rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA
Status: Recruiting

This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.

Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient is at least 18 years of age who are scheduled for a primary elective TKA. Patient can ambulate at least 10 feet independently without human assistance. Patient must be a candidate for same day discharge as determined by American Society of Anesthesiologists (ASA) Physical Status Classification I and II  Exclusion Criteria:  Patients scheduled for bilateral TKAs Contraindication to spinal anesthesia Revision TKAs Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use) Workers' Compensation patient Type I Diabetes Type II Diabetes requiring insulin medication. Pre-operative narcotics use with the exception of tramadol. Renal insufficiency (GFR < 60) that may impact post-operative protocol Cognitive deficiencies that prevent the patient from providing their own informed consent Language barrier preventing completion of study forms in English - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension
Status: Not yet recruiting

In order to reduce the incidence of IOH, various goal-directed therapy (GDT) protocols have already been introduced with success regarding the reduction of postoperative AKI and MINS. However, these studies used an invasive hemodynamic monitoring which offered a continuous surveillance of the blood pressure. In contrast, standard non-invasive blood pressure monitoring results in a blind gap between two measurements (mostly three or five minutes). In order to address this limitation, different continuous non-invasive blood pressure monitoring devices have been introduced. The next evolutional step of non-invasive cardiac output monitoring was to prevent IOH before their onset by using the Hypotension Prediction Index (HPI). Based on the Edward ́s monitoring platform, HPI is a monitoring tool which aims to predict IOH (defined as MAP<65 mmHg for at least one minute) up to 15 min before its onset. The underlying machine learning based algorithm uses analyses features from the pressure waveform and was first calculated from a large retrospective data set of surgical patients and subsequently validated in a prospective cohort. In this study HPI showed a sensitivity of 88% and specificity of 87% for predicting IOH 15 min before its onset. Since then, own and studies of other working groups confirmed the effective prevention of IOH by the use of HPI-based GDT. Until today the arterial waveform analysis was dependent on invasive arterial measurement but since Edwards Lifesciences already promoted the start of the HPI on the ClearSight platform a non-invasive measurement will soon be possible.

Further, until now it has not yet been proven that the perioperative use of a continuous non-invasive blood pressure monitoring has a beneficial effect on the patient´s outcome.

Study objectives The aim of the study is to investigate whether a hemodynamic protocol based on continuous non-invasive cardiac output monitoring (ClearSight system) compared to standard care can reduce the incidence of IOH, postoperative AKI, and MINS in patients undergoing major trauma and orthopedic surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients undergoing major trauma or orthopedic surgery in supine position, which is defined as:  Reconstructive Surgery of the pelvis (e.g., stabilization of fractures) Total hip arthroplasty Surgery of the proximal femur (e.g., stabilization of fractures) Total knee arthroplasty  Surgery of the spine  Performance of general anesthesia with planned duration of &gt;90min Age ≥ 45 years  Exclusion Criteria:  - Predefined exclusion criteria are:  Planned invasive blood pressure monitoring Participation in another interventional study Pregnancy and nursing mothers Surgery without controlled mechanical ventilation ASA I or IV Arterial Fibrillation Allergy against gelantine - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - StdAgeList: Adult, Older Adult
The Relationship Between Scapular Endurance, Core Endurance, and Functional Performance in Adolescent Tennis Players
Status: Not yet recruiting

This study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. The hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. Establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adolescent tennis players  Exclusion Criteria:  Athletes with a history of musculoskeletal injury or surgery in the last year that would prevent the tests from being performed Athletes who feel pain in the trunk and lower extremities during the tests - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 11 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Adolescent tennis players - SamplingMethod: Non-Probability Sample
Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability
Status: Recruiting

The goal of this clinical interventional study is to compare the efficacy of mobile healthcare education in two ways (game-based or text-based) to improve cutaneous self-care capability in cancer patients receiving EGFR-based target therapy. The main questions it aims to answer are:

Impact of different mobile healthcare education ways on cutaneous self-care capability of patients Impact of different mobile healthcare education ways on learning motivation of patients towards cutaneous self-care knowledge and skills

Participants will be randomly divided into two groups. Both groups will download a healthcare education application on their phone. One group will accept the education about the knowledge and self-care skills of cutaneous adverse drug reaction by playing game. In contrast, the other group will accept the same education content by reading text on the phone. Subjects will be asked to use the application at home for two weeks after giving consent to participate this study, and then completed questionnaire three times during study period. The timepoints of completing questionnaire are listed following:

Baseline / pre-intervention test (after signing informed consent form, D1) First post-intervention test (after finishing intervention, D15) Second post-intervention test (D30) Researchers will compare game group and text group to see if game group has better performance on cutaneous self-care capability and learning motivation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults whose age is above 18. Patients are receiving EGFR-base target drugs now. Patients can use smart phone.  Exclusion Criteria:  Patients with visually impaired, hearing impared or other health related factors cause inability to use smart phone. Patients cannot understand study aims and procedures by communicating in Mandarin or Taiwanese. Patients cannot follow study procedures. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
Status: Recruiting

Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Primary tumor of the pelvic bone Primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity in the upper and/or lower jaw. over 10 years of age Primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor aged 7-18 years Intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary aged 18-70years signed informed consent form  Exclusion Criteria:  inoperability; presence of pathological fractures. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult
Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age
Status: Recruiting

Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.

The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.

Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects between the ages of 1 month and 16 years who report to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication (defined as contact with a substance that is toxic per se or in such quantities as to cause a harmful effect on the body or administered by a route not intended for that substance)  Exclusion Criteria:  not acquired informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Month - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: subject between 1 month and 16 years that has reportet to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication - SamplingMethod: Non-Probability Sample
Feasibility Testing a Decision-support Intervention for Clinical Trials
Status: Recruiting

A decision-support intervention are developed for a Danish nationwide randomised controlled trial (RCT) among patients with laryngeal and pharyngeal cancer referred to curative intended radiotherapy. The primary endpoints in this RCT are levels of dysphagia and xerostomia.

The decision-support intervention consists of three components, including (1) a patient decision aid tailored to clinical trial participation and (2) decision coaching consultations carried out by trained healthcare professionals. Finally, (3) a training program in decision coaching will be an integrated part of the intervention.

To feasibility test (beta test) the intervention, 60 patient participants will be included, separated into pre- (n=30) and post- (n=30) intervention groups. Pre-intervention to complete the survey based on current clinical practice. Post-intervention to complete the survey following engagement in the decision support intervention.

A total of 12 physicians will be recruited and trained in decision coaching. To assess the acceptability of the intervention, the physicians will be interviewed. Additionally, they will be asked to audio-record two decision coaching sessions to test the fidelity of the intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with cancer of the pharynx or larynx Received verbal information regarding DAHANCA 35 Read the patient information folder from DAHANCA 35 Above 18 years Danish speaking  Exclusion Criteria:  Dyslexia - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Vaping Adverse Lung and Heart Events Cohort
Status: Recruiting

This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 years or older Daily electronic cigarette user No respiratory infection in the 4 weeks before a visit  Exclusion Criteria:  Women who are pregnant or breast-feeding. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: We seek to recruit 250 volunteers from the community with twice-a-year visits for a 5-year follow-up. We will recruit healthy volunteers as well as volunteers who have been previously diagnosed with chronic illness. - SamplingMethod: Probability Sample
Effects of Exercises on Functional Capacity
Status: Recruiting

In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signing the illuminated consent form, Being smoking at least 1 cigarette for the last 6 months, Not having orthopedic or neurological findings that can prevent the exercises included in the study, To have a low- to medium-level physical activity level, Not to have any lower respiratory infection in the last 3 months.  Exclusion Criteria:  The exercise sessions to be held on time and regularly. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Assessment of Microorganisms and Host Response In Liver Diseases
Status: Not yet recruiting

The normal human gut is home to millions of microbes including bacteria, fungi, and viruses, collectively forming the gut microbiota, which exists in harmony within us. Much research is still required to fully understand the contribution of microbes resident in the large intestine in liver diseases. The liver receives blood from the gut carrying all the necessary nutrients needed for our body but also has to deal with toxins derived from the microbes residing in the intestines. The gut microbiota is altered in liver disease. We still do not know clearly how this change impacts liver function and the health of liver patients. The purpose of our study is to answer this question by assessing the gut microbiota using modern microbiological and molecular methods. By studying the alterations in the gut microbiota in patients with liver disease we can understand how they affect our immune system and metabolism. This will help design novel medicinal products to prevent and treat liver disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Willing and able to provide informed consent Definitive diagnosis of specific liver disease utilising clinical, biochemical, and radiological tests Male or female aged between 18-70 years Able to understand written or verbal information in English  Exclusion Criteria:  Pregnancy and breastfeeding Treatment with antibiotics in the last month Treatment with steroids or immunosuppressive drugs in the last month Regular consumption of over-the-counter prebiotics and probiotics from pharmacies or other retailers in the last month. Known gastrointestinal disease, including but not limited to ulcerative colitis, Crohn's disease, coeliac disease, microscopic colitis, diverticulitis, irritable bowel syndrome Patients diagnosed with cancer who are on chemotherapy, radiotherapy, or immunotherapy within the last 3 months - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients in clinics and wards in secondary care. - SamplingMethod: Non-Probability Sample
Exercise Training for Smoking Students
Status: Recruiting

Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signing the illuminated consent form, To be smoking at least 1 cigarette a day for the last 6 months, Not having orthopedic or neurological findings that can prevent the exercises included in the study, To have low-medium level physical activity level, Not to have any lower respiratory infection in the last 3 months.  Exclusion Criteria:  To the exercise sessions to be held on time and not to arrive regularly - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions
Status: Not yet recruiting

This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. Voluntary participation in this trial and signed the informed consent form; 2. Age: ≥18 and ≤80 years old, regardless of gender; 3. The existence of coronary artery stenosis lesions accompanied by evidence of ischemia in the heart (such as symptomatic coronary heart disease, stable/unstable angina pectoris or asymptomatic myocardial ischemia), suitable for percutaneous interventional therapy.  Exclusion Criteria:  1. Acute myocardial infarction (AMI) within 7 days before surgery; 2. Serum creatinine level >2.0 mg/dL (177 umol/L) within 7 days before surgery; 3. Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery; 4. Stroke or transient ischemic attack (TIA) within 3 months before surgery; 5. Known left ventricular ejection fraction (LVEF) <30% (if LVEF is unknown, it can be measured during this surgery); 6. Known allergies to aspirin or heparin or the existence of contraindications that prevent the subjects from receiving sufficient preoperative medications; 7. Known subjects allergic to ingredients in the test product or contrast agent; 8. Known subjects who are pregnant or breastfeeding; 9. Planned to use coronary atherectomy, laser ablation, other scoring / spiked / cutting balloons (non-study devices) or shock wave balloons to treat the target lesion at the same time; 10. Subjects participating in other drug or device clinical studies; 11. Other situations that are not suitable for participation in this study as assessed by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).
Status: Recruiting

Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.

Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration >1 week) or long-lasting persistent (continuous AF duración >1 year). One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient. Age >=18 years and written informed consent.  Exclusion Criteria:  AF with a reversible cause. Previous pulmonary veins isolation or left atrial linear ablation. Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke <1 month before ablation. Intracranial haemorrhage <3 months before ablation. Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy <1 year. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Precision Study Measuring Potassium (K) in Capillary Specimens
Status: Not yet recruiting

Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed and dated consent form (if required by the IRB) ≥ 18 years of age  Exclusion Criteria:  • Prior enrollment in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Music Therapy After Stroke (Subacute Phase)
Status: Recruiting

The goal of this longitudinal, single-subject study is to investigate the role of motivation in music therapy for stroke patients within the subacute phase, who experience upper limb and/or attention deficits. The main questions it aims to answer are:

Does music therapy increase patient's motivation to rehabilitate?
Do increases in motivation correlate with functional improvements, in particular upper limb and/or attention skills?

Participants will receive up to 9 music therapy sessions within 3-5 weeks, with functional assessments before and after each period. Each participant serves as their own comparison: researchers will compare a period with standard care only (control phase) to a period with music therapy plus standard care (intervention phase), the order of which will be randomized in advance.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects had their first-ever supratentorial stroke between 2 weeks and up to 6 months before enrolment Paretic upper limb and/or attention/ concentration problems Ability to communicate in Dutch or English  Exclusion Criteria:  Severe (global) aphasia paralysis of upper limb severe cognitive decline (MMSE <24) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult