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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 I/II - PK/PD; BRIEF: The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis (RA). Patients will receive different single or multiple doses of either placebo or ALX-0061. ; DRUG USED: Vobarilizumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Ablynx, a Sanofi company; CRITERIA: Inclusion Criteria: - Body mass index (BMI) <35.0 kg/m2 - Diagnosed with rheumatoid arthritis (RA) according to the 2010 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria for at least 6 months prior to randomisation - Treatment with methotrexate (MTX) for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dose, that will remain stable throughout the study period. Inadequate response or or intolerance to disease modifying antirheumatic drugs (DMARDs) (including MTX, where a patient may remain on treatment with %TX at a lower dose for improved tolerance, but with reduced effectiveness) - For patients (men and women) of reproductive potential, use of an acceptable method of contraception for the duration of the study. Female patients must be willing to use appropriate birth control measures that would prevent pregnancy starting from the time of signing the informed consent until 90 days after the last dose of study drug is administered - For single dose part: Disease Activity Score using 28 joint counts (DAS28) score >= 2.4 - For multiple dose part: DAS28 score >= 3.2 - For multiple dose part: swollen joint count >= 3 Exclusion Criteria: - A documented history of an autoimmune disease other than RA (other than secondary Sjögrens syndrome) - Functional class IV by ACR classification - Any new/additional biologic DMARD therapy, cytotoxic drugs and immunosuppressants within four weeks prior to screening, and between screening and Day 1 with the exception of ALX-0061 - Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray - Female patients who are pregnant during the study, or are breastfeeding - History of anaphylactic reactions to protein therapeutics - Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the single dose part of this study and who are eligible to participate in the multiple dose part - Donation of more than 300 mL of blood within 60 days prior to drug administration - Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for non-melanoma skin cancer or resected carcinoma in situ - Any current or recent (within 4 weeks prior to first dose) signs or symptoms of infection that requires parenteral antibiotic administration, any known active viral infection (hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]) that would impair the participation in the study - Major surgery (including joint surgery) within 8 weeks prior to screening and hospitalisation for a clinically relevant event within the 4 weeks prior to screening - Any other disease, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications - Administration of a live, attenuated vaccine within 1 month before dosing with ALX-0061, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose - For multiple dose part: contraindication to MRIs or the use of contrast agents for MRI scanning ; PRIMARY OUTCOME: Safety: number of treatment emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Pharmacokinetics (PK): serum concentration of ALX-0061[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 302 (Adjunctive); BRIEF: The studys purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD) ; DRUG USED: Troriluzole; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obsessive-Compulsive Disorder (OCD); TARGET: Glutamine; THERAPY: Monotherapy; LEAD SPONSOR: Biohaven Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subjects illness must be ≥ 1 year 2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject 3. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed Exclusion Criteria: 1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD. 2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourettes disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results 3. Previous treatment in a study with troriluzole ; PRIMARY OUTCOME: The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS); SECONDARY OUTCOME 1: Frequency of SAEs and AEs leading to discontinuation[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 418; BRIEF: The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset). ; DRUG USED: Bexagliflozin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Theracos; CRITERIA: Inclusion Criteria: - Male or female subjects ≥18 years old - Diagnosed with type 2 diabetes - Body mass index (BMI) ≤ 45 kg/m2 - HbA1c between 7 and 10% (inclusive) at screening - FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies - Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent - If taking anti-diabetic medication, dose and regimen must be stable for past 3 months - If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months - If taking lipid modifying therapy, dose and regimen must be stable for past 3 months - Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at randomization Exclusion Criteria: - Hemoglobinopathy that affects HbA1c measurement - Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor based therapy) - Genitourinary tract infection within 6 weeks of screening - Greater than 2 episodes of genitourinary tract infection in the past year - History of kidney stones, bladder malfunction or other significant risk factor for urinary tract infections - eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), < 50 mL/min/1.73 m2 - Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN - Diagnosis of retinopathy or significant nephropathy (eGFR < 50 mL/min/1.73 m2 - Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >95) - Not willing to use effective birth control, if female with child-bearing potential - Life expectancy < 2 years - New York Heart Association (NYHA) Class 4 heart failure - Sera positive of HCV, HIV, or positive on drug screen - Currently participating in another interventional trial - Previous treatment with EGT0001442 or EGT0001474 - Not able to comply with the study scheduled visits ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c at 24 Weeks; SECONDARY OUTCOME 1: Changes in Systolic and Diastolic Blood Pressure at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - R/R SCLC; BRIEF: A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose. ; DRUG USED: AMG 119; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Delta-like 3 (DLL3), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subject has provided informed consent prior to initiation of any study-specific activities/procedures; - Age ≥ 18 years old at the time of signing the informed consent - Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen: - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor - Subjects with treated brain metastases are eligible provided they meet the following criteria: - - Definitive therapy was completed at least 2 weeks prior to enrollment. - - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor. - - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days. - Adequate organ function - Other inclusion criteria may apply Exclusion Criteria: - History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma. - History of organ transplant. - Major surgery within 28 days of enrollment. - Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment. - History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment. - Untreated or symptomatic brain metastases and leptomeningeal disease - Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. - Known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine). - Evidence of a bleeding diathesis. - Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. ≥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed. - Prior anti-cancer therapy as specified below: At least 21 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy with the exception of subjects who received AMG 119 in this study and are eligible for retreatment. - Primary immunodeficiency - History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment - Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen - Received live vaccine within 28 days prior to enrollment - Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B - Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C - History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion - Other exclusion criteria may apply ; PRIMARY OUTCOME: Incidence of dose limiting toxicities (DLTs); SECONDARY OUTCOME 1: Objective Response (OR)[/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 - SOLSTICE; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study. ; DRUG USED: Losmapimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects with a NSTEMI, defined as: symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, with most recent symptoms occurring within the 24 hours prior to presentation, without persistent ST-segment elevation on admission 12-lead ECG, and with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 18 hours of presentation. - Subject able to be randomized within 18 hours of presentation. - Subjects to be managed with an early invasive strategy, with PCI likely to occur at least 2 hours after the start of dosing [subjects who do not undergo PCI will not be withdrawn from the study]. - Male or female subject who is 45 years of age or older. - 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) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory), or child-bearing potential and agrees to use one of the contraception methods listed in the protocol for the duration of dosing and until the first follow-up visit (approximately 2 weeks post last-dose). - Negative urine or serum pregnancy test (in women of child-bearing potential only). - Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the first follow-up visit (approximately 2 weeks post last-dose). - QTcB or QTcF greater than 530 msec. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: - History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction [ejection fraction less than 30%] regardless of symptomatic status. - Suspected aortic dissection. - Severe aortic stenosis or other severe valvular disease. - Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study. - Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic or acute inflammation (e.g. inflammatory bowel disease, osteomyelitis, pneumonia, etc.). Intermittent conditions treated with short-term oral antibiotics (e.g. typical URI) or conditions that are not currently exacerbated (e.g. gout with no current flair) may be included. - History of myopathy or rhabdomyolysis. - Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Known to be Hepatitis B or Hepatitis C positive. - Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal and topical steroids are allowed. A single prophylactic dose of systemic steroid is allowed at time of PCI for subjects with contrast allergy. - Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g. daunorubicin, doxorubicin, topotecan, mitoxantrone). - Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary.. - Known alcohol or drug abuse within the past 6 months. - Previous exposure to GW856553. - Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study. - Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication non-compliance). - Unwillingness or inability to follow the procedures outlined in the protocol. - Previous MI or coronary artery bypass graft (CABG) surgery. - History of kidney transplant or a history of contrast nephropathy. - Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but is not limited to: intracranial aneurysm clips or other metallic objects; history of intra-orbital metal fragments that have not been removed by an MD; pacemakers and non-MR compatible heart valves; inner ear implants; history of claustrophobia in MR. - Allergy to MRI contrast enhancement agent (gadolinium). - Estimated creatinine clearance by Cockcroft-Gault formula < 30 mL/min. ; PRIMARY OUTCOME: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Mean hsCRP Over Hospitalization Period and Through Week 14[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb ; BRIEF: The purpose of this study is to evaluate the safety and efficacy of NIC5-15 in the treatment of Alzheimers Disease. ; DRUG USED: NIC5-15; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Gamma-secretase; THERAPY: Monotherapy; LEAD SPONSOR: Humanetics Corporation; CRITERIA: Inclusion Criteria: - NINCDS/ADRDA criteria for probable AD - MMSE between 12-27 - Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist with stable dose for at least 12 weeks - Home monitoring available for supervision of medications - Caregiver available to accompany patient to all visits and willing to participate in study as informant - Fluent in English or Spanish - Medical stability for this study as confirmed by review of records, internists physical exam, neurological exam, and laboratory tests - Stable doses of non-excluded medication - No evidence of hepatic insufficiency - Able to swallow oral medications - Ability to participate in the informed consent process Exclusion Criteria: - History of Diabetes Mellitus (OGTT criteria) requiring treatment with an excluded antidiabetic medication (see below) or history of hypoglycemia - Active hepatic or renal disease - Cardiac disease including history of congestive heart failure or current treatment for CHF; history of recent myocardial infarction - Use of another investigational drug within the past two months - History of clinically significant stroke - History of seizure or head trauma with disturbance of consciousness within the past two years - Major mental illness including psychotic disorders, bipolar disorder, or major depressive episode within the past two years Medication Exclusion - Current use of oral hypoglycemic agents including sulfonylureas and meglintinides - Current or past treatment with insulin for longer than two weeks - Current use of drugs with significant anticholinergic or antihistaminic properties ; PRIMARY OUTCOME: Change in Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score; SECONDARY OUTCOME 1: Change in Alzheimers Disease Cooperative Study Clinicians Global Impression of Change (ADCS-CCGIC) Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3587 - BEGIN (ONCE); BRIEF: This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes. ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months - Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) - Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose - HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis - BMI (Body Mass Index) below or equal to 40.0 kg/m^2 Exclusion Criteria: - Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening) - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors - Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty - Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigators opinion could interfere with the results of the trial - Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period - Known or suspected hypersensitivity to trial product(s) or related products ; PRIMARY OUTCOME: Change From Baseline in HbA1c (%) (Analysed by Central Laboratory); SECONDARY OUTCOME 1: Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FREEDOM-EV; BRIEF: This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension. ; DRUG USED: Orenitram; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Combination; LEAD SPONSOR: United Therapeutics; CRITERIA: Subject Inclusion Criteria: 1. Voluntarily gave informed consent to participate in the study. 2. Are 18 to 75 years of age (inclusive) at Screening. 3. Women of childbearing potential must practice abstinence from intercourse when in line with their preferred and usual lifestyle, or use 2 different forms of highly effective contraception for the duration of the study, and for at least 30 days after discontinuing study medication. A negative urine pregnancy test is required at Screening and Baseline prior to initiating study medication. 4. Male subjects must consent to use a condom during intercourse for the duration of the study, and for at least 48 hours after discontinuing study medication. 5. Have a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with HIV infection, PAH associated with repaired congenital systemic-to-pulmonary shunt, or PAH associated with appetite suppressant or toxin use. 6. If known to be positive for HIV infection, have a CD4 lymphocyte count of at least 200 cells/mm^3 assessed at Screening and are receiving current standard of care anti retroviral or other effective medication for the treatment of HIV infection. 7. Have a baseline 6MWD greater than or equal to 150 m in the absence of a concurrent injury, illness, or other confounding factor including, but not limited to, use of an aid for ambulation or connection to a nonportable machine, that would have prevented the accurate assessment of the subjects exercise capacity. 8. Are optimally treated with conventional pulmonary hypertension therapy with no additions, discontinuations, or dose changes for a minimum of 10 days prior to randomization. The exceptions are the discontinuation or dose changes of anticoagulants and/or dose change of diuretics. 9. Are receiving a PAH-approved oral monotherapy at a minimum dose that complies with the approved prescribing information for the product for at least 30 days prior to randomization and are receiving a stable dose for at least 10 days prior to randomization. 10. Have had previously undergone a cardiac catheterization within 3 years prior to the start of Screening or during the Screening Period, and the most recent assessment documented a pulmonary artery pressure mean of at least 25 mmHg, a pulmonary capillary wedge pressure (PCWP) (or in the event a PCWP could not be reliably obtained, a left ventricular end diastolic pressure [LVEDP]) less than or equal to 15 mmHg, and absence of unrepaired congenital heart disease (other than patent foramen ovale). If a reliable PCWP or LVEDP are unable to be obtained during cardiac catheterization, subjects with clinically normal left heart function and absence of clinically relevant mitral valve disease on echocardiography are eligible for enrollment. 11. Undergo echocardiography with evidence of clinically normal systolic and diastolic left ventricular function and absence of any clinically significant left sided heart disease (eg, mitral valve disease). Subjects with clinically insignificant left ventricular diastolic dysfunction due to the effects of right ventricular overload (ie, right ventricular hypertrophy and/or dilatation) are eligible. 12. Have a previous ventilation perfusion lung scan, high-resolution computerized tomography scan of the chest, and/or pulmonary angiography that are consistent with the diagnosis of PAH. 13. Have pulmonary function tests conducted within 6 months before Screening or during the Screening Period to confirm the following: 1. Total lung capacity is at least 60% 2. Forced expiratory volume at 1 second is at least 50% 14. In the opinion of the Principal Investigator, is able to communicate effectively with study personnel and is considered reliable, willing, and likely to cooperate with protocol requirements, including attending all study visits. Subject Exclusion Criteria: 1. Is pregnant or lactating. 2. Have previously received oral treprostinil. 3. Have received a PGI2 (except if used during acute vasoreactivity testing) within 30 days prior to randomization or have previous intolerance or significant lack of efficacy to any PGI2 or PGI2 analogue that resulted in discontinuation or inability to titrate that therapy effectively. 4. Have any background conventional therapies for PAH added, removed, or dose-adjusted within 10 days prior to randomization. The exceptions are removal or dose adjustments of anticoagulants and/or dose adjustments of diuretics. 5. Receive their first dose of a PAH-approved oral monotherapy less than 30 days prior to randomization, or have their PAH-approved oral monotherapy dose changed within 10 days prior to randomization, or the subject discontinues any PAH approved therapy within 30 days prior to Screening, or the subject has previously received 2 PAH approved oral therapies at the same time (specifically, a PDE5-I, an ERA, or a sGC stimulator) concomitantly for more than 90 days cumulatively. 6. Have any disease associated with PAH other than CTD, HIV infection, repaired (for at least 1 year) congenital systemic-to-pulmonary shunt, PAH associated with appetite suppressant/toxin use, or have an atrial septostomy. 7. Have a current diagnosis of uncontrolled sleep apnea as defined by their physician. 8. Have a history of ischemic heart disease, including a previous myocardial infarction or symptomatic coronary artery disease within 6 months prior to Screening or a history of left-sided myocardial disease as evidenced by a mean PCWP (or a LVEDP) greater than 15 mmHg or left ventricular ejection fraction less than 40% as assessed by either multigated angiogram, angiography, or echocardiography. 9. Have uncontrolled systemic hypertension as evidenced by systolic blood pressure (BP) greater than 160 mmHg or diastolic BP greater than 100 mmHg. 10. Have alanine aminotransferase or aspartate aminotransferase levels at least 3 times greater than the upper limit of normal, clinically significant liver disease/dysfunction, or known Child-Pugh Class C hepatic disease at Screening. 11. Have any other disease or condition that would interfere with the interpretation of study assessments. 12. Have a musculoskeletal disorder, is using a device to assist walking, or any disease that is likely to limit ambulation, or is connected to a machine that is nonportable. 13. Have an unstable psychiatric condition or is mentally incapable of understanding the objectives, nature, or consequences of the study, or has any condition which in the Investigators opinion would constitute an unacceptable risk to the subjects safety. 14. Is receiving an investigational drug, have an investigational device in place, or have participated in an investigational drug or device study within 30 days prior to Screening. 15. Have chronic renal insufficiency as defined by either a Screening creatinine value greater than 2.5 mg/dL or the requirement for dialysis. 16. Does not have 3 or more of the following left ventricular disease/dysfunction risk factors: 1. Body mass index at least 30 kg/m^2 2. History of essential hypertension 3. Diabetes mellitus (any type) 4. Historical evidence of significant coronary artery disease established by any 1 of the following: history of myocardial infarction, percutaneous coronary intervention, or angiographic evidence of coronary artery disease; positive stress test with imaging; previous coronary artery bypass graft; or stable angina. ; PRIMARY OUTCOME: Time to First Clinical Worsening Event; SECONDARY OUTCOME 1: Change in 6-Minute Walk Distance[/INST]Yes</s>

<s>[INST]<<SYS>>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 - VIDI; BRIEF: The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3. ; DRUG USED: ASP8232; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Unknown; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Astellas Pharma Europe B.V.; CRITERIA: Inclusion Criteria: - Subject must have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% at Screening - Subject has definite retinal thickening due to diffuse diabetic macular edema (DME) involving the central macula based on evaluating investigators clinical evaluation and demonstrated by spectral domain-optical coherence tomography (SD-OCT) - Subject has central subfield thickness (CST) of at least 375 μm by SD-OCT with presence of intraretinal and/or subretinal fluid at screening visit and at the randomization visit - Subject has early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit Exclusion Criteria: - Subjects study eye has macular edema considered to be due to a cause other than DME - Subjects study eye has a decrease in BCVA due to causes other than DME that is likely to be decreasing BCVA by 3 lines or more - Subjects study eye has significant macular ischemia as shown on angiography - Subjects study eye has any other ocular disease that may cause substantial reduction in BCVA - Subject has active peri-ocular or ocular infection - Subjects study eye has a history of non-infectious uveitis - Subjects study eye has high myopia (-8 diopter or more correction) - Subjects study eye has a history of prior pars plana vitrectomy - Subjects study eye has a history of any ocular surgery within 3 months prior to Day 1 - Subjects study eye has a history of YAG capsulotomy within 3 months prior to Day 1 - Subjects study eye has a history of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study through the Week 12 visit - Subjects study eye has a history of prior IVT, subtenon, or periocular, non-sustained release, steroid therapy within 3 months prior to Day 1 - Subjects study eye has a history of intravitreal sustained release dexamethasone therapy within 6 months prior to Day 1. - Subjects study eye has a history of intravitreal sustained release fluocinolone within 3 years prior to Day 1. - Subjects study eye has a history of prior treatment for DME with IVT anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1 - Subject has a history of prior treatment with any other (than previously listed) approved treatment which is not labeled for DME within 1 year prior to Day 1 - Subjects study eye has high-risk proliferative diabetic retinopathy (PDR) - Subject has uncontrolled glaucoma - Subject has media clarity, papillary constriction (i.e., senile miosis), or subject lacks cooperation that would interfere with any study procedures, evaluations or interpretation of data ; PRIMARY OUTCOME: Percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) at Month 3; SECONDARY OUTCOME 1: Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - M10-467; BRIEF: This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Hidradenitis Suppurativa; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Abbott; CRITERIA: Inclusion Criteria: - Adults with stable, moderate to severe hidradenitis suppurativa - Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy. - Ability to administer subcutaneous injections - General good health otherwise Exclusion Criteria: - Prior anti-TNF therapy - Unstable antibiotic therapy for HS - Required medication washouts for other HS treatments - Prior exposure to Tysabri® (natalizumab); - Recent infection requiring treatment - Significant medical events or conditions that may put patients at risk for participation - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study; - History of cancer, except successfully treated skin cancer - Recent history of drug or alcohol abuse ; PRIMARY OUTCOME: Percentage of Participants Achieving Clinical Response at Week 16; SECONDARY OUTCOME 1: Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - MAB-N007; BRIEF: Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23. ; 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: 1. In-patient at a Neonatal Intensive Care Unit (NICU) 2. Informed consent obtained from the legally authorized representative 3. Less than 48 hours old at the time of first infusion 4. Birth weight between 600 grams and 1200 grams 5. Estimated gestation age ≤33 weeks For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group. Exclusion Criteria: 1. Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation. 2. Infants with proven staphylococcal infection prior to randomization. 3. Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk. 4. Immunodeficiency other than due to prematurity. 5. Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study. 6. Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study 7. Uncontrolled seizures ; PRIMARY OUTCOME: The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ExpeditionPRO; BRIEF: The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimers disease (AD). ; DRUG USED: Solanezumab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimers Association (NIA-AA) diagnostic criteria. - Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening. - Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening. - Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS). - Scores >0 on the Functional Activities Questionnaire (FAQ). - Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology. Exclusion Criteria: - Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD. - Has known allergy to humanized monoclonal antibodies. - Has an ongoing clinically significant laboratory abnormality, as determined by the investigator. - Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E. - Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI. - Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.) ; PRIMARY OUTCOME: Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score; SECONDARY OUTCOME 1: Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)[/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 - STEP 5; BRIEF: This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking dummy medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or dummy medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age more than or equal to 18 years at the time of signing informed consent - Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease - History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion criteria: - HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening - A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records ; PRIMARY OUTCOME: Percentage Change From Baseline (Week 0) to Week 104 in Body Weight; SECONDARY OUTCOME 1: Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Subjects; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort. ; DRUG USED: XC130; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: Xoc Pharmaceuticals; CRITERIA: Major Inclusion Criteria: - Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age. - Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening. - Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs. - Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol. Major Exclusion Criteria: - Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study. - History or presence of clinically significant medical, surgical or psychiatric condition or disease. - History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study. - History of clinically significant hypotension. - History of orthostatic hypotension in the 12 months prior to screening. - Clinically significant hypertension at screening. - History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse. ; PRIMARY OUTCOME: Incidence and severity of Adverse Events; SECONDARY OUTCOME 1: Maximum plasma concentration [Cmax] of XC13-A10H[/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 - PDIT; BRIEF: Ryanodex is being investigated as a potential adjuvant treatment for people suffering from psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that results mainly from the abuse of certain illicit drugs, most notably methamphetamine, and related forms (MDMC or Molly; MDMA or Ecstasy). Ryanodex is approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for prevention of malignant hyperthermia in patients at high risk and in this study, will be investigated for the treatment of PDIT. The hypothesis of this study is that administration of Ryanodex as adjuvant treatment to Standard of Care (SOC) will improve the clinical outcome compared with SOC alone, in subjects with psychostimulant drug induced toxicity. Current SOC is defined as body cooling and supportive measures. ; DRUG USED: Ryanodex; DRUG CLASS: Non-NME; INDICATION: Substance Use Disorder; TARGET: Ryanodine Receptor (RyRs); THERAPY: Monotherapy; LEAD SPONSOR: Eagle Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Male and non-pregnant subjects diagnosed with psychostimulant drug induced toxicity as evidenced by all of the following: core body temperature of greater than or equal to 39.5 degrees C; organ dysfunction, as evidenced by a Logistic Organ Dysfunction System score of greater than or equal to 6 (In the event of any delay in obtaining the results for baseline LODS score determination, subject may be enrolled. After enrollment, if the pending baseline LODS score turns out to be less than 6, the subject will be withdrawn from the study and replaced); known or suspected us of a psychostimulant drug in the judgment of the Investigator; negative blood pregnancy test for females (in the event of any delay in obtaining pregnancy test result, subject may be enrolled and randomized if all of the other eligibility criteria are met). Exclusion Criteria: Diagnosed with or is suspected to have an acute, clinically severe infection, which may, in the opinion of the Investigator, may increase the subjects risk for participating in the study an/or may impair the ability of performing and/or interpreting study assessments; severe hyperthermia secondary to a condition other than a psychostimulant drug-induced toxicity; likelihood of head trauma in the past 3 months, or other systemic disease that might increase the subjects risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments; positive pregnancy test or evidence of active lactation; known history of allergy or hypersensitivity to dantrolene; known history of seizure disorders or epilepsy; current or prior use (within the past 2 weeks) of calcium channel blockers. - ; PRIMARY OUTCOME: Proportion of Subjects Who Achieved a Logistic Organ Dysfuction System (LODS) Total Score Less Than or Equal to 5; SECONDARY OUTCOME 1: Proportion of Subjects Who Achieved a LODS Total Score Less Than or Equal to 5 at Other Planned Time Points.[/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 - LAL-CL06; BRIEF: This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D). ; DRUG USED: Kanuma; DRUG CLASS: Biologic; INDICATION: Lysosomal Acid Lipase Deficiency ; TARGET: Cholesterol/Cholesteryl Ester, Triglycerides; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: 1. Participant was >8 months of age at the time of dosing. 2. Confirmation of LAL-D diagnosis as determined by the central laboratory or, for participants with prior hematopoietic stem cell transplant or liver transplant, historical enzyme activity or molecular genetic testing confirming a diagnosis of LAL-D. 3. Participants >8 months but <4 years of age at Screening had at least 1 of the following documented clinical manifestations of LAL-D: - Dyslipidemia - Elevated transaminases - Impaired growth - Suspected malabsorption - Other clinical manifestation of LAL-D 4. Participants ≥4 years of age at Screening had at least 1 of the following documented clinical manifestations of LAL-D: - Evidence of advanced liver disease - Histologically confirmed disease recurrence in participants with past liver or hematopoietic transplant - Persistent dyslipidemia - Suspected malabsorption - Other clinical manifestation of LAL-D Key Exclusion Criteria: 1. Participant had known causes of active liver disease other than LAL-D, which had not been adequately treated. 2. Participant received a hematopoietic stem cell or liver transplant <2 years from the time of dosing. 3. Participant with co-morbidities other than complications due to LAL-D, which were irreversible or associated with a high mortality risk within 6 months or would interfere with study compliance or data interpretation. ; PRIMARY OUTCOME: Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percent Change In Serum Lipids From Baseline To Week 144[/INST]Yes</s>

<s>[INST]<<SYS>>Predict 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 - 12710A; BRIEF: Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD). ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study). - The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™. - The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline. - The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline - The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form. Exclusion Criteria: - The patient has participated in a clinical study <30 days prior to the Screening Visit. Other protocol defined inclusion and exclusion criteria may apply ; PRIMARY OUTCOME: Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment; SECONDARY OUTCOME 1: Change in CDRS-R Total Score During Treatment (at Week 2)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HoFH; BRIEF: The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids as well as measures of safety over the long-term. ; DRUG USED: Juxtapid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Microsomal Triglyceride Transfer Protein (MTP); THERAPY: Monotherapy; LEAD SPONSOR: Aegerion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Males and females at least 18 years of age 2. Diagnosis of functional homozygous FH by at least one (a-c) of the following clinical criteria: - documented functional mutation(s) in both LDL receptor alleles or alleles known to affect LDL receptor functionality OR - skin fibroblast LDL receptor activity less than 20% normal OR - untreated TC greater than 500 mg/dL AND TG less then 300 mg/dL AND both parents have documented TC greater than 250 mg/dL 3. Concurrent lipid lowering medication/apheresis must be stable for at least 6 weeks before the baseline visit and must remain stable for the first 26 weeks. 4. Body weight at least 40 kg and less than 136 kg 5. Negative screening pregnancy test if female of child-bearing potential (females of child-bearing potential and all males must be following a medically accepted form of contraception) 6. Subjects must be willing to comply with all study-related procedures Exclusion Criteria: 1. Uncontrolled hypertension 2. History of chronic renal insufficiency 3. History of biopsy proven cirrhosis or abnormal LFTs at screening (AST or ALT greater than 2 x upper limit of normal and/or Total Bilirubin greater than or equal to 1.5 mg/dl unless patient has unconjugated hyperbilirubinemia due to Gilberts syndrome) 4. Chronic hepatitis B or chronic hepatitis C 5. Any major surgical procedure occurring less than 3 months prior to the screening visit 6. Cardiac insufficiency defined by the NYHA classification as functional Class III or Class IV 7. Previous organ transplantation 8. History of a non-skin malignancy within the previous 3 years 9. Male subjects reporting more than 2 drinks per day or females reporting more than 1 drink per day (1 drink= 12 oz beer, 1 oz hard liquor, 5 oz wine). 10. Participation in an investigational drug study within 6 weeks prior to the screening visit 11. Known significant gastrointestinal bowel disease or malabsorption such as inflammatory bowel disease or chronic pancreatitis requiring use of daily pancreatic enzymes. 12. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subjects safety or successful participation in the study. 13. Certain prohibited medications known to be potentially hepatotoxic, especially those that can induce microvesicular or macrovesicular steatosis. These include but are not limited to: accutane, amiodarone, heavy acetaminophen use (4g/day greater than 3 x q week), methotrexate, tetracyclines,and tamoxifen 14. Documented diagnosis of any of the following pulmonary conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis 15. Documented diagnosis of any of the following liver diseases: Nonalcoholic Steatohepatitis, Alcoholic liver disease, Autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons disease, hemochromatosis, alpha 1 anti-trypsin deficiency. 16. Current use of corticosteroids or betaine ; PRIMARY OUTCOME: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent Change From Baseline in Total Cholesterol (TC)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - FSV5-002 Ext.; BRIEF: This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months. ; DRUG USED: Helios; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: ForSight Vision5, Inc.; CRITERIA: Inclusion Criteria: 1. Completed FSV5-002 study. 2. Written informed consent prior to any study procedure. 3. Willingness to comply with the visit schedule. Exclusion Criteria: 1. Participation in an investigational drug or device study other than FSV5-002 within the past 6 months or anticipated participation during the study period. 2. Subjects who will require contact lens use during the study period. 3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigators opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subjects ability to participate in the study. ; PRIMARY OUTCOME: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity; SECONDARY OUTCOME 1: Change From Baseline in Mean Intraocular Pressure (IOP)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Daily rhGH; BRIEF: This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH. ; DRUG USED: Albutropin; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - males and females 18 years of age or over - diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection - treated with a stable dose of daily rhGH for at least 3 months prior to screening - stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening - Other criteria apply, please contact the investigator for more information Exclusion Criteria: - patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator - Presence of contraindications to rhGH treatment - patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening - patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year - patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening - presence of Prader-Willi syndrome, Turners syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushings syndrome in the past year. - patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8% - patients using weight reducing agents or appetite suppressants - Other criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Percentage of participants with adverse events; SECONDARY OUTCOME 1: Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/ E/C/F/TAF vs. F/R/TAF; BRIEF: This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants. ; DRUG USED: Harvoni; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female individuals, without cirrhosis, treatment-naive or treatment-experienced with interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI). - Compensated cirrhotic individuals must be HCV treatment-naive. - No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except boceprevir, telaprevir and simeprevir, in combination with IFN and RBV - Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior to screening. - Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values (blips) of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is allowed. - For individuals with 3 or more prior ARV regimens, a regimen history should be provided for approval by the Sponsor. - Note: Individuals that changed from TDF to TAF less than 6 months ago will be eligible as long as the TDF/ TAF change was the only change to the regimen. - Plasma HIV-1 RNA level < 50 copies/mL at the screening visit - Have no documented resistance to any of the HIV study agents at time in the past, including but not limited to the reverse transcriptase resistance mutations K65R, K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L, the combination of K103N+L100I, or 3 or more thymidine analog associated mutations (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). If a historical genotype prior to first ARV is not available or individual had 3 or more prior ARV regimens, individual will have proviral genotype analysis for archived resistance prior to Day 1. - No history of HIV virologic failure - No evidence of Hepatitis B infection - Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by Cockcroft-Gault formula Note: Other protocol defined Inclusion/ Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - KEYNOTE-002 (vs. Chemotherapy); BRIEF: This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after prior therapy. Initial Treatment Period: Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab, higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an open-label fashion. The starting pembrolizumab dose was initially blinded to Investigators and participants until Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of pembrolizumab. Switch-to-Pembrolizumab Treatment Period: Participants who were initially randomized to receive ICC and experienced progressive disease (PD) may have been eligible to switch to receiving pembrolizumab provided they met protocol-specified requirements for switching. Qualified participants were re-randomized to receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03, all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab. ; DRUG USED: Keytruda; 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: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy - Participants must be refractory to ipilimumab - Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor - Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting) - Radiographically measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier - Disease progression within 24 weeks of last dose of ipilimumab - Participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug - Expected to require any other form of systemic or localized antineoplastic therapy while on study - Chronic systemic steroid therapy within 2 weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication - Known history of any other than the current malignancy excepting adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, breast cancer, or other in situ cancers - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease or a history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents - Prior treatment with any other anti-programmed cell death (PD) agent - Active infection requiring systemic therapy - Known history of Human Immunodeficiency Virus (HIV) - Active Hepatitis B or Hepatitis C - Regular user (including recreational use of) illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) - Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study through 120 days after last dose of study drug ; PRIMARY OUTCOME: Progression-free Survival (PFS) - Initial Treatment Period; SECONDARY OUTCOME 1: Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - MM-002 - w/Dex; BRIEF: The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with relapsed and refractory multiple myeloma ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene Corporation; CRITERIA: Inclusion Criteria: - Must be greater than or equal to 18 years at the time of signing the informed consent form - Must be able to adhere to the study visit schedule and other protocol requirements - Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Patients must have received at least 2 prior therapies. Patients must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed PD. Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease) - Patients must have also undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen) - Measurable levels of myeloma paraprotein in serum (greater than or equal to 0.5 g/dL) or urine (greater than or equal 0.2 g/dL excreted in a 24 hour collection sample) - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 - Females of childbearing potential (FCBP) [An FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months)] must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 28 days after discontinuation of study drug and must agree to regular pregnancy testing during this timeframe. - All patients must also agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study - Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study even if he has undergone a successful vasectomy. Males must also agree to refrain from donating blood, semen or sperm during the above referenced timeframe. - All patients must agree not to share medication with another person. Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form. - Any serious concurrent medical conditions that may make the patient non-evaluable or put the patients safety at risk. - Pregnant or lactating females - Any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) < 1,000 cells/mm3 - Platelet count < 75,000/mm3 for patients in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/mm3 for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells - Serum creatinine > 3.0 mg/dL - Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum Glutamic Pyruvate Transaminase/Alanine transaminase (SGPT/ALT) > 3.0 X upper limit of normal (ULN) - Serum total bilirubin > 2.0 mg/dL - Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following: - Basal or squamous cell carcinoma of the skin - Carcinoma in situ of the cervix or breast - Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b) - Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection - Hypersensitivity to thalidomide, lenalidomide, or dexamethasone - Peripheral neuropathy ≥ Grade 2 - Use of any anti-myeloma drug therapy within 14 days of the initiation of study drug treatment or use of any experimental non-drug therapy within 28 days of the initiation of study drug treatment - Radiation therapy within 14 days of initiation of study drug treatment Inability or unwillingness to comply with birth control requirements ; PRIMARY OUTCOME: Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1; SECONDARY OUTCOME 1: Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Study 0110; BRIEF: A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function. ; DRUG USED: Oxbryta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: Hemoglobin; THERAPY: Monotherapy; LEAD SPONSOR: Global Blood Therapeutics; CRITERIA: Inclusion Criteria: All subjects: - Males or females, 18 to 80 years old - Willing and able to give written informed consent Subjects with renal impairment: - Severe renal impairment (eGFR < 30 mL/min/1.73m2, not on dialysis) - Moderate renal impairment (30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2) - Mild renal impairment (60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2) Healthy subjects: - Match in age, gender and body mass index with renal impaired subjects - Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history Exclusion Criteria: All subjects: - Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device) - Any signs or symptoms of acute illness at screening or Day -1 - History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease Subjects with renal impairment: - History of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year ; PRIMARY OUTCOME: Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function; SECONDARY OUTCOME 1: Number of subjects with treatment-related Adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SOLO-Continue; BRIEF: The primary objective of the study was to assess the ability of different Dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with Dupilumab monotherapy compared to placebo. ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Must have completed the treatment phase in 1 of the two 16-week initial treatment studies (R668-AD-1334 or R668-AD-1416). 2. Must have achieved at least 1 of the following 2 treatment success criteria: Investigator Global Assessment (IGA) = 0 or 1 (clear or almost clear) at week 16 OR Eczema Area and Severity Index >= 75% (EASI-75) (at least 75% reduction in EASI score from baseline to week 16) 3. Must be willing and able to comply with clinic visits and study-related procedures 4. Must provide signed informed consent 5. Must be able to understand and complete study-related questionnaires Key Exclusion Criteria: 1. Receipt of rescue medication for AD in the initial treatment study 2. Any conditions that require permanent discontinuation of study treatment in either initial treatment study 3. Planned or anticipated major surgical procedure during the participantss participation in this study 4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during this study 5. Women unwilling to use adequate birth control, if of reproductive potential* and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception, whenever engaging in heterosexual intercourse, throughout the duration of the study and for 120 days after last dose of study drug. These include hormonal contraceptives, intrauterine device, or double barrier contraception (e.g, condom + diaphragm), or a male partner with documented vasectomy. Additional requirements for acceptable contraception may apply in certain countries, based on local regulations. Investigators in these countries will be notified accordingly in a protocol clarification letter. (*For females, menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of >= 25 milli units per milliliter (mU/mL) must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception). ; PRIMARY OUTCOME: Difference Between Current Study Baseline and Week 36 in Percent Change in EASI From Parent Study Baseline (NCT02277743 and NCT02277769); SECONDARY OUTCOME 1: Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response Within 1 Point of Baseline at Week 36[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ORARIALS-01; BRIEF: A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS) ; DRUG USED: Miplyffa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: SOD1; THERAPY: Monotherapy; LEAD SPONSOR: ZevraDenmark; CRITERIA: Inclusion Criteria: - Subject meets revised El Escorial criteria for clinically possible, clinically probable / clinically probable ALS laboratory-supported, clinically definite ALS or clinically definite familial ALS laboratory-supported - 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath) - ALS Functional Rating Scale-Revised (ALSFRS-R) equal to or above 35 and erect (seated) Slow Vital Capacity (SVC) % predicted equal to or above 70% at Screening Exclusion Criteria: - Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of Screening and Baseline - Pregnant or breast-feeding - Current or anticipated use of diaphragmatic pacing - Any other relevant medically significant condition which could present risk to the subject or interfere with the assessment of safety or has an increased risk of causing death during the trial ; PRIMARY OUTCOME: Combined Assessment of Function and Survival (CAFS); SECONDARY OUTCOME 1: Time to Permanent Assisted Ventilation (PAV) / Tracheostomy / Death[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - GATSBY (vs. Taxane); BRIEF: This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy of at least 12 weeks from the first dose of study treatment - Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) - Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization - Participants must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease - HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization) - Participants must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy. - First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy. - Adjuvant or neoadjuvant therapy for AGC is allowed. Exclusion Criteria: - An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization - Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen. - Treatment with any investigational anticancer drug within 21 days of the first study treatment administration - More than one prior line of therapy for advanced gastric cancer - History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome - Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization - Peripheral neuropathy Grade >/=2 - Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia) - Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers) - Clinically significant bleeding within 30 days before enrollment - For female participants, current pregnancy or lactation - Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment - Infection with Human immunodeficiency virus (HIV) or hepatitis B virus, hepatitis C virus ; PRIMARY OUTCOME: Overall Survival (OS)- Phase 3; SECONDARY OUTCOME 1: Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AFUGEM; BRIEF: To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2. ; DRUG USED: Abraxane; DRUG CLASS: Non-NME; INDICATION: Pancreatic Cancer; TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: GERCOR - Multidisciplinary Oncology Cooperative Group; CRITERIA: Inclusion Criteria: 1. Signed and dated informed consent, and willing and able to comply with protocol requirements, 2. Histologically or cytologically proven adenocarcinoma of the pancreas, 3. Metastatic disease confirmed (stage IV), 4. No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months), 5. At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1 guidelines, 6. Age ≥18 years, 7. ECOG Performance status (PS) 0-2, 8. Hematological status: neutrophils (ANC) >1.5x109/L; platelets >100x109/L; haemoglobin ≥9g/dL, 9. Adequate renal function: serum creatinine level <150µM, 10. Adequate liver function: AST (SGOT) and ALT (SGPT) ≤2.5xULN (≤5xULN in case of liver metastases) 11. Total bilirubin ≤1.5 x ULN, albumin ≥25g/L 12. Baseline evaluations performed before randomization: clinical and blood evaluations no more than 2 weeks (14 days) prior to randomization, tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to randomization, 13. Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least six months after the end of study treatment (when applicable). All female patients with reproductive potential must have a negative pregnancy test (β HCG) within 72 hours prior to starting ABI-007 treatment. Breastfeeding is not allowed. Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment, 14. Registration in a national health care system (CMU included for France). Exclusion Criteria: 1. History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy) 2. Local or locally advanced disease (stage I to III), 3. Patient uses warfarin, 4. Uncontrolled hypercalcemia, 5. Pre-existing permanent neuropathy (NCI grade ≥2), 6. Known dihydropyrimidine dehydrogenase (DPD) deficiency, 7. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), 8. Treatment with any other investigational medicinal product within 28 days prior to study entry, 9. Other serious and uncontrolled non-malignant disease (eg. active infection requiring systemic therapy, coronary stenting or myocardial infarction or stroke in the past 6 months), 10. Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C. 11. History or active interstitial lung disease (ILD), 12. Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years, 13. Patients with known allergy to any excipient of study drugs, 14. Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine and concomitant administration of prophylactic phenytoin ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Tumor 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 III - Persistent Asthma (China); BRIEF: Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: - To evaluate the safety and tolerability of dupilumab - To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life - To evaluate dupilumab systemic exposure and immunogenicity ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Adults and adolescent patients (≥12 years of age) with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma 2017 Guidelines and the following criteria: - Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1). - Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤10 mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1). - Pre-bronchodilator FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization. - Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization. - For patients not requiring maintenance OCS, screening blood eosinophil count ≥150 cells/μL or Fractional Exhaled Nitric Oxide (FENO) ≥25 parts per billion (ppb); for patients requiring maintenance OCS, there is no minimum requirement for blood eosinophil count and FENO level. Exclusion criteria: - Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, patient recruitment will be restricted to those who are ≥18 years of age). - Weight is less than 30 kg at the screening visit (Visit 1) or the randomization visit (Visit 2). - Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis) which may impair lung function. - A patient who experiences a severe asthma exacerbation (defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, treatment with systemic steroids, or treatment with systemic steroid at least twice the previous dose for patients on OCS maintenance) at any time from 1 month prior to the screening visit (Visit 1) up to and including the randomization visit (Visit 2). - Evidence of lung disease(s) other than asthma, either clinical or imaging evidence (eg, chest X-ray, computed tomography, and magnetic resonance imaging) within 3 months prior to the screening visit (Visit 1) as per local standard of care. - Current smoker or cessation of smoking within 6 months prior to the screening visit (Visit 1). - Previous smoker with a smoking history >10 pack-years. - Comorbid disease that might interfere with the evaluation of investigational medicinal product (IMP). The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Change in pre-bronchodilator forced expiratory volume (FEV1); SECONDARY OUTCOME 1: Annualized rate of severe exacerbation 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 - w/Erlotinib (NCI); BRIEF: This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together works in treating patients with locally advanced or metastatic pancreatic cancer that is refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ; DRUG USED: Koselugo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Histologically or cytologically proven adenocarcinoma of the pancreas - Patients must have locally advanced unresectable disease not amenable to curative resection or extrapancreatic metastases; patients must have EITHER radiographically measurable disease (defined as at least one lesion that can be accurately measured in at least one dimension [longest diameter to be recorded] as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography [CT] scan) AND/OR a serum CA19-9 measurement > 2 x ULN - One prior line of systemic therapy for advanced disease (locally advanced or metastatic) - The following represent acceptable examples meeting the definition of one prior line of therapy: - Gemcitabine as a single agent or in combination with other agents; patients receiving (a) gemcitabine initially alone, with the eventual addition of a second agent; or (b) gemcitabine as part of a combination regimen, followed by gemcitabine alone; are eligible - A non-gemcitabine-based regimen, including (but not limited to) leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) or any combination of components therein - Treatment as part of a clinical trial involving cytotoxic agents, small molecule inhibitors, monoclonal antibodies, and/or immunomodulatory agents - For patients with locally advanced disease, prior radiation to the primary tumor is allowable as long as there is clear evidence of disease progression (either radiographic locoregional disease progression and/or a rising CA19-9 level); patients may have received chemotherapy both concurrently and/or sequentially with (either before or after) the radiation and still be eligible for the study, as this would be considered all part of the same course of treatment - Treatment given in the adjuvant setting (radiation and/or chemotherapy, given either concurrently or sequentially) does not count as prior therapy as long as progressive disease occurs > 6 months following completion of treatment - Life expectancy of greater than 8 weeks - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Absolute neutrophil count (ANC) >= 1500/uL - Platelet count >= 100,000/uL - International normalized ratio (INR) =< 1.5 (except those subjects who are receiving full-dose warfarin) - Total bilirubin =< 2.0 mg/dL - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 times the upper limit of normal for subjects - Serum creatinine of =< 2.0 mg/dL - Pregnancy test for women of childbearing potential (serum or urine beta-human chorionic gonadotropin [HCG]) - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for four weeks after dosing with AZD6244 ceases; women of child-bearing potential must have a negative pregnancy test prior to entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; please note that the AZD6244 manufacturer recommends that adequate contraception for male patients should be used for 16 weeks post-last dose due to sperm life cycle - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients may not be receiving any other investigational agents - Patients with known brain metastases should be excluded from this clinical trial - History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 (or its excipient Captisol) or erlotinib - Previous mitogen-activated protein kinase kinase (MEK) or epidermal growth factor receptor (EGFR) inhibitor use - Patients with corrected QT (QTc) interval > 480 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that (i) meets New York Heart Association (NYHA) class III and IV definitions or (ii) is demonstrated by an left ventricular (LV) ejection fraction < 55% on baseline echocardiogram, are excluded - Required use of a concomitant medication that can prolong the QT interval - There are potential interactions between erlotinib and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and CYP3A4 promoters; although caution and careful monitoring are recommended when use of these compounds is necessary, use of these compounds does not exclude patients from participating in this trial - Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant women are excluded from this study; therefore, a negative pregnancy test is required for women of childbearing potential; breastfeeding should be discontinued if the mother is treated with AZD6244 - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CLEAR (Ext.); BRIEF: This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe. ; DRUG USED: Zurampic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gout; TARGET: URAT1 (urate trans-porter 1, SLC22A12/Solute carrier family 22, member 12); THERAPY: Combination; LEAD SPONSOR: Ardea Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. - Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit. - Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth Exclusion Criteria: - Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subjects ability to comply with the protocol requirements, or to complete the study. ; PRIMARY OUTCOME: Proportion of subjects with an sUA level that is < 6.0 mg/dL; SECONDARY OUTCOME 1: Resolution of at least 1 target tophi[/INST]Yes</s>

<s>[INST]<<SYS>>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 - 020; BRIEF: The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo for preventing migraines in participants with episodic migraine. After a 28-day Screening period during which baseline number of monthly migraine days was assessed, participants were randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2 weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the initial randomization. In the Run-out Period, participants who received placebo in the Treatment Period continued to receive placebo and participants who received MK-6096 in the Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as measured by the mean change from baseline in monthly migraine days averaged over the 12- week treatment period. ; DRUG USED: MK-6096; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - History of migraine with or without aura for >1 year and with ≥4 and ≤14 migraine days per month in the 3 months prior to study - Male, female not of reproductive potential, or female of reproductive potential who is not pregnant by pregnancy test and agrees to use acceptable contraception Exclusion Criteria: - Pregnancy, breast-feeding, or expecting to become pregnant - Planning to donate egg or sperm during the study or within 90 days after last dose of study medication - Basilar or hemiplegic migraine headache - >50 years old at the age of migraine onset - ≥15 headache-days per month or medication taken for acute migraine or other headaches on more than 10 days per month in any of the three months prior to study - Migraine prophylactic medication (defined as medication taken daily to prevent migraines) taken in the 30 days prior to study - History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition (e.g., asthma, gastroesophageal reflux disease, etc.) - Clinical, laboratory, or electrocardiogram (ECG) evidence of uncontrolled hypertension, uncontrolled diabetes, human immunodeficiency virus (HIV) disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease - Myocardial infarction, unstable angina, coronary artery bypass surgery, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of study - Other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine - Imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others. Exclude any prospective participant reporting suicidal ideation with intent, with or without a plan in the past 2 months or suicidal behavior in the past 6 months - History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer - History of hypersensitivity to more than two chemical classes of drugs, including prescription and over-the-counter medications - Recent history (within the past 1 year) or current evidence of drug or alcohol abuse or recreational use of illicit drugs or prescription medications - Donated blood products or has had phlebotomy of >300 ml within 8 weeks of study, or intends to donate blood products or receive blood products within 30 days before study and throughout study - Consumption of 3 or more alcoholic drinks per day - Body Mass Index >40 kg/m^2 - History of transmeridian travel (across >3 time zones) or shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates needing to travel (across >3 time zones) at any time during the study. ; PRIMARY OUTCOME: Mean Change From Baseline in Monthly Migraine Days; SECONDARY OUTCOME 1: Mean Change From Baseline in Monthly Headache Days[/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 - EGSPZV2; BRIEF: This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via direct venous inoculation (DVI) compared with control groups receiving normal saline (NS) placebo by DVI. In addition, the study will also assess a second PfSPZ-based vaccination approach known as PfSPZ-CVac- the administration of non-irradiated, infectious PfSPZ (PfSPZ Challenge) (1x10^5 PfSPZ) under anti-malarial chemoprophylaxis (chloroquine) in younger adults ages 18 to 35 years for safety, tolerability, immunogenicity and efficacy against controlled human malaria infection (CHMI). ; DRUG USED: PfSPZ Vaccine; DRUG CLASS: Vaccine; INDICATION: Malaria; TARGET: Immune System, Interferon-gamma (IFN-g)/Type II Interferon, Plasmodium, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Sanaria Inc.; CRITERIA: Inclusion Criteria: - Healthy males and females, based on clinical and laboratory findings - From the age 6 months to 65 years - Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or adolescents, children and infants with Z-score of the selected indicator ([weight-for-height], [(height and BMI) for age]) category within ±2SD as detailed in protocol - Long-term (at least one year) or permanent residence in the Baney district or Malabo city - Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study - Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period - Agreement to provide contact information of a third party household member or close friend to study team - Agreement not to participate in another clinical trial during the study period - Agreement not to donate blood during the study period - Able and willing to complete the study visit schedule over the study follow up period, including the hospitalizations required for protocol compliance - .Willingness to undergo HIV, hepatitis B (HBV) and hepatitis C (HCV) tests - Volunteer (subjects 18 years of age and older) or the parent / guardian signing the informed consent (for subjects <18 years of age) is able to demonstrate their understanding of the study by responding correctly to 10 out of 10 true/false statements (in a maximum of two attempts for those who failed to respond correctly to all true/false statements in the first attempt). - Signed written informed consent, in accordance with local practice, provided by adult volunteers, parents or legal representatives and relevant assent for children participants as applicable. - Free from malaria parasitemia by blood smear at enrollment and by PCR for group 1 - Has not been treated with any antimalarial medication for at least two weeks prior to the first immunization. - Free from helminth infections (detected by microscopy) at enrollment. - Female volunteers aged 9 years and above must be non-pregnant (as demonstrated by a negative urine pregnancy test), and provide consent/assent of their willingness to take protocol-defined measures not to become pregnant during the study and safety follow-up period. Exclusion Criteria: - Previous receipt of an investigational malaria vaccine in the last 5 years - Participation in any other clinical study involving investigational medicinal products including investigational malaria drugs within 30 days prior to the onset of the study or during the study period - History of arrhythmias or prolonged QT-interval or other cardiac disease, or clinically significant abnormalities in electrocardiogram (ECG) at screening - Positive family history in a 1st or 2nd degree relative for cardiac disease at age <50 years old - A history of psychiatric disease - Suffering from any chronic illness including; diabetes mellitus, cancer or HIV/AIDS - Any confirmed or suspected immunosuppressive or immune-deficient condition, including asplenia - History of drug or alcohol abuse interfering with normal social function - The use of chronic immunosuppressive drugs or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period - Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis - Positive HIV, hepatitis B virus or hepatitis C virus tests - Volunteers who are have risk factors for tuberculosis and/or signs and symptoms of tuberculosis (TB), plus a positive tuberculin skin test (TST). - Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, blood, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers - Any medical, social condition, or occupational reason that, in the judgment of the investigator, is a contraindication to protocol participation or impairs the volunteers ability to give informed consent, increases the risk to the volunteer because of participation in the study, affects the ability of the volunteer to participate in the study or impairs the quality, consistency or interpretation of the study data - History of non-febrile seizures or atypical febrile seizures ; PRIMARY OUTCOME: Incidence and type of Adverse Events; SECONDARY OUTCOME 1: Level of Antibodies against Pf proteins in volunteer sera[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers (Singapore); BRIEF: The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. ; DRUG USED: LY2608204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Hexokinase/Glucokinase; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Must be a healthy male or a female who cannot become pregnant - Must have body mass index (BMI) of 18.5 to 32 kg/m², inclusive - Blood pressure as well as blood and urine laboratory test results must be acceptable for the study - The veins must be suitable for easy blood collection - Must be willing to be available for the whole study and be willing to follow study procedures - Must have given written informed consent Exclusion Criteria: - Were in another new drug or medical research study in the last 30 days - Have participated in this study or any other study with LY2608204 before - Have taken drugs similar to LY2608204 (glucokinase activators) before and was found to be allergic to the drug - Have drug allergy to more than 3 types of medications given by injection - Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study - Electrocardiogram (ECG) readings are not suitable for the study - Are infected with hepatitis B - Are infected with human immunodeficiency disease virus (HIV) - Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study - Are unwilling to follow dietary restrictions/requirements for the study including (i) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay; (ii) consume only the meals provided during dosing day at the clinical research unit (CRU) - Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit - Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic - Have a history of drug or alcohol abuse - Have donated 450 milliliter (mL) or more of blood in the last 3 months (this is about the same as the usual volume given in a blood donation) - The study doctor thinks the subject should not participate for any other reasons ; PRIMARY OUTCOME: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Renal Impairment; BRIEF: A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment. ; DRUG USED: Cotadutide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: - Must provide written informed consent - BMI greater than or equal to 17 and less than or equal to 40 kg/m2 - Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min) - Females of childbearing potential must use a highly effective form of contraception. Exclusion Criteria: - Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety. - Subjects on dialysis - Subjects with pancreatitis - Renal transplant subjects - Females pregnant or lactating ; PRIMARY OUTCOME: Maximum Observed Concentration of MEDI0382 (Cmax); SECONDARY OUTCOME 1: Time to maximum observed concentration (Tmax)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict 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; BRIEF: This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery. ; DRUG USED: Votrient (Oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Signed written informed consent - Diagnosis of RCC with clear-cell or predominant clear-cell histology - Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading. - pT2, G3 or G4, N0; or, - pT3, G any, N0; or, - pT4, G any, N0; or, - pT any, G any, N1 - Fulfill all of the following criteria of disease-free status at baseline: - Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique. - Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist. - Received no prior adjuvant or neo-adjuvant treatment for RCC - Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4) - Karnofsky performance scale (KPS) of ≥ 80 - Adequate organ system function Exclusion Criteria: - History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible - Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: - Active peptic ulcer disease - Inflammatory bowel disease (e.g. ulcerative colitis, Crohns disease), or other gastrointestinal conditions with increased risk of perforation - History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment - Active diarrhea of any grade - Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: - Malabsorption syndrome - Major resection of the stomach or small bowel - History of human immunodeficiency virus (HIV) infection - History of active hepatitis - Presence of uncontrolled infection. - History of any one or more of the following cardiovascular conditions within the past 6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Coronary artery bypass graft surgery - Symptomatic peripheral vascular disease - History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure - History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. - Corrected QT interval (QTc) > 480 milliseconds (msec) - Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values). - Evidence of active bleeding or bleeding diathesis - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures - Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study. - Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug. - Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment. - Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation. - Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2). ; PRIMARY OUTCOME: Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo; SECONDARY OUTCOME 1: Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. 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 IIb - LATTE Rollover Study (w/Rilpivirine LA); BRIEF: This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants. Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than [<]50 copies (c) per milliliter [mL]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval). Duration of study will vary from country to country, until regimen receives regulatory approval and becomes commercially available. The study plans to enroll approximately 100 participants. Any participant who receives at least one dose of CAB LA and/or RPV LA and discontinues the CAB LA plus RPV LA regimen for any reason will enter a 52-week Long-Term Follow-Up (LTFU) phase. Those participants must remain on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and or RPV LA. ; DRUG USED: Cabenuva; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent. - A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test at Day 1), not lactating, and at least with one of following conditions: (a) Non-reproductive potential defined as: (i) Pre-menopausal females with one of the conditions as documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. (ii) Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. (b) Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA. - The investigator is responsible for ensuring that participants understand how to properly use the methods of contraception. - Capable of giving signed informed consent. - Must have been on oral CAB 30 mg plus RPV 25 mg regimen through at minimum Week 300 of the LATTE study as per LATTE protocol dosing requirements and until Day 1 of the POLAR study. Any disruptions in dosing during LATTE must be discussed with the Medical Monitor for a final determination of eligibility. - Plasma HIV-1 RNA <50 c/mL at Week 300. If participant has plasma HIV-1 RNA >= 50 c/mL at Week 300 in LATTE, a single repeat to determine eligibility may be allowed ONLY after consultation with the medical monitor. Exclusion Criteria: - During the last 6 months of participation in LATTE, consecutive (2 or more sequential) plasma HIV-1 RNA measurements >=50 c/mL. - During the last 6 months of participation in LATTE, any HIV-1 RNA measurement >=200 c/mL. - Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposis sarcoma not requiring systemic therapy. - Participants with moderate to severe hepatic impairment determined by Child-Pugh classification. - Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participants ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. - Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. - Participants who, in the investigators judgment, pose a significant suicide risk. Participants recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. - Participants has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. - Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows; Participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. - Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment within 12 months must be excluded. (HCV treatment on study may be permitted, following consultation with the medical monitor). - Participants with HCV co-infection will be allowed entry into this study if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced. - Additional information (where available) on participants, with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. - In the event that recent biopsy or imaging data is not available or inconclusive, the fibrosis- 4 (Fib-4) score will be used to verify eligibility where Fib-4 score >3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation where the Fibrosis 4 Score Formula: age multiplied by aspartate amino transferase (AST) divided by platelets multiplied by square of alanine aminotransferase (ALT). - Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). - History of liver cirrhosis with or without hepatitis viral co-infection. - Ongoing or clinically relevant pancreatitis. - Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. - Ongoing malignancy other than cutaneous Kaposis sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization. - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. - Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease. - Corrected QT interval (QTc (Bazett)) >450 millisecond (msec) or QTc (Bazett) >480 msec for participants with bundle branch block. - Any verified Grade 4 laboratory abnormality over the last 6 months in LATTE. A single repeat test is allowed to verify a result. - Any acute laboratory abnormality over the last 6 months in LATTE, which, in the opinion of the investigator, would preclude the participants participation in the study of an investigational compound. - ALT>=5 times upper limit of normal (ULN) or ALT >= 3 times ULN and bilirubin >= 1.5 times ULN (with >35 percent [%] direct bilirubin) over the last 6 months in LATTE. - Exposure to an experimental drug (with the exception of those in the LATTE study including CAB and RPV) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study. - Treatment with any of the following agents within 28 days of Day 1: radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]); anti-coagulation agents. - Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. - Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility. - Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. ; PRIMARY OUTCOME: Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12; SECONDARY OUTCOME 1: Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - GO-AHEAD (nr-AxSpA); BRIEF: This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16. ; DRUG USED: Simponi (SQ); DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration - Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs - Females of child-bearing potential must use contraception - No history of untreated latent or active tuberculosis Exclusion Criteria: - Fulfillment of modified New York criteria for ankylosing spondylitis - Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents - Any systemic inflammatory condition other than spondyloarthritis - Serious infection within 2 months - Any known malignancy or a history of malignancy within the previous 5 years - Has or had a substance abuse (drug or alcohol) problem within the previous 2 years ; PRIMARY OUTCOME: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16; SECONDARY OUTCOME 1: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3725 - BEGIN: BB T1 Extension; BRIEF: ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: ; CRITERIA: ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - NG101-201; BRIEF: The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment. ; DRUG USED: NG101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroparesis Therapy; TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Neurogastrx, Inc.; CRITERIA: Inclusion Criteria: - Adult patients with diabetic or idiopathic gastroparesis - Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain) - Documented evidence of no mechanical obstruction - Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test Exclusion Criteria: - Uncontrolled diabetes (defined as HgbA1c > 10%) - Severe postural symptoms or evidence of unexplained recurrent dizziness - Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms - Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit. - Participant engages in daily recreational use of marijuana - Prolactin levels > 2 x ULN ; PRIMARY OUTCOME: Change of Severity of Nausea; SECONDARY OUTCOME 1: Change from Baseline of Symptoms[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Hospitalized Infants and Children; BRIEF: The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR). ; DRUG USED: JNJ-64041575; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Syncytial Virus (RSV) Treatment; TARGET: RNA synthesis, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants hospitalized (or in emergency room [ER]) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization - Participants diagnosed with respiratory syncytial virus (RSV) infection using a polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without co-infection with another respiratory pathogen (respiratory virus or bacteria) - Participants who have an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to <=5 days from the anticipated time of randomization. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection - With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [participants gestational age was less than {<}37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), participant must be medically stable on the basis of physical examination, medical history, vital signs/peripheral capillary oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population and/or the RSV infection. This determination must be recorded in the participants source documents and initialed by the investigator. Participants with comorbidities will be allowed to be enrolled once the Independent Data Monitoring Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest dose that will be used in this study and once the IDMC has recommended opening recruitment to this group. Sites will be notified when the restriction is lifted - The participants estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the participants age Exclusion Criteria: - Participants who are not expected to survive for more than 48 hours - Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization - Participants who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection - Participants being treated with extracorporeal membrane oxygenation - Participant receiving chronic oxygen therapy at home prior to admission - Participants who have a poorly functioning gastrointestinal tract (that is, unable to absorb drugs or nutrition via enteral route) ; PRIMARY OUTCOME: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load; SECONDARY OUTCOME 1: Number of Participants With Emergent Adverse Event[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - ZUMA-6 (w/Atezolizumab); BRIEF: The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL). Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 ; DRUG USED: Yescarta; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: Kite, A Gilead Company; CRITERIA: Key Inclusion Criteria: 1. Histologically confirmed DLBCL 2. Chemotherapy-refractory disease, defined as one or more of the following: - Stable disease (duration of stable disease must be less than or equal to 6 months) or progressive disease as best response to most recent chemotherapy containing regimen - Disease progression or recurrence less than or equal to 12 months of prior autologous stem cell transplantation (SCT) 3. Individuals must have received adequate prior therapy including at a minimum: - anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative; and - an anthracycline containing chemotherapy regimen 4. At least one measurable lesion per revised International Working Group (IWG) Response Criteria 5. Age 18 years or older 6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 7. Adequate organ and bone marrow function 8. All individuals or legally appointed representatives/caregivers, must personally sign and date the institutional review board (IRB)/independent ethics committee (IEC) approved consent form before initiating any study specific procedures or activities. Key Exclusion Criteria: 1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years 2. History of allogeneic stem cell transplantation 3. Prior CAR therapy or other genetically modified T cell therapy 4. Clinically significant active infection 5. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) 6. Individuals with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases 7. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement 8. History of autoimmune disease. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and participants with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study. 9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed. 10. Prior treatment with PD-L1 inhibitor, PD-1 inhibitor, anti-CTLA4, anti-CD137, anti-OX40 or other immune checkpoint blockade or activator therapy with the exception of Individuals who received atezolizumab in this study and are eligible for re-treatment 11. Prior CD19 targeted therapy Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Phase 1 and 2: 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 I - w/GLPG2451; BRIEF: The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo. ; DRUG USED: ABBV-2222; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Female between 18-65 years of age inclusive, on the day of signing informed consent form (ICF). - Of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]). In addition a determination of follicle stimulating hormone (FSH) can be performed with FSH >35 mIU/ml to further confirm postmenopausal status without menstruation for ≥12 months. - A body mass index (BMI) between 18-30 kg/m2, inclusive. - Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), Holter monitoring and a laboratory profile prior to the initial study drug administration. - Discontinuation of all medications (including over-the-counter medications and herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration. In addition, subjects must agree not to take any medications (including over-the-counter medication and herbal supplements), or alcohol during the course of the study.-non-smokers and non-users of any nicotine-containing products. - Non-smokers and non-users of any nicotine-containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to the screening. A non-user is defined as an individual who has abstained from any nicotine containing products for at least 1 year prior to the screening. - Negative urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) and alcohol breath test. - Able and willing to sign the ICF as approved by the IEC, prior to screening evaluations, and willing to adhere to the prohibitions and restrictions. Exclusion Criteria: - Known hypersensitivity or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization. - Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A. - History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection). - Symptoms of clinically significant illness in the 3 months before the initial study drug administration. - Presence or having sequelae of gastrointestinal, liver or kidney (creatinine clearance ≤ 80 mL/min using the Cockroft formula; if calculated result ≤ 80 mL/min, a 24-hour urine collection to determine actual value can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. - History of malignancy within the past 5 years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence). - Clinically relevant abnormalities detected on ECG and/or Holter regarding either rhythm or conduction (e.g. QTcF ≥ 470 msec, or a known long QT syndrome). A first degree heart block will not be considered as a significant abnormality. - Family history (if known) of long QT syndrome in a primary relative. - Clinically relevant abnormalities detected on vital signs. - Significant blood loss (including blood donation [> 500 mL]), or having had a transfusion of any blood product within 12 weeks prior to the initial study drug administration. ; PRIMARY OUTCOME: Change versus placebo in the proportion of subjects with adverse events; SECONDARY OUTCOME 1: Maximum observed plasma concentration of GLPG2451 (Cmax) given alone[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - inTandem1 (North America); BRIEF: This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy. ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participants had given written informed consent to participate in the study in accordance with local regulations. - Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent. - Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). - Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol. - At the Screening Visit, A1C must be between 7.0% to 11.0%. - Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test . Exclusion Criteria: - Use of antidiabetic agent other than insulin or insulin analog at the time of screening. - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to randomization. - Chronic systemic corticosteroid use. - Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in A1C at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With A1C <7.0% (at Week 24) and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) Upto Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 301 (DERMIS-1); BRIEF: This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP. ; DRUG USED: ARQ-151; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: Arcutis Biotherapeutics, Inc.; CRITERIA: Inclusion Criteria: - Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws - Males and females ages 2 years and older (inclusive) - Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator - Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial. - In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis. - Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Exclusion Criteria: - Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. - Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. - Previous treatment with ARQ-151 or its active ingredient - Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. - Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product - Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigators opinion, makes them unsuitable for clinical study participation ; PRIMARY OUTCOME: Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8; SECONDARY OUTCOME 1: Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - B-Cell Malignancies (U.S.); BRIEF: This is an open-label Phase 1b/2 study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)or non hodgkins lymphoma (NHL) who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication. ; DRUG USED: Vecabrutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Sunesis Pharmaceuticals; CRITERIA: Inclusion Criteria (Key factors listed): - Eastern Cooperative Oncology Group Performance Status of ≤2. - Confirmed malignancy with relapsed/refractory disease after ≥2 lines of standard systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM, MCL or MZL and for DLBCL-ABC and FL, after ≥2 lines of standard systemic therapy (Phase 1b). For Phase 2, CLL/SLL patients with confirmed malignancy with relapsed/refractory disease after ≥1 line of standard systemic therapy including prior BTK inhibitor therapy - Presence of measurable disease through various assessments depending on specific cancer type. - Current medical need for therapy of the B-lymphoid malignancy. Exclusion Criteria (Key factors listed): - Active central nervous system involvement. - History of second primary malignancy that has progressed or required systemic treatment in the past 2 years. Exceptions include: local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, hormone sensitive prostate cancer with stable PSA ≥3 months, and other localized solid tumors in situ/other low risk cancers. - Significant cardiovascular disease or electrocardiogram (ECG) abnormalities - Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder, uncontrolled peptic ulcer disease, oral anticoagulation medications. - Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start of drug therapy. - Demonstrated intolerance to BTK inhibitor as shown by discontinuation due to adverse effects. - Use of a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit). ; PRIMARY OUTCOME: Maximum tolerated dose and/or Recommended dose of SNS-062 (Phase 1b); SECONDARY OUTCOME 1: Safety as assessed through reported AEs, SAEs, DLTs and abnormal lab findings (Phase 1b and Phase 2)[/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 - PRIME; BRIEF: This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Men or women must be at least 18 years of age at the time of screening - Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by: - PASI score of >10 - Affected body surface area (BSA) > 10% - DLQI >10 - Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patients medical history or reported by the patient or determined by the investigator at screening. Exclusion Criteria (abbreviated): - Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline - Ongoing use of other prohibited psoriasis and non-psoriasis treatment. - Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations - Patients with severe liver diseases - Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers - Patients with severe kidney diseases or serum creatinine above 1 x ULN - Patients with known hematological disease or lab abnormalities - Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary) ; PRIMARY OUTCOME: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24; SECONDARY OUTCOME 1: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PEARL 3 Ext (Study 234); BRIEF: Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Entry Criteria: - Screening for the present study will take place after subjects participation in Study D1050233 has been completed, and after providing informed consent. Inclusion Criteria: - Completed all required assessments on the final study visit in Study D1050233. - Suitable for treatment in an outpatient setting. Exclusion Criteria: - Any chronic organic disease of the CNS (other than schizophrenia). - Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. ; PRIMARY OUTCOME: Relapse of Psychotic Symptoms; SECONDARY OUTCOME 1: Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Women; BRIEF: The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential. ; DRUG USED: ResVax; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria: - Healthy adult females, ≥ 18 and ≤ 35 years of age. Healthy shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or prevention of disability. - Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with symptoms or disability are eligible, as are users of hormonal contraceptives. - Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with mitral valve prolapse) are eligible. - Ongoing therapy will be defined as continuous or, if intermittent, more frequent than once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced bronchospasm more than once every 3 months). Immunosuppressives are subject to exclusion criterion #5 below. - Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible. - Willing and able to give informed consent prior to study enrollment. - Able to comply with study requirements. - Women who are not surgically sterile must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD. Exclusion Criteria: - Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination. - History of a serious reaction to any prior vaccination. - Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time. - Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination. - Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. - Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration). - Known disturbance of coagulation. - Women who are pregnant or breastfeeding, or plan to become pregnant during the study. - Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse. - Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). ; PRIMARY OUTCOME: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups; SECONDARY OUTCOME 1: Immunogenicity based on neturalizing antibody titer[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Proof-of-Concept; BRIEF: - Thirty six patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 or matching placebo for 4 weeks. - During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined. ; 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: - Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL; - Have received methotrexate for six months or longer and at a stable dose of 7.5 to 25 mg/week (extremes included) for at least four weeks prior to screening and willing to continue on this regimen for the duration of the study; - If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening; - If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening; - Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses); - Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least four weeks after the last dose of study drug. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and - Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments. Exclusion Criteria: - Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate; - Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents); - Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening; - Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening; - Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization; - Positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A; - History of any inflammatory rheumatological disorders other than RA; - History of tuberculosis (TB) infection; - Pregnant or lactating women. ; PRIMARY OUTCOME: The number of patients with an ACR20 score at Week 4 as a measure of efficacy; SECONDARY OUTCOME 1: The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Tacrolimus; BRIEF: The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients. ; DRUG USED: Zortress; DRUG CLASS: New Molecular Entity (NME); INDICATION: Liver Transplant Rejection; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Written informed consent - Subject aged ≥18 years of a primary, orthotopic liver allograft, from a living donor - Subject negative for HIV Incusion criteria at Randomization: - Subject was initated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression Exclusion criteria: - Subjects transplanted for acute liver failure - HCV negativesubjects receiving a transplant from HCV positive donor - Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant. - Subjects receiving an ABO incompatible allograft. - MELD-score > 35 within 1 month prior to transplantation. - Use of immunosuppressive or antibody induction agents not specified in the protocol. - History of malignancy of any organ system (except hepatocellular carcinoma or localized basal cell carcinoma of the skin) - Hepatocellular carcinoma with extrahepatic spread or macrovascular invasion - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 weeks after the last dose of study medication - History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients Exclusion criteria at Randomization: - Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization. - Subjects with a confirmed spot urine protein/creatinine ratio that indicates ≥ 1.0 g/24 hrs of proteinuria - Subjects who have severe hypercholesterolemia (>350 mg/dL; >9.1 mmol/L) or hypertriglyceridemia (>500 mg/dL; >5.6 mmol/L) at randomization. - Subjects with platelet count < 30,000/mm3. - Subjects with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³. - Subjects with systemic infection requiring active use of IV antibiotics. - Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents. - Subjects who require renal replacement therapy within 7 days prior to randomization. - Subjects with detectable HBV DNA at time of randomization - Subjects meeting the following criteria for acute rejection during the run in period: - Any acute rejection in the week prior to randomization. - 2 treated acute rejections. - Any rejection requiring antibody treatment. - Any severe cellular (and/or any humoral) rejection. Long term extension for patients in Japan: Inclusion criteria - Written informed consent must be obtained before any extension specific assessment is performed. - Ability and willingness to adhere to study regimen. - Completed Month 24 visit of core study and continuously being treated with assigned regimen. Exclusion criteria: - Use of medication that is prohibited by the study protocol at Month 24. - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. - History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients ; PRIMARY OUTCOME: Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus; SECONDARY OUTCOME 1: Renal Function by Estimated Glomerular Filtration Rate (eGFR) From Randomization[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Type I/II GM1; BRIEF: Background: GM1 gangliosidosis is a disorder that destroys nerve cells. It is fatal. There is no treatment. People with GM1 are deficient in a certain enzyme. A gene therapy may help the body make this enzyme. This could improve GM1 symptoms. Objective: To test if a gene therapy helps Type I and Type II GM1 gangliosidosis symptoms. Eligibility: Type I subjects will be male and female >= 6 months <= 12 months of age at the time of full ICF signing. Type II subjects will be male and female > 12 months old and < 12 years old at the time of full ICF signing. Design: Participants will be screened with their medical history and a phone survey. Participants will stay at NIH for 8-10 weeks. Participants will have baseline tests: Blood, urine, and heart tests Hearing tests Ultrasound of abdomen EEG: Sticky patches on the participant s head will measure brain function. Lumbar puncture: A needle will be stuck into the participant s spine to remove fluid. MRI scans, bone x-rays, and bone scans: Participants will lie in a machine that takes pictures of the body IQ tests Neurology exams Central line placement Skin biopsy: A small piece of the participant s skin will be removed. Speech tests Participants will have an x-ray while swallowing food. Participants will take drugs by mouth and IV. This will get their immune system ready for therapy. Participants will get the gene therapy by IV. They may stay at NIH for a week to watch for side effects. Participants will have visits 3 and 6 months after treatment. Then visits will be every 6 months for 2 years. Then they will have a visit at 3 years. Visits will take 4-5 days. Participants will return to NIH once a year for 2 years for tests in an extension study.... ; DRUG USED: AXO-AAV-GM1; DRUG CLASS: Biologic; INDICATION: GM1 Gangliosidosis; TARGET: Ganglioside GM1/fucosyl GM1; THERAPY: Monotherapy; LEAD SPONSOR: National Human Genome Research Institute (NHGRI); CRITERIA: - INCLUSION CRITERIA: Type I subjects - Male or female subjects >= 6 months old and <= 12 months old at time of full ICF signing - Biallelic mutations in GLB1 - Documented deficiency of Beta-galactosidase enzyme by clinical laboratory testing - Phenotype consistent with a diagnosis of Type I GM1 gangliosidosis - Symptomatic subjects: as determined by the opinion of the Principal Investigator and based on the criteria set forth by Brunetti-Pierri et al: - Age of symptom onset <= 6 months of age - Rapidly progressive with developmental delay and hypotonia - Pre- symptomatic subjects: must have mutations confirmed to be associated with the Type I subtype - AAV9 antibody titers <=1:50 - Agree to reside within 50 miles of the study site for at least 1 month following treatment Type II subjects - Vineland-3 Adaptive Behavior composite standard score greater than or equal to 40 - Male or female subjects > 6 months old and < 12 years old at time of full ICF signing - Biallelic mutations in GLB1 - Documented deficiency of beta-galactosidase enzyme by clinical laboratory testing - Phenotype consistent with a diagnosis of Type II GM1 gangliosidosis, with symptom onset after the first year of life - AAV9 antibody titers <=1:50 - Agree to reside within 50 miles of the study site for at least 1 month following treatment EXCLUSION CRITERIA: - AAV9 antibody titers >1:50 - Contraindications to concomitant medications - Serious illness that would not allow travel to the study site - Unwilling to undergo study interventions as outlined in the Schedule of Events - Subjects receiving other unapproved, off-label or experimental therapies for GM1 gangliosidosis (i.e. miglustat, Tanganil) within the last 60 days - Any prior participation in a study in which a gene therapy vector or stem cell transplantation was administered - Pregnant or lactating subjects - Immunizations of any kind in the month prior to screening - Evidence of cardiomyopathy on history, exam, or additional testing (echocardiogram or electrocardiogram) or other cardiac disease that in the opinion of the investigator would deem the subject unsafe to participate in the trial - Indwelling ferromagnetic devices that would preclude MRI/fMRI/MRS imaging - Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study - History of infection with human immunodeficiency virus (HIV), hepatitis A, B, C or tuberculosis. - History of or current chemotherapy, radiotherapy or other immunosuppressive therapy within the past 30 days. Corticosteroid treatment may be permitted at the discretion of the PI - Abnormal laboratory values considered clinically significant per the investigator - Failure to thrive, defined as: -- Falling 20 percentiles (20/100) in body weight in the 3 months preceding Screening/Baseline - Underlying defect in immune function - History of multiple and severe life-threatening infections ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II; BRIEF: This study investigates the effectiveness and safety of 12 weeks of treatment with JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of effectiveness is the change in body weight at a clinically relevant dosage level during treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry which is a specialized x-ray test that measures body composition), fasting glucose, lipid levels, and blood pressure. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting. ; DRUG USED: JNJ-16269110; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: Microsomal Triglyceride Transfer Protein (MTP); THERAPY: Monotherapy; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Obese or overweight at screening defined as: BMI greater than or equal to 30 kg/m2 and <50 kg/m2 or BMI greater than or equal to 27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia. For patients receiving antihypertensive and/or hypolipidemic medications, these should have been at a stable dosage for at least 2 months before the start of the run-in period. Controlled hypertension is defined as a diastolic blood pressure <100 mmHg and a systolic blood pressure <160 mmHg, in the presence of antihypertensive drug treatment. For patients who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C greater than or equal to 3.4 mmol/L (130 mg/dL), HDL C <1 mmol/L (40 mg/dL) for men or <1.3 mmol/L (50 mg/dL) for women, or triglycerides greater than or equal to 1.7 mmol/L (150 mg/dL) - A stable weight, i.e., increasing or decreasing not more than 5 kg in the 3 months before the start of the run-in period - Consumption of breakfast and dinner on a daily basis - Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with water, as judged by e.g., the patientss history of having no difficulty with swallowing e.g., capsules or intact tablets - Fasting plasma glucose <7.0 mmol/L (126 mg/dL) at screening - Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control Exclusion Criteria: - History of obesity with a known cause (e.g., Cushings disease) - History of anorexia nervosa, bulimia, or binge-eating disorder - An established diagnosis of diabetes mellitus or treatment with glucose lowering prescription drugs at screening - Prior exposure or known contraindication or hypersensitivity to R256918 - History of weight-reducing diet or receiving any drugs to treat obesity within the 3 months prior to screening - Treatment with any investigational drug or device within 1 month before the start of the run-in period - History or evidence of liver or renal impairment - History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology - History of clinically significant gastro-intestinal disease - History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy - Previous gastric restrictive surgery or other surgical procedures to induce weight loss - Liposuction within the last 3 months before screening - Pregnant or nursing women, or women who plan to become pregnant during the study - History of significant cardiovascular disease or hypertension - Elevated levels of thyroid-stimulating hormone (TSH) - A significant change in smoking habits within 3 months of the start of the run-in period - Malignancy or a history of a malignancy within 5 years before the start of the run-in period, other than basal cell carcinomas of the skin or in situ cervical carcinoma - History of seizures or significant central nervous system-related disorders - History of significant psychiatric disorder, including, schizophrenia, or psychosis ; PRIMARY OUTCOME: Mean change in body weight from baseline to Week 12.; SECONDARY OUTCOME 1: Changes in body weight, body mass index (BMI), body composition, blood pressure, glucose, intestinal hormone levels, beta cell function and lipid parameters.[/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 - VBMCP-VBAD/V (PETHEMA/Gem, <=65y); BRIEF: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus Thalidomide/Velcade. ; DRUG USED: Velcade; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: PETHEMA Foundation; CRITERIA: Inclusion Criteria: 1. Must be able to comply with the protocol requirements 2. Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care, 3. Age <65 years and possibly to do an autologous transplant. 4. Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma. 5. Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours. 6. ECOG < 2. 7. El patient has a life-expectancy > 3 months. 8. Patient has the following laboratory values before beginning induction treatment: 1. Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed if they are due to marrow infiltration. 2. Corrected serum calcium <14mg/dl. 3. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. 4. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. 5. Total bilirubin: ≤1.5 x the upper limit of normal. 6. Serum creatinine ≤ 2 mg/dl. 9. For Patients included in Thalidomide branches: women of childbearing age must not have sex unless they use two anticonceptive methods beginning 4 weeks before the first dose, during all the study until 4 weeks after the last one. Exclusion Criteria: 1. Non-secretor Myeloma. 2. Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment. 3. Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment. 4. Patient had major surgery within 4 weeks before enrolment. 5. Patient has hypersensitivity to bortezomib, boron or mannitol or Thalidomide. 6. Patient has received other investigational drugs within 30 days before enrolment. 7. Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection. 8. Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 9. Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason. 10. Pregnancy or breast-feed women. ; PRIMARY OUTCOME: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.; SECONDARY OUTCOME 1: Evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Patients w/Prior Therapy (China); BRIEF: AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate Capsules has three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress the EGFR mutant tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient suppress the EGFR T790M drug-resistant mutation tumor cell. ; 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: Sun Yat-sen University; CRITERIA: Inclusion Criteria: - Patients of either gender, aged from 18 years older to 70. - Histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC. - At least one measurable disease by CT or MRI, according to RECIST Version 1.1. - Documented evidence of any activating EGFR mutation in the tumor tissue. - Have undergone or are able to undergo a biopsy of either primary or metastatic tumor tissue within 28 days of dosing of Avitinib, and have tissue available to send to central lab for further genetic profiling especially the status of T790M. - Life expectancy of at least 3 months. - ECOG performance status of 0 to 1. - Adequate hematological and physiological functions of heart, lung, liver, and kidney according to definitions given in Appendix D. - Disease progression under at least one treatment with current marketed EGFR TKI therapy for at least 30 days (e.g. Erlotinib, or Gefitinib, or Afatinib) with intervening treatment after most recent EGFR TKI therapy. The washout period for an EGFR TKI (Erlotinib, or Gefitinib) is at a minimum of 7 days. The washout period for an irreversible EGFR inhibitor (Afatinib) and chemotherapy is at a minimum of 14 days. - Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less. - NSCLC patients with asymptomatic brain metastasis or drug-controllable brain metastasis. - Signed consent on an Independent Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation. Exclusion Criteria: - No pathology confirmation - History of interstitial lung disease related to prior EGFR inhibitor therapy. - Symptomatic brain metastases or uncontrollable or unstable brain metastasis. - Positive to HCV or HIV antibody. - Treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal, or immunotherapy) ≤14 days prior to treatment with Avitinb. - Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericias method (QTcF) >450 msec (males) or >470 msec (females). - Family history of long QT syndrome. - Treatment with any Category 1 and 2 drugs (See:https://www.crediblemeds.org/ or www.qtdrug.org). - Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism). - Any other reasons for the investigator to consider the patient should not participate in the study. ; PRIMARY OUTCOME: Safety, tolerability and ORR of AC0010; SECONDARY OUTCOME 1: Plasma concentrations and pharmacokinetic parameters of single dose AC0010[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FUTURE-3 (Pediatric); BRIEF: The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age. ; DRUG USED: Tracleer; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Endothelin Receptor Type A (EDNRA), Endothelin Receptor Type B (EDNRB); THERAPY: Monotherapy; LEAD SPONSOR: Actelion; CRITERIA: Inclusion Criteria: 1. PAH diagnosis confirmed with right heart catheterization (RHC): - Idiopathic or heritable PAH, or - Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery) or - PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary shunts (after global amendment dated 09 May 2012) 2. World Health Organization functional Class (WHO FC) I, II or III 3. Male or female ≥ 3 months and < 12 years of age (maximum age at randomization is 11.5 years) 4. Body weight ≥ 3.5 kg 5. Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air) 6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase type-5 inhibitor) if present, has to be stable for at least 3 months prior to screening. During the study, all background treatments should remain stable 7. Signed informed consent by the parents or legal representatives Exclusion Criteria: 1. PAH etiologies other than listed above 2. Non-stable disease status 3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost 4. Systolic blood pressure < 80% of the lower limit of normal range 5. Aspartate aminotransferase and/or alanine aminotransferase values > 1.5 times the upper limit of normal range. 6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C 7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range. 8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet 9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest: - Glibenclamide (glyburide) - Cyclosporin A - Sirolimus - Tacrolimus - Fluconazole - Rifampicin (rifampin) - Ritonavir - Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole) - Endothelin receptor antagonists (ERAs) other than bosentan 10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment ; PRIMARY OUTCOME: Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan; 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 - PERSEPT 2 (Pediatric); BRIEF: The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years old). ; DRUG USED: SEVENFACT; DRUG CLASS: Biologic; INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Coagulation Factor IX, Coagulation Factor VII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Laboratoire français de Fractionnement et de Biotechnologies; CRITERIA: Inclusion Criteria: - be male with a diagnosis of congenital hemophilia A or B of any severity - have one of the following: - a positive inhibitor test BU ≥5, OR - a Bethesda Unit (BU) <5 but expected to have a high anamnestic response to FVIII or FIX, as demonstrated from the patients medical history, precluding the use of factor VIII or IX products to treat bleeding episodes, OR - a BU <5 but expected to be refractory to increased dosing of FVIII or FIX, as demonstrated from the patients medical history, precluding the use of factor VIII or IX products to treat bleeding episodes - be aged from birth to <12 years old - have experienced at least 3 bleeding episodes of any severity in the past 6 months - parents or legal guardians must be capable of understanding and be willing to comply with the conditions of the protocol - parents or legal guardians must have read, understood, and provided written informed consent Exclusion Criteria: - have any coagulation disorder other than hemophilia A or B - be immunosuppressed (i.e., the patient may not be receiving systemic immunosuppressive medication; cluster of differentiation 4 (CD4) counts at screening must be >200/µL) - have a known allergy or hypersensitivity to rabbits - have platelet count <100,000/mL - have had a major surgical procedure (e.g. orthopedic, abdominal) within 1 month prior to first administration of study drug - have received an investigational drug within 30 days of first study drug administration, or be expected to receive such drug during participation in this study ; PRIMARY OUTCOME: Proportion of Successfully Treated Mild/Moderate Bleeding Episodes Per FDA Requirement.; SECONDARY OUTCOME 1: Patient-Reported Good or Excellent Response for Mild/Moderate Bleeding Episodes[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PSOARING 2; BRIEF: This is a randomized double-blind vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks. ; DRUG USED: Tapinarof; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Aryl hydrocarbon receptor (AhR), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Dermavant Sciences GmbH; CRITERIA: Inclusion Criteria: - Male and female subjects ages 18 to 75 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study. - BSA involvement ≥ 3% and ≤ 20% - A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline - Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment - Capable of giving written informed consent Exclusion Criteria: - Psoriasis other than plaque variant - Any sign of infection of any of the psoriatic lesions - Concurrent conditions or history of other diseases: - Immunocompromised at Screening - Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baseline visit - Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Baseline visit - Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigators opinion, would make it difficult to interpret data or assessments during the study - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN) - Total bilirubin > 1.5 x ULN; total bilirubin > ULN and ≤ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35% - Corrected QT interval > 475 - Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result, or a positive anti-hepatitis B core antigen (anti-HBc) result - Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subjects psoriasis - Use of any prohibited medication within the indicated period before the first dose of study drug - Within a minimum of 5 half-lives for biologic agents: - Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids, psolarens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene - 2 weeks for immunizations with a live viral component; drugs known to possibly worsen psoriasis, unless on a stable dose for > 12 weeks - With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar. - Pregnant females or lactating females - History of sensitivity to the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates the subjects participation in the study - The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug - Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix - Subjects with active infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days of Baseline/Day 1 - Previous known participation in a clinical study with tapinarof - Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or CV system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with interpretation of the results ; PRIMARY OUTCOME: Percent of Subjects Who Achieve a Physician Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) With a Minimum 2-grade Improvement From Baseline at Week 12. Analyses Were Done Using Multiple Imputation; SECONDARY OUTCOME 1: Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Mild/Moderate patients (U.S.); BRIEF: The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease ; DRUG USED: Proxalutamide; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Suzhou Kintor Pharmaceutical Inc,; CRITERIA: Inclusion Criteria: 1. Adult males age ≥18 years of age at the time of randomization 2. Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China) 3. The subjects first positive SARS-CoV-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization 4. Subjects with adequate liver and renal function 5. Agree to the collection of nasopharyngeal swabs and venous blood 6. The participant or legally authorized representative signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: 1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute 2. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen 3. Have known allergies to any of the components used in the formulation of the study drug or placebo 4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo 5. Have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days 6. Have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose 7. Prior, current, or planned future use of any of the following treatments at screening: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening 8. Are investigator site personnel directly affiliated with this study 9. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days prior to randomization ; PRIMARY OUTCOME: Percentage of subjects requiring oxygen by Day 28; SECONDARY OUTCOME 1: Percentage of subjects who experience the events(such as hospitalization,Death etc.) by Day 28. (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)[/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 - Parts A and B; BRIEF: The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS patients. A 48-week treatment period followed by an individualized follow-up period until normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels. ; DRUG USED: Kesimpta; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria - Patients with: - At least two confirmed relapses within the last 24 months or - At least one confirmed relapse within the last 12 months or - One confirmed relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening. - Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening - Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase - Female patients must be either post-menopausal, surgically incapable of bearing children or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period - Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out. Exclusion Criteria: - Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS), Primary Progressive Multiple Sclerosis (PPMS) or Progressive Relapsing Multiple Sclerosis (PRMS) or Neuromyelitis optica - Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML - Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS - Patients unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media) or who lack adequate peripheral venous access - Patients who have had the following treatments: - Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-Cluster of Differentiation (CD4), cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide at any time - Anti-CD20 treatments or any monoclonal antibodies at any time - Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and Interferon Beta (IFN-b). - Glatiramer Acetate or IFN-b within three months prior to the randomization in the trial. - Glucocorticoids or Adrenocorticotropic Hormone (ACTH) within one month prior to the screening in the trial. - Receipt of a live vaccine within one month prior to screening in the trial. - Plasmapheresis for treatment of relapses within 2 months prior to randomization in the trial. - Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening in the trial. - Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis after discussion with the sponsors medical monitor - Past or current history of medically significant adverse effects (including allergic reactions) from: - Cetirizine - Prednisolone - Paracetamol/acetaminophen - Plasma proteins or a known hypersensitivity to components of the investigational product. - Past or current malignancy, except for - Cervical carcinoma Stage 1B or less - Non-invasive basal cell and squamous cell skin carcinoma - Cancer diagnoses with a complete response of a duration of > 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response - Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy. - Electrocardiogram (ECG) showing significant abnormality that the treating investigator determines may jeopardize the subjects health (i.e. acute ischemia, left bundle branch or bifascicular block) - Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric or neurological disease which may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol. - History of severe, clinically significant Central Nervous System (CNS) trauma (e.g. cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease - Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C. Any previous serious infections should be discussed with the sponsors medical monitor (e.g. opportunistic or atypical infections) - Female patients who are pregnant or nursing. - Use of an investigational drug or other experimental therapy for a condition other than MS within 4 weeks prior to screening. Any prior use of an investigational drug or other experimental therapy for MS at any time should be discussed with the medical monitor. - Current participation in any other interventional clinical trial. Participation in non-interventional trial requires approval of the protocol by the sponsor - Serum vitamin B12 below lower limit of normal - Positive polymerase chain reaction (PCR) screening for John Cunningham Virus (JC Virus) as measured by qualitative plasma and/or white blood cell JCV DNA - Serologic evidence of Hepatitis B (HB) infection based on the results of testing for Hepatitis B Surface Antigen (HBsAg), anti- Hepatitis B Core (HBc) and anti- Hepatitis B Surface (HBs) antibodies with eligibility based on the results as follows: - Patients positive for HBsAg are excluded - Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies (indicating past infection) are eligible - Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody (indicating past vaccination) are eligible - Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody will require clarification of their status by testing for HB DNA, which if positive will exclude the patient from participation - Patient with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered eligible for the trial. - Positive serology for HIV - Screening laboratory values: - White Blood Cell (WBC) < 3.0 x 109/L - Neutrophils < 2 x 109/L - Platelets < 100 x 109/L - Circulating IgG level < lower limit of normal (according to central laboratory range) - Serum Alanine Aminotransferase (S-ALAT) > 2.5 times the upper limit of normal (according to central laboratory range) - Serum Alpha Fetoprotein (S-AP) > 2.0 times the upper limit of normal (according to central laboratory range) - Serum Aspartate Aminotransferase (ASAT) >3.0 times the upper limit of normal (according to central laboratory range) - Bilirubin > 1.5 times the upper limit of normal (according to central laboratory range) - S-creatinine > the upper limit of normal (according to central laboratory range) - CD4 count <500 cells/mm3, CD4:CD8 <0.9 - Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder). - Positive test for Hepatitis C antibody confirmed with a Hepatitis C real time (RT) PCR assay. Patients who are positive for Hepatitis C antibody and negative when the Hepatitis C RT PCR assay is performed will be eligible for the study. Patients who are positive for Hepatitis C antibody and have a positive or indeterminate result when the Hepatitis C RT PCR assay is performed will not be eligible for the study. - Positive test results for tuberculosis using the QuantiFERON test and/or Chest X-ray findings suggestive of tuberculosis (TB). For patients who have had a Chest X-ray performed within the past 6 months without any findings indicative of TB, QuantiFERON test alone may be performed. ; PRIMARY OUTCOME: Number of Participants With Any Adverse Event; SECONDARY OUTCOME 1: Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NeoTRIPaPDL1 (Fondazione Michelangelo); BRIEF: This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and nab-paclitaxel in patients with early high-risk and locally advanced triple negative breast cancer. compared to the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in combination with carboplatin and abraxane, while the other half will receive only carboplatin and abraxane. ; 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: Fondazione Michelangelo; CRITERIA: Inclusion Criteria: 1. Female patients aged 18 years or older with early high-risk and locally advanced or inflammatory breast cancers 2. Histologically confirmed unilateral breast cancer with invasive ductal histology not otherwise specified (NOS) of high proliferation or grade 3. HER2 negative disease 4. Negative estrogen receptor (ER) and progesterone receptor (PgR), both < 1% locally assessed 5. Representative paraffin-embedded (FFPE) tumor block taken at diagnostic biopsy for confirmation of HER2, ER and PgR eligibility, for assessment of PDL-1 expression and for further exploratory biomarker evaluation is mandatory 6. ECOG performance status 0 or 1 7. Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures 8. Willing and able to comply with the protocol 9. Consent to the collection of blood samples 10. For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of study drug. Exclusion Criteria: 1. Evidence of bilateral breast cancer or metastatic disease (M1) 2. Cases with an histology different from invasive ductal NOS of high proliferation or grade 3. Patients with HER2-positive disease according to ASCO/CAP guidelines 2013 4. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the last menstrual cycle 5. Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy 6. Previous investigational treatment for any condition within 4 weeks of randomization date 7. Administration of a live, attenuated vaccine within 4 weeks before cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study 8. Previous or concomitant invasive malignancy of any other type or previous invasive breast cancer. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible 9. Pre-existing motor or sensory neuropathy of grade > 1 for any reason 10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 11. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation 12. Patients with prior allogeneic stem cell or solid organ transplantation 13. History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegeners granulomatosis, Sjögrens syndrome, Bells palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis 14. History of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest computed tomography scan 15. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease 16. History of HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen [anti-HBc] test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA 17. Active tuberculosis 18. Severe infections within 4 weeks prior to cycle 1 Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Signs or symptoms of significant infection within 2 weeks prior to cycle 1 Day 1 19. Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1 20. Other serious illness or medical condition including: history of documented congestive cardiac failure; New York Heart Association (NYHA) Class II or greater CHF; angina pectoris requiring anti-anginal medication or unstable angina within 6 months prior to cycle 1 Day 1; evidence of transmural infarction on ECG; myocardial infarction stroke or transient ischemic attack (TIA) within 6 months prior to cycle 1 Day 1; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias 21. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs 22. Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus 23. Abnormal baseline hematological values 24. Abnormal baseline laboratory tests for serum total bilirubin, liver function tests, alkaline phosphatase, serum creatinine, INR and aPTT 25. Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA) 26. Major surgical procedure within 28 days prior to cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study 27. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to cycle 1 Day 1 or at any time during the study. - ; PRIMARY OUTCOME: Event Free Survival (EFS); SECONDARY OUTCOME 1: Pathological complete response (pCR)[/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 - POSTERITY; BRIEF: This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN. ; DRUG USED: Gazyva; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Participants who are age 12 to <18 years at the time of randomization - Participants who are age 5 to <12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population) - International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening - Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible - Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria - Significant proteinuria defined by a UPCR above > 0.5 based on a first-morning void (FMV) collection at screening - During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN. Exclusion Criteria: - Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia - Sclerosis in >50% of glomeruli on renal biopsy - Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions - Presence of rapidly progressive glomerulonephritis - Pure Class V LN - Intolerance or contraindication to study therapies - Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization - History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders - History of serious recurrent or chronic infection - History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years - Significant or uncontrolled concomitant medical disease which, in the investigators opinion, would preclude participant participation - Currently active alcohol or drug abuse or history of alcohol or drug abuse ; PRIMARY OUTCOME: Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP); SECONDARY OUTCOME 1: Percentage of Participants Achieving a CRR (AP)[/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 - ZS-01-302 (China); BRIEF: Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure ; DRUG USED: Neucardin; DRUG CLASS: Biologic; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Zensun Sci. & Tech. Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Age: 18-75 years old, no limitation in gender; 2. Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO); 3. Patients with chronic heart failure (NYHA class II or III); 4. In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable; 5. Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month; 6. Understand and sign the informed consent form; Exclusion Criteria: 1. Atrial fibrillation; 2. Subject underwent cardiac pacemaker treatment; 3. Subject underwent metal graft treatment; 4. Claustrophobia; 5. Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension; 6. Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months; 7. Subject underwent cardiac surgery or cerebrovascular events within the previous six months; 8. Subjects who plan to have cardiac transplantation; 9. Severe hepatic and renal insufficiency (serum creatinine>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range); 10. Subject needs mechanical ventilation; 11. Systolic blood pressure < 90mmHg, or > 160mmHg; 12. Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month; 13. Mobitz Type II or III° atrial ventricular block，severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia); 14. Serum potassium<3.2mmol/L, or>5.5mmol/L; 15. Female subject is pregnant or plan to become pregnant 16. Childbearing-aged female subject who is unmarried or dose not bear child; 17. Subject with life expectancy less than 6 months as assessed by investigators; 18. Subject participated in any other clinical trial within the previous three months; 19. Subject with previous history of tumor, or current tumor patient, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ or cervical epithelial dysplasia) 20. Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement); 21. The Investigator deemed for whatever reason that the subject is not likely to complete the study or comply with the study procedures (due to administration or any other reason). ; PRIMARY OUTCOME: cardiac function measured by MRI; SECONDARY OUTCOME 1: cardiac function[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Pemetrexed/Cisplatin; BRIEF: The purpose of this study was to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB Stage IV, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy). - Radiographically measurable or evaluable disease. - Life expectancy of at least 12 weeks. - Tumor without activating driver mutations for which there is available therapy (eg, tumor without mutations in epidermal growth factor receptor or anaplastic lymphoma). - An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below: - Criteria: - C-reactive protein >10 mg/L AND albumin ≥35 g/L; Score = 1 - C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit. Exclusion Criteria: - Squamous or mixed histology (eg, adenosquamous) NSCLC - Previous systemic therapy for advanced or metastatic disease. - Known active central nervous system (CNS) metastases. - Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval. - Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including New York Heart Association functional classification of 3, or arrhythmia requiring treatment. - Uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD/MAD; BRIEF: The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in healthy subjects, and to assess the relative bioavailability of two formulations of BMS-986195 with or without food. ; DRUG USED: Branebrutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Autoimmune Disorders; TARGET: Unknown; 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: - Body Mass Index(BMI) of 18 to 32 kilograms/meter^2 - Healthy male and female, first generation Japanese with confirmed paternal and maternal Japanese ancestry, 18-55 years old, whose residency outside of Japan does not exceed 10 years with a BMI of 18-30 kilograms/meter^2 inclusive. - Women must not be pregnant or breastfeeding - Women of Childbearing Potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required. - Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required. Exclusion Criteria: - Any significant acute or chronic medical illness - Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosis, polymyalgia rheumatica, giant cell arteritis, Behcets disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment - Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subjects immune status (example: history of splenectomy) - Presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of preexisting skin conditions that increase risks for injection site complications e.g. Behcets Disease, Psoriasis, pustular dermatoses - Any history or risk for tuberculosis (TB) Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: Safety and tolerability of single oral dose of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests; 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 - vs. Non-influenza vaccine - Children; BRIEF: The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014). ; DRUG USED: Fluarix Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. - A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination. - Written informed consent obtained from the parent(s) /LAR(s) of the subject. - Subjects in stable health as determined by medical history and clinical examination before entering into the study. Exclusion Criteria: - Participation in a previous FLU-D-QIV-004 study (115345) cohort. - Child in care. - Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. - Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country. - Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination. - Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period. - Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination. - Any contraindication to intramuscular injection. - Acute disease and/or fever at the time of enrolment. - Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study. - Additional criteria for children ≥ 12 months of age: - Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted. * For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination. - Any history of hepatitis A or varicella diseases. - Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine: - Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted. ; PRIMARY OUTCOME: Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.; SECONDARY OUTCOME 1: Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CLEAR Harmony (1002-040); BRIEF: The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Fasting LDL-C ≥ 70 mg/dL - High cardiovascular risk (diagnosis of HeFH or ASCVD) - Be on maximally tolerated lipid-modifying therapy Exclusion Criteria: - Total fasting triglyceride ≥500 mg/dL - Renal dysfunction or nephrotic syndrome or history of nephritis - Body Mass Index (BMI) ≥50kg/m2 - Significant cardiovascular disease or cardiovascular event in the past 3 months ; PRIMARY OUTCOME: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percent Change From Baseline to Week 12 in 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 - ECREST; BRIEF: This is an open-label, sequential dose exploration study of single agent EEDVSMit administered by intravenous (IV) infusion twice weekly, followed by weekly maintenance dosing, in children with recurrent/refractory solid or CNS tumours. ; DRUG USED: EGFR-EDV-Mitoxantrone; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: DNA, DNA synthesis, EGFR (Epidermal Growth Factor Receptor), Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: Dr David Ziegler; CRITERIA: Inclusion Criteria: - Patients must be ≥ 2 years and ≤ 21 years old at the time of study enrolment. - Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age - Patients must have relapsed or refractory solid or CNS tumours or have a diagnosis of DIPG. Patients must have had histologic verification of malignancy at original diagnosis or relapse, or a diagnosis of DIPG by MRI imaging. - Patients must have either measurable or evaluable disease for Part B of the study only - 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. - Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Exclusion Criteria: - Pregnant or breast-feeding women will not be entered on this study. - Any active uncontrolled infection - Patients who are known to be serologically positive for Hepatitis A, B or C, or have a history of liver disease, other forms of hepatitis or cirrhosis. - Known positive test for human immunodeficiency virus infection - Patients with disease of any major organ system that would compromise their ability to withstand therapy - Concurrent or prior (within 7 days of enrolment) anticoagulation therapy, except low molecular weight heparins or low dose aspirin - Patients receiving corticosteroids must be on a stable dose that has not been increased for at least 7 days prior to study enrolment. - Patients who are currently receiving another investigational drug are ineligible. - Patients who are currently receiving other antineoplastic agents are ineligible. - All herbal supplements, vitamins, and nutritional supplements taken within the last 30 days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed and approved by the Study Chair. - Patient will not be available for protocol-required study visits or procedures, to the best of the subject/parent/guardians and investigators knowledge. - Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject/parent/guardian to give written informed consent and/or to comply with all required study procedures. - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. - Patients will be screened for antibodies to S. typhimurium and will not be eligible until antibodies are non-detectable - Patients will be screened for IL6 and TNFa cytokines and will not be eligible until levels are less than 3x times the detectable limit of the assay. ; PRIMARY OUTCOME: MTD at which fewer than one third of patients experience dose limiting toxicity as assessed by CTCAE v4.0; SECONDARY OUTCOME 1: Assess disease response according to RECIST version 1.1 for children with recurrent/refractory solid or CNS tumours[/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 - PASCAL; BRIEF: A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA). ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Juvenile Rheumatoid Arthritis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: UCB BIOSCIENCES GmbH; CRITERIA: Inclusion Criteria: - Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2) - Study participants must weigh ≥10 kg (22lb) at Baseline (Visit 2) - Study participants must have had onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment for at least 6 months prior to Baseline (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA) - Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline - Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigators clinical judgment) - If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response - If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose Exclusion Criteria: - Study participant has previously been exposed to more than 2 biologic agents - Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug - Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer - Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction - Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not) - Study participant has a history of systemic JIA, with or without systemic features - Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigators opinion is symptomatic enough to interfere with evaluation of the effect of study medication - Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related) - Study participant has active uveitis or a history of active uveitis within the preceding 6 months - Study participant has current, chronic or recurrent clinically significant infections - Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigators opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound) ; PRIMARY OUTCOME: Certolizumab Pegol (CZP) Plasma Concentration level at Week 16; SECONDARY OUTCOME 1: American College of Rheumatology Pediatric 30 % (PedACR30) Response at Week 16[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SAPPHIRE w/Nivolumab (vs. Docetaxel); BRIEF: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy. ; DRUG USED: Sitravatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EPH receptor B4 (EPHB4), Hepatocyte growth factor receptor (c-Met, HGFR), RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Mirati Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of Non-Squamous Non-Small Cell Lung Cancer - Receipt of at least one but not more than two prior treatment regimens in the advanced setting - Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy) - Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment - Candidate to receive docetaxel as second or third line therapy Exclusion Criteria: - Uncontrolled brain metastases - Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions - Unacceptable toxicity with prior checkpoint inhibitor therapy - Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy - Impaired heart function ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Adverse Events (AEs)[/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 - C27003 (vs. Degarelix, Localized); BRIEF: The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression. ; DRUG USED: Orgovyx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Is male, 18 years of age or older. 2. Has histologically confirmed diagnosis of localized prostate adenocarcinoma of intermediate risk for which 6-month neoadjuvant and adjuvant androgen deprivation therapy (ADT) to EBRT is indicated. Intermediate risk per National Comprehensive Cancer Network (NCCN) guidelines includes one of the following: 1. T2b-T2c disease, or 2. Gleason score 7, or 3. Prostate-specific antigen (PSA) 10-20 nanogram per milliliter (ng/mL). 3. Is scheduled for EBRT to begin greater than or equal to (>=) 12 weeks after the Baseline visit. 4. Has serum testosterone at screening greater then (>) 150 nanogram per deciliter (ng/dL) (5.2 nanomoles per liter [nmol/L]). 5. Has screening serum PSA concentration >2 ng/mL. 6. Has body mass index (BMI) >=18.0 at screening or baseline. 7. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening or baseline. 8. Is a male participant, even if surgically sterilized (that is, status postvasectomy), who: Agrees to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or, Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.). 9. Has given voluntary written consent before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 10. Has suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and pharmacodynamic sampling. Exclusion Criteria: 1. Has metastatic disease (based on investigator evaluation and assuming no likely metastatic pelvic lymph nodes >1.0 cm in long axis diameter). 2. Had prior or current use of a gonadotropin-releasing hormone (GnRH) analog or androgen receptor antagonist as first-line hormone therapy, unless total use was less than 6 months and not more recently than 1 year before the planned baseline visit. 3. Had diagnosis of or treatment for another malignancy within 2 years before the first dose of study drug, or previous diagnosis of another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 4. Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: 1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 * institutional upper limit of the normal range (ULN); 2. Serum creatinine >2.0 milligram per deciliter (mg/dL); 3. Total bilirubin >2.0 * institutional ULN (unless documented Gilberts disease); 4. Uncontrolled diabetes (Hemoglobin A1c [HbA1c] >10 [percent] %) or previously undiagnosed diabetes mellitus with HbA1c >8%. 5. Has history of myocardial infarction, unstable symptomatic ischemic heart disease, any ongoing cardiac arrhythmias of Grade >2 (chronic stable atrial fibrillation on stable anticoagulant therapy is allowed), thromboembolic events (example, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other significant cardiac condition (example, pericardial effusion, restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug. 6. Has electrocardiogram (ECG) abnormalities of: 1. Q-wave infarction, unless identified 6 or more months before screening; 2. Heart rate-corrected QT interval millisecond (msec) (QTcF interval) >480 msec. If QTcF is prolonged in a participant with a pacemaker, the participant may be enrolled in the study upon discussion with the project clinician; 3. If the QTcF interval is 450-480 msec, inclusive, in a participant with current use of medications with known effects on QT interval, the participant may be enrolled in the study following discussion with the project clinician. 7. Has congenital long QT syndrome. 8. Is currently using Class IA (example, quinidine, procainamide) or Class III (example, amiodarone, sotalol) antiarrhythmic medications. 9. Has uncontrolled hypertension despite appropriate medical therapy (sitting blood pressure [BP] of greater than 160 millimeters of mercury (mmHg) systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit). Participants with systolic BP measurements >160 mmHg may be rescreened. Participants with systolic BP measurements 141-160 mmHg, although eligible, should be referred for further management of hypertension if indicated. 10. Has known, previously diagnosed human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or any serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with participation in this study. Specific screening for chronic viral illness is at the discretion of the site and/or local institutional review board (IRB). 11. Has received treatment with any investigational products within 3 months before the first dose of study drug. 12. Is a primary family member (spouse, parent, child, or sibling) of anyone involved in the conduct of the study or is a study site employee. 13. Has known gastrointestinal (GI) disease, condition or procedure that could interfere with the oral absorption or tolerance of TAK-385, including difficulty swallowing tablets. 14. Is using any medication or food products listed in the excluded medications and dietary products table within 2 weeks before the first dose of study drug. This list includes moderate and strong inhibitors or inducers of cytochrome P450 (CYP3A4/5) and P-glycoprotein (P-gp). Participants must have no history of amiodarone use in the 6 months before the first dose of TAK-385. 15. Has admission or evidence of alcohol or drug abuse or use of illicit drugs. ; PRIMARY OUTCOME: Percentage of Participants With Effective Castration Rate Over 25 Weeks; SECONDARY OUTCOME 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb; BRIEF: The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation. ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ironwood Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Patient is 18 years of age or older - Patient meets colonoscopy requirements according to the American Gastroenterological Association - Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements - Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests - Patient is fluent in English Exclusion Criteria: - Patient reports loose or watery stools - Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain - Patient may not take prohibited medications per protocol - Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patients ability to complete the clinical study ; PRIMARY OUTCOME: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency; SECONDARY OUTCOME 1: SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SSAIL; BRIEF: Septic shock is a potentially life-threatening condition that can result in multi-organ dysfunction syndrome (MODS) and mortality. LB1148 was formulated to preserve gut integrity during physiological shock and ameliorate the subsequent autodigestion leading to MODS and mortality. The purpose of this study in septic shock patients is to determine if enteral administration of LB1148 will increase the number of days alive without cardiovascular, pulmonary or renal replacement therapy through Day 28. ; DRUG USED: LB1148; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sepsis and Septic Shock; TARGET: Protease; THERAPY: Monotherapy; LEAD SPONSOR: Leading BioSciences, Inc; CRITERIA: Inclusion Criteria: 1. First episode (during the current hospitalization) of documented or suspected sepsis of peritoneum/abdomen, soft tissue, blood, or non-hospital acquired lung origin. 2. Must be receiving antimicrobial therapy for documented or suspected infection. 3. Must have septic shock requiring vasopressors despite adequate fluid resuscitation of 30 mL/kg crystalloid or colloid equivalent, for either an SBP ≤90 mmHg or a MAP ≤65 mmHg (i.e. must have been unable to maintain adequate blood pressure despite adequate fluid resuscitation without the use of vasopressors). Note: 30 mL/kg crystalloid is equivalent to 15 mL/kg colloids. 4. Must have a requirement for vasopressor support after adequate fluid resuscitation, and, at randomization, must require a minimum dose of at least 1 of the following vasopressors: - Norepinephrine ≥5 µg/min; - Dopamine ≥10 µg/kg/min; - Phenylephrine ≥25 µg/min; - Epinephrine ≥5 µg/min, or - Vasopressin ≥0.03 units/min. Exclusion Criteria Patients will not be eligible for participation in the study if they meet ANY of the following criteria: 1. Age <18 or age ≥76 years. 2. Time elapsed since onset of shock is >24 hours. Onset of shock is defined as the first administration of a vasopressor given by continuous infusion (i.e. not a single bolus of norepinephrine, phenylephrine, or ephedrine). 3. Septic shock episode is the second or greater episode in current hospitalization. Note: patients transferred from another healthcare facility that are still within the first 24 hours of the first episode of shock are eligible. 4. Have hospital acquired pneumonia. 5. Have genitourinary infections as the cause of septic shock. 6. Unable to maintain a minimum MAP of 60 mmHg despite the presence of vasopressors and IV fluids. Note: brief transient BPs below 60 mmHg are not disqualifying. 7. Have a serum lactate measurement <2.5 mmol/L after adequate fluid resuscitation (refer to Inclusion Criteria #3). 8. Not expected to survive for at least 28 days due to a preexisting, non-shock related medical condition. 9. Highest total SOFA score (known to staff at the time of randomization) during the screening period <6. Note: each individual organ component sub-score is calculated from the highest (worst) score obtained for that organ during the screening period, up until randomization. 10. Highest total SOFA score (known to staff at the time of randomization) during the screening period >18. Note: each individual organ component sub-score is calculated from the highest (worst) score obtained for that organ during the screening period. 11. Lack of commitment to aggressive source control of infection. 12. The patient or patients surrogate fails to voluntarily sign an informed consent form (ICF). 13. Ineligible for feeding tube placement. 14. Chronic renal insufficiency requiring hemodialysis not associated with the current episode of sepsis. 15. Chronic pulmonary dysfunction requiring mechanical ventilation unrelated to the current episode of sepsis. 16. Undergoing active radiation or cytotoxic chemotherapy treatment for uncontrolled malignancy. Note: hormonal and surgical therapies are permitted. 17. Presence of third degree burns involving >20% body surface area in the 7 days prior to study entry. 18. Known inability to take the study medication (i.e. complete small bowel obstruction). 19. Has acute meningitis. 20. Have any of the following medical conditions: - HIV-positive patients whose most recent CD4 count was ≤50/mm3; - Neutrophils <1000/mm3 unless due to sepsis; - Received chest compressions as part of CPR during this hospitalization without neurologic recovery; - Poorly controlled neoplasm; - End-stage lung disease or Cystic Fibrosis; - End-stage liver disease (Child-Pugh Class C [score >10], evidence of portal hypertension or esophageal varices); - Severe congestive heart failure (New York Heart Association [NYHA] Class IV or pre-sepsis ejection fraction <30%); - Undergone organ transplant (including bone marrow, heart, lung, liver, pancreas, or small bowel transplantation), or - Primary ICU admitting diagnosis of acute myocardial infarction (MI). 21. Have relative contraindications to taking TXA or have a believed adverse risk/benefit ratio for taking the drug. These include patients with: - Known sensitivity to TXA; - Recent craniotomy (past 28 days); - Active cerebrovascular bleed; - Active thromboembolic disease, (such as deep vein thrombosis, pulmonary embolism [PE], cerebral thrombosis, ischemic stroke, or acute coronary syndrome [ACS]); - Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction or; - Continuing use of a combined hormonal contraceptive (including combined hormonal pill, patch or vaginal ring). 22. Exclusion for any other condition that, in the opinion of the investigator or coordinating center, would preclude the subject from being an appropriate candidate for the study. 23. Received any other investigational therapy or device within 4 weeks prior to Screening. 24. Female patients of childbearing potential with a positive urine or serum pregnancy test or who are not taking (or not willing to take) acceptable birth control measures (abstinence, intrauterine devices, contraceptive implants or barrier methods) through Day 28. Additionally, those women who are lactating and insist on breast feeding within 5 days of the last dose of study drug if their sepsis resolves. Note: post-partum patients who have a persistent positive pregnancy test (human chorionic gonadotropin [HCG] values which have not had time to decrease) will be allowed in the study. ; PRIMARY OUTCOME: Number of Days Alive Without Cardiovascular, Renal or Pulmonary Organ Support; 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 - STANDUP AHF; BRIEF: A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function ; DRUG USED: Cimlanod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Guanylate Cyclase (sGC), Ryanodine Receptor (RyRs), Sarcoplasmic reticulum Ca2+-ATPase (SERCA); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Actively being hospitalized for acute decompensated heart failure - At least 1 administration of IV diuretic for the current episode - Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II - Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic - Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40% Exclusion Criteria: - Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm - Have an active infection requiring IV anti-microbial treatment - Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening - Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening - Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis) Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion; SECONDARY OUTCOME 1: Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32[/INST]Yes</s>

<s>[INST]<<SYS>>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; BRIEF: Arimoclomol is a small molecule that upregulates molecular chaperones in cells under stress. Arimoclomol extends survival by five weeks when given both pre-symptomatically and at disease onset in a mutant superoxide dismutase (SOD1) transgenic mouse model of ALS. Furthermore, it has been demonstrated to have neuroprotective and neuroregenerative effects in other rat models of nerve damage. Molecular chaperone proteins are critical in the cellular response to stress and protein misfolding. Recent data suggest that the SOD1 mutation responsible for ALS in some patients with familial disease reduces the availability of a variety of molecular chaperones, and thus weakens their ability to respond to cellular stress. Protein misfolding and consequent aggregation may play a role in the pathogenesis of both the familial and sporadic forms of ALS. Therapeutic agents such as arimoclomol that improve cellular chaperone response to protein misfolding may be helpful in ALS. ; DRUG USED: Miplyffa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: SOD1; THERAPY: Combination; LEAD SPONSOR: CytRx; CRITERIA: Inclusion Criteria: - Familial or sporadic ALS. - Diagnosed with laboratory-supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial criteria for less than or equal to 36 months duration prior to the Screening Visit. - Vital capacity (VC) equal to or greater than 70% predicted value for gender, height and age at the Screening Visit. - Geographic accessibility to the study site. - Ability to take oral medication at the Screening Visit, based on verbal report. - Fluency in English, Spanish or Canadian French. Exclusion Criteria: - History of known sensitivity or intolerability to arimoclomol or to any other related compound. - Prior exposure to arimoclomol through a clinical trial or physician-sponsored IND. - Exposure to any investigational agent within 30 days of the Screening Visit. - Presence of any of the following clinical conditions: 1. Substance abuse within the past year 2. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease 3. AIDS or AIDS-related complex 4. Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression within 90 days of the Screening Visit. - Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, creatinine clearance less than 70 cc/min, alanine aminotransferase (ALT) greater than 3.0 times the upper limit of normal, total bilirubin greater than 1.5 times the upper limit of normal, white blood cell (WBC) count less than 3,500/mm3, platelet concentration of <100,000/ul, hematocrit level of less than 33 % for female or less than 35 % for male, or coagulation tests (PT, PTT) greater than or equal to 1.5 times upper limit of normal. - Female volunteers who are breast-feeding. ; PRIMARY OUTCOME: ALSFRS-R; SECONDARY OUTCOME 1: ALSFRS-R[/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/IIa - MM-001 (w/Dexamethasone); BRIEF: This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 monotherapy and CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma (RRMM), CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX and DARA for Newly Diagnosed Multiple Myeloma (NDMM). ; DRUG USED: Iberdomide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 - Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy - Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM) - Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation Exclusion Criteria: - Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study - Nonsecretory multiple myeloma - Prior history of malignancies, other than MM and select non-invasive malignancies, unless the participant has been free of the disease for ≥ 5 years Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment; SECONDARY OUTCOME 1: Adverse Events (AEs)[/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 - Motor Fluctuation; BRIEF: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinsons disease patients who experience motor-fluctuations. ; DRUG USED: Tavapadon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine 1 (D1) Receptor, Dopamine 5 (D5) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Females of non-childbearing potential and/or male subjects between the ages of 40 and 85 years, inclusive. - Clinical diagnosis of Parkinsons disease. - Able to refrain from any Parkinsons disease medication not permitted by the protocol. Exclusion Criteria: - Female of childbearing potential - History or presence of atypical Parkinsonian syndrome. - History of surgical intervention for Parkinsons disease. - Severe acute or chronic medical or psychiatric condition or laboratory abnormality. - Any condition possibly affecting drug absorption. - Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days. ; PRIMARY OUTCOME: Change From Baseline in Daily OFF Time at Week 10; SECONDARY OUTCOME 1: Change From Baseline in Daily OFF 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 IIb/III - Maintenance (CD03); BRIEF: This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry. Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience virologic failure. ; DRUG USED: Vyrologix; DRUG CLASS: Biologic; INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5); THERAPY: Monotherapy; LEAD SPONSOR: CytoDyn, Inc.; CRITERIA: Inclusion Criteria: 1. Males and females, age ≥18 years 2. Receiving combination antiretroviral therapy for last 24 weeks 3. No change in ART within last 4 weeks prior to Screening Visit 4. Subject has two or more potential alternative approved ART drug options to consider. 5. Exclusive CCR5-tropic virus at Screening Visit 6. Plasma HIV-1 RNA < 50 copies/mL at Screening Visit 7. CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy 8. CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at Screening Visit 9. Laboratory values at Screening of: 1. Absolute neutrophil count (ANC) ≥ 750/mm3 2. Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female) 3. Platelets ≥ 75,000 /mm3 4. Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN) 5. Serum aspartate transaminase (SGOT/AST) < 5 x ULN 6. Bilirubin (total) < 2.5 x ULN unless Gilberts disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease 7. Creatinine ≤ 1.5 x ULN 10. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. 11. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception during the course of the study. 12. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent. Exclusion Criteria: 1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay 2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg) 3. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposis sarcoma) 4. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality. 5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study 6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose 7. Any vaccination within 2 weeks prior to the first study dose or during the study. 8. Subjects who have failed on a maraviroc containing regimen. 9. Subjects weighing < 35kg 10. History of anaphylaxis to any oral or parenteral drugs 11. History of Bleeding Disorder or patients on anti-coagulant therapy 12. Participation in an experimental drug trial(s) within 30 days of the Screening Visit 13. Any known allergy or antibodies to the study drug or excipients 14. Treatment with any of the following: 1. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit 2. Immunosuppressants within 60 days prior to the screening visit 3. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit 4. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception: - Subjects on inhaled, nasal, or topical steroids will not be excluded 15. Any other clinical condition that, in the Investigators judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy ; PRIMARY OUTCOME: Proportion of participants who remain on PRO 140 monotherapy regimen at the end of week 48 without experiencing virologic failure; SECONDARY OUTCOME 1: Proportion of participants experiencing virologic failure while on PRO 140 monotherapy regimen[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IM101-301; BRIEF: The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA ; DRUG USED: Orencia; DRUG CLASS: Biologic; INDICATION: Juvenile Rheumatoid Arthritis; TARGET: Cluster of Differentiation 80 (CD80), Cluster of Differentiation 86 (CD86); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening - Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population - Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion. Exclusion Criteria: - Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded. - Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization. - Subjects who have failed more than two TNFα antagonists or other biologic DMARDs ; PRIMARY OUTCOME: Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17; SECONDARY OUTCOME 1: Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 024 (vs. Glipizide); BRIEF: The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes). ; 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: - Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus ; PRIMARY OUTCOME: Change From Baseline in HbA1c at Week 52; SECONDARY OUTCOME 1: Change From Baseline in HbA1c at Week 104[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - coBRIM (BRAF+, w/Zelboraf); BRIEF: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator. ; DRUG USED: Cotellic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Participants with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist - Participants must be naïve to treatment for locally advanced unresectable or metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed - Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test - Measurable disease per RECIST v1.1 - Eastern Clinical Oncology Group performance status of 0 or 1 - Consent to provide archival for biomarker analyses - Consent to undergo tumor biopsies for biomarker analyses - Life expectancy greater than or equal to (≥) 12 weeks - Adequate hematologic and end organ function Exclusion Criteria: - History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment - Palliative radiotherapy within 14 days prior to the first dose of study treatment - Major surgery or traumatic injury within 14 days prior to first dose of study treatment - Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Participants with a previous malignancy within the past 3 years are excluded except for participants with resected basal cell carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast - History of or evidence of retinal pathology on ophthalmological examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion, or neovascular macular degeneration - Uncontrolled glaucoma with intraocular pressure - Serum cholesterol ≥ Grade 2 - Hypertriglyceridemia ≥ Grade 2 - Hyperglycemia (fasting) ≥ Grade 2 - History of clinically significant cardiac dysfunction - Participants with active central nervous system (CNS) lesions (including carcinomatous meningitis) are excluded. However, participants are eligible if: 1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND 2. There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery - Current severe, uncontrolled systemic disease - History of malabsorption or other condition that would interfere with absorption of study drugs - Pregnant, lactating, or breast feeding women ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Overall Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Total Knee Arthroplasty; BRIEF: The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo. ; DRUG USED: Anjeso; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Baudax Bio; CRITERIA: Inclusion Criteria: - Voluntarily provide written informed consent. - Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an inpatient setting for ≥24 hours, and receive at least two doses of study drug. - ASA physical status category 1, 2, or 3. - Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study. - Have a body mass index <40 kg/m^2 Exclusion Criteria: - Have a known allergy or hypersensitivity to any study treatment. - Have a history of previous TKA. - Has plans for a concurrent surgical procedure (eg, bilateral TKA). - Has TKA planned to be performed under general anesthesia. - Have a history of myocardial infarction within the preceding 12 months. - Have, as determined by the investigator or the sponsors medical monitor, a history or clinical manifestations of significant condition that would preclude participation. - Have active or recent (within 6 months) gastrointestinal ulceration or bleeding. - Have a known bleeding disorder which may be worsened with the administration of an NSAID. - Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery. - Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication. - Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up. ; PRIMARY OUTCOME: Opioid Use Hour 0-24; 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 - Study 009 - NCI; BRIEF: RATIONALE: Brivanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving brivanib together with cetuximab is more effective than cetuximab alone in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying cetuximab to see how well it works compared with cetuximab given together with brivanib in treating patients with metastatic colorectal cancer. ; DRUG USED: Brivanib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: NCIC Clinical Trials Group; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed primary colorectal cancer - Metastatic disease - Tumor must be confirmed to be K-Ras wild type (i.e., No K-Ras mutation found) by means of mutation analysis performed on representative samples of diagnostic tumor tissue by a central reference laboratory (archival tumor samples are acceptable for K-Ras mutation analysis) - Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or tegafur-uracil) for adjuvant and/or metastatic disease - Thymidylate synthase inhibitor may have been given in combination with oxaliplatin or irinotecan hydrochloride - Must meet one of the following criteria: - Received and failed* an irinotecan hydrochloride-containing regimen (i.e., single-agent or in combination) for treatment of metastatic disease - Relapsed within 6 months of completion of an irinotecan hydrochloride-containing adjuvant therapy - Has documented unsuitability** for an irinotecan hydrochloride-containing regimen NOTE: *Failure is defined as either progression of disease or intolerance to the irinotecan-containing regimen, where intolerance is defined as discontinuation due to any of the following: severe allergic reaction or delayed recovery from toxicity preventing retreatment NOTE: **Documented unsuitability for irinotecan includes known hypersensitivity to irinotecan, abnormal glucuronidation of bilirubin, Gilberts syndrome, previous pelvic/abdominal irradiation, or elderly with comorbid conditions - Must meet one of the following: - Received and failed* an oxaliplatin-containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease - Relapsed within 6 months of completion of an oxaliplatin containing adjuvant therapy - Has documented unsuitability** for an oxaliplatin-containing regimen NOTE: *Failure is defined as either progression of disease or intolerance to the oxaliplatin-containing regimen, where intolerance is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity or delayed recovery from toxicity preventing retreatment NOTE: **Documented unsuitability for oxaliplatin includes known hypersensitivity to oxaliplatin or other platinum compounds, pre-existing renal impairment, or Grade 2 or greater neurosensory neuropathy - Measurable or evaluable disease - Patient must consent to provision of, and investigator(s) must confirm access to and agree to submit at the request of the NCIC CTG Central Tumor Bank, a representative formalin fixed paraffin block of tumour tissue - Patient must consent to provision of a sample of blood - No symptomatic CNS metastases - Patients with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI scans PATIENT CHARACTERISTICS: Inclusion criteria: - ECOG performance status 0-2 - Absolute granulocyte count ≥ 1.5 x 10^9/L - Platelet count ≥ 75 x 10^9/L - Hemoglobin ≥ 80 g/L - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.0 times ULN with documented liver metastases) - ALT and AST ≤ 2.5 times ULN (5.0 times ULN with documented liver metastases) - Serum creatinine ≤ 1.5 times ULN or creatinine clearance > 50 mL/min - Magnesium > 0.5 mmol/L (1.2 mg/dL) - LVEF > 45% by ECHO or MUGA scan - No proteinuria ≥ 2+ on dipstick or ≥ 1 g on 24 hour urine collection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception prior to, during, and for 12 weeks after completion of study treatment - Able (i.e., sufficiently fluent) and willing to complete the quality of life (EORTC QLQ-C30 and Skindex-16) and health utilities questionnaires (HUI3) in either English or French Exclusion criteria: - A history of other malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years - Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy - Any condition (e.g., psychological, geographical, etc.) that does not permit compliance with the protocol - Uncontrolled or significant cardiovascular disease including any of the following: - Myocardial infarction within 12 months - Uncontrolled angina within 6 months - Clinically significant congestive heart failure - Stroke, transient ischemic attack, or other ischemic event within 12 months - Severe cardiac valve dysfunction - Uncontrolled hypertension (consistent elevation of systolic BP > 150 and diastolic BP > 100 mmHg) - History of a thromboembolic event in the last 6 months despite being treated with anticoagulation - Patients are eligible if they have experienced a thromboembolic event greater than 6 months previously and have initiated and are stable on anticoagulation or if they have previously initiated and are stable on anticoagulation for prevention of thromboembolic events - Severe restrictive lung disease or radiological pulmonary findings of interstitial lung disease on the baseline chest x-ray which, in the opinion of the investigator, represents significant pathology - Serious non-healing wounds, ulcers, or bone fractures - History of allergy to brivanib (alaninate or related drug class - Unable to swallow tablets PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Adequately recovered from recent surgery, chemotherapy and/or radiation therapy - At least 4 weeks must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or prior radiation therapy - No prior cetuximab or other therapy* with targets the EGFR pathway (e.g., erlotinib hydrochloride, gefitinib hydrochloride, panitumumab) - May have received a single prior regimen which targets the VEGFR pathway (e.g., bevacizumab , vatalanib, AZD2171, sorafenib tosylate, sunitinib malate, or others) - No prior murine monoclonal antibody therapy (e.g., edrecolomab) - No other concurrent chemotherapy - No other concurrent therapies targeting the EGFR pathway (e.g., erlotinib, gefitinib, panitumumab, or others) or other therapies targeting the VEGFR pathway (e.g., bevacizumab , vatalanib, AZD2171, sorafenib tosylate, sunitinib malate, or others) - Concurrent antihypertensive therapies allowed - Concurrent aspirin allowed - No other concurrent noncytotoxic experimental agents ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Progression-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ZENITH20 (EGFR or HER2 Exon 20 Mut.); BRIEF: This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7). ; DRUG USED: Poziotinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Key Inclusion Criteria: - Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements - Patient has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent - Prior treatment status: - Cohorts 1 and 2: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC - Cohorts 3 and 4: Patient is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry. - Cohort 5: Patients who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed - Cohort 6: Patients with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib - Cohort 7: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC - Specific mutations: - Cohort 1 and 3: Documented EGFR exon 20 insertion mutation - Cohort 2 and 4: Documented HER2 exon 20 insertion mutation - Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations - Cohort 6: Documented acquired EGFR mutation (tested after osimertinib progression) - Cohort 7: Documented EGFR or HER2 activating mutations - Patient has adequate organ function at Baseline Key Exclusion Criteria: - Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible (Cohorts 1 and 2). - Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks or 5 half lives, whichever is longer; local radiation therapy for bone pain may be allowed - Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully-treated and stable, early-stage prostate cancer, or carcinoma in situ of the cervix or breast without need of treatment - Patient is pregnant or breast-feeding ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Disease Control Rate (DCR)[/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 - Abuse Potential; BRIEF: The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused. ; DRUG USED: Troxyca ER; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy subjects. - Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit. Exclusion Criteria: - Diagnosis of substance and/or alcohol dependence. - Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder. - History of sleep apnea. - Positive urine drug screen (UDS) for other that marijuana. - Positive for Hepatitis B or C and HIV on Screening. ; PRIMARY OUTCOME: Drug Liking: Peak Effect (Emax); SECONDARY OUTCOME 1: Take Drug Again: Peak Effect (Emax)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Polycystic Ovary Syndrome (PCOS); BRIEF: This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS). ; DRUG USED: Orilissa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycystic Ovary Syndrome (PCOS); TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participants with clinical diagnosis of PCOS. - Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 at time of Screening. Exclusion Criteria: - Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline. - Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery). - Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury). ; PRIMARY OUTCOME: Percentage of Menstrual Cycle Responders; SECONDARY OUTCOME 1: Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 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 - eXalt3; BRIEF: The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor. ; DRUG USED: Ensartinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Anaplastic lymphoma kinase (ALK); THERAPY: Monotherapy; LEAD SPONSOR: Xcovery Holding Company, LLC; CRITERIA: Inclusion Criteria 1. Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive by an FDA-approved assay performed centrally. Patients must be ALK positive by local test prior to submitting tissue to the central lab. Randomization will occur after ALK positive confirmation is received from the central lab. Patients may have received up to 1 prior chemotherapy regimen for metastatic disease, which may also include maintenance therapy. Note that patients that have received adjuvant or neoadjuvant chemotherapy and developed metastatic disease within 6 months from the end of that therapy would be considered to have received 1 prior regimen for metastatic disease. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2. (see Appendix A) 3. Life expectancy of at least 12 weeks. 4. Ability to swallow and retain oral medication. 5. Adequate organ system function, defined as follows: 1. Absolute neutrophil count (ANC) ≥1.5 x 109/L 2. Platelets ≥100 x 109/L 3. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level 4. Total bilirubin ≤1.5 times the upper limit of normal (ULN) 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement. 6. Creatinine < 1.5 x ULN. If >1.5 x ULN, patient may still be eligible if calculated creatinine clearance >50 mL/min (0.83mL/s) as calculated by the Cockcroft-Gault method. 6. Brain metastases allowed if asymptomatic at study baseline. Patients with untreated brain metastases must not be on corticosteroids. If patients have neurological symptoms or signs due to CNS metastases, patients need to complete whole brain radiation or focal treatment at least 14 days before start of study treatment and be asymptomatic on stable or decreasing doses of corticosteroids at baseline. 7. Men with partners of childbearing potential willing to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication. 8. Women who are not of child-bearing potential, and women of child-bearing potential who agree to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication, and who have a negative serum or urine pregnancy test within 1 week prior to initial trial treatment. 9. Patients must be >18 years-of-age. 10. Patients must have measurable disease per RECIST v. 1.1. 11. Willingness and ability to comply with the trial and follow-up procedures. 12. Ability to understand the nature of this trial and give written informed consent. Note the following pertains to patients enrolled in France In France, a subject will be eligible for inclusion in this study only affiliated to the French Social Security system, and currently benefit from the corresponding rights and cover. Exclusion Criteria 1. Patients that have previously received an ALK TKI or PD-1/PD-L1 therapy, and patients currently receiving cancer therapy (i.e., other targeted therapies, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization). 2. Use of an investigational drug within 21 days prior to the first dose of study drug. Note that to be eligible, any drug-related toxicity should have recovered to Grade 1 or less, with the exception of alopecia. 3. Any chemotherapy within 4 weeks, or major surgery or radiotherapy within the last 14 days. 4. Patients with primary CNS tumors and leptomeningeal disease are ineligible. 5. Patients with a previous malignancy within the past 3 years (other than curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any cancer that is considered to be cured and have no impact on PFS and OS for the current NSCLC). 6. Concomitant systemic use of anticancer herbal medications. These should be stopped prior to study entry. 7. Patients receiving 1. strong CYP3A inhibitors (including, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit, grapefruit juice) 2. strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St. Johns Wort) 3. CYP3A substrates with narrow therapeutic window (including, but not limited to, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus). 8. Women who are pregnant or breastfeeding. 9. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. 10. Patients at risk for GI perforation. 11. Clinically significant cardiovascular disease including: 1. QTcF interval >450 ms for men and >470 ms for women, symptomatic bradycardia <45 beats per minute or other significant ECG abnormalities in the investigators opinion. 2. Clinically uncontrolled hypertension in the investigators opinion (e.g., blood pressure >160/100 mmHg; note that isolated elevated readings considered to not be indicative of uncontrolled hypertension are allowed). The following within 6 months prior to Cycle 1 Day 1: 1. Congestive heart failure (New York Heart Class III or IV). 2. Arrhythmia or conduction abnormality requiring medication. Note: patients with atrial fibrillation/flutter controlled by medication and arrhythmias controlled by pacemakers are eligible. 3. Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction. 4. Cerebrovascular accident or transient ischemia. 12. Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have interstitial lung disease/pneumonitis, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. Patients with controlled hepatitis C, in the investigators opinion, are allowed. Patients with known hepatitis B must be HBeAg and HB viral DNA negative for enrollment. Note that, because of the high prevalence, all patients in the Asia-Pacific region (except Australia, New Zealand, and Japan) must be tested and, if HBsAg positive, must be HBeAg and HB viral DNA negative for enrollment. 13. Known hypersensitivity to tartrazine, a dye used in the ensartinib 100 mg capsule. 14. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 15. Concurrent condition that in the investigators opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled. 16. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. Note the following pertains to patients enrolled in France 17. In France, a subject will not be eligible when under legal protection. ; PRIMARY OUTCOME: Progression-free survival (PFS) as assessed by independent radiology review based on RECIST v. 1.1 criteria; SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CardioMems (Investigator Initiated); BRIEF: Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary vasculature, PVR will increase with exercise instead of decreasing as it would in normal patients. Based on published evidence, the investigators intend to investigate the effects of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have separately and previously had an implanted pulmonary artery monitoring device (CardioMems by St Jude Medical, Inc.) placed. ; DRUG USED: INOpulse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Guanylate Cyclase (sGC), Nitric Oxide/ Nitrogen Monoxide; THERAPY: Monotherapy; LEAD SPONSOR: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); CRITERIA: Inclusion Criteria: - Males or females age 18 to 80 years with a diagnosis of pulmonary arterial hypertension (WHO Group I pulmonary hypertension). - Must be able to read and understand English and consent for themselves - Previously implanted CardioMems continuous PA pressure - Ambulatory and able to complete 6MWD test. Exclusion Criteria: - Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program. ; PRIMARY OUTCOME: Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device; SECONDARY OUTCOME 1: Change in CardioMems Cardiac Output[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Chemotherapy +/- Bevacizumab (China); BRIEF: This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer ; DRUG USED: AK104; DRUG CLASS: Biologic; INDICATION: Cervical Cancer; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Akeso; CRITERIA: Inclusion Criteria: 1. signs the written informed consent form. 2. Women aged ≥ 18 and ≤ 75 years. 3. ECOG of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy. 1. The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 2. No prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease. 6. At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy. 7. All subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy. 8. Subjects must have adequate organ function as assessed in the laboratory tests. 9. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug. Exclusion Criteria: 1. Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc. 2. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator. 3. Presence of nervous system (CNS) metastases or carcinomatous meningitis; 4. Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 5. Patients with other active malignancies within 3 years prior to randomization. 6. Patients who have received other prior chemotherapeutic agents. 7. Any prior treatments targeting the mechanism of tumor immunity, such as anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40, CD137, GITR, OX40 targets, etc). 8. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study. 9. Active or potentially recurrent autoimmune disease. 10. Subjects who require systemic treatment with glucocorticoid (> 10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization; 11. Use of live vaccines within 4 weeks prior to randomization. 12. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies. 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 14. Known history of interstitial lung disease or non-infectious pneumonitis; unless induced by radiation therapies. 15. Serious infections requiring hospitalization. 16. Presence of active infection requiring systemic therapy. 17. Subjects with active hepatitis B and active viral hepatitis C. 18. Active or documented inflammatory bowel diseases, active diverticulitis. 19. Subjects with known history of severe hypersensitivity reactions to other monoclonal antibodies. 20. Known any contraindication to cisplatin/carboplatin, paclitaxel or allergy to any of their ingredients. 21. Pregnant or lactating women. 22. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug. ; PRIMARY OUTCOME: progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1; SECONDARY OUTCOME 1: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. TCA in Military Veterans; BRIEF: This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee. ; DRUG USED: Zilretta; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions - Male or female ≥20 and ≤50 years of age - Diagnosis of post-traumatic OA of the knee - Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening - Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) - Body mass index (BMI) ≤ 40 kg/m2 - Willingness to abstain from use of restricted medications and therapies during the study Exclusion Criteria: - Prior osteotomy of the index knee - Any condition that could possibly confound the patients assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain) - Fibromyalgia, Reiters syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease - History of, or clinical signs and symptoms of active infection of the index knee - Crystal disease of the index knee within one month of Screening - Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery - IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening - IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening - Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening - Any other IA investigational drug/biologic within 6 months of Screening - Prior use of FX006 - Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period - Type 1 or Type 2 diabetes requiring insulin - Women of child-bearing potential not using effective contraception or who are pregnant or nursing ; PRIMARY OUTCOME: Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10; SECONDARY OUTCOME 1: Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EAGER (C2302, vs. Tobramycin Solution); BRIEF: This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler ; DRUG USED: TOBI Podhaler; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of cystic fibrosis - Male and female patients at least 6 years of age at the time of screening. - Forced expiratory volume in one second (FEV1) at screening must be at least 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria. - Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit. - Able to comply with all protocol requirements. - Clinically stable in the opinion of the investigator. - Use of an effective means of contraception in females of childbearing potential. - Provide written informed consent, Health Authority Portability and Accountability Act (HIPAA) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure. Exclusion Criteria: - History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to screening and/or sputum culture yielding B cepacia at screening. - Coughing up more than 60 cc of blood from the respiratory tract at any time within 30 days prior to study drug administration. - Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. - Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study. - History of hearing loss or chronic ringing in the ears deemed clinically significant by the investigator. - Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration. - Use of loop diuretics within 7 days prior to study drug administration. - Use of any investigational treatment within 28 days prior to study drug administration. - Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or inhaled corticosteroids within 28 days prior to study drug administration (patients may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 28 days prior to study drug administration). Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events; SECONDARY OUTCOME 1: Serum Tobramycin Concentrations[/INST]Yes</s>

<s>[INST]<<SYS>>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 - CF-203; BRIEF: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness. ; DRUG USED: Bronchitol; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Pharmaxis; CRITERIA: Inclusion Criteria: - Known diagnosis of cystic fibrosis (sweat test or genotype) - Of either gender - Aged between 8 and 18 years - Have a baseline FEV1 of <70% of the predicted normal value - Currently taking rhDNase for at least 4 weeks Exclusion Criteria: - Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA - Listed for transplantation - Known intolerance to mannitol, rhDNase or bronchodilators ; PRIMARY OUTCOME: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase; SECONDARY OUTCOME 1: to compare mannitol to rhDNase on FVC[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1001; BRIEF: This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up. ; DRUG USED: MSRD-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Merz North America, Inc.; CRITERIA: Key Inclusion Criteria: 1. Subjects who are male or female, ≥3 months of age on the date of Baseline Visit. 2. Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for Atopic Dermatitis. 3. Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline. 4. Subjects who have atopic dermatitis covering ≥5% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants). 5. Subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected. Key Exclusion Criteria: 1. Unstable course of Atopic Dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline. 2. Concurrent conditions and history of other diseases. 3. Used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study. 4. Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease. ; PRIMARY OUTCOME: Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group; SECONDARY OUTCOME 1: Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4[/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 - TX-P101; BRIEF: This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug. ; DRUG USED: Trofex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer - Imaging; TARGET: Prostate-specific Membrane Antigen (PSMA), Radiopharmaceutical; THERAPY: Combination; LEAD SPONSOR: Molecular Insight Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Have a prior histological diagnosis of prostate cancer. - Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus: 1. PSA> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or 2. PSA> 20 if intact prostate - Have platelet count of > 50,000/mm3 - Have neutrophil count of > 1,000/mm3 - Provide written informed consent and willing to comply with protocol requirements - Greater than or equal to 18 years of age - Can be on hormonal therapy if dose stable for > 90 days Exclusion Criteria: - Karnofsky performance status of <60 - Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively) - Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants). - Patient received external beam therapy or chemotherapy within the last 30 days - Administered a radioisotope within 5 physical half lives prior to study enrollment - Serum creatinine > 3.5 mg/dL - Total bilirubin > 2.5 times the upper limit of normal - Liver transaminases greater than 5x the upper limit of normal - Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study - Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations - Is determined by the Investigator that the patient is clinically unsuitable for the study - Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin. ; PRIMARY OUTCOME: To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease.; SECONDARY OUTCOME 1: To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TA-650-24 (Japan); BRIEF: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter. ; DRUG USED: Remicade; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma. - Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter. Exclusion Criteria: - Patients who have guttate psoriasis. - Patients who have drug-induced psoriasis - Patients who have previously used any other biological products than infliximab. - Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization. - Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections - Female patients who are pregnant, breast-feeding, or possibly pregnant. ; PRIMARY OUTCOME: Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score; SECONDARY OUTCOME 1: Psoriasis Area and Severity Index (PASI) Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - A18; BRIEF: This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time. ; DRUG USED: Tauvid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease - Imaging; TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: Avid Radiopharmaceuticals; CRITERIA: Inclusion Criteria: - Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study Exclusion Criteria: - Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation - Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer - Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception - Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session - Have received or participated in a trial with investigational medications in the past 30 days ; PRIMARY OUTCOME: Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status; 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 - BREEZE-AD3 (Long-Term); BRIEF: The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm. ; DRUG USED: Olumiant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions: Exclusion Criteria: - Had investigational product permanently discontinued at any time during a previous Baricitinib study. - Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participants participation in the study OR Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria: Inclusion Criteria: - Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months. - Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening. - Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). - Agree to use emollients daily. Exclusion Criteria: - Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. - A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past. - Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. - Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). - Have been treated with the following therapies: - Monoclonal antibody for less than 5 half-lives prior to randomization. - Received prior treatment with any oral Janus kinase (JAK) inhibitor. - Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study. - Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization. - Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg. - Have had major surgery within the past eight weeks or are planning major surgery during the study. - Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. - Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator. - Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. - Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis. - Have specific laboratory abnormalities. - Have received certain treatments that are contraindicated. - Pregnant or breastfeeding. ; PRIMARY OUTCOME: Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigators Global Assessment (IGA) 0 or 1; SECONDARY OUTCOME 1: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Human Abuse Liability (HAL); BRIEF: This single-center study will be a single-dose, randomized, double-blind, placebo- and active-controlled crossover study with a single inpatient treatment visit. The abuse potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety Follow-up visit (Visit 4). ; DRUG USED: Centanafadine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Neurovance, Inc.; CRITERIA: Inclusion Criteria: 1. Subjects must be healthy male nondependent recreational drug users 2. Subjects must be 18 to 55 years old, inclusive. 3. Subjects must have greater than or equal to 10 lifetime nontherapeutic experiences with central nervous system (CNS) stimulants (e.g., amphetamines, cocaine, methylphenidate), greater than or equal to 1 nontherapeutic use of prescription stimulants within the 12 months prior to Screening, and greater than or equal to 1 nontherapeutic use of a CNS stimulant within the 12 weeks prior to Screening. Exclusion Criteria: 1. Subjects that are deemed medically unsuitable or unlikely to comply with the study protocol for any reason. 2. Subjects who do not pass Qualification Phase criteria to be eligible for the Treatment Phase. ; PRIMARY OUTCOME: Maximum effect (Emax) on Drug Liking visual analog scale (VAS); SECONDARY OUTCOME 1: Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 12 hours after study drug administration [TA_AUE])[/INST]Yes</s>

<s>[INST]<<SYS>>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 - 00CH1 (China); BRIEF: This is a randomized, double blinded, placebo-controlled phase Ib clinical trial in adult patients with immune thrombocytopenia. Cross-over treatment will be allowed during the study. ; DRUG USED: HMPL-523; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: Hutchison Medipharma Limited; CRITERIA: Inclusion Criteria: 1. Signed informed consent form 2. 18~75 years old male of female 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Diagnosed immune thrombocytopenia before randomization with platelet decrease for more than 6 months. 5. Patients with refractory or relapsed ITP who have been treated with 1st line anti-ITP regimen or have experienced splenectomy. 6. Relative stable disease with World Health Organization (WHO) bleeding score of 0-1 and no rescue treatment needed within 2 weeks based on investigators judgment. 7. Laboratory tests meet the following conditions： - During screening stage, twice PLT<30x10^9/L(exceed 24 hours) - Hb≥90g/L(if iron-deficiency anemia,Hb>80g/L),WBC>2.5x10^9/L, NEU>1.8x10^9/L - Crea≤1.5xULN and CCR≥50mL/min - TBIL、ALT、AST≤1.5xULN - Amylase、lipase<ULN - INR、APTT<20%xULN Exclusion Criteria: 1. Patients with secondary thrombocytopenia or patients have other auto immune diseases who need long term steroids or immunosuppressants treatment. 2. Patients with Myelofibrosis, Myelodysplastic syndrome, Aplastic anemia, or other hematologic malignancies. 3. Have splenectomy within 12 weeks before randomization 4. Major surgery was performed within 4 weeks before randomization;Or require major elective surgery during the study period. 5. Have malignant tumor(except basal cell carcinoma of skin and carcinoma in situ of cervix) 6. Have previous/significant arterial/venous embolic disease 7. History of serious cardiovascular disease, or QTc≥450 ms. 8. Patients with resistant hypertension (Systolic blood pressure ≥140 mmHg or Diastolic blood pressure ≥90 mmHg) 9. Has a history of severe gastrointestinal diseases, such as dysphagia, active gastric ulcer, and is unable to take oral medication or has absorption disorder 10. HIV infection 11. Uncontrolled, active infections 12. Known history of clinically significant liver disease, such as hepatitis b（HBV DNA ≥2000IU/mL (or ≥1×104 copies)）, hepatitis c, or cirrhosis 13. Prior anti-ITP emergency treatment within 2 weeks before randomization. 14. Prior anti-ITP treatment within 4 weeks before randomization except for stable dose steroids, including but not limited to Thrombopoietin, thrombopoietin receptor agonist, azathioprine, cyclosporine A and mycophenolate mofetil. 15. Any condition requiring anti-coagulant therapy or the regular use of any medication having effluence to Platelet function. 16. Exposure to Rituximab 14 weeks prior to randomization. 17. Treament with Chinese medicine within 1 week before randomization. 18. Use of strong cytochrome P450 isoform 3A inhibitors and inducers and drugs metabolized by cytochrome P450 isoform 3A, cytochrome P450 isoform 2B6, and cytochrome P450 isoform 1A2, and are identified as narrow therapeutic drugs within 14 days or 5 half-lives, whichever is longer, prior to initiation of study treatment. 19. Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (eg, fostamatinib) 20. Allergic to study drug active ingredient or excipient 21. Subjects who have participated in clinical studies of drugs or invasive medical devices within 4 week before randomization 22. Subjects have severe psychological or mental abnormalities 23. Alcoholic or drug abuser 24. Female subjects during pregnancy and lactation 25. The investigator considered that the subjects were not suitable to participate in the study ; PRIMARY OUTCOME: Number of Participants with any Adverse Event; SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COMPACT (Low/High Volume); BRIEF: The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment. ; DRUG USED: Haegarda; DRUG CLASS: Biologic; INDICATION: Hereditary Angioedema (HAE); TARGET: Complement Pathway; THERAPY: Combination; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: Run-In Period Inclusion Criteria: - Males or females aged 12 years or older. - A clinical diagnosis of hereditary angioedema type I or II. - Hereditary angioedema attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment. - For subjects who have used oral therapy for prophylaxis against HAE attacks within 3 months of Screening: use of a stable regimen within 3 months of Screening, with no plans to change. Eligibility Criteria for Entering Treatment Period 1: - Laboratory confirmation of type I or type II hereditary angioedema, including C1-esterase inhibitor functional activity less than 50% AND C4 antigen level below the laboratory reference range. - No clinically significant abnormalities as assessed using laboratory parameters. - During participation in the run-in period, subjects must have experienced hereditary angioedema attacks that required acute treatment, required medical attention, or caused significant functional impairment. Exclusion Criteria: Run-In Period Exclusion Criteria: - History of clinical significant arterial or venous thrombosis, or current history of a clinically significant prothrombotic risk. - Incurable malignancies at screening. - Any clinical condition that will interfere with the evaluation of C1-esterase inhibitor therapy. - Clinically significant history of poor response to C1-esterase therapy for the management of hereditary angioedema. - Receiving therapy prohibited by the protocol, including medications for hereditary angioedema prophylaxis. - Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit. ; PRIMARY OUTCOME: The Time-normalized Number of Hereditary Angioedema Attacks; SECONDARY OUTCOME 1: Percentage of Subjects With a ≥ 50% Reduction in the Number of Hereditary Angioedema Attacks by CSL830 Treatment[/INST]Yes</s>