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NCT ID: NCT03389646 Recruiting - Clinical trials for Hip Prosthesis Infection

CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)

Start date: September 27, 2017
Phase: Phase 4
Study type: Interventional

Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening. The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM|G or V for the same indication. Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice. Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.

NCT ID: NCT03389217 Recruiting - Multiple Sclerosis Clinical Trials

Efficacy of tDCS on Pain in Multiple Sclerosis

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Pain is a common symptom experienced by people with MS and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Pain in people with MS has the potential to become chronic, as a consequence of neuronal reorganization. Transcranial Direct Current Stimulation (tDCS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining tDCS with rehabilitation treatment may have effect in reducing pain in people with MS. This is a pilot randomized control trial to test the effects of tDCS in MS-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with physical functioning), catastrophizing, emotional functioning and quality of life. Furthermore, we will explore the effects on pressure pain threshold and EEG recording. Correlations between sample characteristics and pain features will be investigated. Considering role of tDCS on neuropsychological functions, selective attention will be assessed.

NCT ID: NCT03389035 Completed - Clinical trials for Acute Lymphoblastic Leukemia, in Relapse

Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT

CARCIK
Start date: December 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

NCT ID: NCT03388424 Recruiting - Disease Clinical Trials

Quantification of Microbiota in Health and Diseases

qMHD
Start date: November 22, 2017
Phase:
Study type: Observational

Microbiota consists of trillions of microorganisms located in all the biological cavity. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). The impact of dysbiosis on today's society affects over 70% of the world population

NCT ID: NCT03388255 Terminated - Scleroderma Disease Clinical Trials

Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma Diseases

Start date: November 8, 2016
Phase: Phase 4
Study type: Interventional

This is a phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in patients with fibrotic and atrophic cutaneous lesions in scleroderma diseases during the inactive stage of the disease (experiencing dystrophic outcomes of the disease with no inflammatory component at the time of enrolment). The patients enrolled will be evaluated at study site at screening (V1), then after 3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration) (V2). After completion of the study treatment period, the patients will be followed for an additional period of 3 months without study medication, after which the patient will visit the site for the last visit (V3). 1 investigational site. 45 patients enrolled (included drop-outs).3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration).

NCT ID: NCT03387592 Recruiting - Clinical trials for Neuroendocrine Carcinoma

CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas

SENECA
Start date: March 6, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized phase II non comparative study. Patients with metastatic Neuroendocrine Carcinomas (NEC) Grade 3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment. Disease control rate (DCR) and safety are primary objectives, secondary objectives are Disease control rate (OS), Progression Free Survival (PFS), quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose.

NCT ID: NCT03387059 Terminated - Infertility Clinical Trials

Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle

ENDOMEDE
Start date: January 12, 2018
Phase: Phase 4
Study type: Interventional

This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial condition to implantation after Controlled Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).

NCT ID: NCT03387046 Terminated - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)

INCREASE
Start date: March 26, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the improvement in spontaneous recovery from clinical deficits at the time of an acute relapse in RR-MS participants already receiving interferon (IFN) beta 1a with D-aspartate (versus placebo) as add-on therapy.

NCT ID: NCT03386981 Recruiting - Physical Activity Clinical Trials

Metabolic Profile of Bone in Professional Athletes

SportMarkers
Start date: February 4, 2016
Phase: N/A
Study type: Observational

Physical activity is a key stimulus for bone metabolism through both direct mechanisms (e.g., as a result of the applied load and/or impact) and indirect mechanisms (e.g., the activation of several metabolic pathways and the production of several mediators and effectors that have systemic effects). However, different kinds of physical activity exert different effects on bone and endocrine system. Aim of the study is to investigate the effects of different kinds of physical activity on bone metabolism and on the relationships existing between bone metabolism, energy metabolism, hormone profile, and organ functionality.

NCT ID: NCT03386877 Completed - Clinical trials for Periodontal Diseases

Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

Start date: January 25, 2016
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration.