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NCT ID: NCT03792347 Completed - Clinical trials for Esophageal Squamous Cell Carcinoma

Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus

PALACE-1
Start date: January 21, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer treatment.

NCT ID: NCT03792165 Completed - Knee Osteoarthritis Clinical Trials

Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis

Start date: February 11, 2019
Phase: N/A
Study type: Interventional

The investigators aim to explore the effects of action observation therapy on pain and brain hemodynamics in patients with knee osteoarthritis. This study will create a new perspective to understand the physiology of pain, by applying painful stimulation during the neuroimaging system which has attracted much interest in the literature in recent years, and will shed light on the studies that can be done in this regard. Participants' pain level will be assessed using Visual Analog Scale and pressure algometer. Also joint range of motion in the initial assessments will be measured by electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate evaluation positions. Fear of movement of individuals will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and Go Test. Functional near infrared spectroscopy (fNIRS) will be used for evaluation of brain hemodynamics. The first group, will receive exercises with action observation therapy; and the second group will receive only exercises. The exercise programme will be administered under physiotherapist supervision for three days a week for six weeks. The evaluations will be repeated at the beginning of the study and at the end of the sixth week. Data obtained from the study will be analyzed using appropriate statistical methods.

NCT ID: NCT03791879 Completed - Clinical trials for 164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block

Caudal Dexmedetomidine Analgesia in Pediatrics .

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine >1 µg/kg could not add more analgesic & stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.

NCT ID: NCT03791593 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

EVOlocumab in Stable Heart Failure With Reduced Ejection Fraction of Ischemic Etiology: EVO-HF Pilot

EVO-HF
Start date: December 3, 2018
Phase: Phase 2
Study type: Interventional

Evolocumab has been able to reduce the incidence of cardiovascular events in patients that had at least one cardiovascular risk factor [28]. In patients with chronic HFrEF, as we mentioned before, treatment with statins is not recommended as it has not shown benefits in improving its prognosis. However, CAD control stands as an approach that could improve the course of the disease by preventing microlesions that further weaken the heart. A recent multicenter study, the BIOSTAT-CHF [3436], was performed to determine whether the PCSK9-LDLR axis could predict risk in patients with HF. A multivariate analysis, which included BIOSTAT risk scores, LDLR, and statin treatment as covariates, revealed a positive linear association between PCSK9 levels and the risk of mortality and the composite endpoint (death or HF-related hospitalization). A similar analysis for LDLR revealed a negative association with mortality and the composite endpoint. Future studies must assess whether PCSK9 inhibition will result in better outcomes in HF. There is an unmet clinical need: blockade of the neurohormonal activation has provided advances in patients with HFrEF, yet mortality and morbidity remain unacceptably high. Approaching a strict control of lipid levels and CAD with evolocumab in stable HFrEF of ischemic ethology may represent a complementary pathophysiological pathway to reduce mortality and morbidity. The burden of CAD provides a solid rationale for testing the value of evolocumab in HF patients. Therefore, a pilot trial is proposed to evaluate the beneficial effect of evolocumab by surrogate biological markers before considering an event analysis study. Evolocumab reduces the risk of cardiovascular events in patients with established atherosclerotic disease, so this drug could play a role in HFrEF of ischemic etiology, by limiting macro- and micro-vascular coronary disease progression. In HFrEF patients due to ischemic etiology, there is a continuous troponin release due to persistent myocyte injury, which has been associated with adverse outcomes. Our hypothesis is that evolocumab may have the potential to reduce circulating hs-TnT levels, as a surrogate of myocyte injury due to atheroma progression in HFrEF. A positive result in this EVO-HF Pilot study may lead to the set-up of a large-scale multicenter prospective and randomized events study analyzing the role of lipid-lowering treatment by means of evolocumab in HFrEF of ischemic etiology

NCT ID: NCT03791437 Completed - Lung Diseases Clinical Trials

Optimization of Chest Tube Drainage Management

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Early recovery after surgery was new developing science in recent years. However , there was few reports in thoracic surgery field . Investigators try to using digital chest drainage management system into the field of postoperative care and to see whether it could help patients to recovery from surgery as soon as possible. According to investigators's clinical data collecting , investigators will establish a new postoperative care guideline for those patients who receive thoracic surgery

NCT ID: NCT03791242 Completed - Clinical trials for Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery

Ketogenic Diet and CPAP Previous Bariatric Surgery

Start date: March 21, 2019
Phase: N/A
Study type: Interventional

Obstructive Sleep Apnea Syndrome (OSAS) and obesity tend to coexist and are often associated with arterial hypertension, dyslipidaemia, and insulin resistance [1]. Polysomnography (PSG) is the standard technique for diagnosing OSAS and determining its severity [2]. The results of the examination provide the Apnea-Hypopnea Index [AHI], or the Respiratory Disturbance Index [RDI]), which will be used to quantify apnea and classify its severity based on an international score. In general, an AHI scoring less than 5 is considered "normal" (5-15 mild sleep apnea; >15 moderate sleep apnea; ≥30 severe sleep apnea). In order to improve those parameters in obese patients who have been diagnosed with OSAS and are candidates for BS (BS), national and international guidelines recommend preoperative CPAP (Continuous Positive Airway Pressure) treatment in order to reduce anaesthesia risks [3-6]. Furthermore, several studies report that obese OSAS patients benefit from preoperative weight loss [1,7] (in terms of AHI index, night snoring and arterial hypertension). Obese patients who are candidates for BS often go on a preoperative diet in order to decrease weight and liver volume (especially of the left lobe) and correct any vitamin/mineral deficiency. The results of a recently published study show that 4 weeks of Ketogenic Micronutrient Enriched Diet (KMED) significantly reduce body weight, liver lobe volume and vitamin/mineral deficiencies in obese patients who prepare to undergo BS [8], with resulting foreseeable reduction of intraoperative complications and surgical time. To date, there are no prospective multicenter randomized trials demonstrating whether a preoperative ketogenic diet associated with CPAP use improves OSAS versus treatment with CPAP alone, with the possibility of reducing the preoperative treatment period. Aim of the study: To assess the clinical advantage in combining two preoperative strategies (CPAP + KMED) compared to preoperative treatment with CPAP alone, for the reduction of surgical risks in morbidly obese patients with severe OSAS who are scheduled for BS.

NCT ID: NCT03791203 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effectiveness and Adherence of Modified Alternate-day Calorie Restriction (MACR) in Non-Alcoholic Fatty Liver Disease

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

There is no effective therapy for non-alcoholic fatty liver disease (NAFLD), although intensive calorie restriction is typically recommended but dietary adherence is an issue. Currently, there are no studies had been focusing the effect of Modified Alternate Day Calorie Restriction in NAFLD patient focusing on changes in liver steatosis and fibrosis.

NCT ID: NCT03790267 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty

PaRIS-IOR
Start date: January 1, 2019
Phase:
Study type: Observational

PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).

NCT ID: NCT03790254 Completed - Clinical trials for Antibiotic Prophylaxis

D Mannose for Prevention and Treatment of RUTIs

mannoseRUTIs
Start date: January 1, 2010
Phase:
Study type: Observational

The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.

NCT ID: NCT03790150 Completed - Clinical trials for Mechanical Ventilation Complication

National Approach to Standardize and Improve Mechanical Ventilation

NASAM
Start date: January 1, 2019
Phase:
Study type: Observational

This is a pre-post implementation cohort study. This is a data driven quality improvement project which aims to improve the care of mechanically ventilated patients through the implementation of a bundle of evidence based practices, with a goal of reducing ventilator associated events and mortality.