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NCT ID: NCT04761224 Active, not recruiting - Clinical trials for Prostatic Hypertrophy

Impact of Intraoperative Instillation of Normothermal Saline on the Prevention of Intraoperative Hypothermia and Perioperative Morbidity of Prostatic Enucleation With Holmium Laser

THERMHOLEP
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

For the treatment of benign prostatic hyperplasia (BPH), 2 types of endoscopic surgery are currently performed: transurethral prostate resection (TPR), the reference surgery, and laser prostatic enucleation (LPE). These procedures can be performed under general anesthesia, or local anesthesia, such as spinal anesthesia. The EPL or RTUP procedure requires the instillation of continuous intra-vesical fluids throughout the procedure. These 3L bags are often kept at the ambient temperature of the operating room (around 17°C): the temperature of the instilled solution is therefore much lower than the average body temperature of the patient (37°C). Thus, and by heat exchange, it often results in per and postoperative hypothermia, which is all the more frequent and profound the longer the duration of the operation. In spite of the usual procedures of warming by heating blanket, the prevalence of hypothermia, defined as a body temperature < 36°C, is 53.5% during surgical procedures. This hypothermia is all the more frequent and profound the older the patient is and the longer the duration of anesthesia. Several studies have shown that hypothermia is particularly frequent during abdomino-pelvic surgery, notably due to pathophysiological phenomena induced by anesthetic procedures. Indeed, general anesthesia, or major locoregional anesthesia, disrupts the thermoregulation center upon anesthetic induction, with alteration of peripheral vasoconstriction and tremor capacity, leading to a rapid redistribution of body heat from the center to the periphery. Through exchanges with the environment, this results in a rapid linear decrease in central body temperature that exceeds the metabolic energy produced. However, anesthetic procedures are not the only cause of hypothermic intraoperative phenomena. It has been shown that the decrease in body temperature associated with most genitourinary endoscopic procedures is multifactorial, taking into account the patient's body mass, the volume of fluids instilled, and the type and duration of the operation.

NCT ID: NCT04760704 Active, not recruiting - Covid19 Vaccine Clinical Trials

Covid-19 Vaccine Response in Elderly Subjects

MONITOCOVAGING
Start date: February 19, 2021
Phase:
Study type: Observational

The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).

NCT ID: NCT04760548 Active, not recruiting - Asthma Clinical Trials

Segmentation of Structural Abnormalities in Chronic Lung Diseases

NOVAA
Start date: January 1, 2008
Phase:
Study type: Observational

Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

NCT ID: NCT04759209 Active, not recruiting - Clinical trials for Kidney Transplantation

Development and Validation of a Virtual Biopsy System in Kidney Transplant

Start date: January 1, 2000
Phase:
Study type: Observational

Currently, kidney allograft biopsies are routinely performed to determine diagnosis and prognosis of kidney allografts. The histological interpretation of these biopsies is based on the Banff consensus for renal allograft pathology. The purpose of this study is to provide to the physicians a reliable estimation of renal allograft lesions of the day zero biopsy (kidney donor biopsy performed before transplantation).

NCT ID: NCT04758767 Active, not recruiting - Multiple Myeloma Clinical Trials

CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma

Start date: March 22, 2021
Phase: Phase 1
Study type: Interventional

Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities.

NCT ID: NCT04757753 Active, not recruiting - Clinical trials for Root Canal Obturation

Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRootâ„¢ RCS: a Randomized Controlled Trial

OPTIFILL
Start date: November 6, 2020
Phase: N/A
Study type: Interventional

The study design is a multicentric randomized controlled non-inferiority trial. 160 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (80 in each group). The aim of the study is to assess the efficacy rate and the safety 2 years after root canal obturation undertaken using a ready-to-use calcium silicate sealer (PA1704) compared to the control calcium silicate sealer BioRootâ„¢ RCS. Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRootâ„¢ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months in both groups. The performance and safety of the sealer PA1704 will also be evaluated at 3.5 and 5 years after surgery. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.

NCT ID: NCT04757636 Active, not recruiting - Clinical trials for Neovascular Age-related Macular Degeneration

OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

COAST
Start date: March 12, 2021
Phase: Phase 3
Study type: Interventional

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

NCT ID: NCT04754555 Active, not recruiting - Stroke Clinical Trials

Translation and Transcultural Adaptation of the Arm Activity Measure (ArmA) and Motor Activity Log (MAL)

F-ArmA
Start date: February 9, 2021
Phase:
Study type: Observational

Upper limb impairment occurs in approximately 70 to 80 per cent of adults post stroke. These impairments will have consequences on functional performance in activities of daily living and hence quality of life. Assessment of upper limb function is a component of rehabilitation that contributes to the selection of optimal interventions according to patient individualized needs. The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance that is only available in it's English version. The aim of this study is to translate and conduct a cross-cultural adaptation of the ArmA is order to investigate its psychometric properties through a validation study among stroke patients.

NCT ID: NCT04753749 Active, not recruiting - Clinical trials for Coronary Artery Disease

Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

TARGET-FIRST
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. 1 month duration) followed by P2Y12 inhibitor monotherapy for the next 11 months. It is hypothesized that in the setting of clinically stable, low to moderate complexity acute Myocardial Infarction patients, a modern approach combining a stent with high biocompatibility feature, complete revascularization strategy and modified antiplatelet therapy may be associated with similar outcomes, or even a significant benefit compared with guidelines-recommended 12-month DAPT. This benefit could be driven by a reduced risk in significant bleeding events, while keeping a comparable protection against ischemic risk. Enrolled subjects will be randomized in a 1:1 ratio to either cessation of aspirin at 1 months, either continuation of DAPT. Selection of the P2Y12 inhibitor agent is left to investigator judgment but has to be in line with the current ESC guidelines. Subjects treated with the Firehawk or Firehawk Liberty coronary stent will be included in this study.

NCT ID: NCT04752332 Active, not recruiting - Breast Neoplasms Clinical Trials

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

eMonarcHER
Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.