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NCT ID: NCT04433182 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma

Start date: August 18, 2020
Phase: Phase 2
Study type: Interventional

This is a multicentric single arm phase II trial, to investigate the efficacy (in terms of PFS) of the combination regimen rituximab-bendamustine in association with copanlisib in patients affected by relapsed/refractory DLBCL, not eligible to HDC and ASCT or relapsed after intensified regimens.

NCT ID: NCT04431726 Active, not recruiting - Severe Hemophilia A Clinical Trials

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

HAVEN 7
Start date: February 4, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, multicenter, open-label, single-arm study of prophylactic emicizumab in previously untreated and minimally treated patients at study enrollment from birth to ≤12 months of age with severe hemophilia A (intrinsic factor VIII [FVIII] level <1%) without FVIII inhibitors. The study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at 3 milligrams per kilogram of body weight (mg/kg) once every 2 weeks (Q2W) for 52 weeks. After 1 year of treatment, participants will continue to receive emicizumab (1.5 mg/kg once every week [QW], 3 mg/kg Q2W or 6 mg/kg once every 4 weeks [Q4W]) over a 7-year long-term follow-up period under this study frame.

NCT ID: NCT04431076 Active, not recruiting - Quality of Life Clinical Trials

Patient Reported Outcomes Measures to Predict Pancreatic Surgery Outcomes

PRO-PANC1
Start date: May 7, 2020
Phase:
Study type: Observational

This is a prospective single-center observational study with the mail objective to identify specific subgroups of patients planned for pancreatic resection, at high risk for postoperative morbidity and impaired recovery through preoperative screening of physical, functional, nutritional and psychological risk factors using patient reported questionnaires and performance tests. Consecutive patients planned for pancreatic resection will be enrolled to screen for physical, functional, nutritional and psychological risk factors. The study duration is 3 years: 2 years of recruitment and 1 year of follow-up. The findings of the present study will enable researchers to identify specific risk categories to plan personalized prehabilitation programs and modulate oncologic treatment strategies in cancer patients planned for pancreatic surgery.

NCT ID: NCT04428281 Active, not recruiting - Angelman Syndrome Clinical Trials

A Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of RO7248824 In Participants With Angelman Syndrome

Start date: August 19, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I, multicenter, non-randomized, adaptive, open label, multiple ascending, intra-participant, dose-escalation study with an LTE part. The objective of the study is to investigate the safety, tolerability, PK and PD of RO7248824 in participants administered IT with AS. Two linked sets of dose escalation cohorts are planned based on two different age groups, namely participants with AS aged ≥ 5 to ≤ 12 years in cohorts A1 to A4 (with at least 2 participants ≤ 8 years old in each cohort) and AS participants aged ≥ 1 to ≤ 4 years in cohorts B1 to B5. The two sets of cohorts will be run in parallel, with each cohort A1-A4 preceding and gating the linked cohort B1-B5 (e.g., A1 precedes B1).

NCT ID: NCT04423718 Active, not recruiting - Clinical trials for Neovascular Age-Related Macular Degeneration

Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

PULSAR
Start date: August 11, 2020
Phase: Phase 3
Study type: Interventional

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

NCT ID: NCT04419935 Active, not recruiting - NSCLC Clinical Trials

Lymphadenectomy in NSCLC With and Without Adjuvant Therapy

Start date: May 13, 2020
Phase:
Study type: Observational

Adjuvant therapy in patients affected by NSCLC is indicated in surgically treated cases of N2 disease, while the actual guidelines reported the possibility of a case-by-case decision in case of N1 involvement. On the other hand, the actual categorization of patients based on the hilar or mediastinal involvement (N1 or N2) risks to be too ineffective and straightforward for prognosis prediction and an indication of adjuvant treatments. This issue was underlined in the 8th TNM proposal for the N sub-classification, with a final proposal of different subgroups based on the number of involved stations. However, the IASLC committee noted that this proposal presented some limits due overlapping or not statistical significance among some survival curves, so the proposal was not adopted in the staging system. Moreover, the committee stated that the lack of information regarding some data such as the number of the resected or the metastatic nodes might affect the results and limited other proposals. The objectives of this study are: - To evaluate the prognostic role of the kind of lymphadenectomy, the number of the resected and/or metastatic lymph nodes in surgically treated N positive patients in terms of survival. - To evaluate the indication and the role of adjuvant treatments in these patients. - To identify patients with increased risk of early recurrence or poor survival based on the lymph node involvement characteristics In particular, data will be collect in a prospective database including clinical and pathological data, kind of lymphadenectomy, number of resected nodes, number of metastatic nodes, kind and schedule of adjuvant therapy and follow-up status

NCT ID: NCT04417621 Active, not recruiting - Melanoma Clinical Trials

Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Start date: October 30, 2020
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma

NCT ID: NCT04416646 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma

ZEBRA
Start date: February 27, 2019
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the treatment of patients with renal cell carcinoma.

NCT ID: NCT04415138 Active, not recruiting - Surgery Clinical Trials

Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System

Start date: March 10, 2020
Phase:
Study type: Observational [Patient Registry]

Robotic assistance allows performance of mitral valve operations with a truly minimally invasive and totally thoracoscopic approach, with significant advantages for patients compared to sternotomy-based surgery. Nonetheless, its diffusion has been limited by: 1) significant learning curve and technical requirements; 2) increased immediate financial costs due to dedicated equipment and materials. The aim of the present study is to perform a prospective data collection and evaluation of the in-hospital and follow-up clinical results of mitral valve repair using the last generation DaVinci X robotic platform. A cost-effectiveness analysis of this approach will be also conducted, under a global healthcare system perspective (including the overall patients' pathway starting from diagnosis of mitral valve disease until the completion of the 1st postoperative year). Since the 'competitor' surgical technique is not represented by sternotomy-based mitral surgery, but instead by minimally invasive, video-assisted mitral surgery, patients operated on using such technique will serve as controls.

NCT ID: NCT04412655 Active, not recruiting - Clinical trials for ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion

Primary Angioplasty for STEMI During COVID-19 Pandemic (ISACS-STEMI COVID-19) Registry

ISACS-STEMI
Start date: May 5, 2020
Phase:
Study type: Observational

The ISACS STEMI COVID-19 has been established in response to the emerging outbreak of COVID-19 to provide a European overview to estimate the real impact of COVID-19 pandemic on treatment and outcome of STEMI by primary angioplasty, and to identify any potential category of patients at risk for delay to treatment or no presentation.