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NCT ID: NCT02842086 Active, not recruiting - Clinical trials for Pre-Exposure Prophylaxis of HIV-1 Infection

Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

DISCOVER
Start date: September 2, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.

NCT ID: NCT02839850 Active, not recruiting - Osteoarthritis Clinical Trials

14022 ATTUNE Cementless RP Clinical Performance Evaluation

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

NCT ID: NCT02839655 Active, not recruiting - Clinical trials for Patients With Thyroid Cancer

Prospective Study Assessing Thyroidectomy Using Robot

EVATAR
Start date: June 30, 2016
Phase: Phase 2
Study type: Interventional

The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery. Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.

NCT ID: NCT02838069 Active, not recruiting - Osteoarthritis Clinical Trials

A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis

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

ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects. The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years. This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.

NCT ID: NCT02835638 Active, not recruiting - Clinical trials for Central Sleep Apnea Syndrome in Patients Whose EF is Above 45 Percent

Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV

FACIL-VAA
Start date: June 26, 2017
Phase:
Study type: Observational

The main goal of this French multicenter observational cohort study is to prospectively collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart Failure (HF) with altered ejection fraction, with a predominant central SAS.

NCT ID: NCT02834169 Active, not recruiting - Clinical trials for Pseudomyxoma Peritonei

French National Registry of Rare Peritoneal Surface Malignancies

RENAPE
Start date: October 2010
Phase: N/A
Study type: Observational [Patient Registry]

Despite advances in the management of and changes in clinical practice, little is known about the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies patients in France. In order to better understand the characteristics of rare peritoneal surface malignancies and to evaluate treatment strategies, the RENAPE registry aims at the collection of data from patients presenting with a rare peritoneal surface malignancy in France. Data will be entered prospectively in a specifically designed and secured web database. All RENAPE's centres and physicians are invited to register patients with a rare peritoneal surface malignancy diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focusing on types of rare peritoneal surface malignancies, treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing to the better understanding of these rare cancers.

NCT ID: NCT02833428 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Spinal Cord and Artificial Intelligence

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

The aim of this study was to analyze using an artificial intelligence engine (IA) the influence of the pathophysiological environment (set parametric monitoring data, imaging, biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the principles of a new approach for studying spinal cord injury patients. It does not meet the usual criteria of clinical trials in so far as it does not test on patients the effect of a therapeutic

NCT ID: NCT02832713 Active, not recruiting - Clinical trials for Painful Unilateral Femorotibial Knee Osteoarthritis of Any Etiology

Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis

GOTOX
Start date: June 9, 2017
Phase: Phase 2
Study type: Interventional

In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis. Currently, osteoarthritis management is based on three major axes: 1. Non-pharmacological means, such as patient education, loss of weight and physical activity 2. General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent. 3. Intra-articular pharmacological treatments: 1. Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups 2. Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis. 4. Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment. 5. The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.

NCT ID: NCT02831959 Active, not recruiting - Clinical trials for Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC).

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT02830958 Active, not recruiting - Clinical trials for Replacement, Total Hip

Postoperative Kinesio Taping Effect on Pain and Edema in Patients Who Underwent Total Hip Arthroplasty

Start date: February 16, 2016
Phase: N/A
Study type: Interventional

The hip is a commonly performed operation corresponding to a prosthetic joint replacement surgery whose effectiveness depends on the quality of architectural and mechanical reconstruction of the artificial hip, integrity and balance of the periarticular musculature. To achieve this dual purpose, two elements are essential: access to the hip that best meets the musculature and is able to restore the balance, and adequate prosthesis. Despite the move towards a surgery less invasive hip replacement is a procedure that causes tissue damage. This results in nociceptive and neuropathic pain, which can become chronic in about 30% of cases. Several studies have shown that there are risk factors for chronic post-surgical pain. They are both related to patients but also to surgery. It is thus advantageous to reduce the postoperative pain, localized mainly in the trochanteric region, to decrease the risk of developing chronic post surgical pain. Now medical comunity know that the post-operative bruising and tissue damage are partly responsible for these pains. The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s It is water resistant and retains its properties up to 5 days. It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli. Its designers also claim it would have a beneficial effect on the lymphatic and venous circulation. According Kase Kinesiotaping causes an uprising of the epidermis decreasing the pressure in the dermis and promoting lymphatic drainage through its mechanical action during movement. The lymphatic system is responsible for the capture of waste from venous blood (catabolites, plasma proteins) and thus can promote the absorption of edema. In his study, Donec highlights a significant decrease in pain and a higher absorption of postoperative edema in the Kinésiotape® group than in the control group in surgical patients with total knee arthroplasty . The Curetape® band is used in the orthopedic surgery department since 2010 in current care. Consequently, it seems interesting to evaluate the effect of Curetape® in surgical patients with a total hip replacement.