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NCT ID: NCT04622735 Completed - Acute Pain Clinical Trials

Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction

Start date: February 22, 2020
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.

NCT ID: NCT04621552 Completed - Clinical trials for Intracranial Aneurysm

Virtual Simulation for Woven EndoBridge Device Sizing

VS-WEB
Start date: January 1, 2015
Phase:
Study type: Observational

Selection of the appropriate size of the device is mandatory during aneurysm treatment with a WEB. The Investigators aimed to investigate if virtual simulation with Sim&Size software may have an impact on technical, angiographic, and clinical outcomes after WEB treatment. Data from two large-volume centers were collected and compared (January 2017-January 2020). Virtual simulation was systematically adopted in one center, while conventional sizing was used in the other one. Outcomes were the duration of intervention, the radiation dose (mGy), the number of corrective interventions for inappropriate WEB size, the number of WEBs not deployed, angiographic occlusion, and complications. Univariate and multivariate linear models were adopted.

NCT ID: NCT04621318 Completed - Healthy Clinical Trials

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

Start date: October 19, 2020
Phase: Phase 1
Study type: Interventional

This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.

NCT ID: NCT04621292 Completed - Geriatric Clinical Trials

Prospective Study Assessing Two Scales for Identification of Complex Elderly Patients in the Emergency Department

SOCOLOC
Start date: August 17, 2020
Phase:
Study type: Observational

With the help of medical progress, life expectancy has increased in our country, resulting in an increase in the number of elderly people and especially so-called complex patients. These complex elderly patients present with a combination of poly pathology, locomotor disorders and loss of autonomy, which leads to increased risks of hospitalization, re-hospitalization or difficulty in remaining at home. These risks could be reduced by early adapted care specific to this type of patient. To do this, it is necessary to identify these complex elderly patients as early as possible in their care pathway. Screening complex elderly patients in the emergency department would require trained and educated staff, or the use of a simple, rapid and reliable diagnostic scale. The purpose of this study is to compare two scales for the screening of complex elderly patients, whose use is adapted to the Hospital Emergency Department environment. This study assess the diagnostic performance of the ISAR and SoCoLoc scales for complex elderly patients.

NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

NCT ID: NCT04620330 Completed - Clinical trials for Non Small Cell Lung Cancer

A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer

RAMP202
Start date: December 31, 2020
Phase: Phase 2
Study type: Interventional

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

NCT ID: NCT04618211 Completed - Clinical trials for Hereditary Angioedema

Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

RAPIDe-1
Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

NCT ID: NCT04618042 Completed - Covid19 Clinical Trials

FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia

FX-COVID
Start date: November 13, 2020
Phase: Phase 2
Study type: Interventional

Vascular leakage following endothelial injury, responsible for interstitial and alveolar edema, is a major feature of pathogen induced acute lung injury. As acute respiratory distress syndrome (ARDS) due to pandemic Covid-19 is associated with more than 60% mortality, controlling vascular leakage may be a major target to decrease the mortality associated with the spreading of the disease in France. FX06, a drug under clinical development containing fibrin-derived peptide beta15-42, is able to stabilize cell-cell interactions, thereby reducing vascular leak and mortality in several animal models, particularly during lipopolysaccharide-induced and dengue hemorrhagic shock . A phase I study was conducted in humans, with no specific adverse event detected with a dose up to 17.5 mg/kg. In a phase II randomized multicentre double-blinded trial in 234 patients suffering from ST+ acute coronary syndrome, FX06 treated patients exhibited a 58% decrease in the early necrotic core zone. Importantly, adverse events were highly comparable between groups, indicating a high safety profile for the drug . Lastly, the drug was used as a salvage therapy in a patient exhibiting a severe ARDS following EBOLA virus infection . Altogether, those data indicate that FX06 is well tolerated in humans and is a potent regulator of vascular leakage. Our hypothesis here is that FX06 may decrease pulmonary vascular hyperpermeability during ARDS following SARS-CoV-2 infection, thereby improving gas exchanges and the outcome of infected patients.

NCT ID: NCT04617964 Completed - Clinical trials for Intrauterine Growth Retardation (IUGR)

Reproducibility of the Measurement of the Right Portal Vein Diameter

PORTALGROWTH1
Start date: March 8, 2021
Phase:
Study type: Observational

Although routine ultrasound is offered during the third trimester of pregnancy, less than a quarter of newborns with intrauterine growth retardation (IUGR) are suspected antenatally. The measurement of the right portal vein (RPV) diameter on the transverse abdominal view at the 32 weeks' scan may be a new a tool for detecting small-for-gestational-age (SGA) at birth. The irregular and collapsed aspect of the right portal vein (RPV) on the third trimester ultrasound could be used for identifying hypoxemic and growth-restricted fetuses. However, to our knowledge, the only interoperator reproducibility study of this measurement was performed using the same stored images or datasets without performing a new examination. The main objective of this study is to assess the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound. The secondary objective is to quantify the interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid. Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester. Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.

NCT ID: NCT04617808 Completed - Headache Clinical Trials

Predictive Score for Non-traumatic Secondary Headache After an Emergency Call

CEPHAREG
Start date: October 21, 2020
Phase:
Study type: Observational

The study objective was to identify predictive criteria of severe non-traumatic secondary headache among the information gathered during telephone interview conducted by the on-call regulating physician at the Centre15.