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NCT ID: NCT03898076 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 1

Predictive A1c Based on CGM Data Using CGM Data

A1c
Start date: April 1, 2019
Phase:
Study type: Observational

Introduction. The hemoglobin A1C (HbA1c) reflects the average blood glucose level for last two to three months. Recent advancements in the sensor technology facilitate the daily monitoring of the blood glucose using CGM devices. The future prediction of the HbA1C based on the CGM data holds a critical significance in maintaining long term health of diabetes patients. A higher than normal value of the HbA1c greatly increases the likelihood of diabetes related cardiovascular disease. Goal. The aim this study is to predict the HbA1c in advance by utilizing the CGM data through applying machine learning techniques. The outcomes of this research will assist in improving the health of diabetic patients. Methods. This is a retrospective analysis. The investigators will de-identify and analyze 120 patients with T1D who using CGM sensor for last three months. Past 15 days of CGM data will be analyzed and different glucose variability features such as time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA) will be extracted. A machine learning model will calculate (predict) HbA1c in 2-3 months advance based on these 15 days of CGM data. To evaluate the performance of the proposed prediction model, predicted HbA1c will be compared with the real HbA1c.

NCT ID: NCT03878914 Not yet recruiting - Clinical trials for Nephrotic Syndrome in Children

Steroid Sensitive Nephrotic Syndrome in Children

Start date: May 2019
Phase: Phase 4
Study type: Interventional

Idiopathic nephrotic syndrome (INS) is one of the most common glomerular pathologies in children and corticosteroid therapy is its most effective treatment. The total duration of treatment ranges anywhere from two to six months, generally about 3 months. The main objective of our study is to test the feasibility of a shorter total duration (two months) of corticosteroid therapy in patients who show a quicker treatment response to the initial treatment.

NCT ID: NCT03846973 Recruiting - Tranexamic Acid Clinical Trials

Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid

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

TXA is currently administered pre-hospital in Canada, Germany, United Kingdom and Israel . These studies demonstrated that TXA use did not result in any detectable complications or adverse events. It is considered an ideal pre-hospital treatment because: (a) patients with severe hemorrhage die early more often than patients without hemorrhage; (b) it seems that the earlier treatment is administered, the better; (c) it is stable and easily stored; and (d) it is easily administered by paramedics. Herein, the study aimed to evaluate the effect of administration of second dose of Tranexamic acid infusion in the hospital setting in comparison to not receiving the second dose on the outcomes of trauma patients with an evidence of significant hemorrhage. Recently, HGH ambulance service has included pre-hospital administration of TXA in trauma patients with significant hemorrhage. So, all eligible trauma patients will receive pre-hospital TXA (first dose) slowly over 10 minutes by the critical care paramedics as standard of care. Inclusion Criteria: All adult trauma male and female patients (≥18 or <90 years) with evidence of significant hemorrhage (systolic blood pressure <90 mmHg or heart rate >110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds and received first dose of prehospital TXA will be included in the study. Exclusion criteria: 1. Age > 90 or < 18 years of age 2. Inability to obtain intravenous access (intraosseous access not sufficient) 3. Documented cervical cord injury with motor deficit 4. Known prisoner 5. Known pregnancy 6. Traumatic arrest with > 5 minutes CPR without return of vital signs 7. Penetrating cranial injury 8. Traumatic brain injury with brain matter exposed 9. Isolated drowning or hanging victims 10. Wearing an opt out bracelet. Patient data will include demographics, time since injury, type of injury (blunt or penetrating), Glasgow Coma Score(GCS), Injury severity score (ISS), systolic blood pressure, respiratory rate, central capillary refill time, estimated number of hours since injury, laboratory findings, blood transfusion, units of transfused blood, management, complications and outcome. The primary outcome will be death in hospital within 4 weeks of injury. Secondary outcomes will be morbidity (thromboembolic events, sepsis, Acute respiratory distress syndrome and organ failure), and number of blood transfusions (Massive transfusion protocol) and hospital length of stay.

NCT ID: NCT03842826 Recruiting - Groin Injury Clinical Trials

Inter-examiner Reproducibility of Clinical Examination Tests for Athletes With Longstanding Groin Pain

Start date: February 18, 2019
Phase:
Study type: Observational

This study will investigate the reproducibility of clinical palpation, resistance and stretching tests which are currently being used for the diagnosis of longstanding groin pain in male athletes.

NCT ID: NCT03794518 Not yet recruiting - Risk Reduction Clinical Trials

Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF

Start date: March 2019
Phase: Phase 3
Study type: Interventional

The prevalence of type 2 diabetes mellitus (T2DM) in Qatar and nations worldwide has increased in recent decades into epidemic proportions. Cardiovascular (CVD) disease is the leading cause of death in T2DM patients. Approximately 80% of T2DM patients will die because of CV cause. Congestive heart failure (CHF) is a major cause of CV death in T2DM, and it also is responsible for significant morbidity and health care expenditure due to high rate of hospitalization for heart failure.

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: February 1, 2019
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: NCT03674112 Recruiting - Clinical trials for HER2-Positive Early Breast Cancer

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

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

Qatar Cardiovascular Biorepository of AF Patients

Start date: March 2019
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: March 1, 2019
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: NCT03593590 Recruiting - Multiple Sclerosis Clinical Trials

Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

MuSicalE
Start date: November 2, 2018
Phase:
Study type: Observational

This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.