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NCT ID: NCT02918019 Completed - Asthma Clinical Trials

A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma

Start date: September 20, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The total duration of this study for each participant is approximately 70 weeks including screening, run-in, treatment, and follow-up.

NCT ID: NCT02917772 Completed - Clinical trials for Carcinoma, Renal Cell

Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

TITAN-RCC
Start date: October 2016
Phase: Phase 2
Study type: Interventional

TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

NCT ID: NCT02916953 Completed - Osteoporosis Clinical Trials

CONFIRM - Study of AGN1 LOEP in Patients With Osteoporosis

Start date: December 17, 2016
Phase: N/A
Study type: Interventional

The study will evaluate the immediate procedure and post-procedure profile of the AGN1 Femoral LOEP™ Kit. All subjects will receive the treatment and be evaluated for any adverse or serious adverse events that could occur during the procedure or immediately post-procedure.

NCT ID: NCT02916940 Completed - Sprain Clinical Trials

Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.

Start date: November 16, 2016
Phase: Phase 2
Study type: Interventional

There is currently no real consensus on the optimal management of acute sprains of the proximal interphalangeal joint of the long fingers. The aim of this study is to assess the beneficial effect of an injection of corticosteroids for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute phase). This treatment, if effective, might become the treatment of choice for these types of injuries, instead of a prolonged immobilization or a careful early mobilization.

NCT ID: NCT02916719 Completed - Breast Cancer Clinical Trials

Monitoring of Breast Cancers Treated by Neoadjuvant Radiotherapy Via Magnetic Resonance Imaging

Start date: June 21, 2016
Phase: N/A
Study type: Interventional

Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the loco-regional staging and direct the treatment. European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care consists of realizing a MRI before the start of the NAC and another one after it's ended, six months later. There is currently no consensus on the realization of an interval MRI for early assessment of the chemosensitivity of the tumor. It would allow though alterations in the therapeutic regimen in the event of a non response. Similarly, there is no consensus on when this interval MRI should be performed. Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting for the evaluation of the early response. However, these are preliminary studies with quantitative measures realized by the region of interest (ROI) method. A response to neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC). There is'nt any published data on the potential interest of breast MRI after a radiotherapy treatment and before the surgical treatment. Therefore, the expected benefits of this study are: - to monitor the early modifications of the perfusion and diffusion parameters at the level of the tumor after radiotherapy, and correlate them to the histology of the surgical monster. - to assess if MRI is able to objectivate the early signs of response after a radiotherapy neo-adjuvant treatment of breast cancer. This record is linked to the NCT02858934 record and will share the same cohort of patients

NCT ID: NCT02916004 Completed - Critical Illness Clinical Trials

The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.

Start date: September 26, 2016
Phase: N/A
Study type: Interventional

The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients. Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)

NCT ID: NCT02915744 Completed - Breast Cancer Clinical Trials

A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

ATTAIN
Start date: November 2016
Phase: Phase 3
Study type: Interventional

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

NCT ID: NCT02914665 Completed - Heart Failure Clinical Trials

A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

Start date: October 20, 2016
Phase: Phase 2
Study type: Interventional

This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure

NCT ID: NCT02914561 Completed - Crohn's Disease Clinical Trials

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

DIVERSITY1
Start date: October 31, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

NCT ID: NCT02914522 Completed - Ulcerative Colitis Clinical Trials

Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

SELECTION
Start date: November 14, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).