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NCT ID: NCT03121560 Completed - Metrorrhagia Clinical Trials

Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation

Start date: November 14, 2017
Phase: N/A
Study type: Interventional

Menorrhagia is frequent and occur in 11 to 13 % of the general population. It accounts for 20% of the gynecological consultations and tends to increase with age. It can be the first symptom of a mild uterine disease or cancer (cervical or endometrial), especially if the patient is older. The most common causes are polyps, adenomyosis, fibroids, hyperplasia and cancer. Menorrhagia needs to be investigated -especially after menopause, when the prevalence of endometrial cancer is higher (10-15%). For premenopausal metrorrhagia, the assessment will be made if a pathology is suspected or if there is no response to the medical treatment within 3 to 6 months. The medical check-up consists in the first instance in a questionnaire, a clinical examination and an endovaginal ultrasound examination. If the endometrium is thickened, a focal pathology is suspected, or if the bleeding persists despite a normal endovaginal ultrasound result, further examinations including a possible biopsy are required. While hysteroscopy is widely accepted as a standard examination for uterine cavity exploration, a meta-analysis showed that the diagnostic performance of hysterosonography was equivalent. Both are carried out on an outpatient basis during a gynecological consultation and require no special preparation. Several studies seem to show that hysterosonography is less painful, causes less discomfort and is therefore more accepted by patients than hysteroscopy. This is why many practitioners continue to prefer it to hysteroscopy and associate it with the Pipelle of Cornier for the assessment of postmenopausal metrorrhagia. However, if endometrial cancer is confirmed, the histological type detected within the biopsy is the main predictor of the severity of the disease and the treatment to be given. It is therefore essential to have an accurate biopsy sampling prior to therapeutic management. It is not the case with blind biopsies (without visual control). Indeed, some studies showed that the concordance between the optical aspect of the endometrium under hysteroscopy and the histological result was close to 90%, validating the hypothesis of an improved sensitivity through visual control. The American College of Obstetricians and Gynecologists (ACOG) currently recommends an endovaginal ultrasound assessment followed by an endometrial biopsy in the event of a thickened endometrium or when a pathology is suspected. A biopsy can even be taken during the consultation, at the onset of the complaints. The last recommendations of December 2010 leave the choice to clinicians regarding the histological diagnostic modalities (a blind biopsy with the Pipelle of Cornier or a targeted biopsy under hysteroscopy), although the biopsies under hysteroscopy are recommended since 2015. However, despite its poor sensitivity, the most widely used technique in the world is the blind biopsy by aspiration performed after vaginal ultrasound or hysterosonography because it is an easy low cost method. The development of hysteroscopes with a smaller diameter and the introduction of the vaginoscopy have considerably increased the tolerance of this examination. In addition, hysteroscopy allows a simultaneous therapeutic intervention for certain indications, which is comfortable and well accepted by the patients. Unfortunately, there are few studies comparing the tolerance of the two examinations performed according to the current recommendations of good practice of hysteroscopy. Only one comparative randomized study in 2008 showed that saline infusion sonography (SIS) was less painful than hysteroscopy with vaginoscopy. However, direct comparison was impossible since women only had one of the two examinations. The Brugmann University Hospital set up a consultation called "one stop bleeding clinic" in which the two examinations are performed for each patient with abnormal bleedings, in order to increase diagnostic performance. All included patients will thus undergo a saline infusion sonography (SIS) and a hysteroscopy (HSC). Each procedure will be evaluated on pain level (EVA scale) and tolerance by the patient.

NCT ID: NCT03119649 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis

Start date: March 18, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.

NCT ID: NCT03117764 Completed - Cystic Fibrosis Clinical Trials

1STST and Muscle Weakness in CF Patients

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

The investigators know that peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical activity remains unclear. The aim of the study is to evaluate the impact of intravenous antibiotherapy on peripheral muscular strength in patients with cystic fibrosis (adults and children) who receive intravenous antibiotherapy for an acute exacerbation or electively (decline in lung function without exacerbation).

NCT ID: NCT03117270 Completed - Clinical trials for Ankylosing Spondylitis

A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

TORTUGA
Start date: March 7, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit).

NCT ID: NCT03116685 Completed - Clinical trials for Primary Hyperoxaluria

A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

Start date: January 9, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of OC5 in patients with PH.

NCT ID: NCT03116048 Completed - Breast Cancer Clinical Trials

Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II

Start date: May 2, 2017
Phase: N/A
Study type: Interventional

Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia technique that provides post-surgical pain relief for patients undergoing breast surgery. Post-procedural pain relief is known to diminish persistent pain. In this prospective follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is effective in reducing persistent post-procedural pain after breast cancer surgery in female patients. Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection under general anesthesia were randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain survey.

NCT ID: NCT03115021 Completed - Clinical trials for Disorders of Consciousness

Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness

Start date: May 1, 2018
Phase: Phase 1
Study type: Interventional

This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness.

NCT ID: NCT03114878 Completed - Tinnitus Clinical Trials

The Value of EMDR in the Treatment of Tinnitus

Start date: October 2016
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus.

NCT ID: NCT03114397 Completed - Clinical trials for Disorder of Consciousness

Long-term Effect of tDCS in Patients With Disorders of Consciousness

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

In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected. This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.

NCT ID: NCT03112603 Completed - Clinical trials for Graft-versus-host Disease (GVHD)

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

Start date: June 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).