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NCT ID: NCT04965441 Completed - Clinical trials for Complication of Surgical Procedure

CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap

Start date: December 1, 2020
Phase:
Study type: Observational

A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. The mandibular resection and reconstruction were performed by four experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up postoperatively for at least one year. Eighteen pairs were formed with the matched cohort consisting of a total of 36 patients who underwent primary mandibular reconstruction without additional combined flaps. The surgery-related and patient-related continuous and categorical parameters were assessed in both groups.

NCT ID: NCT04965324 Completed - Clinical trials for Surgery--Complications

Depth of Anaesthesia and Long-term Survival: The Balanced Anaesthesia Follow-up Study

BALANCEDLT
Start date: December 19, 2012
Phase:
Study type: Observational

Anaesthetic depth and complications after major surgery: an international, randomised controlled trial - The BALANCED trial. In this large, international, randomised controlled trial that enrolled patients aged 60 years and over with significant comorbidity and at increased risk of complications after major surgery, we found no evidence that light general anaesthesia (bispectral index 50) was superior to deep general anaesthesia (bispectral index 35) in reducing 1-year mortality. The BALANCED long term follow up study will look at whether depth of anesthesia affects long term (beyond 1 year) survival. The primary hypothesis is that targetting BIS 50 will result in superior long term survival compared to targetting BIS 35. The two secondary hypotheses are that BIS titration to BIS 50 will 1. reduce local cancer recurrence or metastatic spread and consequently improve long-term survival 2. reduce postoperative delirium and associated cognitive impairment and consequently improve long-term survival Both these mechanisms would be expected to take longer to manifest as reduced survival than 1-year all-cause mortality primary outcome in the Balanced trial. Trials of cancer outcomes often use 5-year survival or similar timeframes to determine evidence of clinical benefit. A steeper cognitive trajectory due to intermediate outcomes such as delirium and cognitive impairment may take longer than 1 year to produce a clinically important difference in survival 30. The 10.6% relative risk reduction seen in the Balanced trial could translate to a statistically and clinically meaningful survival difference in this high-risk population. This population may have 5-year survival of ~80% translating to an absolute survival difference of ~2% potentially (if the ~10% RRR is maintained beyond 1 year). The alternative is that there is no long-term mortality difference which would provide continuing clinical guidance of the safety of current practice in patients who are not at high risk of delirium. This study could provide a rationale for trials in larger populations (such as the total Balanced trial population) or targeted subgroups such as cancer and delirium to provide further mechanistic insights. Long-term survival is an important patient-centred outcome. The mechanisms described above may manifest in longer-term outcomes providing a clear rationale for the current trial.

NCT ID: NCT04965285 Completed - Safety Issues Clinical Trials

Operating Room WHO Surgical Safety Checklist Process Completion: an Observational Study

Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

The WHO Surgical Safety Checklist is a simple tool designed to improve the safety of surgical procedures by bringing together the whole operating team (surgeons, anaesthesia providers and nurses) to perform key safety checks during vital phases of perioperative care: prior to the induction of anesthesia, prior to skin incision and before the team leaves the operating room. In 2007, WHO Patient Safety launched the Second Global Patient Safety Challenge, Safe Surgery Saves Lives.Anaesthetists, operating theatre nurses, surgeons, safety experts, patients and other professionals came together and came up with the WHO Surgical Safety Checklist. The 19 items of the surgical checklist have shown to improve on mortality and morbidity. Surgical time out is carried out before the start of any surgical procedures to reduce the occurrence of wrong-site, wrong-procedure, and wrong-person surgery where the patient's identity, the procedure, and the surgical site before surgical incision or the start of the procedure is verified. This also helps to raise any concern regarding the procedural risk and any concerns, prevent medical errors, patient morbidity, patient mortality, and reduce surgical complication rates. The Checklist is intended as a tool for use by clinicians interested in improving the safety of their operations and reducing unnecessary surgical deaths and complications and also help ensure that teams consistently follow a few critical safety steps and thereby minimize the most common and avoidable risks endangering the lives and wellbeing of surgical patients . The aim of this Checklist is to reinforce accepted safety practices and foster better communication and teamwork between clinical disciplines.

NCT ID: NCT04964427 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

The Effects of Methylphenidate and Non-invasive Brain Stimulation on Inhibitory Control in Children With ADHD

Start date: February 8, 2021
Phase: N/A
Study type: Interventional

The aim of this study is comparing the effects of non-pharmacological intervention (transcranial Direct Current Stimulation, tDCS) with those of drug (methylphenidate, MPH) administration in children and adolescents with ADHD. The investigators hypothesized that tDCS would improve inhibitory control and visuo-spatial working memory as well as MPH.

NCT ID: NCT04964401 Completed - Chronic Pain Clinical Trials

US-Guided ESPB Versus TPVB on Acute and Chronic Pain After VATS

Start date: April 13, 2021
Phase: N/A
Study type: Interventional

Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB) and erector spinae plane block (ESPB), which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and randomized controlled prospective studies with ESPB are increasing. In this study, it is planned to compare the effects of US-guided TPVB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.

NCT ID: NCT04964089 Completed - Clinical trials for Wet Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

DAYLIGHT
Start date: June 23, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

NCT ID: NCT04964076 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Clinical Phenotypes of COPD Patients Between in Plateau and Plain

Start date: November 1, 2020
Phase:
Study type: Observational [Patient Registry]

We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

NCT ID: NCT04962217 Completed - Suicidal Ideation Clinical Trials

Experiences of Brief Admission From the Perspective of Family and Significant Others

Start date: June 1, 2021
Phase:
Study type: Observational

As a result of a randomized controlled trial (NCT02985047) BA is continuously offered to persons with self-harm at risk for suicide in Skåne, Sweden. This qualitative inductive study aims to provide experiences among family members, carers and significant others of Brief Admission by self-referral for self-harming and suicidal persons based on individual semi-structured interviews. Participants will be identified through suggestion from persons with an active BA contract. Interviews, estimated to last 30-60 minutes, will be analyzed by a phenomenological hermeneutic method or by content analysis depending on richness and depth in the interviews. Findings from this study will be published.

NCT ID: NCT04961268 Completed - Clinical trials for Symptomatic Irreversible Pulpitis

Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Aim: The purpose of this prospective, randomized, double-blind, controlled study was to compare the preoperative oral tramadol medication with ibuprofen and acetaminophen on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methodology: The study included five study groups, each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar. The patients received identically appearing capsules containing either tramadol 50 mg, tramadol 100 mg, ibuprofen 600 mg, ibuprofen 600 mg/acetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB. Endodontic access was begun 15 min after completion of the IANB, and all patients used for data analysis had profound lip numbness. The IANB success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation. The data were analysed using chi-square χ2 and Kruskal-Wallis tests.

NCT ID: NCT04960878 Completed - Gut Microbiota Clinical Trials

The Effect of Synbiotics on the Upper Respiratory Tract Infection

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

Gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against respiratory infections. However, clinical trials of synbiotics, one of the microbiota-targeted intervention, in this regard is few. Therefore, this study aims to examine the effect of synbiotics on the incidence and severity of upper respiratory tract infection, gut microbiota composition and function, as well as biomarkers of immune function.