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NCT ID: NCT05590676 Terminated - Premature Birth Clinical Trials

Metformin Treatment in Infants After Perinatal Brain Injury

Start date: May 2, 2023
Phase: Phase 1
Study type: Interventional

A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury

NCT ID: NCT05579977 Terminated - Obesity Clinical Trials

Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

Start date: October 27, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study. Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.

NCT ID: NCT05518474 Terminated - COVID-19 Clinical Trials

Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

The rapid development of safe and effective COVID-19 treatment is a global health priority. Numerous studies evaluating therapies for this disease are currently underway, but the majority of these are in hospitalized patients with severe illness. Consequently, there is an urgent need to identify therapies that prevent mild COVID-19 cases in the community from becoming more severe. "Proning" or lying face down in bed has been shown to improve breathing and oxygen levels in COVID-19 patients, reducing the need for breathing tubes and ventilators and increasing survival. The current study will investigate whether proning and repositioning (lying on one's side or sitting up) can prevent mild cases of COVID-19 from becoming more severe resulting in fewer hospitalizations and death. A randomized controlled trial will be used to reduce the risk of bias when testing this intervention. Unvaccinated or partially vaccinated adult patients with a positive COVID-19 test willing to participate and well enough to be treated outside the hospital will be randomly assigned to one of two groups: a home-proning intervention group with instructions and daily reminders to prone and reposition during the day and at night, and a standard care group. Our goal is to assess whether home-proning/repositioning leads to fewer hospitalizations and death when compared with standard care. We'll also compare recovery time, use of antibiotics and follow up emergency department visits between these two groups. The current pilot study will assess the feasibility of a larger investigation or "main trial", meaning it will be small scale test of methods and procedures to be used on a larger scale.

NCT ID: NCT05503823 Terminated - Clinical trials for Understand the Effects of tACS on the Brain

Investigating Transcranial Alternating Current Stimulation (tACS) Preconditioning Effects on Resting and Active Motor Threshold

Start date: September 16, 2022
Phase: N/A
Study type: Interventional

Previous studies have looked at the potential of using transcranial direct current stimulation (tDCS) to prime the brain in order to lower the resting motor threshold. The resting motor threshold (RMT) is the intensity at which repeated transcranial magnetic stimulation (rTMS) is applied for treatments. The RMT is the lowest intensity at which the participant's muscle responds with the motor evoked potential peak-to-peak amplitude greater than 50μV for 5 of 10 trials when the hand is relaxed. The active motor threshold (AMT) is the lowest intensity that produces MEP with peak-to-peak amplitude greater than 100 μV for 5 of 10 trials while the participant maintains 10-30% of maximal voluntary contraction. The RMT and AMT is different for each person and the high intensity TMS pulses can be difficult for some of the patients in the current Alzheimer's rTMS treatment study to tolerate. Therefore, if the treatment can still be applied with lower intensities, it would be more tolerable for some people. The limited research on both tDCS and transcranial alternating current stimulation (tACS) in priming the brain for TMS are not enough to determine if they are effective in priming the brain. The studies that include tDCS have small sample size and inconclusive results. The studies with tACS are using very high frequencies of 140 Hz to 250 Hz. The objective of this research study is to determine if priming the brain with tACS at 40 Hz or tRNS for 10 minutes is able to reduce the resting and active motor threshold. Therefore, for people with higher RMT and AMT, priming with tACS or tRNS could be used to lower intensities while stimulating the brain for treatments.

NCT ID: NCT05488769 Terminated - Cataract Clinical Trials

Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material

Start date: August 25, 2022
Phase:
Study type: Observational

The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.

NCT ID: NCT05473715 Terminated - Clinical trials for Neovascular (Wet) Age-related Macular Degeneration

A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment

XPAND
Start date: April 25, 2023
Phase: Phase 4
Study type: Interventional

Researchers are looking for a better way to treat people who have neovascular (wet) age-related macular degeneration (nAMD or wet AMD). In people with wet AMD, the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in the area of sharpest vision in the eye, called macula. Fluid buildup due to leakage from these vessels can damage the macula, leading to vision problems such as blurring or a blind spot in the central (straight ahead) vision needed for reading or face recognition or car driving. Wet AMD is common in people aged 50 and older. The study treatment intravitreal aflibercept (also called BAY865321) is injected into the eye. It works by blocking the VEGF protein and thus reduces blood vessel growth. It has already been approved for patients with wet AMD to be given as intravitreal injection monthly at start and then every 8 weeks or longer. Repeated injections of aflibercept prevent worsening of vision but place a burden on the patient. Doctors try to increase the time between injections (treatment interval) in routine clinical practice based on individual patient needs. This is called treat and extend (T&E). Treatment intervals are stepwise extended or shortened depending on how the treatment works. This is checked with optical coherence tomography (OCT), an imaging technique used to observe relevant changes in the eye. The main purpose of this study is to learn how well aflibercept works if treatment intervals are extended faster (timepoint of extension is the same for both treatments arms), compared to standard T&E regimen in people with wet AMD in a preselected patient population with no fluid after treatment initiation. To answer this, researchers will assess changes in vision called best corrected visual acuity (BCVA) between study start and after 36 weeks. Changes will then be compared between participants whose treatment intervals were extended early and those on standard T&E regimen. All participants will receive 2 mg aflibercept as intravitreal injection for up to 52 weeks in intervals of every 4 to 16 weeks. Each participant will be in the study for up to 56 weeks. During this time 4 visits to the study site are set for all participants. The other visits are set individually. A final phone call is planned 3 days after treatment at the end of study. During the study, the doctors and their study team will: - check patients' eye health using various eye examination techniques (slit lamp microscopy, OCT, and ophthalmoscopy) that may necessitate eye drops to widen the pupil) - measure patients' eye vision (BCVA) - do physical examinations - check vital signs - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, participants in the fast extension arm will be provided with a home monitoring OCT device.

NCT ID: NCT05442775 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

COURAGE OLE
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)

NCT ID: NCT05439941 Terminated - Atopic Dermatitis Clinical Trials

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials

Start date: June 6, 2022
Phase: Phase 2
Study type: Interventional

This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815. The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.

NCT ID: NCT05438485 Terminated - Propionic Acidemia Clinical Trials

Natural History Study of Patients With Methylmalonic Acidemia and Propionic Acidemia

JUMP
Start date: August 27, 2021
Phase:
Study type: Observational [Patient Registry]

The JUMP (Journey to Understand MMA and PA) Study is being conducted by HemoShear Therapeutics and AllStripes, a rare disease online research platform. JUMP is designed to accelerate understanding of the natural course of methylmalonic acidemia (MMA) and propionic acidemia (PA) disease and treatment for families, researchers, clinicians and industry. The study will collect and provide patient medical record information from multiple institutions for families to access in one place at no cost. AllStripes will remove identifying information like name and address from these medical records and aggregate this data for the HemoShear team to better understand the medical experience and progression of MMA and PA over time. In addition, academic researchers, healthcare practitioners and patient advocacy groups can apply to use the collective patient community data to answer specific research questions at no cost. HemoShear is collecting natural history data on MMA and PA because the company needs insight into the real-world experience of many patients to better understand the disease and be able to scientifically demonstrate whether the potential new treatment they are developing is effective in improving outcomes. This natural history study will include retrospective and prospective components. The retrospective component will consist of data abstracted from primarily electronic health records (eHR) and some paper records. The prospective component will include ongoing collection of medical records from enrolled participants, and participants may opt in to complete health-related questionnaires and an optional genetic testing sub-study. After signing informed consent, participants or their legal guardians will grant permission to AllStripes to collect their health records for data abstraction. Participants may opt into an optional no cost genetic testing sub-study. The JUMP (Journey to Understand MMA and PA) sub-study will help assess whether the genetic variant of the affected person may relate to disease severity and treatment response. Getting genetic testing will enable participants to understand the genetic mutation that causes their type of methylmalonic acidemia (MMA) or propionic acidemia (PA). Knowing the genetic mutations (whether from the MMUT, MMAA or MMAB gene or PCCA or PCCB) can help the impacted person, their caregivers and healthcare professionals understand the potential course of disease and select approaches to better manage the disease. The additional information will enable HemoShear and AllStripes to understand whether different genetic variants impact the disease journey and outcomes. A separate informed consent will be obtained for participating in the sub-study.

NCT ID: NCT05412264 Terminated - Prediabetes Clinical Trials

Step Up For Health Study: A Pedometer and Website Intervention in Those With Prediabetes

Start date: January 2014
Phase: N/A
Study type: Interventional

This study will examine whether a physical activity program, specifically increasing walking steps, offered over the internet is able to increase physical activity in adults with prediabetes. The study will take place over 12 weeks. The investigators want to see if people who receive the intervention increase their physical activity more than people who do not receive the intervention. The physical activity program will include using a pedometer to track daily step counts online, set weekly goals, and receive motivational messages delivered weekly using email. The investigators are also going to collect data on waist circumference, body weight and quality of life at baseline, 12 weeks and 16 weeks after the intervention has completed to see if these change over the course of the study. The investigators will be recruiting 200 adults who have attended the Edmonton, Alberta prediabetes education class offered by Alberta Health Services, Nutrition Services and report they have prediabetes. If able to successfully increase physical activity, this study will identify a web and home-based intervention that can be offered to individuals who participate in lifestyle programs delivered in primary care settings (e.g., Edmonton prediabetes program) in both rural and urban locations.