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NCT ID: NCT04965922 Recruiting - Clinical trials for Multiple System Atrophy

Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy

QUA2-AMS
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. The aim of the study is to evaluate the effect of a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) on the quality of life of patients and their caregivers.

NCT ID: NCT04965766 Recruiting - Clinical trials for Metastatic Breast Cancer

Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

ICARUS-BREAST
Start date: May 11, 2021
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors. Participants may have received multiple lines of endocrine therapy with or without targeted therapies and must have received only one line of chemotherapy for ABC. Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated. A total of 100 participants are planned to be treated in the study. Participants will receive, every three weeks, a dose of U3-1402 equivalent to 5.6 mg/kg of body weight until progression or until unacceptable toxicity. Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis. The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.

NCT ID: NCT04965753 Terminated - Clinical trials for Advanced Synovial Sarcoma

FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors

Start date: August 17, 2021
Phase: Phase 1
Study type: Interventional

This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-609 given intravenously in subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors.

NCT ID: NCT04965649 Recruiting - Leukemia Clinical Trials

Is There an Association Between Innate CD8+ T Cells and the Evolution of Tyrosine Kinase Inhibitor Resistance Mutations in Phi+ Hematological Malignancies.

TIPHI
Start date: January 1, 2021
Phase:
Study type: Observational

The aim of this project is to test whether low levels of BcrAbl1, despite the presence of resistance mutations, are related to high levels of innate CD8+ T cells, in the hypothesis that these cells have an anti-tumor role. This research aims to investigate: - An association between the rate of innate CD8+ T cells and the evolution of Phi+ pathologies (Chronic Myeloid Leukemia and Philadelphia chromosome-positive Acute lymphocytic leukemia (Phi+ ALL) carrying a resistance mutation, according to the ELN 2013 and Phi LMC recommendations. - An association between the level of innate CD8+ T cells and the expansion of TKI resistance clones, assessed as the number of BcrAbl1 copies carrying the mutation relative to the number of Abl1 copies.

NCT ID: NCT04965493 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

BRUIN CLL-322
Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

NCT ID: NCT04965480 Recruiting - Geriatric Clinical Trials

Detecting Delayed Discharge in Acute Geriatric Unit Using Natural Language Processing

COLATERAL
Start date: July 1, 2021
Phase:
Study type: Observational

Delayed discharge in geriatric units is a health and economic issue. There is no algorithm to automatically measure the appropriateness of admissions or hospital days. 30% of the days of hospitalization in acute geriatric units (AGU) are not appropriate. Waiting for a transfer to a follow-up care and rehabilitation unit (SSR) is the main risk factor for inappropriate days. The purpose of this project is to develop an algorithm using natural language processing to predict the appropriateness of an admission to UGA, or a day at UGA.

NCT ID: NCT04964986 Completed - Clinical trials for Short Bowel Syndrome

Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity

STARSnutrition
Start date: June 14, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.

NCT ID: NCT04964934 Recruiting - Clinical trials for ER-Positive HER2-Negative Breast Cancer

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

SERENA-6
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

NCT ID: NCT04964895 Completed - Sexual Dysfunction Clinical Trials

Sexual Quality of Patients After Bladder Cancer Cystectomy

QSCO
Start date: September 20, 2021
Phase: N/A
Study type: Interventional

Bladder cancer is the second most prevalent urological cancer in France. About 1 in 5 new cases of bladder cancer infiltrate the muscles. The standard treatment is neoadjuvant chemotherapy followed by radical cystectomy associated with reconstruction of the urinary tract. The short-term effects on well-being and quality of life are well known. The long-term effects are, on the other hand, poorly understood, particularly sexual function. This study aim to asses the quality of sexual life in patients with cystectomy for bladder cancer. This will be done via various questionnaires given before and after surgery.

NCT ID: NCT04964687 Completed - Clinical trials for Alcohol Use Disorder

Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.

Start date: October 1, 2019
Phase:
Study type: Observational

Investigator seeks to determine wether integrating an addiction team into a liver transplantation unit improves the prognosis of patients with alcohol-related liver disease requiring liver transplantation. Our hypothesis is that patients managed by an addiction team before and after liver transplantation have less frequent alcohol relapses, thus decreasing the risk of cardiovascular complications, de novo cancer, recurrence of alcohol-related cirrhosis, and consequently increasing their overall survival.