Via Cincuentenario, Panama

ABTECT - Maintenance

All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 study which consists of 2 treatment phases. This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit. The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2. At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded. Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with nr-axSpA who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP < 1.3). The maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120. Study treatment will be as follows: - Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL - Double-blind Secukinumab and Placebo PFS will be labeled as AIN457 150mg/1mL/Placebo. Study duration will be up to 128 weeks from Baseline. The treatment duration will be up to 120 weeks with last treatment administration at Week 116. In the Treatment Period 1 participant will attend a site visit approximately 1 month after Baseline and approximately every 12 weeks thereafter. In the Treatment Period 2 participant will attend site visits approximately every 4 weeks.

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Subjects will be assessed for PIK3CA status and then randomized to treatment arms according to their confirmed PIK3CA mutation status.

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

VE202 in Patients with Mild-to-Moderate Ulcerative Colitis

A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Correlation of Various Laboratory Parameters With Outcome in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage - Prospective Case Series

Background The incidence of aneurysmal subarachnoid hemorrhage is 10/100000 person/year. Some epidemiological date suggest that the 30-day mortality of subarachnoid hemorrhage (SAH) is nearly 50%. (ACROSS Group. Epidemiology of aneurysmal subarachnoid hemorrhage in Australia and New Zealand: incidence and case fatality from the Australasian Cooperative Research on Sub- arachnoid Hemorrhage Study (ACROSS). Stroke. 2000;31: 1843-50 Ingall T, Asplund K, Mahonen M, Bonita R. A multinational comparison of subarachnoid hemorrhage epidemiology in the WHO MONICA stroke study. Stroke. 2000;31:1054-61.). In this relative high mortality rate the effect of delayed cerebral ischaemia (DCI) and different extracerebral complications (Takotsubo cardiomyopathy, secondary infections, etc.) have key roles. (Claassen J, Vu A, Kreiter KT, et al. Effect of acute physiologic derangements on outcome after subarachnoid hemorrhage. Crit Care Med. 2004;32:832-8.). DCI occurs in nearly third of patients and its most common cause is cerebral vasospasm (at least 70% of cases). Vasospasm usually develops on day 3 after hemorrhage, it reaches a peak on day 7-8 and solves after the day 14. (Dorsch NWC, King MT. A review of cerebral vasospasm in aneurysmal subarachnoid hemorrhage. Part 1: Incidence and effects. J Clin Neurosci. 1994;1:19-26.). DCI has been shown to be a multifactorial process, in which cerebral vasospasm has a remarkable part, but anemia, cortical spreading depolarization, damage of cerebral autoregulation, and activation of the inflammatory-thrombotic cascade may also play an important role. . (Chamling B, Gross S, Stoffel-Wagner B, Schubert GA, Clusmann H, Coburn M, et al. Early diagnosis of delayed cerebral ischemia: possible relevance for inflammatory biomarkers in routine clinical practice? World Neurosurg (2017) 104:152-7. McBride DW, Blackburn SL, Peeyush KT, Matsumura K, Zhang JH. The Role of Thromboinflammation in Delayed Cerebral Ischemia after Subarachnoid Hemorrhage.Front Neurol. 2017;8:555.). In this prospective study the investigators aim to investigate the role of the following three factors on the development of vasospasm and patient outcome: (1.) anemia; (2.) plasma fibrinolytic activity; (3.) vitamin D. Review of related literature: The role of anaemia in SAH: Depending on definition, anaemia develops in 40-50% of SAH patients, only 16% of patients have a hemoglobin level higher than 110g/l . According to follow-up studies anaemia appears on day 3-4 after hemorrhage (concurrently with vasospasm) and the reduction of hemoglobin concentration is 30 g/l on average. (Sampson TR, Dhar R, Diringer MN. Factors associated with the development of anemia after subarachnoid hemorrhage. Neurocrit Care. 2010;12:4-9.) Clot lysis assay gives an opportunity to detect the plasma fibrinolytic potential. Studies from the recent years identified neutrophil extracellular trap (NET) components, releasing from activated neutrophil granulocytes and play an important role in the modulation of the fibrinolytic process. NETs are the part of the complex system of inherited immunity. A recent study has shown that parameters of the modified CLA correlate with the volume of hematoma and outcome of spontaneous intracranial hemorrhage. (Orbán-Kálmándi R, Árokszállási T, Fekete I, Fekete K, Héja M, Tóth J, Sarkady F, Csiba L, Bagoly Z. A Modified in vitro Clot Lysis Assay Predicts Outcomes in Non-traumatic Intracerebral Hemorrhage Stroke Patients-The IRONHEART Study. Front Neurol. 2021;12:613441.) No similar studies exist about SAH. The role of vitamine D3 in SAH: In a previous pilot study vitamine D3 deficiency was identified as an independent risk factor of SAH outcome , furthermore vitamin D3 level was inversely related to the incidence and severity of vasospasm. (Kashefiolasl S, Leisegang MS, Helfinger V, Schürmann C, Pflüger-Müller B, Randriamboavonjy V, Vasconez AE, Carmeliet G, Badenhoop K, Hintereder G, Seifert V, Schröder K, Konczalla J, Brandes RP. Vitamin D-A New Perspective in Treatment of Cerebral Vasospasm. Neurosurgery. 2021;88:674-685.). Perspectives of the planned study: Considering the currently available therapeutic range for patients with SAH, results of the present study may provide a basis for designing further randomized, prospective trials to investigate the effect of treating anemia, anticoagulation and vitamin D supplementation. Subjects and methods The investigators include patients admitted to the Neurosurgical Intensive Care Unit of the Clinical Center of the University of Debrecen with the diagnosis of SAH. Inclusion criteria: - acut SAH - patients older than 18 years - admission within 48 hours after symptom onset Exclusion criteria: - admission over 48 hours after symptom onset - traumatic SAH - Angioma - A-V malformation - Patient unable to consent and no relative available Planned period of patient enrollment: June 1, 2022 - December 31, 2024 Planned number of patients: approx. 300 patients Patients are treated according to local protocol based on international guidelines(Diringer MN, Bleck TP, Claude Hemphill J 3rd, Menon D, Shutter L, Vespa P, Bruder N, Connolly ES Jr, Citerio G, Gress D, Hänggi D, Hoh BL, Lanzino G, Le Roux P, Rabinstein A, Schmutzhard E, Stocchetti N, Suarez JI, Treggiari M, Tseng MY, Vergouwen MD, Wolf S, Zipfel G; Neurocritical Care Society. Critical care management of patients following aneurysmal subarachnoid hemorrhage: recommendations from the Neurocritical Care Society's Multidisciplinary Consensus Conference. Neurocrit Care. 2011;15:211-240.), and neurosurgeons and interventional radiologists are involved in therapeutic decisions. Investigations and recorded data on admission: - skull CT - angiography - severity classification: Fisher, Hunt-Hess, WFNS, GCS - medical history, especially: hypertension, diabetes mellitus, cardiovascular diseases, kidney diseases (polycystic kidney? ), previous stroke - laboratory investigations: blood count, blood glucose, kidney function, hemostasis + fibrinogen Investigations associated with present study and their timing: Hemoglobin level: - day of admission - day 3-4-7 and 14 after hemorrhage mCLA: - day of admission - day 7 after hemorrhage 25-hydroxy vitamin-D level: - day of admission Transcranial color- coded duplex sonography: - daily basis 30 day follow-up: - mortality - Glasgow Outcome Scale - Karnofsky score - Barthel score 90 day follow-up: - mortality - Glasgow Outcome Scale - Karnofsky score - Barthel score Transcranial color-coded duplex sonography : Transcranial color-coded duplex (TCCD) sonography is performed by two experienced investigators (Béla Fülesdi, Péter Síró) using the 2 MHz sector transducer of the GE Venue Go (GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 U.S.A.) ultrasound device. Regular TCCD measurements are registered in all patients between days 1 through 7. Based on previous suggestions, vasospasm is considered if mean blood flow velocity was higher than 120 cm/s and severe vasospasm is diagnosed if mean blood flow velocity exceeded 200 cm/s. If ultrasound signs of vasospasm are present in any of the cases, duplex sonographies are performed until day 21 on a daily basis. Processing data Correlation of all three parameters with SAV severity parameters, detected on admission: Hunt Hess score, Fischer score, WFNS score Correlation of all three parameters with the development of vasospasm. Definition of anemia based on hemoglobin level: - in males: < 120 g / l - in females: <110 g / l 25-hydroxy vitamin-D level: - definition of low level: <50 nmol/l Statistical analysis: To analyse continuous variables, in the first step a normality test is performed. The t-test is used to analyse samples with a normal distribution, while non-parametric tests are used to analyse samples with non-normal distribution. Bonferroni correction is performed for multiple comparisons. To examine categorical variables, the investigators use a χ2 test with "Yates' correction for continuity" if necessary.