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NCT ID: NCT06232707 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

ALUMMINATE
Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT06202794 Not yet recruiting - Postoperative Pain Clinical Trials

TENS for the Treatment of Pain and Respiratory Function Following Mastopexy With Augmentation

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Background: Pain after breast plastic surgery affects quality of life. Physical therapy offers effective interventions for this condition, such as transcutaneous electrical nerve stimulation (TENS). Although this resource has been used for more than 20 years, no studies have been published that support its use following this type of surgery. Therefore, the aim of the proposed study is to evaluate the effect of TENS on pain intensity in patients undergoing mastopexy with implants, given the existing evidence on the success of TENS for other conditions. Methods: A two-arm, randomized, sham-controlled trial will be conducted with blinded assessors. The study will be carried out at the Exercise Physiology and Metabolism Lab of Finis Terrae University. Eligible participants will be women undergoing mastopexy with implants invited by a board-certified plastic surgeon. The participants will be randomly assigned to one of two study groups: Group 1 (surgery + TENS) and Group 2 (surgery + sham TENS). TENS will be administered only one hour after surgery and will remain for one hour. Four assessments will be performed: before treatment (T0), immediately after treatment (T1), one hour (T2) and four hours after TENS (T3). The primary outcome will be pain intensity at rest, pain intensity during movement (standardized movements of both arms: anterior flexion, abduction, and external rotation), and during respiratory function tests. Secondary outcome measures will be maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and vital capacity (VC). Discussion In this study, the effects of TENS on patients with pain following mastopexy with implants will be compared to the effects of a sham TENS intervention. This RCT will offer novel evidence on the potential benefits of TENS in terms of pain intensity at rest as well as during movements and respiratory function tests. Keywords TENS, Mastopexy, Plastic Surgery, Physical therapy modalities, Clinical trial protocol

NCT ID: NCT06155578 Not yet recruiting - Systemic Sclerosis Clinical Trials

Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis

Cal-23
Start date: January 2, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This prospective placebo-controlled trial will enroll 20 patients with SSc and at least one calcinotic lesion of the hands that is palpable on physical examination and measurable on hand radiographs. Each subject will undergo a screening evaluation 1 month before treatment with the study drug is initiated. Each subject will be instructed to blindly self-apply either topical 25% sodium metabisulfite or placebo cream twice daily. In-person follow-up evaluations will be performed after 4-months, with monthly telehealth follow-up visits to ensure adherence and arrange study drug refill deliveries.

NCT ID: NCT06148077 Not yet recruiting - Clinical trials for Head and Neck Cancer

Manual Therapy for Oral Health on Head and Neck Cancer Survivors

MaTeO
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients. The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on oral health, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors. Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises, b) control motor exercises (usual care) and, c) waiting list. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

NCT ID: NCT06056245 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Methadone Pharmacokinetics in End-stage Renal Disease

MCKD
Start date: January 15, 2024
Phase:
Study type: Observational

The goal of this observational study is to describe the influence of renal function on the pharmacokinetics of methadone used through an intravenous patient-controlled analgesia (IV-PCA) pump for the management of acute postoperative pain. After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it. The main question the study aims to answer is: • Is the pharmacokinetic of methadone used in an IV-PCA pump impaired in patients with chronic kidney disease?

NCT ID: NCT06054399 Not yet recruiting - Migraine Disorders Clinical Trials

Education on Migraine in Pregnant Women

MIGREMB
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Patient education is one type of low-cost intervention that can be easily applied but there are not specific studies about it in pregnant women with migraine. The primary goal of the study is to educate pregnant women experiencing migraine, leading to their understanding of the underlying pathology, management strategies and alarm symptoms. An intervention based on education can lead to empowered individuals capable of self-management, therefore reducing medication overuse and inappropriate use of the emergency department. It is relevant that these patients have access to understandable information; that is, in their own language and avoiding complex medical terms, so that the information can be useful for them and their support system. With this project the investigators aimed to improve the knowledge and satisfaction of participants (patients and healthcare professionals) to better deal with migraines during pregnancy.

NCT ID: NCT06028854 Not yet recruiting - Surgical Wound Clinical Trials

Blood Characteristics and Abdominal Emergency Surgery

Start date: September 15, 2023
Phase:
Study type: Observational

After surgical tissue damage, cellular blood components are involved in tissue repair processes, yet their preoperative characteristics are not considered in routine clinical practice.

NCT ID: NCT06015737 Not yet recruiting - Clinical trials for Cutaneous Lupus Erythematosus

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

LAVENDER
Start date: May 9, 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).

NCT ID: NCT05871983 Not yet recruiting - Clinical trials for Mitral Regurgitation

Munich Transcatheter Mitral Valve Safety and Effectiveness

MUSE
Start date: July 30, 2023
Phase: N/A
Study type: Interventional

The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve. Access is provided through the Femoral Vein and transseptal approach by means of a 27Fr catheter. The bioprosthetic valve consists of a self-expanding, tri-leaflet, dry bovine-pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The valve is available in three sizes and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.

NCT ID: NCT05869578 Not yet recruiting - Clinical trials for Perioperative/Postoperative Complications

Registry of Anesthesia and Perioperative Medicine

RAMP
Start date: June 1, 2023
Phase:
Study type: Observational [Patient Registry]

To assess mortality and morbidity associated to anesthesia interventions