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NCT ID: NCT03127995 Active, not recruiting - Clinical trials for Breast Cancer Female

Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence

HYPOG-01
Start date: September 2016
Phase: N/A
Study type: Interventional

The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks. Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women. The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments

NCT ID: NCT03121469 Active, not recruiting - Clinical trials for Localized Breast Cancer

Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer

RPOS+
Start date: October 25, 2018
Phase: N/A
Study type: Interventional

Phase 1/2 study, open, monocenter, non-randomized

NCT ID: NCT03121456 Active, not recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

18F-FDG PET Scan and MRI Diffusion.Evaluation of the Early Therapeutic Response of Diffuse Large B-cell Lymphoma

LYMPHODTECT
Start date: October 13, 2017
Phase: N/A
Study type: Interventional

Open-label, multicenter, uncontrolled and non-randomized study comparing 18F-FDG PET-Scan and diffusion MRI in the assessment of the early therapeutic response of Diffuse Large B-Cell Lymphoma.

NCT ID: NCT03121183 Active, not recruiting - Heart Failure Clinical Trials

Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers

GAINE LASER
Start date: March 2015
Phase: N/A
Study type: Observational

The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal. The indications of CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices, nonfunctional devices and thrombosis. Removal can be performed according to transvenous or surgical procedures. Transvenous lead removal (TLR) must be done by experimented cardiologists and respecting current consensus. TLR can be done with conventional techniques involving inserting locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue. These conventional procedures have a success rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate until >95%. However, the TLR from chronically implanted CIEDs still carries a significant risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels and cardiac structures, even when performed by experienced operators. Even if the transvenous extraction using laser sheath seems to be more effective, this strategy would be more expensive. Considering the availability of several strategies for TLR and the cost heterogeneity of procedures, a cost assessment in real life of these therapeutic strategies is essential for an optimal choice of therapeutic strategies.

NCT ID: NCT03118258 Active, not recruiting - Clinical trials for Uterine Cervical Neoplasms

Improving Access to Cervical Cancer Screening

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

Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each year. Recent studies highlighted regional, social and economical inequalities with respect to cervical cancer incidence. In France, the pap-smear test is currently the reference test in order to screen for cervical cancer and neoplasia (CIN). Screening and treatment reduced the incidence and the mortality due to cervical cancer by half in the two last decades. That said, many women are still not reached by prevention programs, especially women living in precarious conditions. In 2013, Doctors of the World France estimated that almost 70% of women aged 25 to 65 years old visiting its medical facilities had never had of a pap-smear test. The main study objectives are : Primary objective To compare the proportion of individuals with abnormal cytology across two screening strategies in order to determine which strategy detects a greater proportion of individuals with abnormal cytology. These two strategies consist of a preventive consultation followed by: 1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm) 2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) *A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason. First of secondary objectives: To evaluate the proportion of individuals who completed cervical cancer screening in each study arm in order to determine which strategy resulted in greater screening participation. The above clarification of the study objectives and the related changes in the study protocole have been approved by the Comité de Protection des Personnes Ile de France IV.

NCT ID: NCT03117972 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels

CLavSyn
Start date: August 4, 2017
Phase: Phase 2
Study type: Interventional

In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and strategy stratification are lacking. In this setting, a simple biological scoring system have recently been proposed, including LDH and CD138 binary status seric values, identifying one third of patients with worst prognostic. Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E mutation, concerning 5-8% of first line mCRC. For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard chemotherapy arm, in order to better discriminate treatment strategies, at metastatic diagnosis.

NCT ID: NCT03116750 Active, not recruiting - Clinical trials for Deep Vein Thrombosis

Post-Market Clinical Follow-up Study With ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT

P-MAX
Start date: April 3, 2017
Phase:
Study type: Observational

The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations. CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient. ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.

NCT ID: NCT03116425 Active, not recruiting - Treatment Resistant Clinical Trials

Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia

RETONIC
Start date: April 24, 2017
Phase: N/A
Study type: Interventional

Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia.

NCT ID: NCT03114033 Active, not recruiting - Clinical trials for Out-Of-Hospital Cardiac Arrest

Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest

TAME
Start date: February 15, 2018
Phase: N/A
Study type: Interventional

The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.

NCT ID: NCT03113981 Active, not recruiting - Osteoarthritis, Hip Clinical Trials

Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®

Start date: May 8, 2017
Phase: N/A
Study type: Interventional

The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment. The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis. Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis. A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion, biocompatibility, bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting. No previous clinical trial