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NCT ID: NCT05587062 Completed - Clinical trials for Age-Related Macular Degeneration

Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Aflibercept (produced by CinnaGen Co, Iran) compared with Eylea® (Regeneron, USA) in subjects with Neovascular Age-related Macular Degeneration (nAMD). All the participants will receive one of the following regimens: Aflibercept (CinnaGen Co, Iran) or Eylea® (Regeneron, USA), 2 mg (vial 0.05 ml) by intravitreal injection every 4 weeks for the first 3 injections, followed by 2 mg every 8 weeks until week 48 of study. The primary objective of this study is to verify the non-inferiority of Aflibercept (CinnaGen Co, Iran) versus Eylea® (Regeneron, USA) in achieving maintaining vision (losing<15 letter on ETDRS chart) at week 52 in comparison to week 0 in participants with Neovascular AMD.

NCT ID: NCT05586828 Completed - Malnutrition Clinical Trials

A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.

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

HF is an advanced or terminal stage of various heart diseases, with high rehospitalization and mortality rates. In HF patients, undernutrition is not uncommon and represents one of the most significant determinants of poor clinical outcomes. Therefore, nutritional management is of paramount importance for patients with HF.The basic method of nutritional management is to effectively identify the nutritional status of patients with heart failure, especially in elderly patients with heart failure who are not easy to find in the early stage. Limited data are available regarding the association between CONUT score and prognosis in elder patients with HFpEF, despite its easy availability in routine blood chemistry. Therefore, we aimed to evaluate the prognostic significance of CONUT score and to compare it with other well-established nutritional indices in HFpEF, a common HF phenotype in the elderly population with coronary artery disease. This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of our hospital (TRECKY2021-185). Written informed consent was obtained from all patients. Participants were accorded with diagnostic criteria of CAD and HFpEF excluding rheumatic heart disease, congenital heart disease, acute myocardial infarction, hemodialysis or hemofiltration, tumour activity, urgent surgery, death during hospitalization, HF of unknown reasons, New York Heart Association(NYHA) class1and data deficiency. Demographic characteristics and medical parameters were collected from the electronic medical record system . All enrolled patients were followed-up in an outpatients setting. The primary endpoint of this study was readmission due to heart failure and all-cause mortality in the first year after hospitalization. To explore the prognostic significance of controlling nutritional status score in elderly with ejection fraction preserved heart failure and compare controlling nutritional status score with other objective nutritional indices.All analyses were performed using Statistical Product Service Solutions(SPSS) version 19.0 .

NCT ID: NCT05585138 Completed - Clinical trials for Complications Due to Coronary Artery Bypass Graft

Effects of Segmental Breathing Exercise in Patients Awaiting Coronary Artery Bypass Graft Surgery (CABG)

Start date: May 2, 2022
Phase: N/A
Study type: Interventional

To determine the effects of preoperative segmental breathing exercise on postoperative pulmonary complications in patients awaiting coronary artery bypass graft surgery (CABG). This study will be a randomized controlled trial. This study will be conducted in cardiac surgery department at Faisalabad institute of cardiology. sample size will be 44including both male and female. Non- probability purposive sampling technique will be used. Modified healthy heart questionnaire will be used as a screening tool. Baseline, postoperatively before discharge at week 5 assessment will be done by 6-minute walk test. Subjects in group A (interventional group) will be treated using segmental breathing exercises combined with Conventional Treatment (deep breathing exercise ) and the group B (control group) will be treated with only conventional treatment. Group-A (interventional group) will receive segmental breathing exercises for one month 5 days a week and 2 sessions per day for 15 minutes for each patient. conventional treatment will be for one month 5 days a week 10 to 15 repetitions of deep breathing exercise 2times a day. Dyspnea will be checked baselineand at week5 by modified Borg scale.Sputum cup was used for expectoration of sputum . Quality of life will be checked baseline and at week 5by SF-12 Questionnaire. Outcome variables will be 6MWT, dyspnea, quality of life, oxygen saturation, heart rate, blood pressure and expectoration of sputum. Data will be analyzed on SPSS-25.

NCT ID: NCT05583032 Completed - Clinical trials for Ultrasound Imaging of Anatomical Structures

An Evaluation of the Long-Term Impact of Assistive AI on Anaesthetists' Ultrasound Scanning for UGRA

Start date: November 24, 2022
Phase:
Study type: Observational

A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.

NCT ID: NCT05581940 Completed - Pain, Postoperative Clinical Trials

Pediatric Caudal Anesthesia Block. And Pain Control

CEB
Start date: January 5, 2020
Phase:
Study type: Observational [Patient Registry]

Caudal epidural block CEB is the most commonly performed neuraxial block to provide effective pain relief and analgesia in patients undergoing infra-umbilical pediatric surgery. This study aimed to compare the effectiveness of adding CEB to general anesthesia in terms of intra- and post-operative pain management. Design: Double-unblinded. Prospective. randomized. Study, Setting: salmanyia medical complex. intraoperative, postoperative recovery room Methods: A total of 72 patients American Society of Anesthesiology physical status classification ASA 1. Patients were equally allocated into two groups Group A and with CEB and Group B without CEB, aged two months to six years. respectively, over a study period of six months. Both groups were compared based on hemodynamic stability, level of sedation, analgesia need, pain score, and parental satisfaction. Postoperative pain was evaluated by four different pain scales.

NCT ID: NCT05581043 Completed - Ketosis Clinical Trials

Pre-meals of 3-hydroxybutyrate in Type 2 Diabetes

PreKetone
Start date: January 12, 2023
Phase: N/A
Study type: Interventional

Hyperglycemia following meals in patients with type 2 diabetes mellitus (T2DM) is a common problem. Recently, our group found that oral consumption of the ketone metabolite, 3-hydroxybutyrate (3-OHB), effectively stimulates insulin secretion and delays gastric emptying.The aim of this study is to investigate the dose/response relationship between 3-OHB servings of 0, 10, 20 and 40 grams 30 minutes before an OGTT and, ii) investigate the role of timing by serving 20 grams of 3-OHB at different timepoints ahead of an OGTT (0, 30 and 60 minutes)

NCT ID: NCT05580640 Completed - Knee Arthroplasty Clinical Trials

Investigating the Efficacy of Osteopathic Manipulative Treatment on Gait Dysfunction Following Knee Surgery

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

For patients with a history of knee surgery, especially knee arthroplasty, the persistence of abnormal gait kinematics is a frequently encountered issue that can hinder their ability to return to normal daily living. Muscular imbalances and leg length discrepancy (LLD) following knee arthroplasty can impact a patient's ability to return to a normal gait pattern. In a study of 98 patients who underwent total knee arthroplasty, leg lengthening on the side of the operative knee was reported in 83% of patients as determined by comparing pre- and postoperative leg-length radiographs (Lang JE et al; J. Arthroplasty. 2012;27(3):341-346). LLD can lead to compensations in surrounding joints, muscles, and myofascial structures. Compensatory musculoskeletal changes, including changes in pelvic tilt and curvature of the lumbar spine can alter gait mechanics, lead to mechanical low back pain, and increase the risk of degenerative disc disease (Sheha EDM et al; J. Bone and Joint Surgery, Inc. 2018;6(8)(e6)). In addition, neurologic compensations can occur and include changes in muscular timing and muscular activation patterns. The mainstay of gait rehabilitation following knee surgery is physical therapy (PT) (O'Connor DP et al; J Orthop Sports Phys Ther. 2001;31(7):340-352), where LLD can be addressed with heel lift therapy. The use of Osteopathic Manipulative Treatment (OMT) to address chronic compensatory musculoskeletal changes following knee surgery in order to improve gait has not been extensively studied. Both OMT and PT have been shown to improve gait imbalances in a variety of neurological conditions such as Parkinson's disease, multiple sclerosis, and Prader-Willi syndrome. Previous studies of these neurologic conditions have demonstrated increases in walking velocity, step length, stride length and range of motion of the lower extremities following OMT. It remains to be determined whether OMT can improve gait pattern abnormalities caused by compensatory musculoskeletal patterns that persistent after traditional postoperative knee rehabilitation. The purpose of this study is to determine if OMT of chronic, compensatory, musculoskeletal issues associated with knee surgery improves gait parameters. In addition to providing objective parameters to assess and validate OMT, future patients recovering from knee surgery might benefit from OMT

NCT ID: NCT05579964 Completed - Clinical trials for Cardiopulmonary Bypass

The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot

Start date: October 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Congenital heart disease (CHD) is the most common congenital abnormality found in newborns with Tetralogy of Fallot (TOF) being the most common cyanotic CHD. Total correction of TOF was performed using a cardiopulmonary bypass (CPB) machine. However, the use of CPB has a negative effect that causes inflammation and myocardial injury. Myocardial protection in patients undergoing total correction of TOF surgery is more difficult than other cyanotic CHD due to a hypertrophic right ventricular condition. Dexmedetomidine (DEX) is a selective α-2 adrenergic, which has major effects including hypnosis, sedation, and analgesia as well as cardiovascular effects. The sedation is induced by stimulating the α-2 adrenergic receptor in the locus coeruleus (LC) in the pons cerebri. DEX also increases the level of GABA and Galanin and reduces endogenous norepinephrine. The lower level of endogenous norepinephrine decreases the afterload of the ventricles, increases cardiac output, and reduces myocardial injury as a result. Furthermore, the peripheral effects of DEX can reduce myocardial ischemia-reperfusion (MIR) by inhibiting NF-кB pathway activation and reducing the number of pro-inflammatory cytokines released. Thus, the administration of DEX can prevent myocardial necrosis and apoptosis, also reducing reperfusion injury when using CPB machines. Research related to the effectiveness of administering DEX as a myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery in Indonesia is less reported. The aim of this study is to determine the effectiveness of DEX as myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery.

NCT ID: NCT05579158 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.

NCT ID: NCT05578404 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease

Start date: October 20, 2022
Phase: Phase 2
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder with high prevalence in patients suffering from chronic liver diseases [1]. NAFLD is characterized by the accumulation of > 5% of fat deposits in hepatocytes (hepatic steatosis) with no known other reasons for steatosis as excessive alcohol intake.The global prevalence of NAFLD differs depending on the population reaching 13% in Africa, 32% in the Middle East, and 30 % in the United States