rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response
Status: Not yet recruiting

The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen

Repeated dosing regimen
Standard dosing regimen

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age above 18 years old Atrial fibrillation with rapid ventricular response patient (ventricular rate > 110)  Exclusion Criteria:  Baseline EKG Corrected QT interval (QTc) < 500 msec History of pulmonary fibrosis History of Cirrhosis Cardiac Index <2.2 L/min/m2 or Cardiogenic shock Unstable arrhythmia Receive amiodarone within 3 months prior to present illness Pregnancy Amiodarone or Iodine allergy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Special Drug Use-results Surveillance of Tafinlar/Mekinist
Status: Recruiting

This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who have given written consent to cooperate in this surveillance For patients aged < 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment. Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications  Exclusion Criteria:  Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance Patients with BRAF-mutation-positive malignant melanoma Patients with BRAF-mutation-positive non-small cell lung cancer Patients with BRAF-mutation-positive hairy cell leukemia - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 99 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: patients who used the product for the treatment of BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) as per the package insert. - SamplingMethod: Non-Probability Sample
Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy
Status: Not yet recruiting

In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ASA status 1,2.  Age 18 years or older Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively.  Exclusion Criteria:  • Patient refusal  Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease. Use of drugs that act on the autonomic nervous system (including β- blockers). Coagulation disorders.. Anatomical disorders and/or neuropathic disease. BMI above 40. History of substance abuse. Chronic use of psychotropic and/or opioid. History of psychiatric diseases needing treatment. Allergy to any drug in the study protocol. Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study
Status: Not yet recruiting

This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Type 1 or 2 diabetes Forefoot osteomyelitis Deep tissue infection  Exclusion Criteria:  Pregnancy Severe cognitive impairment Creatinine clearance< 30 ml/min - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
HEARTWISE - P-CARDIAC for Chinese: Population-based Study
Status: Not yet recruiting

Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals aged 18 - 80 years old who visit the medical or cardiology SOPC clinics at the Queen Mary Hospital (QMH), and experienced prior CVD event (such as peripheral artery diseases, coronary heart diseases, myocardial infarction, stroke, revascularization) before the scheduled SOPC clinic visit date are eligible to participate in this study. Participants will be also able to comprehend English or Traditional Chinese as well.  Exclusion Criteria:  People with history of dementia, psychiatric diseases or physical impairment. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Participants with established CVD visiting Queen Mary Hospital during the study period will be recruited. - SamplingMethod: Non-Probability Sample
Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression
Status: Not yet recruiting

Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  any patient with large cystic lesion  Exclusion Criteria:  any patient can't follow home instructions - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 80 Years - StdAgeList: Child, Adult, Older Adult
RAT-HEMATO : Return to Work After Malignant Hemopathy
Status: Not yet recruiting

Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality.

Eligibility:
- EligibilityCriteria: Inclusion Criteria :  Patient with hematological malignancy controlled after treatment Induction/consolidation chemotherapy completed (excluding maintenance therapy) Patient aged 18 to 55 Patient having worked at least 6 months in the 2 years before diagnosis of hematological malignancy Patient who has not yet returned to work since diagnosis of hematological malignancy Signed informed consent form  Exclusion Criteria:  Patient choosing not to return to work Patient not affiliated to a social security system Patient with legal guardian or legal trustee Patient not understanding French Patient with severe cognitive impairment at diagnosis, incompatible with the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients
Status: Not yet recruiting

The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:

Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?
Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Single organ kidney transplant recipient, currently receiving a specific immunosuppression regimen:  Calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30) Calcineurin inhibitor (tacrolimus or cyclosporine), mTOR inhibitor (sirolimus or everolimus), and oral steroid (n = 30) mTOR inhibitor (sirolimus or everolimus), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30) Aged >18 years estimated glomerular filtration rate (GFR) > 15 mL/min/1.73m2 Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)  OR  Healthy household cohabitant of kidney transplant recipient enrolled in trial (n = 30) Aged > 50 years Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)  Exclusion Criteria:  Unable or unwilling to provide informed consent to participate in the trial No previous infection with Varicella zoster (chickenpox) Known allergy to or intolerance of the contents of the SHINGRIX vaccine Current pregnancy For healthy household cohabitants, history of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study
Status: Recruiting

Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients

Eligibility:
- EligibilityCriteria: Inclusion Criteria  age ≥ 18 years ability to provide informed consent; confirmed diagnosis of deep vein thrombosis involving splanchnic veins in liver cirrhosis (with or without hepatocarcinoma); confirmed diagnosis of deep vein thrombosis involving splanchnic veins in absence of liver cirrhosis (with or without portal cavernoma); pregnant patients will be eligible for inclusion in the study; ongoing anticoagulant treatment with vitamin K-antagonists (VKA), direct oral anticoagulants (DOAC), low molecular weight heparin (LMWH), fondaparinux  EXCLUSION CRITERIA  splanchnic vein tumor thrombosis; absence of antithrombotic prophylaxis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Consecutive adult patients referred to the Fondazione Policlinico Universitario Agostino Gemelli IRCCS for SVT, either as inpatients or outpatients, and requiring anticoagulant therapy will be eligible for inclusion in this study - SamplingMethod: Non-Probability Sample
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Status: Recruiting

The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion Patient with 3 ocular intravitreal injections of anti-VEGF in one eye  Exclusion Criteria:  pregnant or breastfeeding woman intravitreal injection before the study intravitreal injection in both eyes allergy of betadine guardianship patient - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: patient with retinal injury who will have 3 injections as the induction protocol (1 injection per month) for one eye and that didn't had any injection before. - SamplingMethod: Non-Probability Sample
Effects of Vitamin C on Skeletal Muscle
Status: Not yet recruiting

As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female, aged 65 years or over Non-smoker (or ex-smoker for at least 1 year). Engages in less than 20 minutes of structured physical activity per week, including cycling. Able to provide informed consent. Able to understand basic instructions in English. Willing to take daily vitamin C or placebo capsules.  Exclusion Criteria:  Consumes more than 3 fruits and vegetables per day, including fruit and vegetable juices. Consumes vitamin C containing supplements, polyphenols, or other antioxidants (e.g. resveratrol or coenzyme q10). Regularly takes anti-inflammatory drugs. Alcohol intake >14 units/week. Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, diagnosed low renal function, neurological disorders or diseases that may affect motor/cognitive functions), except hypertension and hyperlipidaemia. History of kidney stones within the preceding 12 months. Contraindications for undergoing the MRI and exercise study procedures (e.g. major surgery, bilateral hip or knee replacement, non-MRI-compatible pacemaker or metal implants). Parallel participation in another research project that involves an intervention. Relation to, or co-habitation with, a member of the study team. Those who are part of the line manager/supervisory structure of the Chief Investigator. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Biological Females - MinimumAge: 65 Years - StdAgeList: Older Adult
The Effect of HBM-Based Education on Nursing Students
Status: Not yet recruiting

The purpose of the study is to investigate the effect of HBM-based education on CAM knowledge, attitudes, and health beliefs related to medication use among nursing students through a randomized controlled trial.

Research hypotheses:

Hypothesis 01: There is no effect of HBM-based education on CAM knowledge level among nursing students.

Hypothesis 1: There is an effect of HBM-based education on CAM knowledge level among nursing students.

Hypothesis 02: There is no effect of HBM-based education on CAM attitude level among nursing students.

Hypothesis 2: There is an effect of HBM-based education on CAM attitude level among nursing students.

Hypothesis 03: There is no effect of HBM-based education on health beliefs related to medication use among nursing students.

Hypothesis 3: There is an effect of HBM-based education on health beliefs related to medication use among nursing students.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Enrolled in the nursing program at Kafkas University Willing to participate in the study voluntarily  Exclusion Criteria:  - Choosing not to participate in the study voluntarily - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins
Status: Not yet recruiting

This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Each potential participant must satisfy all of the following criteria to be enrolled in the study:  Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations. Subject has voluntarily signed the ICF. Subject must be ≥ 18 years old at the time of signing ICF. Subject is able and willing to take part and be followed-up for the majority of the study duration.  Participants are susceptible to be prescribed any of the following:  Atorvastatin ≥40 mg/day p.o. Simvastatin ≥20mg/day p.o. Pitavastatin≥2mg/day p.o. Rosuvastatin ≥40mg/day p.o. Pravastatin ≥40mg/day p.o. Lovastatin ≥40mg/day p.o. Fluvastatin ≥80 mg/day p.o. Subjects must be naïve to any genotyping test of the following genes: SCLO1B1, ABCG2, CYP2C9, CYP3A4, CYP3A5 and HMGCR. Subjects must be willing to comply and adhere to any treatment plan modifications established and to the procedures specified in this protocol. Women of childbearing potential must commit not to become pregnant. Subjects must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study.  Exclusion Criteria:  Any potential participant who meets any of the following criteria will be excluded from participating in the study:  Subject is currently taking ubiquinone (Q10) supplements. Known personal or family history of statin-associated autoimmune myopathy or HMG-CoA reductase disorder. Pregnant or breastfeeding women  Subject has a personal history or analytical evidence of one of the following disorders:  Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins. Prior SAMS if subject is not statin-naïve. Any condition or situation deemed by the investigator precluding or interfering with the present study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult