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NCT ID: NCT02974322 Withdrawn - Crohn Disease Clinical Trials

A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. All patients who complete the study will have the option to enter a long term active treatment study.

NCT ID: NCT02973191 Withdrawn - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia

ORBIT
Start date: December 20, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential parts, Part A and Part B; subjects will be screened and will provide informed consent before initiating any study procedures in Part A of the study.

NCT ID: NCT02941601 Withdrawn - Clinical trials for Metastatic Squamous Non-Small Cell Lung Cancer

A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.

NCT ID: NCT02934373 Withdrawn - Hearing Loss Clinical Trials

Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products

Start date: n/a
Phase: N/A
Study type: Interventional

Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System

NCT ID: NCT02900079 Withdrawn - Malaria Clinical Trials

Use of Malaria Rapid Diagnostic Tests as a Decision Aid for the Management of Fever by International Travelers

JOKA-I
Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

This study is part of a larger prospective cohort study (JOKA), designed to study the incidence and etiological spectrum of febrile illness occurring during a travel to the tropics, as well as clinical course, care, treatment and outcome of these febrile illness episodes. Its objective is to evaluate the clinical use of malaria rapid diagnostic tests (RDT) by travelers or their peers during travel, as a decision aid for the management of febrile illness in the tropics. If the study demonstrates that malaria can be ruled out safely by travelers themselves using a RDT, a combination of self/peer testing with SBET may become an alternative to antimalarial chemoprophylaxis in travel medicine.

NCT ID: NCT02883439 Withdrawn - Clinical trials for Bioavailability Study

Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasone Propionate

BIODYMF
Start date: August 2016
Phase: N/A
Study type: Interventional

The aim of this study is to investigate and to compare the bioavailability of MP29-02 and fluticasone propionate in nasal tissue after nasal application. This may provide a rational basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has demonstrated the efficacy of the twice-daily treatment; however, so far, no data are available on the local tissue concentrations of MP29-02 after topical application.

NCT ID: NCT02859298 Withdrawn - Premature Delivery Clinical Trials

Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery.

Start date: August 9, 2016
Phase: N/A
Study type: Interventional

Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified. The standard medical examination for the detection of patients with TPD is the endovaginal ultrasonographic examination of uterine cervix (echography). Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging technologies with polarized light. The polarization is the spatio-temporal orientation of a wave's electric field. This light property, invisible with the naked eye, is sensitive to the morphological transformations of a tissue and the orientation of collagen fibers. Such tool would not require an extensive training and should provide an objective quantitative result with a sensitivity and specificity greater than conventional ultrasonography. This would be a considerable contribution to the health care of TPD, a real societal problem in Belgium, Europe and all over the world. The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the structural evolution, the density and the orientation changes of collagen fibers. A relevant scoring of collagen status might provide an alternative, and potentially objective and accurate quantifier of the time left before delivery.

NCT ID: NCT02799914 Withdrawn - Clinical trials for Venous Vascular Diseases and Syndromes

Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease

Start date: April 2016
Phase:
Study type: Observational

Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy.

NCT ID: NCT02796547 Withdrawn - Episiotomy Clinical Trials

Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery

Start date: July 14, 2016
Phase: Phase 2
Study type: Interventional

An episiotomy is an incision of the perineum to facilitate childbirth by natural means. Perineal pain are more frequent and intense if the incision of the perineum is important. In particular, simple vaginal or perineal tears are less painful than episiotomies in the first seven days postpartum, whereas at six weeks postpartum, there is no significant difference anymore.The patients are the most symptomatic in the immediate postnatal period, but the pain may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often undervalued and may interfere with the mother-child bond in the absence of an effective treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal anti-inflammatory drugs given orally or rectally and paracetamol. The scar infiltration is one of the components of a multimodal postoperative analgesia strategy. It consists in the simultaneous use of several drugs or analgesic techniques, acting on different pain components in order to improve the overall efficiency.The most used local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine.Ropivacaine has a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the injection point and a blood resorption that is more spread. The systemic toxicity threshold is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects, and an intermediate systemic toxicity threshold intermediate between bupivacaine and ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in complement infiltrations when a rapid onset of action is desired. So far, there is no data in the literature regarding the effect of levobupivacaine in episiotomies associated pain. The objective of this study is to evaluate the effect of local injections of levobupivacaine on episiotomies associated pain.

NCT ID: NCT02722135 Withdrawn - Clinical trials for Leukemia, Myeloid, Acute

A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed

Start date: November 2016
Phase: Phase 1
Study type: Interventional

This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy will be collected.