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NCT ID: NCT04092972 Recruiting - Clinical trials for Peripheral Arterial Disease

Safety and Efficacy of Atherectomy on VasculaR Functions

SAVioR
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.

NCT ID: NCT04091126 Recruiting - Multiple Myeloma Clinical Trials

Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma

DREAMM 9
Start date: December 18, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

NCT ID: NCT04090151 Recruiting - HIV Clinical Trials

The RESPOND Outcomes Study

Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

The RESPOND Outcomes study is a research study around use of antiretroviral and other relevant drugs and long-term clinical outcomes in patients living with HIV. Data collected in this study will be used to answer key unanswered questions regarding treatment of people living with HIV.

NCT ID: NCT04089631 Recruiting - Clinical trials for Colon Cancer Stage II

Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation

CIRCULATE
Start date: June 26, 2020
Phase: Phase 3
Study type: Interventional

The CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.

NCT ID: NCT04087434 Recruiting - Brain Injury, Acute Clinical Trials

Health Outcomes for Acute Concussion

HOAC
Start date: June 18, 2018
Phase:
Study type: Observational

The primary purpose of this prospective observational trial is to validate the Brain Gauge device as an objective tool for concussion assessment and treatment in order to determine if a method that has proven successful in 18-22 year old collegiate student-athletes will be applicable for military personnel. Overall aims of the study include: 1. Demonstration that the Brain Gauge can objectively measure concussion in this population and thus improve concussion identification and coding. 2. Demonstration of stronger screening for and tracking of acute concussion and documentation of concussion diagnoses, including improved tracking of recovery and greater adherence to DOD/VA Clinical Practice Guidelines for acute concussion.

NCT ID: NCT04086550 Recruiting - Clinical trials for Cerebrospinal Fluid Leak

Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

ENCASE-II
Start date: May 20, 2021
Phase: N/A
Study type: Interventional

The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.

NCT ID: NCT04086225 Recruiting - Clinical trials for Relapsing Multiple Sclerosis (RMS)

Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon®

Start date: January 17, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the potential effects of cladribine on the pharmacokinetics of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).

NCT ID: NCT04083937 Recruiting - Prostate Cancer Clinical Trials

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

PAROS
Start date: September 12, 2018
Phase: N/A
Study type: Interventional

As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation. The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.

NCT ID: NCT04083599 Recruiting - Melanoma Clinical Trials

GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

Start date: September 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.

NCT ID: NCT04083443 Recruiting - Clinical trials for Blood Stream Infections

Model for PK/PD of Antimicrobials in Blood Stream Infection: Feasibility

MOBSI1
Start date: July 23, 2019
Phase:
Study type: Observational

The current study is a pilot study to assess the feasibility of a superordinate project. The final objective of this superordinate project is to describe and model the pharmacokinetic behaviour of a small number of standard antimicrobials used in the treatment of frequent blood stream infections, and to link this via pharmacodynamic models to (inhibition of) bacterial or fungal growth as well as to clinical outcomes in patients.