rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits
Status: Recruiting

This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  History of unilateral supratentorial ischemic stroke that occurred at least 6 months but not more than 10 years prior to enrollment. Age >40 years and <80 years. Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 20 to 50 (inclusive of 20 and 50). Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands. Right- or left-sided weakness of the upper extremity.  Exclusion Criteria  Participant has implanted metallic or electronic devices in the head or neck Hemorrhagic stroke or a heterogenous lesion etiology Participant has a cardiac pacemaker or implanted or wearable defibrillator Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease Participant has a fever or shows clinical signs concerning for an infectious disease Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study Low heart rate (<60 bpm) from a cardiac conduction block or related etiology Participant has a history of trigeminal neuralgia Participant has a history of Bell's Palsy History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve History of recurrent syncopal events Known or newly-discovered aneurysm or arteriovenous malformation Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days Botox injections 12 weeks prior to or during therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease
Status: Not yet recruiting

This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with CKD and SAH, in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Conservative group: stages 3 and 5 of CKD (GFR from 15 to 59 mL/min), receiving nutritional treatment at the Ambulatório de Nutrição Renal - UFF for at least 6 months, following individual dietary prescription (with energy supply of 25-35kcal/kg/day and 0.6g/kg/day protein, as recommended for this treatment - NKF-KDOQI, 2020). Hemodialysis group: on regular HD treatment for at least 6 months, who have a fistula arteriovenous artery (AVF) as vascular access and who are following a dietary prescription individualized (with energy supply of 25-35kcal/kg/day and protein of 1.0 - 1.2 g/kg/day, as recommended for this treatment - NKF-KDOQI, 2020). SAH group: using one to three antihypertensive drugs, being monitored regularly in the outpatient clinic for more than 6 months, and without the need for changes in the doses of medications in the last 3 months  Exclusion Criteria:  Participants with autoimmune and infectious diseases, diabetes, cancer, and AIDS will be excluded; pregnant women; those using catabolic drugs or antibiotics; with catheter access to hemodialysis; use of antioxidant vitamin supplements, prebiotics, probiotics, symbiotics, regular intake of propolis, and who are allergic to corn starch or report being allergic to bee stings. Participants with acute myocardial infarction (AMI) and/or cerebrovascular accident (CVA) in the last 6 months will also be excluded; with SAH stages 2 or 3 according to the Brazilian hypertension guideline. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Lower Silesia Sinus Reducer Registry
Status: Recruiting

Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation .

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  present of chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) despite maximally tolerated anti-angina medical therapy Heart team evaluation with consideration of ineligibility for percutaneous or surgical revascularization procedures.  Exclusion Criteria:  recent acute coronary syndrome (<3 months), recent coronary revascularization (<3 months) a mean right atrial pressure higher than 15 mm Hg coronary sinus proximal diameter <10mm and >14mm life expectancy under 12 months, advanced heart failure (New York Heart Association [NYHA] Classification - classes 3-4), potential implantable cardiac resynchronization therapy defibrillator (CRT-D) implantation candidate. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will consist of subjects with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) who have not responded to treatment with maximally tolerated anti-angina medical therapy. The local Heart Team will evaluate all patients and determine that they are not suitable for percutaneous or surgical revascularization procedures. Following the Heart Team evaluation, patients who do not have any revascularization options available to them are eligible for the procedure or Coronary Sinus Reducer implantation, unless they meet one of the exclusion criteria. - SamplingMethod: Non-Probability Sample
Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation
Status: Not yet recruiting

End-stage renal disease (ESRD) is a significant clinical problem for which dialysis or transplantation is required. The current need for kidneys for transplantation vastly exceeds the supply available from live donors, necessitating the use of kidneys from deceased donors. However, kidneys from deceased donors are associated with reduced viability, as lack of blood supply upon cardiac death increases tissue damage. In addition, the standard protocol for cold preservation of donor kidneys between procurement and transplantation increases the risk of delayed donor kidney function by 23% for every 6-hours of storage. Moreover, compared to other organs, the kidney is particularly prone to transplantation-induced injury due to its high metabolic activities and oxygen consumption. Hence, any minor disturbances in blood supply can easily lead to kidney injury. Therefore, it is not surprising that deceased donor kidneys have a low tolerance for damage associated with lack of blood supply. The focus of the investigators research has been to pioneer the development and supplementation of existing kidney preservation solutions with novel hydrogen sulfide (H2S) donor molecules to improve kidney viability for clinical transplantation. Specifically, the investigators demonstrated that supplementation of standard kidney preservation solutions with non-clinically viable H2S donor molecules significantly increased donor kidney protection and prolonged transplant recipient survival in murine and porcine models of kidney transplantation. Having shown the same salutary effect using sodium thiosulfate (STS; a clinically viable H2S donor drug) in rat kidney transplantation, the investigators aim to repeat this work using STS in porcine and clinical kidney transplantation.

This single-blind study will enroll participants receiving a kidney transplant. Through randomization, half of the participants will receive STS through administration into the pump the kidney is placed on after procurement from the donor and before transplant to the recipient. Participants will be followed for 1-year post transplant where blood and urine will be collected to determine graft function.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age and over End-Stage Renal Disease Receiving a kidney transplant from a deceased donor (NDD or DCD)  Exclusion Criteria:  Under 18 years of age Inability to provide informed consent Living donor kidney recipients Pregnant individuals Known allergy to study medication or its components (non-medicinal ingredients) Multiorgan transplant patients such as simultaneous kidney pancreas or liver kidney transplants Currently enrolled in another interventional transplant clinical trial, or another clinical trial that in the opinion of the QI and PI would greatly impact the results of this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Management of Open Fracture Tibia in Teenagers
Status: Not yet recruiting

The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes

Eligibility:
- EligibilityCriteria: Inclusion Criteria :  • All patients presenting with isolated open fracture tibia in teenagers (aged 10 to 19 Years old )  Exclusion Criteria:  Patient who refuse to participate in the study Patient less than 10 or more than 19 years old Pathologic fractures Open Fracture tibia with other bony or organ injury Open fracture tibia with soft tissue loss or vascular injury - Gender: All - MinimumAge: 10 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult - StudyPopulation: All patients fulfilling the inclusion criteria presenting to our hospital during the study period will be included in the study in 2024 - SamplingMethod: Non-Probability Sample
Comparing Machine Guided VR Based Training With Educator Guided Training in Metaverse
Status: Recruiting

The main aim of this study is to compare the learning outcomes of machine guided VR based training for adult advanced life support with educator guided training in metaverse environment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteering for the study  Exclusion Criteria:  Previously experienced VR-induced motion sickness Previous Advanced Life Support training Other medical conditions like vertigo attacks Being under medication, which may cause vertigo like symptoms. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration
Status: Recruiting

Severe community-acquired pneumonia still has a high incidence and mortality, but the molecular mechanism and prognostic biomarkers of severe community-acquired pneumonia caused by different pathogens are still unclear, and the best treatment strategy has not been determined. Based on this, this project intends to take patients with severe community-acquired pneumonia caused by different pathogens as the research object, explore the molecular mechanism of severe community-acquired pneumonia from multiple angles, integrate relevant research data to evaluate the rationality of initial empirical medication, and lay the foundation for precise treatment of severe pneumonia. The research results will help to develop a new rapid and accurate target for clinical diagnosis and efficacy evaluation of severe pneumonia, and build a precise treatment system for severe pneumonia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age> 18 years old  Clinical diagnosis of community-acquired pneumonia  Exclusion Criteria:  Pregnancy, perinatal and lactating women  Combined immunosuppressive diseases: such as HIV, solid organ transplantation, solid organ/hematologic malignant tumor chemotherapy, rheumatic diseases or glomerular diseases need to take hormone/immunosuppressant therapy  Combined blood system diseases: such as leukemia reactions, aplastic anemia, neutropenia or deficiency of granulocytes, previous bone marrow/stem cell transplantation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: A prospective cohort including 100 patients with severe and 100 patients with non-severe community-acquired pneumonia and 100 healthy people was selected. - SamplingMethod: Non-Probability Sample
Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.
Status: Not yet recruiting

Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD).

The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system.

Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes.

Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain.

Hypothesis:

Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Crohn's Disease or Ulcerative Colitis. Be over 18 years old. Disorder of the peridiaphragmatic abdominal viscera. Chronic mechanical neck pain.  Exclusion Criteria:  Previous trauma or surgery to the cervical spine. Infection. Congenital vertebral anomaly. Neurological diseases. Signs of neural compression or spinal stenosis. Impossibility of applying neuromodulation (fever, pregnancy, pacemaker, epilepsy, neoplastic processes close to the cervical area and skin alterations). Severe cognitive impairment and communication deficits. Application of physiotherapeutic treatment three months prior to the study. Use of analgesics, anti-inflammatory drugs or relaxants in the 24 hours prior to the intervention. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Status: Recruiting

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.  Exclusion Criteria:  steroids or antiemetics within 1 week of surgery chronic opioid therapy history of allergy to any of the study drug serum creatinine > 1.4 mg/dl liver enzymes > triple the normal limits pregnancy patient refusal and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire laparoscopic surgery is converted to open surgery after enrollment - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL
Status: Not yet recruiting

Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.

This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with kidney stones with a size ranging from 20 to 40 millimeters. Patients have undergone mini-PCNL, unilateral Absence of urinary tract infections before surgery. No urological congenital abnormality No coagulopathy  Exclusion Criteria:  Presence of residual stones after the surgery, fragments larger than 4 millimeters. Patients with a single functioning kidney  Complicated cases, including:  massive bleeding in the upper tract during surgery Severe collecting systems injury during surgery Severe UPJ mucosa swelling considered unsafe by the physician, requiring the placement of a DJ stent or nephostomy tube Participants who decline or request withdrawal from the research study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds
Status: Recruiting

When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age or older Able to give informed consent themselves Patient scheduled for cutaneous surgical procedure on the head or neck with predicted primary closure Willing to return for follow up visit  Exclusion Criteria:  Incarceration Under 18 years of age Pregnant Women Unable to understand written and oral English Wounds with predicted closure length less than 3cm - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity
Status: Recruiting

In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with ankylosing spondylitis according to the Modified New York Criteria Patients with BASDAI score <4.1 who received Anti-TNF therapy for at least 6 months Patients whose maximum inspiratory pressure value is <80% in the Pulmonary Function Test Patients who had a cardiac examination within the last year and no cardiac pathology was detected.  Exclusion Criteria:  The patient has a serious mental disorder Presence of neurological and pulmonary disease that would prevent the patient from using the PFT device Presence of uncontrolled hypertension Presence of uncontrolled diabetes Presence of uncontrolled cardiac arrhythmia Uncontrolled heart failure High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis) Symptomatic severe aortic stenosis Acute pulmonary embolism or pulmonary infarction Severe pulmonary hypertension Presence of systemic infection or malignancy Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS: An RCT
Status: Not yet recruiting

This trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study is a prospective, randomized, controlled trial. A total of 68 patients with CP/CPPS will be recruited. After baseline assessment, the patients will be randomized into taVNS group (n = 34) and sham-taVNS group (n = 34). The intervention of two group will last for 4 weeks with a 8-week follow-up period after the treatment. The National Institutes of Health chronic Prostatitis Symptom Score index (NIH-CPSI), International Prostate Symptom Score Scale (IPSS), European quality of Life-5 Dimensions Questionnaire (EQ-5D), self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) will be assessed. The adverse events during the whole study will be recorded detailedly.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Consistent with the diagnostic criteria of CP/CPPS of EAU or CAU, the clinical manifestations were recurrent and persistent prostate pain accompanied by abnormal urination and psychiatric symptoms, without infection or other obvious pathological conditions. The pain symptoms were mainly manifested as pain in the surrounding tissues centered on the prostate, and pain, swelling or discomfort in the scrotum, testis, lower abdomen, perineum, lumbosacral area, and medial thigh. Abnormal urination was characterized by frequent urination, urgent urination, urination pain, urethral burning, residual urination or white discharge from the urethra at the end of urination or defecation in the morning. The neuropsychiatric symptoms included dizziness and tinnitus, insomnia and dreams, anxiety and depression, and even impotence, premature ejaculation, and spermatorrhea. Symptoms lasting more than 3 months in the last six months; 18 ≤ Age ≤ 50 years old; NIH-CPSI ≥15 (patients with moderate to severe CP/CPPS); Signed informed consent and voluntarily participated in the trial; Patients who met the above four criteria were included in this study.  Exclusion Criteria:  Patients with other diseases that cause urinary symptoms were excluded: Such as benign prostatic hyperplasia, testicular and epididymal and spermatic cord diseases, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumors such as carcinoma in situ, prostate cancer, urinary male reproductive system tuberculosis, anorectal diseases, lumbar diseases, central and peripheral neuropathy, etc; Patients with severe diseases of the heart, liver, kidney, hematopoietic system and poor nutritional status; Patients with severe mental and emotional disorders, who were unable to cooperate with the study; Patients who have been treated with CP/CPPS regimen in the past 4 weeks. Any one of the above items is excluded. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult