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NCT ID: NCT06154083 Recruiting - Fertility Clinical Trials

INtensity of OVarian Stimualtion and Euploid Embryos

INOVEE
Start date: December 12, 2023
Phase: Phase 4
Study type: Interventional

This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.

NCT ID: NCT06153693 Recruiting - Hypertension Clinical Trials

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

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

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

NCT ID: NCT06153381 Recruiting - Clinical trials for Shoulder Osteoarthritis

Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement

SIP_LaFe
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

reverse shoulder replacement surgery is performed to improve the functionality and reduce pain of the affected shoulder. Now, it is necessary to carry out an appropriate rehabilitation process to optimize surgical results. The lack of health resources makes it essential for the patient to work autonomously once hospital rehabilitation is completed. But lack of adherence is one of the main barriers to recovery

NCT ID: NCT06153251 Recruiting - Clinical trials for Relapsed and/or Refractory Multiple Myeloma

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

Start date: January 23, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

NCT ID: NCT06152575 Recruiting - Multiple Myeloma Clinical Trials

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Start date: February 8, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: - Are 18 years of age or older and have MM. - Have received treatments before for MM. - Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: - a shot under the skin at the study clinic - through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

NCT ID: NCT06150820 Recruiting - Clinical trials for Pompe Disease (Late-onset)

A Study About Antibody Levels and Biomarkers in the Blood in People With Late-onset Pompe Disease

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

Pompe disease is a genetic condition which causes muscle weakness over time. People with Pompe disease have a faulty gene that makes an enzyme called acid alpha-glucosidase (or GAA). This enzyme breaks down a type of sugar called glycogen. Without this enzyme, there is a build-up of glycogen in the cells of the body. This causes muscle weakness and other symptoms. Pompe disease can happen at any age, but in late-onset Pompe disease, symptoms generally start from 12 months old onwards. The standard treatment for people with Pompe disease is to receive regular infusions of the GAA enzyme. This is known as enzyme replacement therapy. However, people can build up antibodies against the GAA enzyme over time. Gene therapy is used to treat conditions caused by a faulty gene. It works by replacing the faulty gene with a working gene inside the cells of the body. The working gene is delivered into the cells using certain viruses as carriers (vectors). Viruses are often used as carriers as they can easily get inside cells. The genetic material of the original virus is replaced with the working gene, so only the working gene gets inside the cells. A common virus used as a carrier in gene therapy is the adeno-associated virus (or AAV). This is like an adenovirus, which causes the common cold. The original type of AAV does not cause any harm to humans. However, people that have previously been infected with the original type of AAV may have built up antibodies against AAV. These antibodies may stop the AAV carrier with the working gene getting inside the cells. Researchers want to learn more about antibody levels against AAV and the GAA enzyme in people with late-onset Pompe disease. They also want to learn about other substances in the blood that provide more information about late-onset Pompe disease. These are known as biomarkers. In this study, older teenagers and adults with late-onset Pompe disease will take part. They will not have had gene therapy using AAV. There will be 2 groups - those who have never had enzyme replacement therapy, and those who have had enzyme replacement therapy for 6 months or more. No study treatment will be given during the study, but blood and urine samples will be taken for testing. The main aims of the study are to check antibody levels against AAV8 (a type of AAV) in people with late-onset Pompe disease who had not received any treatment using AAV, to check antibody levels against the GAA enzyme in people previously treated with GAA as part of enzyme replacement therapy, to check levels of biomarkers for Pompe disease, and to check for medical problems. In the study, people will visit the study clinic several times. Some visits may be in the person's home. The first visit is to check if they can take part. Those who can take part will have a medical examination, and have their vital signs checked. Vital signs include blood pressure, heart rate, breathing rate and temperature. Blood samples will be taken to check antibody levels against the GAA enzyme and against AAV8. Blood and urine samples will also be taken to check for biomarkers for Pompe disease. Blood and urine samples will be taken about every 4 months for up to 2 years.

NCT ID: NCT06150677 Recruiting - Pain Clinical Trials

Effects of Static Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.

NCT ID: NCT06150638 Recruiting - Clinical trials for Irritable Bowel Syndrome

Treatment of Functional Abdominal Distension by Non-instrumental Biofeedback

Start date: April 29, 2024
Phase: N/A
Study type: Interventional

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a non-instrumental biofeedback technique for the treatment of abdominal distension. Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal. Intervention. Patients will be randomized into biofeedback in placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

NCT ID: NCT06150391 Recruiting - Amblyopia Clinical Trials

Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program

Start date: October 5, 2023
Phase: N/A
Study type: Interventional

Interest in developing alternative methods for the treatment of amblyopia (lazy eye) has long been a topic of interest among clinicians and researchers. Occlusion or penalization of fellow eye do not always provide the desired visual acuity improvement. Moreover, occlusion is associated with a high risk of recurrence and non-compliance. Here, it is presented a protocol of a randomized clinical trial to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer game. The goal of this prospective clinical trial is to compare in visual acuity improvements in patients with amblyopia, following conventional patching therapy or this novel computer-based therapy. The main questions it aims to answer are: - Does computer-based therapy equal or improve patching therapy? Can it be used as an alternative to patching? - Does computer-based therapy used in combination with pathching solve amblyopia when patching fails alone (persistent amblyopia)? Participants will be divided in two groups according to the previous occlusion o penalization of fellow eye. Both groups will be divided in two subgroups, experimental and control. Researchers will compare subgroups outcomes in order to asses this novel approach.

NCT ID: NCT06150313 Recruiting - Clinical trials for Randomized Controlled Trial

Efficacy of the Mediational Intervention for Sensitizing Caregivers for Teachers and Self-Administered Versions

MISC-SA/T
Start date: September 12, 2023
Phase: N/A
Study type: Interventional

OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of 2 new modalities of the Mediational Intervention for Sensitizing Caregivers (MISC) in caregivers from general population, specifically, in teachers at primary school children who are also parents. The main QUESTIONS it aims to answer are: - Are the new versions of MISC (MISC-T for Teachers, and MISC-SA or Self-Administered) efficient to a) improve the quality of caregivers-child interaction, and b) benefit children mental health, compared with a control group defined as Treatment as Usual (TAU)? - Is there any effect-transference to the school-setting despite the MISC is trained out of the school setting? re the new versions of the MISC efficient to benefit teachers' well-being at work in terms of lower burn-out, higher perceived self-efficacy or better classroom climate? PARTICIPANTS will randomly receive one of the 3 versions of MISC: MISC-T (administered by videoconference in teams of 6-10 teachers), MISC-SA (self-administered by the participants in weekly sessions with Genially), and MISC-R (self-administered by the participants but mainly based in readings and cognitive exercises instead of video-feedback, the core element of MISC-T and MISC-SA). COMPARISONS: Researchers will compare all 3 groups among them to see to what extent: - MISC-T shows efficacy compared with MISC-R (TAU; control group) - MISC-SA shows efficacy compared with MISC-R (TAU; control group) - MISC-T is more efficient than MISC-SA