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NCT ID: NCT04495010 Withdrawn - Melanoma Clinical Trials

Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants

CheckMate 7UA
Start date: March 31, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

NCT ID: NCT04254380 Withdrawn - Clinical trials for Diabetes Mellitus, Type 1

Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro

GENTL 1
Start date: December 4, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: • To compare the immunogenicity of Gan & Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM Secondary Objectives: - To evaluate the safety of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM - To evaluate the efficacy of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM

NCT ID: NCT04151563 Withdrawn - Clinical trials for Carcinoma, Non-small Cell Lung Cancer

A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

CheckMate 79X
Start date: April 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy

NCT ID: NCT04138485 Withdrawn - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Start date: December 20, 2019
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

NCT ID: NCT04039477 Withdrawn - Clinical trials for Immune Thrombocytopenia

A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP

MARINA
Start date: July 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 randomized, dose-blind, multicenter study designed to evaluate the safety, tolerability, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) of treatment with KZR-616 in patients with active Autoimmune Hemolytic Anemia or Immune Thrombocytopenia.

NCT ID: NCT03895463 Withdrawn - Clinical trials for Neuroendocrine Tumors

Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical Practice

NETways
Start date: August 2019
Phase:
Study type: Observational

The main aim of this study is to assess the Progression-Free Survival (PFS) at 12 months of Lanreotide Autogel 120 mg use when administered as part of routine GEP-NET treatment and to follow patient treatment pathways, identify prognostic factors of PFS, evaluate patient's QoL, and patient's and clinician's satisfaction with treatment in routine long-term care setting. The study will provide real-world evidence on the use of Lanreotide Autogel 120 mg and will provide information on topics such as optimization of product usage and identification of best practices and will provide evidence on product effectiveness in a realistic setting.

NCT ID: NCT03892863 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

Repetitive Transcranial Magnetic Stimulation as Therapy for Depression in Amyotrophic Lateral Sclerosis

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive loss of central and peripheral motor neurons. ALS leads to death usually within 3 to 5 years from the onset of the symptoms. Available treatment can prolong the disease duration but cannot modify the disease course. Depression is a frequent complication of ALS, which further decreases quality of life and the available data concerning effectivity of antidepressant drugs are conflicting. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity with confirmed antidepressive effect. The purpose of this study is to compare the effectiveness of rTMS in improving the depression in patients with ALS with placebo stimulation. Intervention will include 10 daily sessions. In each session 3000 magnetic pulses will be administered over the left dorsolateral prefrontal cortex. Assessment depression severity will be made before and after therapy, as well as two and four weeks later.

NCT ID: NCT03892382 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

Repetitive Transcranial Magnetic Stimulation as Therapy for Apathy in Amyotrophic Lateral Sclerosis

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive loss of central and peripheral motor neurons. ALS leads to death usually within 3 to 5 years from the onset of the symptoms. Available treatment can prolong the disease duration but cannot modify the disease course. Apathy is a frequent complication of ALS, affecting up to 30% of patients and affecting negatively the survival. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity with confirmed beneficial effect on apathy in several neurologic and psychiatric conditions. The purpose of this study is to compare the effectiveness of rTMS in improving the apathy in patients with ALS with placebo stimulation.

NCT ID: NCT03763812 Withdrawn - Clinical trials for Abdominal Aortic Aneurysm

Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

Start date: December 2019
Phase: N/A
Study type: Interventional

Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage. This study is designed to establish whether EVAS results in a reduced post-operative inflammatory response during the first year after surgery, compared to EVAR as assessed by trends in circulating inflammatory cytokine concentration. Study design: International prospective, comparative, explorative study. Study population: Patients scheduled to undergo infra-renal EVAR with a polyester endograft or EVAS for an infrarenal aortic aneurysm. This is an explorative study and therefore only patients who would normally receive a suitable device as part of standard treatment at the participating institutes will be recruited. Blood samples will be taken at specified time points before and after surgery. Main study parameters/endpoints: The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome. To investigate the incidence of the post-implant syndrome, the rise in CRP, WBC and circulating cytokines, at specified time points up to 12 months after surgery and the change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.

NCT ID: NCT03714412 Withdrawn - Clinical trials for Mitral Regurgitation

Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System

Start date: September 2019
Phase: N/A
Study type: Interventional

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.