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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ENCHANTED; BRIEF: ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study addressing questions (2) and (4) concluded with a publication of the results in February 2019. ; DRUG USED: Activase; DRUG CLASS: Biologic; INDICATION: Ischemic Stroke; TARGET: Fibrin (Coagulation Factor Ia) , Plasminogen, Tissue Plasminogen Activator (TPA); THERAPY: Monotherapy; LEAD SPONSOR: The George Institute; CRITERIA: Inclusion Criteria: - Adult (age ≥18 years) - A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging - Able to receive treatment within 4.5 hours after the definite time of onset of symptoms - Have a systolic BP ≤185 mmHg - Provide informed consent (or via an appropriate proxy, according to local requirements) Specific criteria for arm [A] of low-dose vs standard-dose rtPA (Recruitment completed in August 2015.): - Able to receive either low-dose or standard-dose rtPA Specific criteria for arm [B] of intensive BP lowering vs guideline recommended BP control - Patient will or has received thrombolysis treatment with rtPA, either randomised dose within the trial or physician decided dose rtPA outside of the trial - Sustained elevated systolic BP level, defined as 2 readings ≥ 150 mmHg - Able to commence intensive BP lowering treatment within 6 hours of stroke onset - Able to receive either immediate intensive BP lowering or conservative BP management Exclusion Criteria: - Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset. - Other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mRS scores 2-5)]. - Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to be used. - Participation in another clinical trial involving evaluation of pharmacological agents. - Need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors. ; PRIMARY OUTCOME: Combined death and disability; SECONDARY OUTCOME 1: Symptomatic intracerebral hemorrhage[/INST]Yes</s>

<s>[INST]<<SYS>>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 - ATHOS-3; BRIEF: This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally. ; DRUG USED: Giapreza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypotension/Shock; TARGET: Angiotensin II Receptor Type 1 (AT1), Angiotensin II Receptor Type 2 (AT2); THERAPY: Monotherapy; LEAD SPONSOR: La Jolla Pharmaceutical Company; CRITERIA: Inclusion Criteria: 1. Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of > 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg. 2. Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study. 3. Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study. 4. Patients must have received at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period, and be adequately volume resuscitated in the opinion of the treating investigator. 5. Patients must have clinical features of high-output shock by meeting one of the following criteria. 1. Central venous oxygen saturation (ScvO2) > 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) > 8 mmHg. OR 2. Cardiac Index (CI) > 2.3 L/min/1.73 m2. Patient must meet 5a or 5b to be eligible. 6. Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements. Exclusion Criteria: 1. Patients who are < 18 years of age. 2. Any patient with burns covering > 20% of total body surface area (TBSA). 3. Patients with a Cardiovascular (CV) SOFA score ≤ 3. 4. Patients diagnosed with acute occlusive coronary syndrome requiring intervention. 5. Patients on veno-arterial (VA) ECMO. 6. Patients who have been on ECMO for less than 12 hours. 7. Patients in liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥ 30. 8. Patients with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators, if not mechanically ventilated. 9. Patients with acute mesenteric ischemia or a history of mesenteric ischemic. 10. Patients with a history of, presence of, or highly-suspected of having an aortic dissection or abdominal aortic aneurysm. 11. Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose. 12. Patients with Raynauds phenomenon, systemic sclerosis or vasospastic disease. 13. Patients with an expected lifespan of < 12 hours. 14. Patients with active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of > 4 units of packed red blood cells. 15. Patients with active bleeding AND hemoglobin < 7g/dL or any other condition that would contraindicate serial blood sampling. 16. Patients with an absolute neutrophil count (ANC) of < 1000 cells/mm3. 17. Patients with a known allergy to mannitol. 18. Patients who are current participating in another interventional clinical trial. 19. Patients who are known to be pregnant at the time of Screening. ; PRIMARY OUTCOME: An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP; 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 - OMC-SXB-7 ext. (Canada); BRIEF: This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner. ; DRUG USED: Xyrem; DRUG CLASS: New Molecular Entity (NME); INDICATION: Narcolepsy; TARGET: GABA Receptors, GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial - Signed and dated an informed consent ; PRIMARY OUTCOME: Adverse Experiences; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - DIAN-TU (Washington University); BRIEF: The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimers disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers. ; DRUG USED: E2814; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: Washington University School of Medicine; CRITERIA: Inclusion Criteria: - Between 18-80 years of age - Individuals who know they have an Alzheimers disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimers disease (DIAD) mutation in their family. - Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset. For Cognitive Run-In (CRI): includes participants who are younger than 15 years prior to the expected age of cognitive symptom onset, in addition to those 15 years younger and no more than 10 years older than expected or actual age of cognitive symptom onset. - Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive) - Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning - Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations. - For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide). - Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments. - Has a Study Partner who in the investigators judgment is able to provide accurate information as to the subjects cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion. Exclusion Criteria: - History or presence of brain MRI scans indicative of any other significant abnormality - Alcohol or drug dependence currently or within the past 1 year - Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan. - History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders - Anticoagulants except low dose (≤ 325 mg) aspirin. - Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months. - History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years. - Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial. - Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy. ; PRIMARY OUTCOME: Assess cognitive efficacy in individuals with mutations causing dominantly inherited AD as measured by the change from baseline in the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE); 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 - HANDEL (US); BRIEF: The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids. ; DRUG USED: Toctino; DRUG CLASS: Non-NME; INDICATION: Atopic Dermatitis (Eczema); TARGET: Retinoid Receptors (RAR and RXR); THERAPY: Monotherapy; LEAD SPONSOR: Stiefel, a GSK Company; CRITERIA: Inclusion Criteria: - all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis - rated as severe by the physician - unresponsive to highly potent topical corticosteroids, such as clobetasol Exclusion Criteria: - patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants - patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances - patients with psoriasis lesions - active fungal, bacterial or viral infections of the hands - female patients who are pregnant or breastfeeding - female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception ; PRIMARY OUTCOME: Number of Participants Who Responded as Per Physicians Global Assessment (PGA) at Week 24; SECONDARY OUTCOME 1: Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Safety; BRIEF: The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots. ; DRUG USED: Ervebo; DRUG CLASS: Vaccine; INDICATION: Ebola; TARGET: Ebola Virus, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination. Exclusion Criteria: - Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial. - Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine. - Has been exposed to Ebola virus at any time prior to study entry. - Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination. - Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial. - Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry. - Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry. - Has received systemic corticosteroids exceeding physiologic replacement doses (~5 mg/day prednisone equivalent) within 14 days prior to study entry. - Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry. - Has known or suspected impairment of immunological function (e.g., HIV positive). - Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive). - Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry. - Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin). - Has a history of malignancy <=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. - Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial. ; PRIMARY OUTCOME: Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody; 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 - Japan (CCT-001); BRIEF: This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohns disease. ; DRUG USED: Entyvio; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. In the opinion of the investigator, participants were capable of understanding and complying with protocol requirements 2. Participants or, when applicable, participants legally acceptable representative sign and date the informed consent form prior to initiation of any study procedures 3. Participants aged 15 to 80 years (inclusive) at the time of consent 4. A nonsterilized male participant who has a female partner of child-bearing potential has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug 5. A female participant of child-bearing potential (i.e., nonsterilized or whose last regular menses was within previous 2 years) who has a nonsterilized male partner has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug 6. Participants with a diagnosis of small-intestinal, large-intestinal, or small-/large-intestinal Crohns disease (CD) established based on the Revised Diagnostic Criteria for Crohns disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 3 months before the start of administration of study drug 7. Participants with baseline CDAI score of 220 to 450(inclusive) and meeting at least one of the followings: - C-reactive protein (CRP) at screening test is above 0.30 mg/dL - Participants with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on endoscopy or imaging test within the 4 months before the start of administration of study drugs - Participants with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs 8. In case of the participants who meet any of the following criteria; participants with ≥ 8-year history of extensive or limited colitis, participants aged ≥ 50 years, or participants with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (or the results from total colonoscopy performed within 1 year before giving consent are available) 9. Participants meeting the criteria for treatment failure below with at least one of the following agents received within previous 5 year period before giving consent 1. Corticosteroids - Resistance - Dependence - Intolerance 2. Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate) - Refractory - Intolerance 3. Anti-tumor necrosis factor alpha (TNFα) antibodies - Inadequate response - Loss of response - Intolerance Exclusion Criteria: 1. Participants with an evidence of or suspected abdominal abscess 2. Participants with a history of subtotal or total colectomy 3. Participants who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome 4. Participants with ileostomy, colostomy, or internal fistula, or severe intestinal stenosis 5. Participants who have a treatment history with natalizumab, efalizumab or rituximab 6. Participants who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohns disease, or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration 7. Participants who had received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the treatment of Crohns disease (e.g., Daikenchuto) within 13 days before initiation of study drug administration 8. Participants who had received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of study drug administration. However, this shall not apply to participants who have received these drugs for 83 or more days before initiation of the study drug administration and continued the steady dose administration of the drugs for 27 or more days before initiation of the study drug administration 9. Participants who had received cyclosporin, tacrolimus, tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration 10. Participants who had received adalimumab within 27 days before initiation of study drug administration or any biological drugs other than adalimumab within 55 days before initiation of study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed 11. Participants who had received any live vaccinations within 27 days before initiation of study drug administration 12. Participants who had undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study 13. Participants who had received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration 14. Participants who had received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration or participants who are fasted 15. Participants who had received enteral nutrition at > 900 kcal/day or started enteral nutrition at <= 900 kcal/day within the 20 days before initiation of the study drug administration. Participants receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration 16. Participants who had been infected with Clostridium difficile, cytomegalovirus, or any other intestinal pathogen within 27 days before the first dose of the study drug 17. Participants with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration 18. Participants with a history or an complication of dysplasia of the small or large intestine 19. Participants who were suspected to have enteritis other than CD 20. Participants who were hepatitis B surface (HBs) antigen-positive or hepatitis C virus (HCV) antibody-positive at the screening. Or participants who are hepatitis B core (HBc) antibodypositive or HBs antibody positive, even though HBs antigen-negative. However, this does not apply to participants who are only HBs antibody-positive due to hepatitis B virus (HBV) vaccination, HBV-DNA-negative, HCV antigen-negative, or HCV-RNA-negative 21. Participants who had an evidence of history of tuberculosis or a suspected history of tuberculosis (including those who have findings suggesting previous tuberculosis on chest imaging procedure at the screening). However, this does not apply to participants who had completed prophylactic isoniazid, or participants who had been receiving prophylactic isoniazid for more than 21 days before the first dose of the study drug (in the latter case, the screening period are allowed to extend up to 28 days to ensure at least 21-day prophylactic isoniazid and then the study treatment is allowed to start) 22. Participants who had positive T-SPOT test or QuantiFERON test at the screening 23. Participants who had a history or complication of identified congenital or acquire immunodeficiency syndrome (eg, not-classifiable immunodeficiency, human immunodeficiency virus [HIV] infection or organ transplantation) 24. Participants who had been affected by extraintestinal infection (eg, pneumonia, sepsis, active hepatitis or pyelonephritis) within 27 days before the first dose of the study drug 25. Participants who had a treatment history with MLN0002 26. Female participants who are lactating at the screening, or have positive urine pregnancy test either at the screening or baseline 27. Participants who had serious complications in the heart, lung, liver, kidney, metabolism, gastrointestinal system, urinary system, endocrine system or blood 28. Participants who had a history of a surgery requiring general anesthesia within 27 days before the first dose of the study drug, or with a schedule of a surgery requiring hospitalization during the study period 29. Participants who had a complication or a history of malignancy. However, this does not apply to the following participants: - Participants who had a curative resection of localized skin basal cell carcinoma or have completed curative radiotherapy - Participants who had not experienced recurrence for more than 1 year since completion of a curative resection or curative radiotherapy for skin squamous cell carcinoma - Participants who had not experienced recurrence for more than 3 years since completion of a curative resection or curative radiotherapy for intraepithelial carcinoma of uterine cervix For participants who had a substantially distant history of malignancy (eg, 10 years or longer without recurrence since treatment completion), the investigator and the sponsor had a discussion to decide eligibility on the basis of type of malignancy and treatment applied 30. Participants who had a history or a complication of the central nervous disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease. 31. Participants who had any subjective symptoms in the subjective PML checklist at the screening or baseline 32. Participants who had any of the following laboratory abnormalities at the screening; - Hemoglobin ≤8 g/dL - White blood cells ≤3,000/μL - Lymphocytes ≤500/μL - Platelets ≤100,000/μL or ≥1,200,000/μL - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×upper limit of normal (ULN) - Alkaline phosphatase (ALP) ≥3×ULN - Creatinine ≥2×ULN 33. Participants who had a history or a complication of alcohol dependence or illicit drug use within one year before the first dose of the study drug 34. Participants who had a history or a complication of psychotic disorder that could obstruct compliance with the study procedures ; PRIMARY OUTCOME: Induction Phase: Percentage of Participants With Crohns Disease Activity Index (CDAI)-100 Response; SECONDARY OUTCOME 1: Induction Phase: Percentage of Participants With Clinical Remission[/INST]Yes</s>

<s>[INST]<<SYS>>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 - ZEST (Elderly DLBCL); BRIEF: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy. ; DRUG USED: Zevalin; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 20 (CD20), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Participant was 60-years of age or older at time of randomization 2. Histologically confirmed Ann Arbor stage II, III, or IV diffuse large B-cell lymphoma (DLBCL); or follicular lymphoma (FCL) Grade 3B according to the Revised European American lymphoma (REAL)/ World health organization (WHO) classification (from initial diagnosis made prior to starting R-CHOP therapy. Results from a pre R-CHOP marrow shall be available for review. 3. Local pathology review confirming the DLBCL diagnosis and cluster of differentiation 20 (CD20) positivity, and no evidence of DLBCL in bone marrow upon confirmation of complete remission (CR). 4. A paraffin block or original slides available for confirmatory pathology review. Participants may be randomized based on the local pathology result. 5. Age-adjusted international prognostic index (IPI) of 1, 2, or 3. The age-adjusted IPI was defined by one point for Lactate dehydrogenase (LDH) > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ eastern cooperative operations group (ECOG) performance status >1. 6. First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) chemotherapy. Participants who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible. 7. Complete remission (CR) according to the International Workshop Response Criteria for non-Hodgkins lymphoma (NHL) described by Cheson et al after first-line treatment. Computerized tomography (CT) scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of chemotherapy. Applicability of the neck CT means that the participant had involvement of the neck region by palpation / physical examination at first diagnosis. 8. A negative Fluorine-18-deoxyglucose positron emission tomography (FDG-PET) scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735). 9. Bone marrow cellularity greater than 15%, no evidence of myelodysplasia morphologically and no evidence of involvement with lymphoma either at the pre R-CHOP marrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeat marrow is required for participant randomized to the Zevalin arm only. 10. A world health organization/eastern cooperative oncology group (WHO/ECOG) performance status of 0, 1 or 2. 11. Adequate hematopoietic functions: Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/ liter (L), Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 10^9/L. 12. Life expectancy of 6 months or longer. 13. Written informed consent obtained according to local guidelines. Exclusion Criteria: 1. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, participants treated for Stage I or II cancers are eligible provided they have a life expectancy of > 5 years. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer. 2. Prior radioimmunotherapy, including radiation therapy for Non-Hodgkins lymphoma) NHL, or any other NHL therapy. 3. Presence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis. 4. Histological transformation of low-grade NHL. 5. Active hepatitis B or C. 6. Known history of human immunodeficiency virus (HIV) infection. 7. Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease. 8. Abnormal renal function: serum creatinine > 2.0 × ULN. 9. Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment. 10. Known hypersensitivity to murine or chimeric antibodies or proteins. 11. Granulocyte-colony stimulating factor (G-CSF) or Granulocyte macrophage-colony stimulating factor (GM-CSF) therapy within 4 weeks prior to Zevalin or observation. 12. Concurrent severe and/or medically uncontrolled disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study. 13. Treatment with investigational drugs less than 4 weeks prior to Zevalin or observation. 14. Major surgery less than 4 weeks prior to Zevalin or start of observation. 15. Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment. Participants on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20 milligram (mg) daily, stable for 4 weeks, are permissible. 16. Unwillingness or inability to comply with the protocol. ; PRIMARY OUTCOME: Overall Survival (OS) for Living Participants; SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Gemcitabine + Carboplatin; BRIEF: This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a persons cytotoxic T cells (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the worlds first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30 hospital centers across Asia and the United States. This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma. ; DRUG USED: TT10 EB-VST; DRUG CLASS: Biologic; INDICATION: Nasopharyngeal Cancer; TARGET: Epstein Barr Virus (EBV), Immune System; THERAPY: Combination; LEAD SPONSOR: Tessa Therapeutics; CRITERIA: Key Inclusion Criteria 1. Metastatic or locally recurrent EBV-positive, non-keratinizing and/ or undifferentiated NPC* who do not have curative options such as chemo-radiation or surgery *Subjects will be enrolled based on confirmed histology diagnosis of the NPC 2. Radiologically measurable disease as per RECIST 1.1 3. Human Immunodeficiency Virus (HIV) negative* * Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests available within 4 weeks of screening 4. Bilirubin <2 x upper limit of normal (ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) <3 x ULN 5. Calculated creatinine clearance (CRCL) ≥40 mL/min. Glomerular Filtration Rate (GFR) is calculated based on Cockcroft-Gault method. 6. Normal corrected calcium levels 7. Absolute neutrophil count >1200/mm3, hemoglobin (Hb) ≥10 g/dL and platelets ≥100,000/mm3 8. Male or female 9. Age ≥ 18 years or according to local legal age of consent 10. Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) ≤2 11. Written informed consent 12. Life expectancy >6 months Key Exclusion Criteria 1. Severe concomitant illness i.e. chronic obstructive pulmonary disease (COPD), ischemic heart disease (IHD), active congestive cardiac failure (CCF), active angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension 2. HIV Positive* * Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests available within 4 weeks of screening 3. Pregnant or lactating females 4. Refuse of use of contraception during trial (both male and female patients) 5. Investigational therapy less than one month prior to study entry 6. Pre-existing peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] ≥2) 7. Central nervous system metastasis 8. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis and T1] or any cancer curatively treated >3 years prior to study entry 9. Positive hepatitis B surface antigen (HBsAg) results 10. Known history of hepatitis C and recovery status has not been determined at time of screening 11. Prior anti-cancer treatment for metastatic or locally recurrent disease, EXCEPT: For metastatic or locally recurrent disease, localised palliative radiotherapy is allowed. For locally recurrent disease, the following treatment is allowed - Prior radiotherapy with curative intent - Prior chemo-radiotherapy with curative intent - Adjuvant chemotherapy - Localised palliative radiotherapy Prior chemotherapy must be > 6 months before screening 12. Severe intercurrent infections 13. Prior immunotherapy for metastatic or locally recurrent disease The following is allowable: • Adjuvant immunotherapy/ biologics Prior adjuvant immunotherapy/ biologics must be > 6 months before screening ; PRIMARY OUTCOME: Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma.; SECONDARY OUTCOME 1: Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma.[/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 - U-ACHIEVE; BRIEF: This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib. ; DRUG USED: Rinvoq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit. - Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available. - Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader). - Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator. Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above. - If female, participant must meet the criteria for Contraception Recommendations - Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Exclusion Criteria: - Participant with current diagnosis of Crohns disease (CD) or diagnosis of indeterminate colitis (IC) - Current diagnosis of fulminant colitis and/or toxic megacolon - Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy - Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline - Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline - Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period. - Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib). - Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria ; PRIMARY OUTCOME: Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8; SECONDARY OUTCOME 1: Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Active, Moderate to Severe Patients (China); BRIEF: Primary Objective: To preliminarily evaluate the efficacy of the treatment regimen of HBM9161 680 mg administered subcutaneously weekly and sequentially every other week for 12 weeks in Chinese patients with active moderate to severe TED. ; DRUG USED: Batoclimab; DRUG CLASS: Biologic; INDICATION: Thyroid Eye Disease (TED); TARGET: Neonatal Fc Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Harbour BioMed (Guangzhou) Co. Ltd.; CRITERIA: Inclusion Criteria: 1. Signed written informed consent form. 2. Male or female between the ages of 18 and 70 (including boundary values). 3. Active TED associated with a clinical diagnosis of Graves disease or Hashimotos thyroiditis with CAS ≥ 3 at the screening visit and baseline (both on a 7-item scale) in the eye with the most severe proptosis. 4. The active period of TED starts within 9 months prior to screening visit 5. Positive anti-TSHR antibody at screening visit. 6. Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol. Exclusion Criteria: 1. Other uncontrolled concurrent diseases 2. Serious TED requiring surgery or radiotherapy 3. Suffer from autoimmune diseases or ophthalmic conditions other than TED that, in the opinion of the investigator, would impact the assessment of the study drug 4. No significant laboratory abnormalities ; PRIMARY OUTCOME: Proptosis responder rates of the treatment groups and placebo group at Week 12; SECONDARY OUTCOME 1: The percentage of subjects with a CAS value of 0 or 1 in the study eye[/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 - AHEAD; BRIEF: This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit. ; DRUG USED: Jornay PM; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Ironshore Pharmaceuticals and Development, Inc; CRITERIA: Inclusion Criteria: 1. Subjects must be male or female children (6 to 12 years at the time of consent). 2. Subjects must have a diagnosis of ADHD as defined by DSM5 criteria and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 3. Subjects must have a baseline ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score. In addition, this ADHD-RS-IV total score must be ≥26 at Baseline. 4. Subjects must have a Clinical Global Impression of Severity (CGI-S) score ≥4 and a CGI-P score >10 at the Baseline Visit. 5. Subjects have demonstrated, in the judgment of the investigator, at least a partial clinical response to MPH. 6. Parental or legal guardian confirmation of the childs before-school functional impairment and/or difficulties performing a morning routine of at least 30 minutes minimum duration occurring between 6:00 and 9:00 am. 7. Subject body weight must be ≥20 kg. 8. Subject must be considered clinically appropriate for treatment with MPH and HLD200, including ability to swallow treatment capsules. 9. Subject must be in general good health based upon the medical history, physical, and laboratory examinations (including urine drug screen). 10. Subject and parent or legal guardian must be able to read, write, and/or understand at a level sufficient to provide informed consent (parent/legal guardian) and assent (subject) prior to study participation and to complete study-related materials. Subject and parent or legal guardian must plan to be available for the entire study period. 11. Female subjects of childbearing potential (i.e., post-menarche) are required to have a negative result on urine pregnancy testing at screening (and will be given specific instructions for avoiding pregnancy during the study). 12. A medically highly effective form of birth control must be used during the study and for 90 days thereafter for subjects of either sex of childbearing potential. Examples of medically highly effective forms of birth control are as follows: - No sexual activity - Use of acceptable methods of birth control including intra-uterine device, oral, implantable,or injectable contraceptives. Exclusion Criteria: 1. History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures. 2. Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug. 3. History of seizure disorder (except febrile seizures prior to age 5 and with last occurrence at least 1 year prior to study participation), Tourettes disorder, or intellectual disability of minor severity or greater (DSM5 criteria). 4. History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigators opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures. 5. Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS. 6. History of severe allergic reaction or intolerance to MPH. 7. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or creatinine greater than 1.5x the upper limit of normal. Elevated bilirubin due only to Gilberts syndrome is not exclusionary. 8. History of alcohol abuse or illicit drug use. 9. Use of prescription medications (except per protocol allowed medications) within 7 days of Baseline (Visit 2), except for ADHD stimulant medication (72 hours) and monoamine oxidase inhibitors (MAOIs) (14 days), and over-the-counter medications (except birth control and allowed medications) within the 3 days preceding Baseline (Visit 2). Medications not covered in allowed medications or prohibited medications must be cleared by the medical monitor prior to enrolling the subject. 10. Use of psychotropic medications including antidepressants, mood stabilizers, and antipsychotics. 11. Participation in a clinical trial with an investigational drug within the 30 days preceding study enrollment. 12. Previous treatment experience with HLD200. 13. Positive screening for illicit drug use or nicotine and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject. 14. In the opinion of the investigator, the subject may have problems complying with the protocol or the procedures of the protocol, or for which the study could pose unnecessary safety risks. This includes current health conditions or use of medications that might confound the results of the study or increase risk to the subject. 15. A sibling or step-sibling that is concurrently participating in this study who resides with and is cared for by the same parent/legal guardian as the subject. ; PRIMARY OUTCOME: Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score.; SECONDARY OUTCOME 1: Before School Functioning Questionnaire (BSFQ) Total Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Azelaic; BRIEF: The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea. ; DRUG USED: Mirvaso; DRUG CLASS: Non-NME; INDICATION: Rosacea; TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Galderma R&D; CRITERIA: Inclusion Criteria: 1. Subject is male or female aged 18 years or older. 2. Subject has a clinical diagnosis of facial rosacea. 3. Subject has a clinicians assessment score of moderate to severe erythema prior to enrollment. 4. Subject has a self assessment score of moderate to severe redness prior to enrollment. 5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment. Exclusion Criteria: 1. Female subjects who are pregnant, nursing or planning a pregnancy during the study. 2. Subjects with a condition or who are in a situation, which in the Investigators opinion may put a subject at risk, may confound study results, or may interfere with a subjects participation in the study. 3. Subjects with conditions causing facial erythema which would confound the assessment of treatment. 4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists. 5. Subjects with known allergies or sensitivities to one of the components of the investigational products. ; PRIMARY OUTCOME: Composite Success; SECONDARY OUTCOME 1: Onset of Action[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ESRD-HD; BRIEF: This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a 4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor. ; DRUG USED: Ibsrela; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Sodium-hydrogen exchanger 3 (NHE3) ; THERAPY: Monotherapy; LEAD SPONSOR: Ardelyx; CRITERIA: Inclusion Criteria: - 18 to 80 years old - Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods. - Males must agree to avoid fathering a child and agree to use an appropriate method of contraception - Chronic maintenance hemodialysis 3x/week for at least 3 months - Kt/V ≥ 1.3 at most recent measurement prior to screening - Prescribed and taking at least 3 doses of phosphate binder per day - Serum phosphate levels should be between 4.0 and 7.0 mg/dL (inclusive) at screening - For randomization in the study, after 1 week wash-out of phosphate binders, subjects must have serum phosphate level of at least 9 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value - For randomization in the study, after 2 or 3 weeks wash-out of phosphate binders, subjects must have serum phosphate level of at least 6 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value Exclusion Criteria: - Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening - Serum parathyroid hormone >1200 pg/mL - Persistent metabolic acidosis defined as serum carbon dioxide <18 mmol/L from two consecutive measurements during screening and washout periods - Clinical signs of hypovolemia at randomization - History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (IBS-D) - Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period - Diarrhea or loose stools during the week before randomization defined as BSFS ≥ 6 and frequency ≥ 3 for 2 or more days - Any evidence of or treatment of malignancy within one year, excluding non-melanomatous malignancies of the skin - Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator - Life expectancy < 6 months ; PRIMARY OUTCOME: Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms; SECONDARY OUTCOME 1: Change in Serum Phosphate During 8-Week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Bude/Formo (FULFIL); BRIEF: This is a phase IIIa, randomised, double-blind, double-dummy, parallel group multicenter study evaluating once daily FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg) inhalation powder versus twice daily budesonide/formoterol (400 mcg/12 mcg). The primary purpose of this study is to demonstrate improvements in lung function and health status for subjects treated with FF/UMEC/VI compared with budesonide/formoterol for 24 weeks. Once-daily closed triple therapy of a Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) combination FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) in a single device is being developed with the aim of providing a new treatment option for the management of advanced (GOLD Group D) COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and increase the potential for improvement in lung function, Health Related Quality of Life (HRQoL) and symptom control over established dual/monotherapies. Subjects meeting all inclusion/exclusion criteria and who have successfully completed all protocol procedures at the Screening Visit will enter the two-week run-in period. Following the run-in period, eligible subjects will be randomised (1:1) to one of the following double-blind treatment groups: FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg via the ELLIPTA™ dry powder inhaler (DPI) once daily in the morning and placebo via reservoir inhaler twice daily OR Budesonide/formoterol 400 mcg/12 mcg via reservoir inhaler twice daily and placebo via the ELLIPTA DPI once daily in the morning. The target enrollment is 1800 randomised subjects at approximately 200 study centers globally. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period. Subjects will run-in on their existing COPD medications for 2 weeks and in addition will be provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. Subjects will discontinue all existing COPD medications during the randomised treatment period but may continue their study supplied rescue albuterol/salbutamol. A sub-set of approximately 400 subjects will remain on blinded study treatment for up to a total of 52 weeks to provide additional long term safety data. ELLIPTA and NUBULES are a trade marks of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners ; DRUG USED: Trelegy Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR), Muscarinic acetylcholine receptor; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Informed Consent: A signed and dated written informed consent prior to study participation. - Type of subject: Outpatient. - Age: Subjects 40 years of age or older at Screening (Visit 1). - Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence, Oral Contraceptive, either combined or progestogen alone, Injectable progestogen, Implants of levonorgestrel, Estrogenic vaginal ring, Percutaneous contraceptive patches, Intrauterine device (IUD) or intrauterine system (IUS), Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subjects entry into the study, and this male is the sole partner for that subject. For this definition, documented refers to the outcome of the investigators/designees medical examination of the subject or review of the subjects medical history for study eligibility, as obtained via a verbal interview with the subject or from the subjects medical records.; Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) - COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. - Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >10 pack-years at Screening (Visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history. - Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at Screening (Visit 1). - Severity of Disease: Subjects must demonstrate at Screening: <a post-bronchodilator FEV1 <50% predicted normal OR a post-bronchodilator FEV1 <80% predicted normal and a documented history of >=2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months. Subjects must also have a measured post albuterol/salbutamol FEV1/FVC ratio of <0.70 at screening. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnoea, sputum volume, or sputum purulence (colour). Subject verbal reports are not acceptable. - Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only as required (PRN) COPD medications are not eligible. - Liver function tests: alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase <=1.5xULN; bilirubin <=1.5xULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Exclusion Criteria: - Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). Alpha1-antitrypsin deficiency: Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD. - Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. - Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening. - Risk Factors for Pneumonia: immune suppression (e.g. Human immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinsons Disease, Myasthenia Gravis). Subjects at potentially high risk (e.g. very low Body mass index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the investigator. - Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded. - Respiratory tract infection that has not resolved at least 7 days prior to Screening. - Abnormal Chest X-ray (CXR): Chest X-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a CXR at Screening Visit 1) (or historical radiograph or Computed Tomography [CT] scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation CXR to be over-read by the central vendor or have a CXR conducted at Screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic CXR will need to be obtained from the Federal Office for Radiation Protection (BfS). - Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. For subjects taking part in the physical activity monitor subset: Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns and limit the ability to walk/cycle, as judged by the Investigator. - Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria. - Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure - Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principal Investigator (PI) will determine the clinical significance of each abnormal ECG finding in relation to the subjects medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: Atrial fibrillation (AF) with rapid ventricular rate >120 Beats Per Minute (BPM); sustained or non-sustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate by Fridericias formula (QTcF) >=500 milliseconds (msec) in subjects with QRS <120 msec and QTcF >=530 msec in subjects with QRS >=120 msec. - Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator, contraindicates study participation. - Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment. - Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3litres/minute (L/min) (Oxygen use <=3L/min flow is not exclusionary.) - Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit. - Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded. - Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years. - Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits. - Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. - Affiliation with investigator site: study investigators, sub-investigators, study coordinators, employees of a participating investigator or study site, or immediate family members of the aforementioned that is involved with this study. - Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials. - Medication prior to screening: No use of the following medications within the following time intervals prior to Screening or during the study. Long term antibiotic therapy: Subjects receiving antibiotics for long term therapy are not eligible for the study (Antibiotics are allowed for the short term treatment of an exacerbation or for short term treatment of other acute infections); Systemic, Oral, parenteral corticosteroids: 30 days (Except during the study oral/systemic corticosteroids may be used to treat COPD exacerbations/pneumonia). Intra-articular injections are allowed. Any other investigational drug: 30 days or 5 half lives whichever is longer. ; PRIMARY OUTCOME: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24; SECONDARY OUTCOME 1: Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SASCIA; BRIEF: Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: - Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); - Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting. ; DRUG USED: Trodelvy; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), Trop-2; THERAPY: Monotherapy; LEAD SPONSOR: German Breast Group; CRITERIA: Inclusion Criteria: 1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. 2. Age at diagnosis at least 18 years. 3. Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block from surgery after neoadjuvant chemotherapy and from core biopsy before start of neoadjuvant chemotherapy, which will be used for centralized prospective confirmation of HR status, HER2 status, Ki-67 and tumor-infiltrating lymphocytes (TILs) and for retrospective exploratory correlation between genes, proteins, and mRNAs relevant to sensitivity/resistance to the investigational agents. For patients with bilateral carcinoma, FFPE blocks from both sides have to be provided for central testing. 4. Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically by core biopsy. The lead tumor has to be defined by the investigator based on the inclusion criteria for the respective subtype and on the risk status. 5. Centrally confirmed HER2-negative (IHC score 0-1 or FISH negative according to ASCO/CAP guideline) and either - HR-positive (≥1% positive stained cells) disease or - HR-negative (<1% positive stained cells) assessed preferably on tissue from postneoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion. If not evaluable, core of diagnostic biopsy will be used. In case of bilateral breast cancer, HER2-negative status has to be confirmed for both sides. 6. Patients with residual invasive disease after neoadjuvant chemotherapy at high risk of recurrence defined by either: - For HR-negative: any residual invasive disease > ypT1mi and/or ypN1>1mm - For HR-positive disease: a CPS+EG score ≥ 3 or CPS+EG score 2 and ypN+ using local ER and grade assessed on core biopsies taken before start of neoadjuvant treatment. 7. Adequate surgical treatment including resection of clinically evident disease and ipsilateral axillary lymph node dissection. SNB before NACT is discouraged. Axillary dissection before NACT is not permitted. Axillary dissection, including Targeted Axillary Dissection (TAD) should be performed according to guidelines. Histologic complete resection (R0) of all invasive and in situ tumors is required. 8. Patients must have received neoadjuvant taxane-based chemotherapy for 16 weeks (anthracyclines are permitted). This period must include 6 weeks of a taxane containing neoadjuvant chemotherapy (exception: for patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant chemotherapy, a total treatment period of less than 16 weeks is also eligible). 9. No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion if adequate local control could be obtained. 10. In case of local progression during neoadjuvant therapy, distant metastases must be excluded by adequate imaging (CT/MRI recommend) prior to entering the trial. 11. Immune checkpoint inhibitor / immunotherapy during (neo)adjuvant therapy is allowed until the completion of radiotherapy. 12. Patients with known gBRCA1/2 mutation without indication to adjuvant olaparib therapy are allowed to participate in the trial. 13. An interval of less than 16 weeks since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) and the date of randomization is required. 14. Radiotherapy should be delivered before the start of study treatment. Radiotherapy to the breast is indicated in all patients with breast conserving surgery and to the chest wall and lymph nodes according to local guidelines as well as in all patients with cT3/4 or ypN+ disease treated by mastectomy. 15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 16. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedure or radiotherapy to NCI CTCAE v 5.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patients at the investigator´s discretion). 17. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer. 18. The patient must be accessible for scheduled visits, treatment and follow-up. 19. Normal cardiac function after neoadjuvant chemotherapy must be confirmed according to local guidelines. Results for LVEF must be above the normal limit of the institution. 20. Laboratory requirements: Hematology - Absolute neutrophil count (ANC) ≥1.5 x 109 / L - Platelets ≥100 x 109 / L - Hemoglobin ≥10 g/dL (≥6.2 mmol/L) Hepatic function - Total bilirubin <1.25x UNL - AST and ALT ≤1.5x UNL - Alkaline phosphatase ≤2.5x UNL Renal Function - <1.25x ULN creatinine or creatinine clearance ≥30 ml/min (according to Cockroft-Gault, if creatinine is above UNL). 21. Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. A woman is considered to be of childbearing potential if she is not postmenopausal. Postmenopausal is defined as: - Age ≥60 years - Age <60 years and ≥12 continuous months of amenorrhea with no identified cause other than menopause - Surgical sterilization (bilateral oophorectomy and/or hysterectomy). 22. For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of sacituzumab govitecan for female patients and for at least 3 months for male patients; for at least 6 months after the last dose of capecitabine or carboplatin/cisplatin for female patients and for at least 3 months after the last dose of capecitabine or 6 months after the last dose of carboplatin/cisplatin for male patients. Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices. 23. Complete staging work-up prior to the initiation of neoadjuvant chemotherapy. Missing staging investigations must be performed prior to randomization. Exclusion Criteria: 1. Known hypersensitivity reaction to one of the compounds or substances used in this protocol. 2. Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible. 3. Patients with known gBRCA1/2 mutation and indicated or planned adjuvant olaparib therapy if available. 4. Patients with a history of any malignancy are ineligible with the following exceptions: - Patient has been disease-free for at least 5 years and is at low risk for recurrence of that malignancy - CIS of the cervix, basal cell and squamous cell carcinomas of the skin. 5. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to 6 months after sacituzumab govitecan and up to 6 months after treatment with capecitabine or carboplatin/cisplatin. 6. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study, including Gilbert´s disease, Crigler-Najjar-Syndrome, known hepatitis B, hepatitis C, known HIV positivity or known autoimmune disease other than diabetes, vitiligo, or stable thyroid disease, vitiligo, or other autoimmune skin disease with dermatologic manifestations only are permitted provided all of the following conditions are met: - Rash must cover < 10% of body surface area - Disease is well controlled at baseline and requires only low-potency topical corticosteroids - No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months. 7. Any condition that interferes with the safe administration of the treatment of physician´s choice in case the patient is randomized into the TPC arm. 8. Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of prior infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >150/90 mmHg under treatment with at maximum three antihypertensive drugs), rhythm abnormalities requiring permanent treatment (excluding chronic atrial fibrillation not requiring a pacemaker), clinically significant valvular heart disease, supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;conduction abnormality requiring a pacemaker. 9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis on chest CT scan. 10. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving chemotherapy. 11. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent. 12. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. 13. Known allergic reactions to irinotecan. 14. Concurrent treatment with: - Chronic corticosteroids prior to study entry with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or equivalent corticosteroid. ; PRIMARY OUTCOME: Invasive disease free survival (iDFS) between patients treated with sacituzumab govitecan vs. treatment of physicians choice.; SECONDARY OUTCOME 1: To compare overall survival (OS) between patients treated with sacituzumab govitecan vs. treatment of physicians choice.[/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 - OA of the Knee; BRIEF: The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR). ; DRUG USED: Nucynta ER; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria and functional capacity class of I-III - patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy - Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to <160 mg of oral morphine - baseline score of greater than or equal to 5 on an 11-point numerical rating scale, calculated as the average pain intensity during the last 3 days prior to randomization. Exclusion Criteria: - History of alcohol and/or drug abuse in Investigators judgement - history of significant liver insufficiency - chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months - life-long history of seizure disorder or epilepsy - history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated - uncontrolled hypertension - patients with severely impaired renal function - patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function ; PRIMARY OUTCOME: Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.; SECONDARY OUTCOME 1: Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ETTAU-03; BRIEF: This is a multicenter, parallel group, randomized, double-blind, active controlled, Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent) with acute urticaria requiring treatment. ; DRUG USED: QUZYTTIR; DRUG CLASS: Non-NME; INDICATION: Urticaria; TARGET: Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: JDP Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms; 2. 18 years of age or older; 3. Be willing and able to give informed consent; 4. Patients with a Patient rated Pruritus Severity Score ≥ 1 Exclusion Criteria: 1. Receipt of an investigational drug or device, within the past 30 days; 2. Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy); 3. Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg; 4. Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine; 5. Receipt of an H2 antagonist within the past 2 hours; 6. Receipt of doxepin within the past 2 hours; doxepin is an antidepressant, but it also has antihistamine properties; 7. Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 4 hours to manage an acute allergic reaction; 8. Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes; 9. Anaphylaxis prior to the acute anaphylactic symptoms having been treated. 10. Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine; 11. Pregnancy or breastfeeding; 12. Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication; 13. Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response; 14. Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study; 15. History of HIV or other known immunodeficiency; 16. Major medical or psychiatric illness, other than acute urticaria, at the time of presentation; 17. Inability to provide informed consent. 18. Patients on concomitant p-glycoprotein inhibitors ; PRIMARY OUTCOME: Change of Patient Rated Pruritus Score; SECONDARY OUTCOME 1: Number of Patients Who Needed to Return to Treatment Center[/INST]Yes</s>

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

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GRECO; BRIEF: The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria - Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines - Male and female patients aged 18 to 75 years of age at the time of Visit 1 - Patient or caregiver must be willing and able to self-administer the Investigational product (IP). Caregiver must be age of consent or older at the time of Visit 1, if applicable - Weight of ≥40 kg - Evidence of asthma as documented by airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 1A or Visit 2 - Documented history of current treatment with Inhaled corticosteroids (ICS) and Long-acting β2 agonists (LABA). The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, both the mid- and high-strength maintenance doses approved in the local country will meet this ICS criterion. Additional asthma controller medications (e.g., Leukotriene receptor antagonists (LTRAs), tiotropium, theophylline, oral corticosteroids) are allowed - Pre-bronchodilator (pre-BD) FEV1 of >50% predicted normal at Visit 1 or 1A or Visit 2 - Not well controlled asthma as documented by either: An Asthma Control Questionnaire 6 (ACQ6 ) ≥1.5 OR; A peak flow of 60-80% predicted OR; One or more exacerbation that required oral or systemic corticosteroids in the previous year Exclusion criteria: - Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD (Chronic obstructive pulmonary disease), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome) - Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: Affect the safety of the patient throughout the study; Influence the findings of the studies or their interpretations; Impede the patients ability to complete the entire duration of study - Known history of allergy or reaction to the IP formulation - History of anaphylaxis to any biologic therapy - History of Guillain-Barré syndrome - A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy - Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening - Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete entire duration of the study ; PRIMARY OUTCOME: Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home; SECONDARY OUTCOME 1: Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NuTide:121; BRIEF: NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: - The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care - The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care ; DRUG USED: Acelarin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: DNA synthesis; THERAPY: Combination; LEAD SPONSOR: NuCana plc; CRITERIA: Inclusion Criteria: 1. Written informed consent and authorization to use and disclose health information. 2. Ability to comprehend and willingness to comply with the requirements of this protocol, including the QoL questionnaires. 3. Female or male patients aged ≥18 years. 4. Histologically- or cytologically-confirmed adenocarcinoma of the biliary tract (including gallbladder, intra and extra-hepatic biliary ducts and ampullary cancers) that is locally advanced, unresectable or metastatic (AJCC edition 8, 2018). Patients with measurable (as per RECIST v1.1 criteria) or non-measurable disease are permitted. 5. Life expectancy ≥16 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Adequate biliary drainage with no evidence of ongoing infection. If applicable, treatable and clinically-relevant biliary duct obstruction has been relieved by internal endoscopic drainage/stenting at least 2 weeks previously or by palliative bypass surgery or percutaneous drainage prior to study treatment, and the patient has no active or suspected uncontrolled infection. Patients fitted with a biliary stent should be clinically stable and free of signs of infection for ≥2 weeks prior to study treatment. Patients with improving biliary function who meet all other inclusion criteria may be re-tested during the screening window. 8. Adequate bone marrow, hepatic, and renal function, as evidenced by: - Absolute neutrophil count (ANC) ≥1,500/μL without colony-stimulating factor support - Platelet count ≥100,000/μL - Haemoglobin ≥9 g/dL without need for haematopoietic growth factor or transfusion support in prior 2 weeks - Total bilirubin <2 × upper limit of normal (ULN); does not apply to patients with Gilberts syndrome. Consistent with inclusion criterion 7, patients whose whole bilirubin and biliary function is recovering may be re-tested during the screening period. - Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <5 × ULN - Creatinine clearance ≥45 mL/min actual or calculated by the Cockcroft-Gault method - International normalized ratio (INR) <1.5 and activated partial thromboplastin time (aPTT) <1.5 × ULN; does not apply to patients on an anti-coagulant with stable dose 28 days prior to first dose. 9. QTc interval <450 msec (males) or <470 msec (females), in the absence of bundle branch block. In the presence of bundle branch block with consequent QTc prolongation, patients may be enrolled based on a careful risk-benefit assessment. 10. Human Immunodeficiency Virus-infected patients who are healthy and have a low risk of Acquired Immunodeficiency Syndrome-related outcomes may be included in this study. 11. Female patients of child-bearing potential (i.e., all women except those who are post-menopausal for ≥1 year or who have a history of hysterectomy or surgical sterilization) must have a negative pregnancy test within 3 days prior to the first study drug administration. All 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 of contraception, from the time of screening until 6 months after the last dose of study medication. 12. Male patients with a female partner must either have had a successful vasectomy or they and their female partner meet the criteria above (not of childbearing potential or practicing highly effective contraceptive methods). Exclusion Criteria: 1. Combined or mixed hepatocellular/cholangiocarcinoma. 2. Prior systemic therapy for advanced or metastatic biliary tract cancer. However, prior chemotherapy in the adjuvant setting or low-dose chemotherapy given in conjunction with radiotherapy in the adjuvant setting and completed at least 6 months prior to enrolment is permitted. The following prior interventions are allowed provided the patient has fully recovered: - Surgery: non-curative resection with macroscopic residual disease or palliative bypass surgery. Patients who have previously undergone curative surgery must now have evidence of non-resectable disease requiring systemic chemotherapy. - Radiotherapy: prior radiotherapy (with or without radio-sensitizing low-dose chemotherapy) for localized disease and there is now clear evidence of disease progression requiring systemic chemotherapy. - Photodynamic therapy: prior photodynamic therapy for localized disease with no evidence of metastatic disease or for localized disease to relieve biliary obstruction in the presence of metastatic disease provided there is now clear evidence of disease progression requiring systemic chemotherapy. - Palliative radiotherapy: palliative radiotherapy provided that all adverse events have resolved and the patient has measurable disease outside the field of radiation. 3. Prior treatment with or known hypersensitivity to NUC-1031, gemcitabine, cisplatin or other platinum-based agents or history of allergic reactions attributed to any parenteral excipients (e.g. dimethylacetamide [DMA], Cremophor EL, Polysorbate 80, Solutol HS 15). 4. Symptomatic central nervous system or leptomeningeal metastases. 5. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in situ cancer 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 the patient has had no evidence of recurrence since then. 6. Concurrent serious (as deemed by the Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation. 7. Congenital or acquired immunodeficiency (e.g., serious active infection with HIV). As per inclusion criterion 10, patients with HIV who are healthy and have a low risk of AIDS related outcomes are eligible. 8. Other acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study. 9. Prior exposure to another investigational agent within 28 days prior to randomization. 10. Major surgery within 28 days prior to randomization; patient must have completely recovered from any prior surgical or other procedures. 11. Pregnant or breastfeeding. 12. Residual toxicities from prior treatments or procedures which have not regressed to Grade ≤1 severity (CTCAE v5.0), except for alopecia or ≤ Grade 2 peripheral neuropathy. 13. Concomitant use of drugs at doses known to cause clinically relevant prolongation of QT/QTc interval. 14. Administration of a live vaccination within 28 days prior to randomization. 15. Ongoing or recent (≤6 months) hepatorenal syndrome. ; PRIMARY OUTCOME: Objective Response Rate (ORR); 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 - T3MPO-1 (12-Week Study); BRIEF: This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12 week treatment period and then undergo a 4 week placebo controlled randomized withdrawal. ; DRUG USED: Ibsrela; DRUG CLASS: New Molecular Entity (NME); INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Sodium-hydrogen exchanger 3 (NHE3) ; THERAPY: Monotherapy; LEAD SPONSOR: Ardelyx; CRITERIA: Inclusion Criteria: - 18 to 75 years old - Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception. - Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization - Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS - A colonoscopy based on AGA guidelines; every 10 years at ≥ 50 years old, or the occurrence of any warning signs Exclusion Criteria: - Functional diarrhea as defined by Rome III criteria - IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria - Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction, ischemic colitis or carcinoid syndrome. - Subject has a history or current evidence of laxative abuse (in the clinical judgment of the physician) - Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine > 2mg/dL) - Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year - Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy (unless within 60 days of screening visit) ; PRIMARY OUTCOME: 6 of 12 Week Overall Responder Rate; SECONDARY OUTCOME 1: 6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1218.91 w/Empagliflozin; BRIEF: The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) . Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines. Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels. The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a random assignment. For this study, there will first be a screening visit, followed by a 2-week placebo run-in period (all subjects will take placebo once daily). This run-in period is designed to ensure subjects are able to take the study drugs as described in the study protocol. Thereafter there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension period (week 27-week 52). Following this there will be a follow-up visit at week 55. On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, the subject will be assigned to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg, linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin. After the completion of the 26-week treatment period, the subject will enter a 26-week safety extension period. The same active treatment that the subject had been assigned to at week 14 visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to provide additional information on how well empagliflozin and linagliptin are tolerated. Following the treatment phases, there will be a follow-up visit at week 55 Intervention model description: Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1 ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c < 7% will remain on previously assigned randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c >= 7% will be re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or placebo with Week 12 HbA1c >= 7% will remain on previously assigned treatment. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding. At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1: ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding. ; DRUG USED: Jardiance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion Criteria: - Patients aged 10 to 17 years (inclusive) at the time of randomisation (Visit 2) - Male and female patients - Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patients legal representative information sheet. - Signed and dated written informed consent provided by the patients parent(s) (or legal guardian) and patients assent in accordance with ICH-GCP and local legislation prior to admission to the trial (informed assent will be sought according to the patients age, level of maturity, competence and capacity) - Documented diagnosis of T2DM at Visit 1A: - DINAMO TM: Documented diagnosis of T2DM for at least 8 weeks at Visit 1A - DINAMO TM Mono: Confirmation of T2DM at Visit 1A - Insufficient glycaemic control as measured by the central laboratory at Visit 1A: - DINAMO TM: HbA1c ≥ 6.5% and ≤ 10.5% - DINAMO TM Mono: HbA1c ≥ 6.5% and ≤ 9.0% - DINAMO TM: Patients treated with - diet and exercise plus metformin at a stable dose for 8 weeks prior to Visit 2 or not tolerating metformin (defined as patients who were on metformin treatment for at least 1 week and had to discontinue metformin due to metformin-related side effects as assessed by the investigator) AND/OR - diet and exercise plus stable basal or MDI insulin therapy,, defined as a weekly average variation of the basal insulin dose ≤ 0.1 IU/kg over 8 weeks prior to Visit 2. - DINAMOTM Mono: Drug-naïve patients or patients not on active treatment (including discontinuation of metformin due to intolerance [or previous discontinuation for other reasons] and/or discontinuation of insulin [insulin use must be 8 weeks or less] at investigators discretion) prior to or at Visit 1A) - BMI ≥ 85th percentile for age and sex according to WHO references at Visit 1B - Non-fasting serum C-peptide levels ≥ 0.6 ng/ml as measured by the central laboratory at Visit 1A - Compliance with trial medication intake must be between 75% and 125% during the open-label placebo run-in period - Further inclusion criteria apply Exclusion Criteria: - Any history of acute metabolic decompensation such as diabetic ketoacidosis within 8 weeks prior to Visit 1A and up to randomisation (mild to moderate polyuria at the time of randomisation is acceptable) - Diagnosis of monogenic diabetes (e.g. MODY) - History of pancreatitis - Diagnosis of metabolic bone disease - Gastrointestinal disorders that might interfere with study drug absorption according to investigator assessment - Secondary obesity as part of a syndrome (e.g. Prader-Willi syndrome) - Any antidiabetic medication (with the exception of metformin and/or insulin background therapy) within 8 weeks prior to Visit 1A and until Visit 2 - Treatment with weight reduction medications (including anti-obesity drugs) within 3 months prior to Visit 1A and until Visit 2 - History of weight-loss surgery or current aggressive diet regimen (according to investigator assessment) at Visit 1A and until Visit 2 - Treatment with systemic corticosteroids for > 1 week within 4 weeks prior to Visit 1A and up to Visit 2 Inhaled or topical use of corticosteroids (e.g. for asthma/chronic obstructive pulmonary disease) is acceptable. - Change in dose of thyroid hormones within 6 weeks prior to Visit 1A or planned change or initiation of such therapy before Visit 2 - Known hypersensitivity or allergy to the investigational products or their excipients - Impaired renal function defined as estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m² (according to Zappitelli formula) as measured by the central laboratory at Visit 1A - Indication of liver disease defined by serum level of either alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase above 3 fold upper limit of normal (ULN) at Visit 1A as measured by the central laboratory at Visit 1A - History of belonephobia (needle phobia) - Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1A, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix - Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia) - Any other acute or chronic medical or psychiatric condition or laboratory abnormality that, based on investigators judgement, would jeopardize patient safety during trial participation or would affect the study outcome - Medical contraindications to metformin according to the local label (for patient on metformin background therapy) - Patient not able or cannot be supported by his/her parent(s) or legal guardian to understand and comply with study requirements based on investigators judgement - Previous randomisation in this trial - Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s) - Chronic alcohol or drug abuse within 3 months prior to Visit 1A or any condition that, in the investigators opinion, makes them an unreliable trial patient or unlikely to complete the trial - Female patients who are pregnant, nursing, or who plan to become pregnant in the trial ; PRIMARY OUTCOME: DINAMO TM: Change from baseline in HbA1c (%); SECONDARY OUTCOME 1: DINAMO TM: Change from baseline in fasting plasma glucose (mg/dl)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TEMPO-1 (Fixed Dose, Early Stage); BRIEF: The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD. ; DRUG USED: Tavapadon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine 1 (D1) Receptor, Dopamine 5 (D5) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Cerevel Therapeutics, LLC; CRITERIA: Key Inclusion Criteria: - Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF) - Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment - Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol - Participants with a diagnosis of PD that is consistent with the UK Parkinsons Disease Society Brain Bank diagnostic criteria - Participants with modified Hoehn and Yahr stage 1, 1.5, or 2 - Participants with disease duration (from time of diagnosis) of less than (<) 3 years and disease progression in the 3 years before signing the ICF - Participants with an MDS-UPDRS Part II score >=2 and Part III score >=10 at the Screening Visit and at the Baseline Visit - Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management - Participants who are treatment naïve or have a history of prior incidental treatment with dopaminergic agents (including Levodopa [L-Dopa] and dopamine receptor agonist medications) for <3 months in total but not within 2 months of the Baseline Visit. Prior and concurrent use of monoamine oxidase B (MAO-B) inhibitors is permitted if use was initiated >90 days before the Baseline Visit and the dosage will remain stable for the duration of the trial (i.e, no change in the MAO-B inhibitor dose is permitted during the trial) - Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial. Key Exclusion Criteria: - Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism). - Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages. - Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5). - Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures. - Participants with a history of psychosis or hallucinations within the previous 12 months. - Participants who answer yes on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer yes on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide. - Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days) - Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial - Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding). - Participants who have a positive result for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at screening. - Participants with a history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical intervention; second- or third-degree atrioventricular block; sick sinus syndrome; severe or unstable angina; or congestive heart failure within the last 12 months. A recent (less than or equal to [<=] 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control. - Participants with a history of neuroleptic malignant syndrome. - Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration). - Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any Tetrahydrocannabinol [THC]-containing product), prescription, or over-the-counter medications or products that, in the investigators documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor - Participants with a Montreal Cognitive Assessment (MoCA) score <26 - Participants with clinically significant orthostatic hypotension (eg, syncope) - Participants with a 12-lead ECG demonstrating a QTcF interval >450 msec - Participants with moderate or severe renal impairment (creatinine clearance as estimated by Cockcroft-Gault formula <30 mL/min or on dialysis) - Participants with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary: - Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >=3 × Upper Limit Normal (ULN). - Total bilirubin >=1.5 × ULN. Participants with a history of Gilberts syndrome may be eligible provided they have a value <ULN for direct bilirubin. - Participants with other abnormal laboratory test results, vital sign results, or ECG findings unless, in the judgment of the investigator, the findings are not medically significant and would not impact the safety of the participants or the interpretation of the trial results. ; PRIMARY OUTCOME: Change From Baseline in the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score; SECONDARY OUTCOME 1: Change From Baseline in the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Parts II Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMAGINE 5 (Open-Label); BRIEF: The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: - Change in participants overall blood sugar control - The rate of night time low blood sugar episodes - The number of participants that reach blood sugar targets without low blood sugar episodes at night - The rate of low blood sugar episodes reported over a 24-hour period ; DRUG USED: LY2605541; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have had type 2 diabetes mellitus for at least 1 year - Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose - Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening - Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2) - Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug Exclusion Criteria: - Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks - Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening - For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations - Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss - Have had any episodes of severe hypoglycemia within 6 months prior to screening - Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening - Have cardiac disease with functional status that is New York Heart Association Class III or IV - Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter [µmol/L]) - Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements - Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c - Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator - Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening - Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter [mmol/L]) at screening - Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigators opinion - Lipid-lowering medication: Are using or have used any of the following: - niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or - lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening ; PRIMARY OUTCOME: Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Change From Baseline to 52 Weeks in HbA1c[/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 - Study 302 (Moderate to Severe GERD); BRIEF: The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD). ; DRUG USED: AcipHex ER; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: KEY INCLUSION CRITERIA: 1. Male or female, ages 18 to 75 years. 2. History of GERD symptoms for at least 3 months immediately before screening. 3. Heartburn for at least 2 days a week for at least 1 month before screening. 4. Esophageal erosions of LA Grades C or D based on EGD taken within 14 days prior to enrollment. 5. Subjects who are H. pylori negative based on a screening test. 6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception. 7. Subjects must be able to read, write, and understand the language of the symptom diary. KEY EXCLUSION CRITERIA: 1. Current or a history of esophageal motility disorders. 2. Current or a history of Barretts esophagus. 3. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications). 4. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer. 5. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma. 6. Inflammatory bowel disease. 7. Unstable diabetes mellitus. 8. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer. 9. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day). ; PRIMARY OUTCOME: Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by 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 - 204958; BRIEF: Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb) that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. This study will compare the pharmacokinetics and safety of mepolizumab administered as a liquid drug product in two different devices with the reconstituted lyophilized drug product in healthy subjects. Subjects will receive a single administration of 100 milligram (mg) mepolizumab as a single injection. The randomization will be stratified by body weight (<70 kilogram (kg), 70 <80 kg and >=80 kg) and the site of injection will be randomized 1:1:1 to the upper arm, abdomen or thigh. Approximately 243 healthy subjects will be randomized so that at least 9 subjects are randomized to each mepolizumab treatment within each weight strata and 3 subjects within each mepolizumab treatment, weight strata and injection site. Each subject will participate in the study for up to approximately 16 weeks (up to 85 days after drug administration), and will have a screening visit, a single dose treatment period, and a follow-up visit. ; DRUG USED: Nucala Liquid Formulation; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria - 18 years of age and over 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, vital signs, 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 agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or ability to interpret study results. - Body weight >=50 kg and body mass index (BMI) within the range 19.0-30 kg/square meter(m^2) (inclusive) - Male or Female: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: pre-menopausal females with documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up; confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy; post- menopausal females. Subject is of reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until 16 weeks after the administration of the single dose of study medication. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. The subject must be able to understand and communicate in the native language of the site, e.g. German in German sites. Exclusion Criteria - Alanine transaminase >1.5x upper limit of normal (ULN) - Bilirubin >1.5xULN (isolated bilirubin >1.5x ULN 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) - QTc corrected by Fridericias (QTcF) formula>450 milliseconds (msec) - Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or 12-lead electrocardiogram. - 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) before the first dose of study medication and until study completion, unless in the opinion of the investigator and GlaxoSmithKline 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 units for females and >21 units for males. One unit is equivalent to 8 grams of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. - Urinary nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. Limit of >500 nanogram/mL. - Involved in any activities likely to result in any significant decrease or increase in body weight during the study period (e.g. crash dieting, bodybuilding). - 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. - A positive test for human immunodeficiency virus antibody. - Subjects with known, pre-existing helminthes infestation within 6 months prior to Day 1. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months. - 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. - A positive pre-study drug/alcohol screen. - A vulnerable subject. Defined as individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. - Subjects who work for the Sponsor, contract research organization, or one of the study centers. ; PRIMARY OUTCOME: Maximum Observed Plasma Concentration (Cmax) of Mepolizumab; SECONDARY OUTCOME 1: Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab[/INST]Yes</s>

<s>[INST]<<SYS>>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 - Ritux 3; BRIEF: Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients. The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease, control trials are difficult to conduct. Evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against B- lymphocytes) or immunoadsorbtion. ; DRUG USED: Rituxan; DRUG CLASS: Biologic; INDICATION: Pemphigus Vulgaris; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: University Hospital, Rouen; CRITERIA: Inclusion Criteria: - age >=18 and <= 80years - consent obtained from patient - effective female contraceptive method for women in procreate age - new case of pemphigus vulgaris (PV) or pemphigus foliaceus (PF) Exclusion Criteria: - pemphigus vulgaris (PV) or pemphigus foliaceus (PF) treated - pregnant woman or nursing mother - woman able to have a baby and without contraception during the clinical trial period - age < 18 or > 80 - karnovsky < 50% - serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody - patient with depletion lymphocytic treatment in the next month - unstable angina or ischemic heart disease - cardiac insufficiency - cardiac rhythm trouble uncontrolled - positive HIV serology - positive hepatitis B and / or C serology - no consent ; PRIMARY OUTCOME: Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment; SECONDARY OUTCOME 1: Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab 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 IIIb - Study 1474 (vs. Plasma); BRIEF: The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery. ; DRUG USED: Kcentra; DRUG CLASS: Biologic; INDICATION: Hemostasis; TARGET: Coagulation Factor IX, Coagulation Factor VII, Coagulation Factor X, Protein C, Protein S, Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Male and female subjects greater than or equal to 18 years, - Subjects currently on oral vitamin K antagonist (VKA) therapy, - An urgent surgical procedure is required within 24 hours of the start of investigational medicinal product (IMP), - Due to the nature of the procedure, withdrawal of oral VKA therapy and infusion of plasma are also indicated to reverse the VKA effect, - INR greater than or equal to 2 within 3 hours before start of IMP, - Informed consent has been obtained. Exclusion Criteria: - Subjects requiring urgent surgical procedures where according to the surgeons clinical judgment, an accurate estimate of blood loss is not possible (e.g., ruptured aneurysm), - Subjects for whom administration of intravenous vitamin K and vitamin K antagonists withdrawal alone can adequately correct the subjects coagulopathy before initiation of the urgent surgical procedure, - Administration of intravenous vitamin K more than 3 hours or administration of oral vitamin K more than 6 hours prior to infusion of IMP, - Subjects in whom lowering INR within normal range may present an unacceptable risk for a thromboembolic complication where the INR goal is to lower but not normalize the INR because of risk of a procedure-associated stroke, - Subjects, who despite medical management that includes close monitoring and diuretics, may not, by investigator assessment, tolerate the total volume of IMP required by the protocol, - Expected need for additional non-study blood products before infusion of IMP (Note: Administration of packed red blood cells is not an exclusion criterion), - Expected need for platelet transfusions or desmopressin before Day 10, - Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control or resolve an acute bleeding complication and/or control the acute bleeding event, - Unfractionated or low molecular weight heparin use within 24 hours before randomization or potential need before completion of the procedure, - History of thromboembolic event, myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment, - Reversal of VKA therapy alone may not resolve the coagulopathy (eg, receiving a potent anti-platelet agent, i.e., clopidogrel or prasugrel, or advanced liver disease), - Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies, - Suspected or confirmed serious viral or bacterial infection, e.g., meningitis, or sepsis at time of enrollment, - Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study (Note: Administration of packed red blood cells is not an exclusion criterion), - Pre-existing progressive fatal disease with a life expectancy of less than 2 months, - Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia, - Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study, - Presence or history of hypersensitivity to components of the study medication, - Pregnant or breast-feeding women, - Prior inclusion in this study or any other CSL Behring sponsored Beriplex study, - For subjects with intracranial hemorrhage with: - Glasgow Coma Score <10 (see Appendix 8) - Modified Rankin Score > 3 prior to ICH (see Appendix 9) - Intracerebral hemorrhage - Epidural hematomas - Infratentorial hemorrhage - Subarachnoid hemorrhage (SAH) subjects with a Hunt and Hess Scale >2 - Subdural hematomas that: - are judged to be an acute subdural hematoma (based on neurosurgeon review) - have a concurrent SAH or parenchymal contusion ; PRIMARY OUTCOME: Percentage of Participants Achieving Hemostatic Efficacy During Surgery; SECONDARY OUTCOME 1: Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S[/INST]Yes</s>

<s>[INST]<<SYS>>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 - REPLACE (w/Peginterferon Alfa-2a/Ribavirin GT1); BRIEF: The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1. ; DRUG USED: Incivek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Monotherapy; LEAD SPONSOR: Janssen-Cilag International NV; CRITERIA: Inclusion Criteria: - First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1 - More than 6 months to 10 years post-liver transplant - Patient did or did not receive treatment for HCV prior to liver transplantation - Patient must agree to have a liver graft biopsy during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant) - A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin Exclusion Criteria: - Patient is currently infected or co-infected with HCV of another genotype than genotype 1 - Patient received treatment for hepatitis C following liver transplantation - Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C - Patient with human immunodeficiency virus or hepatitis B virus co-infection - Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma) ; PRIMARY OUTCOME: Number of patients achieving sustained virologic response (SVR) 12 planned; SECONDARY OUTCOME 1: Number of patients achieving SVR12 planned(c)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Cdiffense; BRIEF: The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: - To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: - To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. - To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: - To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: - To describe the safety profile of all participants who received at least 1 injection. ; DRUG USED: ACAM-CDIFF; DRUG CLASS: Vaccine; INDICATION: Clostridium difficile-Associated Diarrhea/Infection (CDAD/CDI); TARGET: Clostridium difficile toxins A and B, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: - Aged >= 50 years on the day of inclusion - Informed consent form had been signed and dated. - Attended all scheduled visits and complied with all trial procedures. - Covered by health insurance (if required). - Must fulfill at least 1 of the following criteria Risk Stratum 1: - Had at least 2 hospital stays, each lasting at least >= 24 hours, in the 12 months before enrollment, and - Had received systemic (not topical) antibiotics in the 12 months before enrollment, or Risk Stratum 2: - Was anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay was planned to be >= 72 hours for a surgery involving 1 of the following: - Kidney/bladder/urinary system - Musculoskeletal system - Respiratory system - Circulatory system - Central nervous system. Exclusion Criteria: - Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination). - Participation in the 4 weeks preceding the first trial vaccination or participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. - Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for influenza (seasonal or pandemic) and pneumococcal vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. - Previous vaccination against C. difficile with either the trial vaccine, another vaccine, or monoclonal antibodies. - Diarrhea on day of enrollment. - Self-reported current or prior CDI episode. - Anticipated or current receipt of kidney dialysis treatment. - History of gastrointestinal surgery for gastrointestinal malignancy (Note: Colonoscopy, polypectomy, and appendectomy are not exclusion criteria). - History of inflammatory bowel disease, irritable bowel syndrome (must include diarrhea as a symptom), colostomy, or small or large intestine bowel surgery where resection was performed. - Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube feeding). - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances. - Self-reported thrombocytopenia, contraindicating intramuscular vaccination. - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. - Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the Investigator. - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>= 100.4°Fahrenheit]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. ; PRIMARY OUTCOME: Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases; SECONDARY OUTCOME 1: Number of Participants With Severe PCR-Confirmed Primary CDI Cases[/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 - Inadequate Control Candesartan Cilexetil Mono; BRIEF: This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone. Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone. Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks. ; DRUG USED: BAY 98-7106; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: - Inclusion Criteria: - Male and female subjects 18 years or older are eligible. - At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP (mean seated systolic blood pressure) of >/= 160 mmHg and < 200 mmHg, and 24 hours MASBP (mean ambulatory systolic blood pressure) >/= 130 mmHg; those subjects treated with antihypertensive medication are to have MSSBP >/= 150 mmHg and < 200 mmHg as measured by a calibrated electronic BP measuring device - At Visit 3,subject must have MSSBP >/= 140 mmHg before randomization. - Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active. This applies since signing of the IC (informed consent)form until the last study drug administration. - Exclusion Criteria: - Mean seated systolic blood pressure (MSSBP) >/= 200 mmHg and/or mean seated diastolic blood pressure (MSDBP) >/= 120 mm/Hg - Mean seated diastolic blood pressure (MSDBP) < 60 mm/Hg - Differences greater than 20 mmHg for systolic blood pressure (SBP) and 10 mmHg for diastolic blood pressure (DBP) are present on 3 consecutive blood pressure readings at visit 0 - Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc. - Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA]) within the previous 12 months - History of hypertensive retinopathy - known Keith-Wagener Grade III or IV. Any history of heart failure, New York Heart Association (NYHA) classification III or IV - Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0 - Clinically significant cardiac valvular disease - Subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study. - Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by glycosylated hemoglobin HbA1C of greater than 9% on visit 0 ; PRIMARY OUTCOME: Change in mean seated systolic blood pressure (MSSBP).; SECONDARY OUTCOME 1: Change in mean seated diastolic blood pressure (MSDBP).[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Children (Ages 5-14); BRIEF: The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia. ; DRUG USED: Voxzogo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Achondroplasia; TARGET: Natriuretic Peptide Receptors; THERAPY: Monotherapy; LEAD SPONSOR: BioMarin Pharmaceutical; CRITERIA: Inclusion Criteria - Parent(s) or guardian(s) consent - 5 to < 18 years old - ACH, documented and confirmed by genetic testing - At least a 6-month period of pretreatment growth assessment in Study 111-901 before study entry - If sexually active, willing to use a highly effective method of contraception - Ambulatory and able to stand without assistance Exclusion criteria: - Hypochondroplasia or short stature condition other than ACH - Have any of the following: - Hypothyroidism or hyperthyroidism - Insulin-requiring diabetes mellitus - Autoimmune inflammatory disease - Inflammatory bowel disease - Autonomic neuropathy - History of any of the following: - Renal insufficiency defined as serum creatinine > 2 mg/dL - Chronic anemia - Baseline systolic blood pressure (BP) < 70 millimeters of mercury (mm Hg) or recurrent symptomatic hypotension (defined as episodes of low BP generally accompanied by symptoms ie, dizziness, fainting) or recurrent symptomatic orthostatic hypotension - Cardiac or vascular disease - Have a clinically significant finding or arrhythmia on screening electrocardiogram (ECG) that indicates abnormal cardiac function or conduction or Fridericias corrected QTc-F > 450 msec - Have an unstable condition likely to require surgical intervention during the study (including progressive cervical medullary compression or severe untreated sleep apnea) - Decreased growth velocity (< 1.5 cm/yr) over a period of 6 months or evidence of growth plate closure (proximal tibia, distal femur) - Treated with growth hormone, insulin-like growth factor 1 (IGF-1), or anabolic steroids in the previous 6 months or treatment greater than 6 months at any time - Greater than 1 month treatment with oral corticosteroids (low-dose ongoing inhaled steroid for asthma, or intranasal steroids, are acceptable) in the previous 12 months - Planned or expected to have limb-lengthening surgery during the study period. Subjects with previous limb- lengthening surgery may enroll if surgery occurred at least 18 months prior to the study and healing is complete without sequelae. - Planned or expected bone-related surgery (ie. surgery involving disruption of bone cortex, excluding tooth extraction), during the study period. Subjects with previous bone-related surgery may enroll if surgery occurred at least 6 months prior to the study and healing is complete without sequelae. - Had a fracture of the long bones or spine within 6 months prior to screening - History of severe untreated sleep apnea - New initiation of sleep apnea treatment (e.g. CPAP or sleep apnea-mitigating surgery) in the previous 2 months prior to screening - History of hip surgery or hip dysplasia atypical for achondroplastic subjects - History of clinically significant hip injury in the 30 days prior to screening - History of slipped capital femoral epiphysis or avascular necrosis of the femoral head - Abnormal findings on baseline clinical hip exam or imaging assessments that are determined to be clinically significant - Concurrent disease or condition that would interfere with study participation or safety evaluations, for any reason - Condition or circumstance that places the subject at high risk for poor treatment compliance or for not completing the study ; PRIMARY OUTCOME: Change From Baseline in Annualized Growth Velocity (AGV) at Week 52; SECONDARY OUTCOME 1: Change From Baseline in Height Z-score at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - X-TRA; BRIEF: A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stroke Prevention in Atrial Fibrillation (SPAF); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Men or women aged >/= 18 years - Hemodynamically stable nonvalvular AF or atrial flutter - LA/LAA thrombus documented at baseline by transesophageal echocardiography (TEE) up to 72 hours prior to start of study medication - vitamin K antagonist(s) (VKA)/ new oral anticoagulant(s) (NOAC)-naïve or untreated within 1 month prior to signing of the informed consent form - VKA pretreated but under ineffective INR levels(<2.0,documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks - Women of childbearing potential and men must agree to use adequate contraception when sexually active Exclusion Criteria: - Transient Ischemic Attack within 3 days prior to study inclusion - Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug - Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion - Acute myocardial infarction within the last 14 days prior to study inclusion - Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, Intracardiac tumor, known left ventricular or aortic thrombus - Active bleeding or high risk for bleeding contraindicating anticoagulant therapy - Concomitant drugs/therapies: Indication for anticoagulant therapy for a condition other than nonvalvular AF or atrial flutter (eg, venous thromboembolism). Concomitant use of anticoagulant drugs, including VKA, or factor IIa or factor Xa inhibitors. Chronic aspirin therapy >100 mg or dual antiplatelet therapy. Concomitant use of strong inhibitors of both cytochrome P450 (CYP) 3A4 and P glycoprotein (P-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents-ketoconazole, itraconazole, voriconazole, and posaconazole-if used systemically - Concomitant conditions: Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding. Hypersensitivity to investigational treatment. Calculated creatinine clearance (CrCl) < 15 mL/minute at the screening visit. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk. Any severe condition that would limit life expectancy to less than 3 months (eg, advanced malignancy, etc.). Planned invasive procedure with potential for uncontrolled bleeding or increased risk of stroke, including major surgery, cardiac catheterization, or cardioversion prior to the end-of-treatment TEE. Inability to take oral medication. Ongoing drug addiction or alcohol abuse ; PRIMARY OUTCOME: The percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatment; SECONDARY OUTCOME 1: Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CD-010 (Open-Label Safety); BRIEF: A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines ; DRUG USED: Tosymra; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion Criteria: 1. Patients with a history of acute migraine (using International Classification of Headache Disorders [ICHD] criteria, second edition); 2. Patients who, in the opinion of the investigator, are willing and able to: - Return to the study site within 72 hours of the first use of study medication, - Record each migraine and each instance of the use of study medication and rescue medication in a patient diary for the duration of the study; 3. Patients who can use the nasal spray device correctly after instruction. Exclusion Criteria: 1. Patients on onabotulinumtoxinA (Botox®) or other botulinum toxin treatment; or history of receiving such treatment 180 days prior to screening; 2. Patients with a history of stroke or transient ischemic attack (TIA); 3. Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder; 4. Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache; 5. Patients with ischemic coronary artery disease (CAD; ie, angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetals angina); 6. Patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; 7. Patients with uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg); 8. Patients with peripheral vascular disease or ischemic bowel disease; 9. Patients taking any medications or with illnesses likely to affect the physiology of the nasal mucosa (ie, patients with nasal septum surgery, chronic sinusitis, or chronic nasal rhinitis). (Note: Patients who have acute conditions such as acute sinusitis may be rescreened 14 days after resolution of acute sinusitis.); 10. Patients with any abnormal nasal physiology or pathology which, in the opinion of the investigator, would not allow the objectives of the study to be accomplished; 11. Patients with known intolerance to nasal sprays; 12. Patients with severe renal impairment (defined as serum creatinine > 2 mg/dL); 13. Patients with serum total bilirubin > 2.0 mg/dL; 14. Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal (ULN); 15. Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection; 16. Patients with a positive urine drug screen for illicit drugs or for prescription drugs not explained by stated concomitant medications. (Positive drug screen for marijuana is exclusionary.): 1. Patients consuming opioids for the treatment of migraine or using opioids or barbiturates temporarily for a legitimate medical cause may participate as long as they do not meet the MOH criteria. 2. Benzodiazepines are allowed if used for legitimate medical use. 3. Chronic use of amphetamines to treat attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) and related disorders is allowed as long as the regimen has been stable for at least 3 months prior to screening and is expected to remain stable throughout the study. Note: For the above-mentioned conditions, the site must obtain medical monitor approval. 17. Patients with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection; 18. Patients who have received treatment with an investigational drug or device within 4 weeks of the screening visit or participated in a central nervous system clinical trial in the 3 months prior to screening; 19. Patients who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody serology testing. 20. Patients with any other medical condition that, in the judgment of the investigator or medical monitor, would confound the objectives of the study (eg, cancer history [except basal cell carcinoma], systemic lupus erythematosus) ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events; 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 - AL012; BRIEF: This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD. ; DRUG USED: MDX; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Alcobra Ltd.; CRITERIA: Inclusion Criteria: - Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening Visit. - Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and DSM5. - Subject has ADHD with at least moderate clinical severity (Clinical Global Impression-Severity [CGI-S]) score of 4 or greater). - Subject has a score on the total ADHD symptom score with adult prompts of the CAARS-Inv of at least 22. - Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study - Subject is able to attend the clinic regularly and reliably. - Subject is able to swallow tablets and capsules. - Subject is able to understand, read, write, and speak English fluently to complete the study-related materials (or Hebrew for Israeli subjects). - Subject is able to understand and sign an informed consent form to participate in the study. Exclusion Criteria: - Subject did not respond in the past to 2 adequate trials of stimulant treatments or 1 adequate trial of atomoxetine treatment (in the investigators judgment). - Subject has any psychiatric condition clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator . - Subject has a known or suspected human immune deficiency virus-positive status or has diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis. - Subject has a history of an allergy or sensitivity to B-complex vitamins. - Subject has a history of intellectual disability or a history or suspicion of autism spectrum disorder. - Subject has a current Axis I diagnosis (other than ADHD) according to the Structured Clinical Interview for DSM IV Axis I Disorders (SCID) or has a lifetime history of bipolar disorder or psychosis. - Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the Screening Visit. - Subject has used high-dose supplements of omega-3 fatty acids ≥ 500 mg on at least 1 day or folic acid supplements during the 2 weeks before the Screening Visit. - Subject has used an investigational medication/treatment in the 30 days before the Screening Visit - Subject has used any medication or food supplement that the investigator or the medical monitor considers unacceptable during the 14-day period before randomization. - Subject has a current drug or alcohol dependence or substance abuse disorder according to DSM-IV. Subject should also agree to keep their caffeine intake consistent and refrain from consuming ≥300 mg per day of caffeine (no more than three 8-ounce servings of coffee) during the study. - Subject has suicidality, defined as active ideation, an intent or plan, or any significant lifetime suicidal behavior. Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded. - Subject has taken any prescription or non-prescription ADHD medications during the 14 days (for all psychotropic medications other than fluoxetine) or 28 days (for fluoxetine) before the randomization visit. - Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses - Subject is related to the sponsor, investigator, or study staff. - Subject has any condition that, in the principal investigators opinion, would place the subject at risk or influence the conduct of the study or interpretation of results, - Subject cannot fully comprehend the implications of the protocol, cannot comply with its requirements, or is incapable of following the study schedule for any reason. - Subject is pregnant, lactating, or using an inadequate contraceptive method. - If there is a ≥25% change in the CAARS-Inv results between the Interim visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. ; PRIMARY OUTCOME: Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks; SECONDARY OUTCOME 1: Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Bunionectomy (Study 022); BRIEF: This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery. ; DRUG USED: MoxDuo IR; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: QRxPharma Inc.; CRITERIA: Inclusion Criteria: - Patient is male or female and at least 18 years of age. - Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment. - Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery. - To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or 4 or more on the 11 point NPRS scale). - At least 40% of study subjects will be 60 years of age or older. Exclusion Criteria: - In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that would jeopardize the patients well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments. - Used opiates continuously (including tramadol) for more than ten days in the past year. - Hypersensitivity or poor tolerance to acetaminophen. - Currently receiving any medications that are not at a stable dose (the same dose for > 2 months prior to date of surgery). - Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003. - Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia). - Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit). ; PRIMARY OUTCOME: Differences in desaturation events per standardized time unit; SECONDARY OUTCOME 1: Difference in efficacy between Q8003 and its components (morphine and oxycodone)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - AiME - 13; BRIEF: The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis. ; DRUG USED: Retacrit; DRUG CLASS: Biosimilar; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Erythropoietin Receptor (EPOR); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities 2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) dose administered IV or SC, 1 to 3 times per week for whom the following apply: - A change in Epogen dosing of no more than 10% from the mean - Mean hemoglobin between 9.0 and 11.0 g/dL - No more than one hemoglobin result outside of range from 9.0-11.0 g/dL - No hemoglobin result more than ±1 g/dL from the mean hemoglobin level 3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer 4. Patients with adequate iron stores, defined as plasma ferritin > 100 μg/L and TSAT >20%, prior to randomization 5. Male or female patients aged 18 to 80 years (both inclusive) 6. If female, patient must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control: - hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to randomization - intrauterine device (IUD) - double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream) If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to randomization. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patients last dose Exclusion Criteria: 1. Maintenance epoetin dosage >600 U/kg per week (1-3 times per week) 2. Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior to randomization 3. Any of the following within 3 months prior to randomization: - Myocardial infarction - Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction - Severe/unstable angina - Coronary angioplasty, bypass surgery, or peripheral artery bypass graft - Decompensated congestive heart failure (New York Heart Association [NYHA] class IV) - Pulmonary embolism - Deep vein thrombosis or other thromboembolic event - Received live or attenuated vaccination (except flu vaccination) 4. Uncontrolled hypertension within the 4 weeks prior to randomization defined as more than 10% of post-dialysis blood pressures >170 mmHg systolic and/or >110 mmHg diastolic, based on blood pressure readings obtained when the patients post-dialysis body weight was not more than 0.5 kg above their listed dry weight 5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not) 6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease that in the Investigators opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral or fungal infection or mental disease 7. Contraindication for the test drug or have been previously treated with Epoetin Hospira 8. Relative or absolute iron deficiency prior to randomization into the Maintenance Period 9. Platelet count below 100 x 10^9/L 10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks 11. Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for the study participation 12. History of any of the following: - Detectable anti-rhEPO antibodies - Clinically relevant malnutrition - Confirmed aluminum intoxication - Myelodysplastic syndrome - Known bone marrow fibrosis (osteitis fibrosa cystica) - Known seizure disorder - Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites) 13. A female patient who is pregnant, lactating or planning a pregnancy during the study 14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator 15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization 16. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study 17. Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization 18. A patient who in the Investigators opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit 19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) ; PRIMARY OUTCOME: Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period; SECONDARY OUTCOME 1: Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance 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 - COAST (w/Aflibercept); BRIEF: A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52. ; DRUG USED: OPT-302; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Opthea Limited; CRITERIA: Inclusion Criteria: - Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye. - An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye. Main Exclusion Criteria: - Any previous treatment for neovascular AMD. - Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging. - Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study. ; PRIMARY OUTCOME: Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters; SECONDARY OUTCOME 1: Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters[/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 - AReSVi 004; BRIEF: The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 3 years following a single dose vaccination of GSKs investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules. ; DRUG USED: GSK3844766A; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants). - Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. - Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable. Exclusion Criteria: Medical conditions - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. - Hypersensitivity to latex. - Serious or unstable chronic illness. - Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. - Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. - Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. - Any history of dementia or any medical condition that moderately or severely impairs cognition. Prior/Concomitant therapy - Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. - Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination. - Previous vaccination with an RSV vaccine. - Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. - Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period. - Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product. Other exclusions - History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. - Bedridden participants. - Planned move during the study period that will prohibit participation in the trial until the study end. This includes: - Planned move during the study period to another LTCF that will prohibit participation in the trial until study end. - Planned move from the community to a LTCF that will prohibit participation in the trial until study end. - Participation of any study personnel or their immediate dependants, family, or household members. ; PRIMARY OUTCOME: Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1; SECONDARY OUTCOME 1: Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 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 - TAO (vs. Heparin + Eptifibatide); BRIEF: Primary Objective: - To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: - To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide - To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide - To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide - To document the safety of Otamixaban as compared to UFH + eptifibatide - To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide ; DRUG USED: Preluent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with: 1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, AND 2. One of the two following criteria: - New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram, - Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal, AND 3. Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified), AND 4. Informed consent obtained in writing. Exclusion criteria: - Revascularization procedure already performed for the qualifying event Acute ST-segment elevation MI. - Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization or who have been treated by abciximab. - Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing. - Patient who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling. - Patient who cannot be treated with eptifibatide according to the national labeling (when available). In countries where eptifibatide is not approved the reference label to be considered is either the European labeling or the US labeling - Patient who cannot be treated with unfractionated heparin according to the national labeling. - Allergy to otamixaban. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction; SECONDARY OUTCOME 1: Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Propofol (EU); BRIEF: A phase III confirmatory trial evaluating the efficacy and safety of remimazolam (CNS7056) compared to propofol for intravenous anesthesia during elective surgery in ASA Class III/IV patients. ; DRUG USED: ByFavo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Paion UK Ltd.; CRITERIA: Inclusion criteria - Male or female ASA III/IV patients at least 18 years old, scheduled for an elective surgical procedure of a minimum duration of approximately 90 minutes under general anesthesia (GA) and planned to be extubated immediately post-operatively. - Total intravenous GA with the requirement for mechanical ventilation via endotracheal tube and necessary invasive blood pressure (BP) monitoring either due to severity of illness, severity of concomitant diseases, type of surgery or decisions of the anesthesia staff. - Patients scheduled to stay in the hospital long enough after the surgical procedure to perform all trial follow-up procedures (~1 day) - For female patients of childbearing potential: Negative result of a pregnancy test taken shortly before the start of the administration of the IMP as well as consent to use highly effective birth control from the last menstrual cycle prior to the start of the IMP until the end of the trial follow-up procedures. Highly effective methods of birth control include: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal and transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable and implantable - Intrauterine device (IUD) - Intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomised partner (provided that the partner is the sole sexual partner of the female patient of childbearing potential and that the vasectomised partner has received medical assessment of the surgical success) - Sexual abstinence (this method is not acceptable in Switzerland) Women who had their last menstruation at least two years ago or who underwent surgical interventions (surgical birth control, bilateral oophorectomy, hysterectomy, etc.) are regarded as having no childbearing potential Exclusion criteria - Patients scheduled for spinal anesthesia, epidural anesthesia (central neuraxial anesthesia) or regional anesthesia. The placement of a peridural catheter with a test dose application of a local anesthetic drug (up to 5 mL) to verify correct positioning to achieve post-operative analgesia and the regional administration of local anesthetic for post-operative analgesia after wound closure is accepted. - Patients undergoing transplant surgery, cardiac surgery, or intracranial neurosurgery, patients which have to be in prone position for surgery, emergency surgery, or any surgical procedure with the need for or scheduled for post-operative ventilator support. - Patients undergoing surgical procedures that require keeping the BP at a high level, e.g. surgical procedures in beach chair position - Patients with severe hypertension, i.e., one baseline result of systolic BP 200 mmHg or more and / or diastolic BP of 120 mmHg or more. Baseline is defined as the time after signature of the informed consent form (ICF) and before arrival in the operating room (OR) suite. - Patients with total bilirubin of ≥3.0 mg/dL or ≥3 times increase in aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) than the institutional reference range in laboratory tests, or any other laboratory results that make the patient unsuitable for the trial. All laboratory tests relevant for subjects enrolment must be performed within 7 days prior to start of IMP* * If the screening samples for the central laboratory were taken earlier than within the last 7 days prior to start of IMP, the lab parameters relevant for subjects enrolment are to be determined in a local laboratory within 7 days prior to start of IMP. If results from samples taken within 7 days prior to the start of the IMP/the surgery from a local laboratory are available, these can be used. If no results from the last 7 days prior to the start of the IMP/the surgery are available, samples need to be taken for the purpose of this trial and to be analysed in a local laboratory. - Patients with end stage renal disease (ESRD) requiring scheduled dialysis - Patients with known anaphylactic reactions to benzodiazepines, propofol, opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), dextran, neuromuscular blocking agents, flumazenil, naloxone, or other anesthetic agents, or a medical condition such that these agents are contraindicated (according to local label) - Presence of acute alcoholic or illicit drug intoxication, shock or coma state - Known current dependency from central nervous system depressant drugs or alcohol - Patients with gastroparesis or delayed gastric emptying, gastric reflux or any other increased risk for gastric aspiration - Patients with an anticipated (small mouth opening, impaired neck movement, goitre, head and neck tumours or any other anatomical reason) or known airway difficulties or with known difficulties in airway maintenance or mask ventilation - Patients in whom Narcotrend (NCT) may not provide reliable results due to organic defect of the brain or forehead, or any neurologic disease interfering with the EEG monitoring - Patients on treatment with valproate - Any pregnant or breast-feeding patient - Patients who participated in any clinical trial within 30 days or 5 times the half-life of the drug under investigation, whichever is longer, prior to the beginning of administration of the IMP. Exception: Non-interventional trials as defined in the European Clinical Trials Directive 2001/20/EC: A trial where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods should be used for the analysis of the collected data. - Any patient judged to lack the ability to give informed consent or perform the trial assessments (e.g., due to dementia) - Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason ; PRIMARY OUTCOME: Percentage (%) of time of Narcotrend Index (NCI) values ≤ 60 during maintenance phase of general anesthesia (defined as time between the first skin incision and the completion of the last skin suture); SECONDARY OUTCOME 1: Number of events of critical decrease(s) in mean arterial blood pressure (MAP)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - 007 - w/ Repevax; BRIEF: This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503. ; DRUG USED: Gardasil 9; DRUG CLASS: Vaccine; INDICATION: Human papillomavirus (HPV) Prevention (Antiviral, Vaccines); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion criteria: - Participant is in good health - Participants parent/legal guardian can read, understand, and complete the vaccination report card - Participant is not sexually active and does not plan on becoming sexually active during the study - Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens. Exclusion Criteria: - Participant has a known allergy to any vaccine component of V503 or REPEVAX™ - Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine - Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine - Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine - Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™ - Participant has a history of severe allergic reaction that required medical intervention - Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections - Participant is concurrently enrolled in clinical studies of investigational agents - Female participant is pregnant - Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study - Participant is immunocompromised, immunodeficient, or has an autoimmune condition - Participant has had a splenectomy - Participant has received immunosuppressive therapies in the prior year - Participant has received immune globulin product or blood-derived product in the last 3 months - Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination - Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial - Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years - Participant has a fever ≥100°F within 24 hours of vaccination - Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate - Participant and parent/legal guardian are unable to give assent/consent - Participant is unlikely to adhere to the study procedures or is planning to relocate during the study - Participant has recent history of illicit drug or alcohol abuse - Participant has a history of HPV ; PRIMARY OUTCOME: Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503; SECONDARY OUTCOME 1: Percentage of Participants Who Seroconvert for Each of the HPV Types[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PROTECT-1 (w/Mesalazine, EU); BRIEF: The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment. ; DRUG USED: LT-02; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: Cell Membrane, Phosphatidylcholine; THERAPY: Combination; LEAD SPONSOR: Dr. Falk Pharma GmbH; CRITERIA: Inclusion Criteria: - Established diagnosis of ulcerative colitis - Active ulcerative colitis disease extent ≥ 15 cm - Active disease despite treatment with mesalamine Exclusion Criteria: - Crohns disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis, - Toxic megacolon or fulminant colitis - Colon resection - Evidence of infectious colitis - Celiac disease - Bleeding hemorrhoids - History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack - Any severe concomitant renal, endocrine, or psychiatric disorder - Any relevant known systemic disease - History of cancer in the last five years - Abnormal hepatic function or liver cirrhosis - Abnormal HbA1c at screening visit - Patients with known hypersensitivity to soy - Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP) - Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins - Treatment with other investigational drug - Existing or intended pregnancy or breast-feeding ; PRIMARY OUTCOME: Rate of clinical remission; SECONDARY OUTCOME 1: Rate of patients with clinical improvement[/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 - RECAPTURE-2; BRIEF: The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis ; DRUG USED: Avycaz; DRUG CLASS: Non-NME; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - 18 to 90 years of age inclusive - Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after - Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem) - Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis Exclusion Criteria: - Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem - Patients urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI - Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant - Patient is immunocompromised - Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality ; PRIMARY OUTCOME: Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test; SECONDARY OUTCOME 1: Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ECOG 1505; BRIEF: This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - In order to be eligible for this trial, patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) [stage IB (>= 4 cm)] - [IIIA (T2-3N0, T1-3N1, T1-3N2] prior to enrollment; accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy; resections by segmentectomy or wedge resection will not be accepted; mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors) - Patients must be no less than 6 weeks (42 days) and no more than 12 weeks (84 days) post-thoracotomy at the time of randomization and must be adequately recovered from surgery - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Patients must not have received the following: - Prior systemic chemotherapy at any time; methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 2 weeks prior to date of registration will be allowed; other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required - Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable) - Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer - Absolute neutrophil count (ANC) >= 1500 mm^3 - Platelets >= 100,000/mm^3 - Prothrombin time/international normalized ratio (INR) =< 1.5 - Or, if patient is on therapeutic anticoagulation, prothrombin time/INR =< 3.0 - Partial thromboplastin time (PTT) =< institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be =< 1.5 x ULN - Total bilirubin =< 1.5 mg/dL - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 5 x upper limit of normal (ULN) - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 x institutional upper limit of normal (ULN) - Urine protein should be screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1000 mg (1 g) for patient enrollment - Patients with a known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 12 months prior to randomization - Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial - Women must not be pregnant or breast-feeding - All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy - Both fertile men and women must agree to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab - Patients must not have any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements - Patients must have no history of bleeding diathesis or coagulopathy - All patients must have a documented blood pressure (BP) with systolic =< 150 and diastolic =< 90 within 28 days of registration; patients with known hypertension must be on a stable regimen of anti-hypertensive therapy - Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory agents (NSAIDS) are eligible; treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed; patients must have stopped taking any of these agents at least 7 days prior to randomization - Patients must not have serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization OR core biopsy within 7 days prior to randomization - Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to randomization - Patients must not have any anticipated major surgical procedure(s) during the course of the study - Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices, provided that coagulation studies meet entry criteria above; caution must be exercised for patients requiring anticoagulation, including treatment with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis while on study - Patients with ongoing post-operative hemoptysis (defined as bright red blood of 1/2 teaspoon or more) are not eligible; patients with pre-operative hemoptysis that has resolved post-operatively are eligible - Patients who will receive pemetrexed (pemetrexed disodium)/cisplatin therapy must also meet the following criteria: - Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology - Calculated creatinine clearance must be obtained within 2 weeks of randomization and calculated creatinine clearance (CrCl) must be >= 45 mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method ([51]chromium-labeled ethylenediaminetetraacetic acid [51-CrEDTA] or technetium 99m diethylenetriamine-pentaacetic acid [Tc99m-DTPA]) must be used to calculate CrCl ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Disease-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 - Persistent Erythema (REVEAL 1); BRIEF: This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea. ; DRUG USED: Rhofade; DRUG CLASS: Non-NME; INDICATION: Rosacea; TARGET: Alpha Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: -Moderate to severe persistent facial erythema associated with rosacea. Exclusion Criteria: - Greater than 3 inflammatory lesions on the face - Current treatment with monoamine oxidase (MAO) inhibitors - Raynauds syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogrens syndrome. ; PRIMARY OUTCOME: Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales; SECONDARY OUTCOME 1: Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KATHERINE (vs. Herceptin adjuvant; HER2+ Residual Invasive); BRIEF: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patient, >/= 18 years of age - HER2-positive breast cancer - Histologically confirmed invasive breast carcinoma - Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible) - Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy - Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol - Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy - An interval of no more than 12 weeks between the date of surgery and the date of randomization - Known hormone-receptor status - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate hematologic, renal and liver function - Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy. - For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug - Documentation of hepatitis B virus and hepatitis C virus serology is required Exclusion Criteria: - Stage IV (metastatic) breast cancer - History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ - Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery - Progressive disease during preoperative systemic therapy - Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment - History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above - Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons - Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy - History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2 - Cardiopulmonary dysfunction as defined by protocol - Prior treatment with trastuzumab emtansine - Current severe, uncontrolled systemic disease - Pregnant or lactating women - Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis - Concurrent serious uncontrolled infections requiring treatment or known infection with HIV - History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product ; PRIMARY OUTCOME: Invasive Disease-free Survival (IDFS); SECONDARY OUTCOME 1: Invasive Disease-free Survival Including Second Primary Non-breast Cancer[/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 - inTandem3 (Safety); BRIEF: This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D). ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participants had given written informed consent to participate in the study in accordance with local regulations - Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent - Participants were being treated with insulin or insulin analog - Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol - At the Screening Visit, A1C was between 7.0% to 11.0% - Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test Exclusion Criteria: - Use of antidiabetic agent other than insulin or insulin analog at the time of screening - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening - Chronic systemic corticosteroid use - Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator ; PRIMARY OUTCOME: Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization; SECONDARY OUTCOME 1: Change From Baseline in A1C[/INST]Yes</s>

<s>[INST]<<SYS>>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 - LOFT; BRIEF: The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants continued to receive the same blinded study medication for a total of up to 5 years of blinded study medication combined between the base study and the extension. After participants received 5 years of blinded study medication, they received open-label odanacatib through the end of the first extension. Participants were then invited to enroll in a second extension study in which they received open-label odanacatib for an additional 5 years. Two imaging substudies (PN032-Base/Extension and PN035) were conducted for participants in the MK-0822-018 Study. Additional safety information was collected for participants who discontinued from the base study or the blinded first extension in an observational follow-up study, MK-0822-083 (EudraCT number: 2007-002693-66) . ; DRUG USED: Odanacatib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoporosis / Osteopenia; TARGET: Cathepsin K (CTSK); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone mineral density - Ambulatory (able to walk) Exclusion Criteria: - Must not be taking osteoporosis therapy or have a metabolic bone disorder other than osteoporosis - Has or has had a hip fracture - Currently participating in another drug study ; PRIMARY OUTCOME: Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture; SECONDARY OUTCOME 1: Base Study: Rate of Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - J04 (HD-CKD Correction, Japan); BRIEF: For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548. ; DRUG USED: Vadadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of CKD - Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the screening period, excluding receiving home dialysis or combination of peritoneal dialysis. - Not being treated with ESAs or if being treated with ESAs, leave defined interval between last ESAs administration and the first day of the screening period - Mean of the two screening Hb levels closest in time to the baseline visit is ≥8.0 g/dL and <10.0 g/dL - Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL - Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period - Folate and vitamin B12 ≥ lower limit of normal during the screening period Exclusion Criteria: - Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia - Active bleeding or recent blood loss within 8 weeks prior to the screening period - RBC transfusion within 8 weeks prior to the screening period - Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period - AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period - Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) at the first day of the screening period and Day 1 - Ophthalmic examinations during the screening period correspond to either of the following criteria; - No available fundal findings - Findings indicating the presence of active fundal disease - Severe heart failure (New York Heart Association Class IV) - Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous intervention for coronary or heart failure within 12 weeks prior to the screening period - Current or history of malignancy. History of malignancy with no recurrence for the recent 5 years is not an exclusion criterion - New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the screening period - Current or history of hemosiderosis or hemochromatosis - History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow - Males and females of childbearing potential who are unwilling to use an acceptable method of contraception during the designated period (Males: during the study and 90 days after the last dose, females: during study and 30 days after the last dose) - Females who are pregnant or breast feeding, or are predicted to be pregnant ; PRIMARY OUTCOME: Mean Hb Level of Week 20 and Week 24; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ISABELA 1; BRIEF: The main purpose of this study was to see how GLPG1690 works together with your current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you got any side effects while on study drug). ; DRUG USED: GLPG1690; DRUG CLASS: New Molecular Entity (NME); INDICATION: Idiopathic Pulmonary Fibrosis (IPF); TARGET: Autotaxin; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Male or female subject aged ≥40 years on the day of signing the Informed Consent Form (ICF). - A diagnosis of IPF within 5 years prior to the screening visit, as per applicable American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at the time of diagnosis. - Chest high-resolution computed tomography (HRCT) historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subjects HRCT only (if no lung biopsy (LB) available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to screening is not available, an HRCT can be performed at screening to determine eligibility, according to the same requirements as the historical HRCT. - Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months. - The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator-determined). - Meeting all of the following criteria during the screening period: FVC ≥45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, diffusing capacity of the lung for carbon monoxide (DLCO) corrected for Hb ≥30% predicted of normal. - Estimated minimum life expectancy of at least 30 months for non IPF related disease in the opinion of the investigator. - Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of investigational medicinal product (IMP) (for the male subject) or the signing of the ICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP. - Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screening Visit 1; without having a contraindication to perform the 6MWT or without a condition putting the subject at risk of falling during the test (investigators discretion). The use of a cane is allowed, the use of a stroller is not allowed at all for any condition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2) should be ≥88% with maximum 6 L O2/minute; during the walk, SpO2 should be ≥83% with 6 L O2/minute or ≥88% with 0, 2 or 4 L O2/minute. Exclusion Criteria: - History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, and Ductal Carcinoma In Situ). - Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QT interval corrected for heart rate using Fridericias formula (QTcF) >450 ms, or a known long QT syndrome. Patients with implantable cardiovascular devices (e.g. pacemaker) affecting the QT interval time may be enrolled in the study based upon investigator judgment following cardiologist consultation if deemed necessary, and only after discussion with the medical monitor. - Acute IPF exacerbation within 6 months prior to screening and/or during the screening period. The definition of an acute IPF exacerbation is as follows: Previous or concurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1 month duration; Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern and deterioration not fully explained by cardiac failure or fluid overload. - Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period. - Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone). - Diagnosis of severe pulmonary hypertension (investigator- determined). - Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period (e.g. acute coronary disease, heart failure, and stroke). - Had gastric perforation within 3 months prior to screening or during screening, and/or underwent major surgery within 3 months prior to screening, during screening or have major surgery planned during the study period. - History of nintedanib-related increase in ALT and/or AST of >5 x upper limit of the normal range (ULN) and increased susceptibility to elevated LFT; moderate to severe hepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT), and/or total bilirubin ≥1.5 x upper limit of the normal range (ULN), and/or gamma glutamyl transferase (GGT) ≥3 x ULN. Retesting is allowed once for abnormal LFT. - Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once. - Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose >10 mg/day or equivalent. ; PRIMARY OUTCOME: Annual Rate of Decline in FVC up to Week 52; SECONDARY OUTCOME 1: Percentage of Participants With Disease Progression up to Week 52[/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 - TERACLES - EFC6058 (RMS); BRIEF: The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: - Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: - Disease activity as measured by brain Magnetic Resonance Imaging (MRI) - Disability progression - Burden of disease and disease progression as measured by brain MRI - Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy - Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy - Assess associations between variations in genes and clinical outcomes (safety and efficacy) - Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life - Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit) ; DRUG USED: Aubagio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Dihydroorotate Dehydrogenase (DHODH), DNA synthesis; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Patient with relapsing forms of MS treated with IFN-beta - Stable dose of IFN-beta (approved brand) for at least 6 months prior to randomization - Disease activity in the 12 months prior to randomization and after first 3 months of IFN-beta treatment (defined by at least 1 relapse supported by EDSS or equivalent neurological examination, or, at least 1 brain or spinal cord MRI with at least one T1 gadolinium enhancing lesion) Exclusion criteria: - McDonald criteria for MS diagnosis not met at time of screening visit - EDSS score greater than (>) 5.5 at randomization visit - A relapse within 30 days prior randomization - Persistent significant or severe infection - Patients must not have used adrenocorticotrophic hormone or systemic corticosteroids for 2 weeks prior to randomization - Prior or concomitant use of cytokine therapy (except baseline interferons), glatiramer acetate or intravenous immunoglobulins in the 3 months preceding randomization - Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2 times the upper limit of normal range (ULN) - Active hepatitis or hepatobiliary disease or known history of severe hepatitis - Pregnant or breast-feeding women or those who were planning to become pregnant during the study - Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia - Human Immunodeficiency Virus (HIV) positive - Known history of active tuberculosis not adequately treated - Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone - Prior use within 6 months preceding randomization or concomitant use of natalizumab, or any other immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, mycophenolate, or fingolimod The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Annualized Relapse Rate (ARR) (Poisson Regression Estimates); SECONDARY OUTCOME 1: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)[/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 - A0081066 (HIV Neuropathy); BRIEF: Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy. ; DRUG USED: Lyrica; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV-Associated Distal Sensory Polyneuropathy (HIV-DSP); TARGET: Voltage-gated calcium channels; THERAPY: Monotherapy; LEAD SPONSOR: Pfizers Upjohn has merged with Mylan to form Viatris Inc.; CRITERIA: Inclusion Criteria: - Subjects with confirmed diagnosis of HIV infection - HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start - subjects with moderate to severe pain - subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study). Exclusion Criteria: - Pregnant or breast feeding females - subjects using street drugs or alcohol abusers during the study - subjects on anti-diabetic medications - use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study - use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study. ; PRIMARY OUTCOME: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline; SECONDARY OUTCOME 1: Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices[/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 - +/- Metformin (Korea); BRIEF: Primary Objective: - To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients. Secondary Objectives: - To assess the effects of lixisenatide over 24 weeks on : - percentage of patients reaching HbA1c<7% or ≤6.5%, - 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, - fasting plasma glucose (FPG), - change in 7-point self-monitored plasma glucose (SMPG) profile), - body weight, - change in daily basal insulin dose. - To assess lixisenatide safety and tolerability. - To assess anti-lixisenatide antibody development. ; DRUG USED: Adlyxin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin. Exclusion criteria: At screening: - Age < legal age of adulthood. - HbA1c<7% or >10.5%. - Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit. - If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit. - History of hypoglycemia unawareness. - Body Mass Index (BMI) ≤20 kg/m². - Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Percentage of patients with HbA1c <7%, =<6.5%[/INST]Yes</s>

<s>[INST]<<SYS>>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 - ENESTPath; BRIEF: This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase. ; DRUG USED: Tasigna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Confirmed diagnosis of chronic phase Ph+ CML - Previous first-line treatment with imatinib for a minimum of 2 years; - Patient in complete cytogenetic response; Key Exclusion Criteria: - Previous achievement of MR4.0 at study entry; - Previous treatment with other target cells inhibitors other than imatinib; - Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening; - Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction; - Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol; - History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively; - Patients who have not recovered from prior surgery; - Treatment with other investigational agents within 4 weeks of Day 1; - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug Other inclusion/exclusion criteria might apply. ; PRIMARY OUTCOME: Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase; SECONDARY OUTCOME 1: Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 024 - 1st Line w/DTIC; BRIEF: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine ; DRUG USED: Yervoy; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Informed Consent - Measurable Disease - Eastern Cooperative Oncology Group (ECOG) 0 or 1 - Lab / imaging requirements - Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C - Men and Women > 18 years (16 were allowable) - Prior therapy restriction (adjuvant only) Exclusion: - Pregnant / nursing - Inadequate contraception - Brain metastasis - Primary ocular or mucosal melanoma ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years[/INST]Yes</s>

<s>[INST]<<SYS>>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 - REDUCE-2; BRIEF: The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen. ; DRUG USED: Duexis; DRUG CLASS: Non-NME; INDICATION: Arthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Histamine H2 Receptor (HRH2); THERAPY: Monotherapy; LEAD SPONSOR: Horizon Pharma Ireland, Ltd., Dublin Ireland; CRITERIA: Inclusion Criteria: - Expected to require daily administration of an NSAID for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain. - Did not use a NSAID within the 30 days prior to study entry Exclusion Criteria: - History of erosive esophagitis - History of any of the following serious gastrointestinal complications: - perforation of ulcers, - gastric outlet obstruction due to ulcers, or - gastrointestinal bleeding. - Active cardiac, renal, and/or hepatic disease - Current Helicobacter pylori (H. pylori) infection - Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry. - Uncontrolled diabetes - Uncontrolled hypertension - Positive pregnancy test at screening - Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. - Currently participating, or participation within 30 days prior to study entry, in an investigational drug study Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria. ; PRIMARY OUTCOME: Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers; SECONDARY OUTCOME 1: Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AUGMENT; BRIEF: The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo. ; DRUG USED: Duaklir Pressair; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Male or female patients at least 40 years of age - Current or former cigarette smoker with a cigarette smoking history of at least 10 pack-years - A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the GOLD guidelines and stable airway obstruction. Patients had to have a postbronchodilator FEV1/FVC ratio < 70% at Visit 1 (GOLD, 2010) - Post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of predicted value. FEV1 was measured at the Screening Visit (Visit 1) 10 to 15 minutes after inhalation of albuterol/salbutamol. Predicted normal used for calculation purposes were based on National Health and Nutrition Examination Survey III predicted values (Hankinson et al, 1999) - Able to perform acceptable and repeatable pulmonary function testing for FEV1 according to ATS/ERS criteria (Miller et al, 2005) at Screening Visit (Visit 1) and throughout their participation in the trial - Negative serum β-human chorionic gonadotropin pregnancy test at Visit 1 and must have been using hormonal contraceptives or a barrier method plus a spermicidal agent; otherwise at least 1-year postmenopausal or surgically sterile, defined as having a hysterectomy or tubal ligation (applied to female patients only) - Judged by the Principal Investigator to be in otherwise good stable health based on medical history, physical examination, ECGs, and routine laboratory data evaluations - Patients previously randomized in an aclidinium monotherapy trial were permitted as long as it had been at least 6 months since the completion of their previous trial participation - Able to understand the study procedures and be willing to participate in the study as indicated by signing the informed consent Exclusion Criteria: - Hospitalization for an acute COPD exacerbation within 3 months before Visit 1 - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. Patients who developed a respiratory tract infection or COPD exacerbation during the washout or run-in period were discontinued from the study before randomization - Any clinically significant respiratory conditions other than COPD, including active tuberculosis, history of interstitial lung disease, pulmonary thromboembolic disease, history of α1-antitrypsin deficiency, pulmonary resection, lung volume surgery, or any other thoracic surgery during the past 12 months, history of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener syndrome), post organ transplantation, or expected to require thoracotomy or other lung surgery during the study - Clinical history suggesting that the patient had asthma as opposed to COPD (Study Physician was to be contacted to discuss eligibility, if necessary) - Chronic use of oxygen therapy ≥ 15 hours/day - Body mass index(BMI) ≥ 40 kg/m2 - Patients who intended to start a pulmonary rehabilitation program during the trial were excluded, as well as those who finished or started it within 3 months prior to Screening Visit - Clinically significant cardiovascular conditions including: myocardial infarction within the previous 6 months; newly diagnosed arrhythmia within the previous 3 months; unstable angina; unstable arrhythmia that had required changes in pharmacological therapy or other intervention within the previous 6 months; the presence of an automated implantable cardioverter-defibrillator; history of thoracic surgery within the past year before screening; hospitalization within the previous 12 months for heart failure of New York Heart Association functional class III (marked limitation of physical activity and only comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea), or class IV (unable to carry out any physical activity without discomfort) (Criteria Committee of the New York Heart Association criteria, 1994) - Any uncontrolled infection that may have placed the patient at risk resulting from human immunodeficiency virus, active hepatitis and/or patients with diagnosed active tuberculosis - QTcB > 470 msec in the resting ECGs performed at Screening (Visit 1), as indicated in the centralized ECG vendor generated report. Patients who were on a stable dose of medication that may prolong the QTc, but had a documented, stable, and normal QTc, could have been considered - QTcB > 470 msec in the resting ECGs performed before randomization at Visit 2, as indicated in the paper tracing generated by the Sponsor-provided ECG equipment - Clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters other than QTc, or in the physical examination or vital signs at Visit 1 except for those related to COPD - History of drug or alcohol abuse within the previous 5 years - Any other serious or uncontrolled physical or mental condition/disease that, as judged by the Investigator, could have placed the patient at higher risk derived from his/her participation in the study, could have confounded the results of the study, or would be likely to have prevented the patient from complying with the requirements of the study or completing the study. If there was a history of such disease, but the condition had been stable for more than 1 year and was judged by the Investigator not to interfere with the patients participation in the study, the patient may have been included, with the documented approval of the Study Physician - History of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) or a history of acute urinary retention, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or narrow-angle glaucoma. (Note: Patients who had well controlled, stable, asymptomatic benign prostatic hyperplasia were not to be excluded) - Sitting, resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 100 mm Hg at Visit 1 and Visit 2 - Unable to use a multidose dry-powder inhaler or a pressurized metered-dose inhaler - Treatment with any other investigational product within 30 days (or 6 half-lives, whichever was longer) before Visit 1 - Previous participation in a clinical trial with aclidinium bromide in an FDC therapy - Pregnant or breastfeeding - Current diagnosis of cancer (present in the patient) other than basal or squamous cell skin cancer. Patients who had a history of cancer must have been cleared before Visit 1 (Screening) on a case-by-case basis - Patients who did not maintain regular day/night, waking/sleeping cycles (eg, night shift workers) - Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication (Appendix III of the protocol, which can be found in Appendix 16.1.1 of this report) - Patients who were unlikely to be compliant with study requirements (eg, take their medication, complete their electronic diaries, attend clinic at the required times) - Patients who were employees or relatives of employees of the investigative study center, FRI, Almirall, SA, or Pharmaceutical Product Development (PPD, Inc.) - Patients who had any other conditions that, in the Investigators opinion, might have indicated the patient to be unsuitable for the study or supported excluding the patient from the study ; PRIMARY OUTCOME: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1); SECONDARY OUTCOME 1: Change in Transition Dyspnea Index (TDI) Focal Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1218.78 (Safety); BRIEF: The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug. ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus 2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug Exclusion criteria: 1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism 2. Impaired hepatic function 3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1 4. Treatment with anti-obesity drugs ; PRIMARY OUTCOME: Incidence of Adverse Events (AEs); SECONDARY OUTCOME 1: Glycosylated Haemoglobin A1c (HbA1c)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - P302 (Low Dose Adolescents); BRIEF: This study will evaluate the efficacy and safety of low doses of SPN-812 in adolescents 12-17 years of age. ; DRUG USED: Qelbree; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Nicotinic Acetylcholine Receptors (nAChR) , Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin 5-HT1 receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy male or female subjects, 12-17 years of age, inclusive. 2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 3. Attention Deficit/Hyperactivity Disorder Rating Scale-5-Home Version: Adolescent, Investigator Administered and Scored (ADHD-RS-5) score of at least 28. 4. CGI-S score of at least 4 at screening. 5. Weight of at least 35 kg. 6. Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study. 7. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram. 8. Written informed consent obtained from the subjects parent or legal representative and informed assent from the subject, if applicable. 9. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose, throughout the study: 1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration 2. surgically sterile male partner 3. simultaneous use of male condom and diaphragm with spermicide 4. established hormonal contraceptive Exclusion Criteria: 1. Current diagnosis of major psychiatric disorders. Subjects with Major Depressive Disorder are allowed in the study if the subject is free of episodes both currently and for the last six months. 2. Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents), or a history of seizure-like events are excluded from the study. 3. Current diagnosis of significant systemic disease. 4. Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening. 5. BMI greater than 95th percentile for the appropriate age and gender. 6. History of an allergic reaction to viloxazine or related drugs. 7. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subjects participation in this study. 8. Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM. 9. Any reason, which, in the opinion of the Investigator, would prevent the subject from participating in the study 10. Positive screen for drugs of abuse at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening as long as the subject agrees to discontinue the stimulant for the duration of the study beginning at least one week prior to the Baseline Visit. 11. Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential) ; PRIMARY OUTCOME: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5); SECONDARY OUTCOME 1: Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BUP-306 - Chronic Low Back Pain; BRIEF: This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain. BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States. ; DRUG USED: Belbuca; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: BioDelivery Sciences International; CRITERIA: Inclusion Criteria: - Male or non-pregnant and non-nursing female aged 18 or older - History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks - Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures - Female subjects of childbearing potential must be using a recognized effective method of birth control - Written informed consent obtained prior to any procedure being performed Exclusion Criteria: - Cancer related pain - Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis - Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit - History of severe emesis with opioids - Clinically significant sleep apnea in the judgment of the investigator ; PRIMARY OUTCOME: Mean change in pain intensity; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - XPORT-MF-034; BRIEF: This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-naïve MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib. ; DRUG USED: Xpovio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: Exportin-1/CRM1/XPO1, Immune System, Interferon-beta (IFNb), SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Karyopharm Therapeutics Inc; CRITERIA: Inclusion Criteria: - A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report. - Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic centimeter (cm^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to screening are acceptable). - Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk. - Participants >=18 years of age. - Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2. - Platelet count >= 100*10^9/liter (L) without platelet transfusion. - Absolute neutrophil count (ANC) >=1.0 *10^9/L without need for growth factors within 7 days prior to C1D1. - Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine aminotransferase (ALT) <= 2.5*upper limit normal (ULN) and serum total bilirubin <= 2 × ULN. - Calculated creatinine clearance (CrCl) greater than (>) 15 milliliters per minute (mL/min) based on the Cockcroft and Gault formula. - Participants with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for > 8 weeks and the viral load is less than (<) 100 international units/milliliter (IU/mL). - Participants with history of hepatitis C virus (HCV) are eligible if they have received adequate curative anti-HCV treatment and HCV viral load is below the limit of quantification. - Participants with history of human immunodeficiency virus (HIV) are eligible if they have CD4+ T-cell counts >= 350 cells/microliter (cells/mcL), negative viral load, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year and should be on established antiretroviral therapy (ART) for at least 4 weeks. - Female participants of childbearing potential must have a negative serum pregnancy test at screening and within 3 days prior to first dose on C1D1 and agree to use highly effective methods of contraception throughout the selinexor treatment period and for 90 days following the last dose of selinexor treatment. A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. - Male participants who are sexually active must use highly effective methods of contraception throughout the study treatment period and for 90 days following the last dose of selinexor treatment. Male participants must agree not to donate sperm during the study treatment period and for at least 90 days after the last dose of selinexor treatment. - Participants must sign written informed consent in accordance with federal, local, and institutional guidelines. - Active symptoms of MF as determined by presence of at least 2 symptoms with a score >=3 or total score of >= 10 at screening using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0. - Participant currently not eligible for stem cell transplantation. - Participants must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study. - Life expectancy of greater than 6 months in the opinion of the investigator. - Participants with no other concomitant malignancies or history of another malignancy within 2 years prior to C1D1 except for adequately treated early-stage basal cell or squamous cell carcinoma of skin, adequately treated carcinoma in situ of breast or cervix or organ confined prostate cancer, or PV or ET. Exclusion Criteria: - More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase). - Previous treatment with JAK inhibitors for MF. - Previous treatment with selinexor or other XPO1 inhibitors. - Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (e.g., vomiting or diarrhea > CTCAE v 5.0 Grade 1). - Received strong cytochrome P450 3A (CYP3A) inhibitors <= 7 days prior to selinexor dosing OR strong CYP3A inducers <= 14 days prior to selinexor dosing (Phase 1 participants only) - Major surgery < 28 days prior to C1D1. - Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to C1D1; however, prophylactic use of these agents is acceptable (including parenteral). - Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigators opinion, could compromise the participants safety, prevent the participant from giving informed consent, or being compliant with the study procedures, or confound the ability to interpret study results. - Female participants who are pregnant or lactating. - Prior splenectomy, or splenic radiation within 6 months prior to C1D1. - Unable or unwilling to undergo CT scan or MRI per protocol. - Participants with contraindications or known hypersensitivity to selinexor or ruxolitinib or excipients. - History of pulmonary hypertension. - History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), cerebrovascular accident (stroke or transient ischemic attack [TIA]), ventricular arrhythmias, congestive heart failure New York Heart Association (NYHA) class > 2 within 6 months of C1D1. - Participants unable to tolerate two forms of antiemetics prior to each dose for at least 2 cycles. ; PRIMARY OUTCOME: Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24; SECONDARY OUTCOME 1: Phase 3: Proportion of Participants with Anemia Response at Week 24, as per the International Working Group Myeloproliferative Neoplasms Research and Treatment and European Leukemia Network (IWG-MRT and ELN) criteria[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Bacterial Vaginosis Prevention (2); BRIEF: A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV. ; DRUG USED: VivaGel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Cell Membrane, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Starpharma Pty Ltd; CRITERIA: Inclusion Criteria: - Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms) - History of recurrent BV (at least 3 episodes in previous year including current episode) - Using an effective method of contraception Exclusion Criteria: - Test positive for a sexually transmitted infection - Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment - Abnormal pelvic exam, including presence of other vaginal or urinary tract infections - Pregnancy ; PRIMARY OUTCOME: Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings; SECONDARY OUTCOME 1: Time to recurrence of BV according to the primary efficacy endpoint definition[/INST]Yes</s>

<s>[INST]<<SYS>>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 - V72_28; BRIEF: The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age. This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule. ; DRUG USED: Bexsero; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: 1. Healthy infants and children according to the following age groups: - Healthy infants 2½ months of age (71 -79 days, inclusive), (only applicable to group I) - Healthy infants 3½ months of age (101 -109 days, inclusive), (only applicable to group II) - Healthy infants 6 months of age (only applicable to group III) (The age window is defined as the first day the subject turns 6 months of age up to the day before the subject turns 7 months of age). - Healthy children 2 to 5 years of age (only applicable to group IVa) (The age window is defined as the first day the subject turns 2 years of age up to the day before the subject turns 6 years of age). - Healthy children 6 to 10 years of age (only applicable to group IVb) (The age window is defined as the first day the subject turns 6 years of age up to the day before the subject turns 11 years of age). - Healthy infants 3 months of age (83-104 days, inclusive), (only applicable to Group V and VI). 2. For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained; 3. Available for all the visits scheduled in the study; 4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria: 1. Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written informed consent to participate in the study; 2. Childrens parents or legal guardian who are not able to comprehend and to follow all required study procedures for the whole period of the study. 3. History of any meningococcal B vaccine administration; 4. Previous ascertained or suspected disease caused by N. meningitidis; 5. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 6. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component 7. Significant acute or chronic infection within the previous 7 days or temperature 38° C within the previous day of receiving the study vaccine; 8. Antibiotics treatment within 6 days prior to enrollment; 9. Individuals with history of allergy to vaccine components. 10. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of high dose systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 14 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion); 12. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment. 13. Receipt of, or intent to immunize with, any other vaccine(s) within 7 days prior to enrollment. 14. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 15. Family members and household members of research staff 16. Individuals with history or 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. 17. History of any meningococcal C vaccine administration (Only applicable to group V and VI). 18. History of any Pneumococcal vaccine administration (Only applicable to group V and VI). ; PRIMARY OUTCOME: Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.; SECONDARY OUTCOME 1: Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 14724B (14724A Ext Study); BRIEF: To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547. ; DRUG USED: Abilify Maintena; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Patients will be recruited among those who complete treatment with aripiprazole in Study 14724A / NCT01795547. Inclusion Criteria: - The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator. - The patient agrees to protocol-defined use of effective contraception. Exclusion Criteria: - The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547. - The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547. - The patient is at significant risk of harming himself/herself or others according to the investigators judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS). - The patient has a disease or takes medication that could, in the investigators opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study. - The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigators opinion, of potential risk to the patients safety. - The patient is, in the investigators opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Safety and Tolerability; SECONDARY OUTCOME 1: Change From Baseline to Week 24 in SWN-S Total Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Spectrum 3; BRIEF: This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: - DE-117 Ophthalmic Solution once daily and Vehicle once daily, or - Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117. ; DRUG USED: DE-117; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin E Receptor 2 (PTGER2); THERAPY: Monotherapy; LEAD SPONSOR: Santen Inc.; CRITERIA: Inclusion Criteria: • glaucoma or ocular hypertension Exclusion Criteria: - Females who are pregnant, nursing, or planning a pregnancy - Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements ; PRIMARY OUTCOME: Intraocular Pressure at Week 1; SECONDARY OUTCOME 1: Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EXPRESS II; BRIEF: The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the bodys immune system to help control the development of inflammation to help reduce painful disease. ; DRUG USED: Remicade; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Centocor, Inc.; CRITERIA: Inclusion Criteria: - Patients with diagnosis of plaque-type psoriasis for at least 6 months - Patients with plaque-type psoriasis covering at least 10% of the body Exclusion Criteria: - Patients with nonplaque forms of psoriasis - Patients who have current drug-induced psoriasis - Patients who are pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment - Patients who had any previous treatment with infliximab or any therapeutic agent targeted at reducing tumor necrosis factor ; PRIMARY OUTCOME: Proportion of patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.; SECONDARY OUTCOME 1: Improvement from baseline in Psoriasis Area and Severity Index response between weeks 16 and 30. Change in Dermatology Life Quality Index from baseline at week 10. Patients with a Physicians Global Assessment score of clear or excellent at week 10.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PAPILLON; BRIEF: The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations. ; DRUG USED: Rybrevant; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation - Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream - A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study Exclusion Criteria: - Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance) - Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible) - Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation - Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis - Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid ; PRIMARY OUTCOME: Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR); 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 III - EPIC; BRIEF: The purpose of this study is to evaluate whether MST-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a recurrence of VOC. Additionally, this study will compare the development of acute chest syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188. ; DRUG USED: Vepoloxamer; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Mast Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Age 4 through 65 years - Subject has a confirmed diagnosis of HbSS, HbSC, HbSβ+thal, or HbSβ0thal - Subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral analgesia - Subject requires hospitalization Exclusion Criteria: - Subject has acute chest syndrome - Subjects laboratory results indicate inadequate organ function - Subject is pregnant or nursing an infant - Subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced > 5 hospitalizations for VOC in the prior 6 months - Subject has been transfused within the past 14 days - Subject is hospitalized for a condition other than VOC - Subject has complications related to SCD ; PRIMARY OUTCOME: Reduction of the duration of vaso occlusive crisis (VOC) in subjects with sickle cell disease.; SECONDARY OUTCOME 1: Re-hospitalization rate for VOC[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - REPRISE (resistant G-negative); BRIEF: To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections. ; DRUG USED: Avycaz; DRUG CLASS: Non-NME; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Patient must be ≥18 and ≤90 years of age - Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after - Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection Exclusion Criteria: - Patient has an APACHE II score >30 (cIAI patients only) - Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.) - Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised - Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period. ; PRIMARY OUTCOME: Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set; SECONDARY OUTCOME 1: Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - IIT (Onset); BRIEF: The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes patients. This two-arm study is designed to evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved therapies among recent onset type 1 diabetes patients. One of the greatest new insights of today in the field of type 1 diabetes, is the understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan 2103). More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some studies have demonstrated as high as a 57% insulin-free remission rate that was not sustained due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988, Eisenbarth 1989, Sobel 2010). Studies among diabetes patients with proton pump inhibitors have shown the potential to increase beta cell mass by 40%, but among type 1 patients without immune protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014). The usage of a beta cell regeneration agent such as omeprazole, in combination with an immune tolerance, like cyclosporine, provides both the potential ability to maintain and regenerate beta cells. This is a new paradigm for the treatment of new onset type 1 diabetes. More than 60 human trials have been conducted among type 1 diabetes with a variety of different therapies aimed at preventing autoimmune attack on insulin-producing beta cells. None have been as effective as cyclosporine in both slowing the decline in beta cell mass and resulting in the potential for insulin-free remissions. (Canadian-European Randomized Control Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010). Because cyclosporine is known for its potential side-effects, most notably in the kidney, all previous studies among type 1 patients have carefully monitored kidney function. Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months did not demonstrate renal or other side effects at the dosages that will be used in this trial (Assan 2002). The most effective initiating dosage for insulin independence in the cyclosporine trials was 7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and will monitor kidney function and cyclosporine levels initially on a weekly basis. This study will use only those dosages of cyclosporine that have not demonstrated toxicity to the kidney or resulted in non-reversible side effects among more than 500 patients with recent onset type 1 diabetes treated with cyclosporine. Omeprazole has been shown to significantly increase gastrin levels which is associated with increased beta cells. Lansoprazole has also been shown to be safe among patients with new onset type 1 diabetes for one year with a trend toward increased beta cell mass among patients with higher gastrin levels. In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those randomized to receive a proton pump inhibitor had significantly increased gastrin levels, higher insulin levels and improved endocrine function by glucose tolerance testing and less pancreatic atrophy as measured by CT scans (Jang 2003). The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta cells was specifically noted to have likely been due to lack of usage of immune therapy to protect beta cells (Griffin 2014, Rigby 2014). Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the control group had a trend towards improved preservation of C-peptide with a suggestion of a decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental data). Glucose levels also trended lower than controls in the intervention arm with gastrin levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006). REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy among type 1 patients (Griffin 2014, Rigby 2014). The combination of cyclosporine with a proton pump inhibitor has the potential to demonstrate maintenance and expansion of residual beta cells. This combination therapy provides the unique ability for patients to become insulin independent. For a request of references, please email info@perlebioscience.com ; DRUG USED: PRL001; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Calcineurin phosphatase , Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Perle Bioscience, Inc.; CRITERIA: Inclusion Criteria Participants included in this study are those who meet all of the following criteria: 1. Male or female participant 10-20 years old. 2. Diagnosis of new onset type 1 diabetes within 12 weeks of symptoms according to the American Diabetes Association (ADA) criteria. 3. History of at least one positive result on testing for any of the following antibodies: Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2), Glutamic Acid Decarboxylase (GAD) autoantibodies, Insulin autoantibodies. 4. Body weight > 30 kg. 5. Signs or symptoms of diabetes within 12 weeks of the first study visit. 6. Requires insulin > 0.2 units/kg body weight/day for T1DM 7. Fasting C-peptide greater than 0.3 ng/mL = 0.1 nmol/L = 100 pmol/L = 0.1 pmol/mL and Glucagon Stimulated C-peptide greater than 0.6 ng/mL = 0.2 nmol/L = 200 pmol/L = 0.2 pmol/mL. 8. Female of child bearing potential must have a negative pregnancy test and practice acceptable contraception [e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine device] or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to first clinic visit)]. Female of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of study drug. 9. Able to swallow capsules. 10. Able to read, understand, and provide signed informed consent for the study (participants under the age of 18, shall provide an assent for the study as per country requirements). Exclusion Criteria Participants must not meet any of the following exclusion criteria to be eligible for the study: 1. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or impact participant safety or evaluability of drug effect. 2. Prior administration of immunosuppressants at any time in the past, including in a clinical trial for type 1 diabetes. 3. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks prior to the first clinic visit. 4. Taking any prescription medications, vitamins or herbal supplements that are contraindicated with cyclosporine within the last 14 days prior to first clinic visit. 5. Pregnant or lactating female. 6. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion. 7. Current treatment with oral antidiabetic agents. 8. Evidence of active or latent tuberculosis. 9. Vaccination with a live virus or organism within the last 8 weeks prior to the first clinic visit. 10. Influenza vaccination with a killed virus, including booster vaccinations, within the last 4 weeks prior to the first clinic visit. 11. Vaccination with other antigens or killed organisms within the last 8 weeks prior to the first clinic visit. 12. Any infectious mononucleosis-like illness within the last 6 months prior to the first clinic visit. 13. History of or known active infection with HIV, HCV, or HBV. 14. Systolic or diastolic blood pressure >150 mmHg and > 90 mmHg, respectively, at the first clinic visit. 15. 95% percentile for weight at the first clinic visit. 16. An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level >2 times the upper limit of normal (ULN) at the first clinic visit. 17. A blood urea nitrogen (BUN) > 50 mg/dL (> 17.85 mmol/L) or a serum creatinine level > 1.3 mg/dL (> 115 µmol/L) at the first clinic visit. 18. A serum amylase level > 1.5 times the ULN or a serum lipase level > 2 times the ULN at the first clinic visit. 19. A history of substance abuse or dependence within the last 12 months prior to the first clinic visit as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria. ; PRIMARY OUTCOME: Insulin Independence and Hemoglobin A1c (A1C) < 6.5%; SECONDARY OUTCOME 1: Safety and tolerability[/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 - IMpower 010 (PD-L1 Selected, Post-Adjuvant); BRIEF: This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: Inclusion Criteria for Enrollment Phase - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009) - Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered from surgery - If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeons decision - Eligible to receive a cisplatin-based chemotherapy regimen - Adequate hematologic and end-organ function - Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC Exclusion Criteria: Exclusion Criteria for Enrollment Phase - Illness or condition that may interfere with a participants capacity to understand, follow, and/or comply with study procedures - Pregnant and lactating women - Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor - Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment - Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment - Participants with hearing impairment - Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol - Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation - History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegeners granulomatosis, Sjögrens syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis - Positive test for human immunodeficiency virus (HIV) - Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C - Active tuberculosis - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan - Prior allogeneic bone marrow transplantation or solid organ transplant - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications - Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded) Specific Exclusions for Pemetrexed Treatment - Participants with squamous cell histology Exclusion Criteria for Randomized Phase - Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia - Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization - Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study - Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study - Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed - Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization ; PRIMARY OUTCOME: Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray; SECONDARY OUTCOME 1: Overall Survival (OS) in the ITT Population[/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 - ATLAS; BRIEF: This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle invasive bladder cancer (LG IR NMIBC). ; DRUG USED: VesiGel; DRUG CLASS: Non-NME; INDICATION: Bladder Cancer; TARGET: DNA, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: UroGen Pharma Ltd.; CRITERIA: Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. 2. Patient who has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks of Screening. 3. Has intermediate risk disease, defined as having 1 or 2 of the following: - Presence of multiple tumors; - Solitary tumor > 3 cm; - Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis). 4. Negative voiding cytology for high grade (HG) disease within 6 weeks of Screening. 5. Has adequate organ and bone marrow function as determined by the following routine laboratory tests: - Leukocytes ≥ 3,000 cells per μL; - Absolute neutrophil count ≥ 1,500 cells per μL; - Platelets ≥ 100,000 per μL; - Hemoglobin ≥ 9.0 g/dL; - Total bilirubin ≤ 1.5 x upper limit of normal (ULN); - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; - Alkaline phosphatase (ALP) ≤ 2.5 × ULN; - Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min. 6. Has no evidence of active urinary tract infection (UTI). 7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment. Exclusion Criteria: 1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment. 2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year. 3. History of HG papillary UC in the past 2 years. 4. Known allergy or sensitivity to mitomycin that in the investigators opinion cannot be readily managed. 5. Clinically significant urethral stricture that would preclude passage of a urethral catheter. 6. History of pelvic radiotherapy. 7. History of: - Neurogenic bladder; - Active urinary retention; - Any other condition that would prohibit normal voiding. 8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC. 9. Current tumor grading of T1. 10. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol. 11. History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately after any previous TURBT. 12. Has previously participated in a study in which they received UGN-102. 13. Has participated in a study with an investigational agent or device within 30 days of randomization. ; PRIMARY OUTCOME: Disease-free survival (DFS); SECONDARY OUTCOME 1: Time to recurrence (TTR)[/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 - PSUNRISE; BRIEF: The purpose of this study is to test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months, without enough improvement in their psoriasis symptoms. ; DRUG USED: Remicade; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Centocor Ortho Biotech Services, L.L.C.; CRITERIA: Inclusion Criteria: - Have plaque psoriasis despite at least 4 months of treatment with etanercept per current product labeling - Have psoriatic target lesions that have a PGA score greater than 1 (minimal) at screening - If receiving methotrexate at screening, must have received methotrexate for at least 3 months and at a stable dose of <= 25 mg/week for at least 4 weeks prior to screening - If receiving cyclosporine at screening, must have received cyclosporine at a stable dose of <= 5 mg/kg daily for at least 4 weeks prior to screening. Exclusion Criteria: - Have already received infliximab or adalimumab - Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product - Have a history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening - Have a concomitant diagnosis or any history of Congestive Heart Failure - Are pregnant, nursing, or planning pregnancy - Have used systemic corticosteroids within the 4 weeks prior to screening - Have used topical corticosteroids or have initiated treatment with other topical therapies that could affect psoriasis or Psoriasis Area and Severity Index (PASI) evaluation (e.g., tar, anthralin, calcipotriene, tazarotene, methoxsalen) within 2 weeks prior to screening - Have used new systemic agents/treatments, other than methotrexate, that can affect psoriasis including, but not limited to, immunosuppressants and/or psoralen plus ultraviolet A light (PUVA) within the 4 weeks prior to screening. ; PRIMARY OUTCOME: Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0); SECONDARY OUTCOME 1: Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - P303 (High Dose Children); BRIEF: This study will evaluate the efficacy and safety of high doses of SPN 812 in children with ADHD ; DRUG USED: Qelbree; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Nicotinic Acetylcholine Receptors (nAChR) , Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin 5-HT1 receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy male or female subjects, 6-11 years of age, inclusive. 2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 3. Attention Deficit/Hyperactivity Disorder Rating Scale-5, Home Version: Child, Investigator Administered and Scored (ADHD-RS-5) score of at least 28. 4. CGI-S score of at least 4 at screening. 5. Weight of at least 20 kg. 6. Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study. 7. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram. 8. Written informed consent obtained from the subjects parent or legal representative and informed assent from the subject, if applicable. 9. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose, throughout the study: 1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration 2. surgically sterile male partner 3. simultaneous use of male condom and diaphragm with spermicide 4. established hormonal contraceptive Exclusion Criteria: 1. Current diagnosis of major psychiatric disorders. Subjects with Major Depressive Disorder are allowed in the study if the subject is free of episodes both currently and for the last six months. 2. Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents), or a history of seizure-like events are excluded from the study. 3. Current diagnosis of significant systemic disease. 4. Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening. 5. BMI greater than 95th percentile for the appropriate age and gender. 6. History of an allergic reaction to viloxazine or related drugs. 7. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subjects participation in this study. 8. Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM. 9. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study. 10. Positive drug screen at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening; the subject will be required to discontinue the stimulant for the study, beginning at least one week prior to the Baseline Visit. 11. Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential) ; PRIMARY OUTCOME: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5); SECONDARY OUTCOME 1: Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ARISE; BRIEF: To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine. ; DRUG USED: Aimovig; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - History of migraines (with or without aura) for ≥ 12 months - Migraine frequency: ≥ 4 and < 15 migraine days per month on average acrossthe 3 months prior to screening - Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening - Demonstrated compliance with the eDiary Exclusion Criteria: - Older than 50 years of age at migraine onset. - History of cluster headache or hemiplegic migraine headache. - Unable to differentiate migraine from other headaches - No therapeutic response with > 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial. - Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study - Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase. - Received botulinum toxin - Anticipated to require any excluded medication, device, or procedure during the study. - Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain). - History of major psychiatric disorder. - History of seizure disorder or other significant neurological conditions other than migraine. - Human immunodeficiency virus (HIV) infection by history. - Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening. - The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study. - Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures. ; PRIMARY OUTCOME: Change From Baseline in Monthly Migraine Days at Week 12; SECONDARY OUTCOME 1: Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VANISH-2; BRIEF: Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins. ; DRUG USED: Varithena; DRUG CLASS: Non-NME; INDICATION: Varicose Veins; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Boston Scientific Corporation; CRITERIA: Inclusion Criteria: - Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein - Ability to comprehend and sign an informed consent document and complete study questionnaires in English - Ability to record symptoms in accordance with the protocol - Symptomatic varicose veins - Visible varicose veins Exclusion Criteria: - Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders). - Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings - Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion - Deep vein reflux unless clinically insignificant in comparison to superficial reflux - Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings - Reduced mobility - Major surgery, prolonged hospitalization or pregnancy within 3 months of screening - Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) - Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions - Current alcohol or drug abuse - Pregnant or lactating women - Women of childbearing potential not using effective contraception - History of DVT, pulmonary embolism, or stroke ; PRIMARY OUTCOME: Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score); SECONDARY OUTCOME 1: Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - nmDBMD (US); BRIEF: The objective of this study is to assess the safety and tolerability of 10, 10, 20 milligrams per kilogram (mg/kg) ataluren in participants with nmDBMD who had prior exposure to ataluren in a PTC sponsored clinical trial or treatment plan, and siblings of those participants (provided those participants have completed the placebo-controlled portion of the trial). The treatment will continue under this protocol until consent withdrawal by participants, withdrawal due to worsen condition after initiating ataluren treatment, withdrawal by investigator, withdrawal due to participant unable to tolerate ataluren, participant is eligible to participate in another ataluren nmDBMD clinical trial program initiated by sponsor, study is discontinued by the relevant regulatory authority and/or sponsor, or until ataluren becomes commercially available. ; DRUG USED: Translarna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: RNA translation; THERAPY: Monotherapy; LEAD SPONSOR: PTC Therapeutics; CRITERIA: Inclusion Criteria: - Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. Note: If the study candidate is considered a child under local regulation, a parent or legal guardian must provide written consent prior to initiation of study screening procedures and the study candidate may be required to provide written assent. The rules of the responsible Institutional Review Board/Independent Ethic Committee (IRB/IEC) regarding whether one or both parents must provide consent and the appropriate ages for obtaining consent and assent from the participant should be followed. - History of exposure to ataluren in a prior PTC study or treatment plan and effected nmDBMD siblings of those participants (provided those participants have completed the placebo-controlled portion of the trial). - Fertile men, who are sexually active with women of childbearing potential and who have not had a vasectomy, must agree to use a barrier method of birth control during the study and for up to 50 days after the last dose of study drug. - Willingness and ability to comply with scheduled visits, drug administration and return plan, study procedures, laboratory tests, and study restrictions Note: Psychological, social, familial, or geographical factors that might preclude adequate study participation should be considered. Exclusion Criteria: - Exposure to another investigational drug within 1 month prior to start of study treatment. - Eligibility for another ataluren clinical trial that is actively enrolling study participants. - Positive for Hepatitis B core antibody or Hepatitis C antibody at screening for ataluren naïve participants (siblings) or participants who have a temporary treatment gap of 1 year before entering study - Known hypersensitivity to any of the ingredients or excipients of ataluren (refined polydextrose, polyethylene glycol 3350, poloxamer 407, mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, colloidal silica, magnesium stearate). - Ongoing intravenous (IV) aminoglycoside or IV vancomycin therapy. - Ongoing uncontrolled medical/surgical condition, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigators opinion, could adversely affect the safety of the participant or make it unlikely that follow-up would be completed. ; PRIMARY OUTCOME: Number of Participants 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 IIIb - w/Metformin (vs Glimepiride, CV181-365); BRIEF: This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52. ; DRUG USED: Qtern; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4), SGLT; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects must be willing and able to give signed and dated written informed consent - Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control - Subjects should have been taking the same daily dose of metformin ≥ 1500 mg - Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L) - Males and females, aged ≥18 years old at time of screening visit - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test - WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug Exclusion Criteria: - Clinical diagnosis of type I diabetes - History of diabetic ketoacidosis - Cardiovascular/vascular diseases within 3 months of the enrollment - Renal disease - Hepatic diseases - History of, or currently, acute or chronic pancreatitis - Hematological and oncological disease/conditions - Patients who have contraindications to therapy being studied - Patients on weight loss program(s) - Replacement or chronic systemic corticosteroid therapy ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52; SECONDARY OUTCOME 1: Change From Baseline in Total Body Weight at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ENDURANCE-2 (GT-2); BRIEF: The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2) infection. - Chronic HCV infection. - Subject must be HCV treatment-naïve (subject had never received a single dose of any approved or investigational regimen) or had failed prior interferon (IFN) or pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN therapy. - Subject must be non-cirrhotic. Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. - Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. - Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. - Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). - HCV genotype performed during screening indicating coinfection with more than 1 HCV genotype. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis; SECONDARY OUTCOME 1: Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority 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 III - CLEAR (First Line); BRIEF: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review [IIR] using Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) as first-line treatment in participants with advanced renal cell carcinoma (RCC). ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: 1. Histological or cytological confirmation of RCC with a clear-cell component (original tissue diagnosis of RCC is acceptable). 2. Documented evidence of advanced RCC. 3. At least 1 measurable target lesion according to RECIST 1.1 meeting the following criteria: - Lymph node (LN) lesion that measures at least 1 dimension as greater than or equal to (>=) 1.5 cm in the short axis - Lymph node (LN) lesion that measures at least 1 dimension as greater than or equal to (>=) 1.5 centimeter (cm) in the short axis - Non-nodal lesion that measures greater than or equal to (>=) 1.0 cm in the longest diameter - The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion. 3.Karnofsky Performance Status (KPS) of >=70 4.Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal (<=) 150/90 millimeter of mercury (mmHg) at Screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1 (C1/D1) 5.Adequate renal function defined as creatinine <=1.5*upper limit of normal (ULN); or for participants with creatinine greater than (>) 1.5*ULN, the calculated creatinine clearance >=30 milliliters per minute (mL/min) (per the Cockcroft-Gault formula) is acceptable. 6.Adequate bone marrow function defined by: - Absolute neutrophil count (ANC) >=1500/cubic millimeter (mm^3) - Platelets >=100,000/mm^3 - Hemoglobin >=9 grams per deciliter (g/dL) NOTE: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the previous 2 weeks. 7.Adequate blood coagulation function defined by International Normalized ratio (INR) <=1.5 unless participant is receiving anticoagulant therapy, as long as INR is within therapeutic range of intended use of anticoagulants. 8.Adequate liver function defined by: - Total bilirubin <=1.5*ULN except for unconjugated hyperbilirubinemia of Gilberts syndrome. - Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3*ULN (in the case of liver metastases <=5*ULN), unless there are bone metastases. Participants with ALP values >3*ULN and known to have bone metastases can be included. 9.Provide written informed consent. 10.Willing and able to comply with all aspects of the protocol. Exclusion Criteria: 1. Participants who have received any systemic anticancer therapy for RCC, including anti-vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agent. Prior adjuvant treatment with an investigational anticancer agent is not allowed unless the investigator can provide evidence of participants randomization to placebo arm. 2. Participants with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy (example, whole brain radiation therapy (WBRT), surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example, radiologic) or symptoms of CNS metastases must be stable for at least 4 weeks before starting study treatment 3. Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months. Participants with history of localized & low risk prostate cancer are allowed in the study if they were treated with curative intent and there is no prostate specific antigen (PSA) recurrence within the past 5 years 4. Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to study treatment start 5. Participants who are using other investigational agents or who had received investigational drugs <=4 weeks prior to study treatment start. 6. Received a live vaccine within 30 days of planned start of study treatment (Cycle 1/Day 1). Examples of live vaccines include, but are not limited to, measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (example, FluMist®) are live attenuated vaccines and are not allowed. 7. Participants with proteinuria >1+ on urine dipstick testing will undergo 24-h urine collection for quantitative assessment of proteinuria. Participants with urine protein >=1 g/24 h will be ineligible 8. Fasting total cholesterol >300 milligram per deciliter (mg/dL) (or ˃7.75 millimole per liter (mmol/L)) and/or fasting triglycerides level ˃2.5 x upper limit of normal (ULN). Note: these participants can be included after initiation or adjustment of lipid-lowering medication 9. Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication 10. Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms) 11. Participants who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy. 12. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib, everolimus, and/or sunitinib. 13. Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy 14. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug 15. Significant cardiovascular impairment within 12 months of the first dose of study drug: history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident, or cardiac arrhythmia associated with hemodynamic instability. The following is also excluded: left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multiple-gated acquisition MUGA scan or echocardiogram 16. Active infection (any infection requiring systemic treatment) 17. Participants known to be positive for Human Immunodeficiency Virus (HIV). 18. Known active Hepatitis B (example, Hepatitis B surface antigen (HBsAg) reactive) or Hepatitis C (example, hepatitis C virus ribonucleic acid (HCV RNA) [qualitative] is detected) 19. Known history of, or any evidence of, interstitial lung disease 20. Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis 21. Participants with a diagnosis of immunodeficiency or who are receiving chronic systemic steroid therapy (doses exceeding 10 mg/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Physiologic doses of corticosteroids (up to 10 mg/day of prednisone or equivalent) may be used during the study 22. Active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (that is, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (example, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. 23. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. 24. Females of childbearing potential who: - Do not agree to use a highly effective method of contraception for the entire study period and for 120 days after study discontinuation, that is: - total abstinence (if it is their preferred and usual lifestyle) - an intrauterine device (IUD) or hormone-releasing system (IUS) - a contraceptive implant - an oral contraceptive (with additional barrier method) OR - Do not have a vasectomized partner with confirmed azoospermia. For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide. 25. Males who have not had a successful vasectomy (confirmed azoospermia) and do not agree to use condom + spermicide OR have a female partner who does not meet the criteria above (that is, is of childbearing potential and not practicing highly effective contraception throughout the study period), starting with the first dose of study therapy through 120 days after the last dose of study therapy, unless sexually abstinent. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant. 26. Known intolerance to any of the study drugs (or any of the excipients) 27. Participant has had an allogenic tissue/solid organ transplant. ; PRIMARY OUTCOME: Progression-free Survival (PFS) by Independent Imaging Review (IIR); 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 III - TROPICS-02 (HR+/HER2- MBC); BRIEF: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physicians choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC). ; DRUG USED: Trodelvy; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), Trop-2; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed. - Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease: - At least 1 taxane in any setting. - At least 1 prior anticancer hormonal treatment in any setting. - At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting. - Eligible for one of the chemotherapy options listed in the TPC arm. - Documented disease progression after the most recent therapy. - Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3). - Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula . - Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilberts syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)). - Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)). Key Exclusion Criteria: - Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations. - History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality. - Active serious infection requiring antibiotics. - Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason. - Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUPREME; BRIEF: A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. 2. Men or women at least 18 years of age at time of screening. 3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria [CASPAR]). 4. Moderate to severe psoriasis as defined at enrollment by: - PASI score ≥ 10 or - PASI score > 5 but < 10 and DLQI ≥10 5. Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these). Exclusion criteria 1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis). 2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1. 3. Anti-TNFα therapy within timelines depending on drug half-life. 4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy. 6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening. 7. Ongoing use of corticosteroid topical treatments or UV therapy. ; PRIMARY OUTCOME: Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set); SECONDARY OUTCOME 1: Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - AlePrevent (CV Outcomes); BRIEF: This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo. ; DRUG USED: Aleglitazar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: PPAR alpha, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigators judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigators judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol - Patients with glucose abnormalities based on one of the following A-B criteria: A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities - Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines Exclusion Criteria: - Current treatment with a thiazolidinedione (TDZ) or fibrate - Prior intolerance to a TDZ or fibrate - Previous participation in a trial with aleglitazar - Other types of diabetes - Inadequate liver, hematologic or renal function - Symptomatic heart failure classified as NYHA class II-IV - Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization - Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin - History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction - Currently scheduled for arterial revascularization procedures - Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening - Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years ; PRIMARY OUTCOME: Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC); SECONDARY OUTCOME 1: Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at 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 - COACT-1; BRIEF: This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped. ; DRUG USED: Cogenzia; DRUG CLASS: Non-NME; INDICATION: Diabetic Foot and Other Ulcers; TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Innocoll; CRITERIA: Inclusion Criteria: - Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria. - Has at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America guidelines for the Diagnosis and Treatment of Diabetic Foot Infections (CID 2012; 54:132-173) (IDSA guidelines): - has ≥ 2 manifestations of inflammation (local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion) - has ≥ 1 of the following characteristics: erythema > 2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis) For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut). - Has documented adequate arterial perfusion in the affected limb(s) (either palpable dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure ≥ 45 mm Hg or participation is approved by a vascular surgeon) - Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis. - Has received appropriate surgical debridement to remove all gangrenous tissue. Exclusion Criteria: - Has a known history of hypersensitivity to gentamicin (or other aminoglycosides). - Has a known or suspected hypersensitivity to bovine collagen. - Has an ulcer infection which, based upon the patients known history of hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol. - Has an ulcer associated with prosthetic material or an implanted device. - Has received any systemic or topical antibiotic therapy for any reason within 7 days of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization. - Requires or is likely to require treatment with any concomitant topical product or wound therapy before the first follow-up study visit. - Is severely immunocompromised, or likely to become severely immunocompromised during the study, in the opinion of the investigator. - Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the investigator. - Has a history of epilepsy. - Has a history of alcohol or substance abuse in the past 12 months. - Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study ; PRIMARY OUTCOME: Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection); SECONDARY OUTCOME 1: Clinical Cure and Baseline Pathogen Eradication (Resolution of All Clinical Signs and Symptoms of Infection) and Baseline Pathogen Eradication)[/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 - SPECTRUM; BRIEF: The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck. ; DRUG USED: Vectibix; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Man or woman at least 18 years old. - Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck. - Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy. - Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy. - Measurable and non-measurable disease. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - History or known presence of Central Nervous System (CNS) metastases. - History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization. - Nasopharyngeal carcinoma. - Prior systemic treatment for metastatic and/or recurrent SCCHN - Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy - Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan. - Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0 - Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program]) ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Overall Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study CR-4539 (Safety); BRIEF: The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers. ; DRUG USED: Ketotifen Contact Lens; DRUG CLASS: Non-NME; INDICATION: Allergic Conjunctivitis (Ophthalmology); TARGET: Histamine H1 Receptor (HRH1), Mast Cell; THERAPY: Monotherapy; LEAD SPONSOR: Vistakon Pharmaceuticals; CRITERIA: Inclusion Criteria: - healthy normal, soft contact lens wearing volunteers - normal ocular health - contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye Exclusion Criteria: - active ocular infection - history of ocular surgery - use of topical ophthalmic preparations (including rewetting drops) - pregnancy or lactation ; PRIMARY OUTCOME: Lid and Lid Margin Erythema, Change From Baseline; 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; BRIEF: The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain. ; DRUG USED: Nabiximols; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cancer Pain; TARGET: Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Willing and able to give informed consent. - Male or female, age 18 years or above. - Diagnosed with cancer of any type, which is considered to be terminal. - Diagnosed with cancer-related pain which is not wholly alleviated with their current strong opioid treatment and whose level of pain measured on a NRS is ³four on at least one occasion per day, during the two day run-in period, leading up to visit 1. - On strong opioid maintenance therapy for at least seven days prior to the screening visit. - Willing to abstain from any use of cannabis during the study, other than the study medication. - No cannabinoids use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabis during the study. - Clinically acceptable blood results at the screening visit. - Able (in the investigators opinion) and willing to undertake and comply with all study requirements. - Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation. - Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only). Exclusion Criteria: - Know history of substance misuse. - Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness. - Received any epidural analgesia within 48 hours prior to study entry. - Either received, within two weeks of study entry, or due to receive chemotherapy or radiotherapy during the study. - Unable to give informed consent. - History of any type of schizophrenia, any other psychotic illness, a serious personality disorder, or other significant psychiatric illness other than depression associated with their chronic pain and/or in response to the underlying condition. - Currently taking levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®). - Had a serious cardiovascular disorder, including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia. - Significant renal or hepatic impairment, who in the opinion of the investigator, were unsuitable for treatment with study medication. - History of epilepsy. - Had oral cavity cancers or whose previous treatments had included radiotherapy to the floor of the mouth. - Female subjects who were pregnant or lactating or of child-bearing potential and were inadequately protected against conception during the study and for three months thereafter. - Male subjects who were sexually active and who were not using adequate forms of contraception during the study and for three months thereafter. - Subjects who had participated in a clinical research study in the past four weeks, prior to study entry. - Planned travel outside the UK during the study (applicable to the UK centres only). - Subjects who, in the opinion of the investigator, were unsuitable to participate in the study for any other reason, not mentioned in the entry criteria. ; PRIMARY OUTCOME: The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.; SECONDARY OUTCOME 1: Sleep Disturbance 0-10 Numerical Rating Scale[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACTIVExtend (Ext.); BRIEF: The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417). ; DRUG USED: Tymlos; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoporosis / Osteopenia; TARGET: Parathyroid Hormone Receptor (PTHR); THERAPY: Monotherapy; LEAD SPONSOR: Radius Health, Inc.; CRITERIA: Inclusion Criteria: 1. The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417). 2. The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417). Exclusion Criteria: 1. Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason. 2. Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417). ; PRIMARY OUTCOME: Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline; SECONDARY OUTCOME 1: Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)[/INST]Yes</s>

<s>[INST]<<SYS>>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 - PANDA-1; BRIEF: The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD. ; DRUG USED: Conbercept; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Chengdu Kanghong Biotech Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Men and women ≥ 50 years of age at the Screening visit; 2. Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the Screening visit; o Women of childbearing potential must agree to use a highly effective method of contraception throughout the study. 3. Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and; 4. Have active subfoveal choroidal neovascularization (CNV) lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal fluorescein angiography (FA) leakage, or definite subfoveal fluid by SD-OCT in the study eye at Screening; 5. Have a ETDRS BCVA letter score of 78 to 25 in the study eye at Screening; 6. Are willing and able to sign the study written informed consent form (ICF). Exclusion Criteria: 1. Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins; 2. Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit; 3. Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is one or more disc areas in size (greater than 2.5 mm2) in the study eye at Screening; 4. Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline; 5. Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening; 6. Have any other cause of CNV; 7. Have had prior pars plana vitrectomy in the study eye; 8. Have presence of a full thickness macular hole at Screening or upon examination at Baseline or a history of a full thickness macular hole in the study eye; 9. Have prior trabeculectomy or other filtration surgery in the study eye; 10. Have uncontrolled glaucoma; 11. Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye; 12. Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye; 13. Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period; 14. Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline; 15. Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography; 16. Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control; 17. If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding. ; PRIMARY OUTCOME: Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye; SECONDARY OUTCOME 1: Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36[/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 - EASE SBS 2; BRIEF: The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848. ; DRUG USED: Glepaglutide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Short Bowel Syndrome (SBS); TARGET: GLP-2 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Zealand Pharma; CRITERIA: Inclusion Criteria: - Informed consent obtained before any trial-related activity - Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073) Exclusion Criteria: - Withdrawal of consent from the lead-in trial - Any condition or disease or circumstance that in the Investigators opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results - Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening - Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods ; PRIMARY OUTCOME: Safety - Adverse Events; SECONDARY OUTCOME 1: Safety - Serious Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KESTREL - w/Tremelimumab (First-Line); BRIEF: This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease. ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Age ≥18 years at the time of screening 2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx). 3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy. 4. No prior systemic chemotherapy for recurrent or metastatic disease 5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment 6. No prior exposure to immune-mediated therapy, Exclusion Criteria: 1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland) 2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting 3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohns disease], diverticulitis ; PRIMARY OUTCOME: Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC); SECONDARY OUTCOME 1: Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)[/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 - ULTIMATE II; BRIEF: This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo. ; DRUG USED: Ublituximab; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: TG Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of relapsing multiple sclerosis (RMS) (McDonald Criteria 2010) - Active disease - Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening Exclusion Criteria: - Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment - Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and Stem cell transplantation - Diagnosed with primary progressive multiple sclerosis (PPMS) - Pregnant or nursing ; PRIMARY OUTCOME: Annualized Relapse Rate (ARR); SECONDARY OUTCOME 1: Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant[/INST]Yes</s>

<s>[INST]<<SYS>>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 - DUAL IX; BRIEF: This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus. ; DRUG USED: Xultophy; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products ; PRIMARY OUTCOME: Change in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change 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 - ENZAMET; BRIEF: The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer. ; DRUG USED: Xtandi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: University of Sydney; CRITERIA: Men starting first line androgen deprivation therapy for metastatic prostate cancer. Inclusion criteria: 1. Male aged 18 or older with metastatic adenocarcinoma of the prostate 2. Target or non-target lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 3. Adequate bone marrow function: Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L. 4. Adequate liver function: Alanine transaminase (ALT) < 2 x Upper Limit of Normal (ULN) and bilirubin < 1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be < 5 x ULN 5. Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with performance status 2 are only eligible if the decline in performance status is due to metastatic prostate cancer. 7. Study treatment both planned and able to start within 7 days after randomisation. 8. Willing and able to comply with all study requirements, including treatment and required assessments 9. Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESS is unable to complete because of limited literacy or vision 10. Signed, written, informed consent Exclusion Criteria: 1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components 2. History of - seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). - loss of consciousness or transient ischemic attack within 12 months of randomization - significant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade >2 [National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. 3. Life expectancy of less than 12 months. 4. History of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours). 5. Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety a. Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide. 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse; 7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception. 8. Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings: - Started less than 12 weeks prior to randomisation AND Prostate Specific Antigen (PSA) is stable or falling. The 12 weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration. - In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg. 9. Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted. 10. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases. ; PRIMARY OUTCOME: Overall Survival Time; SECONDARY OUTCOME 1: Prostate specific antigen progression free survival time[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VISTA - DME (U.S., Canada); BRIEF: The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement. ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: The following is an abbreviated list of inclusion criteria: - Adults ≥ 18 years with type 1 or 2 diabetes mellitus - Decrease in vision determined to be primarily the result of DME in the study eye - BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye Exclusion Criteria: The following is an abbreviated list of exclusion criteria: - Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1 - Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1 - Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1 - Active proliferative diabetic retinopathy (PDR) in the study eye - Uncontrolled diabetes mellitus - Only 1 functional eye even if that eye is otherwise eligible for the study ; PRIMARY OUTCOME: Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF); SECONDARY OUTCOME 1: Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DEFINE (CHD); BRIEF: This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent disease on stable dose regimen of statin with or without other lipid-modifying therapy. The two year extension to this study will further evaluate the long-term safety profile and efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a statin with or without other lipid-modifying therapy. ; DRUG USED: Anacetrapib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Cholesteryl Ester Transfer Protein (CETP); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Base Study: - Patient has Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease and is treated with a statin, with well controlled LDL-C - Extension Study: - Patient has completed the base study including the reversibility period (i.e. 12 or to up to 24 weeks). - Patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study Exclusion Criteria: - History of heart failure, arrhythmias, heart attack, unstable angina, or stroke within 3 months prior to screening, uncontrolled blood pressure, uncontrolled high cholesterol or liver disease. - History of mental instability, drug/alcohol abuse within the past 5 years - Pregnant or breast-feeding - History of cancer within the last 5 years - HIV positive - Donated blood products within 8 weeks - Currently participating or have participated in a study with an investigational compound within the last 30 days ; PRIMARY OUTCOME: Change from baseline in Low Density Lipoprotein Cholesterol; SECONDARY OUTCOME 1: Change from baseline in High Density Lipoprotein Cholesterol[/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 - ARIEL4; BRIEF: The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy. ; DRUG USED: Rubraca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: pharmaand GmbH; CRITERIA: Inclusion Criteria: - Be 18 years of age at the time the informed consent form is signed - Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer - Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment - Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation - Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses Exclusion Criteria: - History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib). - Prior treatment with any PARP inhibitor - Symptomatic and/or untreated central nervous system metastases - Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib - Women who are pregnant or breast feeding - Hospitalization for bowel obstruction within 3 months prior to enrollment ; PRIMARY OUTCOME: Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population); SECONDARY OUTCOME 1: Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III; BRIEF: This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain. The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious. ; DRUG USED: Exalgo; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Mallinckrodt; CRITERIA: Inclusion Criteria 1. Patients must have been provided with written consent to participate in the study prior to any study procedures, and must understand that they are free to withdraw from the study at any time. 2. Patients who can speak, read, write, and understand English, and must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff. 3. Male and female patients aged 18-75 years, inclusive. 4. Documented diagnosis of moderate to severe chronic low back pain that must have been present 5. Patients who are classified as non-neuropathic (Class 1 and 2) or neuropathic (Class 3, 4, 5 and 6) of lower back pain based on the Quebec Task Force Classification of Spinal Disorders will be enrolled for this study. 6. Patients who require daily scheduled opioid analgesics for low back pain for at least 2 months prior to the screening visit. 7. Patients with a daily opioid requirement of ≥ 60 mg oral morphine equivalent (≥ 12 mg hydromorphone), but ≤ 320 mg morphine (≤ 64 mg hydromorphone) per day within the 2 months prior to the screening visit. 8. Patients who, in the Investigators opinion, are on a stable dose (≥ 2 weeks) of all prior analgesics (both opioid and non-opioid) prior to the screening visit. 9. Female subjects of childbearing potential including those who have had a tubal ligation surgery but excluding those who have not experienced a menstrual period for a minimum of 2 years, must have a negative serum pregnancy test at screening visit, and must consent to utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 1 week after the study is completed. Exclusion Criteria 1. Patients with an active diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, severe or progressive lower extremity weakness or numbness, bowel or bladder dysfunction as a result of cauda equina compression, diabetic amyotrophy, meningitis, diskitis, back pain because of secondary infection or tumor, or pain caused by a confirmed or suspected neoplasm. 2. Patients who have undergone a surgical procedure for back pain within 6 months prior to the screening visit. 3. Patients who have had nerve or plexus block, including epidural steroid injections or facet blocks, within 1 month prior to the screening visit. 4. Patients with any other chronic pain condition that, in the investigators opinion, would interfere with the assessment of low back pain (e.g., osteoarthritis, rheumatoid arthritis, postherpetic neuralgia, pain associated with diabetic neuropathy, migraine headaches requiring opioid therapy). 5. Patients who are involved in an active workmans compensation or insurance claim or disability claim or litigation related to back pain. 6. Patients who have by history used any illicit drugs of abuse, abused opioids or exhibited drug seeking behavior within 5 years prior to the screening visit. 7. Patients who have abused prescription medication or alcohol within 5 years prior to the screening visit. 8. Patients with a positive alcohol or drugs of abuse test 9. Women who are pregnant (as indicated by a positive result in a serum pregnancy test administered at screening visit), or breast feeding, or planning to breast feed within 30 days prior to the screening visit. 10. Patients who have demonstrated allergic reactions or hypersensitivity to opioids. 11. Patients who have had no bowel movement within three days, or bowel obstruction within 60 days, prior to the screening visit. 12. Patients with pre-existing severe narrowing of the gastrointestinal tract secondary to: prior gastrointestinal surgery (e.g., vagotomy, antrectomy, pyloroplasty, gastroplasty, gastrojejunostomy) or gastrointestinal disease resulting in impaired gastrointestinal function (e.g., paralytic ileus, gastroparesis, inflammatory bowel disease, short gut syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckel diverticulum) 13. Patients who have a major psychiatric condition (e.g., schizophrenia, major depression) or who have clinically significant anxiety or depression as defined by a Hospital Anxiety and Depression Scale(HADS) score greater than 10. 14. Patients who have received monoamine oxidase (MAO) inhibitors within 14 days prior to the screening visit. 15. Patients with clinically significant abnormal laboratory results in clinical chemistry, hematology or urinalysis including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) ≥ 3.0 times the upper limit of the reference range or a serum creatinine ≥ 2.0 mg/dL at screening. 16. Patients with a serious or unstable intercurrent illness. 17. Patients with a history of uncontrolled seizure disorder. 18. Patients with increased intracranial pressure, mental clouding of unknown etiology, coma, or hypotension. 19. Patients who have severe asthma, severe chronic obstructive pulmonary disease, or any other disorder that predisposes the patient to carbon dioxide retention or respiratory depression. 20. Patients who have taken any investigational drug within 30 days prior to the screening visit or are currently enrolled in another investigational drug study. ; PRIMARY OUTCOME: Change From Baseline to Week 12 in Mean Pain Intensity; SECONDARY OUTCOME 1: [/INST]Yes</s>