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NCT ID: NCT05643105 Enrolling by invitation - Colon Cancer Clinical Trials

Anastomotic Leakage After Colon Cancer Surgery

ANACO II
Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

Anastomotic leak (AL) is one of the most feared complications after colon cancer (CC) surgery. The incidence varies according to the studies, the definition used and the location of the excised segment. In some of the series described, AL incidence have hardly changed, despite the evolution of the technique and technological improvements. The leak rate obtained in the only Spanish prospective multicenter observational study at national level was 9% (ANACO study). The aim of the present study is to determine the current rate of AL in our country, 10 years after the ANACO study, to determine if there has been any evolution and to analyze the factors associated with it. For this purpose, AL is defined with the same criteria as in the first study, as leakage of luminal contents through the junction between two hollow visceras, diagnosed radiologically (radiography with soluble enema or CT with collection adjacent to the anastomosis), clinically (extravasation of luminal contents or gas through the wound or drainage), endoscopically or intraoperatively. To compare AL rates throughout this decade, a 60-day follow-up will be performed, the same as in the ANACO study. As a modification respect to the ANACO study protocol, the aim is to analyze the possible influence of AL and perioperative intra-abdominal infection on short-term oncologic prognosis, with a one-year follow-up. This question has hardly been studied in prospective multicenter studies to date. The variables to be collected are divided into demographic (information about the hospital center, patient comorbidities), diagnostic variables (analytical values, diagnostic reason, neoadjuvant, localization, TNM), surgical variables (type of surgery, preparation, intention, intraoperative findings and complications, type of resection and anastomosis), admission (AL, other complications), histology, 60-day follow-up (AL, readmissions), one-year follow-up (readmissions, local recurrence, peritoneal and distant recurrence). Patients included in the study must be >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed and a derivative stoma should not be associated in the same surgery. According to ANACO data and follow-up times according to the primary objective (AL) at 60 days and the secondary objective (oncologic prognosis) with annual follow-up, inclusion will be carried out until the 1628 individuals required according to the sample size calculation performed are included.

NCT ID: NCT05707416 Enrolling by invitation - Clinical trials for Root Resorption of Maxillary Incisors

Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The present study will be directed to evaluate the effect of low-level laser therapy on root resorption during orthodontic intrusion of upper incisors.

NCT ID: NCT05748262 Enrolling by invitation - COVID-19 Clinical Trials

Characteristics of SARS-CoV-2 Reinfection

Start date: December 15, 2022
Phase:
Study type: Observational

As the COVID-19 pandemic continues and the number of individuals with previous infection rises, numbers of SARS-CoV-2 reinfection are increasing. The second Omicron wave in Shanghai, China caused by BA.5-sublineages led to a large fraction of reinfections among BA.2 primary infections. To better understand the SARS-CoV-2 reinfection rate and clinical severity of reinfections, the investigators conducted a multi-centre cohort study. The investigators hope to provide valuable clinical evidences for reinfections and offer guidance for future policy making.

NCT ID: NCT05842135 Enrolling by invitation - Clinical trials for Small Bowel Obstruction

REsectability Small Bowel Obstruction LAParoscopic (RESBOLAP) Score. Multicentric Data Registry

RESBOLAP
Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

AIM OF THE STUDY The aim of the study is to develop a Resectability Laparoscopic Score as a helpful instrument during intraoperative decision-making in the setting of emergency laparoscopic surgery for small bowel obstruction (SBO) by analyzing a multicenter data registry. DESIGN OF THE STUDY This is a multicenter study composed of a first phase of prospective data collection from patients that undergo laparoscopic surgery with a diagnosis of SBO and undergo Indocyanine green (ICG) fluorescence angiography (FA) for doubts about bowel viability after the resolution of the obstructive mechanism; the second phase of retrospective analysis to develop the Resectability Score. METHODS The FA should be performed in all patients undergoing laparoscopic surgery for SBO that presents concerns bowel viability after the resolution of the occlusive mechanism, with consequent intraoperative enrolment in the study Registry. The investigators adopted the modified Bulkley classification of the fluorescent patterns to identify which patients need more FA to assess bowel vitality. It is expected that most patients for whom the FA will be performed are those with patterns 2 or 3, representing the study's primary object. All participant centers must adopt the same technique to perform FA with the attempt to homogenize the procedure. Twenty-five milligrams of ICG powder is suspended in 10 ml of sterile water and administered intravenously through a peripheral vein and in small repeatable boluses of 2 ml in order to evaluate the intestinal microcirculation extemporaneously. The presence and pattern of arterial supply is tested and compared with that of healthy bowel. Proper clearance of the dye was also appraised to verify adequate venous drainage. Following the reversal of the underlying cause of the ischaemic injury, and after generous irrigation with warm saline, the involved bowel segment was further evaluated with FA after 10 min, regardless of the return of visible peristalsis. Routine postoperative clinical judgment will be considered sufficient to check bowel vitality. The need for a second-look surgery and delayed resections will be recorded. All centers could participate with a maximum of 3-4 members (co-authorship) Data will be recorded by a simple and brief online Case Report Form (CRF) on which upload also a photo/brief video of the FA, will be filled out by every participating center for each patient. A link to a Google Form and the necessary documents will be sent to every center after they have accepted to participate in the study.

NCT ID: NCT05941754 Enrolling by invitation - Depression Clinical Trials

A Clinical Study of Omega-3 on Depression and Cognition

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. Previous studies on the antidepressant effects of Omega-3 mainly focused on chronic effects, and there was a lack of corresponding rapid response clinical studies. Because of the nature of Omega-3 health products, no clinical adverse effects have been reported. We have previously shown that Omega-3 can produce antidepressant and cognitive improvement effects. This study will carry out different doses (low dose and high dose) and single active ingredient (EPA alone) to observe the antidepressant and cognitive improvement effects of Omega-3 in clinical patients with major depression. The antidepressant effect and cognitive improvement effect of Omega-3 will be further verified to provide evidence for future clinical application.

NCT ID: NCT06306573 Enrolling by invitation - Clinical trials for Heart Failure NYHA Class III

CardioMEMS HF System Real-World Evidence Post-Approval Study

Start date: December 15, 2022
Phase:
Study type: Observational

The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.

NCT ID: NCT06307236 Enrolling by invitation - Stress Clinical Trials

Dysmenorrhea of Emotional Freedom Techniques (EFT) and Its Effect on Perceived Stress Level

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

The aim of the study is to determine the effect of EFT application on the level of dysmenorrhea and stress perception in women with dysmenorrhea. For this purpose, EFT will be applied to women with dysmenorrhea with high stress perception assigned to the experimental and control groups, and their stress perceptions and dysmenorrhea levels will be re-evaluated after the application. Perceived Stress Scale (PSS) and Visual Analog Scale (VAS) will be used in the research.

NCT ID: NCT06326125 Enrolling by invitation - Pain Clinical Trials

Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures

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

This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture

NCT ID: NCT04146545 Enrolling by invitation - Clinical trials for Health Related Social Needs (HRSN)

CommunityRx-Dementia

CRx-D
Start date: December 16, 2019
Phase: N/A
Study type: Interventional

Caregivers of home-dwelling people with Alzheimer's Disease and related dementias (ADRD) are one of the most rapidly growing populations in the United States. Among ADRD caregivers with unmet health-related social needs, this study aims to evaluate the effects of the CRx-D intervention versus usual care on caregiver self-efficacy.

NCT ID: NCT04205006 Enrolling by invitation - Ischemic Stroke Clinical Trials

Stroke Card Long-term Follow-Up

Start date: December 16, 2019
Phase:
Study type: Observational

We undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care. To further investigate the long-term efficacy of STROKE-CARD care all participants of the original trial will be invited for a Long-term in Person follow-up (3 - 6 years).