Bleeding score at randomization ≥ Grade 2 according to the World Health Organization (WHO) Bleeding Scale. 13. Any of the following drugs or therapies within 90 days prior to randomization: - anticancer drugs - interferon preparations - radiation therapy - exsanguination - other thrombopoietin receptor agonist - any investigational agent. 14. Any invasive procedure within 14 days prior to randomization. 15. Blood transfusion within 14 days prior to randomization. 16. Prior treatment with lusutrombopag (S-888711). 17. Pregnancy or lactation. 18. Known or suspected ongoing, active alcohol or substance abuse. Patients with a recent history who the investigator feels are able to comply with the study procedures and medications will be allowed to participate. 19. Considered ineligible by the investigator for any other reason. ; PRIMARY OUTCOME: Percentage of Participants Who Required No Platelet Transfusion Prior to the Primary Invasive Procedure and No Rescue Therapy For Bleeding From Randomization Through 7 Days After the Primary Elective Procedure; SECONDARY OUTCOME 1: Percentage of Participants Who Required no Platelet Transfusion During the Study[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MI-NSTEMI (AMI); BRIEF: This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI). ; DRUG USED: MultiStem; DRUG CLASS: Biologic; INDICATION: Acute Coronary Syndrome (ACS); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Athersys, Inc; CRITERIA: Inclusion Criteria: - Subjects of either gender, 18-85 years of age, inclusive - Diagnosis of non-ST elevation myocardial infarction (NSTEMI) - Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45% Exclusion Criteria: - Previous Coronary Artery Bypass Graft (CABG) - Previous autologous, allogeneic bone marrow or peripheral stem cell transplant - Previous solid organ transplant - Anticipated need for additional planned coronary revascularization procedure(s) - Hemodynamic instability - Mechanical complications of the index acute myocardial infarction ; PRIMARY OUTCOME: Incidence and severity of adverse events; SECONDARY OUTCOME 1: To assess the effects of AMI MultiStem therapy on cardiac function[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MS316; BRIEF: IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence. Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally. This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational. ; DRUG USED: Nutropin/Increlex - Short Stature; DRUG CLASS: Biologic; INDICATION: Growth Hormone Insensitivity Syndrome (GHIS); TARGET: Growth hormone receptor (GHR), IGF-1R (Insulin-like Growth Factor-1 Receptor) , Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ipsen; CRITERIA: Inclusion Criteria: - Parents or legally authorized representatives must give signed informed consent before any trial-related activities - IGF-1 SDS of ≤ -1 for age and gender - Short stature, as defined by a height SDS of ≤ -2 for age and gender - Chronological age ≥ 5 years - Bone age ≤ 11 years in boys and ≤ 9 years in girls - GH sufficiency, defined as a maximal stimulated GH response of greater than or equal to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a prior GH stimulation test may satisfy this requirement). - Prepubertal status - Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to the 5th percentile for age and gender Exclusion Criteria: - Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response greater than or equal to 10 ng/mL) - Prior or current use of medications with the potential to alter growth patterns including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase inhibitors, androgens and estrogens - Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations - Current use of medications for attention deficit disorder - A chronic health condition that requires anti-inflammatory steroids or daily medication unless approved by the Medical Monitor ; PRIMARY OUTCOME: Height Velocity; SECONDARY OUTCOME 1: Height Velocity[/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 - PIFR; BRIEF: This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate. ; DRUG USED: Yupelri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Mylan Inc.; CRITERIA: Inclusion Criteria: - Subject is a male or female subject 40 years of age or older with a diagnosis of COPD. - Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years. - Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures. Exclusion Criteria: - Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug. - Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics. - Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention. ; PRIMARY OUTCOME: Change From Baseline in Trough FEV1 on Day 29; SECONDARY OUTCOME 1: Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29[/INST]Yes</s>

<s>[INST]<<SYS>>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/Mitoxantrone; BRIEF: Primary Objective: -Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa. Secondary objectives: - Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among patients with baseline PSA levels >/=5 ng/mL who are treated near the maximum tolerated dose. - Monitor the effect of escalating doses of bortezomib combined with mitoxantrone on selected parameters of clinical benefit (i.e. performance status, tumor-related symptoms, measurable disease response). ; DRUG USED: Velcade; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Patient has given voluntary written informed consent before performance of any study-related procedure not part of standard medical care. 2. Patient has histologically-confirmed advanced and/or metastatic AI-PCa requiring anti-neoplastic treatment. Patients should continue on LHRH analog therapy throughout the study period, if this is their mode of androgen suppression therapy. Patients should have discontinued anti-androgen therapy for >/= than 4 weeks (for flutamide) or >/= 6 weeks (for bicalutamide and nilutamide). 3. Patient has progressive measurable or evaluable disease, defined as meeting at least one of the three criteria, described in protocol section 4.1. 4. Zubrod performance status of </= 2 (Appendix B). 5. Resting Left Ventricular Ejection Fraction (LEVF) >/= 50%. 6. Patient has all of the following pretreatment laboratory data within 14 days (except for serum testosterone which may be done within 28 days prior to registration) before the first study drug dose: Absolute neutrophil count (ANC) >/= 1,500/mm^3. Platelets >/= 100,000/mm^3. Hemoglobin >8.0 g/dL. Total bilirubin </=1.5 x the upper limit of normal (ULN). ALT or AST </= 2.5 x the ULN, or, if the patient has liver metastases, </= 5 x the ULN. Creatinine </= 2 mg/dL. Serum testosterone </= 50 ng/mL. Exclusion Criteria: 1. Patient has received chemotherapy (including thalidomide or ketoconazole) within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment. 2. Patient has received radiation therapy or Samarium-153 within four weeks of enrollment, or Strontium-89 within 12 weeks of enrollment. 3. Patient has not recovered from all serious toxic effects of previous chemotherapy or radiation or antibody therapy. 4. Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment. 5. Patient has had any major surgery within four weeks of enrollment. 6. Patient has a history of allergic reactions to anti-diarrheal medications or anti-emetics suggested to be administered in conjunction with study drug (see Section 5.1.4.1). 7. Patient has a history of severe hypersensitivity reaction to mitoxantrone or other agents formulated with polysorbate 80. 8. Patients with significant atherosclerotic disease, as defined by: a) myocardial infarction within six months of enrollment, uncontrolled / unstable angina pectoris or electrocardiographic evidence of acute ischemia b) clinically significant ventricular arrhythmias, c) symptomatic congestive heart failure d) significant conduction abnormalities: 2nd or 3rd degree AV blocks, bifascicular block (defined as Left Anterior Hemiblock in the presence of Right Bundle Branch Block), e) claudication limiting activity and f) history of cerebrovascular events within the last year (including TIA) 9. Patients who have received > equivalent to 180 mg/m^2 of Doxorubicin cumulative dose. 10. Patients with diabetes mellitus requiring insulin, or those that have required pharmacologic intervention for diabetes mellitus for greater than 5 years 11. Patient has uncontrolled brain metastases or central nervous system disease. 12. Patient has >/= Grade 2 peripheral neuropathy (per NCI CTC v.2). 13. Patient has an uncontrolled intercurrent illness (e.g., active infection). 14. Patient has another serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the patients ability to provide informed consent or with the completion of treatment according to this protocol. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) of Novantrone (Mitoxantrone) combined with PS-341 (Bortezomib); SECONDARY OUTCOME 1: Activity of drugs biochemical target, the 20S proteasome, in peripheral blood white cells[/INST]Yes</s>

<s>[INST]<<SYS>>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 - UP-02 ; BRIEF: This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2, proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring hemodialysis. The purpose of the study is to determine the efficacy and safety profile of PA101B delivered via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic despite using standard treatments. ; DRUG USED: RVT-1601; DRUG CLASS: Non-NME; INDICATION: Pruritus; TARGET: Cell Membrane, Mast Cell; THERAPY: Monotherapy; LEAD SPONSOR: Patara Pharma; CRITERIA: Inclusion Criteria: - Diagnosis of end-stage renal disease (ESRD) requiring hemodialysis for at least 3 months prior to the Screening Period - Receiving conventional hemodialysis (i.e., not hemofiltration or hemodiafiltration) - Pruritus present for at least 6 weeks of Screening - Mean pruritus severity score on a numerical rating scale (NRS) > 4 - Patient-Assessed Disease Severity Scale Type B or C at Screening - Documentation of a urea reduction ratio (URR) >65% or single-pooled Kt/V> 1.4 during Screening - Willing and able to provide written informed consent Exclusion Criteria: - Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator - Myocardial infarction within 6 months or unstable angina, acute coronary syndrome, or interventional coronary procedure within 2 months of Screening - Upper or lower respiratory tract infection (including sinus infection) within 4 weeks of Screening - Severely symptomatic cardiopulmonary disease defined by the use of home oxygen treatment, dyspnea at rest or with minimal exertion, uncontrolled arrhythmias (e.g. atrial fibrillation with inadequate rate control), or history of life-threatening arrhythmias (e.g. cardiac arrest or syncope related to arrhythmia) - Acute exacerbation of asthma or chronic obstructive pulmonary disease resulting in hospitalization or visit to an emergency department or urgent care clinic within 6 months of Screening - Hospitalization for any medical reason other than for a pre-planned procedure or dialysis access related procedure within the 2 weeks of Screening - Malignancy requiring active treatment with a systemic drug - Participation in any other investigation drug study within 4 weeks of Screening - Current or anticipated use of baclofen, gabapentin, pregabalin and nalbuphine for the treatment of pruritus - Current or anticipated use of glucocorticoids administered intravenously, orally, or transdermally - Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study ; PRIMARY OUTCOME: Itching intensity; SECONDARY OUTCOME 1: Pruritus-specific quality of life (QoL)[/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 - CAC-91-10-10; BRIEF: OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II. To assess the safety and tolerability of cholic acid ; DRUG USED: Cholbam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Disorders in Bile Acid Synthesis; TARGET: Bile Acids; THERAPY: Monotherapy; LEAD SPONSOR: Mirum Pharmaceuticals, Inc.; CRITERIA: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical or biochemical evidence of liver disease, unexplained fat-soluble vitamin malabsorption, or peroxisomal dysfunction that compromises bile acid biosynthesis Inclusion criteria for enrollment were: - Infants < age 3 months - Children presenting for evaluation of cholestasis defined as a conjugated bilirubin > 2mg/dl or increased serum bile acids - Older subjects of any age with cholestatic liver disease if urine screens suggested that they had inborn errors of bile acid metabolism - Confirmation of a diagnosis of an inborn error of bile acid synthesis based upon urine analysis by FAB-MS to determine whether specific abnormalities in bile acid synthesis are indicated - The patient and/or parent/legal guardian must have signed the written informed consent document before study start. - The patient must be willing and able to comply with all study assessments and procedures. ; PRIMARY OUTCOME: Number of Participants With Excretion of Atypical Bile Acids in Urine by Category; SECONDARY OUTCOME 1: Change in Liver Function Tests (LFTs) Measured in Serum[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1245.49 - Insulin Add-on; BRIEF: This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population. ; DRUG USED: Jardiance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of T2DM prior to informed consent 2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin 3. Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose 4. HbA1c >=7.5% and <=10% at screening Exclusion criteria: 1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in 2. Any contraindications to metformin according to the local label 3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent ; PRIMARY OUTCOME: Change From Baseline in HbA1c After 18 Weeks of Treatment; SECONDARY OUTCOME 1: Change From Baseline in Insulin Dose After 52 Weeks of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 116266; BRIEF: The primary objectives of this study are to assess the safety, tolerability and pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration. GSK1322322 shows broad spectrum antibacterial activity against pathogens involved in respiratory tract infections as well as methicillin-resistant S. Aureus (MRSA). This study consists of three parts (Part A, Part B and Part C). The results from Part A of this study will enable use of large-scale, commercial tablets produced for administration to patients in pivotal clinical trials of GSK1322322. The results from Parts B and C will support enrolment of Japanese subjects in future clinical studies. Additionally, the results will support the dose selection for further clinical development of GSK1322322 in hospitalized patients with severe bacterial infections in Japan and other Asian populations. In Part A, subjects will undergo screening, 4 treatment periods receiving single dose of each of: 1500 mg Initial, fit-for-purpose tablet (product code AP), 1500 mg Over granulated tablet (product code AR), and the 1500 mg and 2000 mg of intended commercial tablets (product code AU). In Part B of the study subjects will undergo screening, and be randomized to receive 3 doses of GSK1322322 oral cohort (100 mg, 1500 mg and 2000 mg) or IV cohort (600 mg, 900 mg and 1200 mg) each in 3 treatment periods. Part C will be a single-blind, placebo-controlled, repeat dose study of GSK1322322 in healthy Japanese male subjects. GSK1322322 will be administered (fasted) via IV for 4 days BID, followed by administration of GSK1322322 orally (fed) for 6 days BID. A follow-up evaluation will be conducted 7-10 days following last dose of for each subjects in each Part of the study. Approximately 12 subjects will be enrolled in each part of the study such that approximately 8, 6, and 9 subjects complete dosing and critical assessments in part A,B, and C respectively. ; DRUG USED: GSK1322322; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Polypeptide deformylase (PDF); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria - Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening and check in. - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - Part A: Male or female (of non childbearing potential) between 18 and 65 years of age inclusive, at the time of signing the informed consent. - Part A: A female subject 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 [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international unit (MlU)/milliliter (mL) and estradiol <40 picogram [pg]/mL (<147 picomoles [pmol]/litre [L]) is confirmatory]. - Part B and C: Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese. Japanese subjects should also have lived outside Japan for less than 10 years. Subjects should consume a typical Japanese diet on a regular basis. - Parts B and C: Males between 20 and 65 years of age inclusive, at the time of signing the informed consent. - Subjects with female partners of child-bearing potential must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until the final follow up visit. - Body weight >=45.0 kilograms and body mass index (BMI) within the range 18.5 to 29.9 kg/meter^2 (inclusive). - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. - QT duration corrected for heart rate by Bazetts formula (QTcB) <=450 millisecond (msec); or QTcB < 480 msec in subjects with Bundle Branch Block on Screening ECG. Exclusion Criteria - A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody, a positive test for human immune virus (HIV) antibody result within 3 months of screening. - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - A positive pre-study drug/alcohol screen. - History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males. One unit is equivalent to 10 gram (g) of alcohol: 270 mL of full strength beer (4.8%), 375mL of mid strength beer (3.5%), 470mL of light beer (2.7%), 250mL pre-mix full strength spirit (5%), 100mL of wine (13.5%) and 30mL of spirit (40%). - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety due to potential drug interaction. Use of antacids, H2 blockers, proton pump inhibitors, vitamins, and iron supplements within 7 days prior to the first dose of study medication and for the duration of the trial, including follow-up. - History of sensitivity to any of the study medications, 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. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. - Parts B and C: Female subjects. - Part A: Pregnant females as determined by positive [serum or urine] human chorionic gonadotropin (hCG) test at screening or prior to dosing. - Part A: Lactating females. - Part A: Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening. - Part B and C: Subjects with a smoking history of >10 cigarettes per day in the last 3 months. - Unwillingness or inability to follow the procedures outlined in the protocol. - Subject is mentally or legally incapacitated. - History of sensitivity to heparin or heparin-induced thrombocytopenia. - Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication. - Screening Holter monitoring shows one or more of the following: Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization) and/or Any conduction abnormality on Holter monitoring (including but not specific to left or right complete bundle branch block, AV block [second degree or higher in an awake state; similar findings in sleeping subjects would not represent holter based exclusion, provided that they represent physiologic rhythm variants], 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 subject. - Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Male subjects with Heart rate <40 and >100 beats per minute (bpm), PR interval <120 and >220 msec, QRS duration <70 and >120 msec, QT interval corrected for heart rate (Bazett) >450 msec. Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [second degree or higher], 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 subject. ; PRIMARY OUTCOME: Composite of PK parameters for single oral dose of GSK1322322 in Part A; SECONDARY OUTCOME 1: Safety and tolerability of single oral dose of GSK1322322 in healthy subjects assessed by the collection of adverse events (AEs) in Part A[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DM-001 (UPenn); BRIEF: The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine. ; DRUG USED: Lenabasum; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dermatomyositis; TARGET: Cannabinoid-2 (CB2) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Corbus Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria (Part A): - CDASI activity score ≥ 14; - No difficulty with lifting or walking, and no more than 1.5 x the upper limit of normal of creatine phosphokinase or aldolase; - Failed at least 3 months treatment with hydroxychloroquine; - Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1). Inclusion Criteria (Part B): - Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons Exclusion Criteria (Part A and B): - Significant diseases or conditions other than DM that may influence response to the study product or safety; - Any one of the following values for laboratory tests at Screening: 1. A positive pregnancy test (or at Visit 1); 2. Hemoglobin < 10 g/dL; 3. Neutrophils < 1.0 x 10^9/L; 4. Platelets < 75 x 10^9/L; 5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation; 6. Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 x upper normal limit; 7. Total bilirubin ≥ 1.5 x upper limit of normal. - Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments. ; PRIMARY OUTCOME: Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.; SECONDARY OUTCOME 1: Change in Patient-reported Outcomes From Baseline at 84 Days for Part A[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1218.64 (Mod-Severe Renal Impairment); BRIEF: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride). ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Type 2 diabetes mellitus 2. GFR<60 ml/min 3. HbA1c >=7.0% to <= 10% 4. Age >= 18 years 5. BMI <=45 kg/m2 6. Signed and dated written informed consent Exclusion criteria: 1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent 2. Renal impairment requiring dialysis 3. Bariatric surgery 4. Impaired hepatic function 5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors 6. Treatment with anti-obesity drugs 7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent ; PRIMARY OUTCOME: HbA1c Change From Baseline to Week 12; SECONDARY OUTCOME 1: HbA1c Change From Baseline Over Time[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CL-102; BRIEF: The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo. During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Healthy male, age 40-60 years - BMI between 18-30 kg/m2 Exclusion Criteria: - Any condition that might interfere with the procedures or tests in this study - Drug or alcohol abuse - Smoking ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: Pharmacokinetics (PK) and pharmacodynamics (PD)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Safety; BRIEF: This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of PBI-4547 in healthy adult participants. ; DRUG USED: PBI-4547; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: GPR40 (FFAR1, free fatty acid receptor 1), GPR84; THERAPY: Monotherapy; LEAD SPONSOR: Liminal BioSciences Ltd.; CRITERIA: Inclusion Criteria: - Healthy male participants or non-childbearing potential female participants, ≥18 and ≤55 years. - Body mass index > 18.5 and < 30.0 kg/m^2, and body weight ≥ 50.0 kg for male participants and ≥ 45.0 kg for female participants. - Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to screening. - Male participants with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after study drug administration. - Male participants must be willing not to donate sperm until 90 days after study drug administration. Exclusion Criteria: - Any clinically significant abnormality or abnormal laboratory test results. - An estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2. - Positive urine drug screen and history of significant drug abuse. - History of significant allergic reactions to any drug. - Use of any drugs known to induce or inhibit hepatic drug metabolism. - Positive pregnancy test or breast-feeding participant. - Clinically significant abnormalities in ECG, blood pressure, and heart rate at screening. - History of significant alcohol abuse or regular use of alcohol. - Use of medication other than topical products without significant systemic absorption. - Donation of plasma. ; PRIMARY OUTCOME: Number of participants with treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: AUC0-t for PBI-4547[/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 - RAINBOWFISH; BRIEF: A global study of oral risdiplam in pre-symptomatic participants with spinal muscular atrophy (SMA). ; DRUG USED: Evrysdi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Spinal Muscular Atrophy; TARGET: Survival of Motor Neuron (SMN) Protein; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Males and females aged from birth (1 day) to 6 weeks (42 days) of age at the time of first dose (Day 1); a minimum age of 7 days at first dose is required for the first infant to be enrolled - Gestational age of 37-42 weeks for singleton births; gestational age of 34-42 weeks for twins - Body weight >= 3rd percentile for age, using appropriate country-specific guidelines - Genetic diagnosis of 5q-autosomal recessive SMA, including confirmation of homozygous deletion or compound heterozygosity predictive of loss of function of the SMN1 gene - Absence of clinical signs or symptoms at screening (Day -42 to Day -2) or at baseline (Day -1) that are, in the opinion of the investigator, strongly suggestive of SMA - Receiving adequate nutrition and hydration at the time of screening, in the opinion of the investigator - Adequately recovered from any acute illness at baseline and considered well enough to participate in the study, in the opinion of the investigator - Able and expected to be able to safely travel to the study site for the entire duration of the study and in accordance to the frequency of required study visits, in the opinion of the investigator - Able to complete all study procedures, measurements, and visits, and the parent (or caregiver), in the opinion of the investigator, has adequately supportive psychosocial circumstances - Parent (or caregiver) is willing to consider nasogastric, naso-jejunal, or gastrostomy tube placement during the study to maintain safe hydration, nutrition, and treatment delivery, if recommended by the investigator - Parent (or caregiver) is willing to consider the use of non-invasive ventilation during the study, if recommended by the investigator Exclusion Criteria: - Concomitant or previous participation in any investigational drug or device study at any time - Concomitant or previous administration of an SMN2-targeting antisense oligonucleotide, SMN2-splicing modifier, or gene therapy either in a clinical study or as part of medical care - Presence of significant concurrent syndromes or diseases - In the opinion of the investigator, inadequate venous or capillary blood access for the study procedures - Requiring invasive ventilation, tracheostomy or awake non-invasive ventilation - Awake hypoxemia (SaO2 < 95%) with or without ventilator support - Multiple or fixed contractures and/or hip subluxation or dislocation at birth - Systolic blood pressure or diastolic blood pressure or heart rate considered to be clinically significant by the investigator - Presence of clinically relevant ECG abnormalities before study drug administration; corrected QT interval using Bazetts method > 460 ms; personal or family history (first degree relatives) of congenital long QT syndrome indicating a safety risk for patients as determined by the investigator. First-degree atrioventricular block or isolated right bundle branch block are allowed - The infant (and the mother, if breastfeeding the infant) taking any inhibitor of CYP3A4 taken within 2 weeks, any inducer of CYP3A4 taken within 4 weeks, any OCT 2 and MATE substrates within 2 weeks and known FMO1 or FMO3 inhibitors or substrates - Clinically significant abnormalities in laboratory test results - Ascertained or presumptive hypersensitivity to risdiplam or to the constituents of its formulation - Treatment with oral salbutamol or another beta-2 adrenergic agonist taken orally for SMA is not allowed. Use of inhaled beta-2 adrenergic agonists is allowed - Infants exposed to drugs with known retinal toxicity given to mothers during pregnancy (and lactation) should not be enrolled. Anticipated need for drugs known to cause retinal toxicity during the study. - Diagnosis of ophthalmic diseases ; PRIMARY OUTCOME: Percentage of participants with two copies of the survival motor neuron (SMN) 2 gene (excluding the known SMN2 gene modifier mutation c.859G>C) and baseline compound muscle action potential (CMAP) >=1.5 millivolt (mV) who are sitting without support; SECONDARY OUTCOME 1: Percentage of participants developing clinically manifested SMA[/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 - AGA-201 (AGA; US); BRIEF: Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia. ; DRUG USED: ATI-502; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alopecia Areata; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Aclaris Therapeutics, Inc.; CRITERIA: Inclusion Criteria: Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a clinical diagnosis of androgenetic alopecia. Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length on their balding spot. Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the center of the identified target area. Subjects must agree to maintain the same hair style and hair care regimen during the study. Exclusion Criteria: Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication. Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss on the treatment area, due to disease, injury or medical therapy. Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments or efficacy or safety. ; PRIMARY OUTCOME: Mean Change From Baseline in Target Area Hair Count (TAHC); SECONDARY OUTCOME 1: Mean Change From Baseline in Target Area Hair Count (TAHC)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - DLB (Japan); BRIEF: To establish the safety and efficacy of HTL0018318 compared with placebo when administered once daily for 12 weeks to patients with dementia with Lewy bodies. ; DRUG USED: HTL18318; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dementia; TARGET: Muscarinic M1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Heptares Therapeutics Limited; CRITERIA: Inclusion Criteria: - Diagnosed with probable DLB according to the fourth revision of consensus diagnostic criteria for DLB. - Clinical imaging evidence from either SPECT or MIBG cardiac scintigraphy that is consistent with a clinical diagnosis of DLB. - Partner or caregiver able to support the patient for the duration of the clinical trial. Exclusion Criteria: - Patients with a diagnosis of Parkinson disease at least 1 year prior to onset of dementia. - Patients with the presence of severe extrapyramidal symptoms - Patients with the presence of an illness/condition apart from DLB that could contribute to cognitive dysfunction - Patients with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy, who are currently on more than 2 different antihypertensive treatments - Patients with prominent, recurrent episodes of syncope are related to orthostatic hypotension - Patients with pulmonary disease or evidence of clinically significant moderate or severe pulmonary symptoms - Patients who are taking a range of prohibited and restricted medication - Patients who have been prescribed individualised cognitive rehabilitation, stimulation or training that was performed under medical supervision in the 6 months prior to the screening visit - Patients who have any known condition(s) that may be contraindicated or interfere with the completion of the nuclear imaging scans. ; PRIMARY OUTCOME: Incidence and severity of treatment related adverse events; SECONDARY OUTCOME 1: Change from baseline in measures of cognitive impairment[/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 - ENVISION Clarity; BRIEF: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy. ; DRUG USED: ACU-4429; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Age-Related Macular Degeneration (Dry AMD)/Geographic Atrophy (Ophthalmology); TARGET: RPE65 (Retinal pigment epithelium-specific 65 kDa protein); THERAPY: Monotherapy; LEAD SPONSOR: Kubota Vision Inc.; CRITERIA: Inclusion Criteria: - Have a clinical diagnosis of geographic atrophy, as defined in the protocol Exclusion Criteria: - Currently receiving or has received a medication prohibited by the protocol ; PRIMARY OUTCOME: Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire; SECONDARY OUTCOME 1: Pharmacokinetics as measured by plasma ACU-4429 drug 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 I/II - CYNK-001-MM-002; BRIEF: This study will find the maximum tolerated dose (MTD) of CYNK-001 which contain NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given post Autologous Stem Cell Transplant (ASCT). The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating Multiple Myeloma. ; DRUG USED: CYNK-001; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Immune System, Natural Killer Cells (NK Cells), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Celularity Incorporated; CRITERIA: Subject Inclusion Criteria Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject has eligible disease status: Newly diagnosed multiple myeloma undergoing or completed induction therapy prior to undergoing first ASCT and presenting MRD positive by NGS after completion of induction therapy. 2. Subject is > 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF). 3. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 4. Subject is willing and able to adhere to the study schedule and other protocol requirements. 5. Performance status of Eastern Cooperative Oncology Group (ECOG) < 2 6. Ability to be off immunosuppressive drugs for at least 3 days prior to the CYNK-001 cell infusion. Steroids at the equivalent of no more than 5 mg prednisone per day are permissible. 7. Subjects must have autologous peripheral blood stem cell graft available in storage for additional transplant in the event of engraftment failure. 8. Female of childbearing potential (FCBP) must not be pregnant and agree to not becoming pregnant for at least 28 days following the CYNK-001. FCBP must agree to use an adequate method of contraception during the treatment period. FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). 9. Male subjects must agree to use a condom during sexual contact for at least 28 days following the CYNK-001, even if he has undergone a successful vasectomy. Subject Exclusion Criteria The presence of any of the following will exclude a subject from enrollment: 1. Subject has plasma cell leukemia. 2. Subject has non-secretory myeloma. 3. Subject has previously undergone allogeneic stem cell transplant. 4. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 5. Subject has any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he or she were to participate in the study. 6. Subject has any condition that confounds the ability to interpret data from the study. 7. Subject has a known sensitivity or allergy to lenalidomide which will limit the subject from receiving the mandatory lenalidomide maintenance as part of the study plan. 8. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase ≥ 2.5 x the upper limit of normal (ULN) within 7 days prior to melphalan administration. Transient abnormalities should be discussed with the medical monitor. 9. This eligibility criterion removed with Amendment 1 10. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening calculated using the Modification of Diet in Renal Disease Study equation. (Levey, 2006) 11. Subject has a bilirubin level > 2 mg/dL (unless subject has known Gilberts disease) at screening. 12. Subject has had prior treatment with biologic antineoplastic agents less than 7 days before CYNK-001 infusion and at least 5 half-lives since (excludes melphalan). (Exception will be granted for monoclonal antibodies that are known to have long half-lives, in which case a minimum of 2 weeks from last dose will be required). For agents that have known AEs occurring beyond these specified days after administration, this period must be extended beyond the time during which acute AEs are known to occur. Treating physicians are encouraged to discuss cases with the Medical Monitor. 13. Subject is pregnant or breastfeeding. 14. Subject has new or progressive pulmonary infiltrates or pleural effusion large enough to be detected by chest x-ray or computerized tomography (CT) scan within 2 weeks of CYNK-001 infusion. 15. Subject has active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy. 16. Subject who is human immunodeficiency virus (HIV) positive is excluded due to increased risk of lethal infections when treated with myeloablative chemotherapy. 17. Subject has history of malignancy, other than MM, unless the subject has been free of disease for > 3 years from the date of signing the ICF. Exceptions include the following noninvasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin CYNK-001 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) 18. Subject has a history of severe asthma and is presently on chronic medications or has a history of other symptomatic pulmonary disease. 19. Untreated chronic infection or treatment of any infection with systemic antibiotics within 2 weeks prior to melphalan. 20. Subject has any other organ dysfunction (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 3 or greater) that will interfere with the administration of the therapy according to this protocol. 21. Subject has a resting left ventricular ejection fraction (LVEF) of < 35% obtained by echocardiography or multigated acquisition scan (MUGA). 22. Subject was treated with an investigational product no less than 28 days before CYNK-001 infusion. Subject must no longer be a participant in the previous interventional study at the time of the CYNK-001 infusion. (Subjects who are under survival follow-up or observation associated with a study are permitted, and if treatment information is collected for this period, Investigational Study must be used for capturing the study treatment.) ; PRIMARY OUTCOME: Dose-Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Minimal Residual Disease (MRD) 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 - ACCESS; BRIEF: This study evaluates the effect of CCX168, a C5aR Antagonist, Oral Administration on Ex Vivo Thrombus Formation and Disease Activity in ten patients with diagnosis of Atypical Hemolytic Uremic Syndrome with or without genetic abnormalities in the complement system or thrombomodulin, on stable chronic extracorporeal or peritoneal dialysis therapy since at least 6 months. ; DRUG USED: Tavneos; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hemolytic Uremic Syndrome (HUS); TARGET: C5a Receptor, Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Mario Negri Institute for Pharmacological Research; CRITERIA: Inclusion Criteria: - Age >18 years; - Diagnosis of aHUS with or without identified genetic abnormalities in the complement system or thrombomodulin; - Stable chronic extracorporeal or peritoneal dialysis therapy since at least 6 months; - Written informed consent. Exclusion Criteria: - Women of childbearing potential or women who are breastfeeding; - Shiga toxin-associated HUS or secondary forms of thrombotic microangiopathy; - ADAMTS13 activity <10 % or circulating anti ADAMTS13 autoantibodies consistent with the diagnosis of thrombotic thrombocytopenic purpura; - Need for specific intervention with plasma therapy and/or complement inhibitors as deemed clinically appropriate; - Plasma therapy or treatment with complement inhibitors or antiplatelet and antithrombotic agents over the last two weeks; - Liver function impairment (serum liver enzymes or bilirubin levels >3 x upper limit of normal); - Neutrophil count < 2000/μL or lymphocyte count < 1000/μL; - Infection requiring antibiotic treatment within the previous 4 weeks prior to screening; - Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose; - History or presence of any medical condition or disease which, in the opinion of the Investigator may place the subject at unacceptable risk for study participation; - Inability to understand the potential risks and benefits of the study; - Legal incapacity. ; PRIMARY OUTCOME: Ex vivo thrombogenesis.; SECONDARY OUTCOME 1: Complement component 3 serum levels.[/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 - AB-NHL-01 ; BRIEF: This is a Phase 1/2, open-label, multicenter study. ; DRUG USED: PLM60; DRUG CLASS: Non-NME; INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: DNA, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; CRITERIA: Inclusion Criteria: - Signed informed consent prior to study-related procedures - Patients with histologically confirmed, relapsed or refractory NHL after treatment with standard regimens. Patients with both intermediate and aggressive subtypes (for example, diffuse large B-cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, anaplastic large-cell lymphoma) and indolent subtypes that require treatment (for example, follicular lymphoma, small lymphocytic lymphoma) will be enrolled into the Phase 1 part of the study; Patients with indolent types of NHL must have been assessed as needing further treatment by the Investigator, based on the presence of lymphoma-related symptoms or the presence of significant tumor burden;(Phase 1) - Adult patients with histologically confirmed relapsed or refractory aggressive NHL (including diffuse large B-cell lymphoma, peripheral T-cell lymphoma, and natural killer cell lymphoma) who were treated with standard regimens and for whom there is no known effective therapy;(Phase 2) - > 4 weeks since last cycle of chemotherapy prior to the study drug administration; - Recovered from all toxicity from prior chemotherapy at Investigators discretion; - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2; - Patients who have sufficient baseline organ function and whose laboratory data meet the following criteria at enrolment: Absolute neutrophil count ≥ 1.5 x 109/L; Platelets ≥ 75 x 109/L; Hemoglobin ≥ 90 g/L (unless bone marrow involvement is present); Liver function: Serum bilirubin ≤ 1.2 x upper limit of normal (ULN), Aspartate aminotransferase and alanine aminotransferase ≤ 3 x ULN without liver metastases or ≤ 5 x ULN if the patient has documented liver metastases; International normalization ratio < 1.3 if the patient is not on anticoagulants or < 3 if the patient is on anticoagulants o Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate > 40 mL/min/m2; - Left ventricular ejection fraction (LVEF) > 50%; - Life expectancy ≥ 12 weeks; - Women of childbearing potential must have a negative pregnancy test prior to study entry, and agree to use adequate contraception from study entry through at least 3 months after the last dose of study drug. Adequate methods of contraception for patient or partner include vasectomized partner (at least 6 months prior to dosing); intrauterine device; condom with spermicidal gel, foam, cream, film, or suppository; diaphragm with spermicidal gel, foam, cream, film, or suppository; or cervical cap with spermicidal gel, foam, cream, film, or suppository.A female patient of non-childbearing potential must have had at least 12 continuous months of natural (spontaneous) amenorrhea, follicle-stimulating hormone level > 40 mIU/mL at Screening, or have had surgical bilateral oophorectomy or a hysterectomy > 6 weeks prior to Screening; - A male patient must agree to use adequate contraception (male condom with spermicide; sterile sexual partner; or female sexual partner who uses an intrauterine device with spermicide, a female condom with spermicide, a contraceptive sponge with spermicide, an intravaginal system, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives) from study entry through at least 3 months after the last dose of study drug; - Involved lymph nodes or masses should be measurable in at least 2 perpendicular dimensions and be > 1.5 cm in the longest of the perpendicular dimensions (based on Cheson et al 2014) (Additional Inclusion Criteria for Phase 2); - Agree to undergo pretreatment bone marrow biopsy and post-treatment bone marrow biopsy when required to confirm response (Additional Inclusion Criteria for Phase 2). Exclusion Criteria: - Pregnant or breastfeeding women; - Patients with a history of allergy to anthracyclines or liposomal drugs; - Prior treatment with mitoxantrone; - Treatment with doxorubicin with a total cumulative dose > 300 mg/m2, or epirubicin with the total cumulative dose > 500 mg/m2; - Investigational treatment within 4 weeks of the start of PLM60; - Systemic chemotherapy within 4 weeks of the start of PLM60; - Radiotherapy (≥25 % of bone marrow) within 4 weeks of the start of PLM60; - Radio-/toxin-immunoconjugates within 42 days of the start of PLM60; - Prior allogeneic stem cell transplantation; - Known central nervous system involvement by NHL; - Patients who have the following types of cardiac impairment at the time of enrolment: New York Heart Association class III or IV heart disease; Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to enrolment; An LVEF by echocardiogram or multi-gated acquisition (MUGA) scan < 50%; QT interval prolongation (> 450 ms in males, > 470 ms in females); - A past history of cardiac disease caused by anthracyclines; - History of malignancy other than NHL in the past 3 years prior to enrolment, except for adequately treated non-melanoma skin cancer or in situ cervical cancer; - Patients with evidence of an active infection including the following: Patients being treated with antibiotics for an active infection at the time of enrolment; Patients who have evidence of active hepatitis C or chronic active hepatitis B; Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection/ acquired immunodeficiency syndrome (AIDS); - Other severe or poorly controlled illness or circumstance that would interfere with evaluation of key study endpoints or which would put the patient at risk from participating in the study in the opinion of the Investigator. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD)(Phase 1); SECONDARY OUTCOME 1: Maximum serum concentration (Cmax) of PLM60[/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 - Post-Transplant AML; BRIEF: This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing). ; DRUG USED: MT-401; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Melanoma antigen-encoding gene (MAGE), NY-ESO-1 (Cancer-testis antigen), PRAME/MAPE/OIP4, Stem Cells/Other Cell Therapies, Survivin, Synovial Sarcoma X (SSX) Breakpoint Family, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Marker Therapeutics, Inc.; CRITERIA: Inclusion Criteria 1. First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as: - Adjuvant therapy for AML (Group 1) at 85-130 days post-HSCT defined as patients with CRMRD; or - Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as - First relapse (MRD+ or frank relapse) post-HSCT - Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT - Safety Lead-in defined as patients who fit all the criteria for Group 2 only 2. Are ≥18 years of age 3. Karnofsky/Lansky score of ≥60 4. Life expectancy ≥12 weeks 5. Adequate blood, liver, and renal function - Blood: Hemoglobin ≥7.0 g/dL (can be transfused) - Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal - Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min 7. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant. 8. In Group 2, patients may receive bridging therapy at the investigators discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit Exclusion Criteria 1. Clinically significant or severely symptomatic intercurrent infection 2. Pregnant or lactating 3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401 4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401 5. Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401 ; PRIMARY OUTCOME: Safety Lead-In; 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 IIb - POLT-HCV-SVR; BRIEF: This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the new liver caused by HCV. ; DRUG USED: Emricasan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Liver Failure / Cirrhosis; TARGET: Caspases; THERAPY: Monotherapy; LEAD SPONSOR: Conatus Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study - History of orthotopic liver transplantation for HCV-induced liver disease - Diagnosis of HCV infection (HCV-RNA detectable in serum) and liver fibrosis and/or incomplete cirrhosis status post liver transplantation, and achieved a sustained virologic response (SVR) with anti-viral HCV treatment within 18 months of Day 1 - Liver fibrosis on liver histology as read by central histopathologist of Ishak F2 to F6 within three months of Day 1 (Up to 15 subjects with an Ishak score of F6 can be enrolled) - Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug Exclusion Criteria: - Known infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV) - History of renal transplant and/or severe renal impairment defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min/1.73 m2 - Evidence of tumor burden >Milan criteria, or evidence of micro- or macrovascular invasion in explanted liver - Hepatocellular carcinoma (HCC) at entry into the study - Concurrent sirolimus (rapamycin) use - History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec) - Subjects with diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA) - If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding ; PRIMARY OUTCOME: Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score; SECONDARY OUTCOME 1: Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)[/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 - RGT100-001; BRIEF: This is a Phase I/II multicenter, first-in-human open-label, dose escalation study to evaluate the safety, tolerability, and anti-tumor activity of intratumoral (IT)/intralesional (IL) injections of MK-4621 (RGT100) in adult participants with selected advanced or recurrent tumors. ; DRUG USED: MK-4621; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Apoptosis (Cell Death), Immune System, RIG-I (retinoic acid-inducible gene-I), RIG-I-like Receptors (RLR): RIG-I, MDA5, and LGP2; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: 1. Male or female aged ≥18 years 2. Participants with histologically or cytologically confirmed diagnosis of advanced or recurrent tumors (including lymphomas) for whom all standard treatments have been used or are not feasible and MK-4621 (RGT100) is a suitable treatment option and: 1. For Group A: has cutaneous, sub-cutaneous (SC), or lymph node injectable tumors 2. For Group B: has injectable liver tumors or liver metastases 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 4. Life expectancy >3 months as assessed by the Investigator 5. Adequate organ function 6. Negative serum pregnancy test within 2 weeks before first dose of study drug if the participant is a woman of childbearing potential. Participants and participants partners of childbearing potential must agree to use birth control consistently and correctly during the study and for at least 6 months after the last study drug application. 7. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and 1 separate injectable lesion with diameter ≥1 cm but <7 cm 8. Ability to provide written informed consent before any study drug-related screening procedures being performed Exclusion Criteria: 1. Any tumor-directed therapy within 4 weeks before study treatment 2. Treatment with investigational drugs within 4 weeks before study enrolment 3. Systemic steroids at a dose of >10 mg of prednisolone, >2 mg of dexamethasone a day or equivalent, except topical (inhaled, topical, nasal) for the last 28 days and ongoing 4. Participants with rapidly progressing disease (as determined by the Investigator) 5. Ongoing immune-related adverse events (irAEs) and/or adverse events (AEs) ≥ grade 2 not resolved from previous therapies except vitiligo, stable neuropathy grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy 6. Within 4 weeks of major surgery 7. Prior splenectomy 8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy 9. Primary or secondary immune deficiency 10. Active allergy requiring systemic medication or active infections requiring anti-infectious therapy 11. Seropositive (except after vaccination) for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) 12. Clinically significant cardiac disease including heart failure (New York Heart Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year before study entry 13. Dementia or altered mental status that would prohibit informed consent 14. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator 15. History of stroke, seizures, encephalitis, or multiple sclerosis 16. Gastric ulcer or inflammatory bowel disease or Crohns disease or ulcerative colitis in the last 6 months 17. Active drug or alcohol abuse 18. Pregnant or breast feeding ; PRIMARY OUTCOME: Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria; SECONDARY OUTCOME 1: Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)[/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 - R477-101; BRIEF: This is a randomized, placebo-controlled, double-blind study to evaluate safety, tolerability and pharmacodynamics of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This proof of concept study will determine whether glucagon receptor blockade using a single dose REMD-477 can improve short-term glucose homeostasis in people with Type 1 diabetes. ; DRUG USED: REMD-477; DRUG CLASS: Biologic; INDICATION: Diabetes Mellitus, Type I; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: REMD Biotherapeutics, Inc.; CRITERIA: Inclusion Criteria: - Men and women between the ages of 18 and 60 years old, inclusive, at the time of screening; - Females of non-child bearing potential must be ≥1 year post-menopausal (confirmed by a serum follicle-stimulating hormone (FSH) levels ≥ 40 IU/mL) or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception; - Male subjects must be willing to use clinically acceptable method of contraception during the entire study; - Body mass index between 18.5 and 26.9 kg/m2, inclusive, at screening; - Diagnosed with Type 1 diabetes for greater than 2 years, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria; - HbA1c ≥6.0 % but <9.0 % at screening; - Fasting C-peptide <0.2 ng/mL; - Current use of insulin pump and willing to use continuous glucose monitoring (CGM) system (e.g. DexCom) throughout the entire study; - ALT and/or AST within <1.5x ULN at screening; - Serum amylase and lipase within normal limits at screening; - Able to provide written informed consent approved by an Institutional Review Board (IRB). Exclusion Criteria: - History or evidence of clinically-significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion; - Significant organ system dysfunction (e.g., clinically significant pulmonary or cardiovascular disease, anemia [Hemoglobin <10.0 g/dL], and renal dysfunction [eGFR <90 ml/1.73M2/min]); - Any severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or medical facility in the past 6 months; - Current or recent (within 1 month of screening) use of diabetes medications other than insulin; - Use of steroids and/or other prescribed or over-the-counter medications that are known to affect the outcome measures in this study or known to influence glucose metabolism; - Smokes tobacco; - Known sensitivity to mammalian-derived drug preparations, recombinant protein-based drugs or to humanized or human antibodies; - History of illegal drug use or alcohol abuse within the last 6 months or a positive drug urine test result at screening; - History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine neoplasia; - History of pheochromocytoma, or family history of familial pheochromocytoma; - Known or suspected susceptibility to infectious disease (eg, taking immunosuppressive agents or has a documented inherited or acquired immunodeficiency); - Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C antibodies (HepC Ab); - Participation in an investigational drug or device trial within 30 days of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known, whichever period is longer; - Blood donor or blood loss >500 mL within 30 days of Day 1; - Women who are pregnant or lactating/breastfeeding; - Regular exercise >120 min/week within 14 days of Day 1; - Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits; - Family history of multiple endocrine neoplasia. Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Number of treatment emergent adverse events per subject, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs; SECONDARY OUTCOME 1: Immunogenicity: Incidence of REMD-477 neutralizing and non-neutralizing antibodies[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Probenecid (Healthy); BRIEF: The purpose of this study is to evaluate the effect of multiple-dose administration of probenecid on the pharmacokinetics of JNJ-63549109 and JNJ-64167896 after a single dose of JNJ-64041575 in healthy adult participants. ; DRUG USED: JNJ-64041575; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Syncytial Virus (RSV) Treatment; TARGET: RNA synthesis, RSV, Respiratory Syncytial Virus; THERAPY: Combination; LEAD SPONSOR: Janssen-Cilag International NV; CRITERIA: Inclusion Criteria: - Participants must have a body mass index (BMI; weight in [Kilogram] kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per meter square (kg/m^2, extremes included, and a body weight not less than 50.0 kg, inclusive, at screening - Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol - Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, extremes included, and no higher than 90 mmHg diastolic. If blood pressure is out of range, 1 repeated assessment is permitted after an additional 5 minutes of rest - Participants must have normal values for alanine transaminase (ALT) and aspartate aminotransferase (AST) (less than or equal to [<=]1.0 × upper limit of normal [ULN]) - A female participant, except if postmenopausal, must have a negative serum beta human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 and Day 21 Exclusion Criteria: - Participant has a history of current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease (example: glucose-6-phosphate-dehydrogenase deficiency), coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness, that in the investigators and/or sponsors medical monitor opinion should exclude the participant or that could interfere with the interpretation of the study results - Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table: [1] Serum creatinine grade 1 or greater (>1.0 × [Upper Limit of Normal] ULN) [2] Hemoglobin grade 1 or greater (<=10.5 grams per deciliter [g/dL]) [3] Platelet count grade 1 or greater (<=99,999/ cubic millimeter [mm^3]) [4] Reticulocyte count (absolute) below the lower limit of laboratory normal range [5] Absolute neutrophil count grade 1 or greater (<=1,500/mm^3) [6] Total bilirubin grade 1 or greater (>1.0 × ULN) [7] Any other toxicity grade 2 or above, except for grade 2 elevations of low density lipoprotein cholesterol and/or cholesterol - Participants with a history of uric acid kidney stones, conditions associated with elevated urinary uric acid excretion, participants with peptic ulcer disease or a history of peptic ulcer disease, or other contra-indications for the use of probenecid - Participants has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments - Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs ; PRIMARY OUTCOME: Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of JNJ-64041575); SECONDARY OUTCOME 1: Maximum Observed Plasma Concentration (Cmax) of JNJ-64167896 (Metabolite of JNJ-64041575)[/INST]Yes</s>

<s>[INST]<<SYS>>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. Lidocaine; BRIEF: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs. ; DRUG USED: ABT-639; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Voltage-gated calcium channels; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria - Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. - Subject must have an average score of greater than or equal to 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit. Exclusion Criteria - Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from diabetic neuropathic pain or interfere with the pain assessments of diabetic neuropathic pain. - A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with diabetic neuropathic pain assessments or other functions. - Subject has clinically significant abnormalities in clinical laboratory tests. ; PRIMARY OUTCOME: Spontaneous activity in peripheral c-nociceptors; SECONDARY OUTCOME 1: Pain intensity measurements[/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 - AROANG3-2001; BRIEF: The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3. ; DRUG USED: ARO-ANG3; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Angiopoietin-like 3 (ANGPTL3); THERAPY: Monotherapy; LEAD SPONSOR: Arrowhead Pharmaceuticals; CRITERIA: Inclusion Criteria: - Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL - Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy - Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart - Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care - Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication - Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding - Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1 - Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication - Able and willing to provide written informed consent and to comply with study requirements Exclusion Criteria: - Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule - Active pancreatitis within 12 weeks prior to Day 1 - Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study - Acute coronary syndrome event within 24 weeks of Day 1 - Major surgery within 12 weeks of Day 1 or planned surgery during the study - Planned coronary intervention (e.g., stent placement or heart bypass) during the study - Uncontrolled hypertension - Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV) - Uncontrolled hypothyroidism or hyperthyroidism - Hemorrhagic stroke within 24 weeks of Day 1 - History of bleeding diathesis or coagulopathy - Current diagnosis of nephrotic syndrome - Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study - Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) Note: additional inclusion/exclusion criteria may apply per protocol ; PRIMARY OUTCOME: Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24; SECONDARY OUTCOME 1: Percent Change from Baseline in Fasting TG Over Time[/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 - LUMINOS-103; BRIEF: This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which will be referred to throughout this protocol as anti-PD-1/L1 therapy) therapy in adult patients with solid tumor cancers. Non-muscle invasive Bladder Cancer has been selected as the tumor specific cancer of interest for enrollment. ; DRUG USED: PVSRIPO; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: Istari Oncology, Inc.; CRITERIA: Master Protocol Inclusion Criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Age ≥ 18 years of age at the time of signing the informed consent. 3. Prior CDC-recommended vaccination series against PV and has received a boost immunization with trivalent Poliovirus Vaccine Inactivated (IPOL®) (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to Cycle 1 Day 1. * Note: Patients who are unsure of their vaccination status must provide evidence of anti-PV immunity prior to enrollment, as applicable. 4. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 5. A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting the histology of the tumor type of interest must be confirmed to be available to send to the Sponsor. * Note: additional details can be found in the tumor specific appendix. 6. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. 7. Adequate bone marrow and liver function as assessed by the following: - Hemoglobin ≥9.0 g/dl (patients may be transfused) - Lymphocyte count ≥ 0.5 x 109/L (500/µL) - Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL) - Platelet count ≥100 x 109/L (100,000/µL) without transfusion - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) - Subjects with documented liver metastases: AST and ALT ≤5 x ULN - Serum total bilirubin ≤1.5 x ULN OR direct bilirubin <ULN for patients with total bilirubin > 1.5 x ULN - For patients not receiving therapeutic anticoagulation: international normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT) (or activated partial thromboplastin time [aPTT]) ≤ 1.5 x ULN 8. Resolution of nonhematologic toxicities from prior therapy or surgical procedures to ≤ Grade 1 or baseline (except alopecia). 9. Contraceptive use by men or women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Master Protocol Exclusion Criteria: 1. Any radiotherapy, chemotherapy, immunotherapy, biological, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or prostate-specific antigen persistence/recurrence without metastatic disease) within 21 days of Cycle 1 Day 1. 2. Patients requiring anticoagulation with warfarin are excluded. Additional eligibility criteria for anticoagulation requirements for each solid tumor cancer of interest will be provided in the tumor specific appendix. 3. Presence of central nervous system (CNS) metastases requiring immediate treatment with radiation therapy or steroids (ie, patient must be off steroids administered for brain metastases for ≥ 14 days prior to Cycle Day 1). Leptomeningeal disease is excluded regardless of clinical stability or treatment status. 4. Clinically significant (ie, active) cardiovascular disease at the time of signing the informed consent; for example, cerebrovascular accidents (≤ 6 months before the first dose of lerapolturev, myocardial infarction (≤ 6 months before the first dose of lerapolturev), unstable angina, serious cardiac arrythmia requiring medication, or uncontrolled symptomatic congestive heart failure [Class II or higher as defined by the New York Heart Association [NYHA] functional classification system; see Appendix 4]). 5. QTcF interval > 450 msec (males) or > 470 msec (females) at Screening (confirmed in triplicate). For patients with ventricular pacemakers or bundle branch block, QTcF >500 msec. 6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle Day 1, or anticipation of the need for major surgical procedure during the course of the study. 7. Active or history of autoimmune disease or immune deficiency within previous 2 years, with the following exceptions: - History of autoimmune-related hypothyroidism that is managed by thyroid replacement hormone - Type 1 diabetes mellitus that is well-controlled (as determined by the Investigator) by an established insulin regimen - Eczema, psoriasis, or lichen simplex chronicus with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded), provided all of the following conditions are met: - Rash must cover < 10% of body surface area - Disease is well-controlled (as determined by the Investigator) at baseline and requires only low-potency topical corticosteroids - No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within 12 months of Cycle 1 Day 1 8. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. - History of radiation pneumonitis in the radiation field (fibrosis) is allowed. 9. Uncontrolled pleural effusion, pericardial effusion, or ascites; patients with indwelling catheters (eg, PleurX®) are allowed. 10. Known serious active infection (eg, human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.). - Participants with a negative hepatitis B surface antigen (HBsAg) test and a positive total hepatitis B core antibody (HBcAb) test are allowed. - History of positive hepatitis C virus (HCV) antibody test, but negative HCV RNA test is allowed. - Participants with a historical positive HIV test are not allowed. 11. Treatment with systemic immunosuppressive medication within 28 days of Cycle 1 Day 1, with the following exceptions: - Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (eg, 48 hours of corticosteroids for a contrast allergy) are eligible. - Patients receiving mineralocorticoids (eg, fludrocortisone), or systemic prednisone equivalent corticosteroid doses of < 10 mg per day are eligible for the study. 12. Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation. 13. Receipt of any live, attenuated vaccines within 28 days of Cycle 1 Day 1. Vaccination to prevent symptomatic SARS-CoV-2 infection is allowed as long as the vaccine is NOT a live attenuated vaccine (e.g. adenovirus-based constructs); however, the vaccine should be administered ≥ 1 week before or after a lerapolturev injection. 14. Known hypersensitivity to any of the drugs used in this study. 15. Pregnant or lactating women. 16. History of human serum albumin allergy. 17. History of neurological complications due to PV infection. 18. History of agammaglobulinemia. 19. Legal incapacity or limited legal capacity. 20. Other uncontrolled serious chronic disease or psychiatric condition that in the Investigators opinion could affect the patients safety, compliance, or follow-up in the protocol. Non-Muscle Invasive Bladder Cancer Specific Inclusion Criteria: 1. Prior history of stage Ta, T1, or Tis urothelial carcinoma of the bladder 1. Tumors with up to 50% squamous or glandular differentiation are eligible 2. History of variant bladder histologies are excluded (eg, sarcomatoid, plasmacytoid, small cell or neuroendocrine, pure pure squamous cell carcinoma, pureadenocarcinoma, micropapillary, nested, lymphepithelioma-like, clear cell) 2. Documented tumor recurrence at cystoscopy where the tumor is amenable to TURBT or cystectomy. 3. Measured or calculated (per institutional standard) creatinine clearance ≥ 45 ml/min (glomerular filtration rate [GFR] can also be used in place of creatinine clearance). 4. If the patient has an available formalin-fixed paraffin-embedded (FFPE) tumor specimen with an associated pathology report documenting NMIBC, the specimen must be confirmed to be available to send to the Sponsor. Patients without an available FFPE specimen are still eligible to enroll. 5. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is NOT required. This is an exception to the inclusion criterion outlined in the master protocol. Non-Muscle Invasive Bladder Cancer Specific Exclusion Criteria: 1. Patients with exposure to intravesical agents (e.g. BCG, mitomycin C, epirubicin, oncolytic viruses, anti-PD-1/L1 inhibitors, investigational therapies, etc.) within 3 months prior to the administration of lerapolturev. 2. Patients whose anticoagulation or antiplatelet medications cannot be managed by local institutional guidelines to accommodate the safe intravesical instillation of lerapolturev followed by TURBT, as determined by the treating physician. 3. Received prior radiation to the pelvis. 4. Received prior systemic therapy for bladder cancer, including PD-1/L1 inhibitors. 5. History of vesicoureteric reflux or an indwelling urinary stent. 6. History of stage T2 or higher bladder cancer 7. Medical conditions (as determined by the investigator) that would interfere with the ability of the patient to retain urine for 2 hours. Examples include urinary incontinence, overactive bladder, or low bladder compliance. ; PRIMARY OUTCOME: Proportion of patients who undergo TURBT or cystectomy as scheduled; 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 - Keynote 596; BRIEF: This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal tumors and CGX1321 in combination with encorafenib + cetuximab in BRAFV600E mutated colorectal tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity. ; DRUG USED: CGX1321; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Curegenix Inc.; CRITERIA: Inclusion Criteria The following criteria must be met by ALL subjects 1. Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 1) or immune-related (ir)RECIST 1.1 (Phase 1b and Roll-over Cohort). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions 2. Minimum estimated life expectancy of 3 months 3. Age 18 years or older 4. Must have adequate organ function, including the following: - Absolute neutrophil count (ANC) ≥ 1.5 x109/L; platelet count ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L - International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal (ULN) unless subject is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants - Hepatic: total bilirubin ≤ 1.5 times ULN, aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases) - Renal: serum creatinine ≤ 1.25 times the ULN or estimated creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula [http://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation/]) 5. Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities 6. Ability to swallow capsules 7. Ability to comply with treatment, laboratory monitoring and required clinic visits 8. Able to understand and willing to sign the informed consent form (ICF) In addition, the following criteria must be met based on the group to be enrolled into: For subjects in the Phase 1 Single Agent CGX1321 Dose Escalation phase: 1. Pathologically-confirmed, locally advanced or metastatic solid tumors in subjects that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment 2. Eastern Cooperative Oncology Group (ECOG) score of 0 - 2 3. Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment For subjects in the Phase 1 Single Agent CGX1321 Dose Expansion phase: 1. Histologically diagnosed advanced GI tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma in subjects that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment. Subjects must have confirmed genetic alterations (e.g., Rspo2 fusion, Rspo3 fusion or predicted loss-of-function mutations in RNF43) upstream in the WNT pathway and no predicted change-of-function alterations in genes (e.g., APC, CTNNB1 and Axin1) downstream in the WNT pathway 2. ECOG score of 0 - 2 3. Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment For subjects in the Phase 1b or Roll-over Cohort CGX1321 in combination with pembrolizumab: 1. Histologically or cytologically confirmed diagnosed advanced colorectal tumors that are mismatch repair-proficient or MSS in subjects that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (for dose escalation) and histologically or cytologically confirmed diagnosed advanced colorectal tumors with confirmed genetic alterations (e.g., Rspo2 fusion, Rspo3 fusion or predicted loss-of-function mutations in RNF43) upstream in the WNT pathway and no predicted change-of-function alterations in genes (e.g., APC, CTNNB1 and Axin1) downstream in the WNT pathway (for dose expansion) Note: Not applicable for subjects entering Roll-over Cohort 2. Previous enrollment into either Phase 1 single agent dose escalation or Phase 1 single agent dose expansion with documented disease progression while on treatment with single agent CGX1321 Note: Not applicable for subjects entering Phase 1b 3. ECOG score of 0 - 1 4. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of pembrolizumab. Subjects of childbearing potential are those who have not been surgically sterilized or have been free from menses for > 1 year. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of pembrolizumab through 120 days after the last dose of pembrolizumab Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject For subjects in the Phase 1b Cohort CGX1321 in Combination with Encorafenib + Cetuximab: 1. Histologically diagnosed advanced colorectal tumors (CRC) carrying a BRAF V600E mutation in tumor tissue, (as detected by an FDA-approved test) with confirmed genetic alterations (e.g., Rspo2 fusion, Rspo3 fusion or predicted loss-of-function mutations in RNF43) upstream in the WNT pathway and no predicted change-of-function alterations in genes (e.g., APC, CTNNB1 and Axin) downstream in the WNT pathway 2. Have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment in the metastatic setting Note: Prior treatment with encorafenib + cetuximab is will be is permitted Exclusion Criteria All subjects must be excluded from participating in the study if subjects meet any of the following criteria: 1. Prior exposure to a WNT inhibitor. Note: Not applicable for subjects entering Roll-over Cohort 2. Received any of the following within the specified time frame prior to administration of study drug: • Previous therapy for malignancy within 21 days, including any investigational agents, chemotherapy, immunotherapy, biological or hormonal therapy Note: Only applicable for subjects in single-agent dose escalation cohorts 3. Major surgery within 4 weeks of first dose of study treatment 4. Radiotherapy within 2 weeks of first dose of study treatment. Note for Phase 1b or Roll-over Cohorts: Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. 5. Significant GI or variceal bleeding or subdural hematoma within 3 months of first dose of study treatment 6. Known active central nervous system metastases and/or carcinomatous meningitis Note: Subjects with previously treated brain metastases may participate provided they are radiographically stable (without evidence of progression by imaging (using the identical imaging modality for each assessment, either magnetic resonance imaging [MRI] or computed tomography [CT] scan) for at least four weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to the first dose of study treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability 7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug 8. Currently receiving medications known to be inhibitors of CYP3A4/5. Subjects currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded unless determined by the Investigator to be in the best interest of the subject and are approved by the Sponsor 9. Osteoporosis based on a T-score of < -2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1 - L4) as determined by dual-energy x-ray absorptiometry (DXA) scan 10. Subjects with bone metastases that: - Have a prior history of a pathologic fracture - Have a lytic lesion requiring an orthopedic intervention or - Are not receiving a bisphosphonate (zoledronic acid or denosumab) as per institutional guidelines 11. Current bisphosphonate therapy for symptomatic hypercalcemia 12. History within last 6 months of New York Heart Association Class III or IV heart failure, acute myocardial infarction, angina pectoris, uncontrolled arrhythmia, acute coronary syndromes, stent placement, uncontrolled hypertension 13. Subjects with QTc interval of > 470 msec 14. Known human immunodeficiency virus positive (such patients are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy) 15. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer 16. Active systemic infection requiring IV antibiotics within 2 weeks of the first dose of study treatment 17. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subjects participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator 18. Known psychiatric or substance abuse disorders that would interfere with the subjects ability to cooperate with the requirements of the study. 19. Pregnancy or lactation 20. Has had an allogeneic tissue/solid organ transplant In addition, subjects must be excluded from participating if they meet any of the following criteria based on the group to be enrolled into: For subjects in the Phase 1 Single Agent CGX1321 Dose Escalation or Dose Expansion phase: 1. Known active hepatitis A, B or C Note: Subjects who are HBsAg+ and have DNA load < 2000 IU/mL (104 copies/mL) are eligible to participate in the Phase 1 study For subjects in the Phase 1b or Roll-over Cohort CGX1321 in combination with pembrolizumab: 1. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority 2. Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to first dose of study treatment 3. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment 4. History of (non-infectious) pneumonitis that required steroids or current pneumonitis 5. History of interstitial lung disease 6. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment 7. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CG137) and was discontinued from that treatment due to a Grade 3 or higher irAE or if the patient has previously participated in Merck MK-3475 clinical studies 8. Has severe (≥ Grade 3) hypersensitivity to any of the excipients of pembrolizumab 9. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier 10. Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted For subjects in the Phase 1b Cohort CGX1321 in Combination with Encorafenib + Cetuximab: 1. Symptomatic brain metastases or leptomeningeal disease 2. History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) 3. Known history of acute or chronic pancreatitis 4. History of chronic inflammatory bowel disease or Crohns disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to enrollment 5. Uncontrolled blood pressure despite medical treatment 6. Impaired GI function or disease that may significantly alter the absorption of encorafenib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption) 7. History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli 8. Concurrent neuromuscular disorder that is associated with the potential of elevated creatinine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) 9. Active hepatitis B or hepatitis C infection 10. Known history of Gilberts syndrome 11. Known contraindication to receive Encorafenib or Cetuximab at the planned doses ; PRIMARY OUTCOME: Number of participants with adverse events and/or abnormal laboratory values that are related to treatment; SECONDARY OUTCOME 1: CGX1321 area under the curve[/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 - SC/IV Single Dose (B1481006); BRIEF: This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy. ; DRUG USED: Bococizumab; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Fasting LDL-C greater than or equal to 130 mg/dL at two qualifying screening visits. - Total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to 150 kg (330 lbs) Exclusion Criteria: - Lipid-lowering prescription medications, homeopaths, herbal medicines, or nutritional supplements. - Poorly controlled type 1 or type 2 diabetes. - History of a cardiovascular or cerebrovascular event or related procedure during the past year. - Poorly controlled hypertension. ; PRIMARY OUTCOME: Maximum Observed Plasma Concentration (Cmax) of PF-04950615; SECONDARY OUTCOME 1: Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - C22001; BRIEF: Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This study will be the first to administer TAK-960 to humans. The patient population will consist of adults with a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential, or for which no standard treatment is available. ; DRUG USED: TAK-960; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Polo-like kinase 1 (Plk1); THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: - Male or female 18 years or older - Clinical laboratory values as specified in protocol - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histologically and/or cytologically confirmed diagnosis of metastatic, unresectable, advanced evaluable nonhematologic malignancy for which standard treatment is not available or no longer effective - Radiographically or clinically evaluable tumor - Suitable venous access for study-required blood sampling - Female patients who are postmenopausal, surgically sterile or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse - Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse - Voluntary written consent - Willing to undergo biopsy procedures (expansion phase only) - Weight at least 40 kg - Recovered from the reversible effects of prior antineoplastic therapy to Grade ≤ 1 or to patients baseline values, excluding alopecia Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: - Diagnosis of primary central nervous system malignancy or carcinomatous meningitis - Patient has symptomatic brain metastasis. Patients with brain metastases must: have stable neurologic status for at least 2 weeks following completion of local therapy AND be without neurologic dysfunction that would confound the evaluation of adverse events - Prior allogeneic bone marrow or stem cell transplant - Prior therapy or treatment as specified in protocol - Female patients who are lactating or who have a positive serum pregnancy test during the screening period of within 3 days before the first dose of TAK-960 - Myocardial infarction within 6 months before first dose of TAK-960 - Any of the cardiovascular conditions or values as specified in the study protocol within 6 months before the first dose of TAK-960 - Infection requiring systemic anti-infective therapy within 14 days before the start of TAK-960, or other severe infection - Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or known suspected active hepatitis C infection - A diagnosis of or treated for another malignancy within 2 years before the first dose of TAK-960 or previous diagnosis of another malignancy and any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection - Any serious medical or psychiatric illness that could potentially interfere with the completion of treatment - Recurrent nausea or vomiting or requirement for antiemetic therapy within 14 days before the first dose of TAK-960 - Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerability of TAK-960, including difficulty swallowing capsules - Treatment with any investigational products within 21 days before the first dose of TAK-960 - Systemic use of strong CYP3A inhibitors or inducers within 14 days before the first dose of TAK-960 - Patients enrolled in the expansion cohorts where tumor biopsies are required must meet additional criteria according to the study protocol ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960; 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 - V1.4 (China); BRIEF: The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. ; DRUG USED: Gerilimzumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Genor Biopharma Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Understand the study procedures and contents, and voluntarily sign the informed consent form; 2. Chinese healthy adult volunteers aged 18 to 45 years, males and females; 3. The subjects have qualified physical examination within 30 days before the study, the body mass index (BMI) is within the range of 19~24 and the body weight is within the range of 45~75kg; 4. Males or females agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 6 months after the end of this study. 5. The investigator considers that the patients have good health condition according to the physical examination, medical history, vital signs and ECG etc. 6. Patients have good compliance, can receive follow-up visits as scheduled, are able to well communicate with the investigators and complete the study as required by the study. Exclusion Criteria: 1. Any of the following is met: allergic constitution; known allergic to the components of the investigational product or allergy history to any drug or food or pollen; subjects who have medical history of skin allergy such as physical urticaria; subjects who have abnormal serum immunoglobulin E (IgE) test; 2. Any of the current symptoms, signs or laboratory test abnormalities indicating the possible presence of acute or subacute infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.) 3. Patients with active pulmonary tuberculosis; patients who previously had medical history of active pulmonary tuberculosis; 4. Subjects who have medical history of drug addiction or drug abuse; 5. Subjects who have clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or subjects with other significant diseases; subjects with medical history of hypertension or screening systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, which are clinically significant at the discretion of the investigators; subjects who have medical history of orthostatic hypotension; 6. Subjects who have medical history of malignant tumors; 7. Subjects who participated in other clinical studies within 3 months before enrollment, or subjects who received drugs which are known to injure the major organs within 3 months before enrollment; 8. Subjects who used prescription drugs or non-prescription drugs within 14 days before enrollment; 9. Subjects who have blood donation history within 3 months before enrollment; 10. Subjects who meet any of the following criteria: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN), serum creatinine (Cr) > the upper limit of normal (ULN); 11. Abnormal routine blood tests: any of the following is met: white blood cells (WBC)<3.0×109/L or >9.5×109/L, neutrophil count (ANC)<1.5×109/L, platelet count (PLT)<100×109/L, hemoglobin (HGB)<104g/L; 12. Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab); 13. Subjects who have positive tuberculosis skin test (5 units of dosage, induration of not less than 5 millimeters (mm) within 48 ~ 72 hours); 14. Subjects with positive anti-nuclear antibody (ANA), anti-double stranded DNA antibody (ds-DNA) and anti-extractable nuclear antigens (ENA); 15. Subjects with positive anti-drug antibody (ADA); 16. Subjects with positive tumor markers (CEA, AFP, PSA and CA-125); 17. Subjects with abnormal coagulation function, which is clinically significant at the discretion of the investigators; 18. Subjects with medical history of psychiatric disorders; 19. Smoking more than 5 cigarettes/day or equivalent tobacco; 20. Weekly alcohol consumption more than 28 units (1 unit = 285 mL of beer or 25 mL of spirits or a glass of wine); or subjects who have positive breath alcohol test within 24 hours before the use of investigational drug; 21. Subjects who have clinically significant abnormal laboratory test values at screening; 22. Female subjects who have positive serum/urine pregnancy tests at screening or lactating women; 23. Patients who have insufficient communication, understanding and cooperation; or patients who have poor compliance and cannot guarantee to strictly follow the study protocol; 24. Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator. ; PRIMARY OUTCOME: Adeverse Effect, AE; SECONDARY OUTCOME 1: AUC0-t[/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 - INSPIRE-CKD; BRIEF: The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months). ; DRUG USED: Aprocitentan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Endothelin Receptor Type A (EDNRA), Endothelin Receptor Type B (EDNRB); THERAPY: Monotherapy; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: - Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic, - Participants with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology equation), - Women of childbearing potential are eligible only if the following applies: - Negative pregnancy test at the screening visit and at baseline (i.e., end of run-in period). - Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation. - Agree to use highly-effective methods of contraception up to at least 30 days after study treatment discontinuation. Exclusion Criteria: - Mean sitting systolic blood pressure above 170 mmHg measured by automated office blood pressure measurement (AOBPM), - Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM, - Change in renal function requiring hospitalization, documented eGFR decline of greater than 20% in the 3 months prior to the screening visit, dialysis in the 3 months before the screening visit, - Planned dialysis or kidney transplant during the course of this study, - Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g, - Known and documented chronic heart failure. ; PRIMARY OUTCOME: Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.; SECONDARY OUTCOME 1: Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.[/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 - 01.1.1.H1 ; BRIEF: The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate asthma over a 4-week period. ; DRUG USED: RNS60; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Secretin receptor; THERAPY: Monotherapy; LEAD SPONSOR: Revalesio Corporation; CRITERIA: Inclusion Criteria: For single-dose safety (Groups 1a and 1b): 1. Male or female, aged 18 to 65 years. 2.1. For healthy subjects; clinically considered healthy and no diagnosis of asthma. 2.2. For subjects with mild asthma, clinical diagnosis of mild chronic asthma as determined by National Heart, Lung, and Blood Institutes (NHLBI) 2007 guidelines, and who are not regularly using a chronic asthma medication (< 3 doses/week). 3. Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent. 4. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry. For multi-dose safety study (Group 2e): 1. Male or female, aged 18 to 65 years. 2. Patients with clinical diagnosis of mild to moderate asthma, as determined by NHLBI 2007 guidelines, who are not already using a chronic asthma medication. 3. Historical documentation of asthma in the patients medical record. 4. Men and women of reproductive potential who document use of adequate contraception during the study and for 1 month following the last day of treatment (Day 28). 5. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry. 6. Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent. Exclusion Criteria (for all groups of the study): 1. With a chronic or acute disease that might interfere with the evaluation of RNS60 therapy. 2. Pregnancy or lactation. 3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated). 4. History of infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV). 5. Infections that require intravenous antibiotic therapy. 6. Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry). 7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry. 8. Treatment with any investigational drugs or therapies within 4 weeks prior to study entry. 9. Any use of antidepressants or other psychiatric medicine in the previous 4 weeks days. 10. Group 1b: Any use of oral, systemic corticosteroids within 2 weeks prior to enrollment. Group 2e: Any use of oral, systemic corticosteroids within 4 weeks prior to enrollment. ; PRIMARY OUTCOME: Forced expiratory volume in 1 second (FEV1); SECONDARY OUTCOME 1: Peak expiratory flow[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COMMODORE 3 (China); BRIEF: This study will enrol participants aged 12 years or older with a body weight >= 40 kilograms (kg) diagnosed with PNH who have not been previously treated with complement inhibitor therapy. Approximately 50 participants will be treated with Crovalimab for at least 24 weeks. ; DRUG USED: Crovalimab; DRUG CLASS: Biologic; INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Body weight >= 40 kg at screening. - Willingness and ability to comply with all study visits and procedures. - Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry. - LDH Levels >= 2x the ULN at screening. - Participants who have at least four transfusions during 12 months prior to screening (documented in the medical record). - Presence of one or more of the following PNH-related signs or symptoms within 3 months of screening. - Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of study treatment (Day 1) - Vaccination against Haemophilius influenzae type B and Streptococcus pneumonia according to national vaccination recommendations. - For participants receiving other therapies (e.g., immunosuppressants, corticosteroids): stable dose for >= 28 days prior to screening and up to the first drug administration. - Adequate hepatic and renal function. - Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 46 weeks (approximately 10.5 months) after the final dose of crovalimab. - Platelet count >=30,000 cubic millimeter (mm^3) at screening - ANC > 500/μl at screening Exclusion Criteria: - Current or previous treatment with a complement inhibitor. - History of allogeneic bone marrow transplantation. - History of Neisseria meningitidis infection within 6 months prior to screening and up to first drug administration. - Known or suspected immune or hereditary complement deficiency. - Known HIV infection with CD4 count < 200 cells per microlitre (cells/µl) within 24 weeks prior to screening. - Infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 28 days prior to screening and up to the first drug administration, or oral antibiotics within 14 days prior to screening and up to the first drug administration. - Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration. - Presence of fever (>= 38˚C) within 7 days before the first drug administration. - Splenectomy < 6 months before screening. - History of malignancy within 5 years prior to screening and up to the first drug administration. - Pregnant or intending to become pregnant during the study or within 46 weeks (10.5 months) after the final dose of study treatment. - Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater. ; PRIMARY OUTCOME: Mean Percentage of Participants With Hemolysis Control; SECONDARY OUTCOME 1: Percentage of Participants With Breakthrough Hemolysis (BTH)[/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 - Acute Mountain Sickness; BRIEF: Acute mountain sickness (AMS) is one of three syndromes of altitude illness. It is very common when people venture over 2500 meters altitude. This illness is mainly induced by acute exposure to low partial pressure of oxygen at high altitude that will cause a pathological effect on humans. T89 capsule is a modernized industrialized traditional Chinese herbal medicine. It is a botanical drug for oral use. In recent years, several literatures and clinical studies have showed that oral administration of T89 may provide substantial benefits in the prevention or alleviation of symptoms associated with acute mountain sickness (AMS), including nausea, vomiting, headache, dizziness, fatigue, and sleep disturbance. Such effect was also observed in a pilot clinical study recently conducted in Tibet in China. This study is a prospective, double-blind, randomized, placebo-controlled phase 2 clinical trial having three arms including T89 low-dose, T89 high-dose and a placebo controlled group. People will be screened against the inclusion/exclusion criteria after informed consent signed. Eligible subjects will be randomly assigned into one of three arms and instructed to use T89 orally twice daily for 14 days (Days 1-14) before ascending, and 5 days after ascending during the observation period (Days 15-19). The primary efficacy parameter is Lake Louise Scoring System (LLSS) which will be evaluated by subject-self and principal investigator in clinic. ; DRUG USED: Dantonic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Emesis; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Tasly Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy volunteers: ages 18 - 55 years old; 2. Primary residence elevation of 1,000 ft or lower; 3. Not ascending to altitude >10,000 ft within 4 months prior to screening; 4. Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigators opinion is acceptable. Females must agree to remain on their established method of contraception from the time of the screening visit and throughout the study period. 5. Willing to participate voluntarily and to sign a written informed consent. Exclusion Criteria: 1. Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma; 2. Subjects with clinically significant respiratory system disease, digestive disease, mental disease, metabolic disease, acute infection or anemia; 3. Total LLSS self-assessment score and clinical assessment score is greater than 1 before ascending (Screening visit and Visit 1); 4. Blood oxygen saturation (SpO2) <95% at sea level; 5. Subjects with abnormal renal or liver function with clinical significance (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2×upper limits of normal(ULN), Creatinine> ULN); 6. Subjects with C reactive protein (CRP) > ULN; 7. Subjects with primary headache; 8. Surgery or blood donation within 3 months prior to screening; 9. On treatment of any medications (including any dietary supplements)except for birth control within 14 days prior to screening and throughout the study period; 10. Contradictive to treatment of Danshen (Radix Salivae Miltiorrhizae, RSM) products; 11. Women in pregnancy or lactation period; 12. Substance abuse. Subjects with a recent history (within the last 2 years) of alcoholism or known drug dependence; 13. Participation in any other clinical trial or on an investigational drug within 30 days prior to screening; 14. A family member or relative of the study site staff; 15. Any other condition that, in the opinion of the investigator, is likely to prevent compliance with the study protocol, interfere with the assessment, or pose a safety concern if the subject participates in the study. ; PRIMARY OUTCOME: The LLSS self- and clinical assessments score on Day 16 morning(next morning of arrival at high altitude) between T89 and Placebo groups.; SECONDARY OUTCOME 1: The area under the curve (AUC) of LLSS self- and clinical assessments score in the mean LLSS score-time profile during rapid ascent (Days 15-19) between T89 and Placebo 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 I - Relapsed/Refractory CD123+; BRIEF: This phase I trial studies the side effects and the best dose of genetically modified T-cells after lymphodepleting chemotherapy in treating patients with acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm that has returned after a period of improvement or has not responded to previous treatment. An immune cell is a type of blood cell that can recognize and kill abnormal cells in the body. The immune cell product will be made from patient or patients donor (related or unrelated) blood cells. The immune cells are changed by inserting additional pieces of deoxyribonucleic acid (DNA) (genetic material) into the cell to make it recognize and kill cancer cells. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells. ; DRUG USED: MB-102; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), IL-3 (Interleukin-3), Immune System, Stem Cells/Other Cell Therapies; THERAPY: Combination; LEAD SPONSOR: City of Hope Medical Center; CRITERIA: Inclusion Criteria: - ARM 1 - AML: Research patients enrolled are those patients with relapsed or refractory CD123+ AML de novo, or secondary OR participants who are at high risk for disease recurrence NOTE: CD123+ biphenotypic acute leukemia or CD123+ acute lymphoblastic leukemia (ALL) may also be considered but only after discussion with the study principal investigator (PI) - Relapsed AML is defined as patients that had a first complete remission (CR) before developing recurrent disease (increased bone marrow blasts) - Refractory AML is defined as patients that have not achieved a first CR after 2 cycles of induction chemotherapy; for patients with AML evolving from myelodysplastic syndrome, they should have completed at least one cycle of induction chemotherapy - ARM 2 - BPDCN: Research participants with a diagnosis of BPDCN, according to World Health Organization (WHO) classification by hematopathology, who underwent at least 1 line of systemic therapy for BPDCN and who have persistent or recurrent disease in at least one of the following are eligible: peripheral blood, bone marrow, lymph nodes, spleen, cutaneous lesions or other sites OR participant who are at high risk for disease recurrence - FOR BOTH STUDY ARMS: Research participants must have bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML or BPDCN; CD123 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry; cytogenetics, flow cytometry, and molecular studies (such as FMS-like tyrosine kinase-3 [FLT-3] status) will be obtained as per standard practice; however, for research participants who are at a high risk of recurrence, they must have historical bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML or BPDCN; CD123 positivity must be confirmed by either flow cytometry or immunohistochemistry prior to start of lymphodepletion - Karnofsky performance status score >= 70 - A life expectancy >= 16 weeks at time of enrollment - Pediatric research participants must weigh > 50 kg - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately - Calculated creatinine clearance (absolute value) of >= 50 mL/minute or creatinine < 2.0 mg/dl or < 2 times upper limit of normal for the research participants age group - Serum bilirubin =< 3.0 mg/dL - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 times the institutional upper limits of normal - Ejection fraction measured by echocardiogram (ECHO) or multi gated acquisition scan (MUGA) >= 50% - ONLY research participants experiencing hypoxia with oxygen saturation less than 92% are required to have diffusion capacity of carbon monoxide (DLCO) or forced expiratory volume in one second (FEV1) > 45% predicted - Research participants last dose of prior chemotherapy or radiation must be >= 2 weeks before leukapheresis * Note: the above criterion is not applicable if the research participants donor is undergoing leukapheresis - If a research participant has undergone prior allogeneic stem cell transplant, he/she must be off all immunosuppressants for graft versus host disease (GVHD) for at least 2 weeks before undergoing leukapheresis * Note: the above criterion is not applicable if the research participants donor is undergoing leukapheresis - Negative serum or urine pregnancy test - All research participants must have the ability to understand and willingness to sign a written informed consent or age appropriate assent for pediatric patients * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed - ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PMBC) COLLECTION: * If research participant is undergoing leukapheresis: - He/she has acceptable venous access as assessed by Donor Apheresis Center or if venous access was not acceptable, a Hickman Catheter or temporary line was placed prior to scheduled leukapheresis - He/she has undergone prior alloSCT, they must be at least 2 weeks from having received the last dose of immunosuppressant medications to undergo PBMC collection for T cell manufacturing - His/her last dose of prior chemotherapy, immunotherapy or radiation is at least 2 weeks out from PBMC collection - ELIGIBILITY TO UNDERGO LYMPHODEPLETION Note: evaluations should be performed no more than 7 days prior to lymphodepletion - Research participant with central nervous system (CNS) leukemic involvement that is refractory to intrathecal chemotherapy and/or cranio-spinal radiation but effectively treated to completion remission (< 5 white blood cell[WBC]/mm^3 and no blast in cerebrospinal fluid [CSF]) is eligible to proceed with lymphodepletion - Research participants must have a donor or stem cells source identified for allogeneic transplantation, either related (7/8 or 8/8 allele matched or haploidentical), unrelated 7/8 or 8/8 allele match) donor, or cord blood stem cell source (at lease 4/6 matched) - Research participants with a response less than a CR or complete response with incomplete hematopoietic recovery (CRi) or detectable minimal residual disease (MRD) positive disease - Research participant has a released cryopreserved T cell product for CAR T cell infusion on approximately day 0 - Research participant must be at least 2 weeks out from having received the last dose of investigational agent - Karnofsky performance status (KPS) >= 70 - Documented measurable or evaluable disease - Non hematological toxicity related to prior therapy must either have returned to =< grade 2, baseline, or deemed irreversible - Research participants of reproductive potential must agree to use and utilize and adequate method of contraception throughout treatment and for at least 8 weeks after T cell infusion - If a research participant has undergone prior allogeneic stem cell transplant, he/she must be off all immunosuppressants for GVHD for at least 7 days before beginning lymphodepletion - Pulmonary: not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or higher on room air - Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension - Renal Function: calculated creatinine clearance (absolute value) of >= 50 mL/minute or creatinine < 2.0 mg/dl or < 2 times upper limit of normal for the research participants age group - Liver Function: adequate liver function defined as total bilirubin =< 3.0 mg/dl - ALT and AST =< 5 times the institutional upper limits of normal - Neurological: research participant without clinically significant encephalopathy/new focal deficits - Infectious diseases: no clinical evidence of uncontrolled active infectious process - ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED T CELLS - Research participants has undergone lymphodepletion - Pulmonary: not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or higher on room air - Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension - Renal Function: calculated creatinine clearance (absolute value) of >= 50 mL/minute or creatinine < 2.0 mg/dl or < 2 times upper limit of normal for the research participants age group - Liver Function: adequate liver function defined as total bilirubin =< 3.0 mg/dl - ALT and AST =< 5 times the institutional upper limits of normal - Neurological: research participant without clinically significant encephalopathy/new focal deficits - Infectious diseases: no clinical evidence of uncontrolled active infectious process - Research participant must be off all anti-leukemic drugs, with the exception of the lymphodepleting regimens, at least 7 days prior to CAR T cell infusion - ELIGIBILITY CRITERIA TO UNDERGO OPTIONAL T CELL ABLATION - Research participant has >= 1% CAR T cells in the peripheral blood - Pulmonary: not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or higher on room air - Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension - Renal Function: serum creatinine did NOT increase by more than 2.5 fold from baseline (at time of screening) - Liver Function: adequate liver function defined as total bilirubin =< 3.0 mg/dl - AST =< 5 x ULN, ALT =< 5 x ULN - Neurological: research participant without clinically significant encephalopathy/new focal deficits - Infectious diseases: no clinical evidence of uncontrolled active infectious process - ALLOGENEIC DONOR CRITERIA FOR APHERESIS DONATION: - Related donor selection will be conducted in accordance with City of Hopes Department of Hematology & Hematopoietic Cell Transplantation criteria and, in the case of unrelated donor from a transplant center, will comply with the National Marrow Donor Programs (NMDP) donor selection standards; when a potentially eligible recipient of an unrelated donor product from an NMDP Center is identified, the recipient will complete an NMDP search transfer request to allow City of Hope (COH) NMDP staff to contact the NMDP Coordinating Center, who in turn, will contact the donors prior Donor Center; the search will follow the NMDP Policy for subsequent donation requests; any form deemed appropriate and necessary by the NMDP, including the Subsequent Donation Request Form, Therapeutic T Cell Collection Prescription and Therapeutic Stem Cell Collection Prescription, will be submitted as required - In the case of a related donor: The identified donor must be the original donor whose stem cells were used for the research participants allogeneic stem cell transplantation (alloSCT) - For both related and unrelated donors: The donors hepatitis B surface antigen must be negative and the hepatitis C antibody must be nonreactive; in the case of a positive hepatitis C antibody result, the hepatitis C virus (HCV) viral polymerase chain reaction (PCR) will have to be performed and the results should be negative Exclusion Criteria: - Research participants with uncontrolled intercurrent illness including, but not limited to ongoing or active or poorly controlled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, poorly controlled pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements; such social situations include but are not limited to lack of reliable means of transportation for follow up, inability to make time for required clinic visits due to work or family needs, or lack of reliable ways of communication with the study team in the event that the participant is seriously ill - Research participants who have tested human immunodeficiency virus (HIV) positive, or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment - Research participants with presence of other active malignancy. However, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible - Pregnant and lactating women are excluded from this study Study-Specific Exclusion - Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study - History of allergic reactions attributed to compounds of similar chemical or biological composition to cetuximab - Dependence on corticosteroids: - If the participant is undergoing leukapheresis: physiological replacement doses of steroids are allowed - prednisone no more than 7.5 mg, hydrocortisone less than 12 mg/m^2/day - However, all participants must be able to reduce steroid requirement to no more than physiological replacement doses prior to start of lymphodepletion - Active autoimmune disease requiring systemic immunosuppressive therapy - Research participants will be excluded, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study ; PRIMARY OUTCOME: Dose-limiting toxicity (DLT) defined as any grade 3 or higher toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; SECONDARY OUTCOME 1: Engraftment of transferred CD123+ CAR T cells[/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 - w/Trastuzumab or Trastuzumab/Pertuzumab; BRIEF: This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically documented HER2-positive and HER2-negative (cohort E only) breast cancer - Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (>) 2 centimeter (cm) (Stage 2) - Eastern cooperative oncology group (ECOG) performed status of 0, 1 or 2; 0 or 1 (cohort E only) - Life expectancy of 12 or more weeks - Adequate hematologic and end-organ function - Left ventricular ejection fraction greater than or equal to (>=) 50 percentage (%); >=55% (cohort E only) Exclusion Criteria: - Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases - Leptomeningeal disease - Pregnancy or lactation - History of autoimmune disease - Prior allogeneic stem cell or solid organ transplantation - Positive test for human immunodeficiency virus (HIV) - Active hepatitis B or hepatitis C ; PRIMARY OUTCOME: Percentage of Participants With Dose Limiting Toxicities (DLT) - Cohort 1A, 1B, 1C, 1D, 1F; SECONDARY OUTCOME 1: Maximum Serum Concentration (Cmax) of Atezolizumab[/INST]Yes</s>

<s>[INST]<<SYS>>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 - PoC; BRIEF: The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers. ; DRUG USED: Selepressin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sepsis and Septic Shock; TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion Criteria: - Signed informed consent form by the patient or a legal representative according to local regulations - Man or woman 18 years of age or older - Proven or suspected infection - Low blood pressure - Signs of decreased circulation in the tissues - Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from the day of informed consent to one week after the end of infusion of study medication. Exclusion Criteria: - Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible. - Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test. - Known or suspected cardiac failure - Pregnancy or breastfeeding - Any cause of hypotension other than early septic shock - Use of vasopressin or terlipressin for blood pressure support during the current hospital admission - Proven or suspected acute mesenteric ischemia, as judged by the investigator - Known episode of septic shock within 1 month prior to randomisation - Underlying chronic heart disease - Traumatic brain injury - Present hospitalisation with burn injury - Symptomatic peripheral vascular disease including Raynauds syndrome - Previously randomized in this trial - Intake of an investigational drug within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study) - Known participation in another clinical trial - Considered by the investigator to be unsuitable to participate in the trial for any other reason ; PRIMARY OUTCOME: Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine); SECONDARY OUTCOME 1: Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Female Volunteers; BRIEF: This trial will consist of three parts: the first two parts will enroll healthy female volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment groups. The SAD treatment group is comprised of at least 3 cohorts where subjects will be randomized to a single dose of either PTI-428 or placebo and will be followed for 7 days post dose. A total of 24 subjects are anticipated to participate in this part of the study. Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult female subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 cohorts where subjects will be randomized to either PTI-428 or placebo and will be followed for a total of 14 days. The SRC will convene after the completion of each cohort to evaluate safety, PK and other relevant data. The SRC will determine whether to proceed to the next planned dose level, to reduce the dose, or to stop the study. The next cohort may commence only after written SRC approval. A total of 24 subjects are anticipated to participate in this part of the study. Following completion of the SAD and MAD, 40 female healthy volunteers will participate in two treatment periods of the DDI study component: Treatment period A will consist of once daily oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off). Treatment period B will randomize subjects to PTI-428 or placebo in combination with once daily OC for 28 days (21-day hormonal active and PTI-428 or placebo + 7 days off). Following completion of the subjects second treatment period, they will be followed for 7-days after their last dose. ; DRUG USED: Nesolicaftor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Proteostasis Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Adult females age 18 - 55 years old, inclusive, at the time of informed consent. - For the DDI Oral Contraceptive Cohort, women of child bearing potential with intact ovarian function by medical history and history of regular menstrual. cycles. - Body mass index (BMI) ≥18 < 30 kg/m2. - Subject must be non-smoker and non-tobacco user for a minimum of 30 days prior to screening and for the duration of the study. - Subject understands the full nature and purpose of the study, including possible risks and side effects, and is willing and able to comply with all compulsory study procedures and provides informed consent/permission prior to any study procedures being performed. Exclusion Criteria: - History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator. - Abnormal liver function as defined by: - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin > 1.5 x upper limit of the normal range. - Abnormal renal function at screening defined as: - Creatinine clearance < 80mL/min using the Cockroft-Gault equation. - No clinically significant screening results that would exclude subject from the study (e.g., medical histories, physical examination, ECGs, vital signs,and laboratory profiles) as deemed by the investigator. - Platelet count < 150,000 cell/mm3 - Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1. - History of cancer within the past five years (excluding non-melanoma skin cancer). - History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator. - Positive urine screen for prohibited drugs (cocaine, cannabinoids, nicotine [urine cotinine is the detection mechanism for nicotine], opiates, barbiturates, amphetamines, and benzodiazepines) or positive alcohol test at screening. - Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb). - Clinically significant infection within 3 months of screening as determined by the Investigator. - Known or suspected hypersensitivity or idiosyncratic reaction to study medication or any components thereof. - Has donated blood within 3 months of screening or plans to donate blood within 3 months of study completion. - Pregnant or nursing women. - Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subjects participation in or completion of the study. - Females of child-bearing potential, unless they are willing to use highly effective methods of contraception during participation in the clinical study and for 30 days after termination from study. - Use of prohibited medications within 14 days prior to dosing of study drug. ; PRIMARY OUTCOME: SAD and MAD: Safety and tolerability measured by number of subjects who experience adverse events and potential clinically significant changes in safety labs, electrocardiograms (ECGs), physical examinations, and vital signs; 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 - GEN-01 (w/Zelboraf, Bevacizumab); BRIEF: This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1) standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood vessel formation and can stimulate the immune system. Previous clinical studies in melanoma have shown that bevacizumab may improve clinical benefit (progression free survival) if combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a role in resistance to BRAF inhibitors. This randomized study will ask whether the addition of bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates and clinical benefit. Patients may have received no therapy for advanced disease or up to 2 prior therapies, excluding BRAF and MEK inhibitors. ; DRUG USED: Cotellic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Melanoma Research Foundation Breakthrough Consortium; CRITERIA: Inclusion Criteria: 1. Patients must have histological or cytological confirmed melanoma that is metastatic or unresectable stage IIIc and clearly progressive. 2. Patients must have melanoma that is documented to contain a BRAFV600E or BRAFV600K mutation by a FDA-approved test. 3. Age >= 18 years. 4. Women must not be pregnant due to the fact that the effects of vemurafenib, cobimetinib, and/or bevacizumab on the developing human fetus are unknown. For this reason and because antiangiogenic agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; defined in Appendix G) prior to study entry and for the duration of study participation. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. 5. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 6. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with bevacizumab, cobimetinib, and vemurafenib, female participants who are breastfeeding must agree to discontinue nursing prior to Day 1 of the study. 7. Patients must have measurable disease as defined in Section 10.1 (cutaneous lesions measuring at least 1 cm will be considered measurable). Baseline CT or MRI scans of measurable disease sites must be performed within 4 weeks of study entry. 8. Patients must have discontinued immunotherapy or other systemic therapy including investigational agents at least 4 weeks prior to entering the study and have recovered from adverse events due to those agents. Patients must agree to not receive any other investigational agents during study participation. 9. Patients must have an ECOG performance status of 0, 1, or 2. 10. Patients must have the following baseline laboratory values: 1. White Blood Count > 3,000/mm3 2. Absolute Neutrophil Count > 1,500/mm3 3. Platelet Count > 100,000/mm3 4. Serum creatinine < 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl)> 40ml/min (CrCl= Wt (kg) x (140-age)*/72 x Cr. level, *female x 0.85) 5. Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN for patients with documented liver metastases) 6. Alkaline Phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement) 7. International Normalized Ratio (INR) < 1.5 and aPTT within 1.1 x ULN 8. Total Bilirubin < 1.5 x ULN 9. UPC ratio < 1.0 at screening or 24 hours urine protein < 1 gm (Appendix D) 11. Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients may not have received more than 2 prior systemic treatment regimens for distant metastatic disease. The following prior therapy is permitted in either the adjuvant or metastatic disease setting, provided treatment is discontinued at least 4 weeks prior to initiating study treatment: 1. Immunotherapy, such as interferon, interleukin-2, GM-CSF, ipilimumab, anti-PD1 or other experimental agent. 2. Cytotoxic chemotherapy, such as dacarbazine, temozolomide, carboplatin +/-paclitaxel. 2. Patients may not have had radiation therapy within the last 4 weeks prior to initiation of study treatment. 3. Patients who have had prior VEGF pathway inhibitor, BRAF or MEK inhibitor therapy are ineligible. 4. Patients must have no clinical evidence of active brain metastasis. Patients with a history of brain metastases must meet all of the following criteria: 1. Have completed treatment greater than 4 weeks prior to enrollment. 2. Have CNS lesions that are confirmed to be stable or regressing on imaging since the time of the last CNS treatment including the pre-treatment CT or MRI scan for this trial. 3. Patients must have no residual neurologic symptoms while taking no steroids, a stable or decreasing dose of steroids, or a stable dose of anti-seizure medication for the 2 weeks prior to enrollment. 5. Patients must not have other concurrent uncontrolled malignancies, defined as a malignancy that currently requires therapy or other intervention. Patients with suspected cuSCCs should have them excised prior to study registration. Surgical resection should not be performed within 7 days of starting protocol therapy. 6. Patients may not have had a major surgical procedure, open biopsy (excluding skin cancer resection, cutaneous/subcutaneous melanoma metastasis resection or biopsy or vascular access device insertion), or significant traumatic injury within 28 days prior to Day 1, or have an anticipated need for major surgical procedure or a planned elective surgical procedure during the course of the study. 7. Patients may not have had a core biopsy, skin cancer resection, or other minor surgical procedure, including placement of a vascular access device, within 7 days prior to Day 1 of the protocol. 8. Patients must not have a serious intercurrent illness including, but not limited to: 1. Ongoing or active infection requiring parental antibiotics on Day 1 2. A history of malabsorption or other condition that would interfere with absorption of vemurafenib or cobimetinib. 3. History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 4. History of congenital long QT syndrome or mean corrected QTc interval > 450 msec at baseline 5. Clinically significant cardiovascular disease, defined as any of the following conditions: i. Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) ii. Prior history of hypertensive crisis or hypertensive encephalopathy iii. Myocardial infarction within 6 months iv. Unstable angina v. New York heart association grade II or greater congestive heart failure (Appendix C) vi. Serious cardiac arrhythmia requiring medication vii. LVEF < 50% or below institutional limit of normal f) History of stroke of TIAs within 6 months prior to Day 1 g) Grade II or greater peripheral vascular disease within 1 year prior to study entry or other significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 h) Serious, non-healing wound, active ulcer, or untreated bone fracture i) History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 j) Known hypersensitivity to any component of bevacizumab k) Known CNS disease, except for stable or regressing brain metastases. l) Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) m) Psychiatric illness/social situations that would limit compliance with study requirements. n) Significant ocular issues including history of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration. The risk factors for RVO are listed below. Patients should be excluded if they have the following conditions: 1. Uncontrolled glaucoma with intra-ocular pressures >21mm Hg 2. Serum cholesterol >= Grade 2 3. Hypertriglyceridemia >= Grade 2 4. Hyperglycemia (fasting) >= Grade 2 9. Patients must not have the following foods/ supplements at least 7 days prior to initiation of and during study treatment: 1. St. Johns wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer) 2. Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor). 10. Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with bevacizumab, vemurafenib and cobimetinib. ; PRIMARY OUTCOME: Maximum Tolerated Dose; 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 I - 001; BRIEF: This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study using two dose levels of an investigational vaccine directed against S. aureus and Candida. The study is designed to evaluate the safety, tolerability and immunogenicity of the investigational vaccine, NDV-3 ; DRUG USED: NDV-3; DRUG CLASS: Vaccine; INDICATION: Staphylococcal Vaccines and Other Staphylococcus-Specific Agents (Antibacterial); TARGET: Candida, Staphylococcus; THERAPY: Monotherapy; LEAD SPONSOR: NovaDigm Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to screening. The informed consent document will be written in English, therefore the subject must have the ability to read and communicate in English. 2. Completed the screening process within 30 days prior to dosing. 3. Healthy male and female subjects 18-50 years of age, inclusive, at the time of dosing. 4. No clinically significant deviation from normal as judged by the investigator(s) in the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. 5. Female subjects must be: - of childbearing potential and practicing an acceptable method of birth control described below as judged by the investigator(s); or - of postmenopausal status (no menses) for at least 1 year and has a documented FSH level ≥ 40 mIU/mL; or - sterile (surgically [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy] or the Essure® Procedure). Exclusion Criteria: 1. Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing. 2. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s). 3. Clinical laboratory test values outside the accepted range. 4. When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody. 5. Reports a clinically significant illness during the 28 days prior to dosing (as determined by the clinical investigators). 6. Demonstrates a positive drug screen for non-prescription drugs. 7. Reports a history of allergic response(s) to nickel or anaphylaxis (or other serious reactions) to aluminum. 8. Reports receiving any live attenuated vaccine including FluMist® within 6 weeks prior to dosing or any licensed inactivated vaccine within 3 weeks prior to dosing. 9. Reports the use of any immunosuppressive drugs, including systemic corticosteroids, within 4 weeks prior to dosing. 10. Reports the use of any medications or treatments that may alter immune responses to the study vaccine within 3 weeks prior to dosing (e.g., cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, radiation therapy). 11. Reports a history of clinically significant allergies including food or drug allergies or anaphylaxis (or other serious reactions) to vaccines. 12. Reports a history of drug or alcohol addiction or abuse within the past year. 13. Reports receiving any blood products within 3 months prior to dosing and throughout the study. 14. Reports donating blood within 28 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study. 15. Reports donating plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study. 16. Reports an intolerance of direct venipuncture. 17. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study (females only). 18. Demonstrates a positive pregnancy screen (females only). 19. Any other medical and/or social (e.g. non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study. - ; PRIMARY OUTCOME: The primary objective of this study is to assess the safety and tolerability of one dose of NDV-3 vaccine compared to placebo at two different dose levels.; SECONDARY OUTCOME 1: The secondary objective is to compare the humoral and cellular immune responses between the two dose levels compared to placebo at several time points over a 6 month 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 I - MTD (China); BRIEF: The aim of the study was to explore the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) of oral administration of TG02 capsules twice a week for 4 weeks. ; DRUG USED: TG02; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Cyclin Dependent Kinase (CDK), FMS-like tyrosine kinase 3 (FLT-3) , JAK/STAT , Mitogen-activated protein kinase 7 (MAPK7/ERK5/BMK1); THERAPY: Monotherapy; LEAD SPONSOR: Lees Pharmaceutical Limited; CRITERIA: Inclusion criteria: 1. Age: 18 ~ 75 years old, both men and women. 2. Histologically proven glioblastoma or anaplastic astrocytoma that has failed from temozolomide treatment in the past. 3. According to RANO criteria, patients with clinically evaluated recurrence or progression with clearly measurable lesions. 4. If previous radiotherapy has been performed, it must be completed for a period of more than 3 months, or within 3 months but tumor progression occurs in the original radiation field or has been confirmed by histopathology. . 5. The first day of treatment was ≥ 2 weeks from the second surgery of recurrence, and the incision is healed in grade A. 6. ECOG 0 - 2 points, can swallow the drug and maintain oral administration. 7. The expected survival time was more than 3 months. 8. The hematopoietic function of bone marrow was adequate: ANC≥1.5×109/L，PLT≥100×109/L，Hb≥90 g/L；. 9. Patients who had previously undergone surgical resection were able to provide no less than 15 tumor tissue sections and pathological reports for the study. Exclusion criteria 1. Other cytotoxic drugs were received within 28 days prior to the start of the study, or adverse reactions from previous systematic treatment have not recovered (except alopecia and pigmentation). 2. Bevacizumab was treated within 6 weeks before the start of the study. 3. Previous treatment with carmostine sustained-release implants or intracerebral implantation of radiotherapy. 4. A patient with a major seizure that cannot be effectively controlled by drugs. 5. MRI examinations cannot be performed (e.g. pacemakers, undesirable metal dentures, etc.). 6. Patients with severe impairment of liver and kidney function: ALT ≥ 2.5 ULN,AST ≥ 2.5 ULN in patients without liver metastasis; ALT ≥ 5 ULN,AST ≥ 5 ULN in patients with liver metastasis; Or TBIL ≥ 1.5 ULN, or Cr ≥ 1.5 ULN, or creatinine clearance ≤ 60 ml/ min calculated by Cockcroft-Gault formula; 7. Unstable or uncontrollable diseases or conditions related to or affecting cardiac function (e.g. unstable angina pectoris, congestive heart failure [NYHA > II], uncontrolled hypertension [diastolic blood pressure > 85 mmHg; systolic blood pressure >145 mmHg]), arrhythmia or prolonged QTc interval (male > 450 Ms; female > 470ms). 8. A history of arterial thromboembolism (such as stroke, transient ischemic attack, or myocardial infarction) within 6 months. Bleeding or hypercoagulable coagulation disorder occurred within 6 months prior to the first day of the study. 9. Active peptic ulcer or inflammatory bowel disease. 10. Active hepatitis, or HIV, Treponema pallidum infection. 11. Pregnant or breastfeeding. 12. Subjects who were unable to use adequate contraception during the study and for six months after the end of the study were unable to use adequate contraception. 13. Currently participating in another clinical trial or within 30 days of the last administration of the trial drug. 14. The subjects had conditions that affected their provision of written informed consent and / or compliance with the research process. 15. There were cases in which any other investigator did not consider it appropriate to join the group. ; PRIMARY OUTCOME: Dose limiting toxicity (DLT); SECONDARY OUTCOME 1: Overall 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 III - Pediatric Pts; BRIEF: The primary purpose of this study is to evaluate the efficacy of alogliptin 25 milligram (mg) once daily compared to placebo when administered as monotherapy, or when added onto a background of metformin alone, insulin alone, or a combination of metformin and insulin, as measured by the glycosylated hemoglobin (HbA1c) change from Baseline at Week 26 in pediatric participants with type 2 diabetes mellitus (T2DM). ; DRUG USED: Nesina; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has a confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of fasting plasma glucose [FPG] greater than or equal to [>=] 126 mg/dL, random glucose >=200 mg/dL [>=11.10 mmol/L], HbA1c >=6.5 percent (%), or 2-hour oral glucose tolerance test [OGTT] glucose >=200 mg/dL), documented in the participants medical record. 2. The participant and/or his/her legal representative (that is, parents or legal guardians) are able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete participant diaries. Exclusion Criteria: 1. Has a history of hypersensitivity or allergy to alogliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, metformin, insulin or related compounds. 2. Has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY). 3. Has a hemoglobin level <11.0 gram per deciliter (g/dL) (<110 gram per liter [g/L]) for males and <10.0 g/dL (<100 g/L) for females. 4. Has a history of any hemoglobinopathy that may affect determination of HbA1c levels. 5. Has a history of bariatric surgery. 6. Has a history of proliferative diabetic retinopathy within the 6 months prior to Screening. 7. Has had more than 1 episode of diabetic ketoacidosis (DKA) at any time after diagnosis of T2DM. 8. Has a history of more than 1 episode of pancreatitis. 9. Has serum creatinine >=1.5 mg/dL for male participants or >=1.4 mg/dL for female participants, or creatinine clearance <60 milliliter per minute (mL/min) based on calculation by central lab using the Schwartz formula for estimated glomerular filtration rate (eGFR) at screening Visit. 10. Has a documented history of infection with human immunodeficiency virus or chronic active viral hepatitis. 11. The participant and/or his/her legal representative (that is, parents or legal guardians) is unable to understand verbal or written English, or any other language for which a certified translation of the approved informed consent/assent is available. Additional Criteria That Must be Met Prior to Randomization: For participants who have had the diagnosis of T2DM for less than 1 year and/or who are taking insulin at Screening, additional criteria will need to be met prior to randomization: 1. Must have an HbA1c level of >=6.5% to <11.0% if the participant is treatment naïve or on metformin alone or >=7.0% to <11.0% if the participant is on insulin alone or in combination with metformin. 2. The participant must not have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to randomization. 3. Must not have received an antidiabetic agent other than metformin or insulin within the 12 weeks prior to randomization. 4. Must not have received oral or parenteral steroids for more than 3 weeks (cumulatively) within the 6 months prior to randomization or have received a course of oral or parenteral steroids within the 2 months prior to randomization. 5. Has a systolic blood pressure <160 millimeter of mercury (mmHg) and a diastolic pressure <100 mm Hg. (Antihypertensive medications will be allowed during the study). 6. Has an alanine aminotransferase (ALT) level <3*upper limit of normal (ULN) or an ALT level <5 *ULN with a confirmed diagnosis of nonalcoholic fatty liver disease (NAFLD).7. Does not plan to leave the geographic area within 1 calendar year following randomization. For participants who have had the diagnosis of T2DM for less than 1 year and/or who are taking insulin prior to randomization, the following criteria must also be met: 8. Must have a fasting C-peptide concentration>=0.6 nanogram per milliliter (ng/mL) (>=0.20 nanomole per liter [nmol/L]) (drawn at least 1 week after treatment for ketosis or acidosis, if applicable). 9. No presence of autoantibodies as documented by glutamic acid decarboxylase [GAD] 65 and islet antigen [IA]-2 antibodies below the upper limit of the normal reference ranges at randomization. 10. Have a body mass index (BMI) greater than (>) 85th percentile, documented at randomization. ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26; SECONDARY OUTCOME 1: Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52[/INST]Yes</s>