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NCT ID: NCT03505268 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effect of telemedicine intervention program upon glycemic control in type 1 diabetes mellitus children and their parents in Israel. Half of the participants will receive the telemedicine intervention for a period of six months while the other half will receive the regular treatment then vice versa. Each group will receive in the intervention period 6 telemedicine meeting with a dietician and six telemedicine meetings with a nurse. The investigators hypothesized that the participants that are recieving the telemedicine intervention will have a better glycemic control after 6 months.

NCT ID: NCT03504423 Completed - Clinical trials for Pancreatic Cancer Metastatic

Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas

Start date: November 9, 2018
Phase: Phase 3
Study type: Interventional

A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

NCT ID: NCT03504397 Active, not recruiting - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

Spotlight
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6. A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.

NCT ID: NCT03504189 Completed - Pregnancy Clinical Trials

Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

NCT ID: NCT03503812 Completed - Atrial Fibrillation Clinical Trials

Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches

MEDEA
Start date: September 24, 2018
Phase: N/A
Study type: Interventional

The MEDEA project is envisioned to provide the field-based evidence for the adoption of a strategic plan for mitigating the health effects of desert dust storm (DDS) events in South-Eastern Europe. Over the past decade, several studies have demonstrated that DDS in Mediterranean countries, originating mostly from the Sahara and Arabian Peninsula deserts, have been increasing in number and magnitude and linked it to desertification, climatic variability and global warming. EU legislation considers DDS impossible to prevent, implicitly harmless and discounts their contribution to daily and annual air quality standards of particulate matter up to 10 microns (PM10). However, there is increasing evidence from epidemiological studies, which correlates exposure to PM10 during DDS with a significant increase in mortality and hospital admissions from cardiovascular and respiratory causes. Therefore, there is a pressing need for EU policies to reduce population exposures and increase individual, population and institutional resilience to the growing frequency and intensity of DDS. MEDEA ultimate goal is to demonstrate the feasibility and effectiveness of an adaptation strategy to DDS and better inform EU policy making. The adaptation strategy will be carried out within two panel studies, with two different groups of patients; 1. Children with asthma and 2. Adults with atrial fibrillation (AF). The primary objective will be to quantify the vulnerability of children with asthma and adults with AF during DDS outbreaks and provide evidence-based estimates demonstrating which interventions/recommendations work best in mitigating adverse health effects in this group of patients after randomization of each group of patients to three parallel intervention groups: a) No intervention for DDS; b) Intervention for outdoor exposure reduction, and c) Interventions for both outdoor and indoor exposure reduction. The secondary objective of the study is to demonstrate which of the recommendations are effective in reducing outdoor and indoor exposures to DDS in a panel of children with asthma and in a panel of AF adults. Intervention: Each group of patients (children with asthma and AF patients) will be recruited and will be randomized during the high DDS outbreaks season (Spring 2019 and 2020) with 1:1:1 ratio into three parallel groups to receive: a) No intervention for DDS; b) Intervention for outdoor exposure reduction, by reducing the time spend outdoors and by avoiding physical activity and c) Interventions for outdoor (as above) and indoor exposure reduction (by minimizing home ventilation and filtering indoor air). Disease-related adverse health outcomes will be assessed in the three parallel arms of the study. Approaches for delivering the intervention: A bidirectional, patient-centered e-Platform will be developed in order to facilitate prompt communication with the participants and provide early warnings regarding forecasted upcoming DDS events through text messaging and smartphone applications. Furthermore, the same IT platform and mobile application will be utilised for the dissemination of the exposure reduction guidelines that the participants will follow. Assessment of adherence to intervention: 1.Monitor compliance to exposure-reduction guidelines using remote sensors. The intervention for outdoor exposure reduction, entailing reduction of the time spend outdoors and avoidance of physical activity, will be assessed with the use of smart wristwatches that will be equipped with Global Positioning System (GPS) and an accelerometer. 2.The intervention for indoor exposure reduction, entailing minimization of home ventilation and filtering of indoor air, will be assessed with the use of particle samplers that will be placed outside and inside of houses and school classrooms.

NCT ID: NCT03503357 Completed - Clinical trials for Anesthesia Awareness

ConsCIOUS2 Study of the Isolated Forearm Technique Commands

Start date: April 4, 2018
Phase: N/A
Study type: Interventional

ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic.

NCT ID: NCT03502811 Completed - Clinical trials for Mitral Regurgitation

The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices

Start date: April 26, 2018
Phase:
Study type: Observational

The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.

NCT ID: NCT03502616 Completed - Clinical trials for Ankylosing Spondylitis

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Start date: June 7, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

NCT ID: NCT03502473 Withdrawn - Clinical trials for Excess Abdominal Fat

UltraShape Power Device for Fat Reduction in Flanks

Start date: March 7, 2018
Phase: N/A
Study type: Interventional

Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.

NCT ID: NCT03501784 Recruiting - Cervical Caries Clinical Trials

Nobio Antimicrobial Particles Effect in a Split Mouth Model

Start date: September 22, 2018
Phase: N/A
Study type: Interventional

The study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable Composite versus standard of care within a split mouth model.The study population will include 35 subjects considered to be at high risk for cervical caries and affected by uncontrolled plaque accumulation