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NCT ID: NCT03620669 Active, not recruiting - NSCLC Stage IV Clinical Trials

1st Line Durvalumab in PS 2 NSCLC Patients

Start date: December 4, 2018
Phase: Phase 2
Study type: Interventional

The aim of the trial is to assess efficacy and safety of the treatment with durvalumab in PS 2 patients with treatment-naïve, locally advanced or metastatic, PD-L1 positive NSCLC who are considered unsuitable for combination platinum-containing therapy.

NCT ID: NCT03614260 Active, not recruiting - Hypertension Clinical Trials

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

RADIANCE-II
Start date: December 14, 2018
Phase: N/A
Study type: Interventional

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

NCT ID: NCT03603184 Active, not recruiting - Endometrial Cancer Clinical Trials

Atezolizumab Trial in Endometrial Cancer - AtTEnd

AtTEnd
Start date: October 2, 2018
Phase: Phase 3
Study type: Interventional

Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1. In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant); in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Finally, in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Combinations of atezolizumab with chemotherapeutic agents and/or targeted therapies were studied in different solid tumors such as melanoma, NSCLC, renal cell carcinoma and colorectal carcinoma. From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents. Finally, preliminary results of a Phase Ia study of Atezolizumab (NCT01375842) monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017. Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 11.2 months. No G4-5 related AEs occurred. Regarding efficacy ORR was 13% [2/15] by RECIST. Atezolizumab seemed to have a favorable safety profile, with durable clinical benefit in some patients. Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options.

NCT ID: NCT03600883 Active, not recruiting - Clinical trials for KRAS p.G12C Mutant Advanced Solid Tumors

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Start date: August 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

NCT ID: NCT03600688 Active, not recruiting - Clinical trials for Mitral Regurgitation

Edwards Cardioband European Post-Market Study, MiBAND

MiBAND
Start date: June 6, 2018
Phase:
Study type: Observational

To demonstrate reduction of MR with durable performance and im-provements in functional status

NCT ID: NCT03599713 Active, not recruiting - Clinical trials for Metastatic Merkel Cell Carcinoma

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

Start date: February 25, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

NCT ID: NCT03598530 Active, not recruiting - Tibial Fracture Clinical Trials

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

FROST
Start date: April 4, 2019
Phase:
Study type: Observational [Patient Registry]

Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required. Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment

NCT ID: NCT03570892 Active, not recruiting - Clinical trials for Non-Hodgkin Lymphoma

Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

BELINDA
Start date: May 7, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.

NCT ID: NCT03569293 Active, not recruiting - Atopic Dermatitis Clinical Trials

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Measure Up 1
Start date: August 13, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03569241 Active, not recruiting - Prostate Cancer Clinical Trials

PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

STORM
Start date: April 27, 2018
Phase: Phase 2
Study type: Interventional

A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions).