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NCT ID: NCT03374514 Recruiting - Clinical trials for Sensorineural Hearing Loss

Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery

Start date: August 9, 2017
Phase: Phase 3
Study type: Interventional

Hearing is the ability to perceive sounds through the ear. If the transmission of sound is defective, the person suffers some degree of hearing loss. Cochlear Implants (CI) provide partial hearing by stimulating auditory nerve cells. The evaluation of the functionality of the CI is facilitated by several analysis tools, such as the clinical calibration software. This offers the possibility of measuring electrical impedances in the cochlea. The electrical impedance is the opposition to the current flow between two electrodes. It is composed of two main elements: resistance and reactance. The impedances in a cochlear implant are not stable over time. The value is minimal immediately after surgery, and increases progressively in the first 2 to 3 weeks after the procedure due to the immune response of the organism against a foreign body and the trauma of the array insertion. Several authors have suggested the use of topical or intravenous corticosteroids to decrease intracochlear fibrosis. The use of Dexamethasone could have a protective effect by reducing the initial inflammatory response, apoptosis, and delayed fibrosis, which could impact the impedance. There is limited evidence on the effect of intra-surgical topical corticosteroids on the impedance of the cochlear implant. The aim of this clinical trial is to evaluate the impact of topical dexamethasone on the electrical impedance of the cochlear implant, with special attention to the analysis of the capacitive component. It will be carried out through an experimental, prospective, randomized and double-blind study. Objective To determine whether the use of topical dexamethasone in a single dose applied in the tympanic cavity (middle ear) during cochlear implant surgery modifies the capacitive component of the electrical impedance of the electrodes in the cochlea before the activation of the cochlear implant. Material and methods A phase 3 clinical trial will be conducted. The design is a parallel, randomized, controlled and double-blind experimental study. Expected impact The use of local dexamethasone during cochlear implant surgery would decrease the inflammatory response, improving postoperative impedances.

NCT ID: NCT03359447 Recruiting - Anemia Clinical Trials

Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

This study compares weekly versus daily administration of iron for prevention of anemia in 6 months old infants. One third of the infants that are exclusively breast fed will not receive iron, the second third will receive iron weekly and the last third will receive iron daily. Half of the infants that take infant formula will receive iron weekly and the other half will receive iron daily.

NCT ID: NCT03340506 Recruiting - Melanoma Clinical Trials

Dabrafenib and/or Trametinib Rollover Study

Start date: December 28, 2017
Phase: Phase 4
Study type: Interventional

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

NCT ID: NCT03321669 Recruiting - Small Bowel Disease Clinical Trials

Impact of Diet on Capsule Endoscopy

Start date: October 4, 2017
Phase: N/A
Study type: Interventional

Capsule endoscopy studies are used for the diagnosis of small bowel mucosal lesions. Since capsule endoscopy depends on the small intestinal peristaltism, the food intake - especially the amount of fat ingested - after the ingestion of the capsule may have an impact on the capsule endoscopy transit time and thus its diagnostic yield. As a consequence, an open-label randomized pilot study was designed to determine wether increased dietary intake of fat after the ingestion of the capsule endoscopy may influence small intestinal transit time and thus the diagnosis of small bowel lesions.

NCT ID: NCT03301506 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Start date: December 12, 2017
Phase: Phase 3
Study type: Interventional

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

NCT ID: NCT03233191 Recruiting - Breast Screening Clinical Trials

Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

Start date: September 28, 2017
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

NCT ID: NCT03225586 Recruiting - Cancer Clinical Trials

Prospective Urban Rural Epidemiology Study

PURE
Start date: January 1, 2002
Phase:
Study type: Observational

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).

NCT ID: NCT03210298 Recruiting - Colorectal Cancer Clinical Trials

International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

PIPACRegis
Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

NCT ID: NCT03206814 Recruiting - Clinical trials for Hypertension,Essential

Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System

CHARGE-APP
Start date: May 11, 2021
Phase: N/A
Study type: Interventional

The CHARGE-APP project will investigate whether an innovative management strategy of hypertension based on the combination of usual care visits and ESH CARE App compared to standard care, is associated with differences in outcome, including control rate of office, home and ambulatory BP, cardiovascular and renal intermediate end points at one year, and changes in a number of blood pressure-related variables throughout the study.

NCT ID: NCT03178552 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

B-FAST
Start date: September 22, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.