rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Status: Recruiting

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Have Lipoprotein(a) [Lp(a)] ≥175 nanomoles per liter (nmol/L).  Meet criteria of either 2a or 2b:  2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.  2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.  Exclusion Criteria:  Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening. Have uncontrolled hypertension Have New York Heart Association class IV heart failure. Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.  Have severe renal failure, defined as  Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis. Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy
Status: Not yet recruiting

To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Spasticity level II in lower limb muscles according to Modified Ashworth Scale. Able to follow order. Aged from 6 to 12 years old.  Exclusion Criteria:  Visual or obvious detected vestibular sensory disorders or cerebellar disease. Botox injection in the last 6 months. Cognitive deficits or disturbed conscious level. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 12 Years - StdAgeList: Child - StudyPopulation: children diagnosed with cp spastic diplegia with postural instability will represent the sample of this study.  They will be selected from the clinic of faculty of physical therapy, delta university and my private clinic. - SamplingMethod: Probability Sample
Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation
Status: Not yet recruiting

The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥ 18 years of age Newly implanted with a HeartMate 3™ LVAD for the first time Able to ambulate independently (with or without the use of an assistive device) Owns a smartphone with Internet connection Patient will be discharged home with LVAD or patient will be living at home with LVAD within 45 days of index discharge  Exclusion Criteria:  1. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia
Status: Not yet recruiting

This is a randomised controlled study aiming to evaluate the implementation of a website ('Small Steps') to support the modification of participants' time-use behaviour to reduce the risk factors for dementia. 'Small Steps' website provides the tools for this with a visual representation of the participant's current use of time and allowing manipulation to demonstrate how small lifestyle changes may improve and meet sleep and physical activity needs. Participants will be assisted to make changes to current behaviours with the aim to reduce the time they spend sitting (sedentary behaviour), increase physical activity, and improve sleep duration and quality.

Participants (aged 65 or older) will be randomly allocated to one of two groups, the 'Extended Program' (intervention) group or the 'Condensed Program' (control) group.

There are 3 phases (Introductory, Maintenance and Follow-Up; each 12-weeks long) to this program and in total the program is 36-weeks long. Participants will use a tailored website to help support them in making progressive changes over the first 12 weeks. They will then try to maintain these behaviour changes for as long as possible. There will be in-person health testing during each phase and information about sleep habits, sleep quality, and motivation will be assessed using online surveys. Physical activity levels and sleep duration will also be assessed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 65 years or older Ambulatory and community dwelling Fluent in the English Language (required for cognitive assessments) Resident of Onkaparinga Council Access and competency in using technology (i.e., phone, tablet, computer) Not meeting the Australian physical activity guidelines - 150 minutes per week of moderate intensity physical activity (self-report) Deemed safe to participate in physical activity (ESSA APSS stage 1) or clearance from health professional  Exclusion Criteria:  Scores below the mild cognitive impairment (MCI) cut-off (<13/22) on the Montreal Cognitive Assessment-Blind (MoCA-B) or a current diagnosis of dementia Self-reported meeting the Australian physical activity guidelines Major neurological or psychiatric diagnosis Known intellectual disability Major physical disability Lack of English fluency Involved in another intervention trial involving physical activity, brain training, and/or diet Have vision problems which may prevent them from reading a computer and/or phone screen - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
Status: Recruiting

This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity>75% and specificity>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women aged between 45 and 74 years Asymptomatic Signed informed consent form before starting any study activity Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or previous BC) Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthesis (DBT) (collecting oblique mediolateral projection [MLO] of the right breast, craniocaudal projection [CC] of the right breast, MLO projection of the left breast, CC projection of the left breast), performed within the past month with available results or planned to be performed in the same day of the MammoWave test or in the subsequent days Spontaneous willingness to comply with CIP and recommendations  Exclusion Criteria:  Woman with breast prostheses Women with symptoms or some sign of suspected BC Women with BRCA1, 2, TP53 or previous BC Pregnant women Women who do not have mammographic manifestation of the tumor (known occult breast tumor with only axillar manifestation) Women with breast size larger than the largest MammoWave cup size - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 45 Years - MaximumAge: 74 Years - StdAgeList: Adult, Older Adult
Predictors of Post-COVID Clinical and Cognitive Consequences
Status: Recruiting

The CDC describes Post-acute sequalae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All individuals 18 years or older, with prior history of COVID-19 infection diagnosis Both genders including all racial and ethnic groups Patients with OSA (apnea hyponea index ≥ of 5/hour on polysomnography) with history of COVID-19 infection will be eligible with prior history of COVID-19 infection and without Covid-19 for Aim 2.  Exclusion Criteria:  Inability to give consent Active suicidal symptoms Children of all ages Pregnant women - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: We will include all individuals 18 years or older, both genders, all racial and ethnic groups, with diagnosis of COVID-19 infection, diagnosed using any validated antigen detection test and/or polymerase chain reaction (PCR) test and of any severity level of COVID. Eligible patients with COVID-19 history of infection should be at least 1 month after the diagnosis of COVID-19 and should have been discharged to home if admitted to an acute care facility. COVID-19 antigen test positive patients who were completely asymptomatic at the time of COVID positive testing will be excluded. Controls will be patients without history of COVID-19 infection and age 18 years or older. In addition, patients with OSA (apnea hypopnea index ≥of 5/hour on polysomnography) with history of COVID-19 infection will be eligible for Aim 2. - SamplingMethod: Non-Probability Sample
A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.
Status: Not yet recruiting

The purpose of this study is to collect information on the:

general information of a group of people such as their age, sex
clinical information of the patients such as any other illness before having COVID 19.
the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations
adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.

This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.

This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.

The study will include patient information of those who:

had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.
are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:Age 18 years and older Patients with a diagnosis of COVID-19 whose information can be extracted from the I-Seha database  Exclusion Criteria:  There are no exclusion criteria for this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This will be a retrospective observational cohort study of patients diagnosed with COVID-19 in the Kingdom of Bahrain. Treated patients are defined as those have been prescribed nirmatrelvir, ritonavir and managed in the outpatient setting (eg, receiving medical treatment without being admitted to a hospital for COVID-19) while control group is those not treated with nirmatrelvir, ritonavir. Data will be from the I-Seha electronic medical records and descriptive analyses will be conducted for these two cohorts and will compare healthcare resource use in patients treated with nirmatrelvir, ritonavir and those not treated with nirmatrelvir, ritonavir. - SamplingMethod: Non-Probability Sample
Self-Adhering Magnetic Device to Treat Corneal Exposure
Status: Not yet recruiting

Paralytic lagophthalmos can be difficult to treat and manage. It has a host of causes and effects, one of which (for the latter) is exposure keratopathy. Untreated, this can lead to corneal ulceration, inflammation, and potentially blindness. Despite a variety of attempts at treating this complex condition, none have satisfactorily reduced complications ranging from ease of use to aesthetics. With improvement in magnetic technology, however, that may change. Barmettler et al (2014) have demonstrated preliminary success of externally affixed magnets in closing both model and patient eyelids. As such, we hypothesize that magnetic devices can be used to treat corneal exposure by controlling eyelid position.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Males and females ages 18-80 years old. Patients with recent corneal abrasion and no signs of infection in the examination Patients with lagophthalmos Normal Controls  Exclusion Criteria:  Individuals with adhesive or tape allergies. Individuals with a history of metal pieces/shavings embedded in the eye (such as from welding or metalworking) Individuals with eye infections - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Phenotyping and Characterization of wtATTR-CM (TRACE 1)
Status: Recruiting

Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity.

Eligibility:
- EligibilityCriteria: Group 1: wtATTR-CM patients  Inclusion Criteria:  Patients > 18 years diagnosed with ATTRwt-CM by: endomyocardial biopsy DPD scintigraphy with Perugini grade 2-3 where variant amyloidosis is ruled out due to genetic testing. Informed oral and written consent  Exclusion Criteria:  AL amyloidosis (light-chain amyloidosis). Myelomatosis Waldenström macroglobulinemia  Group 2: Control group  Inclusion Criteria:  Patients > 18 years Informed oral and written consent  Exclusion Criteria:  Known cardiovascular disease including ischemic heart disease, heart failure, atrial fibrillation, presence of a pacemaker, or malignant hypertension. Well-controlled hypertension is acceptable. Suspicion of cardiac amyloidosis assessed through clinical history, physical examination, ECG, and echocardiography focusing on "red flags": Echocardiography with: Myocardial hypertrophy (septum >11 mm) Apical sparing in LV-GLS Infiltrative changes in the right ventricle free wall, thickened atrioventricular valves, or thickened atrial septum Symptoms of polyneuropathy Low voltage on ECG or discrepancy between left ventricular thickness and ECG amplitude indicative of low voltage Atrioventricular block (AV block) Bilateral carpal tunnel syndrome Surgery for spinal stenosis Elevated troponin I or NT-pro-BNP - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Including variating severity of wtATTR-CM by including 40 patients with NAC stage 1, 40 patients with NAC stage 2, and 20 patients with NAC stage 3. Furthermore, including a healthy control group in order to examine normal values of mis- and frag-TTR - SamplingMethod: Non-Probability Sample
Otago Exercise Program Applied By Telerehabilitation
Status: Recruiting

The aim of this study is to examine the effects of Otago Exercise Program (OEP) on pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life and balance with the telerehabilitation method in individuals with a history of falling, which is frequently seen in elderly individuals due to aging.

45 people between the ages of 65 and 78 participated in the study. They were randomly divided into 3 groups as control, telerehabilitation otago exercise program (TOEG) and face-to-face otago exercise program (FOEG). 45 minutes of OEP was applied 3 times a week for 8 weeks. Pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life, and balance were evaluated before the Otago Exercise Program, at the 4th week, at the 8th week, and 4 weeks after the end of the exercise program. Significance was evaluated at the p<0.05 level in the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Presence of the ability to walk without assistance Living independently at home Having a history of at least one fall in the last 12 months  Exclusion Criteria:  Having a score below 24 on the Mini Mental State Test Using a walking aid Having a history of uncontrolled epileptic seizures Having a history of surgery within the last six months - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - MaximumAge: 90 Years - StdAgeList: Older Adult
Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine
Status: Recruiting

This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine.
It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population.

Eligibility:
- EligibilityCriteria: pancreatic cancer group  Inclusion Criteria:  Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy) Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon Patients with informed consent  Exclusion Criteria:  History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment) Patient with Inflammatory disease(e.g. severe pancreatitis, cholangitis) Patients with underlying diseases at high risk of general anesthesia Other subject whom the investigator deems inappropriate control group Inclusion Criteria included healthy individuals as well as patients with benign diseases.  Exclusion criteria for the control group included a previous cancer diagnosis within the past five years, active inflammatory diseases, borderline malignant pancreatic tumors, or a postoperative pathological finding of malignancy. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Pancreatic cancer group: comprised patients who were scheduled for curative surgery for pancreatic cancer  Control group: The control group included healthy individuals as well as patients with benign diseases - SamplingMethod: Non-Probability Sample
Gestational Diabetes After Gastric Bypass Surgery
Status: Recruiting

The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery.

The main question it aims to answer is:

How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women.

Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Understands written and spoken Swedish Previous Gastric Bypass surgery Diagnosed with gestational diabetes according to our local criteria Planned follow up at the Specialized Maternity Ward at Skane University Hospital Understands the use of CGM and is willing to use the system Have signed informed consent  Exclusion Criteria:  Other kinds of bariatric surgery - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department
Status: Not yet recruiting

The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  asthma exacerbation  Exclusion Criteria:  life-threatening conditions requiring intubation allergy to steroid or its components patient under investigation of Corona Virus Disease, 2019 (COVID-19) pulmonary tuberculosis unable to cooperate for pulmonary function testing - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult