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NCT01339273
Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold standard for open colo-rectal procedures it can be associated with significant complications and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an increased incidence of nausea, vomiting and sedation and reduced bowel motility which can also prolong recovery. Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, earlier return of bowel function and earlier hospital discharge. The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in our hospital and a retrospective audit demonstrated better analgesia and lower consumption of morphine in the TAP block group.The differences were not statistically significant as the number patients in the audit were not large enough.The investigators are hoping that this study will demonstrate that the difference is real by recruiting the necessary number of patients into each group (36 per group)
NCT04251104
Background: The ability to retrieve specific memories is a cognitive and emotional protective factor. Among the most effective techniques to generate autobiographical memories is the use of audio-visual stimuli, particularly images. Developing and improving techniques that facilitate the generation of such memories could be highly effective in the prevention of depressive symptoms, especially in the elderly population. The aim of the present study is to examine how the level of personal relevance of pictures as autobiographical memory cues to induce positive emotions may affect an individual's emotion regulation. Methods: The participants, 120 older adults aged 65 and over and 120 young adults aged between 18 and 35, of both sexes and without depressive symptoms, will be induced to a negative mood state by means of viewing a film clip. Following the negative mood induction, the participants will be shown positive images according to experimental group to which they were randomly assigned (high personal relevance: personal autobiographical photographs; medium personal relevance: pictures of favourite locations associated with specific positive autobiographical memories; and low personal relevance: positive images from the International Affective Picture System). The investigators will analyse the differences in subjective (responses to questionnaires) and objectives measures (EEG signal, heart rate variability and electrodermal activity) between the groups before and after the induction of negative affect and following the recall of positive memories. Discussion: The use of images associated with specific positive autobiographical memories may be an effective input for inducing positive mood states, which has potentially important implications for their use as a cognitive behavioural technique to treat emotional disorders, such as depression, which are highly prevalent among older adults.
NCT03103022
Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of the heart that usually closes after birth but remains open in some premature infants born before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause problems such as bleeding in the lung and brain, lung injury due to prolonged need of ventilator, and poor kidney function. It sometimes becomes necessary to close this blood vessel in the preterm infant. Currently, this blood vessel can be closed either by medication or surgery. Pain medications such as Ibuprofen and Indomethacin are routinely used medications to close PDA. However, in the last 5 year, acetaminophen has been found as an alternative medication to close PDA in preterm infants. In multiple studies, acetaminophen is found to be a safe alternative medication with lower side effects than current standard management. Intravenous Ibuprofen is approved by FDA to treat PDA in preterm infants. Although not approved by FDA, oral ibuprofen is being used for the management of PDA. However, the success rate of a single medication is approximately 70%. Both medications have been used in the previous clinical studies to treat the same condition in the preterm infants and fewer side effects were reported. Mechanism of both medications to close PDA is different and may work more effectively together than single medication alone. In this study, the investigator are going to use these two medications (Ibuprofen and Acetaminophen) at the same time if the child needs treatment and is eligible to participate in this study. This study is based on the assumption that by using both medications at the same time, investigator can close this blood vessel more effectively than with either drug alone.
NCT01816841
This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.
NCT00089011
This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or without fludarabine phosphate followed by donor peripheral blood stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
NCT03863717
The aim of the study is to investigate the efficacy of upper limb exercise training in Chronic Obstructive Pulmonary Disease (COPD) patients. For the purpose of the study, a controlled trial will be conducted within Respiratory Clinic of Nicosia General Hospital. The sample will be divided in two groups. The intervention group will participate in a pulmonary rehabilitation program which includes upper and lower extremities exercises, with addition of arm ergometer. The second group (control group) will participate in the same program but without arm ergometer training. The study's hypothesis is that the intervention group will improve the outcome measures significantly better than the control group.
NCT00712361
1. Aim: SoftTouch is a non-invasive device intending for use in the temporarily quantitative measurement of peripheral blood biomarkers. The aim of the clinical trial is to study the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive and non-invasive devices. 2. Hypothesis: Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the SoftTouch finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.
NCT01988987
Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to 30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is essential because serious health problems can result. Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks after delivery for women diagnosed with GDM in order to identify those with continued DM or impaired glucose metabolism. However, approximately half of these women do not get glucose testing after delivery. The ability to test women while they are still hospitalized after having a baby could greatly increase diagnosis, care and treatment of women with abnormal glucose metabolism. Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks after delivery.
NCT02796638
The primary hypothesis of this study is: the use of minute ventilation-adaptive servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal function and prevent kidney injury in patients admitted with acute heart failure (AHF) compared to those receiving usual care. We will validate and extend our pilot study by taking a deeper dive into the effects of ASV on diuretic dose, urine output and new and exciting biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly suggests that ASV lessens injury to the kidney and could lead to a new paradigm for the treatment of AHF. When use of high dose of diuretics are anticipated or in whom chronic kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the Emergency Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective glomerular filtration. Since kidney injury is a major factor in those patients with early 30-day readmission following discharge, this therapy could become quite popular.
NCT03759483
Glaucoma is currently the leading cause of irreversible blindness in the world. The multi-center study is designed to evaluate the efficacy of the convolutional neural network based algorithm in differentiation of glaucomatous from non-glaucomatous visual field, and to assess its utility in the real world.
NCT03550105
Physical Inactivity and excessive sedentary behavior are risk factors for diabetes and cardiovascular disease. Movement is important for overall health. This study will assess the validity and usefulness of low risk, non-invasive wellness device, the Gentle Jogger® (GJ) that passively simulates the physical activities of jogging. The study will evaluate whether or not use of GJ modifies glycemic control and muscle strength in subjects who are known to be diabetic and those who are not. The study volunteers are subjects between the ages of 25-80yr.
NCT02280629
The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
NCT04237896
Rationale. Currently there are well-established guidelines for the management of stable COPD. However, recommendations on the treatment of COPD exacerbations (E-COPD) are based on observational studies and low-quality clinical trials. In addition, there are some controversial aspects, such as treatment with systemic steroids. On the other hand, the available information on the adherence to the recommendations of the clinical practice guidelines (CPG) and its impact on the outcome of patients is scarce. Main objectives. (1) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the current management of hospitalized exacerbations of COPD; (2) To determine in real-life clinical practice the impact of adherence to CPG recommendations for management of COPD exacerbations as an outcome of the disease (stay, in-hospital mortality, and 90-days post-discharge readmissions and mortality); (3) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the treatment of stable COPD at admission and after discharge in patients hospitalized with exacerbated COPD; (4) To determinate in real-life clinical practice the impact of the suitability to CPG recommendations for treatment of stable COPD on 90-day post-discharge mortality and readmission of COPD. Method. National, multicenter, observational and longitudinal study of the first consecutive 20 patients hospitalized for exacerbations of COPD between December 10 and 23, 2019 in the Internal Medicine Services of the participating Centers. Patients will be followed 90 days after discharge. A total of 400 patients will be recruited in 20 Spanish hospitals (20 per center). Independent variables: age, sex, admission service, body mass index, dyspnea (mMRC), obstruction (FEV¬₁), exacerbations in the previous year, comorbidities, bronchodilator treatment prior to admission, criteria of adequacy to the CPG in the clinical evaluation and treatment, hyperglycemia during the first 24 hours of admission, treatment of hyperglycemia and bronchodilator treatment at discharge. Outcomes: in-hospital mortality, mortality at 90 days, re-admission at 90 days. Statistical analysis: Parametric and non-parametric tests, Kaplan-Meier and ROC curves and multiple logistic regression.
NCT02516072
With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is rising. With approximately one quarter of all PAD patients ultimately progressing to Critical Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to accurately assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A \& B) can be treated with angioplasty+/- stenting and accurate assessment relies on the imaging gold standard of angiography. Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal impairment placing them at increased risk of developing contrast induced nephropathy (CIN) when exposed to iodinated contrast media. High risk individuals with decreased eGFR \<60ml/min have a risk of between 20-30% of developing CIN. They have increased morbidity and mortality risks with a greater need for dialysis and prolonged in patient hospital stays. Ideally, the investigators should be searching for ways to decrease the incidence of CIN. Animal studies and more recently pilot human trials have shown that subjecting a remote vascular bed to a brief ischaemic stress, followed by a period of reperfusion; in what has been termed remote ischemic preconditioning (RIPC), may confer a protective benefit against the development of CIN. This study aims to determine if RIPC can protect against CIN in patients undergoing elective peripheral angiography for infrainguinal disease.
NCT04242758
In this open clinical trial, 30 subjects with inadequately controlled T2D and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor vs other oral-antidiabetic drugs (OADs) therapy for 3 months. Measures will be performed at baseline, after 2 days, after one month and at the end of the study protocol, as per good clinical practice
NCT03551756
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
NCT02037698
The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Recently, the success rate of the recanalization of CTOs has been raised in several studies. Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from CTO intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. We suggest that success rates and clinical outcome of intervention of CTO lesion can be improved by pre-procedural CCTA.
NCT01431794
This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib). The objective is to assess tolerability and the resection rate of patients with borderline resectable pancreatic adenocarcinoma who use this treatment.
NCT04046640
Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes.Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study is designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermal imaging. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.
NCT04222218
Objective of the study: To test the efficacy of theta burst cerebellar stimulation on postural instability in progressive supranuclear palsy using a cross-over design and wearing sensors technology Design: Twenty probable PSP patients with no dementia and still able to walk will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days. Each patient will be evaluated before and after stimulation by berg balance tests (BBS), Tinetti scale, PSP-rating scale (PSP-RS), and a battery of gait and movement tests. Static balance was assessed by 30-seconds-trials in semitandem and tandem positions with eyes open and closed using wearing sensors technology.