rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
Status: Recruiting

The main objective of this project is two-fold

to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.

Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.

Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria (group of SMC):  > 65 years old self-reported memory complaints score on Mini-Mental State Examination greater than or equal to 27/30 (normal range)  Exclusion Criteria:  no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating < 0.5  Inclusion Criteria (group of MCI):  > 65 years old a self-reported (or reported by a caregiver) cognitive decline an objective impairment on the neuropsychological testing scores on the Clinical Dementia Rating < 0.5.  Exclusion Criteria:  no dementia - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Factors Associated With Posttransplant Cardiac Outcomes
Status: Not yet recruiting

Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age > 18 years, End-stage cirrhosis patients who will receive liver transplantation, Patients voluntarily take part in the study and write informed consent.  Exclusion Criteria:  Decreased left ventricular systolic function (ejection fraction <45%), Significant uncorrectable structural cardiac abnormalities (eg, symptomatic coronary heart disease, advanced cardiomyopathy, severe valvular disease, severe congenital heart disease, etc), Uncontrolled pulmonary hypertension defined as pulmonary arterial systolic pressure ≧ 35mm Hg at rest despite maximal medical management, Circulatory or respiratory system with a score of 4 based on the preoperative Organ Dysfunction (CLIF-SOFA) score, Second-time liver transplantation, Combined organ transplantation, Satisfactory quality echocardiography could not be obtained before operation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with end-stage cirrhosis who are going to undergo liver transplantation in the Third Affiliated Hospital of Sun Yat-sen University - SamplingMethod: Probability Sample
Adolescents' Non-suicidal Behavior and Perception of Parents' Negative Emotional Expression and Family Communication
Status: Not yet recruiting

The starting point of this project is to study young people and adolescents, aiming to explore the correlation between non-suicidal behavior of young people and adolescents and the negative emotional expression of their parents and family communication. The purpose of this project is to investigate the non-suicidal self-injury behavior of teenagers aged 15-25 years by issuing questionnaires (sample size: 327 people). In order to find out whether there is any connection between family communication and non-suicidal self-injury behavior of young people and adolescents.

Eligibility:
- EligibilityCriteria: 1.Case group: NSSI patient group:  Inclusion Criteria:  Patients who meet the diagnostic criteria in DSM-5 and are clinically diagnosed as NSSI; Age range: 15-25 years old; Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese;  Exclusion Criteria:  Users with organic diseases and psychoactive substances; NSSI； caused by autism, TIC disorder, mental retardation and other emotional instability and bad mood; Religious self-injury or customary self-injury; Patients with schizophrenia, schizoaffective disorder, alcohol dependence, organic mental disorder and other mental disorders have been previously diagnosed.  2.Control group 1: Non-NSSI patients  Inclusion criteria:  Psychiatric outpatients or inpatients can read and understand the contents of the questionnaire; Patients who do not meet the diagnostic criteria in DSM-5 and are clinically diagnosed as NSSI. Age range: 15-25 years old; Patients and/or guardians can give informed consent and participate in this study.  Exclusion criteria:  Patients whose illness causes them unable to communicate or fill out questionnaires; Non-serious mental diseases, such as schizophrenia and schizoaffective disorder.  3.Control group 2: Healthy group  Inclusion criteria  No mental illness; Age range: 15-25 years old; Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese; Patients and/or guardians can give informed consent and participate in this study.  Exclusion criteria  (1) Young people and adolescents who are unable to communicate or fill out questionnaires due to various organic reasons. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 15 Years - MaximumAge: 25 Years - StdAgeList: Child, Adult - StudyPopulation: The group of adolescents and young adults diagnosed as NSSI, and the control group includes adolescents and young adults with other mental diseases other than NSSI, healthy adolescents and young adults. - SamplingMethod: Non-Probability Sample
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
Status: Not yet recruiting

The primary objectives of this study are:

To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module [Fp/ABS eMDPI]) in participants with asthma
To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
To compare the PK profiles of ABS between the 2 different strengths of TEV-56248

The secondary objective is:

• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit Demonstrate acceptable inhalation technique with the training inhaler Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3 Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg) Able to achieve a peak inspiratory flow (PIF) rate of at least 60 liters per minute (L/min) on an inhaler training device  NOTE- Additional criteria apply, please contact the investigator for more information  Exclusion Criteria:  Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit  NOTE- Additional criteria apply, please contact the investigator for more information - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 11 Years - StdAgeList: Child
Cannabidiol and Older Adult Cannabis Users
Status: Not yet recruiting

Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 60 years of age Able to provide informed consent Must have used a cannabis product at least once with no negative effects Must not have been regularly using any cannabis products (<3x/month) in the last 6 months Female participants must be postmenopausal Liver function tests (Alanine transaminase (ALT) and Aspartate transaminase (AST)) must show levels no greater than 2x the upper normal limits for age Must be currently taking medication/s for pain, sleep, and/or mood  Exclusion Criteria:  Blood alcohol level > 0 at screening (to sign consent form) Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs Past or current diagnosis, or family history of diagnosis of psychosis Current use of anti-epileptic medications (e.g. clobazam, sodium valproate) Current use of medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide). Current use of antipsychotic medications Currently undergoing chemotherapy (to prevent drug interactions) - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers.
Status: Recruiting

The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals over the age of 65 who are currently driving. Individuals capable of understanding and following the researcher's instructions. Individuals who can understand the purpose of the research and have consented to participate  Exclusion Criteria:  Those who have not signed the consent form. Individuals with a history of severe dizziness or epilepsy. Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes. Patients with severe shoulder pain. Patients whose range of motion in major joints is restricted by more than 50%. Pregnant women. Patients with pressure sores. Patients with limitations on simulator use due to heterotopic ossification. Patients with acute fractures. Other patients for whom participation in the study is expected difficult. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data
Status: Recruiting

A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The subjects voluntarily participated in the study and signed an informed consent form; The age is between 18 years old (inclusive) and 85 years old (inclusive), regardless of gender; Body mass index (BMI) ≤ 45; Clinically clearly diagnosed neuropathological pain (pain VAS score ≥4 or above); Did not participate in the drug/medical device test within 3 months before the test;  Exclusion Criteria:  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who are in poor condition and cannot objectively describe their symptoms or complete the questionnaire score; People with severe mental system, respiratory system, cardiovascular system diseases, liver and kidney insufficiency, malignant tumors; Lactation, pregnant women, or subjects with pregnancy plans within 1 month after the trial (including male subjects); People with allergic diseases and allergic constitution; People with infected or damaged skin at the EEG collection site; Have a history of drug abuse or drug addiction; - SamplingMethod: Probability Sample
A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR
Status: Recruiting

A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18-85 years old male and female; Patients clinically diagnosed with chronic pain; Chronic pain lasts for more than 3 months; The average intensity of pain in the past month is 40mm and above (VAS); Willing to abide by the relevant regulations of the experiment;  Exclusion Criteria:  Serious cognitive impairment; Current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects; Symptoms of nausea or dizziness; Sensitive to luminous screens; No stereo vision or severe hearing impairment; Eye, face or neck injuries, which hinder the comfortable use of glasses; The evaluated patient GAD-7 questionnaire 10 points and above, PHQ-9 questionnaire 10 points or above; Have used VR or MR and other related devices to treat pain; Other clinical studies have been completed now or recently (the past 2 months); Currently pregnant or planning to get pregnant during the study; At present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Chronic pain lasts for more than 3 months; - SamplingMethod: Probability Sample
Study of Tamibarotene in Patients With ADPKD
Status: Recruiting

Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed as ADPKD by modified Pei-Ravine eGFR(CKD-EPI) is equal to or greater than 60 mL/min/1.73m^2 Patients who are judged to be hard to treat with tolvaptan or who do not wish to be treated with tolvaptan, at the time of obtaining consent Patients with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg. For patients receiving angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, the dose must be constant for at least 6 weeks before obtaining informed consent  Exclusion Criteria:  Women who are pregnant or may be pregnant Nursing mother  Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:  Female: From informed consent to 2 years after the last administration of the study drug Male: From informed consent to 6 months after the last administration of the study drug Patients within 12 weeks from the last dose of a drug that affects renal cysts, such as tolvaptan, to the first dose of the study drug Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function - HealthyVolunteers: No - Gender: All - MinimumAge: 26 Years - MaximumAge: 55 Years - StdAgeList: Adult
StrokeNet Thrombectomy Endovascular Platform
Status: Not yet recruiting

STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO).

Eligibility:
- EligibilityCriteria: STEP PLATFORM INCLUSION CRITERIA:  Suspected diagnosis acute ischemic stroke Likely causative intracranial large or medium vessel occlusion  STEP PLATFORM EXCLUSION CRITERIA:  Proven contraindication to endovascular thrombectomy Prisoners/incarcerated  DOMAIN-SPECIFIC ELIGIBILITY CRITERIA:  Each domain may have additional eligibility criteria.  STEP EVT INDICATION EXPANSION DOMAIN INCLUSION CRITERIA:  Age 18 years or older Pre-stroke modified Rankin Scale score 0-2 Within 24 hours of last known well  Has one of the following presentations:  a. Low NIHSS Patient (must have both): i.) Mild presenting neurologic deficits - NIHSS 0-5 ii.) Occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)  b. Medium/Distal Vessel Occlusion (must have all 3): i.) Lumen diameter >/= 0.75 ii.) Non-dominant/Co-dominant M2 or M3,4 or A1,2,3 or P1,2,3 iii.) Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on Non-contrast Computed Tomography (NCCT) or ADC <620 mm2/s on diffusion MRI or rCBF<30% on Computed Tomography Perfusion (CTP) after 6h of symptom onset.  STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:  Clinical  Presumed septic embolus; suspicion of bacterial endocarditis Seizure at stroke onset or between onset and enrollment Allergy to contrast material that precludes endovascular reperfusion therapy Intracranial occlusion suspected to be chronic, based on history and/or imaging Intracranial dissection, based on history and/or imaging Cerebral vasculitis, based on history and/or imaging Known pregnancy Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment  Laboratory  a. Known platelet count <100.000 uL  Imaging  Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy. Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) Significant mass effect with midline shift (>5mm) Evidence of intraaxial tumor (except small meningioma) Evidence of acute intracranial hemorrhage - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire
Status: Recruiting

The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  To be between 25-75 years old, To be literate in Turkish, Being a mother, father or other caregiver of a child, Voluntarily agreeing to participate in the study, Be taking care of the child for at least one year  Exclusion Criteria:  Having cognitive impairment at a level that prevents cooperation with the scales, Not living in the same household with a child with cystic fibrosis. - HealthyVolunteers: No - Gender: All - MinimumAge: 25 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The population of the study will consist of parents of CF patients who come to the Pediatric Chest Diseases Outpatient Clinic of a private hospital for routine control. The sample will consist of parents who fulfill the inclusion and exclusion criteria and volunteer to participate in the study. - SamplingMethod: Non-Probability Sample