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NCT ID: NCT03703869 Recruiting - Diabetes Clinical Trials

Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

ATOS
Start date: March 6, 2018
Phase:
Study type: Observational

Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives: - Assess effectiveness in achieving glycemic goal measured by HbA1c; - Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; - Assess requirement for intensification of therapy by additional antidiabetics. - Assess incidence of hypoglycemia; - Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); - Assess change in body weight.

NCT ID: NCT03687255 Recruiting - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.

NCT ID: NCT03684044 Not yet recruiting - Influenza Clinical Trials

Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

Start date: November 30, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.

NCT ID: NCT03671239 Not yet recruiting - HIV Prevention Clinical Trials

Rectal Microbicide Acceptability, Tolerability and Adherence

Start date: November 2018
Phase: N/A
Study type: Interventional

MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences of rectal microbicide placebo product application.

NCT ID: NCT03668119 Recruiting - Pan Tumor Clinical Trials

A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

CheckMate 848
Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)

NCT ID: NCT03622580 Recruiting - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

Start date: September 5, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

NCT ID: NCT03619213 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

DELIVER
Start date: August 27, 2018
Phase: Phase 3
Study type: Interventional

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

NCT ID: NCT03539991 Recruiting - Tobacco Counseling Clinical Trials

SWOG Tobacco Program for the Oncology Practice

Start date: April 18, 2018
Phase: N/A
Study type: Interventional

The goal of this research study is to develop an electronic learning (eLearning) program and smartphone application ("app") for Spanish and Portuguese speaking cancer care providers to use in tobacco counseling of their patients. Researchers also want to learn if this eLearning program and app can provide effective tobacco counseling and treatment.

NCT ID: NCT03537859 Recruiting - Hospitalized Child Clinical Trials

Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients

Start date: June 5, 2018
Phase: N/A
Study type: Interventional

Hospitalization is a stressful event that might impact in a patient's recovery. Children are more susceptible to suffer acute stress as a result of a hospital stay. Stress is often quantized using cortisol levels, a substance which increases following stressful stimuli. Since stress management is important in a patient's recovery, different therapies are used and have been evaluated and proven effective to diminish cortisol levels such as play interventions and clown therapy. Nevertheless, they rely on volunteers or trained staff to perform them. Nowadays, technology such as augmented reality allow us to provide therapy without the need of volunteers. This project aims to test if augmented reality technology is effective in lowering salivary cortisol levels in hospitalized children.

NCT ID: NCT03524456 Recruiting - Hypertension Clinical Trials

Home Blood Pressure SMS Telemonitoring in the Primary Care Setting

Start date: April 9, 2018
Phase: N/A
Study type: Interventional

Hypertension is a public health problem worldwide, being responsible for 9.4 million deaths worldwide each year, as well as contributing to the burden of coronary, cerebrovascular, renal diseases, among others. The monitoring of blood pressure at home has gained importance in recent years, being related to adherence to treatment, as well as in the prevention of complications and optimization of pressure levels; In the same way, the use of information and communication technologies (ICT) in health has contributed to the improvement of communication systems by providing alternative tele-monitoring in this type of diseases. Objective: To evaluate the impact of tele-monitoring at home through tensiometers with integrated SMS system (text message), for the sending and recording of blood pressure and heart rate data in the primary care setting. Methods: A randomized controlled trial will be conducted, evaluating the intervention with the integrated blood pressure device with SMS capability, comparing it with the standard care. After a follow-up of 1 month, the effect on the values of systolic and diastolic blood pressure will be evaluated, as well as the adherence to treatment and complications related to arterial hypertension. A sample number of 20 participants per group was calculated, with a significance of 95% and a power of 80%, to detect a minimum significant difference of 10 mmHg.