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NCT ID: NCT04922437 Active, not recruiting - Neurogenic Bladder Clinical Trials

Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?

ICODE
Start date: January 1, 2020
Phase:
Study type: Observational

PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty. METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).

NCT ID: NCT04919408 Active, not recruiting - Clinical trials for Chronic Post-cesarean Pain

Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.

ChroCéRAAC
Start date: July 12, 2021
Phase: N/A
Study type: Interventional

Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery. The ERAS has been scientifically validated and standardized in many surgical disciplines since the implementation of guidelines in France in 2016. Regarding the obstetrical field, it was not until 2018 that the caesarean section could benefit from ERAS, with the publication of specific guidelines. Several studies have been able to demonstrate ERAS effectiveness in reducing the length of hospitalization, postoperative complications, the consumption of analgesics immediately after surgery, and the financial cost, including in the context of cesarean sections. But beyond immediate benefit, the impact of an ERAS protocol on chronic pain has not yet been evaluated. Chronic pain is defined as physical discomfort that persists for more than 2 months after surgery. It was not until 2004 that research focused on chronic post-cesarean pain, finding an incidence of chronic pain of 18.6% at 3 months and 12.3% at 6 months. In 2016, another study estimated an incidence of chronic pain in the caesarean scar at 15% at 3 months and 11% at 1 year. The investigators can notice that the presence of chronic post-cesarean pain remained stable over this period. Several risk factors have been identified, such as the presence of acute pain immediately after surgery, the type of anesthesia, the type of surgical incision or a significant state of anxiety before the operation. In this context, the investigators wish to assess the rate of chronic post-surgical pain in scheduled cesarean sections (excluding emergencies) under spinal anesthesia as part of a ERAS protocol. The investigatrors will also specify the type of pain and its impact on the daily activities of young mothers and will assess the level of adherence of medical and paramedical teams to the ERAS protocol. To answer these questions, the investigators will conduct a telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section. The pain studied is defined as being the pain at the level of the caesarean scar. This is an innovative subject evaluating the impact of the implementation of an ERAS protocol on chronic pain. Depending on the results, the investigators will be able to optimize the prevention of chronic pain of cesarean section.

NCT ID: NCT04915755 Active, not recruiting - Neoplasms, Breast Clinical Trials

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

ZEST
Start date: June 28, 2021
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.

NCT ID: NCT04914897 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)

Start date: September 23, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: -To determine the antitumor activity of SAR444245 in combination with other anticancer therapies. Secondary Objectives: - To confirm the dose and to assess the safety profile of SAR444245 when combined with other anticancer therapies. - To assess other indicators of antitumor activity. - To assess the pharmacokinetic (PK) profile of SAR444245 when given in combination with pembrolizumab. - To assess the immunogenicity of SAR444245.

NCT ID: NCT04913220 Active, not recruiting - Malignant Melanoma Clinical Trials

A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

Start date: July 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: - To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab - To assess other indicators of antitumor activity - To assess the concentrations of SAR444245 when given in combination with cemiplimab - To assess the immunogenicity of SAR444245 - To assess active concentrations of cemiplimab when given in combination with SAR444245

NCT ID: NCT04909801 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.

NCT ID: NCT04909294 Active, not recruiting - Clinical trials for Adenocarcinoma of the Prostate

Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma

STEREO-RML
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Stereotaxic prostatic radiotherapy on Linac MRI, with monitoring of movements of the pelvic organs per fraction on the prostate in real time, in 4 sessions, with integrated boost on the index tumor (if it is visible on the diagnostic MRI), could reduce the digestive, urinary and sexual toxicities accumulated at 5 years and guarantee excellent local tumor control, for patients with localized prostate cancer, with a favorable prognosis, intermediate or very local high risk, according to the D'Amico classification. The benefits that patients participating in this research could obtain are: - Better disease control efficiency - A reduction in the duration of treatment to 4 radiotherapy sessions (2 weeks maximum) instead of 40 sessions (8 weeks) for usual treatment. - Avoid the risks associated with the implantation of prostate markers necessary for stereotaxic radiotherapy on a standard accelerator (anesthetic risks, infectious risks, hemorrhagic risks, pain risks) - Better quality of life

NCT ID: NCT04908202 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Start date: July 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

NCT ID: NCT04903990 Active, not recruiting - Breast Cancer Clinical Trials

Circulating Fetal Cells and Breast Cancer

MoSaiC2
Start date: May 14, 2021
Phase:
Study type: Observational

After pregnancy, fetal cells remain in a woman's body for years. These cells may be involved in different physiological situations (e.g. wound healing) and diseases (e.g. cancer).The study will evaluate the level of circulating fetal immune cells in patients with breast cancer vs controls with benign breast tumors, and further characterize these fetal cells. Patients participation will be limited to accepting that an additional blood sample is collected on the day of their preop consultation and blood test.

NCT ID: NCT04903626 Active, not recruiting - Clinical trials for Hepatitis C Virus (HCV)

Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

Start date: August 24, 2021
Phase: Phase 3
Study type: Interventional

Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.