rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Genomic Medicine Risk Assessment Care for Everyone - Implementation Phase
Status: Not yet recruiting

The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The three primary aims are:

Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.

Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.

Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.

Three sets of participants will be engaged: patients (n=750), providers (n=25), and family members of "probands" (i.e., patients that have a genetic change that increases risk, n~500).

Patient participants will be asked to complete a baseline survey, enter their family health history information into MeTree (a family health history web-based platform) and complete a survey about their experience using the platform. Subsequent study procedures will depend on: 1) the results of their MeTree risk evaluation, 2) their acceptance/declination of genetic testing (for those categorized as needing testing by MeTree), and 3) the results of the test (for those accepting testing).

Provider participants will be providers who are the primary care physicians treating one or more patients enrolled in the patient participant group. Providers will be notified on a patient by patient basis once the patient participant under their care has complete the risk assessment process and the risk report is available from MeTree. At study completion, provider participants will be asked to complete a survey about their demographics, practice, and experiences with the study.

Blood relatives of the probands who are identified by the proband as open to engaging with the study will be contacted and offered genetic counseling and genetic testing.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Receiving primary medical care in one of the 5 participating clinics Age 18 years or older Able to read and communicate in English Able to provide written and verbal informed consent Willing to use the Internet  Exclusion Criteria:  Anyone not meeting inclusion criteria Previous genetic counseling and/or previous hereditary panel testing - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
Status: Recruiting

This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with heart failure as defined by European Society of Cardiology guidelines  Signs and/or symptoms of heart failure AND LVEF <50% OR LVEF ≥50% and objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised filling pressures AND indication for cardiac pacing as defined by European Society of Cardiology guidelines  Exclusion Criteria:  Age under 18 years old Pregnancy Inability to provide consent or to undergo follow-up Class 1A indication for classical CRT as defined by European Society of Cardiology guidelines. Patients with a class 2A or higher indication for CRT can be included. However, patients with Class 1A indication for classical CRT but failure or suboptimal result of CS lead placement can be included. Significant cardiac or extracardiac comorbidity precluding maximal exercise testing, examples: Recent (<4 weeks) decompensation of heart failure, angina pectoris class ≥2 , uncontrolled hypertension or arrhythmia , severe valvular heart disease, significant peripheral vascular disease, orthopaedic limitation ... Comorbidity that may influence 6-month prognosis, examples:  Severe chronic kidney disease (eGFR ≤20 mL/kg/min or dialysis) , severe chronic obstructive pulmonary disease (≥GOLD 3) , active malignancy ... - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
Status: Recruiting

Objectives:

Assess the extent of financial burden of patients undergoing radiotherapy
Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity
Design a structured social consultation to reduce financial burden induced by radiotherapy

Inclusion criteria:

age ≥ 18 years of age
indication for radiation treatment of a malignant disease
Karnofsky Performance score (KPS) ≥ 70%
Life expectancy ≥ 3 months

Exclusion criteria:

Inability to provide informed consent
Inability to attend study visits and fulfill data collection requirements
Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapy

Secondary outcomes:

Socio-Economic factors at baseline
Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months
Depression (PHQ-9) at baseline and 3 months
Coping mechanisms to address financial burden

Primary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.

Secondary Endpoints:

Changes in the COST-Score over time
Changes in PHQ-9 over time
Changes in EORTC QLQ-C30 over time

This is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.

To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  cancer diagnosis with indication for radiation Karnofsky index minimum 70% able to consent minimum 18 years old  Exclusion Criteria:  Inability to provide informed consent Inability to attend study visits and fulfill data collection requirements Simultaneous participation in other studies which could interfere with this study - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients who are about to receive radiotherapy due to a malignancy are eligible. They must meet the inclusion criteria. - SamplingMethod: Non-Probability Sample
Adaptation and Validation of the LUNS for Use in Turkey.
Status: Not yet recruiting

According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.

Our hypothesis in this study is:

- The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants who were diagnosed with stroke More than 1 years after the stroke onset Age 18 to 70 years Had a physical therapy and rehabilitation after stroke Cognitive functions are sufficient to fill in the questionnaires in the study Who give consent to participate in the study  Exclusion Criteria:  Had delirium, confusion, or other severe consciousness problems Suffered from uncontrolled comorbid systemic medical conditions Unable to follow commands because of severe cognitive impairment Had a serious visual disturbance Individuals with musculoskeletal disabilities Currently participating in physical therapy or another interventional study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will include 110 chronic stroke patients who are in the follow-up of the study centers and attend for an outpatient visit at the Department of Physical Medicine and Rehabilitation - SamplingMethod: Probability Sample
Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
Status: Not yet recruiting

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:

How the two formulations compare in terms of their effectiveness in treating TRD.
How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.

Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5) Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD Aged ≥18 years Written informed consent for research study obtained  Exclusion Criteria:  Not able to give informed consent Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration
Status: Recruiting

The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-552 in healthy, male volunteers following administration of a single oral dose.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Male volunteers in general good health at Screening.  Exclusion Criteria:  - Considering fathering a child or donating sperm during the study and for 100 days after study drug administration. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy
Status: Recruiting

For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  laparoscopic hysterectomy for benign reasons planned patients The operation will be performed in our hospital Reporting preoperative endometrial and cervical samplings as benign After discharge, control examinations will be carried out in our hospital.  Exclusion Criteria:  Abdominal, robotic or vaginal hysterectomies malignant reporting of preoperative cervical and endometrial samplings Patients do not want to participate in the study - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: cystoscopy after laparoscopic hysterectomy - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who will undergo laparoscopic hysterectomy for benign reasons in our hospital - SamplingMethod: Probability Sample
Upper Extremity Pathologies in Spinal Cord Injuries
Status: Not yet recruiting

This study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who have experienced spinal cord injury, can comply with two-stage verbal commands, voluntarily agree to participate in the study and are medically stable.  Exclusion Criteria:  Tetraplegia A significant comorbid condition such as severe heart disease and uncontrolled hypertension. Cognitive dysfunction Active infection Malignancy History of trauma to the upper extremity Brachial plexus and peripheral nerve injury History of surgery on the upper extremity - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Spinal cord injuries who use manual wheelchairs and spinal cord injuries who do not use manual wheelchairs, aged between 18-65 years who applied to our clinic will be included in the study. - SamplingMethod: Non-Probability Sample
Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy
Status: Recruiting

This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age>18 years old ≥2+ FMR Receiving GDMT  Exclusion Criteria:  degenerative mitral regurgitation myocardial infarction, percutaneous coronary intervention, coronary bypass grafting surgery, cardiac resynchronization therapy, or stroke within three months prior to this study ≥2+ aortic stenosis or regurgitation previous surgical mitral valve repair or replacement restrictive cardiomyopthy, hypertrophic cardiomyopathy, or constrictive pericarditis severe heart failure (NYHA class IV) or left ventricular ejection fraction < 20% symptomatic hypotension affecting GDMT prescription severe hepatic or renal insufficiency life expectancy < 12 months Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Chinese - SamplingMethod: Non-Probability Sample
Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability
Status: Not yet recruiting

Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function.

In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.

Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged between 18-45 years. Non-smoker. Engaged in sports activity at least 3 times a week for a minimum of one year.  Exclusion Criteria:  Having a medical condition that impedes engaging in physical activity. Individuals with compromised cognitive capacities. Subjects with any chronic disease (cardiorespiratory, neurological, metabolic, oncological, etc.). Subjects with tympanic perforation or middle-inner ear pathology. Subjects who have undergone lower limb surgery within the past 12 months. Subjects experiencing an active episode of lower limb pain. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment
Status: Not yet recruiting

The overarching goal of this randomized-controlled trial is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI. The main questions it aims to answer are:

Aim 1: To investigate the association between gut microbiota, MCI and AD biomarkers. Investigators plan to compare gut microbiota profiles in a well-characterized cohort between individuals with MCI and cognitively normal adults using metagenomics sequencing data. Also, the relationship between gut microbiota and AD biomarkers, such as amyloid PET and plasma tau, will be explored in MCI and cognitively normal adults.

Aim 2: To determine the efficacy of precision probiotic supplementation on cognitive decline (primary outcome) and functional brain changes (secondary outcome) in individuals with MCI due to AD using a randomized, double-blind, placebo-controlled trial. Investigators plan to recruit 120 individuals with MCI due to AD, i.e., MCI with positive amyloid biomarkers. Participants will be randomized to a 12-month supplement of precision probiotics based on the individual gut probiotic profile or placebo. The primary outcome measure will be the changes in cognitive functions over 6 months (primary endpoint) and 12 months. The secondary outcome measure will be resting-state functional brain changes.

Aim 3: To investigate potential mediators underlying the effect of probiotic supplementation. The most apparent mediator will be a shift or changes in gut microbiota. Other potential mediators will be related to decreased lipopolysaccharide, proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-6 and IL-10, and increased brain- derived neurotrophic factor, short-chain fatty acid, etc.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  60 years old and above Diagnosis of MCI based on 2011 NIA-AA criteria Amyloid (+) measured by either amyloid PET imaging or CSF amyloid markers No dietary supplements, including other probiotics, yogurts with live, active cultures or supplements, and immune-enhancing supplements in the past three months (or wash-out period for three months for individuals taking supplements) No use of antibiotics, anti-inflammatory medications, gastrointestinal medicine within the past three months (or wash-out period for three months for individuals taking medications) Consenting to be randomly assigned intervention  Exclusion criteria:  Currently undergoing cancer treatment. The anticipated life expectancy of less than six months. Suffering from severe mental disorders such as schizophrenia, bipolar disorder, or major depressive disorder. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Multiple Study of Electroaccpuncture in ARDS
Status: Not yet recruiting

In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Meet the diagnostic criteria of the Surviving Sepsis Campaign: Updated International Guidelines for the Treatment of Sepsis and Septic Shock 2021 Meet the diagnostic criteria of the European Society of Critical Care Medicine (ESICM) Guidelines for Acute Respiratory Distress Syndrome: Definition, Phenotype and Respiratory Support Strategies Age >18 years Expected duration of mechanical ventilation>48 hours Expected ICU stay of more than 7 days Signed informed consent.  Exclusion Criteria:  Participated in other clinical trials Pregnant, lactating or miscarriage Patients with disseminated tumors or tumors receiving chemotherapy and other special treatments Alcohol abuse Severe cardiovascular, brain, liver, kidney, psychiatric diseases, diabetes, multiple system atrophy, cauda equina injury or myelopathy Systolic blood pressure < 90mmHg within 2 hours before the start of the study Severe burns or severe skin diseases Pacemaker placement, metal allergy or severe needle sickness Abnormal coagulation function - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
Status: Not yet recruiting

The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care).

Primary Objectives within cmRCT cohort:

Provide a framework for multiple randomized (eHealth) interventions for asthmatic children
Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort.

Secondary Objectives within cmRCT cohort:

Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care.
Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path.
Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Is 4 to 18 years old Is patient at the children's department at Medisch Spectrum Twente at moment of inclusion  Is diagnosed with asthma by a pediatrician following the Global Initiative for Asthma(GINA) guidelines 2022 [8]:  *Medical history fitting asthma diagnosis:  Based on (typical) symptoms: (nighttime) wheezing, dyspnea, coughing (triggered by either viral infections, exercise, allergens or weather changes) (Possibly) supplemented with a family history/atopy  AND  *Spirometry variable expiratory airflow limitation by at least one of these criteria:  FEV1/FVC reduced compared to lower limit of normal(Z-score ≤ -1.64) Positive bronchodilator responsiveness(increase FEV1>12%) Positive Exercise Challenge Test (ECT)(decrease FEV1≥ 13%) Excessive variation in lung function (LF) between tests from different dates (variation FEV1>12% pred)  Exclusion Criteria:  The child and/or parent(s) has/have insufficient command of the Dutch language resulting in the insufficient ability to understand and/or answer questions - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult