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NCT ID: NCT05840211 Recruiting - Clinical trials for Stage IV Breast Cancer

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

ASCENT-07
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

NCT ID: NCT05836220 Recruiting - Clinical trials for Secondary Hyperparathyroidism

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2

PATH-2
Start date: May 15, 2023
Phase: Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.

NCT ID: NCT05835310 Recruiting - Clinical trials for Systemic Lupus Erythematosus

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

SLE
Start date: March 14, 2024
Phase: Phase 3
Study type: Interventional

A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE

NCT ID: NCT05832931 Recruiting - Clinical trials for Secondary Hyperparathyroidism

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

PATH-1
Start date: April 28, 2023
Phase: Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.

NCT ID: NCT05831657 Recruiting - Pedophilia Clinical Trials

Prevent It 2.0/PRIORITY - An iCBT to Reduce the Risk of Committing Child Sexual Abuse

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

Child sexual exploitation and abuse is a large-scale global issue that has been drastically rising since the advent of the internet that has brought about communication technologies enabling new ways to sexually abuse children. Prevent It is a free, anonymous, internet-delivered, and clinician-guided, cognitive behavioral therapy (CBT) intervention for adults who are concerned about their urges to engage in child sexual exploitation or abuse behaviors. It was developed based on many years of clinical experience from working with this patient group, as well as results from several previous research projects in the area of child sexual abuse. Using a randomized controlled trial with waitlist control - a scientifically rigorous design - we will evaluate the effectiveness of the Swedish, German, and Portuguese versions of Prevent It 2.0 - an updated version of the initial Prevent It program. This evaluation is being funded by the European Commission and will consist of an international, multicentre, and academically initiated randomized controlled clinical trial for which those actively enrolled in Prevent It 2.0 will be compared to a waitlist control for each language version (Swedish, German, and Portuguese). Data will be collected across the three sites (Sweden, Germany, and Portugal), in their corresponding languages (Swedish, German, and Portuguese), over 18 months. All data will be collected through the Iterapi platform that will be housed in a server by members of the Swedish subgroup located at Linköping University (LiU), Sweden. PRIORITY will provide intervention to 420 participants who will be recruited via multiple channels (darknet, Clearnet, police referral). Participation in the program will take place on both Darknet and Clearnet. All contact with participants, the treatment evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi. The Iterapi platform is designed specifically for clinical trials of internet-mediated CBT.

NCT ID: NCT05828355 Recruiting - Clinical trials for Anterior Cruciate Ligament Reconstruction

The Knee Care @Home Programme Following Anterior Ligament Reconstruction

KC@H
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Background: Patients who are unable to fully comply with conventional clinic-based rehabilitation sessions after anterior cruciate ligament reconstruction may find additional internet-based sessions beneficial. These remote sessions include therapeutic exercises that can be done at home, potentially extending the reach of rehabilitation services to underserved areas, prolonging the duration of care, and providing improved supervision. Objective: To determine if the Knee Care at Home programme is more effective than conventional clinic-based rehabilitation alone in improving patient-reported, clinician-reported, and physical functional performance outcome measures after anterior cruciate ligament reconstruction. Additionally, the trial pursues to assess the significance of changes in outcome measures for clinical practice. Methods/design: This protocol outlines a randomised controlled trial for postoperative recovery following anterior cruciate ligament reconstruction. Adult participants of both sexes who meet specific criteria will be randomly assigned to either the Clinic-based Rehabilitation group or the Knee Care at Home group. Only the latter group will receive internet-based sessions of therapeutic exercises at home, in addition to clinic-based rehabilitation sessions. A follow-up evaluation will be conducted for both groups 12 weeks after the intervention ends. Expected Results: The Knee Care at Home programme is superior to conventional clinic-based rehabilitation alone for patients recovering from anterior cruciate ligament reconstruction across multiple outcome measures. Also, the programme has the potential to promote superior recovery and extend the reach and duration of care.

NCT ID: NCT05827016 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Start date: June 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

NCT ID: NCT05826314 Recruiting - Clinical trials for Healthy People Programs

Boxing Training, Physical-functional Fitness and Cognitive Performance in Older Adults

Boxe4Ageing
Start date: October 17, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate and to compare the effects of two exercise regime (Boxing Training -BT and Multicomponent Training -MT) on cognitive health status, physical-functional fitness, and risk of falls in community-dwelling elders. This is a quasi-experimental controlled trial using a parallel-group design. Participants will be allocated to 3 groups (i.e. BT, MT or control group [no intervention]). Both exercise programs (BT and MT) will last 24 weeks, twice a week, 45 minutes per session. Only participants in the intervention groups (BT and MT) will be assessed for Senior Fitness test, and body weight at 3 moments (baseline, 12 weeks and 24 weeks). Participants in the control group will participate in the assessments (initial [baseline] and final [24 weeks]). Our hypotheses are: 1. In comparison with the control group, both exercise regimes groups (BT and MT) will positively impact on physical-functional fitness, cognitive health status and risk of falls in community-dwelling elders. 2. The observed effects on physical-functional fitness, cognitive health status, and risk of falls as a result of the BT program will be superior to the effects arisen from the MT exercise regime.

NCT ID: NCT05819359 Recruiting - Parkinson's Disease Clinical Trials

Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

ACTIVATE
Start date: March 31, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

NCT ID: NCT05814627 Recruiting - Clinical trials for Rheumatoid Arthritis

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

SELECT- SWITCH
Start date: June 15, 2023
Phase: Phase 3
Study type: Interventional

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. 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, checking for side effects and completing questionnaires.