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NCT ID: NCT06182254 Recruiting - Surgery Clinical Trials

Personalized Perioperative Care Based on Patient Reported Outcomes Measures

SUPPORT
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

In the perioperative setting, Patient Reported Outcomes Measures (PROMs) are important for both patients and clinicians. Reliable PROMs, like the Quality Of Recovery 15 (QoR-15) questionnaire, are available for patients experiencing surgery. These PROMs are significantly used as endoints for clinical interventions assessment. These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway. However data about the efficacy of PROMs-based perioperative clinical follow up are lacking. The clinical hypothesis is that a PROMs (QoR-15) based perioperative clinical care is more efficient that the usual care non based on the QoR-15.

NCT ID: NCT06321627 Recruiting - Clinical trials for HPV-Related Carcinoma

Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach

ICARUS
Start date: April 14, 2023
Phase:
Study type: Observational

The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body.

NCT ID: NCT06446635 Recruiting - Perianal Fistula Clinical Trials

Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study

Semiflex Pilot
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses/sinuses and fistulas: The Semiflex Dome System. This system will allow for a better and faster treatment and it will offer conformability with various fistula shapes and sizes. Objective: With this pilot study, the investigators aim to test our novel catheter set for vacuum therapy of perianal abscesses/sinuses and fistulas for feasibility and efficacy. Study design: The design of this prospective, multicentre study is a feasibility study. Study population: Patients (≥ 18 years) with (Crohn's) perianal fistulas and patients with perianal abscesses/sinuses are eligible. Intervention: A tailored (length and diameter) Semiflex dome catheter is inserted under general anaesthesia, after 6 weeks of seton drainage in patients with a perianal fistula and right away in patients with a perianal abscess/sinus. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew) and is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. After two - three days the catheter will be exchanged by a shorter catheter in the outpatient setting. The therapy is continued for a maximum of four weeks in patients with a perianal abscess/sinus and two weeks in patients with perianal fistulas. Main study parameters/endpoints: The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing the semiflex catheters, capability of proper fixation of the catheter and maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Secondary objectives are efficacy of drainage of the perianal abscess/sinus, efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration, efficacy of management of perianal fistula in terms of clinical and radiological healing, and safety in terms of complications. Nature and extent of the burden and risks associated with participation: The Semiflex Dome Catheter System will be placed in patients with perianal fistulas and perianal abscess/sinus who would otherwise be treated using prior-art passive drainage catheters or repurposed vacuum-assisted closure therapy sponges. There are no known additional risks stemming from the proposed therapy. The Semiflex Dome Catheter System is made entirely of medical-grade silicone certified with ISO 10993- 05 and ISO 10993-10. The catheters will be connected with a tube configured to be connected to a CE certified vacuum generating system. Sample size: Since this is a pilot study no sample size is required. The pilot study will consist of 2 parts. In the first part, 10 patients in each study group will be included and it will be assessed per study group if the catheter meets the proof of principle. After a positive result in one or both study groups, the second part of the study will start. 10 patients in each study group will be included. The proposed treatment protocol is considered feasible if at least 70% of the Semiflex dome catheter treatment per study group meets the four primary objectives.

NCT ID: NCT05820737 Recruiting - Clinical trials for Gastrointestinal Dysfunction

A Study to Assess the Gut Health Effects of Heat-killed Post-biotics in Overweight and Obese Adults

Start date: April 14, 2024
Phase: N/A
Study type: Interventional

The present study is a randomized, double-blind (Double dummy), placebo-controlled, parallel-group study to assess the gut health effects of heat-killed post biotics in overweight and obese individuals

NCT ID: NCT05890664 Recruiting - Atrial Fibrillation Clinical Trials

Colchicine After Electrocardioversion for Atrial Fibrillation

COLECTRO-AF
Start date: April 14, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.

NCT ID: NCT06087029 Recruiting - Clinical trials for Type B Aortic Dissection

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

IMPROVE-AD
Start date: April 14, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

NCT ID: NCT06122246 Recruiting - Blood Pressure Clinical Trials

PRESSURE CHECK: Find Your Path to Better Health

PRESSURE CHECK
Start date: April 14, 2024
Phase: N/A
Study type: Interventional

This study seeks to evaluate whether a community-partnered, multi-level health system strategy to manage elevated blood pressure (BP) in the community, either with a medical model of remote BP management (RBPM) alone or RBPM plus a social model with a community health worker (CHW), is more effective in controlling hypertension than standard community screening and referral to primary care.

NCT ID: NCT06312176 Recruiting - Breast Neoplasms Clinical Trials

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Start date: April 14, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

NCT ID: NCT06376721 Recruiting - Clinical trials for T-lymphoblastic Lymphoma

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

Start date: April 14, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.

NCT ID: NCT06386861 Recruiting - Adult ALL Clinical Trials

Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM).

Start date: April 14, 2024
Phase: N/A
Study type: Interventional

the investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino/a, or Latinx. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population.