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NCT ID: NCT03755479 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 1

Evaluation of Minimed 670G in T1D Patients on Multiple Daily Injection

Start date: December 1, 2018
Phase:
Study type: Observational

Introduction. Sensor Augmented Pump has demonstrated superiority over insulin pump and Multiple Daily Injection (MDI) in achieving optimal glucose control and can improve quality of life in Type 1 Diabetes (T1D) patients. Hybrid closed loop (HCL) insulin pump Minimed 670G is a FDA approved device and European Conformity (CE) mark with SmartGuard technology and closed loop algorithm, which will allow the patients to improve their diabetes management. Hybrid closed loop insulin pump Minimed 670G monitors glucose in the subcutaneous tissues and automatically adjusts the delivery of rapid acting insulin as basal rate based on the user's glucose reading. SmartGuard technology in insulin pump, based on user's sensor glucose values can predict when glucose is approaching low levels, 30 minutes in advance and automatically stop insulin delivery. When user's glucose levels recover, SmartGuard will automatically resume insulin delivery. CareLink is personal software, which downloads the data from insulin pump, glucose sensor and glucometer to visualize diabetes information with charts, statistics and events that help patient and health provider to identify and understand patterns and trends The objective of this study is to assess structured group education on boarding protocol of the HCL Minimed 670 G in achieving glucose control of patients on MDI. Methods. This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 30 subjects (age 6 - 17) will be enrolled in order to reach 26 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from CGM will be performed at baseline and 3 months during the study. The following parameters will be analyzed: % patients achieving Time in Range (TIR) > 67% from 70 mg/dl to 180 mg/dl; % patients achieving TIR <3%, below time in range (<70 mg/dl) and % patients achieving both TIR > 67% and <3% time below Range. Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium, North Kansas City, US) and will be kept as electronic data on a separate research server.

NCT ID: NCT03660696 Not yet recruiting - Atrial Fibrillation Clinical Trials

Qatar Cardiovascular Biorepository of AF Patients

Start date: October 2018
Phase:
Study type: Observational [Patient Registry]

Qatar Cardiovascular Biorepsoitory-AF (QCBio-AF) of plasma and DNA of Qatari patients with atrial fibrillation (AF) is to establish. AF cases will include patients with acute and chronic AF identified in the Heart Hospital (HH) arrhythmia clinics and Emergency Room (ER). Controls will include blood donors who have no history of AF. Such a resource will enable validation of biomarkers to assess AF risk, response to therapy, and prognosis. QCBio-AF will also allow genomic, marker and proteomic studies of AF and response to drug therapy (pharmacogenetics and pharmacoproteomics). This study will accomplish the following specific aims: Aim 1: Establish a DNA and plasma biorepository (QCBio-AF) of 300 Qatari AF cases and Family members to enable investigation of genomic and proteomic biomarkers for early detection and prognostication and to identify new targets for drug development. Aim 2: Annotate the biorepository of with 1) demographic, laboratory, and clinical variables derived from the EMR using electronic phenotyping algorithms, and 2) detailed information regarding history of cardiovascular diseases and risk factors derived from patient surveys. Aim 3: Develop processes to promote use of the biorepository by Qatari investigators by facilitating access to the biorepository for biomarker research, while maintaining the highest ethical standards with emphasis on patient confidentiality and stewardship of the biospecimens. Timeline. Following IRB approval, the intended collection period will be over 12 months where 300 Qatari patients with AF and their immediate families will be recruited. Significance: Although atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, the worldwide burden of AF in non-white populations is unknown. Furthermore, a substantial proportion of AF in the population is not explained by traditional risk factors. There is increasing evidence that susceptibility to AF is not only determined by underlying etiologic risk factors but also ethnicity with AF occurring more frequently in white than in non-white populations. While reasons for this ethnic variability are unknown, studies have shown that both common and rare genetic variants increase susceptibility to AF in an individual in the presence of ethnic-specific risk factors.

NCT ID: NCT03658031 Not yet recruiting - Clinical trials for Myocardial Infarction

Effect of Dapagliflozin on the Progression From Prediabetes to T2DM in Subjects With Myocardial Infarction

Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

It is hypothesize that, because dapagliflozin will reverse the metabolic defects responsible for the development of prediabetes (i.e. insulin resistance and beta cell dysfunction) and progression from prediabetes to T2DM (beta cell dysfunction) and will cause weight loss, it will markedly reduce the progression from prediabetes to T2DM and reverse glucose tolerance to NGT in patients with prediabetes experiencing acute myocardial infarction. Further, it is hypothesized that the hemodynamic actions of dapagliflzoin will exert cardiovascular benefit in subjects with prediabetes and acute MI by reducing cardiac remodeling, preserve LV function and decrease the risk of development of heart failure and hospitalization for heart failure. Hence, aim to examine the impact of SGLT2 inhibitor on T2DM and cardiovascular risk in patients with prediabetes and cardiovascular disease. The primary objective of the study is to examine the effect of dapagliflozin (10 mg) on the progression from prediabetes to T2DM in patients with prediabetes who experience acute myocardial infarction (MI). A secondary objective is to examine the effect of dapagliflozin on a composite of CV outcome including incidence and hospitalization for heart failure in patients with prediabetes with acute MI. Other secondary outcome is the change from baseline to end of study in LD systolic and diastolic function.

NCT ID: NCT03590145 Recruiting - Inguinal Hernia Clinical Trials

Reliability of the Doha Agreement Classification of Groin Pain

Start date: October 25, 2017
Phase:
Study type: Observational

This study will investigate the reproducibility of a clinical diagnostic classification system for groin pain between two different examiners, and will be performed with similar populations in two different countries.

NCT ID: NCT03549754 Recruiting - Type 2 Diabetes Clinical Trials

DISCOVER Global Registry

Start date: February 17, 2018
Phase:
Study type: Observational [Patient Registry]

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes and established micro- and/or macrovascular disease

NCT ID: NCT03548766 Not yet recruiting - Blood Disease Clinical Trials

Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Blood Doping

Transfusion
Start date: December 2018
Phase: Phase 3
Study type: Interventional

A total of 12 subjects will be recruited for participation in this study. 6 subjects will receive re-infusion of autologous blood, and 6 subjects (anemic patients) will receive a homologous transfusion.

NCT ID: NCT03523221 Recruiting - Clinical trials for Mild -Moderate Anaphylaxis - Symptoms That Affect the Skin With Cardiovascular, Respiratory or Gastrointestinal Involvement, But no Signs of Hypotension ,Laryng

Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis

Start date: April 15, 2018
Phase: Phase 1
Study type: Interventional

Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators and it is potentially fatal [1, 2]. Between 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after the initial presentation, called biphasic (late-phase) [14]. The mainstay of treatment for children experiencing anaphylaxis remains adrenaline and H1-antihistamines. Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis but may help reduce or prevent a biphasic "late phase" reaction (24.26). The aim of this study is to compare the efficacy of oral glucocorticoids in prevention of the second phase or biphasic reaction of anaphylaxis, as compared to placebo in children, presenting to the pediatric emergency department (PEC Al-Sadd) with mild to moderate anaphylaxis (Prospective Study). Patients will be randomized to either one of the two treatment: Treatment 1: Dexamethasone 0.6mg/kg oral. Treatment 2 : Placebo All patients will be urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of the study medications orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse. The treating physician will discharge patient when he/she looks well, breathing comfortably, has oxygen saturation >94%, stable blood pressure and no gastrointestinal or neurological manifestation. Discharge patients will be sent home on anti-histamine (cetirizine) for 5days. All patients will be followed up for one week post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.

NCT ID: NCT03518476 Not yet recruiting - Smoking Cessation Clinical Trials

Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial

Start date: September 14, 2018
Phase: N/A
Study type: Interventional

In Qatar, tobacco use is one of the main causes of premature deaths and preventable diseases. As per the 2013 Global Adult Tobacco Survey (GATS), 12.1% of adults and 20.2% of men in Qatar smoke tobacco, and 55.4% of this smoke an average of 16 cigarettes or more per day. Moreover, 15.7% of school students aged 13 to 15 years currently use some form of tobacco according to the 2013 Global Youth Tobacco Survey (GYTS). In Qatar, tobacco-related diseases including cardiovascular diseases and cancers are highly prevalent. In an effort to reduce tobacco use, Qatar has ratified the WHO Framework Convention on Tobacco Control (FCTC) and has implemented many tobacco control initiatives. In spite of these measures, tobacco use is still rising in Qatar. Pharmacists practicing in retail/community pharmacy are often the first port of call for individuals requiring health advice in general. Evidence has proven that they have a pivotal role in health promotion and disease prevention including tobacco cessation. Hence, pharmacists have excellent opportunities to reduce tobacco use in Qatar. Yet, ambulatory and community pharmacists in Qatar are not sufficiently contributing to tobacco control. Based on published data, only 21% of community pharmacists in Qatar always or most of the time ask patients about their smoking status. Furthermore, when asked about their smoking cessation training, 89% of pharmacists did not receive any kind of education or training about smoking cessation counseling in the past. In an effort to build the capacity of pharmacists in Qatar, the aim of the proposed study is to design, implement and evaluate an intensive education program on tobacco treatment for pharmacists in Qatar. The study will be a prospective randomized controlled trial comparing the effectiveness of the education program on pharmacists' tobacco cessation-related knowledge, attitudes, self-efficacy, and skills.

NCT ID: NCT03472339 Recruiting - Pain Management Clinical Trials

Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics

Start date: January 15, 2018
Phase: Phase 4
Study type: Interventional

NSAIDs are commonly used in the management of acute pain; Diclofenac is one from the same class. It is an amino phenyl acetic acid derivative which inhibits prostaglandin biosynthesis to produce analgesic, antipyretic and anti-inflammatory effect. The drug efficacy and safety in acute pain management has been proved by several studies like in renal colic, post and pre-operative pain management, migraines etc. It's also known to have an opioid-sparing effect. Mode of administration is one of the important factors to consider in a busy emergency room. Perception about the route of administration differs among patients. As believed,injectable have rapid onset, easier to titrate, and patients respond better to them as they consider them stronger than oral medication. Number of trials has compared oral and parenteral NSAIDs. Most found no benefit to the parenteral route. Considering the limitations of the previously done studies like small sample size, heterogeneity in the group of patients enrolled, improper blinding and comparing of two different drugs from the same class. Therefore, aim of the study is to conduct a Double blind randomized clinical trial to assess the clinical efficacy and pharmacokinetic parameters of oral diclofenac compared to intramuscular diclofenac in patients with acute limb injury. In this two group double blind randomized clinical trial, the clinical efficacy and pharmacokinetic parameters among the two groups will be assessed. Eligible patients visiting to HGH-ED, age (above 18 years) with acute limb injury, having moderate to severe pain (defined as pain score of >=4 on Numerical rating scale) will be recruited. With the use of computer generated block randomization, subjects will be allocated to one of the two treatment groups in the ratio of 1:1. Each group will receive either (intramuscular diclofenac / oral placebo) or (oral diclofenac / intramuscular placebo). Among the 300 subjects enrolled for the study, further stratified randomization will be done in order to enroll 20 patients for pharmacokinetic study within the subjects.High-performance liquid chromatography, method will be used for the determination of drug concentration in human plasma, for detailed pharmacokinetics. The pain score will be assessed by using the validated pain scale i.e. Numerical rating scale (NRS). The participants, clinicians and investigators will be masked to treatment assigned and the results will be analyzed by the intention to treat analysis among the two group treatment.

NCT ID: NCT03464656 Recruiting - Infertility, Male Clinical Trials

Oxidative Stress In Semen And Male Infertility

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

The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants. After completing the data analysis, we intend to publish the study in high impact perr reviewed journals and present it in international conferences.