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NCT ID: NCT04479826 Completed - type1diabetes Clinical Trials

Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition

Start date: July 16, 2020
Phase: N/A
Study type: Interventional

The study will follow participants for the periods of 3 months while using an advanced hybrid closed loop algorithm in free living conditions . Each period will have a different meal handling protocols. The objective is to identify the mitigation of the algorithm with different meal handling approaches.

NCT ID: NCT04477707 Completed - Clinical trials for Diabetic Retinopathy

A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy ,DR)

ReFineDR
Start date: July 23, 2020
Phase:
Study type: Observational

Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be. In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.

NCT ID: NCT04471285 Completed - Clinical trials for Pain/Sensitivity >5 on Numeric Rating Scale (NRS)

Symphysiolysis: Acupuncture Therapeutic Benefits: a Randomized Placebo Controlled Study.

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

a randomized, observer blind and placebo-controlled cross-over study in which true acupuncture (Verum)(V) was compared to "placebo" acupuncture (P). the investigators evaluate the effect of the acupuncture on the pain and the ability of the pregnant patient.

NCT ID: NCT04470960 Completed - Clinical trials for A Community Center as a Health Promoting Setting

Evaluation of a Health Promoting Community Center Network (HPCCN) Innovation.

HPCCN
Start date: December 11, 2017
Phase: N/A
Study type: Interventional

The purpose of this research study is to design, implement and evaluate the setting for a "Healthy Community Center". This is a program review of a program which will be planned in a community based participatory level, based on the socioecological model. A pre-post design will be utilized where all community centers in the study will be exposed to the intervention components. It is hypothesized that community centers who will receive the intervention will have better skills at building sustainable participatory effective health promotion projects and will provide a healthy setting for the community within its juristiction.

NCT ID: NCT04469465 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

NCT ID: NCT04467840 Completed - COVID-19 Clinical Trials

Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia

Start date: August 21, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.

NCT ID: NCT04466306 Completed - Acute Kidney Injury Clinical Trials

Pediatric Acute Kidney Injury in COVID-19

SPARC-1
Start date: April 15, 2020
Phase:
Study type: Observational [Patient Registry]

This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.

NCT ID: NCT04460885 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

ONWARDS 1
Start date: November 25, 2020
Phase: Phase 3
Study type: Interventional

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04458857 Completed - Migraine Clinical Trials

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Start date: July 15, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab. The total duration of the study is planned to be up to 51 months.

NCT ID: NCT04455607 Completed - Old Adults Clinical Trials

Perturbation Training to Improve Balance Recovery of Old Adults

BalancING
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Falls are major contributors for immobility and independency. Most falls in older adults occur during walking after a sudden unexpected loss of balance. It was well-established that balance can be improved by performance of a training program that provides perturbation (unexpected perturbations of balance). The main aim of the current study is to investigate the effects of two perturbation-training methods: 1) random perturbation training; vs. 2) block (non-random) perturbation training. We also aim to explore brain area's (as measured by MRI) that are related to balance function in older adults. We hypothesize that response to an unexpected loss of balance is the balance responses will be improved in both training methods, but more in the random training method. We also hypothesize that brain function as seen in MRI will be improved in both training methods, more in the random training method. As far as we know, there is a lack of studies investigating the learning effect of random vs. block non-random training on balance recovery responses while walking and exposure to unexpected loss of balance and on brain function.