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NCT ID: NCT02145962 Completed - Clinical trials for Neuropathic Diabetic Ulcer - Foot

Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.

Start date: December 2006
Phase: N/A
Study type: Interventional

An open multicenter trial to document the efficacy and safety of two therapeutic Extremely Low Frequency Magnetic Fields stimulation devices to promote wound healing of Diabetic Foot Ulcers.

NCT ID: NCT02145468 Completed - Clinical trials for Acute Coronary Syndrome

A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)

LATITUDE
Start date: June 3, 2014
Phase: Phase 3
Study type: Interventional

Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

NCT ID: NCT02144025 Completed - Clinical trials for Graft-Versus-Host Disease

Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT

HSCT
Start date: May 2014
Phase: Phase 2
Study type: Interventional

Ocular Graft Versus Host Disease (OGVHD) is a serious potential complication of allogeneic bone marrow transplants. The usual treatment is topical cyclosporine but when the treatment is initiated the damage to the lacrimal glands has already taken place. The present study aims to prevent OGVHD in reduced-intensity allogeneic hematopoietic transplants by using topical cyclosporine immediately after the engraftment has been achieved

NCT ID: NCT02141672 Completed - Lupus Nephritis Clinical Trials

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

AURA-LV
Start date: June 2014
Phase: Phase 2
Study type: Interventional

To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT02141438 Active, not recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

REASSURE
Start date: August 20, 2014
Phase:
Study type: Observational

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

NCT ID: NCT02140476 Unknown status - Clinical trials for Papillary Thyroid Cancer

Comparative Analysis Between Bipolar Device and Conventional Tie & Suture Technique in Thyroidectomy

Start date: May 2014
Phase: N/A
Study type: Interventional

Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical instruments that use electrical powered diathermic energy to seal and transect tissue. These devices have shown high efficiency in a wide variety of open and laparoscopic general and gynecological surgical procedures. The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic cutting devices in several studies. However, the efficacy of this instrument and in particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in thyroid surgery. Our primary aim is to verify whether the EnSeal® performance is superior to the standard surgical technique for thyroidectomy in a randomized clinical trial on 2 different institutions.

NCT ID: NCT02136134 Completed - Multiple Myeloma Clinical Trials

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Start date: August 15, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.

NCT ID: NCT02134353 Completed - Cystic Fibrosis Clinical Trials

A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects

Start date: September 2014
Phase: Phase 3
Study type: Interventional

This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however, this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample size for statistical power while retaining trial feasibility in an orphan disease population

NCT ID: NCT02134028 Completed - Asthma Clinical Trials

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Start date: August 5, 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: - Systemic exposure - Anti-drug antibodies - Biomarkers

NCT ID: NCT02132949 Completed - Breast Cancer Clinical Trials

A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer

BERENICE
Start date: July 14, 2014
Phase: Phase 2
Study type: Interventional

This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.