rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
Status: Not yet recruiting

Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA >6 mm2 would indicate no revascularisation, a MLA <4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged ≥18 years Patients with intermediate lesion in the LMCA (Left Main Coronary Artery) (25-60% angiographic stenosis by visual estimation) in whom a study with intracoronary imaging technique is considered (at least one pullback with IVUS (Intravascular ultrasound) and OCT (OPTICAL COHERENCE TOMOGRAPHY) from one of the main branches is mandatory). Patients able to give informed consent form.  Exclusion Criteria:  Patients with indication for coronary surgery regardless of significance of LMCA lesion. Patients with LMCA lesion showing ulceration, dissection or thrombus. Patients with lesion in a previous functioning arterial or venous graft in the territory supplied by the LMCA (protected LMCA). Patients with acute coronary syndrome with potentially culpable injury in LMCA. Patients unable to give informed consent. Patients with ostial LMCA lesion. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with intermediate lesion in the LMCA (Left Main Coronary Artery) (25-60% angiographic stenosis by visual estimation) in whom a study with intracoronary imaging technique is considered (at least one pullback with IVUS (Intravascular ultrasound) and OCT (OPTICAL COHERENCE TOMOGRAPHY) from one of the main branches is mandatory) - SamplingMethod: Non-Probability Sample
Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer
Status: Recruiting

A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with malignant tumors of the head and neck without metastasis Age ≥18, ≤80 years old ZPS score ≤2 Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy, including at least one parotid gland Judged to be able to receive acupuncture treatment, with all needle positions identified as accessible Signed informed consent form  Exclusion Criteria:  History of dry mouth, Sjogren's syndrome, or other underlying systemic condition known to cause dry mouth Suspected or confirmed physical closure of both salivary gland ducts Have a phobia of needles or prohibit the use of acupuncture at any acupuncture points Have a history of head and neck radiotherapy Have contraindications to acupuncture, including but not limited to bleeding disorders, having skin infections, ulcers or frequent infections Have taken any medications or herbs within the past 30 days that may affect salivary function, plan to or eventually take such substances during the study period Poor oral hygiene or severe periodontitis Poor compliance Other patients who, in the opinion of the investigator, are not suitable for participation in this study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Exercise Rehabilitation for Children With Asthma
Status: Not yet recruiting

Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with bronchial asthma; No acute asthma attacks in the past three months; Currently undergoing stable prophylactic treatment for asthma, with no changes in the treatment plan in the past three months.  Exclusion Criteria:  Suffering from other severe heart, lung, or musculoskeletal diseases; Frequent acute asthma attacks or recent hospitalization records; Changes in asthma medication treatment plan in the last three months; Currently participating in other clinical trials that could affect the results of this study; Any medical contraindications, such as severe exercise-induced asthma or other health issues affecting the ability to exercise; Severe psychological or behavioral issues that may affect participation in training or adherence to the research protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 17 Years - StdAgeList: Child
Comparison of Patient Satisfaction With Home Induction and In-patient Induction.
Status: Recruiting

Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.

Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.

Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patient Singleton pregnancy Indication for induction of labour ≥ 37SA+0d Unfavourable cervix (Bishop<6) Living less than 30 minutes' drive from hospital Having a relative at her side for a return home  Exclusion Criteria:  Scarred uterus : previous caesarean section or myomectomy Premature rupture of membranes Fetal death in utero Placenta previa/accreta/percreta Severe maternal pathology : decompensated respiratory, cardiac, hepatic, renal, digestive or psychiatric disease, severe pre-eclampsia, severe growth retardation or anamnios Patient under guardianship, curatorship or safeguard of justice - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Any pregnant woman with a singleton pregnancy, giving birth at the Saint-Etienne University Hospital, with an indication for induction of labour from 37SA. The indications could be for a maternal pathology, a maternal wish or a foetal pathology. - SamplingMethod: Non-Probability Sample
Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage
Status: Not yet recruiting

Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients > 40 years old. CON (non diabetes control group)：patients undergoing phacoemulsification surgery. NDR (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery. NPDR (non proliferative diabetes retinopathy): patients with history of diabetes, fundus microangiopathy shown by fundus fluorescein angiography, including microangioma, hard exudation, wadding exudation and other non proliferative diabetes retinopathy signs, and did not receive invasive ophthalmic treatment within 3 months. PDR (proliferative diabetes retinopathy): patients with a history of diabetes, fundus neovascular lesions shown by fundus fluorescein angiography, and did not receive invasive ophthalmic treatment within 3 months. Patients voluntarily signed informed consent.  Exclusion Criteria:  CON (non diabetes control group)：patients with a history of other ophthalmic operations. NDR (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history. NPDR (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography. PDR (proliferative diabetes retinopathy):patients undergoing vitrectomy。 Patients with active ocular inflammation, high myopia, pregnancy. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: CON (non diabetes control group)：Non diabetes patients undergoing phacoemulsification surgery. NDR (non diabetes retinopathy diabetes patients): Non DR diabetes patients undergoing phacoemulsification surgery. NPDR (non proliferative diabetes retinopathy): DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery. PDR (proliferative diabetes retinopathy): DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery. - SamplingMethod: Non-Probability Sample
Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact
Status: Recruiting

There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.

Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.

Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.

Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.

Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).

Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).

Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients&#39; and health professionals&#39; experiences on health care, as well as improve patients&#39; health.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service In possession of an email account and having basic knowledge of how to manage emails In possession of a smartphone, computer, or tablet with access to the Internet Fluent and able to read in Spanish  Exclusion Criteria:  - Under 18 years of age - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome
Status: Not yet recruiting

Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Have a diagnostic of PSPS-T1/2 with leg pain and back pain, Patients older than 18 years 6 months with pain Visual Analogue Scale score >7 Spanish native language  Exclusion Criteria:  Previous surgeries in abdominal area Pregnant or lactating Severe fractures or pathologies Spine structural deformity Neurologic or psychiatric issues. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Internet-Based Self-Help Intervention for Social Anxiety Symptoms
Status: Not yet recruiting

This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.

The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  volunteering to participate in the study; having a valid e-mail address; having internet access (computer, laptop, tablet, or mobile device); being aged 18 or older; score of 25 or above on both anxiety and avoidance subscales of the Liebowitz Social Anxiety Scale Turkish Form  Exclusion Criteria:  receiving any psychological help (i.e., medication or psychotherapy/counseling) during the research period - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Influencing Factors for Physical Activity in People With Head and Neck Cancer
Status: Not yet recruiting

The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.

Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:

What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?
What motivates people with advanced head and neck cancer to be physically active?
How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?

The interviews will be transcribed verbatim and analysed with a structuring content analysis approach.

Eligibility:
- EligibilityCriteria: Inclusion criteria for people with head and neck cancer:  minimal age 18 diagnosis of a primary head and neck squamous cell carcinoma within the last 24 months oral, pharyngeal, or laryngeal cancer stage III or IV completed surgery and/or radio(chemo)therapy in curative intent  Exclusion criteria for people with head and neck cancer:  not having the physical, mental, and cognitive ability to understand, follow and hold a conversation in (Swiss-)German treatment in palliative intent recurrence of the head and neck tumour (local or distant)  Inclusion criteria for significant others of people with head and neck cancer:  minimal age 18 being a significant other (partner, spouse, close family member or friend) of an individual with a head and neck cancer with the above-mentioned criteria having the permission of the individual affected by head and neck cancer to talk about their experiences  Exclusion criteria for significant others of people with head and neck cancer:  - not having the physical, mental, and cognitive ability to understand, follow and take part in a group discussion in (Swiss-)German - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: individual interview participants: 12 individuals with a diagnosis of a stage III or IV head and neck squamous cell carcinoma, after surgery & (chemo)radiotherapy  focus group interview participants: 8 significant others (partner, spouse, close familiy member or friend) of individuals with a diagnosis of a stage III or IV head and neck squamous cell carcinoma - SamplingMethod: Non-Probability Sample
Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)
Status: Recruiting

The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to <60 mL/min/1.73m^2 Mean seated office SBP ≥140 mmHg and ≤170 mmHg 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM Must be on stable therapy with 2 to 4 classes of antihypertensive medications  Exclusion Criteria:  Secondary hypertension Orthostatic hypotension Proteinuria >3 g/day Serum potassium >4.8 mEq/L - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery
Status: Recruiting

Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).

For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.

For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.

Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively.

Eligibility:
- EligibilityCriteria: INCLUSION CRITERIA:  Patients aged 18 or older. American society of anesthesiologists' (ASA) physical status of I-III. Elective open colorectal surgery.  NON INCLUSION CRITERIA:  Patients with contraindications to lidocaine or ketamine. Corticosteroid therapy within the last 6 months. History of immunosuppressive therapy. History of surgery in the last 3 months. Personal medical history of inflammatory bowel disease. Personal medical history of cardiac arrythmias or conduction disorders. Alcohol or drug abuse. Chronic use of opioids or benzodiazepines.  EXCLUSION CRITERIA:  Severe intraoperative complications. Duration of surgery longer than 5 hours. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult