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NCT ID: NCT02752737 Active, not recruiting - Atrial Fibrillation Clinical Trials

Cryo Global Registry

Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry

NCT ID: NCT02752347 Recruiting - Malocclusion Clinical Trials

An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients

Start date: April 2016
Phase: N/A
Study type: Interventional

Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of the same preadolescent unilateral crossbite patient before the expansion and after one month of the completion treatment period using surface electromyography device.

NCT ID: NCT02746471 Completed - Clinical trials for Arrhythmias, Cardiac

Reveal LINQ Registry

Start date: April 2014
Phase:
Study type: Observational

The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.

NCT ID: NCT02746432 Not yet recruiting - Colon Cancer Clinical Trials

Insulin Therapy Reduce Post-Operative Inflammatory Response After Curative Colorectal Cancer Resection: Randomization Controlled Trial

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

Research Problem: Surgical stress induces inflammation and postoperative immuno-suppression, which are risk. factors for both post-operative complication and possible disease recurrence. Colorectal cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males. Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of death in these patients. Despite the new era of laparoscopic surgery, still surgical stress is present and equally traumatic to the conventional open colorectal resection, earlier studies showed no major differences in post-operative inflammatory and immunological reactions. The previous studies revealed the anti-inflammatory effects of the hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative inflammation. The hypothesis is "Can intraoperative hyper-insulinimic euglycemic infusion reduce post operative inflammation and immunomodulation in colon cancer patients undergoing a curative surgery?" Research methodology Triple blinded randomized controlled study with estimated sample size of 144 patients of non-metastatic colorectal cancer patients operated at King Saud University Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients Consented will undergo computer randomization to receive intraoperative hyper-insulinimic normoglycemic infusion (experimental) or standardized insulin sliding scale and saline (control). A common preoperative and postoperative pathway with standardized management and pain control in both groups. Outcomes will be measured via a battery of laboratory test consist of routine labs, inflammatory markers and immunological markers to be repeated at fixed timed intervals. All patients will be followed by regularly for 5 years. Research objectives Primary outcomes to examine: - The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery. - The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion Secondary outcomes: - Thirty days post-operative morbidity. - Overall survival rate. - Disease-free survival rate.

NCT ID: NCT02746159 Completed - Clinical trials for Arteriovenous Fistula

Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae

AVR
Start date: June 7, 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

NCT ID: NCT02736097 Completed - Critical Illness Clinical Trials

Drug Resistance Factors In Healthcare-associated Pneumonia

DEFINE
Start date: November 2016
Phase: N/A
Study type: Observational

Recently clinical guidelines categorize pneumonia in to three types: community, healthcare-associated, and hospital-acquired. Much of the existing research to describe the epidemiology of pneumonia in critically ill patients comes from single-center studies or from retrospective database analyses, which limit generalizability and lead to over-prescription of broad-spectrum antibacterial agents. This will be a prospective, multicenter epidemiological study to characterize pneumonia epidemiology in critically ill adult patients.

NCT ID: NCT02735707 Recruiting - Clinical trials for Community-acquired Pneumonia, Influenza, COVID-19

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

REMAP-CAP
Start date: April 11, 2016
Phase: Phase 3
Study type: Interventional

REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.

NCT ID: NCT02735200 Recruiting - Clinical trials for Vitamin D Deficiency

Topical Delivery of Vitamin D3 as Vitamin D Supplementation

Start date: April 2016
Phase: Phase 1/Phase 2
Study type: Interventional

After obtaining the approval from the IRB of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.

NCT ID: NCT02733809 Recruiting - Clinical trials for Hepatocellular Carcinoma

Mechanism of Sorafenib Resistance in Patients With Advanced Hepatocellular Carcinoma

Start date: January 2014
Phase: Phase 4
Study type: Interventional

It has been shown previously that gene expression profiling signature (a set of dysregulated genes) can be used for molecular classification, diagnosis, and prognosis of several types of cancers. In This study the hypothesise that resistant tumor may be due to genetic mutations and/or other alternative pathways that could be the reason to overcome the Sorafenib and still proliferate. Primary objectives To evaluate the primary and secondary potential mechanisms by which HCC patients on Sorafenib treatment would be resistant to therapy and also identify the favorable genetic makeup of patients responding to treatment. Measures of primary outcome: - cDNA microarray analysis on the MAP kinase pathway. - mRNA quantification of genetic expression (RT-PCR) for identification of upregulated genes, and confirmed by corresponding proteomic testing (by Mass Spectroscopy) in the serum for potential serum markers. Secondary Objectives Progression free survival: Time to disease progression in patients in Saudi Arabia with HCC receiving Sorafenib: [defined as time, in weeks, from the baseline visit to progression of the disease or death from any cause] will be diagnosed using the RECIST criteria based on a trimestrial abdominal CT evaluation. - Survival rates and Predictors of survival: - Survival defined as the time from baseline visit to death from any cause [in weeks]. - Variables identified in multivariate regression analysis from overall treated patients independently associated with survival till study completion or death. Justification and Value to the Kingdom Sorafenib in the treatment of advanced HCC is a recent development. Since the only current effective treatment for advanced HCC is resection or transplantation and the list for these procedures are ever-growing due to the confounding effect of the lack of infrastructure in the Kingdom, selecting treatment for patients who are more likely to respond to Sorafenib treatment The Long-Term Comprehensive National Plan for Science, Technology and Innovation will help to reduce costs of managing HCC. Among Saudi Arabia population, there are a unique set of patients here (e.g. non-alcohol related HCC, genotype 4 HCV patients and genotype D HBV patients, high percentage of obese patients i.e. NASH) which is different from other parts of the world. There is increasing incidence of HCC in Saudi Arabia. Due to available expertise in management of HCC patients in the participating institutions in the study, this project will represent a bridge for the transfer of technology so that our research staff and doctors will have more expertise in carrying out these techniques independently. This study will also run in parallel to the on-going initiative to start a HCC biobanking establishment which will provide the samples needed to carry out our genetic studies in future. Finally, since the use of Sorafenib (at present, the only approved treatment for advanced HCC) in the treatment of advanced HCC is a new field, the findings of our study will have important implications in the management of HCC, both locally and internationally. HCC is the third most common cancer in Saudi Arabia. In 2001, HCC was the second most common cancer affecting Saudi males and the eighth most common cancer affecting females. Most of patients (90%) present at a more advanced stage when symptoms prevail. Given the high prevalence of HCC in the Kingdom, it is pertinent to study why some patients are resistant to Sorafenib compared to others. Elucidation of the differences in mechanisms among responders and non-responders to Sorafenib therapy will enable physicians to make better decisions in terms of treating Saudi HCC patients.

NCT ID: NCT02729506 Recruiting - Clinical trials for Hepatocellular Carcinoma

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new patients a year. The intermediate stage of HCC is controlled by radiological interventions such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y radioembolization is increasingly being used in clinical practice, there is no high quality clinical evidence to justify this. To date, no prospective studies have been performed comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients in each arm from. Investigators will compare between the two groups the time to progression (TTP) as the primary outcome and also examine time to local progression (TLP) as well as other factors like overall survival, response to therapy, toxicities and adverse events, quality of life and treatment-related costs.