rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Status: Recruiting

Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  American Society of Anesthesiologists (ASA) Class I or II; Single healthy pregnancy; Head showing first; 37 to 41 weeks; The labor process is active, and the cervix dilates<5cm; Require epidural labor analgesia; Volunteer to participate in this study and sign an informed consent form.  Exclusion Criteria:  Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes; Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction; Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture; Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate. Patients with long-term use of opioids, steroids, and chronic pain. - HealthyVolunteers: No - Gender: Female - MinimumAge: 20 Years - MaximumAge: 45 Years - StdAgeList: Adult
Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
Status: Not yet recruiting

Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The results of pathology and fungal culture were all patients with sporotrichosis. Informed consent to the purpose and content of the study, and follow-up as required The physical condition and self-condition can cooperate with the treatment.  Exclusion Criteria:  Subjects who are unable to maintain a relatively stable posture during treatment. Those who are sensitive or allergic to this experimental drug. Systemic antifungal or KI therapy within 12 months Local antifungal therapy within 1 month. Previous history of immunodeficiency virus (HIV) infection, or positive HIV antibody in screening period. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Percutaneous Cryoablation of Low-risk Early Breast Cancer
Status: Not yet recruiting

Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Tumour, Node, Metastasis stage (TNM) = dimension up to 15 mm as measured by breast ultrasound, MRI, Mammography, Node negative, absence of distant metastasis Unifocality All invasive cancer, except lobular Biology= luminal A and luminal B* (Estrogen Receptor (ER) positive/human epidermal growth factor receptor-2 (HER2)negative) (Documented estrogen receptor (ER)-positive tumor assessed locally and defined as ≥10% of tumor cells stained positive.  Documented HER2-negative tumor (in accordance to 2018 American Society of Clinical Oncology guidelines, as determined per local assessment)  Any grade (G) Radiological detection= breast ultrasound, MRI, Mammography Tumor site= not located superficially (≥1 cm from the skin plane) Breast size= any, appropriate for the procedure in relation to ultrasound examination Referral to breast cryoablation by a multidisciplinary tumor board Planned treatment with cryoablation using IceCure (TM-trade mark) system Informed consent *Luminal B and G3 BC: previous specific patients' selection and Oncotype Dx [31] on cancer tissue from needle biopsy before procedure and eventual Prediction Analysis of Microarray 50 (PAM50) test.  Exclusion Criteria:  Plurifocality Invasive lobular breast cancer HER2 overexpressed or Triple Negative Breast Cancer (TNBC) tumor dimension >15 mm Node positive post NeoAdjuvant ChemoTherapy (NACT) breast cancer <50 years Presence of intraductal component (DCIS) Absence of psychological compliance in understanding and adhering to rationale of the study Inability to perform MRI Breast augmentation with implants - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergone percutaneous cryoablation of early stage breast cancer - SamplingMethod: Probability Sample
Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level
Status: Not yet recruiting

The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnancy week between 24 and 34, Able to read and write Turkish, No communication problems, Those who voluntarily agreed to participate in the research  Exclusion Criteria:  Those who have risky pregnancies, Those with diagnosed psychiatric problems, Participating in a different training program (meditation, relaxation, etc.) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block
Status: Not yet recruiting

Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.

The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy  Exclusion Criteria:  Allergy to the study medications . Patients will also be excluded if they have history of chronic pain conditions, opioid dependence or if they received prolonged analgesic therapy prior to surgery. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult
Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease
Status: Not yet recruiting

Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.

This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years Diagnosis of CKD defined as at least one hospital encounter with the following ICD-10 codes in the primary diagnostic positions ≤ 5 years before intervention delivery: N18- N19, I12, E102, E112, E132, E142 Access to the official, mandatory Danish electronic mailbox system  Exclusion Criteria:  None - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Synbiotic Supplementation in Cyclists
Status: Not yet recruiting

The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.

The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female between the ages of 18-45 Currently cycling for at least 3 hours per week for the past 3 months Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively.  Exclusion Criteria:  Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period) Current laxative use Are a smoker or use tobacco products Consume >21 units of alcohol per week Have donated blood in the previous 3 months Have a BMI ≥30kg/m2 Are pregnant or lactating or planning to become pregnant for the duration of the study Are dieting for weight loss or are following a low carbohydrate diet Have participated in another clinical trial within the 30 days preceding study enrollment Are taking medications known to affect cardiovascular or metabolic responses to exercise Have a medical condition that could interfere with study intervention and assessment Have current musculoskeletal injuries that limit exercise capacity Are non-English speaking - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Cetylated Fatty Acid for Reducing Pain After TKA
Status: Recruiting

To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 50-80 years Osteoarthritic knee patients underwent unilateral primary TKA Participants understand and consent to the protocol of the trial  Exclusion Criteria:  Inflammatory knee arthritis Previous knee surgery or trauma Previous knee infection Skin problem around the knee such as eczema, psoriasis, wound infection Allergy to studied drug - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO
Status: Not yet recruiting

The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years old, both male and female. Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).  Exclusion Criteria:  Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) . Other inflammatory diseases. Active autoimmune diseases. Pregnant or lactating women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest
Status: Recruiting

The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients after cardiac arrest  Exclusion Criteria:  refused register participation by patient or legal representative - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients treated after out-of-hospital cardiac arrest - SamplingMethod: Probability Sample
Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark
Status: Recruiting

The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.

The objective of this project is to describe:

The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.
The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.
Outcomes available for assessment of benefits and harms from the SET intervention.

Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Relevant symptoms of intermittent claudication; leg pain when walking due to arteriosclerosis and relieve of symptoms during rest. Distal blood pressure with an ankle-brachial index (ABI) > 50 mmHg for non-diabetics or toe brachial index (TBI) > 40 mmHg for diabetics.  Exclusion criteria:  • Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke
Status: Recruiting

Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age - < 75 years; type of stroke - ischemic; structure of the lesion - cerebral hemisphere; disease type - primary; functional ability to walk for at least 5 minutes without using external means of support; absence of reduced higher mental functions, sensorimotor aphasia, muscle tone in the limbs above 2 points according to Ashworth (Modified Ashworth Scale); no history of orthopedic and neurological pathology; absence of pronounced pain syndrome  Exclusion Criteria:  Signs of orthostatic hypotension during training, patient desire to withdraw from the study, neurological deficit worsening. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
WORK-ON Vocational Rehabilitation
Status: Not yet recruiting

People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues.

Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥18 years Diagnosed with RA, PsA or ax-SpA by a rheumatologist. Undertakes paid work (full or part-time work or studying) Answers "unlikely" or "not certain" to question #6 from the Work Ability Questionnaire (WAI): "Do you believe, according to your present state of health, that you will be able to do your current job two years from now?" Willing to participate in a trial of the modified WORK-ON intervention.  Exclusion Criteria:  Planned adjustment or change in pharmacological anti-rheumatic treatment. Morbidities other than IA that may explain reduced work ability. Under examination for comorbidities influencing their work ability. Had major surgery within the past six months or if future surgery is planned Unable to understand or speak Danish at a sufficient level to participate. Cognitive or psychological impairments that may affect participation. Involved in another rehabilitation program (apart from physiotherapy). An ongoing retirement application process or do not plan a retirement within the next three years. On long-term sick leave (> 4 weeks). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult