rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Analysis of the Pulmonary Microbiome
Status: Recruiting

The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with acute respiratory failure Patients with suspect of pneumonia  Exclusion Criteria:  pregnancy age < 18 years - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population consists of three groups: one ICU-patients with a diagnosis acute respiratory failure, another group of non - ICU patients, and finally, a control group of individuals without pulmonary involvement. - SamplingMethod: Non-Probability Sample
Reducing ESKAPE Transmission in the Operating Room
Status: Recruiting

This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria: Adult patients undergoing surgery requiring general anesthesia and peripheral IV and/or central line placement.  Exclusion Criteria:  Pediatric patient, not requiring general anesthesia and/or IV/central line placement. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients undergoing surgery requiring general anesthesia and intravascular access. - SamplingMethod: Probability Sample
Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process
Status: Not yet recruiting

Radiation therapy (RT) is a key component in the treatment of breast and prostate cancer. However, patients may experience significant side effects. Patients can accurately self-report side effects from RT and these patient-reported outcomes (PROs) can direct communication between patient and healthcare provider (HCP), and facilitate joint decision making.

Patients state that using mobile phone applications (apps) to collect PROs (mPROs) is easily incorporated into their daily routines, allowing them to engage at a time and pace that suits them. When mPRO collection is combined with remote symptom monitoring by HCPs, these systems result in improvements in symptom control and quality of life.

Currently, patients receiving RT are seen by a Radiation Oncologist once per week during RT and once every few months after RT has finished. Recent evaluations indicate that patients and physicians consider the number of visits to be too frequent during RT, and too infrequent immediately after RT. This research will use weekly mPROs (remotely monitored by RT HCP) to determine if a patient needs (or wants) to be seen by a RT HCP during and/or immediately after RT.

Using mPROs to optimize RT patient assessment processes will ensure patients are seen if and when required. For a patient, this could result in reduced time and costs at the hospital. For the physician, resources could be re-allocated to improve access to RT services. Using mPROs after RT has the potential for earlier treatment of side effects, which has been linked to improved survival and quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical diagnosis of breast or prostate cancer About to receive a course of radical or adjuvant radiation therapy as an outpatient at Princess Margaret Cancer Centre Able to enter PRO responses into the mobile app in English or French  Exclusion Criteria:  Significant comorbidities that would render the patient not suitable for remote monitoring - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
COVID-19 Antibody Responses In Cystic Fibrosis
Status: Recruiting

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments.

Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Consenting people with cystic fibrosis of any age, genotype, transplant status and disease severity  Exclusion Criteria:  Refusal to give informed consent Contraindication to venepuncture  Participants already enrolled in a clinical trial are eligible for enrollment in this study. Inclusion in CAR-CF should not preclude enrollment in other observational clinical trial studies or clinical trials of an investigational medicinal product (CTIMP). - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Consenting people with cystic fibrosis of any age, genotype, transplant status and disease severity will be eligible to participate in the study. The study population is expected to be representative of the general CF population. - SamplingMethod: Non-Probability Sample
U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block
Status: Recruiting

The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female patients. Scheduled for unilateral conservative mastectomy. Age 18-65 years. American Society of Anesthesiologists (ASA) physical status I- II.  Exclusion Criteria:  Patient refusal. Coagulation disorders. Body mass index > 40 kg/m2. Uncooperative or psychiatric patients. Infection at the injection site. Patients with a history of allergy to local anesthetics. Patients with a history of treatment for chronic pain. Previous history of breast surgery or other chest surgery. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
Status: Not yet recruiting

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects must have completed a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol. Evidence of an informed consent document, signed and dated by the subject or his/her legal representative, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP). WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.  Exclusion Criteria:  Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee). Have any other condition or reason that, in the opinion of the Investigator or in the opinion of the Sponsor's MM (or designee) in consultation with the Investigator, would prohibit the subject from participating in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Status: Not yet recruiting

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF). Pediatric patient (<18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liver dysfunction at the time of enrollment and is expected to require Omegaven treatment for at least eight weeks. Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN.  Exclusion Criteria:  Patient has received Omegaven within four weeks before inclusion in the study Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc. Patient has known cirrhosis (liver biopsy is not required under this protocol). Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis. Patient has previously received a liver-only or liver-inclusive transplant. Patient has hemodynamic instability due to any major cardiac anomaly. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer). Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention. Patient has renal failure and requires renal replacement therapy. Patient has a severe hemorrhagic disorder. Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level > 1,000 mg/dL). Patient has a record of EFAD before inclusion in the study Patient has been diagnosed with or is suspected to have an inborn error of metabolism. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven. Patient is subject to treatment limitation. Patient is enrolled in any other study with an investigational medicinal product during the course of the current study. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 17 Years - StdAgeList: Child
Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction
Status: Not yet recruiting

The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients recommended to receive a nail biopsy procedure in our specialty nail clinic.  Exclusion Criteria:  Age less than 18 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Visually Impaired Women Model-based Cancer Education and Breast Self-examination
Status: Not yet recruiting

The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being visually impaired Volunteering to participate in research Not having any disability other than visual impairment Being knowledgeable individuals who can communicate Not being diagnosed with breast cancer  Exclusion Criteria:  Not being willing to participate in the research Not filling out research-related forms completely Abandoning the study at any time during the research - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Visually impaired women aged 20-69 - MinimumAge: 20 Years - MaximumAge: 69 Years - StdAgeList: Adult, Older Adult
Responses to E-cigarette Message Source and Presentation
Status: Not yet recruiting

The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  US residents ages 18-24 Fluent in English Reporting either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping  Exclusion Criteria:  Age less than 18 or above 24 Not fluent in English Not a member of partnering crowdsourcing behavioral research platform conducting the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 24 Years - StdAgeList: Adult
Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites
Status: Not yet recruiting

The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.

The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study.

Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients hospitalized in the Heart-Lung Unit of the Montpellier University Hospital, for any reason whatsoever Patient with lower extremity artery disease (LEAD) (stage 1 to 4 according to Leriche and Fontaine) or not (absence of LEAD) Age ≥ 18 years  Exclusion Criteria:  Patient with a metal implant in the vicinity of the device's area of use Patient requiring additional hygiene precautions Subject not affiliated to a social security scheme or not benefiting from such a scheme. Pregnant or breast-feeding woman, patient unable to give consent, protected adult, vulnerable persons Subject deprived of liberty by judicial or administrative decision Patient refusing to give consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
Status: Not yet recruiting

The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.

The main question it aims to answer:

- Is there a significant decrease on anxiety level thanks to VR-assistance?

Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.

Researchers will compare standardised anxiety scores with a control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Indication for prostate biopsies Informed consent  Exclusion Criteria:  Local anaesthesia contra-indication (allergy) Claustrophobia Major cognitive impairment and impossibility of answering the standardised questionnaires - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury
Status: Recruiting

The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with a traumatic or non-traumatic spinal cord injury and have ≥4/5 strength in at least one cervical 5 myotome (elbow flexors), allowing to utilize the arm ergometer and level of injury at or above the 6th thoracic vertebra Classified as A, B, C, D (motor and sensory complete or incomplete) on the American Spinal Injury Association (ASIA) Impairment Scale (AIS) Longer than 6 months post the onset of injury and have been discharged to the community from inpatient rehabilitation prior to enrollment English is the first language At least one of the cerebral arteries (i.e., middle cerebral artery and/or posterior cerebral artery) can be found via transcranial Doppler  Exclusion Criteria:  Medical conditions that preclude exercise, such as unstable angina, uncontrolled arrhythmias, a recent history of congestive heart failure that has not been evaluated and effectively treated, severe valvular disease, uncontrolled hypertension (i.e., resting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg) Moderate-severe traumatic brain injury Diabetes Color blindness Pre-existing shoulder injuries Pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study will include people with SCI with level of injury T6 or above and age- and sex-matched non-injured controls. - SamplingMethod: Non-Probability Sample
IVUS CHIP China Registry
Status: Not yet recruiting

The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The patient must be ≥18 years of age  Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:  Angiographic heavy calcification Ostial lesions True bifurcation lesions involving side-branches >2.5mm Left main lesions Chronic total occlusion In-stent restenosis Long-lesions (estimated stent length > 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS) All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions) The patient is willing and able to cooperate with registry procedures and follow-up until registry completion Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee  Exclusion Criteria:  ST-elevation myocardial infarction or cardiogenic shock within prior 7 days Known untreated severe valvular heart disease Requiring PCI in a diseased aorto-coronary bypass Known contraindication or hypersensitivity to anticoagulants Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors Non-cardiac co-morbidities with a life expectancy less than 1 year Currently participating in a clinical trial that is not yet at its primary endpoint. The patient is not allowed to participate in an investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study Women who are pregnant or who are breastfeeding Subject's circumstances that will not allow appropriate consenting procedures or follow-up activities (per investigator's discretion) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: IVUS-guided approach in patients with complex coronary lesions undergoing PCI - SamplingMethod: Non-Probability Sample