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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 - 1314.1 (Germany); BRIEF: The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses. A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing. ; DRUG USED: BI 113608; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions ; PRIMARY OUTCOME: Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test; SECONDARY OUTCOME 1: 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 Ib/II - EMERA (w/Dabrafenib); BRIEF: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and dabrafenib therapy regimen in patients with BRAFV600 mutant unresectable and/or metastatic cutaneous melanoma resistant to the dabrafenib/trametinib combination. In addition, the study aims to assess the safety profile of the combined APR-246 and dabrafenib therapy regimen, to explore potential biomarkers, and to further describe the anti-tumour activity of the combination of APR-246 and dabrafenib. The trial will enroll up to 31 evaluable patients. ; DRUG USED: Eprenetapopt; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: p53; THERAPY: Combination; LEAD SPONSOR: Aprea Therapeutics; CRITERIA: Inclusion Criteria: - Patients with confirmed BRAF V600 mutation-positive unresectable and/or metastatic malignant cutaneous melanoma, as determined locally by a validated test and treated with dabrafenib/trametinib first line combination therapy or second line after first line immunotherapy. - Patients that have progressed according to RECIST 1.1 after at least 4 weeks of treatment with dabrafenib/trametinib and remained on dabrafenib full dose (150mg bid) treatment for the study. - Measurable disease according to RECIST 1.1 criteria. For phase II only, metabolic measurable disease (according to PERCIST). - Availability of tissue from a metastatic lesion. A new biopsy is required unless inaccessible. An archival sample is accepted in that case after discussion with the sponsor. - ECOG Performance Status of 0 or 1. - Patients able to swallow and retain oral medication. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. - For female patients of childbearing potential, a pregnancy test (serum) will be performed within 7 days before inclusion. Woman of childbearing potential must be willing to use one highly effective form of contraception during anticancer treatment and for at least six months thereafter. Men must agree to use condom during the course of this study and at least six months after the last administration of the study treatment and contraception should be considered for partner of childbearing potential. - Adequate organ system function. - Signed informed consent before any study specific procedure and/or treatment happens. Exclusion Criteria: - Presence of uveal melanoma and/or other non-cutaneous melanomas. - Current use of a prohibited medication or need for any of these medications during treatment with study drug and within 28 days before the first administration of APR-246. I.e., no anti-cancer other than that given in this clinical trial, no immunotherapy, no hormonal cancer therapy, no radiation therapy (except palliative) and no experimental medications are permitted during the trial. All alternative therapies must first be approved by the sponsor. Supportive care therapies are allowed. - Unresolved toxicity greater than NCI-CTCAE(v4) Grade 1 from previous anti-cancer therapy except alopecia. - Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs. - Known HIV, active hepatitis B or hepatitis C infection. - Primary malignancy of the central nervous system. - History of familial long QT, serious ventricular arrhythmia (no VT > 130 bpm and > 5 extra beats per minute), no QTc ≥ 480 msec calculated from a single ECG reading or a mean of 3 ECG readings using Fridericias correction (QTcF = QT/RR0.33) or bradycardia (< 45 bpm). - Untreated or symptomatic brain metastasis, leptomeningeal disease or spinal cord compression. Patients who are on a stable dose of corticosteroids > 1 month or off corticosteroids for 2 weeks can be enrolled. - History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting, or thrombo-embolic event within the past 24 weeks from signature of ICF. - Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs, or excipients. - Uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity. - Pregnant or lactating woman. ; PRIMARY OUTCOME: Phase Ib: Adverse Events (AEs); SECONDARY OUTCOME 1: Clinical benefit 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 - A3051035 (52 Weeks); BRIEF: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52. ; DRUG USED: Chantix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Smoking Cessation; TARGET: Nicotinic Acetylcholine Receptor - a4ß2 subtype &lt;br&gt;(a4ß2 nAChR), Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: - Subjects with clinically significant cardiovascular disease in the past 6 months. ; PRIMARY OUTCOME: Continuous abstinence Weeks 13 -24.; SECONDARY OUTCOME 1: Continuous abstinence Weeks 13-52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CC6; BRIEF: This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy. ; DRUG USED: Polyclonal Antibody Stimulator; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: gastrin1-17 (G17), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Cancer Advances Inc.; CRITERIA: Inclusion Criteria: - Have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases - Have measurable disease - Have previously been treated with an irinotecan based chemotherapy - Have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer - Be at least 18 years of age - Have laboratory data as specified below: - Aspartate aminotransferase (AST) and ALT less than 2.5 times upper limit of normal - Bilirubin less than 1.5 mg/dL (SI units, 25.65 mol/L) - Creatinine less than 1.5 mg/dL (SI units, 132 mol/L) - White blood cell (WBC) count greater than 3,000/mm3 - Platelets greater than 100,000/mm3 - Hemoglobin more than 9.5 g/dL (SI units, 5.9 mol/L) - International normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits - Have a life expectancy of at least 3 months - Have a KPS score of 70 or greater - Use contraceptive methods, if sexually active - Have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments Exclusion Criteria: - Be pregnant or nursing - Have only symptomatic locally recurrent colorectal cancer - Have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer - Have received any prior anticancer immunotherapy - Have central nervous system metastasis, whether treated or not - Have bone metastases as sole manifestation of metastatic colorectal cancer - Have received chemotherapy within the previous 21 days - Have had major surgery within 21 days - Have immunodeficiency (primary or acquired) - Have undergone bone marrow transplantation within the last year - Require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed - Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids - Have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before G17DT irinotecan administration - Have contraindication to irinotecan based therapy - Have hypersensitivity to diphtheria toxoid - Use in the past 14 days or chronic concomitant use of proton pump inhibitors - Have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness - Have any condition that is likely to detrimentally affect regular follow up ; PRIMARY OUTCOME: Tumor response; 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 - SUSTAIN 3 (vs. Exenatide Q1W); BRIEF: This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subjects safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV ; PRIMARY OUTCOME: Change From Baseline in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change From Baseline in Body Weight[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EMS0815; BRIEF: Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia. ; DRUG USED: Valsartan/Rosuvastatin FDC; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Angiotensin II Receptor Type 1 (AT1), HMG CoA Reductase (HMGR); THERAPY: Monotherapy; LEAD SPONSOR: EMS; CRITERIA: Inclusion Criteria: - Participants of both sexes aged between 18 and 65 years; - Participants diagnosed with uncontrolled hypertension; - Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis; - Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) . Exclusion Criteria: - Participants with a previous diagnosis of familial hypercholesterolemia (homozygous); - Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE); - participants with isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis; - research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL; - participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg; - research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg in orthostatic position in relation to the sitting position); - History of congestive heart failure (CHF) functional class III or IV (NYHA);; - any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants; - Creatine phosphokinase (CPK) levels above the established laboratory normal range; - Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range; - Body mass index (BMI) ≥35 kg / m²; - Immunocompromised participants (eg .: malignancies, patients with Acquired Immunodeficiency Syndrome etc); - Chronic use of drugs that may interact with the drugs of the study; - Patients on concomitant lipid-lowering therapy; - History hypersensitivity to the active ingredients used in the study; - Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception; - History of alcohol abuse or illicit drug use; - Adherence to uniformization medication <80%; - Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it; ; PRIMARY OUTCOME: Reduction of systemic blood pressure measured between the first visit and last visit.; SECONDARY OUTCOME 1: Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - BC1-09 (EU) - Breast; BRIEF: The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed. ; DRUG USED: Xofigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: DNA, Radiopharmaceutical, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Patient is female, and either post-menopausal (cessation of menses for more than 1 year) or surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy) or in therapy-induced premature menopause with LHRH agonists. If of childbearing potential the result of a urine human chorionic gonadotropin pregnancy test, performed on the same day as and with the result known before study drug administration, must be negative. - Histological or cytological evidence of primary breast cancer. - Bone dominant disease (with or without metastases in soft tissue, lymph nodes and/or skin) with at least one non-irradiated bone metastasis on planar bone scintigraphy/SPECT ± CT within previous the 12 weeks. - Patient has unequivocally progressed on endocrine therapy and further benefit from endocrine therapy is considered unlikely (progression must be documented based on imaging and/or other clinically relevant information). - Patient has been on bisphosphonate therapy for at least 3 months prior to treatment start and no change to bisphosphonate therapy is expected during the treatment phase of the study, or patient is not being treated with bisphosphonates, and such treatment is not planned to start during the treatment period. - Latest endocrine therapy stopped at least 2 weeks prior to treatment start. - ECOG PS 0 - 2. - Life expectancy ≥6 months. - Patient fulfils the following certain laboratory requirements. Exclusion Criteria: - Received an investigational drug within 4 weeks prior to the administration of Alpharadin, or is scheduled to receive one during the treatment period. - Received chemotherapy, immunotherapy, or external beam radiation therapy within the last 4 weeks prior to administration of study drug, or has not recovered from acute ARs as a result of such therapy. - Is likely to require chemotherapy or immunotherapy within the 16 weeks treatment period. - Presence of imminent or established spinal cord compression based on clinical findings and/or MRI. - Presence of other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not breast cancer metastases. - Presence of unequivocal visceral metastases requiring chemotherapy treatment in the next 6 months, based on Investigators judgement. Brain metastases are allowed only if well controlled and if not associated with symptoms. Treatment for brain metastasis should have been completed at least 8 weeks prior to treatment start. - Patients with any other serious illness or medical condition, such as: - any uncontrolled infection - clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or heart failure more severe than this (NYHA Heart Failure Class III or IV) - Crohns disease or ulcerative colitis - Bone marrow myelodysplasia - Unmanageable faecal incontinence ; PRIMARY OUTCOME: Changes in bone markers (urine levels of NTX (uNTX) and bone-alkaline phosphatase (ALP); SECONDARY OUTCOME 1: All safety data, including adverse events, changes in laboratory variables, vitals signs, physical examination, late toxicity[/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 - Pediatric (GBM/AA/Ependymoma); BRIEF: This study will evaluate the administration of AdV-tk followed by valacyclovir in children with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary objective is to determine if this approach is safe and can be effectively delivered without disturbing standard therapy. ; DRUG USED: CAN-2409; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Thymidine Kinase, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: Candel Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Patients must be 3 years of age or older - Patients must be planning to undergo standard of care treatment with surgery and radiation therapy. - Patients must have malignant glioma or recurrent ependymoma - Tumor must be accessible for injection and must not be located in the brainstem or deep midbrain - Performance Score: Karnofsky ≥60% if >10y/o, Lansky ≥60 if ≤10y/o - Bone Marrow Function: Patients must have adequate bone marrow function defined as a peripheral absolute neutrophil count ≥ 1000/µl, platelet count ≥ 100,000/µl (transfusion independent) and hemoglobin ≥ 8.0 gm/dL - Renal Function: Patients must have serum creatinine ≤ 1.5 times upper limit of institutional normal for age and/or GFR ≥ 70 mL/min/1.73 m2. - Hepatic Function: Bilirubin ≤ 1.5 times institutional normal; SGPT (ALT) < 3 times institutional normal - Serum electrolyte values (sodium, potassium, magnesium, calcium) must be checked prior to enrollment and clinically significant abnormalities corrected prior to surgery/AdV-tk injection - Patients with seizure disorder may be enrolled if well controlled - Signed informed consent according to institutional guidelines must be obtained Exclusion Criteria: - Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection - Patients on immunosuppressive drugs (with exception of corticosteroid) - Known history of HIV or underlying immunodeficiency - Patients with acute infections (viral, bacterial or fungal infections requiring therapy) - Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy - Other serious co-morbid illness or compromised organ function - No other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from study entry until tumor progression) ; PRIMARY OUTCOME: Incidence of treatment emergent adverse events; 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 II - Cardiovascular Surgery (Germany); BRIEF: This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia. ; DRUG USED: ByFavo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Paion UK Ltd.; CRITERIA: Inclusion Criteria: - scheduled for major elective cardiac surgery. - scheduled for mechanical ventilation via tracheal intubation. Exclusion Criteria: - thoraco-abdominal replacement of the aorta or other procedure expected to be accompanied by a massive hemorrhage (at least 15% of the circulating blood volume). ; PRIMARY OUTCOME: Proportion of patients with successful anesthesia; 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 IIa - 201; BRIEF: The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne. ; DRUG USED: ASC-J9; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: AndroScience Corp; CRITERIA: Inclusion Criteria: - At least 12 years of age. - Facial acne, with: 20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face Exclusion Criteria: - Women who are pregnant or breastfeeding - Skin diseases other than acne vulgaris - Use of oral retinoids within 6 months of Baseline Visit - Unwilling to discontinue all other treatments for facial acne - Unwilling to avoid excessive swimming/sun exposure and use of cosmetics ; PRIMARY OUTCOME: Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12; SECONDARY OUTCOME 1: Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Light Chain Amyloidosis; BRIEF: This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally. ; DRUG USED: Ninlaro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyloid light-chain (AL) Amyloidosis; TARGET: Proteasome; THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female participants 18 years or older - Biopsy-proven systemic relapsed or refractory light-chain (AL) amyloidosis, which after at least 1 prior therapy, in the investigators opinion, requires further treatment - If received stem cell transplant, must be at least 3 months posttransplantation and recovered from side effects - Must have measurable disease defined as serum differential free light chain concentration ≥ 40 mg/L - Must have objective measurable organ (heart or kidney) amyloid involvement - Must have cardiac biomarker risk stage I or II disease - Must have adequate hematologic, hepatic, and renal function - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 - Female participants who are postmenopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse - Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse - Voluntary written consent Exclusion Criteria - Peripheral neuropathy that is greater or equal to Grade 2 - Cardiac status as described in protocol - Severe diarrhea (≥ Grade 3) not controllable with medication or requires administration of total parenteral nutrition - Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of MLN9708 - Uncontrolled infection requiring systematic antibiotics - Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection - Presence of other active malignancy with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate-specific antigen is within normal limit, or any completely resected carcinoma in situ - Female participants who are lactating or pregnant - Major surgery within 14 days before the first dose of study drug - Serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to the protocol ; PRIMARY OUTCOME: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE); SECONDARY OUTCOME 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib[/INST]Yes</s>

<s>[INST]<<SYS>>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 - A6631033; BRIEF: PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD) ; DRUG USED: PH-797804; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female subjects between, and including, the ages of 40 and 80 years. - Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease: Subjects must have a post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 30 - 80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel ECCS standards or NHANES III standards. - Subjects must have a smoking history of at least 10 pack-years* and meet one of the following criteria: They are current smokers, or they are ex-smokers who have abstained from smoking for at least 6 months. - Subjects treated with tiotropium bromide (SPIRIVA HandiHaler) 18 microgram daily for at least 1 month prior to screening. - Subjects must have had stable disease for at least 1 month prior to screening. During the screening and run-in phase subjects must be able to manage disease symptoms adequately with tiotropium bromide +/- salbutamol (albuterol) rescue medication (subjects should not use >10 actuations [100 microgram/actuations] daily for more than 2 consecutive days), without reliance on other therapies including oral or inhaled corticosteroids, other long-acting bronchodilators, nebulizer therapy, theophylline, roflumilast or regular oxygen. Exclusion Criteria: - A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening. - History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization. - History or presence of respiratory failure, cor pulmonale or right ventricular failure. - Subjects with home oxygen therapy (either PRN or long-term oxygen therapy). - Any clearly documented history of adult asthma or other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis). - Known previous diagnosis of Hepatitis B or C or HIV infection (specific screening is not required). - History of cancer (other than cutaneous basal cell) in the previous 5 years. - Active or past history of GI hemorrhage of any etiology, peptic ulceration, erosive esophagitis, gastric outlet obstruction or inflammatory bowel disease. - Regular use of aspirin at a dose greater than 325 mg/day. - History within the previous 6 months of: myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks). - A family history of long QT syndrome. - Presenting with: Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy). - Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0. - Any clinically significant active systemic or cutaneous infection including herpetic lesions. - Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV. - ECG abnormalities at screening or randomization, including those listed below: Subjects with pre-randomization evidence of QTcF prolongation (defined as >450 ms) at screening or baseline (Week 0) are not eligible for randomization. This assessment is based on a confirmed mean of the triplicate ECG recordings and is made by the investigator at the time of ECG collection. - Predominant heart rhythm other than normal sinus rhythm eg, atrial fibrillation, atrial flutter, supraventricular tachycardia. - Atrioventricular (AV) block greater than first degree. - Resting heart rate >100 or <40 bpm. - Evidence of previous myocardial infarction in the absence of clinical history consistent with these findings. - Evidence of acute ischemia. ; PRIMARY OUTCOME: Change from baseline in trough (pre-treatment and pre-bronchodilator) Forced Expiratory Volume1 at Week 12.; SECONDARY OUTCOME 1: Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume1 at Weeks 2, 6, and 10[/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 - CLC-102; BRIEF: The purpose of this study is to determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies. ; DRUG USED: CB-5083; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Cdc48p/p97; THERAPY: Monotherapy; LEAD SPONSOR: Cleave Biosciences, Inc.; CRITERIA: Inclusion Criteria: 1. Males and females ≥18 years of age at the time of signing the consent form. 2. Dose Escalation Phase: Have a documented diagnosis of a lymphoid hematological malignancy as described by the 2008 World Health Organization (WHO) classification that requires therapy and for which there is no standard of care or standard of care is not expected to be effective. Subjects must not be candidates for anti-tumor regimens known to provide clinical benefit. MM Dose Expansion Cohort: 3. Must have a documented diagnosis of relapsed and refractory multiple myeloma defined by the International Myeloma Working Group (IMWG) criteria. 4. Must have measurable disease defined as: - Serum M-protein ≥ 0.5g/dL of IgA or ≥ 1 g/dL of IgG, or - Urine M-protein ≥ 200 mg/24 hr, or - Involved FLC assay > 10 mg/dL with abnormal FLC ratio. 5. Must have received at least 4 prior therapies, including an alkylating agent (unless not clinically indicated), proteasome inhibitor, an immunomodulatory (IMiD) and CD38 targeted therapy. At least 3 prior therapies where CD38 targeted therapies are not approved, not commercially accessible, contraindicated or refused by subject. DLBCL Dose Expansion Arm: 6. Must have histologically confirmed DLBCL that is relapsed or refractory to previous therapy. 7. Must have ≥1 measurable disease sites as defined by standard Lugano classification. 8. Must have received at least 2 prior therapies, including a CD20 targeted therapy, alkylating agent or corticosteroid; subjects who are not eligible for high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) are eligible with exposure to at least 1 prior therapy. Waldstroms Macroglobulinemia Dose Expansion Arm: 9. Must have a confirmed diagnosis of WM as defined by the Second International Workshop, with a clinical indication for treatment. 10. Must have measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of ≥ 2 times the upper limit of each institutions normal value is required. 11. Must have relapsed/refractory disease after receiving 1 or more lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor (eg ibrutinib) if approved by the local health authority and commercially accessible. All Arms: 12. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2. 13. Adequate bone marrow function without transfusion or growth factor support, defined as: - Absolute neutrophil count ≥ 1,000/μL; - Platelet count ≥ 50,000/μL; - Hemoglobin ≥ 8.0 g/dL 14. Adequate organ function defined as: - Serum creatinine ≤ 1.5 mg/dL or creatinine clearance > 45 mL/min according to Cockcroft-Gault formula; (If creatinine clearance calculated from a 24-hour urine sample is ≥45 mL/min, the subject will qualify for the study). - Serum total bilirubin ≤ 2.0 mg/dL (34.2 μmol/L); or > 3.0 × upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia - AST (SGOT) ≤ 3 × the ULN; - ALT (SGPT) ≤ 3 × the ULN; 15. Subjects who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female subjects need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if subject is of childbearing potential. Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized). 16. Willing and able to provide written Informed Consent and adhere to study procedures. Exclusion Criteria: 1. Subjects with leukemia are excluded, with the exception of chronic lymphocytic leukemia (CLL), who are allowed in the dose escalation phase. Subjects with Burkitt lymphoma, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or amyloidosis are also excluded. 2. Clinically active central nervous system (CNS) cancer involvement. Imaging to exclude CNS involvement not required. 3. Previous or concomitant malignancy, except for basal-cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix. Subjects with other malignancies are eligible if they have remained disease free for at least 2 years prior to study entry; 4. Use of any anti-cancer drug therapy within 14 days prior to Baseline (within 28 days for monoclonal antibodies [eg anti-CD38]). 5. Use of any investigational agent within 28 days prior to Baseline. 6. Presence of clinically significant non-hematological toxicity of prior chemotherapy that has not resolved to ≤ Grade 1 as determined by CTCAE v 4.0, with the exception of alopecia and peripheral neuropathy. Note: Peripheral neuropathy > Grade 2 plus pain, or Grade 3 or Grade 4 are excluded. 7. Radiotherapy within 14 days prior to Baseline. 8. Major surgery within 6 weeks prior to Baseline. The subject must have recovered from surgery and be without current complications of infection or dehiscence. 9. Peripheral autologous stem cell transplant within 12 weeks prior to Baseline; prior allogeneic transplants within 16 weeks or chronic use of immunosuppressants. 10. Active infection requiring systemic therapy, including known human immunodeficiency virus (HIV), acquired immunodeficiency syndrome-related illness, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 11. Major cardiac abnormalities as defined but not limited to the following: uncontrolled angina or unstable life-threatening arrhythmias, history of myocardial infarction within 12 weeks prior to Baseline, Class 3 or higher New York Heart Association (NYHA) congestive heart failure, or severe cardiac insufficiency, persistent (3 consecutive electrocardiograms (ECGs) performed ≥ 5 minutes apart) prolongation of the QTc (Fridericia) interval to > 480 msec. 12. Cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 12 weeks prior to Baseline. 13. Major gastrointestinal (GI) disease as defined but not limited to the following: history of inflammatory bowel disease or other illness resulting in chronic diarrhea, known achlorhydria or history of GI surgery that could reduce the acidity of the stomach, acute pancreatitis or cholecystitis within 6 months prior to Baseline, or GI disease that may interfere with the absorption of orally-administered drugs. 14. Grade 3 or 4 eye disorder at study entry, unless stable and longstanding (>3 months) and unlikely to interfere with protocol-required ophthalmology assessments. 15. A condition that is expected to require concomitant use of any medication listed as prohibited while on study. 16. Is a pregnant or lactating female. 17. Has any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of the study results and, in the Investigators opinion, would make the subject inappropriate for entry into this study. ; PRIMARY OUTCOME: To determine the dose limiting toxicities (DLTs) of oral CB-5083 in subjects with lymphoid hematological malignancies; SECONDARY OUTCOME 1: To assess the pharmacodynamic (PD) effects of CB-5083 in peripheral blood cells and cancer cells[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ABC (IST); BRIEF: Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups. ; DRUG USED: Botox - Therapeutic; DRUG CLASS: Biologic; INDICATION: Overactive Bladder (OAB); TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: NICHD Pelvic Floor Disorders Network; CRITERIA: Inclusion Criteria: - Subject has signed informed consent. - Females at least 21 years of age - Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type. - Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary. - Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required. - Request for treatment for urge urinary incontinence. The patient may have tried other non-pharmacologic treatments for urge incontinence, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation. - Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment. - Subject is able to complete all study related items and interviews. Exclusion Criteria: - Any previous therapy with trospium chloride, solifenacin, or darifenacin - Failed three or more anticholinergic drugs. - Contraindication to anticholinergic therapy, specifically with solifenacin or trospium. - Current symptomatic urinary tract infection that has not resolved prior to randomization. - Uncontrolled narrow-angle glaucoma - Gastric retention - Baseline need for intermittent self catheterization - PVR >150ml on 2 occasions with void(s) of greater than 150ml - Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s). - Any prior intra-detrusor botulinum toxin A injections - Previous or currently implanted neuromodulation (sacral or tibial). - Surgically altered detrusor muscle, such as augmentation cystoplasty. - Known allergy to botulinum toxin A. - Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease). - Known allergy to lidocaine. - Currently pregnant or lactating patients or patients planning pregnancy within the next year. - Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study. - Cystoscopic findings that preclude injection, in the opinion of the investigator. - Current or prior bladder malignancy. - In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary. - Subjects who are on anticoagulant therapy,excluding aspirin - Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome. - Subjects with hematuria who have not undergone a clinically appropriate evaluation. - Subjects taking aminoglycosides at the time of injection. - Serum creatinine level greater than twice the upper limit of normal within the previous year. - Two or more hospitalizations for medical conditions in the previous year. - Plans to move out of area in the next 6 months. ; PRIMARY OUTCOME: Change in Urge Urinary Incontinence (UUI) Episodes; SECONDARY OUTCOME 1: Change From Baseline in Score on OABq-SF[/INST]Yes</s>

<s>[INST]<<SYS>>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 - NCI (Age 60+, Newly Diagnosed); BRIEF: This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days - Diagnostic biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy - Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH) - Previously untreated disease - Must have declined standard AML cytotoxic chemotherapy regimens - WBC ≤ 30,000/mm³ - History of prior myelodysplastic syndromes (MDS) allowed - No acute promyelocytic leukemia (FAB M3) - No blastic transformation of chronic myelogenous leukemia - Zubrod performance status 0-2 - Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilberts syndrome or hemolysis, but not to liver dysfunction) - AST and ALT ≤ 3.5 times ULN - Creatinine ≤ 1.5 times ULN - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment - No known allergy to thalidomide - Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients) - No prior systemic chemotherapy for acute leukemia except hydroxyurea - Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy - No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support - Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., < 100 mg/m²/day) for treatment of MDS allowed - At least 30 days since prior therapy for MDS (excluding growth factors) - No prior lenalidomide for MDS - At least 6 months since prior chemotherapy or radiotherapy for another malignancy - No concurrent therapy for another malignancy - Concurrent hormonal therapy allowed ; PRIMARY OUTCOME: Complete Response; SECONDARY OUTCOME 1: Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug[/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 - NEO3-06; BRIEF: The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. ; DRUG USED: Lymphoseek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer - Imaging; TARGET: Macrophages, Mannose, Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Navidea Biopharmaceuticals; CRITERIA: Inclusion Criteria: Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study: 1. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study. 2. The patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage T1-T4a, N0, M0. 3. Clinical nodal staging (N0) has been confirmed by negative results from contrast CT scan or gadolinium-enhanced MRI or lateral and central neck ultrasound. PET scan cannot be used for this evaluation. 4. Imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy. 5. The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan. 6. Patients with prior malignancy are allowed provided the patient meets the following criteria: Underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; AND No malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence. 7. The patient is at least 18 years of age at the time of consent. 8. The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2. 9. If the patient is a female, the patient has a confirmed negative pregnancy test within 72 hours priors to administration of Lymphoseek, OR has documentation of surgical sterilization, OR has documented evidence of postmenopausal status for at least 1 year. Exclusion Criteria: Patients meeting any of the following exclusion criteria at the end of the screening phase will not be enrolled in the study: 1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oral pharynx, nasal pharynx, hypo-pharynx and larynx. 2. The patient is pregnant or lactating. 3. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes. 4. Patients with a history of neck dissection, or gross injury to the neck that would preclude reasonable surgical dissection for this study, or radiotherapy to the neck. 5. Patients who have had other nuclear imaging studies conducted within 15 days or consenting. 6. The patient is actively receiving systemic cytotoxic chemotherapy. 7. Patient is currently participating in another investigational drug study or participated within 30 days prior to consenting. 8. Patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy. ; PRIMARY OUTCOME: False Negative Rate (FNR); SECONDARY OUTCOME 1: Negative Predictive Value (NPV)[/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 - C326 (TKA); BRIEF: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 232 adult subjects undergoing primary unilateral TKA under general or spinal anesthesia. ; DRUG USED: Exparel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Male or female, at least 18 years of age at screening. 2. Scheduled to undergo primary unilateral TKA under general or spinal anesthesia. 3. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3. 4. Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study. 5. Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch. 6. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: 1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. 2. Planned concurrent surgical procedure (e.g., bilateral TKA). 3. Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery). 4. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted. 5. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics. 6. Contraindication to any one of the following: bupivacaine, oxycodone, morphine, or hydromorphone. 7. Use of any of the following medications within the times specified before surgery: long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours. 8. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration. 9. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study. 10. Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration. 11. History of impaired kidney function, poorly controlled chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in extremities. 12. Impaired kidney function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L] or blood urea nitrogen level >50 mg/dL [17.9 mmol/L]) or impaired liver function (e.g., serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN] or serum alanine aminotransferase [ALT] level >3 times the ULN.) 13. Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments. 14. Any chronic neuromuscular deficit effecting the peripheral nerves or muscles of the surgical extremity. 15. Any chronic condition or disease that would compromise neurological or vascular assessments. 16. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. 17. Suspected or known history of drug or alcohol abuse within the previous year. 18. Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2. 19. Previous participation in an EXPAREL study. 20. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subjects participation in this study. ; PRIMARY OUTCOME: Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores Through 72 Hours; SECONDARY OUTCOME 1: Total Postsurgical Opioid Consumption Through 72 Hours[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Open-Label; BRIEF: This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension. Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total). Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose. ; DRUG USED: BAY 98-7106; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of >/= 160 mmHg and < 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP >/= 160 mmHg and <200 mmHg after wash out. - Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active Exclusion Criteria: - Mean seated systolic blood pressure >/= 200 mmHg and/or mean seated diastolic blood pressure >/= 120 mm/Hg - Mean seated diastolic blood pressure < 60 mm/Hg - Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0 - Any history of hypertensive emergency - Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc. - Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the previous 12 months - History of intracerebral hemorrhage or subarachnoid hemorrhage - History of hypertensive retinopathy - known Keith-Wagener Grade III or IV - Any history of heart failure, New York Heart Association (NYHA) classification III or IV - Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0 - Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0. - Hyperkalemia: potassium above the upper limit of normal in the laboratory range ; PRIMARY OUTCOME: Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28; SECONDARY OUTCOME 1: Number of Subjects With Clinically Relevant Changes in Laboratory 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 II - Progressive; BRIEF: The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS). ; DRUG USED: Elezanumab; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months. - Evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test. Exclusion Criteria: - Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification. - Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab. ; PRIMARY OUTCOME: Mean Overall Response Score (ORS); SECONDARY OUTCOME 1: Disability Improvement 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 II - CheckMate 908 (+/- Ipilimumab); BRIEF: The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Must have received standard of care therapy, and there must be no potentially-curative treatment available, in one of the following cohorts: - A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with radiation therapy (RT) but no chemotherapy - A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma (HGG) previously treated with surgical resection and RT - A histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy - A histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT - A histologically-confirmed high grade CNS malignancy other than above which is recurrent or progressive after at least one line of prior therapy - Lansky play score (LPS) for ≤ 16 years of age or Karnofsky performance scale (KPS) for > 16 years of age assessed within two weeks of enrollment must be >= 60 - A tumor sample must be available for submission to central laboratory (not required for DIPG) Exclusion Criteria: - An active, known, or suspected autoimmune disease - A concurrent condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment - Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Other protocol defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Progression-Free Survival (PFS), Cohort 1 Only[/INST]Yes</s>

<s>[INST]<<SYS>>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 - ET1; BRIEF: This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid. ; DRUG USED: KANAb001; DRUG CLASS: Biologic; INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: CX3C chemokine receptor 1 (CX3CR1) , Immune System; THERAPY: Monotherapy; LEAD SPONSOR: EA Pharma Co., Ltd.; CRITERIA: Inclusion Criteria: - Diagnosed with primary biliary cholangitis corresponding to one of the following criteria: - Histologically confirmed chronic non-suppurative destructive cholangitis (CNSDC) with laboratory findings compatible with primary biliary cholangitis (PBC) - Positivity for antimitochondrial antibodies (AMAs) with histological findings compatible with PBC but in the absence of characteristic histological findings of CNSDC - No histological findings available, but positivity for AMAs as well as clinical findings and a course indicative of typical cholestatic PBC - Aged ≥20 and <75 years old at the time of informed consent - Taking stable dose of ursodeoxycholic acid for at least 6 months (≥600 milligrams [mg]/day) prior to Screening - Screening and Week 0 alkaline phosphatase (ALP) values between 1.67 and 10 times the upper limit of normal - Outpatient - Has voluntarily consented, in writing, to participate in this study, and is able to comply with all aspects of the protocol Exclusion Criteria: - Received the following drugs within 12 weeks before starting the study treatment: - Drugs that suppose the efficacy to PBC: o azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, penicillamine, fibrates, and other systemic corticosteroids - Potentially hepatotoxic drugs o methyl-dopa, sodium valproic acid, and isoniazide - History or current condition of hepatic decompensation with variceal bleeds, encephalopathy ≥ grade 2 and poorly controlled ascites, and history of liver transplantation - History or current condition of other concomitant liver diseases including hepatitis due to hepatitis B virus (HBV)/hepatitis C virus (HCV) infection, primary sclerosing cholangitis, alcoholic liver disease (including liver cirrhosis), autoimmune liver disease requiring the treatment of systemic corticosteroids or biopsy proven non-alcoholic steatohepatitis (NASH) - History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent - Immunodeficiency or history of human immunodeficiency virus (HIV) infection - Infection requiring hospitalization or intravenous administration of antibiotics or disease requiring administration of antivirus drugs (eg, herpes zoster) within 4 weeks before starting the study treatment - History of tuberculosis or current complication of active tuberculosis - Positive tuberculosis test (QuantiFERON®TB Gold Test or T-SPOT®.TB Test) at Screening - History of clinically important vasculitis - History of severe allergy (shock or anaphylactoid symptoms) - Complication of uncontrolled disorders such as acute cardiac infarction, unstable angina, brain infarct, or symptomatic intracerebral hemorrhage - Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, or renal disease) that could affect the participants safety or interfere with the study assessments in the opinion of the investigator or subinvestigator - Tested positive for any of the following at Screening: HIV, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, HBV deoxyribonucleic acid (DNA), HCV antibody, human T-lymphotropic virus type 1 (HTLV-1) antibody, or syphilis - Demonstrated prolonged QT interval corrected using Fridericias formula (QTcF) interval (>450 milliseconds [ms]) in repeated electrocardiogram examinations - Received immunoglobulin preparations or blood products within 24 weeks before starting the study treatment - Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive - Females who are, or may be pregnant, who are breastfeeding, who wish to become pregnant during the study period, and females or their partners who do not wish to use reliable contraceptive measures. - Scheduled for surgery before Week 64 - Has been treated with investigational drugs in other E6011 study - Currently enrolled in another clinical study, including the follow-up - Used any investigational drug within 28 days (or 5× the half-life, whichever is longer) before informed consent - Judged to be ineligible to participate in this study by the investigator or sub-investigator ; PRIMARY OUTCOME: Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12; SECONDARY OUTCOME 1: Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - C-EDGE IBLD; BRIEF: This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%. ; DRUG USED: Zepatier; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease - has cirrhosis or is non-cirrhotic - is human immunodeficiency virus (HIV) coinfected or not infected with HIV - is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception Exclusion Criteria: - has evidence of decompensated liver disease - is coinfected with hepatitis B - has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer - has hepatocellular carcinoma (HCC) or is under evaluation for HCC - has clinically-relevant drug or alcohol abuse within 12 months of screening ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EFFECT II (vs. Dapagliflozin); BRIEF: This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as measured with magnetic resonance imaging (MRI)) ; DRUG USED: Epanova; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Diglycerol Acyltransferase (DGAT), Lipoprotein lipase, PPAR gamma; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture; Have liver fat content as assessed by MRI >5.5%; Diagnosis of Type 2 diabetes since at least 6 months in accordance with WHO criteria. Exclusion Criteria: Any condition when MRI is contraindicated such as, but not limited to, having a pacemaker or claustrophobia; Diagnosis or signs of Type 1 diabetes (e.g. history of positive islet antibodies); Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula). ; PRIMARY OUTCOME: Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo); SECONDARY OUTCOME 1: Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - OPT; BRIEF: A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®) ; DRUG USED: Plenvu; DRUG CLASS: Non-NME; INDICATION: Colon Cleansing/Laxatives; TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Norgine; CRITERIA: Inclusion Criteria: - The subjects written informed consent must be obtained prior to inclusion. - Subjects age 40 to 70 years. - Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject: 1. is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or 2. is aged 55 to 70. - Part A: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms. - Females of child bearing potential must be surgically sterile, post- menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in (unless post-menopausal). - Willing, able and competent to complete the entire procedure and to comply with study instructions. - Ferrous sulphate should be stopped at least one week prior to study medication. Exclusion Criteria: - Part A only: Subjects undergoing screening colonoscopy. - Presence of current clinically significant functional gastrointestinal (GI) disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome [IBS]). - Regular use of laxatives or colon motility altering drugs in the last month. - Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug. - Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection. - Known glucose-6-phosphatase dehydrogenase deficiency. - Known phenylketonuria. - History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency. - Known hypersensitivity to polyethylene glycols and/or ascorbic acid. - History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension. - Evidence of dehydration. - Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances. - Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal. - Clinically relevant findings on physical examination based on the Investigators judgement. - Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation. - Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening. - History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations. - Subjects who are unwilling to comply with the provisions of the study protocol. - Concurrent participation in an investigational drug study or participation within 3 months of study entry. - Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly. - Previous participation in the study. - Persons who are ordered to live in an institution on court or authority order ; PRIMARY OUTCOME: Stool weight output; SECONDARY OUTCOME 1: Tolerability of medication (vomiting 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 - Cabozantinib-2003 (Japan); BRIEF: The purpose of this study is to evaluate the efficacy and safety of cabozantinib in Japanese participants with advanced hepatocellular carcinoma (HCC) who have received prior systemic anticancer therapy. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Male or female Japanese participants 20 years of age or older on the day of consent. 2. Histological or cytological diagnosis of HCC (results of a previous biopsy will be accepted). 3. Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 as determined by the investigator. 4. Participants who have disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation). 5. Participants who have received 1 or 2 prior anticancer therapies for advanced HCC. - Cohort A: participants who have received prior sorafenib. - Cohort B: participants who have not received prior sorafenib. Note: Additional prior systemic therapies used as adjuvant or local therapy are allowed. 6. Radiographic progression following prior systemic anticancer therapy for advanced HCC. 7. Recovery to =<Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 from toxicities related to any prior treatments, unless the Adverse Events (AEs) are clinically nonsignificant and/or stable on supportive therapy. 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, and life expectancy of at least 3 months. 9. Child-Pugh Score of A. 10. Adequate organ and marrow function at Screening (within 10 days before Week 1 Day 1): 1. Absolute neutrophil count (ANC) >=1,200/mm^3. 2. Platelets >=60,000/mm^3. 3. Hemoglobin >=8 g/dL. 4. Serum creatinine =<1.5 × upper limit of normal (ULN) or calculated creatinine clearance >=40 mL/min using the Cockroft-Gault equation. 5. Urine protein-to-creatinine ratio (UPCR) =<1 mg/mg Cr. 6. Total bilirubin =<2 mg/dL. 7. Serum albumin >=2.8 g/dL. 8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<5.0 × ULN. 9. Hemoglobin A1c (HbA1c) =<8% (if HbA1c results are unavailable [eg, hemoglobin variant], a fasting serum glucose =<160 mg/dL). 11. Antiviral therapy per local standard of care if active hepatitis B virus (HBV) infection. 12. Female participants who: 1. Are postmenopausal (natural amenorrhea, not due to other medical reasons) for at least 1 year before the Screening visit, OR 2. Are surgically sterile, OR 3. If they are of childbearing potential, agree to practice 1 highly effective method of birth control with a condom, which is an effective barrier method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR 4. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant, from the time of signing the informed consent through 4 months after the last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], condoms only, withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who: 5. Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug. If their partner are of childbearing potential, their female partner should use 1 highly effective method of birth control at the same time, OR 6. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant, from the time of signing the informed consent through 4 months after the last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner], condoms only, withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.) 13. Voluntary written consent must be given 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. 14. Participant is willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: 1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma. 2. Any type of anticancer agent within 14 days before the first day of study drug administration (Week 1 Day 1). 3. Radiation therapy within 28 days (14 days for radiation for bone metastases) or radionuclide treatment (eg, I-131 or Y-90) within 42 days before Week 1 Day 1 (participant is excluded if there are any clinically relevant ongoing complications from prior radiation therapy). 4. Prior Cabozantinib treatment. 5. Treatment with any investigational products (excluding anticancer products approved in Japan) within 28 days before Week 1 Day 1. 6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before Week 1 Day 1. Eligible participants must be without corticosteroid treatment at Week 1 Day 1. 7. Concomitant anticoagulation, with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). Note: Low-dose aspirin for prophylactic use (per local applicable guidelines) and low-dose, low molecular weight heparins (LMWH) are permitted (LMWH has not been approved for the use for cardioprotection in Japan). Anticoagulation with therapeutic doses of LMWH is allowed in participants without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 12 weeks before Week 1 Day 1, and who have had no complications from a thromboembolic event or the anticoagulation regimen. 8. Participants who have uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: 1. Cardiovascular disorders including - Symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias. - Uncontrolled hypertension defined as sustained blood pressure (BP) >150 mm Hg systolic, or >100 mm Hg diastolic despite optimal antihypertensive treatment. - Stroke (including transient ischemic attack [TIA]), myocardial infarction, or other ischemic event within 6 months before Week 1 Day 1. - Thromboembolic event within 3 months before Week 1 Day 1. - A left-ventricular ejection fraction =<50%. 2. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: - Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohns disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction. - Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before Week 1 Day 1. Note: Complete healing of an intra-abdominal abscess must be confirmed prior to Week 1 Day 1. 3. Major surgery within 2 months before Week 1 Day 1. Complete healing from major surgery must have occurred 1 month before Week 1 Day 1. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before Week 1 Day 1. Participants with clinically relevant complications from prior surgery are not eligible. 4. Cavitating pulmonary lesion(s) or endobronchial disease. 5. Lesion invading a major blood vessel including, but not limited to: inferior vena cava, pulmonary artery, or aorta. Participants with invasion or thromboses of portal/hepatic vasculature attributed to underlying liver disease and/or liver tumor are eligible. 6. Clinically significant bleeding risk including the following within 3 months before Week 1 Day 1: hematuria, hematemesis, hemoptysis of >0.5 teaspoon (>2.5 mL) of red blood, or other signs indicative of pulmonary hemorrhage, or history of other significant bleeding if not due to reversible external factors. 7. Other clinically significant disorders such as: - Active infection requiring systemic treatment. - Known infection with human immunodeficiency virus, or known acquired immunodeficiency syndrome -related illness. - Active hepatitis B and/or C. Participants with active hepatitis virus infection controlled with antiviral therapy are eligible. - Serious non-healing wound/ulcer/bone fracture. - Malabsorption syndrome. - Uncompensated/symptomatic hypothyroidism. - Requirement for hemodialysis or peritoneal dialysis. - History of solid organ transplantation. 9. Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding. Participants treated with adequate endoscopic therapy (according to institutional standards) without any episodes of recurrent GI bleeding requiring transfusion or hospitalization for at least 6 months before Week 1 Day 1 are eligible. 10. Moderate or severe ascites. 11. Corrected QT interval calculated by the Fridericia formula (QTcF) >500 msec within 14 days before Week 1 Day 1. Note: If the QTcF is >500 msec in first electrocardiogram (ECG), a total of 3 ECGs each separated by at least 3 minutes should be performed within 30 minutes. If the average of these 3 consecutive results for QTcF is =<500 msec, the participant meets eligibility in this regard. 12. Inability to swallow tablets. 13. Previously identified allergy or hypersensitivity to components of the study treatment formulations. 14. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period. Note: Female participants who are in the lactation period, even if they discontinue breastfeeding, will be excluded from the study. 15. Previously diagnosed with another malignancy and have any evidence of residual disease within 2 years before Week 1 Day 1. Note: Participants with superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy are not excluded. 16. Any serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol. 17. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of Cabozantinib. 18. Use of strong cytochrome P450 (CYP) 3A inhibitors and CYP3A inducers within 14 days before Week 1 Day 1. 19. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse. ; PRIMARY OUTCOME: 24-Week Progression-Free Survival Rate (PFSR); SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PROTEUS; BRIEF: The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT. ; DRUG USED: Erleada; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate - High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3 5) and >=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement - Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 - Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies - Able to receive androgen deprivation therapy (ADT) for at least 13 months Exclusion Criteria: - Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0 - (a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature - History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer - Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time - Major surgery <=4 weeks prior to randomization - Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary ; PRIMARY OUTCOME: Percentage of Participants with Pathologic complete response (pCR); SECONDARY OUTCOME 1: Prostate Specific Antigen (PSA)-Free Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1250 pts; BRIEF: The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults ; DRUG USED: Otenabant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: Cannabinoid-1 (CB1) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Obese adults with a body mass index > or = 30 kg/m ; > or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia Exclusion Criteria: - Pregnancy - Diabetes - Adults with serious or unstable current or past medical conditions ; PRIMARY OUTCOME: Change in body weight and proportion of subjects with 5% weight loss; SECONDARY OUTCOME 1: Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK[/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 - Chronic Rhinosinusitis; BRIEF: This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis. ; DRUG USED: LYR-210; DRUG CLASS: Non-NME; INDICATION: Inflammatory Disorders; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Lyra Therapeutics; CRITERIA: Inclusion Criteria: - Diagnosis of CS. - Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study. - The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site. - The study subject agrees to comply with all study requirements Exclusion Criteria: - Known history of intolerance to corticosteroids. - Oral-steroid dependent condition. - Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit. - Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system). - Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range. - Previous pituitary or adrenal surgery. - History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts. - Recent participation in another clinical trial within 1 month of screening visit. - Subjects currently participating in an investigational drug or device study. ; PRIMARY OUTCOME: Product related serious adverse events from baseline visit to 4 weeks post procedure; SECONDARY OUTCOME 1: Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3103 (Safety/Efficacy); BRIEF: The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experienced. ; DRUG USED: Vantrela ER; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - The patient has had moderate to severe chronic low back pain for at least 3 months duration before screening. - The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in this study. - The patient is willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the study center for scheduled study visits, as specified in the protocol. - The patient is 18 through 80 years of age at the time of screening. - Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception, agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening. - Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. NOTE: A woman will be considered surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy. - Other criteria apply. Exclusion Criteria: - The patient is taking a total of more than 135 mg/day of oxycodone, or equivalent, during the 14 days before screening. - The patients primary painful condition under study is related to any source of chronic pain other than low back pain. - The patient has radicular (nerve compression) pain or another type of purely neuropathic pain. - The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug. - The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse, with the exception of nicotine. - The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. - Other criteria apply. ; PRIMARY OUTCOME: Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI); SECONDARY OUTCOME 1: Change From Baseline to Week 12 of the Treatment Period in Weekly Average Pain Intensity (API)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Dose Escalation/Expansion; BRIEF: This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism. ; DRUG USED: INBRX-105; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Cluster of Differentiation 137 (CD 137), Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Inhibrx, Inc.; CRITERIA: Inclusion Criteria: - Parts 1 and 3 (escalation cohorts; completed): Patients with locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite standard therapy and for whom no further standard therapy exists. - Part 2 (expansion cohorts): Patients with non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma or solid tumors amenable to paired biopsies, with locally advanced or metastatic, non-resectable disease, which has progressed despite standard therapy or for whom no standard or clinically acceptable therapy exists. - Part 4 relapsed or refractory to CPI cohorts: NSCLC, cutaneous melanoma, HNSCC, MSI/TMB-high or MMRd solid tumors - Part 4 CPI naive cohorts: locally advanced or metastatic, non-resectable NSCLC or HNSCC - Refractory or relapsed to anti-PD-1 or anti-PD-L1, and anti-CTLA4 if applicable (NOTE: For all tumor types with checkpoint inhibitor approvals) with exception of the treatment naive NSCLC cohort. - PD-L1 positivity by immunohistochemistry (IHC): Parts 1 and 3 (escalation cohorts) PD-L1 positivity is not required. Parts 2 and 4 (expansion cohorts): Combined Positive Score (CPS) or Tumor Proportion Score (TPS) above certain thresholds as defined per protocol. - Adequate hematologic, coagulation, hepatic and renal function as defined per protocol. - Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. Exclusion Criteria: - Prior exposure to 4-1BB agonists. - Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug. Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives. NOTE: Previous exposure to anti-PD-L1 checkpoint inhibitor requires a minimum washout period of 24 weeks prior to the first dose of study drug. - Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin lymphoma and multiple myeloma). - Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-105. - Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply. - Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply. - Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply. - Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. Certain exceptions as defined in protocol apply. - History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Exceptions as defined in protocol for expansion cohorts will apply. - History of hepatitis or cirrhosis (e.g., non-alcohol steatohepatitis, alcohol or drug-related, autoimmune, hepatitis B, or hepatitis C). Exceptions as defined in protocol for expansion cohorts will apply. - Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications. - Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. - Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial. - Major surgery within 4 weeks prior to enrollment on this trial. - Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug. - Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation. ; PRIMARY OUTCOME: Frequency of adverse events of INBRX-105; SECONDARY OUTCOME 1: Area under the serum concentration time curve (AUC) of INBRX-105[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - DEFLECT-1; BRIEF: The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT. ; DRUG USED: Dificid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Clostridium difficile-Associated Diarrhea/Infection (CDAD/CDI); TARGET: RNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: - Male or female 18 years of age or older. - Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment. - Is undergoing HSCT with planned Fluoroquinolone prophylaxis. - Informed consent is provided. Exclusion Criteria: - Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin A and/or B [or their respective genes, tcdA and/or tcdB] of C. difficile in the stool) or current treatment for CDAD. - Undergoing cord blood transplants. - Has fulminant colitis, toxic megacolon, or ileus. - A history of inflammatory bowel disease (ulcerative colitis or Crohns disease). - Women who are pregnant or are actively breast feeding (all women of childbearing potential must have a negative pregnancy test result prior to dosing study drug). - Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin, Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide). - Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study. - Participation in other clinical research studies utilizing an investigational agent within one month prior to screening and during the study treatment period. ; PRIMARY OUTCOME: Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.; SECONDARY OUTCOME 1: Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - ICP-1701-102; BRIEF: The objectives of this study are: Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study. ; DRUG USED: Olinciguat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiovascular Disease; TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Cyclerion Therapeutics; CRITERIA: Inclusion Criteria: - Subject is an ambulatory male or female between 18 and 55 years old at the screening visit - Subjects body mass index score is > 18.5 and < 30.0 kg/m2 at the screening visit - Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study - Subject is in good health and has no clinically significant findings on a physical examination - Other inclusion criteria per protocol Exclusion Criteria: - History of any clinically significant medical conditions - Other exclusion criteria per protocol ; PRIMARY OUTCOME: Treatment Emergent Adverse Event; 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 IIa - COURSE; BRIEF: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) ; DRUG USED: Tezepelumab; DRUG CLASS: Biologic; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Thymic stromal lymphopoeitin (TSLP); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value. 2. History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment. 3. CAT score of ≥15 at enrollment and on day of randomization. 4. Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment. Exclusion Criteria: 1. Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis). 2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable. 3. Major surgery within 8 weeks before enrollment. 4. History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment. 5. Pregnant or breastfeeding. 6. The chest/lungs with pathology that precludes the patients ability to complete the study 7. The patient has active COVID 19 infection during screening period. ; PRIMARY OUTCOME: Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo); SECONDARY OUTCOME 1: Time to first moderate or severe COPD exacerbation[/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 - 588; BRIEF: This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery. ; DRUG USED: Mapracorat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor – Transrepression Selective Agonist (SEGRA); THERAPY: Monotherapy; LEAD SPONSOR: Bausch & Lomb Incorporated; CRITERIA: Inclusion Criteria: - Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent. - Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations. - Subjects who are candidates for cataract surgery. - Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening. - Subjects must be able and willing to comply with all treatment and follow- up procedures. Exclusion Criteria: - Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components. - Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study. - Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment or follow-up. ; PRIMARY OUTCOME: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.; SECONDARY OUTCOME 1: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.[/INST]Yes</s>

<s>[INST]<<SYS>>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 - (China); BRIEF: AB-106 will be administered once a day. Each treatment cycle is defined as 21 days of continuous medication. Dosing will continue until any of the following conditions are met: disease progression, intolerable drug-related adverse events, researchers recommend discontinuation of treatment, withdrawal of informed consent, pregnancy during the study, use of other anti-tumor therapy, loss of follow-up, death and other causes, whichever occurs first. The study includes a screening period, treatment period, safety follow-up and long-term follow-up. ; DRUG USED: AB-106; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: ROS kinase, Trk (Tropomyosin Receptor Kinase) Receptors; THERAPY: Monotherapy; LEAD SPONSOR: AnHeart Therapeutics Inc.; CRITERIA: Inclusion Criteria: 1. Diagnosis of locally advanced or systemic metastatic solid tumors with NTRK1/2/3 fusion gene; 2. Subjects who failed or refused to accept the standard treatment; 3. At least one measurable target tumor lesion as accessed by RECIST v1.1; 4. Subjects diagnosed with primary CNS tumors should meet the following criteria: (1) Received previous treatment, including radiotherapy, chemotherapy, targeted therapy; (2) At least one measurable lesion by two-dimensional measurement (confirmed by MRI and using RANO). At least one measurable lesion in each dimension should be ≥ 1cm and on more than one image; (3) The imaging exam should be completed within 28 days before dosing, and the disease should be in stable; 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6. Minimum life expectancy of 3 months; 7. Adequate organ function defined per protocol; 8. Coagulation function: international standardized ratio (INR) ≤ 1.5, and partial prothrombin time (PT) or activated partial prothrombin time (APTT) ≤ 1.5 × ULN (Upper limit of normal); 9. For patients enrolled via local molecular testing, an archival or fresh tumor tissue is required to be submitted for independent central molecular testing; 10. Any toxic effect caused by prior therapies must be recovered to CTCAE Grade ≤1 except for alopecia. Exclusion Criteria: 1. Current participation in another therapeutic clinical trial within 4 weeks before first dose; 2. Prior treatment with NTRK fusion gene and immune checkpoint inhibitors (including PD-1/PD-L1, etc.); 3. Subjects with symptomatic or unstable brain metastasis (asymptomatic brain metastasis subjects can be selected for) and CNS primary tumor, but need to be in stable for at least 7 days, will be enrolled; 4. Had major surgery or radiotherapy within one month before the first dose, or were expected to need a major surgery during study; 5. Pneumonia caused by interstitial lung disease, interstitial fibrosis, or tyrosine kinase inhibitors; 6. Active and uncontrollable systemic bacterial, viral or fungal infectionsx; 7. Clinically active viral disease with positivity of serum HIV, HBV, HCV testing; 8. Historical immunodeficiency, including acquired, congenital immunodeficiency diseases, or a historical organ transplant; 9. The systematically use of strong CYP3A inhibitors, including ( but not limited to) atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit or grapefruit juice; 10. The systematically use of strong CYP3A inducers, including ( but not limited to) carbamazepine, phenobarbital, phenytoin, rifampicin, rifampicin and St. Johns grass; 11. Any other anti-tumor drug use within 14 days before first dose or during the study; 12. Historical, neurological or mental disorders, such as epilepsy or dementia; 13. Historical drug abuse; 14. Spinal cord compression caused by tumor (unless the subjects pain is completely controlled and neurological function is stable or restored),cancerous meningitis or leptomeningeal disease; have risk of cerebral hernia determined by investigator; 15. Active gastrointestinal or other malabsorption disease, such as gastrectomy or enterectomy; 16. With 3 months before first dose, have unstable cardiovascular disease like as, myocardial infarction, severe / unstable angina pectoris, coronary artery / peripheral artery bypass grafting, congestive heart failure (NCICTCAEv5.0 ≥ 3), arrhythmia (NCICTCAEv5.0 ≥ 2), uncontrollable atrial fibrillation (arbitrary grade) or female QTcF > 470ms or male QTcF > 450ms; 17. Cerebrovascular accidents (exclude transient ischemic attacks) occurred within 3 months before first dose; 18. Other malignant tumors, exclude cured non-melanoma skin cancer, cervical cancer in situ and prostatic intraepithelial neoplasia; 19. Other protocol specified criteria accessed by investigator. ; PRIMARY OUTCOME: Best overall response (BOR); SECONDARY OUTCOME 1: Best overall response (BOR)[/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 - CR-AIR-004; BRIEF: The purpose of this study is to determine whether the administration of a donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted stem cell transplant from a related, haploidentical donor enhances survival by improving the immune effect against infections while preventing graft-versus-host disease . ; DRUG USED: ATIR101; DRUG CLASS: Biologic; INDICATION: Bone Marrow and Stem Cell Transplant - Graft vs. Host Disease (GVHD) Prophylaxis; TARGET: Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Kiadis Pharma; CRITERIA: Inclusion Criteria: One of the following hematological malignancies: - Acute Myeloid Leukemia (AML) - Acute Lymphoblastic Leukemia (ALL) - Myelodysplastic Syndrome (MDS) - Ph-positive chronic myeloid leukemia (CML) - Non-Hodgkin Lymphoma (NHL) - Myelodysplastic Syndrome (MDS) - Chronic Myeloid Leukemia (CML) - Multiple Myeloma (MM) - Chronic Lymphocytic Leukemia (CLL) - Myeloproliferative Syndrome (MPS) Exclusion Criteria: - AML in 1st complete remission with good risk karyotypes - MM featuring concurrent extramedullar disease or being non-responsive to prior therapy - CML in blast crisis - CLL concurrently transformed into high-grade lymphoma and failing to demonstrate at least partial remission - NHL with concurrent bulky disease (≥ 5 cm) - Diffusing Capacity for Carbon Monoxide (DLCO) < 40% predicted - Left ventricular ejection fraction < 40% - AST/SGOT > 2.5 x ULN - Bilirubin > 1.5 x ULN - Creatinine > 1.5 x ULN - HIV positive - Positive pregnancy test for women of childbearing age - Prior haploidentical peripheral blood stem cell or cord blood transplantation - Less than 2 years from a prior allogeneic stem cell transplantation - Estimated probability of surviving less than three months - Major anticipated illness or organ failure incompatible with survival from transplant - Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible - Known allergy to any of the components of ATIR - Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study Donor Inclusion Criteria: - Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or DR loci of the unshared haplotype. - Male or female, age ≥ 16, ≤ 75 years. - Donors must be fit to receive G-CSF and undergo apheresis (normal blood count, normotensive and no history of stroke). - Donor must have Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. - Donor must provide written informed consent. Donor Exclusion Criteria: - Medically uncontrolled coronary heart disease. - Myocardial infarction within the last 3 months. - History of uncontrolled seizures. - History of malignancy (except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up). - Positive test result for any of the mandatory viral tests in the applicable region, except for a positive cytomegalovirus (CMV) result, which does not lead to exclusion. - Presence of a transmissible disease (such as HIV positive), a major illness, a suspected systemic dysfunction and/or an active inflammatory or autoimmune disorder. - Female donors who are pregnant or nursing. ; PRIMARY OUTCOME: Transplant Related Mortality; SECONDARY OUTCOME 1: Incidence and Severity Graft-versus-host Disease (GVHD)[/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 - Mod-Severe; BRIEF: The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis ; DRUG USED: SHR-1314; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Jiangsu HengRui Medicine Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Men or women at least 18 years of age at time of screening. 2. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization. 3. Moderate to severe psoriasis as defined at Baseline/ randomization by: PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater. 4. Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy. 5. Body Mass Index (BMI) is 18 kg/m2 or above at screening Exclusion Criteria: 1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization. 2. Drug-induced psoriasis. 3. Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0). 4. Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis. 5. History of inflammatory bowel disease or have other ongoing active autoimmune diseases. 6. At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. History of congestive heart failure (New York Heart Association [NYHA] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study. 8. Active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization. 9. History of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline (Posner K et al, 2011), The subjects will be exluded if any answer to question is yes in the questionnaire orare clinically judged by the investigator to be at risk for suicide. 10. All subjects will be tested for tuberculosis status using IGRA and X-ray test. 11. Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies. 12. Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study. ; PRIMARY OUTCOME: Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12; SECONDARY OUTCOME 1: Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12；[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DREAM-T2D; BRIEF: In Phase 1 and 2 studies already conducted, Metformin DR, with its targeted delivery to the distal small intestine, has shown the potential to be a safe and effective way to improve glycemic control in patients with T2DM and CKD with less systemic metformin exposure. The primary purpose of this Phase 3 clinical study is to collect pivotal data confirming the safety and efficacy of Metformin DR in T2DM patients with varying renal function from normal up to CKD3B. ; DRUG USED: NewMet; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK); THERAPY: Monotherapy; LEAD SPONSOR: Anji Pharma; CRITERIA: Inclusion Criteria: 1. Is male or female and at least 18 years old 2. Has body mass index 20.0 to 45.0 kg/m2 (inclusive) 3. Has T2DM 4. Has HbA1c of 7.0% to 9.5%, inclusive, at Visit 1A and HbA1c value of 7.0% to 10.5%, inclusive, at Week -2 (Visit 3/3A as applicable) 5. Has an eGFR value of ≥30 mL/min/1.73 m2 based on the CKD-EPI equation at Visit 1A and Visit 3/3A (Week -2) 6. Stable treatment with a metformin preparation or a combination product containing metformin for 8 weeks prior to Visit 1A 7. If treated with the following medications, must be on a stable regimen for a minimum of 6 weeks prior to Visit 1B 1. Drugs known to affect body weight, including prescription medications (e.g., phentermine, phentermine/topiramate, orlistat, lorcaserin, bupropion/naltrexone) and over-the-counter anti-obesity agents 2. Hormone replacement therapy (female patients) and testosterone (male patients) 3. Oral contraceptives (female patients) 4. Antihypertensive agents including ACEi/ARB 5. Lipid-lowering agents 6. Thyroid replacement therapy 7. Antidepressant agents 8. Ability to understand and willingness to adhere to protocol requirements Exclusion Criteria: 1. Is currently on dialysis, has been on any dialysis within 1 year of Visit 1B, or is expected to undergo dialysis during the study period 2. Has a history of lactic acidosis 3. Has a fasting plasma glucose (FPG) value >240 mg/dL (>13.3 mmol/L) at Week -2 (Visit 3/3A as applicable) 4. An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN at Visit 1B or Visit 3/3A (Week -2) (except in case of documented Gilberts syndrome) 5. Has a fasting plasma lactate value >2 mol at Visit 1B 6. Has a bicarbonate value ≤20 mEq/L at both Visit 1A and 1B. If bicarbonate value is <20 at Visit 3/3A or 4, patient may be excluded if the investigator considers this clinically significant 7. A history of >5% weight change within 12 weeks prior to Visit 1A 8. Has mean BP measurements >180 mmHg (systolic BP) or >100 mmHg (diastolic BP) at Visit 1A or Visit 3/3A, which can be rechecked within 1 week (Note: re-screening is allowed 6 weeks after initiation/modification of antihypertensive agents if the patient is screen failed due to BP only) 9. Oral antidiabetic agent or insulin use that is not stable for 8 weeks prior to randomization (i.e., change in oral medication dose or basal insulin dose increased or decreased by more than 20% during the 8 weeks prior to Visit 4 [Day 1]) 10. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications: 1. Prescribed metformin preparation after initiation of metformin washout following Visit 1B 2. Greater than 10 consecutive days of systemic corticosteroids by oral, intravenous, or intramuscular route within 12 weeks of Visit 1B; inhaled, intranasal, ophthalmic, topical, or intra-articular corticosteroids are not exclusionary 3. Planned use of proton pump inhibitors after Visit 2 (Week -6); such use could potentially affect the DR and PK of Metformin DR. Proton pump inhibitor treatment may be replaced by other treatment (such as H2 receptor antagonists [excluding ranitidine], or calcium carbonate antacids) prior to Visit 4 (Day 1), if appropriate per the judgment of the Investigator 4. Cationic drugs that are eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, flecainide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) within 1 week of Visit 3 (Week 2) 5. Iodinated contrast dye within 1 week prior to Visit 3 (Week -2) 6. Investigational drug within 8 weeks (or 5 half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication 7. Metformin DR or double-blind matching placebo for Metformin DR at any time prior to Visit 1B 11. Has a clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions: 1. Hepatic disease 2. Gastrointestinal disease, including but not limited to: i. History or presence of inflammatory bowel disease or other severe gastrointestinal disease, particularly those that may impact gastric emptying, such as gastroparesis and pyloric stenosis ii. Prior or expected surgical gastrointestinal procedure that may impact the gut hormonal response to study medication such as gastric bypass surgery or gastric banding surgery iii. Active diagnosis of pancreatitis c. Endocrine disorder other than T2DM or hypothyroidism on replacement therapy d. Cardiovascular disease, including history of stroke, decompensated heart failure New York Heart Association Class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty within 3 months prior to Visit 1A (screening) e. Central nervous system diseases such as epilepsy f. Psychiatric or neurological disorders that in the Investigators opinion would cause the patient to be noncompliant with study procedures g. Organ transplantation h. Chronic or acute infection requiring systemic antibiotic treatment i. Orthostatic hypotension or syncope j. Active malignancy within the past 5 years with exception of basal cell and squamous cell carcinoma 12. Known allergy or hypersensitivity to Metformin DR, Metformin IR, or placebo or any inactive component of study medication, active comparator, or placebo, unless the reaction is deemed irrelevant to the study by the Investigator (prior history of gastrointestinal intolerance to metformin is not exclusionary) 13. Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within 1 year prior to Visit 1B 14. A physical, psychological, or historical finding that, in the Investigators opinion, would make the patient unsuitable for the study 15. Any verified clinically significant abnormality identified on physical examination, laboratory tests, ECG, vital signs, or any adverse event (AE) at the time of Visit 1B through Visit 4 that, in the judgment of the Investigator or any Sub-investigator, would preclude safe completion of the study or constrains efficacy assessment 16. Currently abuses drugs or alcohol or has a known history of abuse that in the Investigators opinion would cause the patient to be noncompliant with study procedures 17. Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 8 weeks prior to Visit 1B, or is planning to donate blood or have a blood transfusion during the study 18. Prior or planned major surgery of any kind (requiring overnight hospitalization) within 6 months of Visit 1B 19. Patients insufficiently compliant with study medication during the placebo run-in phase (<85% or >115%) as assessed at Visit 4 20. Is screening for the study at more than one clinical site or is participating in any other clinical study 21. Is currently pregnant (confirmed by serum pregnancy test at Visit 1B) or breastfeeding or plans to become pregnant during the course of the study 22. Women of childbearing potential not willing to use highly effective method(s) of birth control during the entire study, or who are unwilling or unable to be tested for pregnancy 23. If the patient has evidence of coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection), the patient cannot be enrolled in the study 24. Is employed by Anji Pharma (that is an employee, contract worker, or designee of the company). ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: HbA1c response (Metformin DR vs. placebo)[/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 - 1237.22 - Long-Term Safety (Japan); BRIEF: The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD). ; DRUG USED: Stiolto Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of chronic obstructive pulmonary disease. 2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%. 3. Male or female Japanese patients, 40 years of age or older. 4. Smoking history of more than 10 pack years. Exclusion criteria: 1. Significant disease other than COPD 2. Clinically relevant abnormal lab values. 3. History of asthma. 4. Diagnosis of thyrotoxicosis 5. Diagnosis of paroxysmal tachycardia 6. History of myocardial infarction within 1 year of screening visit 7. Unstable or life-threatening cardiac arrhythmia. 8. Hospitalization for heart failure within the past year. 9. Known active tuberculosis. 10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 11. History of life-threatening pulmonary obstruction. 12. History of cystic fibrosis. 13. Clinically evident bronchiectasis. 14. History of significant alcohol or drug abuse. 15. Thoracotomy with pulmonary resection 16. Oral ß-adrenergics. 17. Oral corticosteroid medication at unstable doses 18. Regular use of daytime oxygen therapy for more than one hour per day 19. Pulmonary rehabilitation program in the six weeks prior to the screening visit 20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit 21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA 22. Pregnant or nursing women. 23. Women of childbearing potential not using a highly effective method of birth control 24. Patients who are unable to comply with pulmonary medication restrictions 25. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc. ; PRIMARY OUTCOME: Number (%) of Patients With Drug-related AEs; SECONDARY OUTCOME 1: FEV1 AUC0-3h Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - C-004-402 (India); BRIEF: This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India. The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or booster, while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals already vaccinated with BCG. ; DRUG USED: AERAS-402; DRUG CLASS: Vaccine; INDICATION: Tuberculosis; TARGET: Immune System, Tuberculosis; THERAPY: Monotherapy; LEAD SPONSOR: Aeras; CRITERIA: Inclusion Criteria: - Is male or female - Is age 18 through 45 years on Study Day 0 - Has completed written informed consent - Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar - Has general good health, confirmed by medical history and physical examination - Has Body Mass Index (BMI) between 19 and 30 (kg/m2) - Has ability to complete follow-up period of 182 days as required by the protocol - Females: Ability to avoid pregnancy from 28-days prior to initial study vaccination through the duration of their participation in the study. - Will commit to avoiding elective surgery for the duration of the study - Has ability to stay in contact with the investigative site for the duration of the study - Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol Exclusion Criteria: - Acute illness on the day of randomization - Oral temperature ≥37.5°C on the day of randomization - Evidence of significant active infection - Used immunosuppressive medication within 42 days before entry into the study - Received immunoglobulin or blood products within 42 days - Received any investigational drug therapy or vaccine within 182 days - Received any standard vaccine within 42 days - Participated in any clinical trial of an investigational adenovirus-based vaccine previously. - Current chronic drug therapy - History or laboratory evidence of any past, present or future possible immunodeficiency state which will include (but is not limited to) any laboratory indication of HIV infection - History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine - Previous medical history that may compromise the safety of the subject in the study - Evidence of a new acute illness that may compromise the safety of the subject in the study - Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other) - Inability to discontinue daily medications except contraceptives during the study period - History of alcohol or drug abuse within the past 2 years - Tobacco or cannabis smoking three or more days per week - Positive urine test for illicit drugs (opiates, cocaine, amphetamines) - History or evidence of any systemic disease on physical examination - History or evidence (including chest X-ray) of active tuberculosis - Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis - All females: Positive urine pregnancy test during screening; positive serum pregnancy test on the day of study vaccination; are nursing - Abnormal (per local laboratory parameters) hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, absolute lymphocyte count, prothrombin time (PT), partial thromboplastin time (PTT), serum creatinine, GGT, ALT, AST, total bilirubin, alkaline phosphatase (ALP), or creatinine drawn within 36 hours prior to randomization. - Laboratory test evidence of Mtb infection - Tuberculin skin test evidence of Mtb infection, defined as 15 mm of induration or greater. - Anal intercourse with another man at least one time (with or without condoms) - Exchange of goods, money, services or drugs for sex. - Use of intravenous drugs. - Sexual intercourse or genital contact within the last 12 months with a known HIV positive individual - Vaginal intercourse within the last 12 months without use of a condom with a known user of intravenous drugs - Oral to genital contact within the last 12 months with a known user of intravenous drug - Vaginal intercourse within the last 12 months without use of a condom with an individual known to have more than one sex partner - Oral to genital contact within the last 12 months with an individual known to have more than one sex partner ; PRIMARY OUTCOME: Number and Percentage of Adverse Events by treatment group; SECONDARY OUTCOME 1: Immune Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Antidepressant Effects; BRIEF: The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo. ; DRUG USED: AZD6765; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features - Females must be of non-childbearing potential. Exclusion Criteria: - Treatment with Clozapine or ECT within 3 months prior to study - Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV ; PRIMARY OUTCOME: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.; SECONDARY OUTCOME 1: The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).[/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 - RELIEF; BRIEF: The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is also designed to demonstrate that these responses are durable with continued treatment. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycythemia Vera (PV); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Subjects must currently be reporting symptoms while on a stable dose of HU monotherapy and be eligible to continue HU on study after randomization. - Before screening, the subject must have been receiving HU for at least 12 weeks AND be receiving a stable dose. - Subjects must meet baseline symptom criteria - Subjects should meet at least 1 of the following criteria: - No more than 2 phlebotomies within the 6 months before screening OR - No palpable splenomegaly. - Subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization. Exclusion Criteria: - Subjects with inadequate liver or renal function at screening. - Subjects with clinically significant infection that requires therapy - Subjects with known active hepatitis A, B, or C at screening or with known HIV positivity. - Subjects with an active malignancy over the previous 2 years - Subjects with clinically significant cardiac disease (Class III or IV). ; PRIMARY OUTCOME: Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary; SECONDARY OUTCOME 1: Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C 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 - PATENT-1; BRIEF: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH). ; DRUG USED: Adempas; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use) - Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.). Exclusion Criteria: - All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure. ; PRIMARY OUTCOME: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12; SECONDARY OUTCOME 1: Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Severe Crohns (Extension Study); BRIEF: The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab. ; DRUG USED: Brazikumab; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Male or female participants with successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008). Meets 1 of the following criteria for successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008): 1. A participant is considered to have completed the D5271C00001 (Legacy #3150-301-008) study if they have received scheduled study interventions, completed scheduled visits, and completed Week 52 assessments. 2. A participant in Study D5271C00001 (Legacy #3150-301-008) who discontinued from the study due to lack of efficacy after a minimum of 12 weeks of double-blind treatment and met criteria for the use of rescue treatment in the lead-in protocol. 2. Criterion deleted as part of Amendment. 3. Each participant must have had the ileocolonoscopic procedure at the final visit (Week 52, Week 12, or early termination after Week 12 of Study D5271C00001 (Legacy # 3150-301-008). 4. Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from signing the ICF throughout the study duration and for at least 18 weeks after last dose of study intervention. 5. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to signing the ICF without an alternative medical cause. 6. Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks. 7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 8. Written informed consent from the participant has been obtained prior to any study related procedures. 9. Legally authorized representative consent has been obtained (if applicable). 10. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. 11. Demonstration of adequate compliance with the study procedures in Study D5271C00001 (Legacy #3150 301-008) in the opinion of the investigator and/or sponsor. 12. Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study. Complete inclusion criteria are in the study protocol Exclusion Criteria: 1. Any participant with an unresolved AE from the Study D5271C00001 (Legacy #3150 301-008) that would limit the participants ability to participate in or complete this study. 2. Current diagnosis of ischemic colitis, colonic mucosal dysplasia, or primary sclerosing cholangitis. 3. Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant. 4. Any other condition or finding that, in the investigators or sponsors opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk. 5. History of cancer except for basal cell and/or squamous cell carcinoma of the skin, and carcinoma in situ of the cervix within 12 months of screening. 6. Participant meets criteria for discontinuation of study intervention during prior the D5271C00001 (Legacy #3150 301-008) study (excluding lack of efficacy). 7. Criterion deleted as part of Amendment. 8. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection. 9. Prolonged QTcF interval (QTc >450 msec or QTC >480 for participants with bundle branch block; determined by central ECG), or conditions leading to additional risk for QT prolongation (eg, congenital long-QT syndrome). 10. Clinically significant kidney disease including but not limited to: (a) Chronic kidney disease with an estimated glomerular filtration rate of less than 30 ml/min calculated by MDRD equation, as applicable, by the central laboratory at screening are excluded. 11. Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication), biological treatment, or prohibited treatment. 12. Participant received a Bacille Calmette-Guérin vaccination within 12 months of Week 0 (Visit 1) or any other live vaccine < 4 weeks prior to Week 0 (Visit 1) or is planning to receive any such vaccine over the course of the study. 13. Participant received a prohibited medication during participation in the lead-in study or during screening for this study. 14. Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5271C00002 (Legacy #3150-303-008) with the exception of registry or cohort trials. 15. Participants with a known hypersensitivity to brazikumab or any of the excipients of the product. 16. Protocol-defined abnormal laboratory results at screening. 17. Females who are pregnant, nursing, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use a highly effective method of contraception consistently and correctly. 18 Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, other study staff member, or employee of AstraZeneca, or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is enrolled in this study at another clinical study site. 19 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 20 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 21 Previous participation in the present study. Complete exclusion criteria are in the study protocol ; PRIMARY OUTCOME: Number and percentage of patients with adverse events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Healthy and Chronic Cough Subjects; BRIEF: ; DRUG USED: MK-7264; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Cough; TARGET: P2 (Purine) Receptors; THERAPY: Monotherapy; 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 - Cognitive Deficits; BRIEF: This is a double-blind, placebo-controlled 2-period 10-week treatment within-subject crossover study of neflamapimod in early-stage Huntington disease (HD). The primary objective is to determine whether neflamapimod can reverse hippocampal dysfunction in patients with early-stage HD, as assessed by the virtual water-maze-test for evaluating spatial learning and selected tests on the Cambridge Neuropsychological Test Automated Battery (CANTAB). ; DRUG USED: Neflamapimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Huntingtons Disease; TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: EIP Pharma Inc; CRITERIA: Inclusion Criteria: 1. Men and women age 30 to 70 years, inclusive. 2. Willing and able to provide informed consent. 3. Must have genetically confirmed HD and identified cognitive deficits: 1. Stage 1, as defined by Unified Huntingtons Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) score >10, and, 2. CANTAB Paired Associate Learning Total Adjusted Error Score of >16. 4. Normal or corrected eye sight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments. 5. No history of learning difficulties that may interfere with the subjects ability to complete the cognitive tests. Exclusion Criteria: 1. A profile of impairment that is not consistent with HD. 2. Diagnosis of any other ongoing central nervous system condition other than HD, including, but not limited to, vascular dementia, dementia with Lewy bodies, and Parkinsons disease. 3. Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigators opinion, at serious risk of suicide. 4. Ongoing major and active psychiatric disorder, moderate to severe depressive symptoms, and or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements. 5. Diagnosis of alcohol or drug abuse within the previous 2 years. 6. Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude treatment with p38 mitogen activated protein (MAP) kinase inhibitor and/or assessment of drug safety and efficacy. 7. Anemia with a hemoglobin ≤10 g/dL, clinically significant thyroid function abnormality, electrolyte abnormalities. 8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5. 9. Known human immunodeficiency virus; or active hepatitis B or hepatitis C virus infection; evidence of active or latent tuberculosis. 10. Subject participated in a study of an investigational drug less than 3 months or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study. 11. History of previous neurosurgery to the brain. 12. Female subjects who are pregnant or breast-feeding. 13. Male subjects with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements specified in the protocol (see Section 5.8). 14. Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy and are not willing or unable to adhere to contraceptive requirements specified in the protocol (see Section 5.8). 15. Requires concomitant use of cytochrome P450 (CYP) 3A4 inhibitors or anti-tumor necrosis factor-alpha therapies during study participation. 16. Known allergy to any ingredient of the trial medication or placebo. ; PRIMARY OUTCOME: Change in Latency During the Learning Phase of Virtual Morris Water Maze Test (vMWM); 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 - ACCL0431 (Children); BRIEF: RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss. PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy. ; DRUG USED: Pedmark; DRUG CLASS: Non-NME; INDICATION: Hearing Loss - Chemotherapy-Induced ; TARGET: Chemotherapy Agents; THERAPY: Monotherapy; LEAD SPONSOR: Childrens Oncology Group; CRITERIA: DISEASE CHARACTERISTICS: - Newly diagnosed (previously untreated or currently receiving cancer treatment for the diagnosis that made the patient eligible for this study) with germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy - Planning to receive a chemotherapy treatment regimen that includes a cumulative cisplatin dose ≥ 200 mg/m² with individual cisplatin doses to be infused over ≤ 6 hours - Enrolled on hearing assessment clinical trial COG-ACCL05C1 - Normal auditory results PATIENT CHARACTERISTICS: - Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) - Lansky PS 50-100% (for patients ≤ 16 years of age) - Serum sodium normal - Absolute granulocyte count > 1,000/mm³ - Platelet count > 100,000/mm³ - Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine between 0.4 and 1.7 mg/dL, based on age and gender - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age - AST or ALT < 2.5 times ULN for age - Not pregnant or nursing - Negative pregnancy test (if patient has child-bearing capacity) - Fertile patients must use effective contraception - No known hypersensitivity to sodium thiosulfate or other thiol agents (e.g., amifostine trihydrate, N-acetylcysteine, MESNA, or captopril) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior platinum-based chemotherapy (cisplatin or carboplatin) - Other prior chemotherapy allowed - Prior cranial radiotherapy (e.g., for treatment of medulloblastoma) allowed provided normal hearing is documented after completion of radiotherapy and before enrollment and administration of cisplatin chemotherapy - At least 6 months since prior hematopoietic stem cell transplantation. - No evidence of graft-versus-host disease - No concurrent enrollment on another COG clinical trial for treatment of the cancer. - Concurrent enrollment on a non-COG clinical trial (e.g., Head start) allowed. - Cranial irradiation after the completion of all systemic chemotherapy allowed provided post end-of-treatment audiometry is completed prior to beginning irradiation. - Concurrent radiotherapy to extracranial sites allowed. ; PRIMARY OUTCOME: Incidence of Hearing Loss; SECONDARY OUTCOME 1: Change in Hearing Thresholds For Key Frequencies at 500 hz[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 001 (Pediatric) ; BRIEF: This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks. ; DRUG USED: AR08; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Arbor Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical interview, MINI-KID, as assessed by the Investigator 2. Minimum score of 28 on the ADHD-RS-IV at Baseline 3. Male or female ages 6 - 17 years, inclusive, at the time of Screening 4. Weighs ≥21 kg (46 pounds). 5. Is functioning at age appropriate levels intellectually, as deemed by the Investigator. Exclusion Criteria: 1. Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the MINI-KID interview). 2. Has a positive response to either question 4 or 5 of the Baseline /Screening version of the pediatric Columbia Suicide Severity Rating Scale (C-SSRS) 3. History of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to Screening 4. Current usage of medications known to cause QTc prolongation or ADHD medications. ; PRIMARY OUTCOME: ADHD-RS-IV; SECONDARY OUTCOME 1: CGI-ADHD-S/I[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - GS-US-342-4022 (w/Ribavirin); BRIEF: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis. ; DRUG USED: Epclusa; 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: - A body mass index (BMI) of ≥ 18 kg/m^2 - Chronic HCV infection (≥ 6 months) as documented by either prior medical history or liver biopsy - Quantifiable HCV RNA at screening - Individuals may be non-transplanted or with recurrent HCV post-liver transplant. - If listed for liver transplant, then the projected date of transplant must be ≥12 weeks after Day1 of treatment - If post-liver transplant, then Day1 must be ≥ 6 months from date of transplant - CPT score of 10 to 12, inclusive, as determined at screening - Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC) - If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening - Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization - Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception - Females must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last - Lactating females must agree to discontinue nursing before the study drugs are administered - Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last - Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments Key Exclusion Criteria: - Current or prior history of any of the following: - Clinically significant medical or psychiatric illness or individual is currently under evaluation for a potentially clinically significant illness - Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug - Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy - Significant pulmonary disease, significant cardiac disease or porphyria - Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Adults under evaluation for possible malignancy are not eligible - Significant drug allergy (such as anaphylaxis or hepatotoxicity) - Any history of organ transplant other than liver or kidney - Chronic liver disease of a non-HCV etiology - Inability to exclude HCC by imaging within 6 months of Day 1 - Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening - Active spontaneous bacterial peritonitis at screening - Infection requiring systemic antibiotics at the time of screening - Evidence of fibrosing cholestatic hepatitis at screening - Life threatening serious adverse event (SAE) during screening - Active variceal bleeding within 6 months of screening - Prior placement of a portosystemic shunt (such as TIPS) - ECG with clinically significant abnormalities - Laboratory parameters with clinically significant abnormalities - Hepatitis B surface antigen positive at screening - Infection with human immunodeficiency virus (HIV) - Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude individuals unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator - Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor - Current use of corticosteroids at any dose >10 mg of prednisone/day (or equivalent dose of corticosteroid) - Use of any prohibited concomitant medications - Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other hematopoietic stimulating agents within 2 weeks of screening - Male with pregnant female partner - History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia) - Contraindications to RBV therapy - Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients - Participation in a clinical study with an investigational drug or biologic within 3 months prior to Day 1 NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (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 I - Healthy Volunteers; BRIEF: This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule. ; DRUG USED: Vumerity; DRUG CLASS: Non-NME; INDICATION: Multiple Sclerosis (MS); TARGET: NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) ; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: - Has a body-mass Index (BMI) >/=18.0 and </=32.0 kg/m2 - Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration - Additional criteria may apply Exclusion Criteria: - Is currently pregnant or breastfeeding - Has a lifetime history of menopausal hot flashes - Has a clinically significant medical condition - Has had a clinically significant illness in the 30 days prior to first study drug administration - Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration - Has had any vaccinations in the 4 weeks prior to inpatient admission - Has a lifetime history of diabetes - Additional criteria may apply ; PRIMARY OUTCOME: Safety and tolerability will be measured by incidence of adverse events; SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Window of Opportunity Trial; BRIEF: This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back (recurrent) who are undergoing surgery. NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells. The body produces T-cells which play an important role in bodys immune response and its ability to recognize tumor cells. This immunotherapy drug may boost bodys T-cells to help fight cancer and enhance bodys response to cancer. ; DRUG USED: HyLeukin; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: IL-7 (Interleukin-7) and IL-7 receptor (IL-7R), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Hyunseok Kang, MD; CRITERIA: Inclusion Criteria: - Patients must have histologically or cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx with recurrent disease which is amenable for curative intent surgical resection - Age >= 18 years. - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) - Absolute neutrophil count >= 1,500/microliter (mcL) - Platelets >= 100,000/mcL - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless elevated due to Gilberts syndrome and direct bilirubin is within normal limits - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =< 3 X institutional upper limit of normal - Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT) =< 3 X institutional upper limit of normal - Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for subjects with documented liver involvement or bone metastases) - Creatinine =< 1.5 x within institutional upper limit of normal OR - Creatinine clearance glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2,calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 - Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - The effects of NT-I7 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception for the duration of study participation and for 3 months after the study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately - Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation for 3 months after the study treatment Exclusion Criteria: - Had received immune check point inhibitor within 6 weeks prior to study entry OR chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry) - Has history of autoimmune disease which requires active immune suppression (steroid replacement for iatrogenic deficiencies, prednisone 5 mg or less [or equivalent dose], or topical steroids are allowed) - Is currently receiving any other investigational agents - Has uncontrolled tumor-related pain - Has uncontrolled intercurrent medical illness, including but not limited to congestive heart failure, recent acute cardiac event within 6 months, and recent major bleeding event within 6 months - Pregnant women are excluded from this study because effects of NT-I7 on developing fetus is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with NT-I7, breastfeeding should be discontinued if the mother is treated with NT-I7 - Is not recovered from adverse events (AEs) (other than alopecia, vitiligo, neuropathy or endocrinopathy managed with replacement therapy) due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1) - Had major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study initiation - Had concurrent or previous other malignancy within 5 years of study entry, except noninvasive or indolent malignancy - Has spinal cord compression not definitively treated with surgery and/or radiation - Has active autoimmune diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegeners granulomatosis, Sjogrens syndrome, Bells palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis - Has active and clinically relevant bacterial, fungal, viral, or Tuberculosis (TB) infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required) or have been hospitalized within 4 weeks prior to NT-I7 injection ; PRIMARY OUTCOME: Proportion of treatment-related adverse events; SECONDARY OUTCOME 1: Changes in Absolute lymphocyte count (ALC)[/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 - 116664; BRIEF: This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season. ; DRUG USED: FluLaval; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - A male or female 18 years of age and older at the time of the first vaccination. - Written informed consent obtained from the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Female subjects of non-childbearing potential may be enrolled in the study. - Female subjects of childbearing potential may be enrolled in the study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination, and - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. - Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period. - Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period. - Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination. - Acute disease and/or fever at the time of enrolment. - Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. - Any confirmed or suspected immunosuppressive or immunodeficient condition. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. - Insulin-dependent diabetes mellitus. - Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder. - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. - A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome. - History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. - Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible. - Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. - Any known or suspected allergy to any constituent of Fluviral® and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury. - A history of severe adverse reaction to a previous influenza vaccination. - Pregnant and/or lactating/nursing female. - Any condition which, in the opinion of the investigator, prevents the subject from participation in the study. ; PRIMARY OUTCOME: Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.; SECONDARY OUTCOME 1: Number of Subjects Reporting Any and Grade 3 Solicited Local 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 I - Japan (Solid Tumors); BRIEF: The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers. ; DRUG USED: Prexasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Cell Cycle Checkpoint Kinase 1 (Chk1), Cell Cycle Checkpoint Kinase 2 (Chk2); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed - Participant must have diagnosis of cancer that is advanced or metastatic - Participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy - If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug - If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding Exclusion Criteria: - Participant must not have symptomatic central nervous system malignancy or metastasis - Participant must not have current hematologic malignancy - Participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C - Participant must not have a serious cardiac condition ; PRIMARY OUTCOME: Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT); SECONDARY OUTCOME 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib[/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 - SHRINK ; BRIEF: SHRINK (Standard cHemotherapy Regimen and Immunotherapy with NKR-2) is an open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells administered concurrently with a standard chemotherapy treatment (FOLFOX) in potentially resectable liver metastases from colorectal cancer. The trial will test three dose levels. At each dose, the patients will receive three successive administrations, two weeks apart, NKR-2 cells. The study will enroll up to 36 patients (dose escalation and expansion phases). ; DRUG USED: CYAD-01; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Immune System, NKG2D / NKG2D Ligands, Stem Cells/Other Cell Therapies; THERAPY: Combination; LEAD SPONSOR: Celyad Oncology SA; CRITERIA: Inclusion Criteria: 1. Men or women ≥ 18 years old at the time of signing the ICF 2. Patients with histologically proven colorectal adenocarcinoma with potentially resectable liver metastases, 3. No previous chemotherapy for metastatic CRC, 4. The patient is due to receive first-line metastatic chemotherapy regimen with FOLFOX as a neoadjuvant 5. The patient must have an ECOG performance status 0 or 1 6. The patient must have sufficient bone marrow reserve, hepatic and renal functions Detailed disease specific criteria exist and can be discussed with contacts listed below Exclusion Criteria: 1. Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis 2. Patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration 3. Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent, other than the treatment authorized per protocol 4. Patients who underwent major surgery within 4 weeks before the planned day for the first treatment 5. Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder 6. Patients who have received a live vaccine within 6 weeks prior to the planned day for the first NKR 2 administration 7. Patients with a family history of congenital or hereditary immunodeficiency 8. Patients with history of any autoimmune disease ; PRIMARY OUTCOME: The occurrence of Dose Limiting Toxicities (DLT) in all patients during the study treatment until 14 days after the first NKR-2 study treatment administration; SECONDARY OUTCOME 1: The occurrence of AEs and SAEs and any toxicity corresponding to DLT definition during the study treatment until resection visit[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HESTIA3 (Pediatric); BRIEF: The purpose of the study is to Evaluate the Effect of Ticagrelor versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients with Sickle Cell Disease ; DRUG USED: Brilinta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Adenosine Diphosphate P2Y12 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of signed and dated informed consent prior to any study specific procedures not part of standard medical care (local regulations and international guidelines are to be followed in determining the assent/consent requirements for children). 2. Male or female paediatric patients aged ≥2 to <18 years and body weight of ≥12 kg (at Visit 1), diagnosed with HbSS or HbS/β0 as confirmed by high-performance liquid chromatography or haemoglobin electrophoresis. Note: Diagnosis of SCD (if not confirmed prior to screening and records available on the medical file) should be confirmed for HbSS or HbS/β0 by high-performance liquid chromatography or haemoglobin electrophoresis, performed at the sites local lab, in order to confirm the type of mutation. 3. Have experienced at least 2 VOCs (painful crisis and/or ACS) as judged by the Investigator in the past 12 months prior to Visit 1. These VOCs need to be documented in the patients medical records or in other documents that can be reconciled. 4. If ≤16 years old, must have had transcranial Doppler (TCD) within the past year prior to Visit 1. If this is not the case, a TCD examination must be done before proceeding in the study. 5. If ≥10 years old, must have had an ophthalmological examination within the past year prior to Visit 1. If this is not the case, the patient must be examined by an ophthalmologist before proceeding in the study. If local guidelines dictate ophthalmological examination at younger ages, those local guidelines should be followed. 6. If treated with hydroxyurea, the weight-adjusted dose must be stable for 3 months before screening. 7. Suitable venous access for the study-related blood sampling 8. Prior to dosing on day of randomisation (Visit 2), a negative urine (dipstick) pregnancy test performed at Screening (Visit 1) and at Visit 2 must be available for female patients of childbearing potential. 9. Females of childbearing potential (after menarche) must not become pregnant during study. Sexually active females must use a highly effective method of contraception which results in a low failure rate (ie, less than 1% per year). If use of effective contraception cannot be secured in sexually active females, the patient cannot be included in this study. Exclusion Criteria: 1. History of transient ischaemic attack (TIA) or cerebrovascular accident (ischaemic or haemorrhagic), severe head trauma, intracranial haemorrhage, intracranial neoplasm, arteriovenous malformation, aneurysm, or proliferative retinopathy. 2. Findings on TCD: Current or previous values for time averaged mean of the maximum velocity (TAMMV) that are Conditional or Abnormal. Patients with Conditional TAMMV values or higher (≥153 cm/sec using TCD imaging technique [TCDi] which is corresponding to ≥170 cm/sec by the non-imaging technique). Both the middle cerebral artery and the internal carotid artery should be considered. Any other criteria that would locally be considered as TCD indications for chronic transfusion would also exclude the patient. 3. Active pathological bleeding or increased risk of bleeding complications according to Investigator 4. Haemoglobin <6 g/dL from test performed at Screening (Visit 1) 5. Platelets <100 x 10^9/L from test performed at Screening (Visit 1) Undergoing treatment with chronic red blood cell transfusion therapy. 6. Undergoing treatment with chronic red blood cell transfusion therapy. 7. Chronic use of NSAIDs defined as continuous intake >3 days per week that cannot be discontinued 8. Receiving chronic treatment with anticoagulants or antiplatelet drugs that cannot be discontinued 9. Moderate or severe hepatic impairment defined as laboratory values of alanine aminotransferase (ALT) >2 × upper limits of normal (ULN), total bilirubin >2 × ULN (unless judged by the Investigator to be caused by haemolysis), albumin <35 g/L (3.5 g/dL) and International normalised ratio (INR) >1.4, or symptoms of liver disease (eg, ascites) from test performed at Screening (Visit 1). 10. Renal failure requiring dialysis 11. Patient considered to be at risk of bradycardic events (eg, known sick sinus syndrome or second or third degree atrioventricular block) unless already treated with a permanent pacemaker. 12. Concomitant oral or intravenous therapy with strong or moderate cytochrome P450 3A (CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers, which cannot be stopped at least 5 half-lives before randomisation. 13. Active untreated malaria. Patients with suspected malaria at Screening (Visit 1) will be tested. 14. Known hypersensitivity or contraindication to ticagrelor 15. Patients who are currently pregnant or breastfeeding, or planning to become pregnant during the study or have given birth less than 3 months prior to Screening (Visit 1) 16. Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the patient to participate in this study 17. Concern for the inability of the patient or caregiver (defined as legally authorized representative) to comply with study procedures and/or follow-up 18. Previous randomisation in the present study. 19. Participation in another clinical study with an IP or device during the last 30 days preceding screening. 20. Involvement of member of patients family, or patient self, in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). ; PRIMARY OUTCOME: Number of Vaso-Occlusive Crisis Events; SECONDARY OUTCOME 1: Number of Painful Crisis 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 I - NuTide:302; BRIEF: This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two administration schedules, either as monotherapy or as part of various combinations with agents commonly used to treat CRC (leucovorin, oxaliplatin, irinotecan, bevacizumab, cetuximab and panitumumab). The primary objective is to identify a recommended dose and schedule for NUC-3373 when combined with these agents. ; DRUG USED: NUC-3373; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Thymidylate Synthase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: NuCana plc; CRITERIA: Inclusion Criteria: All patients 1. Provision of written informed consent 2. Have histological confirmation of CRC with evidence of locally advanced/unresectable or metastatic disease 3. Age ≥18 years 4. Life expectancy of ≥12 weeks 5. ECOG Performance status 0 or 1 6. Measurable disease as defined by RECIST v1.1 7. Known RAS and BRAF status. Patients with wild-type KRAS tumours who are to be enrolled to a cohort that does not contain an EGFR pathway inhibitor (Arms 2a, 2b, 2c, 2d, 3a, 3b, 3c, 3d and 3e) must have received prior treatment with an EGFR inhibitor, unless this was not standard of care according to relevant region-specific treatment recommendations. Patients with BRAF V600E mutant tumours should have received prior treatment with encorafenib in combination with an EGFR inhibitor, unless this was not standard of care according to relevant region-specific treatment recommendations 8. Adequate bone marrow function as defined by: ANC ≥1.5×10^9/L, platelet count ≥100×10^9/L (with no evidence of bleeding), and haemoglobin ≥9 g/dL 9. Adequate liver function as defined by serum total bilirubin ≤1.5×ULN, AST and ALT ≤2.5×ULN (or ≤5×ULN if liver metastases present) 10. Adequate renal function assessed as serum creatinine <1.5×ULN or glomerular filtration rate ≥50 mL/min. This criterion does not apply to Arm 1d. 11. Serum albumin ≥3 g/dL 12. For the cohort in which the patient will participate, there are no contra-indications to receiving the approved partner combination drugs 13. Ability to comply with protocol requirements 14. Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to the first study drug administration. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy. Male patients and female patients of child-bearing potential must agree to practice true abstinence or to use two highly effective forms of contraception, one of which must be a barrier method. 15. Patients must have been advised to take measures to avoid or minimise exposure to UV light for the duration of study participation and for a period of 4 weeks following the last dose of study medication 16. Male patients receiving oxaliplatin must have been offered advice on and/or sought counselling for conservation of sperm prior to the first dose of study medication >3rd-line patients 1. Received at least two prior lines of therapy for locally advanced or metastatic CRC, including one fluoropyrimidine plus oxaliplatin and one fluoropyrimidine plus irinotecan containing regimen. Previous treatment with SoC regimens in combination with molecular targeted therapies is permitted and patients who received FOLFOXIRI-based regimens in 1st-/2nd-line settings may be included. 2. Patients due to receive NUFOX should be suitable for re-challenge with an oxaliplatin-based regimen 3. Patients due to receive NUFIRI should be suitable for re-challenge with an irinotecan-based therapy 2nd-/3rd-line patients 1. Received at least one but no more than two prior lines of fluoropyrimide-containing therapy in combination with oxaliplatin and/or irinotecan for locally advanced or metastatic CRC. Previous treatment with SoC regimens in combination with molecular targeted therapies is permitted and patients who received FOLFOXIRI-based regimens in 1st-/2nd-line settings may be included. 3rd-line patients enrolled to Arms 2c and 2d must have received prior bevacizumab treatment, unless ineligible or unless bevacizumab was not standard of care according to relevant region-specific treatment recommendations 2. Patients in Part 2 due to receive NUFOX should be suitable for re-challenge with an oxaliplatin-based regimen 3. Patients in Part 2 due to receive NUFIRI should be suitable for re-challenge with an irinotecan-based regimen Combination chemotherapy ineligible patients 1. May have received one prior fluoropyrimidine-containing regimen for locally advanced or metastatic CRC 2. Ineligible to receive combination therapy for locally advanced or metastatic CRC 3. Creatinine clearance >30mL/min Rapid progressors 1. Received no more than two prior lines of fluoropyrimidine-containing therapy in combination with oxaliplatin and/or irinotecan for locally advanced or metastatic CRC. Previous treatment with SoC regimens in combination with molecular targeted therapies is permitted and patients who received FOLFOXIRI-based regimens in 1st-/2nd-line settings may be included. 2. Have had tumour progression ≤3 months of starting the last fluoropyrimide-containing regimen 3. Patients due to receive NUFOX should be suitable for re-challenge with an oxaliplatin-based regimen 4. Patients due to receive NUFIRI should be suitable for re-challenge with an irinotecan-based regimen 2nd-line patients 1. Received one prior line of fluoropyrimidine-containing therapy in combination with oxaliplatin and/or irinotecan for locally advanced or metastatic CRC. Previous treatment with SoC regimens in combination with molecular targeted therapies is permitted and patients who received triplet chemotherapy based regimens is allowed. Maintenance patients 1. Received at least 12 weeks of 1st-line SoC therapy for locally advanced or metastatic CRC and achieved at least stable disease 2. Eligible for maintenance therapy Exclusion Criteria: All patients 1. Prior history of hypersensitivity or current contra-indications to 5-FU or capecitabine 2. Prior history of hypersensitivity or current contra-indications to any of the combination agents required for the study arm to which the patient is assigned 3. History of allergic reactions attributed to the components of the NUC-3373 drug product formulation 4. Symptomatic CNS or leptomeningeal metastases 5. Symptomatic ascites, ascites currently requiring drainage procedures or ascites requiring drainage over the prior 3 months 6. Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy [e.g. for bone pain]), immunotherapy or exposure to another investigational agent within 28 days (or five times half-life for a biological or molecular targeted agent or three times the half-life for an immunotherapy agent) of first receipt of study drug 7. Residual toxicities from prior chemotherapy or radiotherapy, which have not regressed to Grade ≤1 severity (CTCAE v5.0) except for alopecia. In cohorts not containing oxaliplatin, residual Grade 2 neuropathy is allowed. 8. History of another malignancy diagnosed within the past 5 years, with the exception of adequately treated non-melanoma skin cancer curatively treated carcinoma in situ of the cervix, surgically excised or potentially curatively treated ductal carcinoma in situ of the breast, or low grade prostate cancer or patients after prostatectomy not requiring treatment. Patients with previous invasive cancers are eligible if treatment was completed more than 3 years prior to initiating the current study treatment and there is no evidence of recurrence. 9. Presence of active bacterial or viral infection (including SARS-CoV-2, Herpes Zoster or chicken pox), known HIV positive or known active hepatitis B or C 10. Presence of any uncontrolled concurrent serious illness, medical condition or other medical history, including laboratory results, which, in the Investigators opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results 11. Any condition (e.g. known or suspected poor compliance, psychological instability, geographical location) that, in the judgment of the Investigator, may affect the patients ability to sign the informed consent and undergo study procedures 12. Currently pregnant, lactating or breastfeeding 13. QTc interval >450 milliseconds for males and >470 milliseconds for females 14. Required concomitant use of drugs known to prolong QT/QTc interval 15. Required concomitant use of strong CYP3A4 inducers or strong CYP3A4 inhibitors, or use of strong CYP3A4 inducers within 2 weeks of first receipt of study drug or use of strong CYP3A4 inhibitors within 1 week of first receipt of study drug 16. For patients receiving irinotecan: Use of strong UGT1A1 inhibitors within 1 week of first receipt of study drug 17. Has received a live vaccination within four weeks of first planned dose of study medication 18. Known DPD or TYMP mutations associated with toxicity to fluoropyrimidines 19. Use of warfarin and other types of long acting anti-coagulants is prohibited within 4 weeks of the first dose of study treatment Patients receiving bevacizumab 1. Patients with a history of haemoptysis (≥1/2 tsp of red blood) 2. Wound healing complications or surgery within 28 days of starting bevacizumab 3. Severe chronic wounds, ulcers or bone fracture 4. Arterial thromboembolic events or haemorrhage within 6 months prior to study entry (except for tumour bleeding surgically treated by tumour resection) 5. Bleeding diatheses or coagulopathy 6. Receiving full-dose anti-coagulation treatment 7. Uncontrolled hypertension 8. Clinically significant coronary heart disease or myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia 9. Severe proteinuria 10. Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhoea 11. Any contraindications present in the bevacizumab Prescribing Information Patients receiving cetuximab or panitumumab 1. Clinically significant coronary heart disease or myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia 2. Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhoea 3. Hypomagnesaemia or hypokalaemia not controlled by oral therapy 4. Any contraindications present in the cetuximab or panitumumab Prescribing Information ; PRIMARY OUTCOME: Number of patients reporting treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Tolerability of NUC-3373 in each combination cohort measured by dose intensity in Cycle 1[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - B-cell Lymphomas (w/MEDI-551); BRIEF: This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy. ; DRUG USED: MEDI0680; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: MedImmune LLC; CRITERIA: Key inclusion criteria: - Histologically confirmed aggressive diffuse large B-cell lymphoma (DLBCL), including follicular lymphoma (FL) transforming to DLBCL, transformed indolent lymphoma, mantle cell lymphoma (MCL), or Grade 3B FL for dose-escalation cohorts. Only participants with DLBCL will be enrolled in the dose-expansion cohort. - Willing to provide a fresh tumor sample - Evaluable/measurable disease with measurable disease defined as greater than or equal to (>= 1) lesion less than or equal to (<=) 20 mm in one dimension or ≥ 15 mm in 2 dimensions as measured by conventional or high-resolution (spiral) computed tomography (CT). Disease evaluable by the International Working Group criteria (Cheson et al, 2007). (NOTE: Irradiated lesions will not be evaluable.) - Baseline fludeoxyglucose positron emission tomography (FDG-PET) or FDG-PET/CT scans must show positive lesions compatible with CT-defined anatomical tumor sites. - Relapsed from or refractory to >= 2 prior chemotherapy regimens with >= 1 regimen containing rituximab or failed 1 prior rituximab-containing regimen and unable to tolerate additional multiagent chemotherapy. NOTE: Subjects enrolled in the dose-escalation portion of the study must have exhausted all available standard therapy. - At least 100 days past autologous stem cell transplant (ASCT). - At least 1 year past allogeneic stem-cell transplant (SCT) and off immunosuppression therapy, with no evidence of graft-versus-host disease. - Eastern Cooperative Oncology Group performance status 0-2. - Adequate hematological function - Adequate organ function - Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product. - Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1through 90 days after receipt of the final dose of investigational product. Key exclusion criteria: - Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer. - Receipt of any experimental therapy, mAb, cancer vaccine, chemotherapy or small molecule within 28 days prior to Cycle 1 Day 1 or 5 half-lives of that therapy, whichever is shorter. - Previous therapy directed against cluster of differentiation 19 (CD19) - Prior exposure to immunotherapy such as but not limited to other anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), anti-PD 1, or anti-PD-L1 antibodies excluding cancer vaccines. - Vaccination with a live virus within 28 days prior to receiving the first dose of study drug - History of other invasive malignancy within 2 years except for cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured. - Evidence of significant active infection requiring antimicrobial, antifungal, antiparasitic, or antiviral therapy or for which other supportive care is given unless the subject is clinically stable. - Human immunodeficiency virus (HIV) positive serology or acquired immunodeficiency syndrome (AIDS). - Active hepatitis B - Ongoing >= Grade 2 toxicities from previous cancer therapies or any unresolved > Grade 1 immune-related adverse event (irAE) event unless specifically allowed in the inclusion/exclusion criteria. - No immunosuppressive therapy within 14 days of Cycle 1 Day 1 of MEDI0680 (AMP-514) dosing. - Active or prior documented autoimmune or inflammatory disease except vitiligo. - History of primary immunodeficiency. - Major surgical procedures (as defined by the principal investigator) within 28 days of Cycle 1 Day 1 or still recovering from prior surgery. - History of tuberculosis, including those who may have completed prophylactic isoniazid (INH) therapy. - Documented current central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression. - Pregnancy or lactation. - Clinically significant abnormality on electrocardiogram (ECG). - Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, current pneumonitis, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from MEDI-551 or MEDI0680 (AMP-514), or compromise the ability of the subject to give written informed consent. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) of MEDI-551; SECONDARY OUTCOME 1: Mean Peak and Trough Concentrations of MEDI551[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - +/- Nivolumab or Cetuximab; BRIEF: The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors. ; DRUG USED: BMS-986315; DRUG CLASS: ; INDICATION: Solid Tumors; TARGET: Natural Killer Group 2A (NKG2A); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1 - Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor - Eastern cooperative oncology group performance status of 0 or 1 - Women of childbearing potential must agree to follow methods of contraception Exclusion Criteria: - Participants with active, known or suspected autoimmune disease - Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications - Uncontrolled or significant cardiovascular disease - History of or with active interstitial lung disease or pulmonary fibrosis - Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study - History of allergy or hypersensitivity to study drug components Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Incidence of adverse events (AEs); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TRUST-II (EU); BRIEF: This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only. This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohns disease. ; DRUG USED: CNDO-201; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Dr. Falk Pharma GmbH; CRITERIA: Major Inclusion Criteria: - Signed informed consent, - Man or woman between 18 and 75 years of age, - Established diagnosis of Crohns disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria, - Negative pregnancy test in females of childbearing potential. Major Exclusion Criteria: - Bowel surgery within the last 3 months prior to baseline, - Resection of more than 50 cm of the ileum, - Ileostomy or colostomy, - Septic complications, - Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture), - Abscess, perforation, fistulas, or perianal lesions, - Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus), - Clinical signs of stricturing disease, - Parenteral or tube feeding, - Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN] at screening), liver cirrhosis, or portal hypertension, - Abnormal renal function (Cystatin C > ULN) at screening, - Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patients compliance or the interpretation of the results, - Any condition associated with significant immunosuppression, - Active malignancy or treatment with anticancer drugs during the last 5 years. - Existing or intended pregnancy or breast-feeding, - Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial. ; PRIMARY OUTCOME: Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150; SECONDARY OUTCOME 1: Reduction of > 100 points in CDAI[/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 - ENDURE; BRIEF: The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients. ; DRUG USED: Nesina; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Has a diagnosis of type 2 diabetes mellitus. - Must meet one of the following: - Has been inadequately controlled on a stable daily dose of ≥1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening. - Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 - 10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose. - No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B). - Has body mass index within 23 kg/m^2 and 45 kg/m^2 unless the patient is Asian or of Asian descent, for whom the allowable body mass index will be ≥ 20 kg/m^2 and ≤ 35 kg/m^2, inclusive. - Has fasting C-peptide concentration at least 0.8 ng. - If regularly using non-excluded medications, must be on a stable dose at least 4 weeks prior to Screening/Pre-screening. - Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova from Screening throughout the duration of the study. - Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments. Exclusion Criteria: - Systolic blood pressure greater than or equal to 150 mmHg and/or diastolic pressure greater than or equal to 90. - Hemoglobin less than or equal to 12 g/dL for males and less than or equal to 10 g/dL for females at Screening Visit. - Alanine aminotransferase greater than or equal to 2.5 times the upper limit of normal at Screening Visit. - Serum creatinine greater than or equal to 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance less than 60 L/min. - Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study. - A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 years. - A history of laser treatment for diabetic retinopathy within 6 months of screening. - Treated for diabetic gastric paresis, gastric banding, or gastric bypass. - New York Heart Association Class III or IV heart failure. - History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening. - Known history of human immunodeficiency virus, hepatitis B or C. - Alcohol or substance abuse within 2 years prior to screening. - Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: - Any investigational drug within 30 days - Any investigational diabetic drug within 3 months - Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin - Prior treatment with alogliptin. - Weight-loss drugs - Oral or systemically injected glucocorticoids - A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide. - Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules). ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52; SECONDARY OUTCOME 1: Change From Baseline in Glycosylated Hemoglobin at Other Time Points[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Multi-Dose (New Zealand); BRIEF: Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel. ; DRUG USED: Xpovio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Foot and Other Ulcers; TARGET: Exportin-1/CRM1/XPO1, Immune System, Interferon-beta (IFNb), SARS-CoV-2; THERAPY: Combination; LEAD SPONSOR: Karyopharm Therapeutics Inc; CRITERIA: Inclusion Criteria: - Patient has a clinical diagnosis of Type I or Type II diabetes mellitus with an HbA1c ≤ 10.0 and has a BMI ≤40. - The DFU(s) to be treated must be: - Anatomically discrete, - Non-healing, but has persisted for ≤12 months - Measures 1 cm2 ≤ area ≤ 5 cm2 following debridement, - Has a Wagner Grade 1 (i.e., not involving bone, muscle, tendons, or ligaments), - The Target DFU is located distal to the ankle (i.e., below the malleolus), and - Is able to be adequately off-loaded. - The patient has adequate arterial blood supply in the affected limb at screening. - Patient has the inability to perceive 10 grams pressure in the peri-ulcer area and other regions of the affected foot and toes using Semmes-Weinstein 5.07 monofilament at screening. Exclusion Criteria: - Patient has a foot ulcer that is clearly of non-diabetic pathophysiology. - Patient has more than two (2) DFUs on the target lower extremity. - DFU is clinically infected. - Patient has active osteomyelitis of the foot or active, uncontrolled, connective tissue disease ; PRIMARY OUTCOME: Presence of Local Skin Reactions (LSR); SECONDARY OUTCOME 1: Ulcer Closure[/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 - C2501004; BRIEF: This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647. ; DRUG USED: PF-06826647; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: JAK/STAT , Tyrosine kinase 2 (TYK2); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female between the ages of 18 and 75 years. - Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months. - Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe). - Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA). Exclusion Criteria: - Have non-plaque forms of psoriasis. - Drug-induced psoriasis. - Current active infection. - Infected with Mycobacterium tuberculosis (TB). - Have any history of malignancies. - Require treatment with prohibited concomitant medications(s). - Positive for hepatitis B or C, or human immunodeficiency virus (HIV). ; PRIMARY OUTCOME: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period; SECONDARY OUTCOME 1: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ATMOS-1; BRIEF: The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis. ; DRUG USED: Qbrexza; DRUG CLASS: Non-NME; INDICATION: Dermatology; TARGET: Muscarinic acetylcholine receptor, Sweat gland activation; THERAPY: Monotherapy; LEAD SPONSOR: Journey Medical Corporation; CRITERIA: Inclusion Criteria: - Male or female ≥ 9 years of age. - Primary, axillary hyperhidrosis of at least 6 months duration - Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline - Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline - Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically Exclusion Criteria: - Prior surgical procedure for hyperhidrosis. - Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational). - Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1. - Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials. - Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline. - Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline. - Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months. - Other treatment with glycopyrrolate within 4 weeks prior to Baseline. - Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis. - History of Sjögrens syndrome or Sicca syndrome. - History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness. - Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy. - History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. - Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study. ; PRIMARY OUTCOME: Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4; SECONDARY OUTCOME 1: Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MOVEMENT (Open-Label Safety); BRIEF: MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks. ; DRUG USED: AXS-07; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Cyclooxygenase 2 (COX2) / Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Axsome Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Has participated in a prior study with AXS-07 for the treatment of migraine Exclusion Criteria: - Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07 - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study ; PRIMARY OUTCOME: Long-term Safety of Chronic Intermittent Use of AXS-07; 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 - ATP; BRIEF: Depression is one of the most important causes of disability in the world today, with major personal, social and economic costs. Although some moderately effective drug treatments are already available, about a third of patients with major depressive disorder (MDD) remain depressed despite current treatment. There is growing evidence that inflammation - the response of the bodys immune system to physical and social stresses - can cause depressive symptoms in some patients. It is therefore predicted that anti-inflammatory drugs could have anti-depressant effects and the research team aims to test this using a new drug, JNJ-54175446, which blocks the activity of a receptor called P2X7. P2X7 is present on many immune cells and plays a key role in the release of inflammatory molecules during stress, which may be linked to stress-related depression. The research team will recruit approximately up to 142 participants with MDD to this clinical trial. Patients will have moderate-severe depressive symptoms despite ongoing treatment with a conventional anti-depressant drug, and they will have blood test results at screening that indicate they are likely to have active P2X7 signalling in the brain. Eligible participants will be randomly allocated to receive either 50mg/day JNJ-54175446 or placebo for 8 weeks. Participants will be assessed at weeks 2, 5 and 8 using a standard clinical depression scale and the scores compared between those treated with placebo and those treated with JNJ-54175446. To understand more about the effects of JNJ-54175446 on the immune system and the brain, patients will also complete additional blood tests, questionnaires and magnetic resonance imaging (MRI) brain scans at different visits throughout the trial. The trial will be carried out across 5 centres in the UK. ; DRUG USED: JNJ-54175446; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: P2X7 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: CCTU-Core; CRITERIA: The key eligibility criteria are listed below, to obtain the full list please contact the trial team. Inclusion Criteria: 1. Provided written informed consent 2. Between the age of 18 to 60 years inclusive 3. Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0. 4. Has PHQ-9 score of ≥10. 5. BMI between 18.0 and 36.0 kg/m2 inclusive. 6. Currently being treated with one antidepressant monoaminergic drug (e.g. SSRI, SNRI, TCA) at an adequate dose, and for at least 6 weeks. 7. Must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed. 8. Agree to practice highly effective method of birth control as stated in the protocol. 9. A woman of childbearing potential must have a negative serum pregnancy test at screening. 10. Agree not to donate eggs or sperm from start of dosing and for at least 3 months after receiving the last dose of study drug. Exclusion Criteria: 1. Has a primary DSM-5 diagnosis of posttraumatic stress disorder. 2. Has failed to respond to more than 3 antidepressant treatments despite an adequate dose and duration, in the last 24 months. 3. Presence of two copies of the loss-of-function C allele at rs3751143, and/or has one copy of the loss-of-function A allele at rs1653624 in the P2RX7 gene. 4. Has a current or recent history of clinically significant suicidality. 5. Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening. 6. Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy). 7. Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder) 8. Has used: - Monoamine oxidase inhibitors (MAOIs) within 12 weeks before screening - Within 6 weeks prior to enrolment use of other antidepressant drugs not belonging to the allowed classes of SSRI, SNRI, or TCA. 9. Is currently treated with antipsychotic drugs (D2-antagonists; except for low-dose quetiapine), lithium, other mood stabilizers or opiates. 10. Unable to complete MRI scans. 11. Has current signs/symptoms of liver or renal insufficiency, diabetes mellitus (type I and II), hypothyroidism or hyperthyroidism without stable treatment, or other significant and uncontrolled medical conditions. 12. Is a woman who is pregnant or breast feeding. 13. Plans to conceive a child while enrolled in this study or within 3 months after the last dose of IMP. 14. Has a history of malignancy within 5 years before screening. 15. Has received an investigational drug/vaccines, used an invasive investigational medical device within 60 days before the planned first dose of IMP, or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in any drug or non-drug interventional study. 16. Venous blood concentration of C-reactive protein, measured by high sensitivity assay (hs-CRP) less than 1 mg/L. 17. Has had major surgery, (i.e. requiring general anaesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time they are expected to participate in the study. ; PRIMARY OUTCOME: Change from baseline in total score on the MADRS scale at week 8; SECONDARY OUTCOME 1: Change from baseline in total score on the MADRS scale[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - GENA-21b; BRIEF: The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data. ; DRUG USED: Nuwiq; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Octapharma; CRITERIA: Inclusion Criteria: - Severe Haemophilia A (FVIII:C < 1%) - Male patients >= 18 years of age - Previous treatment with a FVIII concentrate for at least 150 EDs - Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start - Immunocompetence (CD4+ count > 200/uL) Exclusion Criteria: - Any coagulation disorder other than Haemophilia A - Present of past FVIII inhibitor activity - Severe liver or kidney disease ; PRIMARY OUTCOME: Annualized Total Bleeding Rate of Individually Tailored Prophylaxis; SECONDARY OUTCOME 1: Annualized Spontaneous Bleeding Rate of Individually Tailored Prophylaxis[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Indian; BRIEF: The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis. ; DRUG USED: Prolia (Osteoporosis); DRUG CLASS: Biologic; INDICATION: Osteoporosis / Osteopenia; TARGET: RANK Ligand (RANKL); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Ambulatory Indian postmenopausal women with osteoporosis - greater than 5 years postmenopausal - aged 55 to 75 years old - absolute bone mineral density value consistent with a T-score less than -2.5 and greater than - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than or equal to -4.0 are at very high risk for fracture and will be excluded. Exclusion Criteria: - previous or current metabolic bone disease, Pagets or Cushings disease, or hyperprolactinemia - current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria - rheumatoid arthritis - cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal - medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates - medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists - malignancy within 5 years except certain resected types - malabsorption syndrome or gastrointestinal disorders associated with malabsorption - abnormal calcium level - vitamin D deficiency - any laboratory abnormality that will prevent the subject from completing the study or interferes with interpretation of study results - oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery - any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures - any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results - known to have tested positive for HIV - less than two lumbar vertebrae evaluable for DXA measurements - height, weight, or girth that may preclude accurate DXA measurements - drug or alcohol abuse within 12 months that interferes with understanding or completing the study - known sensitivity to mammalian cell-derived drug products - use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s) ; PRIMARY OUTCOME: Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6; SECONDARY OUTCOME 1: Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I (Vancouver Coastal Health); BRIEF: This is a single centre, open label, phase I dose escalation trial using a modified accelerated titration design. Patients with superficial bladder tumour (Ta or T1) or CIS and candidates for transurethral resection or muscle invasive disease (>T2) and candidates for radical cystectomy will be enrolled. OGX-427 will be given neoadjuvantly over 8 days, followed by a transurethral resection (for superficial disease) or radical cystectomy (for muscle invasive disease). Baseline Hsp27 levels will be determined from pre-treatment cytological samples from bladder washings and tumour biopsies performed prior to therapy. Post-treatment PK and PD data will be determined from TUR (for Ta, T1 tumours) or radical cystectomy (for T2 tumours) specimens. A recommended phase II dose will be determined from the toxicity, tissue pK, and percentage of Hsp27 knockdown. Effects of treatment on Hsp27 client protein levels and apoptotic index will also be evaluated. Evaluation during protocol treatment will take place to assess toxicity. Assessments will occur on various visits as per Evaluation Schedule. Adverse event evaluation based on NCI CTCAEv3.0. For quality of life assessment during treatment, the EORTC QLC-BLS24 will be used before first treatment (day 1) and prior to surgery (TURBT or radical cystectomy). The Day 1 QOL assessment will serve as baseline. After removal from protocol treatment, all subjects will be followed for toxicity related to study drug for 30 days. After the study, subjects will be followed according to standard of care. Follow-up for tumour recurrence or superficial tumours will be assessed every three months by cystoscopic examination for two years, then every six months for the next two years, and then yearly thereafter. ; DRUG USED: Apatorsen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: Heat Shock Protein 27 (HSP27); THERAPY: Monotherapy; LEAD SPONSOR: Vancouver Coastal Health; CRITERIA: Inclusion Criteria: 1. Patient age must be > 18 2. Histologic evidence of bladder cancer (superficial or muscle invasive) or CIS as evidenced by: - Patients presenting with superficial tumours and unknown pathological stage will have in-clinic bladder washings (performed cystoscopically) and biopsy (cup biopsy). - Patients with recurrent superficial disease (Ta or T1) and tissue that is available for baseline studies (i.e. tissue from previous transurethral resection stored in paraffin blocks) will be eligible for trial without requiring cytology or biopsy. - Patients with previously diagnosed T1 tumours and requiring re-resection of bladder tumour will be eligible if tissue from the original TURBT is available for baseline studies. - Patients presenting as muscle invasive (>T2) disease will be eligible if they are candidates for radical cystectomy and if baseline tissue from initial resections is available for baseline studies 3. No intravesical therapies within the previous 6 months 4. No evidence of metastatic disease as determined by physical exam, CT scan or chest- x-ray, where indicated. 5. ECOG status must be 0, 1, or 2 6. Laboratory requirements (within 7 days of treatment): - negative urine cultures - Absolute neutrophils count> 1.5 x 109 cells/L, and platelets count> 100 x 109/L, - Total bilirubin < 1.5 x upper normal limit (ULN), AST and/or ALT < 1.5 x ULN, alkaline phosphatase < 1.5 x ULN, and serum creatinine < 1.5 x ULN. - PTT and INR, within normal limits 7. Patient must be able to complete the quality of life questionnaires in either English or French 8. Patients must provide written informed consent. Exclusion Criteria: 1. Patients with indeterminate or negative results from biopsy or cytology will be ineligible for the trial. 2. Patients taking warfarin or Coumadin anticoagulation therapy or who have a bleeding disorder. NOTE: Patients who require anticoagulation therapy while on study will be removed from study treatment. 3. Pregnant or lactating women 4. Patients not accessible for follow-up 5. Patients with an active urinary tract infection, upper tract urothelial tumors, active infection including tuberculosis, concurrent febrile illness or impaired immune response from any cause 6. Patients with contraindication to spinal or general anesthesia required for a transurethral resection or radical cystectomy 7. Recent (<14 days) urethral trauma or inability to perform catheterization or cystoscopy safely 8. Patients known to have a serious illness or medical condition that would impair protocol treatment delivery. ; PRIMARY OUTCOME: To define the maximum tolerated dose (MTD) of OGX-427 administered as an intravesical instillation.; SECONDARY OUTCOME 1: To determine the toxicity profile of OGX-427 when administered intravesically.[/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 - Single Dose PK/PD; BRIEF: This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will be used to assess the fed condition. ; DRUG USED: Doptelet; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thrombocytopenia; TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria 1. Platelet count between the lower limit of normal and 350 x 109/L, inclusive, at Screening and each Baseline; measurements can repeated for verification, if necessary 2. Nonsmoking, healthy white and Japanese adult male and female subjects, greater than or equal to 20 years and less than or equal to 55 years old at the time of informed consent. (Nonsmokers are defined as those who have discontinued smoking for at least 4 weeks before dosing.) 3. Japanese subjects must be born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan. 4. Body mass index greater than or equal to 18 and less than or equal to 28 kg/m2 at Screening and Baseline Period 1. The BMI in white subjects must be within +/- 2 kg/m2 of the BMI in Japanese subjects. 5. Nonsmoking, healthy white and Japanese adult males and females between the ages of 20 and 55, inclusive 6. BMI between 18 and 28. inclusive 7. Females must not be pregnant or lactating, and if they are of childbearing potential they must agree to use a highly effective method of contraception or abstain 8. Males must have a vasectomy or they and their partner must use a highly effective method of contraception Exclusion Criteria 1. Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history (eg, history of splenectomy); history of arterial or venous thrombosis, including partial or complete thromboses (eg, stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, pulmonary embolism); known family history of hereditary thrombophilic disorders (eg, Factor V Leiden, antithrombin III deficiency) 2. Recent clinically significant illness or infection that requires medical treatment 3. Evidence of disease that may influence the outcome of the study (eg, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system), or subjects who have a congenital abnormality in metabolism 4. Any history of gastrointestinal surgery (eg, hepatectomy, nephrotomy, digestive organ resection) 5. Any clinically abnormal symptom or organ impairment found by medical history, physical examination, vital sign electrocardiogram (ECG) assessment, or laboratory test results 6. A known or suspected history of drug or alcohol dependency or abuse or a positive urine drug, cotinine, or alcohol test 7. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at Screening 8. Weight loss or gain of >10% within 4 weeks before dosing 9. Known history of clinically significant drug or food allergy 10. Currently enrolled in another clinical trial ; PRIMARY OUTCOME: Pharmacokinetic (PK) profiles of avatrombopag; SECONDARY OUTCOME 1: Pharmacodynamic (PD) profiles of avatrombopag[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Post-Cardiac Surgery Sternal Infection; BRIEF: This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized controlled study. ; DRUG USED: D-PLEX; DRUG CLASS: Non-NME; INDICATION: Bone and Joint Infections (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: PolyPid Ltd.; CRITERIA: Inclusion Criteria: 1. Male or non-pregnant female above 18 years old 2. Female of childbearing potential should have a negative serum pregnancy test prior to index procedure. Note: All female of childbearing potential must agree to use a highly effective method of contraception (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study. 3. Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically. 4. Subjects with (20≤BMI≤40) 5. Subjects who sign a written informed consent. Exclusion Criteria: 1. Received any investigational drug within 30 days of start of study or within 5½ half-lives (pharmacokinetic or pharmacodynamics) prior to enrollment (whichever is longer). 2. Are ineligible to receive treatment with: - Any preoperative active significant infection - Antibiotic sensitivity to Doxycycline and/or tetracycline family of drugs - Known allergies to more than 3 substances.(Patients should fill the allergy questioners during the enrolment process) - History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic / hypersensitivity reactions. - History of uncontrolled Asthma (GINA III-IV) - History of chronic urticaria 3. Pregnant or breastfeeding women. 4. Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening. 5. Subjects who undergo cardiac/open chest surgeries, which are classified as emergency. 6. Immunocompromised subjects from any reason, at screening. 7. Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment. 8. Subjects that previously underwent any cardiac surgery through mid-sternum. 9. In the opinion of investigator, subject is not eligible to participate in the study due to a cognitive status, medical condition or medication status (other than items listed above) ; PRIMARY OUTCOME: Sternal Infection identified within 90 days post-cardiac surgery. Primary sternal infection as measured by the proportion of subjects with at least 1 identified primary sternal infection within 90 days post-cardiac surgery.; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Lupus Arthritis; BRIEF: This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis. ; DRUG USED: Prezalumab; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Cluster of Differentiation 28 (CD28) /ICOS and B7RP-1 Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria - Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening; - Other inclusion criteria may apply. Exclusion Criteria: - Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years - Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE - Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies - Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening - Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study - Other exclusion criteria may apply ; PRIMARY OUTCOME: Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.; SECONDARY OUTCOME 1: Proportion of subjects achieving a) one letter improvement; and b) C or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.[/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 - ROAD; BRIEF: Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora. The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis. ; DRUG USED: Rifaximin EIR; DRUG CLASS: Non-NME; INDICATION: Diverticular Disease; TARGET: RNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Alfasigma S.p.A.; CRITERIA: Key Inclusion Criteria: - Men and women aged 18-80 years at screening. - Female participants must be either of non-childbearing potential or of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception. - A previous documented episode of diverticulitis between 30 and 180 days prior to screening. - Clinical remission from acute diverticulitis at screening Key Exclusion Criteria: - History of two or more acute diverticulitis episodes or history of any diverticular complication. - Any documented current organic disease of the gastrointestinal tract other than diverticulosis - Laboratory signs of clinically significant acute inflammation or signs/symptoms of diverticular complications. - Diagnosis or history of inflammatory bowel disease (or other conditions associated with ulcerative lesions of the intestinal tract). - Patients with positive Clostridium difficile toxin stool assay. - Use of marketed rifaximin (or neomycin or other low-absorbable oral antibiotics) during or after the previous episode of acute diverticulitis. - Severe hepatic impairment - Severe kidney impairment - Any other current significant health condition that in the Investigators judgement may: i) jeopardize the patients safe participation in the trial or ii) make unlikely the patients completion of the study or iii) make unlikely the patients compliance with the study procedures. - History of hypersensitivity to rifaximin, rifamycin-derivatives or any of the rifaximin delayed release or placebo excipients. NOTE: Other protocol defined Inclusion/Exclusion criteria apply ; PRIMARY OUTCOME: Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.; SECONDARY OUTCOME 1: Rate of patients with an acute episode of prolonged (≥24 hours) left-lower quadrant abdominal pain plus leukocytosis/elevation of CRP [Time Frame: 12-month treatment period][/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EXPEDITION-5; BRIEF: This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Male or female (of non-childbearing potential or using allowed contraceptive methods) at least 18 years of age time of Screening - Participant had a positive anti-hepatitis C virus (HCV) antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at the Screening Visit. - Participant had an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method at Screening according to the following formula: eGFR (mL/min/1.73 m^2 ) = 175 × (Serum Creatinine) ^-1.154 × Age^-0.203 × (0.742 if female) × (1.212 if black), or were dialysis dependent. Subjects requiring dialysis had to have been receiving dialysis for at least 1 month prior to enrollment, and may have been on hemodialysis or peritoneal dialysis. - Cirrhotic participants only: absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Participants who had an ultrasound with results suspicious of HCC followed by a subsequent negative CT or MRI of the liver were eligible for the study. Exclusion Criteria: - Female participants who were pregnant, breastfeeding, or were considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug - Current hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection on screening tests, defined as: - Positive test result at Screening for hepatitis B surface antigen (HBsAg), or; - HBV deoxyribonucleic acid (DNA) greater than lower limit of quantification (LLOQ) in participants with isolated positive hepatitis B core antibody (HBcAb), (i.e., negative HBsAg and Anti-HBsAg), or; - Positive anti-HIV antibody (Ab). - Any current or historical clinical evidence of decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding; radiographic evidence of small ascites; or prior or current empiric use of lactulose/rifaximin for neurologic indications. Prophylactic use of beta blockers was not exclusionary. - Clinical history of acute renal failure in the 3 months prior to Screening - History of severe, life-threatening, or other significant sensitivity to any excipients of the study drugs - Clinically significant abnormalities or co-morbidities, or recent (within 6 months prior to study drug administration) alcohol or drug abuse that could preclude adherence to the protocol in the opinion of the investigator - Receipt of any investigational or commercially available direct acting anti-HCV agents other than sofosbuvir ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-treatment Virologic Failure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - 15266; BRIEF: The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage IV). The study will also investigate how the body processes the combination treatment and how the study drug affects the body. The study will also collect disease-related symptoms and participant-reported pain related to NSCLC. ; DRUG USED: Verzenio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - For all Parts: The participant must have stage IV non-small cell lung cancer (NSCLC). - For Part A (abemaciclib + pemetrexed): Non-squamous subtypes only. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC. - For Part B (abemaciclib + gemcitabine): Any subtype. The participant must have received at least one but not more than three prior therapies for advanced/metastatic NSCLC. - For Part C (abemaciclib + ramucirumab): Any subtype. The participant must have received at least two but not more than three prior therapies for advanced/metastatic NSCLC. - For Part D (abemaciclib + LY3023414): Any subtype. The participant must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide 3-kinase (PI3K) or mammalian target of rapamycin (mTOR) inhibitor. - For Part E (abemaciclib + pembrolizumab): Any subtype. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC. - Have either measureable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). - Have adequate organ function including: - Hematologic: Absolute neutrophil count (ANC) 1.5 x 109/liter (L), platelets 100 x 109/L, and hemoglobin 8 gram/deciliter (g/dL). - Hepatic: Bilirubin 1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) 3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling ≤5.0 times ULN are acceptable. Alkaline phosphatase ≤5.0 times ULN for participants with tumor involvement of the bone is acceptable. - Renal: Serum creatinine 1.5 times ULN. - Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale. - Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia. - Male and female participants of reproductive potential must agree to use medically approved contraceptive precautions during the trial and 3 to 4 months (as appropriate) following last dose of study drug. - Have an estimated life expectancy of ≥12 weeks. - Are able to swallow oral medications. Exclusion Criteria: - Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment are eligible. - Parts A, B, D and E: Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug. - Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years. - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 3 to 4 months after the last dose of trial treatment (as appropriate). - Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment. - Parts A, B, C, and E: Have QTc interval of > 470 millisecond (msec) on screening electrocardiogram (ECG). Part D participants have QTc interval of >450msec on screening ECG. Additional Exclusion Criteria For Part C - History or evidence of cardiovascular risk including any of the following: - History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment. - History or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association. - Treatment refractory hypertension defined as a blood pressure of systolic >140 millimeter of mercury (mmHg) and/or diastolic >90 mmHg which cannot be controlled by antihypertensive therapy. - Participants with intracardiac defibrillators. - History or evidence of CNS disease. Radiographic screening of all participants without history of CNS metastasis is required. - Radiographically documented evidence of major vessel invasion or encasement by cancer. - Uncontrolled thromboembolic or hemorrhagic disorders. - Participants receiving daily treatment with aspirin >325mg/day or other known inhibitors of platelet function. - History of gross hemoptysis within 2 months of study entry. - Evidence of nonhealing wounds, ulcers, or bone fractures within 28 days prior to study entry. - Undergone major surgery within 28 days prior to first dose of study drug or have subcutaneous venous access device placement within 7 days prior to first dose. Additional Exclusion Criteria For Part D - Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus. - Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetic agents as documented by hemoglobin A1c (HbA1c) <7%. - History or evidence of cardiovascular risk including any of the following -- History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment. Additional Exclusion Criteria for Part E - Received prior monoclonal antibody (mAb) within 4 weeks prior to study. - Has active autoimmune disease that has required treatment in the past 2 years. - Has history of interstitial lung disease or pneumonitis. ; PRIMARY OUTCOME: Number of Participants With Dose-Limiting Toxicities (DLT) or DLT-equivalent in Part A, B, C, D and E; SECONDARY OUTCOME 1: Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) in Part A, B, C, D and E[/INST]Yes</s>

<s>[INST]<<SYS>>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 - INCB 106385-102; BRIEF: This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) ; DRUG USED: INCB106385; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Adenosine A2a Receptor, Adenosine A2b Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Ability to comprehend and willingness to sign an ICF. - Willing and able to conform to and comply with all Protocol requirements. - Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable). - Willingness to undergo pre- and on-treatment tumor biopsy. - Have CD8 T-cell-positive tumors. - Presence of measurable disease according to RECIST v1.1. - ECOG performance status 0 to 1. - Life expectancy > 12 weeks. - Willingness to avoid pregnancy or fathering children based. - Acceptable laboratory parameters Exclusion Criteria: - Clinically significant cardiac disease. - Known or active CNS metastases and/or carcinomatous meningitis. - Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease.. - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment. - Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment. - Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment. - Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. - Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage. - Any prior chemotherapy, biological therapy, or targeted therapy to treat the participants disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. - Any prior radiation therapy within 28 days before the first dose of study treatment. - Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. - Concomitant treatment with strong CYP3A4 inhibitors or inducers. - Receipt of a live vaccine within 30 days of the first dose of study treatment. - Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment. - Evidence of HBV or HCV infection or risk of reactivation. - Known history of HIV (HIV 1/2 antibodies). - History of organ transplant, including allogeneic stem-cell transplantation. - Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components. - Presence of a gastrointestinal condition that may affect drug absorption. - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study. - Any condition that would, in the investigators judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data ; PRIMARY OUTCOME: Number of treatment-emergent adverse events (TEAE); SECONDARY OUTCOME 1: Cmax of INCB106385 as a single agent or in combination with INCMGA00012[/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/Cisplatin/Gemcitabine; BRIEF: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer. ; DRUG USED: Cyramza; DRUG CLASS: Biologic; INDICATION: Biliary Tract Cancer; TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have an Eastern Cooperative Oncology Group performance status of 0 or 1. - Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) . - Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST). - Have adequate biliary drainage. - Have adequate organ function. - Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method. - Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose. - Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations. Exclusion Criteria: - Previous systemic therapy for locally advanced or metastatic disease is not allowed. - Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade >1, or cirrhosis with Child-Pugh Stage B or higher. - Have ongoing or recent (≤6 months) hepatorenal syndrome. - Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization. - Anticipate having a major surgical procedure during the course of the study. - Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression. - Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. - Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical management. - Have a previous malignancy within 5 years of study entry or a concurrent malignancy. - Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. - Have a known allergy or hypersensitivity reaction to any of the treatment components. - Have a history of uncontrolled hereditary or acquired thrombotic disorder. - Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain. - Have mixed hepatocellular biliary tract cancer histology. - Have a corrected QT interval >470 milliseconds as calculated by the Fridericia equation. ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/MK-8669/MK-2206/MK-0752; BRIEF: This is an open-label, two-part study to evaluate the safety and tolerability of combination treatment with dalotuzumab + MK-2206, dalotuzumab + MK-0752, or dalotuzumab + ridaforolimus (MK-8669). Part 1 of the study will determine the dose-limiting toxicities (DLTs) observed after administration of each of the combinations at various doses and define the maximum tolerated dose (MTD) of each combination. Part 2 of the study will assess preliminary anti-tumor activity of these combinations (at MTD) in two groups of participants with selected tumor biomarkers: one group with metastatic or recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer and one group with metastatic or recurrent colorectal cancer. The dalotuzumab + ridaforolimus and dalotuzumab + MK-2206 arms will be enriched with female platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer participants. The dalotuzumab + MK-0752 arm will be enriched with metastatic or recurrent wild-type kirsten rat sarcoma (KRAS) colorectal cancer participants. The primary hypothesis is that the DLTs observed in adult patients with locally advanced or metastatic solid tumors after administration of each of the MK-MK doublets will be dose-dependent to allow for definition of a MTD within each MK-MK doublet. ; DRUG USED: Dalotuzumab; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Participants must not have any medical conditions that may impact compliance with the protocol, limit interpretation of study results, or pose an unacceptable medical risk. - Participant must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (EGOG) Performance Scale. - Participant is able to swallow capsules and has no condition that will preclude swallowing and absorbing oral medications on an ongoing basis. - Participant has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with prostatic specific antigen (PSA) < 1.0; or has undergone potentially curative therapy with no evidence of that disease for five years, or is deemed at low risk for recurrence by his/her treating physician. - Participant has at least one measurable metastatic or recurrent lesion according to Response Criteria in Solid Tumors (RECIST). Part 1: - Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. There is no limit on the number of prior treatment regimens. Part 2: - A female participant assigned to the dalotuzumab + MK-2206 or dalotuzumab + ridaforolimus treatment arms must have histologically-confirmed metastatic or recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. Participants may have received any number of prior treatment regimens. - A participant assigned to the dalotuzumab + MK-0752 treatment arms must have histologically-confirmed metastatic or recurrent wild-type KRAS colorectal cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. Participants may have received any number of prior treatment regimens. - Participant agrees to provide archival tumor tissue sample or undergo biopsy for analysis of gene expression levels. Exclusion Criteria: - Participant has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas or mitomycin C) or who has not recovered from adverse events due to agents administered more than 4 weeks earlier, or major surgery <4 weeks earlier. - Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with a monoclonal antibody will be eligible to participate after a 28 day washout period. - Participants with known central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded. - Participant has significant or uncontrolled cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a myocardial infarction within the last 6 months. - Participant is known to have diabetes that is poorly controlled. - Participant is pregnant, breastfeeding, or expecting to conceive or father children during the study. - Participant is known to be human immunodeficiency virus (HIV)-positive. - Participant has active Hepatitis B or C infection. - Participant has symptomatic ascites or pleural effusion. - Participant requires treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for at least two weeks prior to the first dose of study drug. - Participant requires treatment with medication(s) that strongly or moderately induce or inhibit cytochrome P450. - Participant is using growth hormone or growth hormone inhibitors. - Participant requires treatment with therapeutic warfarin. ; PRIMARY OUTCOME: Number of Participants With Dose-limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Number of Participants Whose Best Response is a Partial Response (PR) or Complete Response (CR)[/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 - Imaging; BRIEF: This is an open label study designed to evaluate the biodistribution and imaging characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types. ; DRUG USED: ABT-806; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Subject has a solid tumor of a type likely or known to either overexpress wild-type Epidermal Growth Factor Receptor (EGFR) or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, Non-small Cell Lung Carcinoma (NSCLC), and colorectal carcinoma). - Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent. - Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage. - Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. - Subject must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with at least 1 extrahepatic 2 cm lesion. Exclusion Criteria: - Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 14 days prior to the first dose of ABT-806i. - Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806i. - Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher. - Subject has had major surgery within 21 days prior to the first dose of ABT-806i. - Subject has a clinically significant uncontrolled condition(s) including but not limited to the following: - Active uncontrolled infection - Symptomatic congestive heart failure - Unstable angina pectoris or cardiac arrhythmia - Psychiatric illness/social situation that would limit compliance with the study requirements ; PRIMARY OUTCOME: Single-Photon Emission Computerized Tomography (SPECT); SECONDARY OUTCOME 1: Pharmacokinetic profile evaluation - Cohort 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/III - MAGELLAN; BRIEF: The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder. ; DRUG USED: Hetlioz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Melatonin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria; - Current episode ≥4 weeks and ≤1 year; - CGI-Severity score ≥4 at screening and baseline. Exclusion Criteria: - Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder; - Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder; - A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months; - Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable; - Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D); 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 - GRACE; BRIEF: This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance and/or uncontrolled hypertension ; DRUG USED: Relacorilant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cushings Syndrome; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Corcept Therapeutics; CRITERIA: Inclusion Criteria: - Has a confirmed diagnosis of endogenous Cushing syndrome - Meets at least one of the following criteria: - Has Type 2 diabetes mellitus - Has impaired glucose tolerance - Has hypertension Exclusion Criteria: - Has non-endogenous source of hypercortisolemia - Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism - Has poorly controlled hypertension - Has poorly controlled diabetes mellitus - Has severe renal insufficiency ; PRIMARY OUTCOME: In patients with hypertension, the proportion of patients with a loss of response with respect to hypertension from visit OL22 to RW12; SECONDARY OUTCOME 1: In patients with diabetes mellitus/impaired glucose tolerance (DM/IGT), the mean change in area under the curve for glucose from Week OL22 to Week RW12 as compared between relacorilant and placebo[/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 - VELIA (w/Carboplatin/paclitaxel); BRIEF: The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with chemotherapy alone. ; DRUG USED: Veliparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation. 2. High-grade serous adenocarcinoma 3. Willing to undergo testing for gBRCA. 4. Adequate hematologic, renal, and hepatic function. 5. Neuropathy (sensory and motor) less than or equal to Grade 1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment. 8. Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms. 9. Participant has one of the following available for pharmacodynamic analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1. Exclusion Criteria: 1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenners tumor. 2. Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions. 3. Participants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocols therapy. 4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis. 5. Received prior chemotherapy for any abdominal or pelvic tumor. 6. Clinically significant uncontrolled condition(s). 7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug. 8. History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day 1. ; PRIMARY OUTCOME: Progression-Free Survival (PFS) in the BRCA-deficient Population; 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 I - 200207; BRIEF: The proposed study, 200207 is a double blind, placebo controlled, single and repeat dose escalation study to investigate the safety, tolerability and PK of GSK2838232 alone and when co-administered with RTV 100 milligram (mg) Once daily (QD). This study will enable future clinical development of GSK2838232 in healthy subjects and in a Phase IIa proof of concept study in Human Immunodeficiency Virus (HIV) infected patients. This study is a single and repeat dose escalation study and will be conducted as two Parts. Part A will evaluate GSK2838232 20 mg and 50 mg administered QD for 8 days and Part B will evaluate GSK2838232 10 mg, 20 mg, and 50 mg, co-administered with RTV 100 mg, QD for 11 days. The extended period of dosing is to account for the longer terminal phase half-life of GSK2838232 when given with RTV. Dose cohorts will be enrolled sequentially; enrollment into a cohort will commence following review of interim PK and safety data from at least 4 subjects in the preceding cohort. Subjects in both parts will have a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation will be approximately 7 weeks. Approximately 40 healthy subjects will be enrolled, 8 subjects/cohort. Subjects will be randomized 3:1 to receive GSK2838232 or placebo. ; DRUG USED: GSK2838232; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Gag protein; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Between 18 and 55 years of age inclusive, at the time of signing the informed consent - Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - A Creatinine clearance (CLcr) >80 millilitre per minute (mL/min) as determined by Cockcroft-Gault equation where age is in years, weight (Wt) is in kg, and serum creatinine (Scr) is in units of milligram / decilitre (mg/dL); CLcr (mL/min) = (140 - age) * Wt / (72 * Scr) (times 0.85 if female). - Body weight >= 50 kilogram (kg [110 pounds {lbs}]) for men and >= 45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kilogram per meter square kg/m^2 (inclusive) - Male or Female; Female subject of non-reproductive potential : is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy; 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) must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until one week after the last dose of study medication. a) Vasectomy with documentation of azoospermia, b) Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label, Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label, Oral Contraceptive, either combined or progestogen alone Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Exclusion Criteria: - Alanine aminotransferase and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones) - Subjects who have asthma or a history of asthma. - Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome. - Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, subjects with presence of hepatitis B core antibody (HBcAb) should also be excluded. - Screening or baseline cardiac troponin I greater than the 99% cutoff (>.045 nanogram/ milliliter [ng/mL] by the Dimension Vista Cardiac troponin assay). - A positive pre-study drug/alcohol screen. - A positive test for HIV antibody. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Exclusion Criteria for 24-Hour Screening Holter: Any symptomatic arrhythmia (except isolated extra systoles), Sustained cardiac arrhythmias (such as atrial fibrillation or flutter, supraventricular tachycardia (>=10 consecutive beats), complete heart block). Non-sustained or sustained ventricular tachycardia (defined as >= 3 consecutive ventricular ectopic beats). Any conduction abnormality (including but not specific to left or right incomplete or complete bundle branch block, atrioventricular (AV) block [2nd degree or higher], Wolff-Parkinson-White [WPW] syndrome etc.). Sinus Pauses > 3 seconds. 300 or more supraventricular ectopic beats in 24 hours. 250 or more ventricular ectopic beats in 24 hours. - Any clinically significant abnormal echocardiogram finding. Abnormal echocardiogram findings should be discussed with the Medical Monitor prior to enrolment. - Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate <45 and >100 beats per minute (bpm) (Males); <50 and >100 bpm (Males); For both Males and Females: PR Interval <120 and >220 msec, QRS duration <70 and >120 millisecond (msec); QTc interval (Fridericias) >450 msec. Notes: A heart rate from 100 to 110 bpm can be rechecked by ECG or vitals within 30 minutes to verify eligibility. Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], WPW syndrome). Sinus Pauses > 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator or GlaxoSmithKline medical monitor, will interfere with the safety for the individual subject. Non-sustained or sustained ventricular tachycardia (>= 3 consecutive ventricular ectopic beats). ; PRIMARY OUTCOME: Adverse events (AEs) assessments; SECONDARY OUTCOME 1: Composite pharmacokinetic profile of GSK2838232 to dose proportionality with and without RTV[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II/III - Children (6 Months to 11 Years Old); BRIEF: This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated. ; DRUG USED: Comirnaty; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: BioNTech SE; CRITERIA: Inclusion Criteria 1. Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and <16 years of age. 2. Participants parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 4. Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation. 5. Negative urine pregnancy test for female participants who are biologically capable of having children. 6. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 7. The participant or participants parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written). Exclusion Criteria 1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19. 2. Phase 1 only: Known infection with HIV, HCV, or HBV. 3. Receipt of medications intended to prevent COVID-19. 4. Previous or current diagnosis of MIS-C. 5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigators judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results 6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 8. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted. 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 10. Female who is pregnant or breastfeeding. 11. Previous vaccination with any coronavirus vaccine. 12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study. 14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. 15. Previous participation in other studies involving study intervention containing LNPs. 16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. ; PRIMARY OUTCOME: Percentage of participants in Phase 1 reporting local reactions; SECONDARY OUTCOME 1: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1218.40 (OLE); BRIEF: The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study) ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Signed and dated written informed consent in accordance with the GCP and local legislation. 2. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication. Exclusion criteria: 1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial. 2. Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who: - are nursing or pregnant, - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made. 3. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation. 4. Drug abuse which, in the opinion of the investigator, would interfere with trial participation. 5. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication. ; PRIMARY OUTCOME: Frequency of Patients With Adverse Events (AEs); SECONDARY OUTCOME 1: Change in HbA1c From Baseline to Week 6[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1301.4 (1301.1 Extension Study); BRIEF: The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult patients with moderately to severely active rheumatoid arthritis (RA) who have successfully completed treatment in Trial 1301.1. ; DRUG USED: Biosimilar Rituximab (Boehringer Ingelheim); DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Must give written informed consent and be willing to follow this Clinical Trial Protocol. 2. Male or female patients, with moderately to severely active RA who have previously participated in the double-blind randomized clinical Trial 1301.1. 3. Current treatment for RA on an outpatient basis: 1. Patients must continue to receive and tolerate oral or parenteral methotrexate (MTX) therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose). 2. Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or folinic acid (at least 1 mg per week or as per local practice) or equivalent during the entire trial. 3. If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent. During the 4 weeks prior to Baseline (Day 1) the dose must remain stable. 4. Intra-articular and parenteral corticosteroids are not permitted throughout the trial, with the exception of IV administration of 100 mg methylprednisolone 30 to 60 minutes prior to each infusion as part of the trial procedures. 5. Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable throughout the trial. 6. Patients may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day, or chloroquine provided that the dose is not greater than 250 mg/day. These doses must have been stable for a minimum of 12 weeks prior to Day 1. The hydroxychloroquine or chloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the trial. 4. For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial, i.e., a combination of 2 forms of effective contraception (defined as hormonal contraception, intrauterine device, condom with spermicide, etc.). Females of childbearing potential must also agree to use an acceptable method of contraception (see above) for 12 months following completion or discontinuation from the trial medication. Exclusion criteria: 1. Patients receiving current treatment with corticosteroids must not be receiving a dose exceeding 10 mg/day prednisone or equivalent. 2. Serious underlying medical conditions, which, per the investigator¿s discretion, could impair the ability of the patient to participate in the trial (including but not limited to ongoing severe infection, severe immunosuppression, severe heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). 3. Pregnancy or breast feeding. For women of childbearing potential, a positive serum pregnancy test at the Screening Visit. 4. Patients who have significant cardiac disease, including but not limited to congestive heart failure of Class III or IV of the New York Heart Association (NYHA) classification; uncontrolled angina or arrhythmia; any uncontrolled or severe cardiovascular or cerebrovascular disease; or uncontrolled hypertension. 5. Treatment with IV or intramuscular corticosteroids. The only exception will be the administration of 100 mg IV methylprednisolone 30 to 60 minutes before each infusion as part of the trial procedures. 6. Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial. 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times upper limit of normal (ULN). 8. Hemoglobin <8.0 g/dL. 9. Levels of Immunoglobulin G(IgG) <5.0 g/L. 10. Absolute neutrophil count <1500/µL. 11. Platelet count <75000/µL. ; PRIMARY OUTCOME: The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase; SECONDARY OUTCOME 1: Change From Baseline in Clinical Trial 1301.1 in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 48 of Clinical Trial 1301.4[/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 III - SELECT; BRIEF: Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH. ; DRUG USED: Uptravi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Actelion; CRITERIA: Main Inclusion Criteria: - Signed and dated informed consent form - Male and female participants from greater than or equal to (>) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and less then or equal to (<=85) years old at Screening (Visit 1) - With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee - With pulmonary hypertension (PH) in WHO FC I-IV. - Participant able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit. - Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization. Main Exclusion Criteria: - Planned or current treatment with another investigational treatment up to 3 months prior to randomization. - Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. - Known concomitant life-threatening disease with a life expectancy < 12 months. - Planned balloon pulmonary angioplasty within 26 weeks after randomization. - Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort - Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag) within 90 days prior to randomization (visit 2) except those given at vasodilator testing during RHC - Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed) - Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc). - Any other criteria as per selexipag Summary of Product Characteristics (SmPC). - Exclusion criteria related to comorbidities: severe coronary heart disease or unstable angina as assessed by the investigator; mocardial infarction within the last 6 months prior to or during Screening; decompensated cardiac failure if not under close supervision; severe arrhythmias as assessed by the investigator; cerebrovascular events (example transient ischemic attack, stroke) within the last 3 months prior to or during screening; congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. (PH); known or suspicion of pulmonary veno-occlusive disease ; PRIMARY OUTCOME: Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20; 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 IIa - H03_04TP (Kenya); BRIEF: The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic. ; DRUG USED: GVGH 1790GAHB Vaccine; DRUG CLASS: Vaccine; INDICATION: Antibacterial and Antifungal - Miscellaneous Vaccines and Treatments; TARGET: Immune System, Shigella; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: 1. Individuals ≥18 years to ≤45 years of age on the day of informed consent who are resident in the study area and are not planning to leave during the study period. 2. Individuals who, after the nature of the study has been explained, have voluntarily given written consent according to local regulatory requirements, prior to study entry. 3. Individuals who can comply with study procedures including follow-up. 4. Individuals in good health as determined by the outcome of medical history, physical examination, hematology, renal function, and liver function tests, urine dipstick/urinalysis and the clinical judgment of the investigator. 5. Males Or Females of childbearing potential who are using an effective birth control method which they intend to use for the duration of the study Or Females without childbearing potential (i.e. irrespective of birth control method) Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations. Exclusion Criteria: 1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subjects ability to participate in the study. 2. Individuals with any progressive or severe neurological disorder, seizure disorder or previous Guillain-Barré syndrome. 3. Individuals who, in the judgment of the investigator, may not be able to comply with all the required study procedures. 4. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 5. Individuals with history of reactive arthritis. 6. Individuals with known HIV or hepatitis B virus infection or HIV related disease, history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system. Individuals under systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to screening. 7. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 8. Individuals with a neutrophil count lower than 1.8 x 10^9/L (applicable to the initial 18 subjects) or lower than 1.0 x 10^9/L (applicable to the additional subjects if approved by DSMB) at screening 9. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, Type 2 diabetes mellitus, hypertension, cardiac, renal or hepatic disease and tuberculosis). 10. Individuals who have any malignancy or lymphoproliferative disorder. 11. Individuals with history of allergy to vaccines components or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial. 12. Individuals participating in any clinical trial with another investigational product within 28 days prior to the screening study visit or intent to participate in another clinical study at any time during the conduct of this study. 13. Individuals who received vaccines containing meningococcal A, C, W, Y or tetanus, diphtheria or pertussis antigens within 12 months before screening, or any other vaccines within 4 weeks prior to screening in this study or who are planning to receive any vaccine within the entire study duration. 14. Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the 12 weeks prior to the first dose of the study vaccine. 15. Individuals who are study personnel or immediate family members (parents, children, spouse and brothers/sisters) to the personnel conducting this study. 16. Individuals with body temperature > 38.0°C within 3 days of intended study vaccination is a reason for delay of vaccination 17. Individuals with Body Mass Index (BMI)> 30 kg/m^2 18. Individuals with history of substance or alcohol abuse within the past 2 years. 19. Women who are pregnant or are breast-feeding, or are of childbearing age who have not used (for the two months preceding the 1st vaccination) and are not willing to use acceptable contraceptive measures, for the duration of the study. If subjects are women of childbearing potential, they must have a negative pregnancy test at screening visit and prior to enrollment (visit 1). For the purposes of this study acceptable methods of contraception are oral, injected or implantable contraceptives. 20. Individuals who have a previously laboratory confirmed case of disease caused by S. sonnei. 21. Any condition which, in the opinion of the investigator, may pose an increased and unreasonable safety risk to the subject if they participated in the study. 22. Individuals with a previous history of Benign Ethnic Neutropenia or drug related neutropenia. 23. Individuals who have or are likely to require concomitant treatment with neutropenic agents. ; PRIMARY OUTCOME: Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination; SECONDARY OUTCOME 1: Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - C-Early Extension (RA0055B); BRIEF: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1. ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Combination; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1 Exclusion Criteria: - Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1 ; PRIMARY OUTCOME: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring; SECONDARY OUTCOME 1: Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK/PD; BRIEF: This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage. ; DRUG USED: APG-2575; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Monotherapy; LEAD SPONSOR: Ascentage Pharma Group Inc.; CRITERIA: Inclusion Criteria: 1. Age ≥18 years old. 2. Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, and non-Hodgkins lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid leukemia 3. Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In addition, a. AML Patients will be eligible if they have failed standard induction regimen, are not considered candidate for further chemotherapy or stem cell transplantation or have primary refractory AML. 4. Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation ; 0-2 in dose expansion. 6. QTc interval ≤450ms in males, and ≤470ms in females. 7. Adequate bone marrow function independent of growth factor: 8. Absolute neutrophil count (ANC) ≥1.0 X 109/L. 9. Hemoglobin ≥ 8.0 g/dL. 10. Platelets count ≥ 30 X 109/L (entry platelet count must be independent of transfusion within 7 days of first dose). 11. Adequate renal and liver function as indicated by: Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study: 1. Prior history of allogeneic cell transplant. 2. Subjects have been diagnosed with Burkitts lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia. 3. Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to entering the study. 4. Received biologic (< 28 days), small molecule targeted therapies (< 5 half-life) or other anti-cancer therapy within 21 days of study entry. 5. Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. 6. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator. 7. Has known active central nervous system (CNS) involvement. 8. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy. 9. Concurrent treatment with an investigational agent, 14 days for small molecular agents and/or 28 days for biologics treatment prior to the first dose of therapy. 10. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry. 11. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry. 12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation. 13. Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV disease. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); 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 - ACRobat (Israel, Europe, Canada); BRIEF: This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis will relieve signs and symptoms of the disease. CF101 effect will be in comparison to MTX in this study population. ; DRUG USED: Piclidenoson; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: Adenosine A3 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Can-Fite BioPharma; CRITERIA: Inclusion Criteria: 1. Males and females ages 18-75 years. 2. Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al. Arthritis Rheum 1988;31:315-324, Appendix 1). 3. Not bed- or wheelchair-bound. 4. Active RA, as indicated by EULAR Disease Activity Score (Fransen, vanRiel, 2005, DAS28, 2015) (DAS28) >3.2. 5. Demonstrate at least 6 swollen and at least 6 tender joints. 6. If taking an NSAID, dose has been stable for at least 1 month prior to the Screening Visit, and will remain unchanged during protocol participation. 7. If taking an oral corticosteroid, dose is <10 mg/day prednisone or equivalent, has been stable for at least 1 month prior to the Screening Visit, and will remain unchanged during protocol participation. 8. In the Investigators opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol. 9. Negative Screening serum pregnancy test for female subjects of childbearing potential. 10. Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method). 11. All aspects of the protocol explained and written informed consent obtained. Exclusion Criteria: 1. Prior receipt of MTX. 2. Prior receipt of >1 regimen of synthetic small-molecule DMARDs. 3. Receipt of any non-MTX synthetic small-molecule DMARDs (including but not limited to sulfasalazine, chloroquine/hydroxychloroquine, azathioprine, and/or leflunomide) for at least 1 month prior to the Screening Visit or concomitantly during the trial. 4. Receipt of tofacitinib at any time during the 4-week period prior to the Screening Visit or concomitantly during the trial. 5. Receipt of a biologic anti-rheumatic agent (including, but not limited to, etanercept, abatacept, infliximab, golimumab, adalimumab, tocilizumab, certolizumab, and rituximab) at any time prior to or concomitantly during the trial. 6. Levels of rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibody that are both >3 times the upper limit of the laboratory normal value at the Screening Visit. 7. Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the Screening Visit. 8. Participation in a previous trial CF101 trial. 9. Presence or history of uncontrolled arterial hypertension or symptomatic hypotension. 10. Heart disease which is, in the Investigators judgment, clinically significant or unstable, including coronary artery disease, congestive heart failure, uncontrolled arrhythmia, or other significant findings on Screening electrocardiogram (ECG). 11. Clinical laboratory abnormalities at the Screening Visit as follows: 1. Hemoglobin level <9.0 gm/dL 2. Platelet count <125,000/mm3 3. White blood cell (WBC) count <3000/mm3 4. Serum creatinine level outside the central laboratorys normal limits 5. Liver aminotransferase (ALT and/or AST) levels greater than 2 times the central laboratorys upper limit of normal. 12. Known or suspected immunodeficiency or human immunodeficiency virus positivity. 13. Pregnancy, lactation, or inadequate contraception as judged by the Investigator. 14. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening. 15. Active drug or alcohol dependence. 16. History of malignancy within the past 2 years (excluding excised basal or squamous cell carcinoma of the skin). 17. Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subjects ability to complete the study, and/or compromise the objectives of the study. ; PRIMARY OUTCOME: Efficacy of oral CF101, BID for 12 weeks to subjects with active rheumatoid arthritis (RA) relative to oral methotrexate (MTX) as assessed by the proportion of subjects achieving a Disease Activity Score (DAS) of Low Disease Activity (LDA); SECONDARY OUTCOME 1: Determine the efficacy of oral CF101 when administered daily for 24 weeks to subjects with active RA relative to oral MTX, as assessed by the proportion of subjects achieving DAS remission[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - PROTI; BRIEF: This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreichs ataxia. The objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment (placebo or idebenone) they received during the randomised phase of the trial, and identify any potential changes on symptoms or activities. ; DRUG USED: Catena; DRUG CLASS: New Molecular Entity (NME); INDICATION: Friedreichs Ataxia; TARGET: Mitochondrial Electron Transport Chain, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Santhera Pharmaceuticals; CRITERIA: Inclusion Criteria: - Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study - Patients who in the opinion of the investigator are able to comply with the requirements of the study - Body weight ≥ 25kg - Negative urine pregnancy test Exclusion Criteria: - AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone - Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine - Parallel participation in another clinical drug trial - Pregnancy or breast-feeding - Abuse of drugs or alcohol - Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study ; PRIMARY OUTCOME: Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone; SECONDARY OUTCOME 1: Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study. ; DRUG USED: Cotempla XR-ODT; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Neos Therapeutics, Inc; CRITERIA: Inclusion Criteria: - Currently being treated for ADHD Exclusion Criteria: - Other psychiatric diagnoses - Significant cognitive impairment - Chronic medical illnesses - Structural cardiac defects - Significant abnormal lab tests - Taking disallowed medications - Positive drug test ; PRIMARY OUTCOME: Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score; SECONDARY OUTCOME 1: Onset of Effect[/INST]Yes</s>

<s>[INST]<<SYS>>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 - JKB-122AIH; BRIEF: This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly. ; DRUG USED: JKB-122; DRUG CLASS: Non-NME; INDICATION: Autoimmune Hepatitis; TARGET: Toll-like receptor 4 (TLR4); THERAPY: Monotherapy; LEAD SPONSOR: TaiwanJ Pharmaceuticals Co., Ltd; CRITERIA: Inclusion Criteria: - Has definite or probable AIH diagnosis. - Has had a liver biopsy or Fibroscan™ within 3 years and the severity of hepatic dysfunction is limited to the following: - Metavir Stage 0 to stage 3 fibrosis (according to liver biopsy) or Fibroscan™ results - ALT and AST values not exceeding 10x ULN - Normal bilirubin and prothrombin time (PT/INR) - Has elevated liver test results (ALT) at least 1.25 x ULN and not exceeding 10 x ULN at baseline. - Has had a failed response, incomplete response, intolerant, ineligible or unwilling to take current immunosuppressive therapies. Current immunosuppressive therapy is defined as prednisone or other steroids with or without azathioprine. Exclusion Criteria: - Has history of allergy to JKB-122 or related compounds - Has human immunodeficiency virus (HIV) or is hepatitis B virus or hepatitis C virus (HCV) positive - Has positive urine drug screen at Screening - Has been diagnosed with other overlapping liver diseases such as primary biliary cirrhosis (PBC) or primary sclerosing cholangitis (PSC) - Is currently consuming alcoholic drinks greater than 25g/day and within 3 months prior to the first screening visit. - Is being treated with any prescription narcotic drug (including transdermal delivery systems) - Concurrent medications within 30 days prior to screening: - Opioids - Thioridazine - Silymarin and related medications - Potentially hepatotoxic drugs - Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold - Has unstable and uncontrollable hypertension (>180/110 mmHg) or a blood pressure reading at baseline of 150/90 mmHg on 2 occasions separated by a 30 minute interval - Is currently receiving dietary supplements other than a multivitamin to treat AIH - Has received other investigational agents within 90 days prior to the first screening visit - Has impaired renal function - Has malignancy. - If female, pregnant or lactating - Has history of gastroesophageal varices, ascites, hepatic encephalopathy, hepatocellular carcinoma, and s/p liver transplantation ; PRIMARY OUTCOME: Changes in ALT in AIH subjects given daily doses of JKB-122; 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 - 005 (SHaRCS); BRIEF: The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL). ; DRUG USED: NB-001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Herpes Simplex Virus (HSV) (Antiviral); TARGET: Herpes Simplex Virus (HSV); THERAPY: Monotherapy; LEAD SPONSOR: NanoBio Corporation; CRITERIA: Inclusion Criteria: - A healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigators discretion) be included in the study. - Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months; - Have the majority of their cold sore recurrences preceded by a well defined history of prodromal symptoms. Exclusion Criteria: - Subjects with severe chronic illness - Received (within the last 6 months) or receiving chemotherapy; - Significant skin disease on the face - Previously received herpes vaccine; - Active alcohol or drug abuse; - Prior randomization into any NanoBio study; - Known allergies to topical creams, ointments or other topical medications. ; PRIMARY OUTCOME: Time of Healing of the primary lesion complex; SECONDARY OUTCOME 1: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - B014; BRIEF: The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in HIV patients who have never received treatment for their HIV, who have not been taking highly active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their current first or second HAART regimen for at least 12 weeks. ; DRUG USED: Z-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Zeria Pharmaceutical; CRITERIA: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV positive but do not show symptoms. - Are male or female, 18 years or older. - Have not received treatment for HIV. - Have received treatment but have discontinued HAART for at least 8 weeks prior to screening, have had stable viral loads on at least 2 separate time points at least 1 month apart including screening, and have had stable CD4 levels on at least 2 separate time points at least 1 month apart including screening. - Use birth control while on the study and during the follow-up period. - Have viral loads of 2,000 to 55,000 copies/ml within 2 weeks of randomization. - Have CD4 counts of greater than 350 cells/mm within 2 weeks of randomization. - Have a negative serum pregnancy test within 2 weeks of randomization (women able to have children). Exclusion Criteria Patients will not be eligible for this study if they: - Have failed HAART treatment. - Have opportunistic infection or cancer. - Have a history of tuberculosis. - Have very abnormal laboratory test results. - Have heart, liver, kidney or nervous system conditions. - Have serious problems digesting and absorbing food or have serious long-term diarrhea within 4 - weeks of randomization. - Have received radiation (localized is allowed) or chemotherapy within 30 days before randomization. - Have seizure disorders that cannot be controlled. - Have received any other drugs that affect the immune system or experimental drugs within 60 days before randomization. - Have had any vaccination within 15 days before randomization. - Have a mental condition which makes the patient unable to understand what the study is about and what it involves. - Have a history of alcohol or drug abuse, unless the investigator feels that it will not interfere with participation in the protocol. - Are pregnant or breast-feeding. - Have a history of being very sensitive to the study drug or similar drugs. ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CA224-061; BRIEF: The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy. ; DRUG USED: BMS-986213; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Immune System, LAG3 (Lymphocyte-Activation Gene)/CD223, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery - Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen - Available tumor tissue for biomarker analysis Exclusion Criteria: - Must not have squamous cell or undifferentiated GC or GEJ - Untreated known central nervous system (CNS) metastases - Uncontrolled or significant cardiovascular disease Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: Overall response rate (ORR); SECONDARY OUTCOME 1: Incidence of 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 III - Long-Term Extension; BRIEF: The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352). (Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor). - Must agree to use a reliable method of birth control. Exclusion Criteria: - Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered. - Have a known hypersensitivity to ixekizumab or any component of this investigational product. - Had investigational product permanently discontinued during a previous ixekizumab study. - Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participants participation in the study. - Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol. - Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. ; PRIMARY OUTCOME: Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment); SECONDARY OUTCOME 1: Percentage of Participants Who do Not Experience a Flare[/INST]Yes</s>

<s>[INST]<<SYS>>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 - NX03-0040; BRIEF: This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy. ; DRUG USED: Fexapotide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Apoptosis (Cell Death), Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Nymox Corporation; CRITERIA: Inclusion Criteria: - T1c prostate cancer - Gleason score ≤ 6 with no Gleason pattern of 4 or 5. - Life expectancy ≥ 5 years. - Single positive prostate biopsy core with ≤ 50% cancer - PSA ≤ 10 ng/mL Exclusion Criteria: - Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer. - Evidence of metastatic disease or previous positive bone scan. - Previous hormonal therapy for prostate cancer. - Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics. - Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months. - Pelvic irradiation. - Urinary tract infection more than once in the past 12 months. - Acute or chronic prostatitis in the past 12 months. - Clinically significant renal or hepatic impairment. - Bleeding disorder. - Poorly controlled diabetes type 1 or type 2. - Urinary retention in the previous 12 months. - Self-catheterization for urinary retention. - Post-void residual urine volume > 200 mL. - Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula. - History of alcohol or substance abuse or dependence within the past 2 years. ; PRIMARY OUTCOME: Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.; SECONDARY OUTCOME 1: Change in tumor grade in the region of the baseline 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 - Children/Adolescents (HoFH); BRIEF: Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment in children and adolescents with homozygous familial hypercholesterolemia (hoFH) of 8 to 17 years of age on top of background treatments. Secondary Objectives: - To evaluate the efficacy of alirocumab after 24 and 48 weeks of treatment on LDL-C levels. - To evaluate the effects of alirocumab on other lipid parameters (eg, apolipoprotein B [Apo B], non-high density lipoprotein cholesterol [non-HDL-C], total cholesterol [Total-C], high density lipoprotein cholesterol [HDL-C], lipoprotein a [Lp (a)], triglycerides [TG], apolipoprotein A-1 [Apo A-1] levels) after 12, 24, and 48 weeks of treatment. - To evaluate the safety and tolerability of alirocumab up to 48 weeks of treatment. ; DRUG USED: Praluent; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Participants genetically diagnosed with hoFH. - Participants treated with optimal dose of statin +/- other lipid modifying therapies (LMTs), or non-statin LMTs if statin-intolerant at stable dose(s) for at least 4 weeks. - A signed informed consent indicating parental permission with or without participants assent. - For participants on apheresis, currently undergoing stable LDL apheresis therapy prior to the screening visit (Week -2) and had initiated apheresis treatment for at least 6 months. Exclusion criteria: - Participants with LDL-C <130 milligram per deciliter [mg/dL] (3.37 millimoles per liter [mmol/L]) obtained during the screening period after the participant had been on stable apheresis procedure or LMT (i.e., stable optimal dose of statin ± other stable LMTs, or stable non statin LMTs in statin-intolerant participants) treatment for at least 4 weeks. - Participants with BW <25 kg. - Participants aged 8 to 9 years not at Tanner Stage 1 and participants aged of 10 to 17 years not at least at Tanner Stage 2 in their development. - Participants with uncontrolled Type 1 or 2 diabetes mellitus. - Participants with known uncontrolled thyroid disease. - Participants with uncontrolled hypertension. - Participants who will receive statin de novo during the run-in period. - Fasting triglycerides greater than (>) 350 mg/dL (3.95 mmol/L) at the screening visit. - Severe renal impairment (i.e., estimated glomerular filtration rate <30 milliliter per minute/1.73 meter square) at the screening visit. - Alanine aminotransferase or aspartate aminotransferase >2 * upper limit of normal (ULN) at the screening visit. - Creatine phosphokinase >3 * ULN at the screening visit. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12: Intent-to-Treat (ITT) Analysis; SECONDARY OUTCOME 1: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12: On-treatment Analysis[/INST]Yes</s>

<s>[INST]<<SYS>>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/SAR245408; BRIEF: Primary Objective: - To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors. Secondary Objectives: - To characterize the global safety profile of SAR245408 in combination with SAR256212 - To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination - To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only) - To determine the immunogenicity of SAR256212 as administered with SAR245408 ; DRUG USED: Seribantumab; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: ErbB3/HER3; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Metastatic or locally advanced nonhematological cancer, for which no alternative therapy is available - Written informed consent - For dose expansion only: - Patients tumor harbors activating mutations in phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) - Tissue from archived sample - Measurable and evaluable disease Exclusion criteria: - Patient less than 18 years old - ECOG (Eastern Cooperative Oncology Group) performance status >2 - Any serious active disease or comorbid condition, which, in the opinion of the Investigator, could interfere with the safety of the patient or the ability of the patient to comply with the study, or with the interpretation of the results - Poor bone marrow reserve as defined by absolute neutrophils count <1.5 x 109/L or platelets <100 x 109/L - Poor organ function as defined by 1 of the following: - Total bilirubin >1.5 x ULN (upper limit of normal) - AST (aspartate aminotransferase) and/or ALT (alanine aminotransferase) >2.5 x ULN - Serum creatinine >1.5 x ULN and/or creatinine clearance <60 mL/min - PT/ (INR) (prothrombin time) (International Normalized Ratio) and/or partial thromboplastin time (PTT) test results ≥1.3 ULN - Pregnant or breast-feeding women - No use of effective birth control methods, when applicable - No resolution of all specific toxicities (excluding alopecia) related to any prior anticancer therapy to Grade ≤1 according to the NCI common terminology criteria for adverse events (CTCAE) v.4.0 - Any of the following within 6 months prior to enrollment: myocardial infarction, severe/unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (Grade 3/4) - Baseline corrected QT interval (QTc) >460 ms. - NYHA Class III (New York Heart Association) or IV congestive heart failure or LVEF (left ventricular ejection fraction) < the lower limit of normal (LLN) for institution - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including cytomegalovirus, Epstein-Barr virus, toxoplasmosis, and hepatitis B and C, positive for the human immunodeficiency virus (HIV), hypertension, or uncontrolled diabetes. - Previous treatment with a selective PI3K inhibitor (phosphoinositide-3-kinase, catalytic, alpha polypeptide), mTOR (mechanistic target of rapamycin) inhibitor, or AKT inhibitor (v-akt murine thymoma viral oncogene homolog 1) - Known hypersensitivity to the investigational medicinal product(s) or to its excipients, or patient who has had hypersensitivity reactions to fully human monoclonal antibodies - Cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (antibodies, immune modulators, cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks, before the first dose of study treatment - Prior radiation therapy within 2 weeks before the first dose of study treatment - Prior major surgery from which the patient has not recovered or stabilized - Any other investigational therapy within 4 weeks prior to the first dose of study treatment - Brain tumor or brain metastasis are considered eligible if the patient has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks - Ongoing anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤1 mg/day is permitted). - HBA1C (hemoglobin A1c) >7 or any patient requiring medication for glycemic control The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Maximum tolerated dose; SECONDARY OUTCOME 1: Peak and trough levels of SAR256212 and SAR245408[/INST]Yes</s>