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NCT ID: NCT04152980 Recruiting - Clinical trials for Neonatal Late Onset Sepsis

Pentoxifylline Dose Optimization in Neonatal Sepsis

Start date: January 12, 2020
Phase: Phase 3
Study type: Interventional

Sepsis is a very important cause of death and morbidity in preterm infants. There are strong indications that preterm neonates with sepsis could benefit, next to antibiotics, from treatment with pentoxifylline (PTX). Knowledge about optimal dosing is however limited. This study is a dose optimization study using a step-up and step-down model. In order to find the optimal dose, the infusion of pentoxifylline in different dosages will be studied, next to antibiotics with 3 patients per dosage. After the dose optimization study an additional cohort of 10 patients will be treated with the found dosage as a validation of the dose.

NCT ID: NCT04152200 Active, not recruiting - Clinical trials for Primary Hyperoxaluria

A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1

ILLUMINATE-C
Start date: January 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).

NCT ID: NCT04151563 Withdrawn - Clinical trials for Carcinoma, Non-small Cell Lung Cancer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: NCT04151420 Completed - Ulcerative Colitis Clinical Trials

Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment

Start date: June 15, 2020
Phase:
Study type: Observational

Inflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g. rheumatoid arthritis, psoriasis) a complex interaction between a genetically altered immune response, the gut microbiota and environmental factors is causing the disease. Systemic suppression of the immune response with corticosteroids, immunomodulatory, biologicals and combination therapies increases the risk of opportunistic infections in IBD patients. Data on mild and moderate infections in medically treated IBD patients is scarce, mainly since infections treated by the general practitioner or in an outpatient setting are not systematically registered in real life. To help gastroenterologists with clinical decision making, real world data with long term follow-up concerning the risk for infectious complications, is warranted. Several observations underline the importance of real world data on mild and moderate infections in medically treated IBD patients. Mild and moderate infections mostly have a benign course, but they take longer to clear and have a large impact on (work)disability and quality of life in IBD patients. Recurrent infections influences peoples willingness to use a drug and negatively effects adherence. Furthermore, recurring mild and moderate infections might prognosticate serious infections, and systematic assessment of all infections could be used to timely adjust treatment regimens and prevent serious infections. The investigators of this study previously developed a questionnaire on self-reported infections according to the FDA guideline for patient-reported outcome measures (PROM) by interviewing 36 patients with IBD and through input of expert meetings with gastroenterologists, IBD specialists, rheumatologists, immunologists and IBD-nurses. This questionnaire has already been implemented in myIBDcoach, a validated telemedicine system implemented in routine care for over 4000 patients with IBD in the Netherlands. Assesment of reliability and validity are the last steps in validation of this remote monitoring tool. In the current study the investigators aim to: 1. Assess the reliability, construct validity and criterion validity of a remote monitoring tool (questionnaire) for infections as last step in the validation 2. Assess the relative risk of all infections (mild, moderate and severe) in a real-life population for IBD patients on different maintenance treatments 3. Identify the predictors and risk factors of mild and moderate infections. 4. Assess the relation between patient reported infections and the risk for serious infectious complications

NCT ID: NCT04149574 Terminated - Clinical trials for Urinary Bladder Neoplasms

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

CheckMate 7G8
Start date: January 15, 2020
Phase: Phase 3
Study type: Interventional

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

NCT ID: NCT04148066 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

ctDNA Guided Treatment of Early Resistance to Targeted Treatment

TATIN
Start date: July 17, 2019
Phase: N/A
Study type: Interventional

The current strategy is to test for treatment resistance at the time of radiological progression and design subsequent treatment based on the mechanism of resistance. However, upon disease progression patients tend to deteriorate quickly and 30% - 40% of patients will not be in the clinical condition to receive next line treatment. Therefore, there is a potential for early resistance identification and directing treatment against it in order to improve patient outcome.

NCT ID: NCT04145700 Terminated - Synovial Sarcoma Clinical Trials

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma

Start date: March 4, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

NCT ID: NCT04145440 Completed - Clinical trials for Glomerulonephritis, Membranous

Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)

M-PLACE
Start date: October 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

NCT ID: NCT04143945 Completed - Clinical trials for Healthy Volunteers Obesity

A Study Comparing the Injection Site Pain Experience After the Injection of Semaglutide B and Semaglutide D With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity

Start date: October 28, 2019
Phase: Phase 2
Study type: Interventional

This study in healthy men and women looks at the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (s.c., under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.

NCT ID: NCT04143711 Recruiting - Solid Tumor, Adult Clinical Trials

Study of DF1001 in Patients With Advanced Solid Tumors

Start date: November 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.