title: Phase I Dose Escalation Trial of Efavirenz for Patients With Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.

acronym: ESCALE

summary:
Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal resistant prostate cancer lead us to continue clinical development of efavirenz. Furthermore, all available pre-clinical and clinical data lead us to conduct a Phase 1 study with efavirenz. Objective of this Phase I is to test doses above 600 mg / day in patients with cancer in order to determine the maximum tolerated dose to improve therapeutic effect.

This study is a single center Phase I trial, conduct with dose escalation scheme of efavirenz by continual reassessment method likehood approach (CRML) on solid tumours (except pancreatic cancer) and non-Hodgkin lymphoma (NHL).

Main objective is to determine the safety profile, and particularly the maximum tolerated dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer) or NHL in therapeutic failure.

Secondary objectives are:

Evaluate efavirenz pharmacokinetics at 2, 4 and 12 weeks;
Evaluate objective response at 12 weeks;
Evaluate progression free survival at 6 months;
Assess biological progression-free survival at 6 months (prostate tumours only).

Primary Endpoint

Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of Efavirenz and will be defined as follows:

Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia, nausea and vomiting, regardless of grade),
Any drug-related toxicity, regardless of grade, who led a treatment delay> 14 days,
Score ≥ 19 HAD during treatment. Secondary Criteria
Solid tumors: response and progression defined by RECIST v1.1 [Eisenhauer EA et al. EJC 2009).
Non-Hodgkin lymphomas: Response and progression defined according to Cheson criteria [Cheson BD et al. JCO 1999]
Biological progression (particular case of prostate tumors): defined according to Scher [Scher HI et al. JCO 2008] Statistical Considerations This is a Phase I dose escalation strategy using the method CRML, described by O'Quigley and Shen [O'Quigley et al. Biometrics 1996] and commonly used in Phase I trials in oncology.
Maximum number of eligible and evaluable subjects is 30.
Six dose levels are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000 mg.
The risk of dose limiting toxicities maximum allowed is 25%.


type: Other Identifier

title: Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge

acronym: SORTIDIAB

summary: One third of the costs of medical care for people with diabetes are related to hospitalization." Difficult" diabetic patient, i.e. those with very high HbA1c, patients > 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an initial hospitalization related to diabetes or its complications. The objective of the study is to test if a coaching with a care coordinating team after hospital discharge would decrease diabetes-related rehospitalization rate compared with usual care.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Unknown


title: Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients

summary: Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.

study_type: Observational

lead_sponsor: French Society of Coloproctology

location_facility: Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard

lead_sponsor_type: industriel


type: EudraCT Number

title: Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?

acronym: Loop-NVPO

summary: The investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

ReferenceCitation: Song JW, Park EY, Lee JG, Park YS, Kang BC, Shim YH. The effect of combining dexamethasone with ondansetron for nausea and vomiting associated with fentanyl-based intravenous patient-controlled analgesia. Anaesthesia. 2011 Apr;66(4):263-7. doi: 10.1111/j.1365-2044.2011.06648.x.

ReferenceType: derived

ReferenceCitation: Bataille A, Letourneulx JF, Charmeau A, Lemedioni P, Léger P, Chazot T, Le Guen M, Diemunsch P, Fischler M, Liu N. Impact of a prophylactic combination of dexamethasone-ondansetron on postoperative nausea and vomiting in obese adult patients undergoing laparoscopic sleeve gastrectomy during closed-loop propofol-remifentanil anaesthesia: A randomised double-blind placebo-controlled study. Eur J Anaesthesiol. 2016 Dec;33(12):898-905.

lead_sponsor: Hopital Foch

intervention_type: Drug

status_simplified: Completed


primary_purpose: Treatment

acronym: DESMOPAZ

title: PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial

lead_sponsor: Institut Bergonié

source: euctr

study_start_date_type: Actual

ReferenceCitation: Toulmonde M, Pulido M, Ray-Coquard I, Andre T, Isambert N, Chevreau C, Penel N, Bompas E, Saada E, Bertucci F, Lebbe C, Le Cesne A, Soulie P, Piperno-Neumann S, Sweet S, Cecchi F, Hembrough T, Bellera C, Kind M, Crombe A, Lucchesi C, Le Loarer F, Blay JY, Italiano A. Pazopanib or methotrexate-vinblastine combination chemotherapy in adult patients with progressive desmoid tumours (DESMOPAZ): a non-comparative, randomised, open-label, multicentre, phase 2 study. Lancet Oncol. 2019 Sep;20(9):1263-1272. doi: 10.1016/S1470-2045(19)30276-1. Epub 2019 Jul 19.

summary:
Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at diagnosis is about 30 years.

Only a complete surgical excision is recommended in desmoids tumors. Some forms of desmoid tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical treatment. In these clinical situations, only a medical treatment may achieve tumor control and quality of life maintenance. Place of systemic treatments in the management of desmoids tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is actually the best evaluated combination, which allowed observing objective response rate between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity.

Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type receptors -1, -2 and -3 of VEGF receptors on the PDGFA and B, and c-Kit. It is currently under clinical development in humans in the treatment of several tumor types.


title: Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)

summary:
Use lay language.

To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route

ReferenceCitation: Collado V, Faulks D, Nicolas E, Hennequin M. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety. PLoS One. 2013 Aug 5;8(8):e71240. doi: 10.1371/journal.pone.0071240. Print 2013.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other


title: Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial

acronym: JOBSTRESS

summary: A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical errors, and also increase coronary heart disease. Emergency physicians subjectively complain of stress related to changes in work shifts. Several potential biomarkers of stress have been described, but never investigated in emergency physician, who may represent a good model of stress due to the complex interplay between stress (life-and-death emergencies, which is the defining characteristic of their job), lack of sleep and fatigue due to repeated changes in shifts.The aim of this study was to compare biomarkers in emergency physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day (clerical work on return from leave). We also followed these markers three days following each shift (D3/24hS and D3/14hS).

primary_purpose: Screening

ReferenceCitation: Dutheil F, Marhar F, Boudet G, Perrier C, Naughton G, Chamoux A, Huguet P, Mermillod M, Saâdaoui F, Moustafa F, Schmidt J. Maximal tachycardia and high cardiac strain during night shifts of emergency physicians. Int Arch Occup Environ Health. 2017 Aug;90(6):467-480. doi: 10.1007/s00420-017-1211-5. Epub 2017 Mar 7.


title: Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study

summary:
Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the most effective possible tool for hemostasis allows a bleeding decrease during liver transection and thus could reduce postoperative morbidity.

In the past decade, the improvement of techniques of transection of the hepatic parenchyma was one of the most important factors to ensure the hepatectomy safety. But the clinical performances of these technological innovations (ultrasound dissectors, monopolar radiofrequency probes and dissection devices using pressurized water) remain still unclear.

The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology of "transcollation" combining a source of radiofrequency associated with a conductive liquid (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device consists in maintaining the tissue to a temperature of 100°C, while using a conductive liquid which acts as process of cooling and avoids the drying out of tissues, smoke, risks of electric arc and overheating met with conventional electrosurgery. This device allows the coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the postoperative morbidity and mortality due to a decrease of blood loss and biliary leak. These clinical benefits could be translated by an improvement of the direct and indirect costs associated to the surgery. However the Aquamantys® technology has not been scientifically validated in the context of the hepatic surgery, and this technology is expensive due to the purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®) and to the investment in a generator (Aquamantys Pump Generator®).

Consequently, it is essential to realize a study measuring the clinical and medical economic impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.

intervention_type: Device


title: Randomized and Single Blind Study Comparing Remifentanil Sedation Versus Propofol for Performing Bronchial Fibroscopies Under Intravenous Anesthesia

acronym: REVPRO

summary: The purpose of this study is to determine whether the use of Target-Controlled Infusion (TCI) of Remifentanil can deliver better conditions for performing bronchial fibroscopy with spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of Propofol.

location_facility: Hôpital Saint-Louis - Anesthésie Réanimation


title: Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia

acronym: FABLORA

summary: A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.

lead_sponsor: Hospices Civils de Lyon


summary: The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.

lead_sponsor: Poitiers University Hospital


title: A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy

summary:
The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution.

Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard preparation solution.

lead_sponsor: novoGI

location_facility: Department of Hepato-Gastroenterology, Nouvel Hopital Civil


title: Maxillary Sinus Floor Augmentation With Bioss® and Enamel Matrix Derivative: Evaluation of Osteogenic Properties

acronym: EMDOGAIM

summary: The main problem of using xenogenic bone in sinus floor elevation is the slow rate of absorption, which gives the percentages of vital bone low (20 to 30% depending on the study) in which the dental implant will be positioned However, osseointegration of the implant can be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and osteogenic properties known, could promote bone healing during surgery sinus floor elevation by increasing the percentage of vital bone reformed, when added to xenografts.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus in Adults Patients

acronym: LORACLOFT

summary: The main purpose of this study is to know on one hand if lorazepam is more (effective) than clonazepam and on the other hand if lorazepam is also effective as the association clonazepam + fosphenytoin in out-of-hospital treatment of the generalized convulsive status epilepticus in adult patients.

location_facility: Département d'Anesthésie - Réanimation - SMUR - Hôpital Lariboisière


title: Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.

acronym: IONTO-CXL

summary:
The primary purpose of the protocol is to compare the current standard CXL with iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.

Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the progression of keratoconus. In the current standard CXL, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium debridement can cause severe pain, infection and stromal haze. The study hypothesis is that iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.

status: Terminated

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ReferenceType: result

ReferenceCitation: Touboul D, Robinet-Perrin A, Fournié P, Malecaze F. [Efficacy of corneal cross-linking for the treatment of keratoconus]. J Fr Ophtalmol. 2016 Mar;39(3):308-14. doi: 10.1016/j.jfo.2015.12.002. Epub 2016 Mar 16. Review. French.

lead_sponsor: University Hospital, Toulouse


title: Study of the Role of Acid Sensing Ion Channels (ASICs) in Human Inflammatory Pain

summary: In recent years, ion channels have emerged as new therapeutic targets for pain. Among these channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are directly activated by extracellular acidity, which is a major cause of pain. Indeed, many painful conditions such as ischemia, inflammation, tumor development or tissue incision are accompanied by tissue acidification. ASIC are excitatory ion channels that are expressed in neurons, including nociceptive sensory neurons. In humans, the use of amiloride, a nonspecific inhibitor of ASICs, has demonstrated their role in the perception of pain induced by subcutaneous injections of acidic solutions. ASICs thus appear as new candidates capable of mediating pain in humans. A growing number of data suggests that, in addition to protons, ASICs may also be activated by one or more endogenous compounds produced during inflammation. The purpose of this research project is to identify these compounds by testing the effects of human inflammatory exudates on ASICs activity. The discovery of such compounds would definitely validate ASICs as novel therapeutic targets for pain treatment in humans


title: Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients

acronym: ACTIVDIAL

summary: Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.


title: Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.

acronym: FINGER

summary:
Sensory disorders in patients with multiple sclerosis are among the most common symptoms encountered.

A functional impairment based on sensory disorders of the hand. The hand is a sensory organ that transmits the cerebral cortex protopathic sensitive information, proprioceptive or epicritiques. The view-hand association plays an important role in the understanding of the environment. Its exploratory use remains an essential and voluntary basis. The process of recognition of the object passes through manipulation, but operates instantaneously. The brain is able to do a quick summary of the information it receives to determine the nature of the manipulated object. The exploration takes a posteriori, the brain can then determine the details component object (texture, shape, composition, temperature and weight).

Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous electrical nerve stimulation (TENS) are not fully understood. Several theories underlying its use as a neuromodulator of pain. The gate control theory has led to the development of TENS devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent fibers increases the control exerted on spinal level, thereby inhibiting the action of afferent fibers of small caliber related to nociception. This stimulation strengthens the blocking of "gate" at the corresponding cell bodies of spinothalamic tract and reduces the transmission of nociceptive impulses to the spinal cord dorsal horn. This is segmental presynaptic inhibition depends on the area and stimulated.

The objective of this study is to improve the quality of life through improved sensitivity disorders of the hand in patients with MS, thanks to reeducation of the hand.


title: Evaluation of MRI Sequences in Hepatic Overload.

summary: MRI, without any contrast injection, allows a non-invasive evaluation and quantification of hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads, but in certain clinical circumstances, cases require to improve performances. The aim of the study is to add to MRI scans which currently must be performed innovative sequences appropriate for the clinical question to overall appreciate on a varied range of patients their quality, their robustness, their relative performance and, for patients having a biopsy, their accuracy.

time_perspective: Prospective

lead_sponsor: Rennes University Hospital


title: IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

summary:
Actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the COPD. An in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena.

Our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children

The study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. This study will be a pilot study completed by an animal experimental study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Genetic


title: French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL)

acronym: PC-QOL

summary:
Cough is one of the most common reasons for consultation. Even if cough is a non-specific symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A. B.

Objective : The aim of the study is to validate the French version of the PC-QoL, a parent-proxy QoL chronic cough specific questionnaire.

Methods : Linguistic validation will be performed using backward/forward translation guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested in 150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (> 4 weeks); 18 years of age or younger; all etiologies excepting cystic fibrosis. Informed consent from parents will be obtained. At enrollement, each parent will fulfill the PC-QOL questionnaire and two cough-related measures (visual analogue score, verbal category descriptive). Clinical data (medical history, physical examination) will be collected. Children QoL will be assessed using VSPA, Kidscreen and Qualin questionnaires. For assessing reproductibility and sensitivity to change, parents will be retested 7 and 21 days later. Content validity, construct's validity, external validity and instrument's reliability will be explored.


title: Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study

acronym: SCI-COG

summary: Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupé P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27.

lead_sponsor: University Hospital, Bordeaux


title: Multimodal Approach of Undernutrition in Chronic Heart Failure : a Controlled, Randomized Trial

acronym: NUTRICARD

summary:
The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an independent risk factor for mortality and complications. Up-to-date, interventional studies involving nutrition are scarce in CHF. Academic societies are recommending the use of oral nutritional supplements (ONS) in case of weight loss, without defining the modalities. ONS could improve nutritional status in undernourished CHF patients, but solely administered, have a limited impact on undernutrition, physical performance and prognosis. A multimodal approach integrating physical exercise, nutritional intakes, polyunsaturated n-3 fatty acids (n-3 PUFA), and anabolizing hormones, has to be privileged. A recent trial has shown the clinical benefits of such an approach in patients with chronic respiratory insufficiency (CRI), who have similar nutritional and muscular characteristics.

Exercise rehabilitation is well validated in CHF patients, but has never been validated in case of undernutrition. Exercise rehabilitation allows improving exercise capacity, quality of life and cardiovascular outcomes including mortality.

N-3 PUFA supplementation improves muscle strength and endurance in CRI patients. n-3 PUFA supplementation decreases by 30% cardiovascular mortality of CHF patients. n-3 PUFA could be useful for CHF patients rehabilitation.

Androgenopenia is a prognostic factor in CHF. Androgen substitution improves significantly muscle strength, walking endurance and quality of life. In the context of a multimodal approach, Androgen substitution together with exercise rehabilitation and ONS could have a beneficial effect on muscle mass, strength and endurance of CHF patients, as already described in CRI, elderly and HIV patients.

The study hypotheses that a 3-month multimodal approach associating exercise rehabilitation, androgen substitution, n-3 PUFAs and ONS improves exercise capacity of undernourished CHF patients.


title: Position of Children During Urine Collection: Evaluation Study

acronym: PUCES

summary: Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.

primary_purpose: Other

lead_sponsor: University Hospital, Limoges


title: Evaluation of Adrenocortical Functions by Insulin Tolerance Test and Sodium Depletion in Women With Nonclassical Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency in Comparison With Healthy Volunteers.

summary:
The risk of adrenal insufficiency in patients with nonclassical congenital adrenal hyperplasia due to 21-hydroxylase deficiency is not well documented. Indication of cortisol replacement therapy in situation of acute stress or at long term is thus controversial. The mineralocorticoid reserve of these patients has never been evaluated.

Hypothesis: The glucocorticoid and mineralocorticoid function of the adrenal glands in women with nonclassical 21-hydroxylase deficiency is comparable with the adrenal functions of healthy age- sexe- and BMI-matched subjects.

ReferenceCitation: Kamenický P, Blanchard A, Lamaziere A, Piedvache C, Donadille B, Duranteau L, Bry H, Gautier JF, Salenave S, Raffin-Sanson ML, Genc S, Pietri L, Christin-Maitre S, Thomas J, Lorthioir A, Azizi M, Chanson P, Le Bouc Y, Brailly-Tabard S, Young J. Cortisol and Aldosterone Responses to Hypoglycemia and Na Depletion in Women With Non-Classic 21-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2020 Jan 1;105(1). pii: dgz005. doi: 10.1210/clinem/dgz005.


title: Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment

acronym: PRESH

summary: Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect demographic information as well as information about asthma history, asthma control and treatment.


title: Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?

acronym: DIAPASON

summary:
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.

The main objective is to compare the reverse left ventricular remodeling between patients with type II diabetes and case-control patients without diabetes at one(1) year after surgical aortic valve replacement.

The secondary objectives are :

assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
assess the predictive value of myocardial fibrosis and other LV characteristics present prior to aortic valve surgery on the LV reverse remodeling and their influence on cardiovascular events at one (1) year after surgery,
assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.

The investigators main hypothesis is that patients with type II diabetes and aortic valve stenosis requiring aortic valve replacement have poorer LV function and less favorable post surgery clinical outcomes than patients without type II diabetes.

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY

acronym: ACFI

summary:
Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.

The patient is compared to himself between day zero to ten and three months.

The study hypotheses are:

A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).
This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.
This atrophy is correlated with disability at three months, assessed by Rankin score.

primary_purpose: Basic Science

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title: Neutrophils Function and Identification of Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener's Granulomatosis).

acronym: NeutroVasc

summary:
Anti-neutrophil cytoplasm antibodies (ANCA)-associated vasculitis are rare diseases characterized by inflammation of blood vessels. Among the numerous cell types that play a role in vasculitis, one of the key actors is the neutrophil. Neutrophils are equipped with very powerful molecules that they use to destroy the invading microbes. Therefore, the mechanisms controlling neutrophil activation should be tightly controlled. If that is not the case, neutrophils may destroy the tissues of the host. This is what happens during chronic inflammation in vasculitis. Autoantibodies directed against neutrophils, ANCA, produced thus demonstrating that neutrophils are also targets of the immune system in these diseases. In addition, molecular studies provided evidence that genes normally silenced in mature neutrophils under normal conditions can be re-expressed in neutrophils from patients with ANCA-associated vasculitis thus strongly suggesting a profound deregulation of neutrophil functions in these conditions. Notably, the investigators have preliminary data showing that neutrophils from patients with granulomatosis with polyangiitis (GPA, formerly Wegener's granulomatosis), an ANCA-associated vasculitis, interfere with the normal phase of resolution of inflammation.

The objective of the investigators' study is to understand the mechanisms underlying this increased activation state and determine if neutrophils could be used to define prognostic markers by clinicians to optimize patients' care. Therefore, the investigators plan to study the expression of proteins implicated in GPA pathophysiology at the membrane of neutrophils when they undergo apoptosis. The investigators will also study the deregulation of protein expression in neutrophils. This point will be the molecular translation of neutrophil deregulation. This technique is powerful and well adapted to identify by mass spectrometry the proteins that will be differentially expressed between the control and the disease state. After identification of proteins differentially expressed in patients with GPA, the investigators will further investigate whether their expression is modulated during the disease course and/or modified by the treatment.

The investigators believe that understanding these neutrophil perturbations can lead to better monitoring of disease activity. Ultimately, the investigators may propose more targeted anti-inflammatory therapies which would be better tolerated by patients. the investigators also can identify new markers for disease activity which allow clinicians to define a better therapeutic strategy.

ReferenceCitation: Millet A, Martin KR, Bonnefoy F, Saas P, Mocek J, Alkan M, Terrier B, Kerstein A, Tamassia N, Satyanarayanan SK, Ariel A, Ribeil JA, Guillevin L, Cassatella MA, Mueller A, Thieblemont N, Lamprecht P, Mouthon L, Perruche S, Witko-Sarsat V. Proteinase 3 on apoptotic cells disrupts immune silencing in autoimmune vasculitis. J Clin Invest. 2015 Nov 2;125(11):4107-21. doi: 10.1172/JCI78182. Epub 2015 Oct 5.


type: Registry Identifier

title: Effect of Acute Preoperative Stress Assessed With Salivary Amylase on the Severity of Maternal Hypotension After Spinal Anesthesia for Planned Cesarean Section

acronym: SAS

summary: Spinal anesthesia is the technique of choice for planned cesarean section. It is associated with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by maternal stress that can be measured with salivary amylase. The goal of this study is to assess the relationship between salivary amylase and severity of maternal hypotension after spinal anesthesia for planned cesarean section.

time_perspective: Retrospective


title: Evaluation of Palliative and Supportive Care for Spinal Muscular Atrophy (SMA) Type 1 Patients

summary: The purpose of this study is to evaluate the quality of supportive and palliative care for SMA type 1 patients.

ReferenceCitation: Ziegler HK, Unanue ER. Decrease in macrophage antigen catabolism caused by ammonia and chloroquine is associated with inhibition of antigen presentation to T cells. Proc Natl Acad Sci U S A. 1982 Jan;79(1):175-8.

ReferenceCitation: Kaufmann P, Greiss C, Brown J. Survival in SMA type 1. Neuromuscul Disord. 2009 Jan;19(1):76; author reply 76. doi: 10.1016/j.nmd.2008.10.010. Epub 2008 Dec 12.

ReferenceCitation: Roper H, Quinlivan R; Workshop Participants. Implementation of "the consensus statement for the standard of care in spinal muscular atrophy" when applied to infants with severe type 1 SMA in the UK. Arch Dis Child. 2010 Oct;95(10):845-9. doi: 10.1136/adc.2009.166512. Epub 2009 Oct 8. Review.

ReferenceCitation: Hully M, Barnerias C, Chabalier D, Le Guen S, Germa V, Deladriere E, Vanhulle C, Cuisset JM, Chabrol B, Cances C, Vuillerot C, Espil C, Mayer M, Nougues MC, Sabouraud P, Lefranc J, Laugel V, Rivier F, Louvier UW, Durigneux J, Napuri S, Sarret C, Renouil M, Masurel A, Viallard ML, Desguerre I. Palliative Care in SMA Type 1: A Prospective Multicenter French Study Based on Parents' Reports. Front Pediatr. 2020 Feb 18;8:4. doi: 10.3389/fped.2020.00004. eCollection 2020.

ipd_sharing: No


title: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

acronym: BiRDS

summary:
The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients.

The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.

lead_sponsor: University Hospital, Angers

location_facility: Medical Intensive Care Unit, University Hospital of Angers

intervention_type: Biological


title: Percentage of Oxygen Saturation of Haemoglobin in Tissues (StO2) Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning

acronym: IMACS

summary:
The primary purpose of the protocol is to evaluate the StO2 performance measured at the admission to the emergency department to identify hemodynamic failure at the admission or within the first three hours of monitoring patients with drug poisoning.

The study hypotheses are:

The early detection of hypoperfusion by StO2, essential to prevent the development of collapse.
To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning, hospital stay and cost.

ReferenceCitation: Lambert H, Manel J, Bellou A, el Kouch S. [Morbidity and mortality from acute drug poisoning in France]. Rev Prat. 1997 Apr 1;47(7):716-20. French.

ReferenceCitation: F.Adnet, S.Atout, M. Galinski. Evolution des intoxications médicamenteuses volontaires en France, 2005, Société de réanimation de langue française

ReferenceCitation: Cohn SM, Nathens AB, Moore FA, Rhee P, Puyana JC, Moore EE, Beilman GJ; StO2 in Trauma Patients Trial Investigators. Tissue oxygen saturation predicts the development of organ dysfunction during traumatic shock resuscitation. J Trauma. 2007 Jan;62(1):44-54; discussion 54-5.

ReferenceCitation: Reducing the severity of road injuries through post impact care. European Transport Safety Council. Eur J Emerg Med. 1999 Sep;6(3):271-4.

ReferenceCitation: Cohn SM, Crookes BA, Proctor KG. Near-infrared spectroscopy in resuscitation. J Trauma. 2003 May;54(5 Suppl):S199-202. Review.

ReferenceCitation: Crookes BA, Cohn SM, Bloch S, Amortegui J, Manning R, Li P, Proctor MS, Hallal A, Blackbourne LH, Benjamin R, Soffer D, Habib F, Schulman CI, Duncan R, Proctor KG. Can near-infrared spectroscopy identify the severity of shock in trauma patients? J Trauma. 2005 Apr;58(4):806-13; discussion 813-6.

ReferenceCitation: Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007 Sep;33(9):1549-56. Epub 2007 Jun 16.


title: Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation: The AMPHORE Study

acronym: AMPHORE

summary: Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.

ReferenceCitation: Collet JP, Funck-Brentano C, Prats J, Salem JE, Hulot JS, Guilloux E, Hu MY, He K, Silvain J, Gallois V, Brugier D, Anzaha G, Galier S, Nicolas N, Montalescot G. Intravenous Clopidogrel (MDCO-157) Compared with Oral Clopidogrel: The Randomized Cross-Over AMPHORE Study. Am J Cardiovasc Drugs. 2016 Feb;16(1):43-53. doi: 10.1007/s40256-015-0145-0.

lead_sponsor: The Medicines Company


acronym: ABIGENE

title: Pharmacogenetic Study in Castration-resistant Prostate Cancer Patients Treated With Abiraterone Acetate

lead_sponsor: Centre Antoine Lacassagne

summary:
Prostate cancer is the 2nd leading cause of mortality in men in developed countries. For metastatic prostate cancer patients, the 1st-line treatment relies on hormone therapy. However, the efficacy of androgen deprivation therapy remains limited in time and most patients eventually develop castration-resistant prostate cancer (CRPC), while remaining androgen-dependent.

Docetaxel is currently the standard of care for metastatic CPRC. It has been shown that testosterone levels within metastatic tumoral tissue from men receiving hormone therapy were significantly higher than those from primitive tumors of untreated prostate cancers. Among the mechanistic explanations for this observation, it has been shown that CYP17A1, a key enzyme in de novo steroid synthesis localized in testis and adrenal gland, is up-regulated in CRPC metastases. The existence of de novo CYP17A1-dependent androgen biosynthesis at the tumor level has supported the development of novel antiandrogens, including abiraterone acetate (AA), an irreversible CYP17A1 inhibitor. Based on a placebo-controlled phase III trial, demonstrating that abiraterone prolonged overall survival (14.8 vs 10.9 months) and increased PSA response rate (29% vs 6%) in patients with metastatic CRPC who previously received docetaxel, AA was recently approved by the FDA and French Health Authorities. AA is well-tolerated and main toxicities are urinary tract infections (2%) and a syndrome of secondary mineralocorticoid excess characterized by fluid overload, hypertension and hypokaliema (1% to 4% of grade 3-4).

Almost concomitantly, a novel taxane-class cytotoxic agent, cabazitaxel, has proven efficacy in CRPC treatment after failure to docetaxel, and has recently been approved by the FDA and French Health Authority. Although cabazitaxel exhibits a less favorable toxicity profile, this precise context creates a need to dispose of objective individual criteria so as to orientate patients to treatment towards AA or towards cabazitaxel. To this purpose, several approaches are of potential interest for identifying good candidates for a treatment by AA: tumor-specific TMPRSS2-ERG gene fusion measurement, circulating tumor cell analysis, tumoral CYP17A1 expression, analysis of splicing forms of the androgen receptor. However, the clinical relevance of these potential predictive factors remains to be established in this setting.

Pharmacogenetics examines germinal gene polymorphisms likely to influence the pharmacodynamics of anticancer agents. Encouraging results have recently been reported by our group for irinotecan pharmacogenetics with concrete possibilities of individual dose adaptations, and very recently by other investigators for sunitinib pharmacogenetics. Concerning AA, one can hypothesize that tumors with elevated CYP17A1 expression will be more likely to respond better to AA. This hypothesis is indirectly supported by the observation that in CPRC patients receiving AA, PSA-based response is higher in patients with elevated pre-treatment blood concentration of DHEA and androstenedione.

The CYP17A1 gene presents numerous single nucleotide polymorphisms (SNPs), whose frequencies of rare alleles are at least 12%. Their functional impact has been suggested for nine of them, which were linked either to the risk of developing prostate cancer or to survival of prostate cancer patients. So far, no study has examined the links between these polymorphisms and the efficacy of a CYP17A1 inhibitor. Also, relationships with the efficacy of androgen deprivation therapy have recently been reported for SNPs of genes involved in the membrane-transport testosterone and dehydroepiandrosterone, namely SLCO2B1 and SLCO1B3. One can make the hypothesis that gene polymorphisms of these transporters may play a role for the intratumoral concentration of testosterone locally-produced through the mediation of CYP17A1 activity.

To resume, two second-line treatments of metastatic CRPC cancers are currently available, thus is raising the question in practice of which treatment is more appropriate for a given patient. Herein, the present study proposes an original pharmacogenetic approach in order to highlight a relationship between AA activity and patient's genetic profile. Ultimately, this could reveal evidences of genetic predispositions for potentially good responders to AA treatment.


title: Evaluation of Laryngeal Ultrasonography Performance in Predicting Major Post Extubation Laryngeal Edema in Intensive Care Patients

acronym: ECHOLPE

summary:
For patient in intensive care unit, extubation failure is defined as the necessity of early reintubation after scheduled extubation, with Increased morbidity and mortality, so it seems important to quickly identify patients with high risk of post-extubation acute respiratory failure.
Major post-extubation laryngeal edema is one of extubation failure causes, and its incidence vary in literature from 4 to 37%.
We can't currently predict arising of a major post-extubation laryngeal edema. However, a recent pilot study showed that laryngeal ultrasonography could help to identify patients with high risk of post-extubation stridor, measuring ultrasonic leak volume and cuff-deflated air-column width, of which we propose to assess diagnostic performance.

ReferenceCitation: Ding LW, Wang HC, Wu HD, Chang CJ, Yang PC. Laryngeal ultrasound: a useful method in predicting post-extubation stridor. A pilot study. Eur Respir J. 2006 Feb;27(2):384-9.

ReferenceCitation: Wittekamp BH, van Mook WN, Tjan DH, Zwaveling JH, Bergmans DC. Clinical review: post-extubation laryngeal edema and extubation failure in critically ill adult patients. Crit Care. 2009;13(6):233. doi: 10.1186/cc8142. Epub 2009 Dec 1. Review.

ReferenceCitation: Sustić A. Role of ultrasound in the airway management of critically ill patients. Crit Care Med. 2007 May;35(5 Suppl):S173-7. Review.

ReferenceCitation: Frutos-Vivar F, Esteban A, Apezteguia C, González M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Pérez F, Peñuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire Besançon


title: Characterization of Sitting Postures in Healthy Subjects

acronym: CaPAS

summary: The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.

lead_sponsor: University Hospital, Grenoble


title: Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI

acronym: HISTO-RAD

summary:
Inclusion criteria:

Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

Study Design:

Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
Histoscanning™ and MRI results will be compared to biopsy results.

A total of 30 patients will be included


acronym: PropofolTE

title: Therapeutic Equivalence Study of Propofol Using Target-Controlled Infusion of Propofol 2% (20 mg/mL) MCT Fresenius Compared With Diprivan® 20 mg/mL (AstraZeneca) in Patients Undergoing Elective Surgery

lead_sponsor: Fresenius Kabi

location_facility: CHU de Bordeaux, Groupe Hospitalier Pellegrin

summary: The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).


title: Up Regulation of Alpha-1 Receptors Upon Septic Shock ?

acronym: CATACHOC

summary: The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.

acronym: ROPI

summary:
After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.

Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.

Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.

lead_sponsor: Centre Jean Perrin


title: Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

acronym: PHARO

summary:
Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these reflux and to identify patients with abnormal LPR.

To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.


title: Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature

acronym: b-Mhyalines

summary: Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study

acronym: ANTALAIT

summary: The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into mature breastmilk that could allowed breastfeeding during a long time


title: Phase I of Infusion of Selected Donor NK Cells After HLA Identical Allogeneic Stem Cell Transplantation Prepared With Reduced Intensity Conditioning - DLI-NK/IPC 2012-003

acronym: DLI-NK

summary: The goal of our study will be to determine the clinical and biological safety of infusing immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion" (DLI), that contain the whole range of immune effectors. The trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-IL2) activation of selected NK cells in vitro prior to re-infusion.

ReferenceCitation: Mfarrej B, Gaude J, Couquiaud J, Calmels B, Chabannon C, Lemarie C. Validation of a flow cytometry-based method to quantify viable lymphocyte subtypes in fresh and cryopreserved hematopoietic cellular products. Cytotherapy. 2021 Jan;23(1):77-87. doi: 10.1016/j.jcyt.2020.06.005. Epub 2020 Jul 25.

lead_sponsor: Institut Paoli-Calmettes


title: Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma

summary:
Recent data highlight the role of vascularity in melasma and a recent study showed the interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser can target both the vascular and pigmented components of melasma. A preliminary study has shown its efficacy and excellent tolerability in the treatment of melasma. This study requires however to be confirmed by a comparative study versus reference treatment.

Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in an intra-patient study.

Secondary objectives

To study the frequency of PPI.
Compare the rate and extent of recurrence 6 months after completion of treatment.
To study the occurrence of possible adverse effects.
Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end of treatment).
To study patient satisfaction on the effectiveness and tolerability of the study treatments.

Methods Monocentric prospective interventional randomized split face comparative study between experimental treatment versus reference treatment.

Intervention

Visit Selection Patients will be selected from those presenting to the consultation of the department of dermatology at University Hospital of Nice. Participation will be offered to patients corresponding to the selection criteria of the study.

Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin the study. This will ensure that patients signed informed consent. An initial clinical evaluation of melasma with calculation of MASI score and standardized photographs (see chapter 'assessment') will be made. An examination by confocal microscopy in vivo will be realized. All patients will receive treatment by stabilized kilnman trio for four weeks.

In the week prior to Visit 1, the side of the face to receive the laser treatment will be determined by randomisation.

Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The contralateral side will receive its first laser session. Given the results of analysis by intention to treat, the occurrence of serious side effects will result in discontinuation of treatment but monitoring will continue with the assessments.

Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The laser side will receive its second session. Patients continue the applications of cream on the contralateral side.

Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The laser side will receive its third session.Patients continue the applications of cream on the contralateral side.

Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The laser side will receive its fourth and final session. Patients continue the applications of cream on the contralateral side during 4 weeks.

Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
Visit V7 (final week 36):

Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized. The evaluation of safety and patient satisfaction will be performed using a visual analog scale.

The primary endpoint will be the MASI score, score approved for assessment of melasma treatments.

ReferenceCitation: Hammami Ghorbel H, Boukari F, Fontas E, Montaudié H, Bahadoran P, Lacour JP, Passeron T. Copper Bromide Laser vs Triple-Combination Cream for the Treatment of Melasma: A Randomized Clinical Trial. JAMA Dermatol. 2015 Jul;151(7):791-2. doi: 10.1001/jamadermatol.2014.5580.


title: Reduced Intensity Conditioning Allogeneic Transplantation for CLL With Preemptive MDR Management (ICLL 03 RICAC-PMM)

acronym: RICAC

summary: Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However, the diagnosis in young patients become more frequently with poor prognosis. The identification of new prognostic factors permits early determination of the high risk population and provide them the therapeutic intensification. Allogeneic transplantation of hematopoietic stem cells transplantation (AHSCT) allows to long-term remission and in some cases complete and definitive eradication of the disease. After chemotherapy or antibodies, the Minimal Residual Disease (MRD) negativity is associated with better disease-free survival. MRD negativity occurs in some patients with the appearance of GVHD, stopping the immunosuppression or after donor lymphocyte injection (DLI). The negativity of MRD in the first year post-transplant is correlated with better progression-free survival or overall survival (Dreger 2010, Farina 2009, Caballero 2005, Algrin, 2011). So, MRD negativity may be an objective after AHSCT. The aim of this prospective study is to evaluate a standardized preemptive immunointervention of post-allograft immunosuppressive therapy modulation and DLI administration according to MRD level. The objective is to obtain MRD negativity at 12 months after AHSCT.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.

acronym: CORAC

summary:
Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.

The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.

lead_sponsor: University Hospital, Rouen


title: Peut-on améliorer la Marche de l'amputé fémoral en Guidant la Correction prothétique Par l'Analyse Des Pressions Dans l'emboîture ?

summary:
This study aims at evaluating the relation between quality of the interface between the stump and the prosthesis, and the quality of gait in above-knee amputees.

The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee amputees corresponds to an homogeneous pressure distribution pattern onto the stump.


title: Impact of Adding a Limitation Section in Abstract of Systematic Review on Interpretation by Readers: a Randomised Controlled Trial

acronym: ILMARI 2

summary:
Objective: The investigators aim to evaluate the impact of a adding a " limitations " section in systematic review's abstract on result's interpretation by readers Design: randomized controlled trial with two parallel arms. Participants will be invited to participate in an online survey.

Participants: Eligible participants are corresponding authors of clinical trials published between 2010 and 2012 and referenced in Medline.

Intervention: The investigators will evaluate the impact of the presence of a " limitations " section in abstract of systematic review with meta- analysis. The investigators selected abstracts of meta-analysis from a sample.

Selected abstract will be standardised and the treatment's name hidden. Two groups of abstract will be presented as follow: 1) abstract without " limitations " section 2) abstract with " limitations " section. The " limitations " section will be written by authors and will briefly describe the risk of bias of included studies.

Selected participant are invited by e-mail to answer the survey. After reading one abstract from his/her group of randomisation they are invited to answer 5 questions about their interpretation of the results.

ReferenceCitation: Yavchitz A, Ravaud P, Hopewell S, Baron G, Boutron I. Impact of adding a limitations section to abstracts of systematic reviews on readers' interpretation: a randomized controlled trial. BMC Med Res Methodol. 2014 Nov 24;14:123. doi: 10.1186/1471-2288-14-123.


title: Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer

acronym: SPIIN

summary:
1Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid dissemination of trial results and their translation into clinical practice is particularly important. Abstracts published or presented in conferences are a large, rapid and free method to disseminate these results. However, this mode of dissemination may have serious consequences for patients if abstracts are not an accurate and unbiased reflection of the trial results. Indeed, investigators have great freedom when writing their abstracts and articles. They can choose the data to present and decide how to present them. Consequently, they have many opportunities to shape readers' impressions of their results, that is, to add "spin" (ie, spin is a specific way of reporting to convince readers that the beneficial effect (efficacy, safety) of the experimental treatment is higher than shown by the results).

Objective: To assess the impact of spin on the interpretation of results in abstracts of randomized controlled trials with nonstatistically significant results in the field of cancer.

Design: The investigators performed a RCT comparing the interpretation of results in abstracts a) with and b) without spin.

Identification of abstracts of randomized trials with spin. The investigators selected a sample of negative published RCTs (i.e. non statistically significant results) with a spin in abstract conclusion identified in previous works. Inclusion criteria were 1) RCTs with non statistically significant primary outcome, 2) spin in the abstract conclusion.
Abstracts' modification Selected abstracts were systematically rewritten to contain no "spin". All abstracts were presented in the same format without the names of authors, references, or the name of the journal in which it was published, and the names of treatments were masked by using generic terms (e.g., treatment A, comparator B). All abstracts had the same number of words +/-20
Assessment Abstracts were assessed by corresponding authors of randomized trials, experts of specific grants and investigator of trials registered in clinicaltrials.gov. Experts were invited to participate in our study. They were not informed of the objectives of our study. Each clinician were randomized to evaluate 1 abstracts with or 1 abstracts without spin.
The primary endpoint was the interpretation of abstract results by the participants. All readers participating in the study evaluated the abstract of randomized trial and answered the following question: Based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0-10)


title: Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)

acronym: GAME

summary: Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10% of women. Our hypothesis is that offering acupuncture in addition to standard care would reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units will be randomized over a 3 year period to receive standard care or standard care plus acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤ 4/10. Secondary outcomes will compare groups for an impairment score and for direct and indirect costs.

ReferenceCitation: Nicolian S, Butel T, Gambotti L, Durand M, Filipovic-Pierucci A, Mallet A, Kone M, Durand-Zaleski I, Dommergues M. Cost-effectiveness of acupuncture versus standard care for pelvic and low back pain in pregnancy: A randomized controlled trial. PLoS One. 2019 Apr 22;14(4):e0214195. doi: 10.1371/journal.pone.0214195. eCollection 2019.

location_facility: Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière


title: Satisfaction Understanding of Patients and Relatives in Emergency Room

summary:
Evaluation of global understanding and with items of patients admitted to the emergency.

Prospective observational study randomized in cluster during 6 weeks in 14 centers

primary_purpose: Health Services Research


title: A Telemedicine System for the Follow-up of Patients With SAS

summary: Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

location_facility: Assistance Publique - Hôpitaux de Paris, Béclère Hospital


title: Conception of an ICF Core Set for Systemic Sclerosis

acronym: SCISCIF

summary: The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis

ReferenceCitation: Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005 Jul;37(4):212-8.

ReferenceCitation: Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün BT, Stucki G. Identification of candidate categories of the International Classification of Functioning Disability and Health (ICF) for a Generic ICF Core Set based on regression modelling. BMC Med Res Methodol. 2006 Jul 27;6:36.

ReferenceCitation: Clements PJ. Systemic sclerosis (scleroderma) and related disorders: clinical aspects. Baillieres Best Pract Res Clin Rheumatol. 2000 Mar;14(1):1-16. Review.

ReferenceCitation: Coenen M, Cieza A, Stamm TA, Amann E, Kollerits B, Stucki G. Validation of the International Classification of Functioning, Disability and Health (ICF) Core Set for rheumatoid arthritis from the patient perspective using focus groups. Arthritis Res Ther. 2006;8(4):R84.

ReferenceCitation: Daste C, Abdoul H, Foissac F, Papelard A, Alami S, Kwakkenbos L, Carrier ME, Lefèvre-Colau MM, Thombs BD, Poiraudeau S, Rannou F, Mouthon L, Nguyen C. Development of a new patient-reported outcome measure to assess activities and participation in people with systemic sclerosis: the Cochin 17-item Scleroderma Functional scale. Br J Dermatol. 2020 Oct;183(4):710-718. doi: 10.1111/bjd.18922. Epub 2020 Mar 18.

ReferenceCitation: Papelard A, Daste C, Alami S, Sanchez K, Roren A, Segretin F, Lefèvre-Colau MM, Rannou F, Mouthon L, Poiraudeau S, Nguyen C. Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis. Rheumatology (Oxford). 2019 Dec 1;58(12):2260-2272. doi: 10.1093/rheumatology/kez209.