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NCT ID: NCT05939986 Not yet recruiting - Anxiety Clinical Trials

A Protocol for a Virtual Reality Exposure Therapy for Fear of Flying.

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

This study aims to assess whether adding vibrotactile stimulation to visual and auditory stimulation increases the efficacy of VRET for FoF treatment. Eighty-four participants (18-65 years old) will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET) without sensory feedback. FoF-related symptoms (primary outcomes) will be measured administering the Fear of Flying Questionnaire-II (QPV-II), the Fear of Flying Scale (FFS), and the Visual Analogic Scale (VAS-A) before and after eight sessions of treatment, and at six- and 12-month follow-ups. Anxiety and the sense of presence experienced during exposure sessions (secondary outcome measures: VAS-A and VAS-P) will also be assessed. It is expected that participants in the VRET-M group will report a further reduction of FoF-related symptomatology after the treatment and at follow-ups compared to participants in the VRET-B and IET groups. Likewise, participants in the VRET-M group are expected to show higher sense of presence levels during exposure sessions in comparison to participants in the VRET-B and IET groups. It is expected that the IET group will report the lowest level of sense of presence and the poorest outcome after treatment and at follow-ups.

NCT ID: NCT05936580 Not yet recruiting - Hemophilia A Clinical Trials

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Start date: February 2024
Phase: Phase 4
Study type: Interventional

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

NCT ID: NCT05923047 Not yet recruiting - Clinical trials for Rhinosinusitis Chronic

Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

MELYSA
Start date: September 1, 2023
Phase: Phase 4
Study type: Interventional

This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment. All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include different questionnaires and nasal endoscopy. This trial includes three treatment arms. 1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach. The presence of adverse effects will be assessed in each treatment arm.

NCT ID: NCT05914584 Not yet recruiting - Clinical trials for Hospital-acquired Pneumonia

"Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype.

TREAT-HAP
Start date: July 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to determine the safety (phase II), then efficacy (phase III) of baricitinib plus standard of care (SOC) as compared to SOC alone for the treatment of hospital-acquired pneumonia in patients with a pro-inflammatory profile.

NCT ID: NCT05911191 Not yet recruiting - Clinical trials for Exercise Based Prehabilitation in Valvular Surgery

Preoperative Strength-resistance Training in Valvular Heart Disease Patients

CardiacEBPhb
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Cardiovascular diseases (CVD) are a group of illnesses that include coronary heart disease, cerebrovascular disease, congenital heart disease, and deep vein thrombosis. CVD is the leading cause of mortality worldwide, representing 31% of deaths. In Spain, CVD caused 24% of all deaths in 2020. Major surgery is often chosen as the treatment of choice for CVD. The concept of fast-track rehabilitation after surgery appeared in the 1970s. Participation in these exercise-based prehabilitation programs may decrease postoperative complications and length of hospital stay. The purpose of the present study is to evaluate whether the implementation of an additional resistance training (RT) prehabilitation protocol within a cardiac exercise-based prehabilitation can reduce ICU length of stay, postoperative complications, and hospital length of stay (LOS). Additionally, the secondary objective is to determine whether a program that includes RT in addition to respiratory and aerobic training can have better effects on ventilatory variables. This study follows the protocol of a prospective, parallel, non-randomized clinical trial. Ninety-six adult patients diagnosed with valvular pathology and who have been scheduled for surgery will be included. The control group will be treated with ventilatory and strengthening of respiratory muscles, as well as aerobic exercise. The experimental group, in addition, will receive RT targeting peripheral muscles. Variables such as hospital stay, quality of life, respiratory values, and exercise capacity will be evaluated. Quantitative variables will be analyzed using a t-test or ANOVA, or Mann-Whitney test if the distribution is non-parametric.

NCT ID: NCT05900388 Not yet recruiting - Clinical trials for Venous Thromboembolism

A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

XAPAEDUS
Start date: December 31, 2024
Phase:
Study type: Observational

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: - Age, gender, and other information about the child and their illness - Type of VTE treatment given to the child - Occurrence of medically important bleeding and its severity Further information that researchers will collect: - Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE - Return of VTE symptoms - Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: - end of the anticoagulation treatment period e.g. discontinuation of all study drugs, - their information is no longer available, or - the study ends.

NCT ID: NCT05884996 Not yet recruiting - Healthy Clinical Trials

Kabat Training Program With Elastic Bands for Shoulder in Amateur Swimmers

Start date: June 2023
Phase: N/A
Study type: Interventional

It has been shown that 90% of swimmers experience shoulder pain at some point in their career. During the macrocycle, swimmers present significant alterations in the muscular balance between external and internal rotators of the shoulder: the IR assumes much prominence in strength levels and RE goes progressively weaker. furthermore, all overhead athletes (such as swimmers) present a glenohumeral Internal Rotation Deficit and an increase in External Rotation. The objective of this study is to propose an exercise with an elastic band aimed to strengthening the RE of the shoulder to analyze the effects on the muscular balance between IR and RE. In addition, the effect caused in the limitation of internal rotation is going to be studied

NCT ID: NCT05878444 Not yet recruiting - Obese Clinical Trials

Evaluation of the Colonization Capacity of a Probiotic Bacterium.

BIOPRED
Start date: June 1, 2023
Phase: Phase 1
Study type: Interventional

The goal of this interventional study is to test the colonization of a new generation probiotic in normal weight and overweight/obese people. The main question aims to answer is if our bacteria is able to colonize the human intestine. Participants will recieve a probiotic pill every day during 15 consecutive days and fill in questionaries.

NCT ID: NCT05877378 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy of PICO Single-use System in Chronic Ulcers

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

A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.