About 1,077,623 results

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

Oct 14th, 2022 - The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

Oct 14th, 2022 - PRIMARY OBJECTIVE: I. To evaluate the tolerability of azacitidine in addition to Interfant-06 standard chemotherapy in infants with newly diagnosed acute lymphoblastic leukemia (ALL) with KMT2A gene rearrangement (KMT2A-R). SECONDARY OBJECTIVE: I. To evaluate the biologic activity of azacitidine by pharmacodynamic assessment of global deoxyribonucleic acid (DNA) methylation in peripheral blood ...

Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Oct 14th, 2022 - Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Oct 14th, 2022 - This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outc...

Effect of COVID-19 Related COntainment in ChildreN

Oct 14th, 2022 - Parents of children aged 8 to 15 will be approached from different levels / places of selection / recruitment. A clinical researcher of pediatric clinical investigation center will collect the responses. If one of the holders of parental authority and the child agree to participate, an information notice will be sent to them, then they will be contacted by telephone by a clinical research assis...

Study of ALXN2050 in Participants With Renal Impairment

Oct 14th, 2022 - The study will initiate (Part 1) with participants with severe impaired renal function (Cohort 1) and their matched healthy control participants (Cohort 4). Following data review, the study may proceed (Part 2) with participants with moderate (Cohort 2) and mild (Cohort 3) impaired renal function if deemed necessary.

Adaptation of Skills Training Manuals for Patients Receiving Hematopoietic Stem Cell Transplantation and Their Caregivers

Oct 14th, 2022 - A two-part, qualitative descriptive design will be employed to systematically adapt the Coping Together manuals based on recommendations of HSCT patients, CGs, dyads and clinicians (for Phase 1 only). For this study, CG is defined as spouse, partner, family member, friend, colleague, or neighbor who can, but do not necessarily live together, and provide uncompensated care. A dyad is defined as ...

Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)

Oct 14th, 2022 - A Randomized, Double-Blind, Placebo-Controlled Trial of Tomivosertib in Combination With Anti-PD-(L)1 Therapy in Subjects With Non-Small Cell Lung Cancer as First Line Therapy or When Progressing on Single-Agent First-Line Anti PD (L)1 Therapy

Management of Depression and Anxiety in HF

Oct 14th, 2022 - Heart failure (HF) is a complex clinical syndrome characterized by inability of the heart to pump an adequate amount of blood. Heart failure affects patients' ability to carry out even simple activities of daily living and therefore has negative psychological impact. Many studies reported that depression is prevalent among HF patients and it is being associated with high morbidity, mortality an...

Web-based Collaborative Care Intervention Study

Oct 14th, 2022 - The investigators will enroll patients at two UPMC sites: Montefiore Hospital, an academic medical center, and Passavant Hospital, a community based hospital. Based on our sample size estimate the investigators will have at least 364 patients and caregivers with complete data at 12 months follow up. The patient and caregiver will be randomly assigned to one of two arms (intervention versus enha...

Axi-cel in CNS Lymphoma

Oct 14th, 2022 - This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. This study will examine the safety and efficacy of axi-cel in participants who either currently or previously had had central nervous system...

Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Oct 14th, 2022 - This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Oct 14th, 2022 - Background: T-cell lymphomas (TCLs) are a heterogeneous group of lymphoid malignancies defined by clonal proliferation of post-thymic T lymphocytes. Patients with newly diagnosed TCLs are most commonly treated with a CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone)-like regimen, with less than 30% having durable complete responses (CRs). Of the chemotherapy agents used, doxorubi...

Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants

Oct 14th, 2022 - This is a multi-center, open-label trial to be conducted in up to 70 pre-term infants in order to evaluate the safety and suitability of two feeding systems as they would typically be used in the neonatal care unit. Growth (in comparison to recommended growth goals), feeding tolerance, biochemical parameters, and adverse event reporting will be evaluated. The two feeding systems will be tested ...

Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Who Are Infected With Acute Respiratory Syncytial Virus (RSV) of the Upper Respiratory Tract

Oct 14th, 2022 - This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.

Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure

Oct 14th, 2022 - Inhibitors of the type 2 sodium-glucose co-transporter (iSGLT2) may improve the metabolic and hemodynamic profile in patients with DM2 and heart failure.

ACS Registry - A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow

Oct 14th, 2022 - Cardiovascular diseases (CVD) are currently the leading cause of death in industrialized countries and are expected to become the leading cause of death in emerging countries by 20201. According to the official Russian statistics, in 2015, CVD was the cause in 34% of deaths in Russia2. Acute Coronary Syndrome (ACS) is the most prevalent manifestation of CVD and is associated with high mortality...

Niemann-Pick Type C Treatment With Adrabetadex for Symptoms of Brain and Nervous System

Oct 14th, 2022 - This study was amended from extended access to a clinical trial. Information will be collected about long-term safety and effectiveness of adrabetadex shots in the spine every 2 weeks. Participants who were already taking adrabetadex will receive their stable dose. Participants who have not ever taken it will start by receiving 400 mg. Participants will receive treatment every 2 weeks until the...

Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

Oct 14th, 2022 - The researchers aim is to investigate the effects of Tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with RRMS. The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task and also on how cognitive fatigue changes as a function of duration of treatment.

Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Diseas...

Oct 14th, 2022 - Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and...