rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula
Status: Recruiting

Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients in need of AVF for hemodialysis due to end-stage renal failure, Patients aged 18 and older but younger than 70, Patients who have not undergone dialysis before, Patients with normal sinus rhythm on EKG, Patients with triphasic flow in upper extremity arterial Doppler ultrasonography, Patients with a minimum vessel diameter of ≥2 mm for arteries and ≥2.5 mm for veins on Doppler ultrasonography.  Exclusion Criteria:  Patients with reduced ejection fraction (EF) (<50%), Patients with heart valve disease, Patients with coronary artery disease or those who have undergone coronary artery bypass grafting surgery, Patients with a history of fistula creation, Patients undergoing fistula revision, Patients with peripheral vascular disease, Patients with venous embolism/thrombosis or occlusion history in the upper extremity superficial/deep venous system, superior vena cava, Patients with arterial embolism or occlusion in the upper extremity, Patients with burn scars in the upper extremity, Patients with atrophy/paralysis/plegia in the upper extremity, Patients with uncontrolled diabetes, Patients with connective tissue disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergoing the first-time autologous arteriovenous fistula creation surgery in end-stage renal failure will be included in the study. - SamplingMethod: Probability Sample
Video-conferencing FACT for Young Children With Special Needs
Status: Recruiting

Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.

Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.

Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.

Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.

Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Language and Residency: Must be a Cantonese-speaking Hong Kong resident aged 21 years or older. Child's age and health status: Must be cohabiting with a preschool or school-aged child (2-9 years old) diagnosed with or suspected of having special needs. Caregiver role: Must be the primary caregiver responsible for daily care for the child. Technology access: Must have daily access to a smartphone, with either an iPhone or Android operating system, to participate in the study and for potential app-based interventions or communications.  Exclusion Criteria:  Any parents with severe mental illness, are pregnant, are less than six months postpartum, or have a developmental disability that interferes with their ability to comprehend the programme's content. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer
Status: Not yet recruiting

This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men aged between 45 - 75 years Life expectancy > 10 years upon recruitment Able to understand the trial and can provide informed and written consent, dated and signed before the enrollment and before any exam required by the trial Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy Organ-confined prostate cancer on MRI PSA < 20 ng/mL  1-2 MRI visible lesion present and size ≤15mm, with targeted biopsy showing:  ISUP grade group 2 or 3, or ISUP grade group 1 with tumor size ≥10mm  Exclusion Criteria:  Patients not fit for general or spinal anaesthesia Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of <50 ml/min) Patients with coagulopathy that cannot be corrected Patients on anticoagulants or antiplatelets that cannot be stopped (Low dose Aspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMA treatment) Patients with previous treatment of prostate cancer Patients with prior pelvic radiotherapy for prostate cancer or other cancer Patients with maximal length of target lesion >15mm Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI . Patients with >2 areas (MRI-visible or invisible) of prostate cancer Patients with Gleason score 4+4 or any Gleason pattern 5 cancer Patients with systematic cores showing any Gleason 4 pattern PCa which are not adjacent to the target lesions (1 core of pure Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable) Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable) Patients with bladder pathology including bladder stone and bladder cancer Patients with known urethral stricture Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection. - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - MinimumAge: 45 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
The Comparisonof Mediastinal/Hilar Lymph Node Biopsies by EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB
Status: Not yet recruiting

The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic efficacy and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB) in mediastinal/hilar lymph node biopsies.

Participants will divided into EBUS-TBNA group, EBUS-TBCB group, and EBUS-TBFB group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBCB, or EBUS-TBFB according to the group.

Researchers will compare the adequacy of sampling by the three biopsy techniques, their sample quality, diagnostic rate, and incidence of each adverse events.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 15 years; At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure; Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.  Exclusion Criteria:  The lesion is a mediastinal cyst or abscess; Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy; EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy; EBUS did not detect lesions in the hilum and/or mediastinum; Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult
A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
Status: Recruiting

This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject has a confirmed diagnosis of Notalgia Paresthetica. Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica. Subject has moderate to severe pruritus. Subject is able and competent to read and sign the informed consent form (ICF).  Exclusion Criteria:  Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica. Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Lemborexant Treatment of Insomnia Linked to Epilepsy
Status: Not yet recruiting

The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Sleep-related focal epilepsy Contraception  Exclusion Criteria:  Changes in antiseizure medication 1 month before study protocol or during study protocol Concomitant medications per SUNRISE1 Individuals with hepatic impairment Female participants who are pregnant or breastfeeding Individuals with compromised respiratory function Individuals with a history of complex sleep-related behaviour Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation Individuals with a diagnosis of narcolepsy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
Status: Recruiting

According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Able to provide consents and agree to follow the trial requirement and assessment; Age >=18 ECOG score: 0 or1 Biopsy pathological diagnosis as MSI-H/dMMR( both IHC and PCR method required) Measurable and assessible primary tumor sites according to RECIST 1.1 Able to provide 22ml peripheral blood for assessment for ctDNA With all organ function sufficient No bowel obstruction or fistula No previous chemotherapy, radiotherapy and immunotherapy accepted history Distant metastasis excluded before surgery by CT scan Contraception required for women for the whole enrollment time until 3 months after last dose of immunotherapy  Exclusion Criteria:  self-autoimmune diseases history such as SLE People who using the immune suppressor Severe allergy to other mono-clone antibody Cerebral metastasis which hasn't be managed yet Hypertension(SBP>140mmHg，DBP>90mmHg) Uncontrolled diabetes(FBG>10mmol/L) Accepted anti-PD-1 or anti-PD-L1 immunotherapy in the past Uncontrolled heart diseases such as NYHA II heart failure, unstable angina , cardiac infarction in 1 year and arrhythmia Systemic inflammation which needs whole body treatment Urine routine: protein >=++ or 24hr urine protein>=1g Innate or acquired immune deficiency like HIV and HBV Enrolled in other clinical trial already Confirmed as metastasis before the surgery Other malignancies has been diagnosed before Tuberculosis Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases
Status: Recruiting

The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  all nurses staff  Exclusion Criteria:  nurses who refuse participation - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: all nurses - SamplingMethod: Non-Probability Sample
Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy for Peripheral Lung Cancer
Status: Recruiting

This research aims to develop an innovative photodynamic therapy (PDT) for peripheral lung tumors. Current treatments involve surgery, chemotherapy, and radiation. Photodynamic therapy, using light and photosensitizing drugs, is promising but has limitations. Our team proposes using Lipiodol, a contrast agent, instilled into the trachea via bronchoscopy, surrounding the tumor. Preliminary pig model trials showed safety. Clinical trials, building on a U.S. study (NCT02916745), commenced in October 2021, treating three cases. Initial results suggest safety, but efficacy requires further investigation. Based on ongoing trials, we propose a phase I trial with multiple light treatments from different directions and an additional dose after 48 hours to assess safety and efficacy. This study will guide future clinical trials for optimal PDT dosage.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with advanced or terminal malignant lung tumors (including primary lung cancer and lung metastases from other cancers). Patients who have failed standard treatments (surgery, radiotherapy, or first and second-line chemotherapy/immunotherapy/targeted therapy) or are unsuitable for standard treatments. Tumor size less than or equal to 3 cm, clearly assessable on chest computed tomography.  Patients capable of providing informed consent and willing to undergo regular follow-ups during the trial.  Exclusion Criteria:  Diagnosis of small cell lung cancer or non-solid malignancies. Tumors located in the central part of the lungs. Previous radiation therapy to the treatment site. Abnormal blood biochemical values. Chemotherapy received within the past 4 weeks. Tumor invading major blood vessels. Allergy to porphyrins or porphyrin-related metabolites, or allergy to Lipiodol or iodine-containing contrast agents. Planning radical surgery for lung tumors within the next 90 days. Potential need for slit lamp ophthalmic examination within the next 30 days due to existing eye diseases. Inability to undergo bronchoscopy due to mental health conditions. Pregnancy, planning pregnancy, breastfeeding, or planning to breastfeed within the next 6 months. Previous photodynamic therapy within the past 1 month. Severe kidney or liver disease with abnormal function. Planning to participate in other cancer treatment clinical trials within the next 3 months. HIV-positive patients. Individuals deemed unsuitable for the trial by the principal investigator and the safety monitoring committee due to severe illnesses. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia
Status: Not yet recruiting

Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.

Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.

Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with cancer by Western medicine doctors. regardless of cancer type, gender. aged 20 or above, experiencing WBC < 3000/μL or ANC < 1500/μL for the first time after starting chemotherapy.  Exclusion Criteria:  Patients not suitable for moxibustion, including those with wounds at moxibustion points. Patients who refuse to sign the consent form. Minors, pregnant women, individuals with mental illnesses, those vulnerable to harm, or in disadvantaged groups. Patients with leukemia, where the disease itself affects changes in blood cells. Patients currently receiving other forms of Traditional Chinese Medicine treatment or alternative therapies that may increase white blood cell counts. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Status: Not yet recruiting

The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:

To determine oncologic outcomes, specifically 2-year recurrence-free survival
To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
To determine time to recurrence and recurrence patterns
To determine use of adjuvant therapies
To determine perioperative complications

Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults > 18 years Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade) Planned for nephroureterectomy by their urologic surgeon Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis. No concomitant muscle-invasive bladder cancer Subjects must have the ability to understand and the willingness to sign a written informed consent document.  Exclusion Criteria:  Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (>cN0) Presence of distant metastases Concomitant muscle invasive bladder cancer The participant is in a reduced general condition or has a life-threatening disease. The participant has a psychiatric disorder that precludes them from understanding the consent process. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain
Status: Not yet recruiting

The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms .

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The age of the subjects will be ranged from 20 to 35 years. All participants had vaginal delivery with episiotomy. They are in late post partum period over 6 months Their BMI will be ranger from 25 to 30 kg/m2. All participants have mechanical low back pain. All participants have perineal pain. The Number of parity Ranged from 2-3 times.  Exclusion Criteria:  Females will be excluded if they have any spine or lower extremities injuries or previous surgeries. Females with radicular back pain. Inability to understand the written and verbal instruction. Females had irregular menstrual cycle - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 35 Years - StdAgeList: Adult