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NCT ID: NCT03194867 Completed - Plasma Cell Myeloma Clinical Trials

Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Start date: February 21, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma. - To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria. Secondary Objectives: - To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS). - To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination. - To assess the immunogenicity of isatuximab and cemiplimab when given in combination.

NCT ID: NCT03192813 Completed - Clinical trials for Aortic Valve Stenosis

Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II

SCOPE II
Start date: April 20, 2017
Phase:
Study type: Observational

Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

NCT ID: NCT03192332 Completed - Ischemic Stroke Clinical Trials

Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke

SWIFT DIRECT
Start date: November 29, 2017
Phase: N/A
Study type: Interventional

Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation has currently become a matter of debate and is a relevant unanswered question in clinical practice. The main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects treated with combined IV t-PA and MT. The secondary objectives are to study causes of mortality, dependency and quality of life in these AIS patients.

NCT ID: NCT03191864 Completed - Clinical trials for Eosinophilic Esophagitis

Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)

FLUTE
Start date: June 22, 2017
Phase: Phase 2
Study type: Interventional

Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.

NCT ID: NCT03191799 Completed - Hemophilia A Clinical Trials

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

STASEY
Start date: September 5, 2017
Phase: Phase 3
Study type: Interventional

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

NCT ID: NCT03191786 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy

IPSOS
Start date: September 11, 2017
Phase: Phase 3
Study type: Interventional

This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).

NCT ID: NCT03191578 Completed - Clinical trials for High-Risk Non-Muscle-Invasive Bladder Cancer

Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®

RUTIVAC-1
Start date: June 16, 2017
Phase: Phase 1
Study type: Interventional

The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC. The study will enroll individuals treated with Transurethral resection of bladder tumor (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable candidates for BCG therapy and who meet all eligibility criteria. Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of 25 μg RUTI® or placebo. After vaccination, individuals will receive the standard induction course, of intravesical Bacillus Calmette-Guerin (BCG)therapy (weekly BCG for six weeks). 4 to 8 weeks after the last intravesical BCG administration (BCG6) a visit will be performed (Visit 1, end of the interventional phase). Once all participants have performed VISIT 1 immunological assays will be performed and data will be analyzed. At the end of the Interventional Phase the blind will be opened, except for the study physicians who will remain blind during all the follow-up. All the individuals will be followed up for three years since TURBT.

NCT ID: NCT03191396 Completed - Clinical trials for Diabetes Mellitus, Type 2

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

SUSTAIN 10
Start date: June 27, 2017
Phase: Phase 3
Study type: Interventional

This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

NCT ID: NCT03191162 Completed - Chagas Disease Clinical Trials

Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.

MULTIBENZ
Start date: April 21, 2017
Phase: Phase 2
Study type: Interventional

A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.

NCT ID: NCT03190447 Completed - Nursing Clinical Trials

Wich is the Best Dressing in Wounds by Primary Surgery of THA and / or TKA?

Start date: April 20, 2017
Phase: N/A
Study type: Interventional

Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. Currently, in Corporació PT after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. In many cases the appearance of blistering caused by the use of these conventional dressings is observed, which increases the risk of infection, pain and the final cost of the procedure. There are other types of dressings that could improve these aspects but comparative data are not currently available. Main objective: to identify the dressing that better preserves the integrity of the skin. Design: Prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (TKA and THA). Secondary Objectives: To identify the dressing that provides greater advantages and minor inconveniences in TKA and THA surgery. Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110 patients