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NCT ID: NCT03712852 Completed - Gingival Recession Clinical Trials

Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession

Start date: October 20, 2018
Phase: N/A
Study type: Interventional

Gingival thickness plays a key role not only in the etiology but also in the treatment of gingival recessions. a thin marginal tissue lining the hard periodontal tissues seems to be one of the main risk factor for the onset of gingival recession ; more recently, authors reported that as the gingival thickness decreases, the gingival recession severity increases . When gingival inflammation occurs, if the tissue is thin the consequent destruction can quickly produce a gingival recession (GR) . When treating a gingival recession, the clinician should aim not only to completely cover the exposed root surface but also to prevent a future recession recurrence Currently, CAF associated with graft is considered as the gold standard for exposed root coverage; this technique has demonstrated high rates in gingival recession reduction and positive predictability in obtaining complete root coverage . However, some disadvantages about this surgical approach can be easily highlighted: patients experience more discomfort, longer chair-time it's necessary and a second wound area is created . On the other hand, CAF procedure alone does not require a second surgical site, with better post-operative course, also reducing the surgical time. However, long term-studies report lower probability of complete root coverage when using the CAF technique without a simultaneous increase of the gingival thickness as compared to CAF+graft treatment. In this scenario, The Platelet rich fibrin (PRF) could be a valuable alternative treatment of gingival defects. It's a platelet concentrate, obtained by a fast and simple procedure that does not require anticoagulant and bovine thrombin . It can also be categorized as a live tissue thanks to platelets, leukocytes, growth factors and stem cells trapped in a polymerized fibrin mesh. PRF is used in various fields of regenerative medicine; It promotes stabilization and revascularization of the flaps, contributes to soft tissue wound healing and reduces post-operative discomfort. The purpose of this clinical study will be to determine if the combination of platelet rich fibrine membrane with a modified coronally advanced flap (MCAF) improved the gingival biotype compared to CAF + graft or CAF alone.

NCT ID: NCT03712787 Terminated - Alzheimer's Disease Clinical Trials

An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)

Start date: March 22, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.

NCT ID: NCT03712696 Completed - Breast Cancer Clinical Trials

Efficacy and Safety of DIGNICAP™ System

DIGNICAP
Start date: July 18, 2014
Phase: N/A
Study type: Interventional

Chemotherapy-induced alopecia (CIA) is one of the most common and emotionally distressing side effects of cancer therapy. In this study we sought to assess the feasibility and the effectiveness of scalp cooling system DigniCap® to prevent alopecia in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT). A prospective two-stage design clinical trial conducted at a single Institution of women with primary breast cancer scheduled to receive anthracycline with or without taxane-based adjuvant CT. Patients were enrolled from July 2014 to November 2016, with ongoing annual follow up for 5 years. The scalp cooling period initiated approximately 30 minutes before CT. Scalp temperature was to be maintained at 3-5°C throughout CT and for 90 to 120 minutes afterward, depending on the CT drug and dose.

NCT ID: NCT03711968 Completed - Multiple Sclerosis Clinical Trials

Interoception and Sense of Movement in the Patient With Multiple Sclerosis

Start date: September 13, 2018
Phase: N/A
Study type: Interventional

To evaluate the effectiveness of an experimental rehabilitative protocol with specific tasks for the improvement of body awareness and the motor scheme in the patient with multiple sclerosis (EDSS <2.5). Primary outcome: improvement of the interoception (awareness of the body) and of the related motor capacity Secondary outcomes: improvement of balance and postural self-correction control

NCT ID: NCT03711929 Terminated - Clinical trials for Non Infectious Uveitis

LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Start date: November 19, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.

NCT ID: NCT03711032 Recruiting - Clinical trials for High-risk Non-muscle Invasive Bladder Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

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

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

NCT ID: NCT03710876 Active, not recruiting - Clinical trials for Malignant Pleural Mesothelioma

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

INFINITE
Start date: January 21, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen. Eligible patients will be randomized 1:1 to either: 1. Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine 2. Control group: Celecoxib followed by Gemcitabine Patients randomized to the treatment group will receive rAd-IFN administered into the pleural space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1. The primary objective of this study is to compare the overall survival (OS) associated with rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM

NCT ID: NCT03710603 Active, not recruiting - Multiple Myeloma Clinical Trials

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

Perseus
Start date: December 14, 2018
Phase: Phase 3
Study type: Interventional

Background of the study: The combination of daratumumab with VRd is anticipated to further improve response rates in patients and may lead to improved long-term outcomes in newly diagnosed patients with multiple myeloma. Given this potential, and based upon the initial safety and efficacy observed in the ongoing Phase 2 Study MMY2004, as well as continued positive results with daratumumab in various disease settings and combination regimens, this Phase 3 study is designed to demonstrate improved outcomes for patients treated with daratumumab+VRd. The Phase 3 study will utilize the subcutaneous (SC) formulation of daratumumab instead of the IV formulation utilized in the Phase 2 study, which may limit additional toxicity to patients treated with the quadruplet regimen.

NCT ID: NCT03710291 Terminated - Clinical trials for Chronic Kidney Disease

Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

VALOR-CKD
Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

NCT ID: NCT03710200 Completed - Clinical trials for Dietary Modification

Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia

Start date: October 12, 2018
Phase: N/A
Study type: Interventional

Wheat is one of the most important crop for humans and it represents a source of multiple nutrients, dietary fiber and bioactive compounds, especially if consumed as wholegrain. Several studies have suggested that Triticum heritage varieties could present a healthier and better nutritional profile than modern wheats, by providing more vitamins, minerals and nutraceutical compounds. Although the effect of ancient grain consumption have been partially investigated in both animal and human studies, the potential impact of Triticum heritage varieties compared to modern ones on post-prandial glucose metabolism is still unclear. Thus, the aim of the study was to evaluate the impact on post-prandial glycaemia and insulinemia of different types of breads formulated with flours derived from mix of heritage varieties belonging to the Triticum genus selected and cultivated in specific areas of Emilia Romagna region, compared to breads made with conventional/modern wheat flours.