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NCT ID: NCT05724602 Recruiting - Clinical trials for Locally Advanced Head and Neck Squamous Cell Carcinoma

Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

RAVINA
Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, placebo-controlled, triple blind, phase II study to determine the efficacy and safety of xevinapant with radiotherapy in older patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of oral cavity, oropharynx, hypopharynx, or larynx. Upon confirmation of eligibility, subjects will be enrolled and randomized in a 1:1 ratio to: - Arm A: 3 cycles of xevinapant (200 mg/day from Day 1 to 14, per cycle) + intensive modulated radiotherapy (IMRT) followed by 3 cycles of xevinapant in monotherapy phase (200 mg/day from Day 1 to 14, per cycle) - Arm B: 3 cycles of placebo (from Day 1 to 14, per cycle) + IMRT followed by 3 cycles of placebo in monotherapy phase (from Day 1 to 14, per cycle). Patients will be stratified by institution, disease location/p16 status (p16 positive oropharyngeal cancer, versus others), G8 score. Three strata for the G8 will be used (>14, versus 11-14 versus <11). Patients will undergo imaging in week 20 and upon clinical suspicion of progression/recurrence. Clinical examination will take place every 12 weeks in the first 3 years.

NCT ID: NCT05724199 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-SHUTTLE
Start date: February 21, 2023
Phase: Phase 3
Study type: Interventional

The coprimary objectives of the study are to: - evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). - evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

NCT ID: NCT05724069 Active, not recruiting - Clinical trials for Chronic Intestinal Pseudo-obstruction

Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

This is a phase II, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of velusetrag once a day, compared to placebo, in subjects with CIPO.

NCT ID: NCT05723133 Recruiting - Dental Plaque Clinical Trials

Visual Feedback on Brushing Technique and Habits on Patient Oral Hygiene

Start date: February 24, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the influence of providing visual feedback on brushing technique and habits on oral health of patients undergoing periodontal treatment. The main question[s] it aims to answer are: - Is patients' oral health improved by providing visual feedback on their brushing technique using the smartphone brushing app? - Is there behavioural change of patients based on this daily visual feedback? Participants will receive oral hygiene instructions after initial periodontal treatment and will be randomized in group 1, 2 or 3. Participants will be asked to - fulfill a brushing diary with the time of brushing every day. - come back for a check-up appointment every 3 weeks during the study to evaluate oral hygiene. Researchers will compare manual toothbrush, electric toothbrush without daily personal feedback and electric toothbrush with daily personal feedback to see if visual feedback provide improved oral health

NCT ID: NCT05722938 Recruiting - Clinical trials for Community-acquired Pneumonia

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

ESsCAPE
Start date: September 9, 2023
Phase: Phase 3
Study type: Interventional

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

NCT ID: NCT05722899 Completed - Exercise Training Clinical Trials

Football 4 Health in Middle-aged to Older Adults

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Ageing in humans is accompanied by a progressive decline in lower-limb muscle power production. In addition to a decline in musculoskeletal fitness, ageing is associated with a reduction in cardiovascular and metabolic fitness. Therefore, if exercise interventions aim for a high impact on the overall health status of middle-aged and older adults, they should combine endurance, high-intensity interval training and muscular strengthening activities. Recreational football training combines all these training components, which implies that it could constitute an adequate training modality for participants of all ages. What remains to be investigated in more detail, is whether recreational football training can improve muscle power production in middle-aged to older adults and whether this potential improvement is present across the full force-velocity (F-V) profile. Next to a detailed analysis of the leg-extensor F-V profile as primary outcome, simultaneous effects on functional capacity, body composition and endurance exercise capacity were investigated. In addition, feasibility and the physical demands (internal and external load indicators) of the training program were tracked throughout the intervention period.

NCT ID: NCT05721573 Active, not recruiting - Clinical trials for Inclusion Body Myositis

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

Start date: February 28, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis

NCT ID: NCT05720676 Not yet recruiting - Breast Cancer Clinical Trials

Clinical, Histological and In-depth Molecular Characterization as Well as Experimental Models of Liver Metastasis From Patients With Breast Cancer in Order to Identify New Potential Treatment Avenues.

OLiver Pro
Start date: March 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to learn about breast cancer liver metastasis in patients who met the following criteria: - female; - be ≥ 18 years of age on the day of signing informed consent; - confirmed diagnosis of breast cancer liver metastases. Newly diagnosed patients with de-novo liver metastases are eligible; - be planned for liver surgery. The main questions it aims to answer are: 1. To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level; 2. To determine the levels and patterns of immune infiltrates in liver metastases from BC patients; 3. To identify biological features associated with the histopathological growth patterns in liver metastases. 4. To create patient-derived xenografts (PDX) and organoids (PDO) from liver metastases isolated from patients with BC; 5. To perform a histopathological and molecular comparison of liver metastases, PDX and PDO isolated from the same patient Participants will be willing and able to provide written informed consent for this study and tissue samples for research purposes.

NCT ID: NCT05720117 Recruiting - Solid Tumor Clinical Trials

Study of PYX-201 in Solid Tumors

Start date: March 14, 2023
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors.

NCT ID: NCT05719259 Recruiting - Clinical trials for Ventilator Associated Pneumonia

Perpetual Observational Study - Ventilator Associated Pneumonia

POS-VAP
Start date: August 3, 2022
Phase:
Study type: Observational [Patient Registry]

Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics. Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials. The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.