Detroti, Michigan
- Featured
Paris, Ile-de-France
Recruiting
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Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial for HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1). Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. Participants who complete the Double-blind Treatment Period (Week 52) may be eligible to enter a 52-week extension trial (HZNP- HZN-825-302). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.
Phase
2Span
139 weeksSponsor
Horizon Therapeutics Ireland DACParis
Recruiting
- Featured
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
* Interventional Study * Estimated Enrollment:170 participants * Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations. * This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. * There is no difference in the treatment regimen between the cohorts.
Phase
2Span
Sponsor
Paris, Paris
Recruiting
- Featured
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
For more information, please contact Incyte Corporation at 1.855.463.3463 or visit **[www.incyteclinicaltrials.com](https://www.incyteclinicaltrials.com/)**
Phase
3Span
Sponsor
Paris, Ile-de-France
Recruiting
Women Hypertensive and Young-Renal Denervation
Investigators will include women with essential hypertension, treated or untreated, who are planning a short term pregnancy (D0). If high blood pressure is confirmed by ABPM after one month without treatment (D30), investigators will proceed to the arteriography during which they will be randomized in the renal denervation group or in the control one. After the randomization, BP monitoring by Home BP measurement will be performed every month and send to the investigator. Then the patient will benefit from a new ABPM two months after the intervention (D100), and she may stop contraception and may become pregnant. BP will be monitored during pregnancy by home BP and by a new ABPM at the beginning of the 6th month of pregnancy as well as one, one month after delivery. From the D100, the patient will be able to start an antihypertensive treatment at any time depending on HBPM or ABPM.
Phase
N/ASpan
305 weeksSponsor
University Hospital, BordeauxParis
Recruiting
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Phase
2Span
296 weeksSponsor
Merck Sharp & Dohme LLCParis
Recruiting
Transition From Paediatric Intensive Care to General Paediatrics and Pneumology Units : a Study of the Post-intensive Care Syndrome
Several large databases report mortality rates around 4% in pediatric intensive care units (PICUs) in developed countries, indicating that most children admitted to these units survive. Some pediatric survivors experience long-term morbidity associated with their PICU care, but comprehensive descriptive data are lacking. In 2010, the Society of Critical Care Medicine (USA) organized a working group to raise awareness of long-term cognitive, psychological and physical impairments in adult ICU survivors. Impairments in these three domains are collectively referred to as Post-Intensive Care Syndrome ""PICS"". In the adult population, PICS affects 50-70% of ICU survivors, and its effects may persist for 5-15 years after ICU hospitalization. In adults, recovery and quality of life after ICU stay has been described by the World Health Organization. In pediatrics, the framework of the pediatric post-intensive care syndrome ""PICS-p"" was developed in 2018. In addition to the elements corresponding to the three conventional domains of physical, cognitive and emotional health constituting the adult PICS, the PICS-p include a domain of ""social health"" of children and their families. This latter aspect is justified by the fact that serious illness affects the social functioning of children and their families; that is, reintegration with friends at school, their social capital and the impact on the work of parents caring for a sick child. These social health problems, intertwined with morbidity in other health domains, can have a further negative impact on the quality of child development and survival. A variety of recovery trajectories for surviving children and their families have been described in the PICS - p framework: improvement, deterioration, vacillation or plateau in the days or decades following PICU discharge. The available data, although still limited, suggest that the situations of children and parents with respect to PICS are more heterogeneous than those of adult post-resuscitation survivors. A 2017 review described the physical, neurocognitive and psychological outcomes in several cohorts of children who survived critical illness in intensive care, with most cohorts investigating a single health domain (physical or neurocognitive or psychological morbidity). In the same review, the authors found that outcomes were more common in younger children, from families with low socioeconomic status, with more invasive procedures or interventions, with high doses of benzodiazepines and narcotics, and varied by disease type. A wide range of psychological complications have also been described in families. While research on siblings is limited, one review reported prevalence of acute stress, post-traumatic stress symptoms, anxiety and significant depression in parents after their child's discharge from intensive care (between 10 and 84% varying between studies and symptoms). Psychological symptoms persist for several months. Risk factors for long-term problems include unexpected admission to the ICU and the number of medical interventions performed there, limited social support and negative memories of the ICU stay. It should be noted that post-traumatic symptoms in children are associated with parental symptoms. Today, in the majority of hospitals, there is no specific procedure for the prevention or management of PICS-p. In a recent editorial, pediatricians questioned the role of everyone in promoting a full recovery of children after intensive care: intensive care professionals, families, pediatricians in downstream services, professionals in rehabilitation, psychology or psychiatry, or ambulatory medicine; without giving a single answer. Our hypothesis is that PICS-p affects a significant proportion of children and families and that identifying its prevalence and associated needs through a descriptive survey will improve management beyond research. The aim of this study is to describe (in nature and frequency) the alterations in health defined by the WHO of children who have been admitted to PICU and that might constitute a PICS-p. We will perform a prospective cohort study in Robert-Debré University Hospital including children admitted to the PICU and hospitalized more than 72 hours. We will include children with an unplanned hospitalization for acute complication of sickle cell disease (such as acute chest syndrome or vaso-occlusive crisis), acute asthma or sepsis for more than 72 hours and aged from 3 to 17 years. We plan to include 40 patients admitted to the PICU as well as 40 controls admitted to the general pediatrics unit or the pneumology unit without PICU admission, matched on diagnosis, age range and period. Patients with intellectual retardation or with no health insurance coverage will be excluded. The primary endpoint will be the prevalence of children that had been admitted to PICU and reporting cognitive, psychological, physical and social impairments measured by questionnaire and medical record data collection on the day before discharge and at the routine post-hospitalization visit. Secondary objectives will be to study the risk factors for PICS-P, to compare alterations in cognitive, psychological, physical and social domains in children with the same diagnosis and age not admitted to the PICU during their hospitalization. In order to this, we will measure the association with the PICU stay characteristics, parental experience and social characteristics of families. We will also report the prevalence of children not admitted in PICU and reporting cognitive, psychological, physical and social impairments measured by questionnaire and medical record data collection on the day before discharge and at the routine post-hospitalization visit. Children will be included on the occasion of an unscheduled hospitalization in general pediatrics or pediatric pulmonology. After informing the family and collecting the consent form, the parents and/or the child will be asked to fill in a questionnaire the day before discharge. Patients and their parents will be given questionnaires the day before discharge and during the first follow-up consultation between 1and 3 months after hospital discharge. In fact, medical consultations are systematically carried out on these children to validate the discharge of patients from hospital (either in the general pediatric department or in the pediatric pneumology department) and a follow-up consultation is systematically carried out between 1 and 3 months after discharge. Questionnaires will include the Pediatric Symptom Checklist (PSC) long version (Assessment of cognitive, psychological and social domains - 35 items scored from 0 to 2) reported by parents for children under 8 years and by the patients for children older than 8 years. older), the physical items of Pediatric Quality of Life scale (8 items scored from 0 to 4) and a parent self-questionnaire (including relationship to child, annual income, household composition, understanding and use of the French language, highest diploma of mother and father, social support (""How many people can you really count on when you need help?"")) and a parental mental health self-assessment (PHQ-8). The selected questionnaires are validated and available in French and English. One of them will be available in pictorial form (PSC). The most appropriate translation will be offered to the family. If the family has difficulty understanding and/or reading French, it will be systematically proposed to complete the questionnaires with a clinical study technician trained in research who will offer assistance in completing the questionnaires with the ""voice"" function of the Google translate tool, in the family's preferred language. The results of these questionnaires may eventually lead to changes in the patient's usual care, as for ethical reasons, families will be provided with psychological support contacts to contact if they feel the need, and any disorders identified will be managed. In addition to questionnaires, additional data will be collected in the computerized medical record: child gender, child date of birth, diagnosis, date of diagnosis, number of previous unscheduled hospitalizations, reason for hospitalization, number of previous PICU visits, unpredictability of ICU admission, reason for PICU visit, length of stay in PICU, number and nature of medical interventions performed in PICU (non-invasive ventilation, intubation, mechanical ventilation, central catheter placement, arterial catheter placement, intraosseous catheter placement, pleural puncture, chest tube placement…), sedations used (molecules, number), withdrawal syndrome, delirium, date of discharge from PICU, number and nature of medical interventions performed outside the PICU, date of admission to general pediatrics or pneumology unit and dat of discharge from hospital, mode of discharge (home, transfer to other facilities including rehabilitation centers), psychologic disorders during stay, reported sequelae including respiratory and neurologic ones. The analyses will be descriptive (description of the nature and frequency of alterations) and comparative (between children who have or have not been in PICU). Univariate tests will be performed to identify possible risk factors for post intensive care syndrome. Statistics will be carried out on SAS 9.4 software.
Phase
N/ASpan
72 weeksSponsor
Assistance Publique - Hôpitaux de ParisParis
Recruiting
Piperacillin-tazobactam and Temocillin as Carbapenem-alternatives for the Treatment of Severe Infections Due to Extended-spectrum Beta-lactamase-Producing Gram-negative Enterobacteriaceae in the Intensive Care Unit
Phase
3Span
173 weeksSponsor
Assistance Publique - Hôpitaux de ParisParis
Recruiting
International Multicenter Study on Lipin-1 Deficiency
This study evaluates survival, cardiac function, quality of life, fatigability, treatment tolerance and comparison of the efficacy of different current treatments in patients with Lipin-1 deficiency.
Phase
N/ASpan
162 weeksSponsor
Imagine InstituteParis
Recruiting
Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV
Phase
N/ASpan
537 weeksSponsor
Groupe Hospitalier Paris Saint JosephParis
Recruiting