rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
Status: Recruiting

Trial design: A single centre phase II non-randomised study

Trial population: Men with intermediate risk localised prostate cancer

Recruitment target: 20 patients in total

Trial objectives:

Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects

Secondary

To assess levels of acute GU and GI toxicity (CTCAE)
To assess levels of late GU and GI toxicity (CTCAE)
To assess late sexual quality of life (expanded EPIC, IIEF-5)
To assess biochemical relapse-free survival at 2 years

Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men aged ≥18 years Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3) MRI stage T2 or less (as staged by AJCC TNM 2018) MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology Dominant lesion &lt;50% of prostate on any axial slice and &lt;50% total prostate volume PSA &lt;20 ng/ml prior to starting ADT Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. LHRH analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. WHO Performance status 0-2 Ability of the participant understand and the willingness to sign a written informed consent form. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.  Exclusion Criteria:  Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia) IPSS 19 or higher High grade disease (GG3) occult to MRI-defined lesion Post-void residual &gt;100 mls, where known Prostate volume &gt;90cc Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging Previous pelvic radiotherapy Patients needing &gt;6 months of ADT due to disease parameters. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies
Status: Recruiting

Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children aged >3 years and adults Diagnosis of epilepsy with presumed or confirmed genetic etiology. Diagnosis of genetic epilepsy is made by next-generation sequencing (NGS) analysis or Diagnosis of primary (non-hemicranial) headache, in the absence of alterations on neuroimaging, and no known genetic condition Obtaining informed consent  Exclusion Criteria:  Age <3 years Presence of contraindications to TMS: history of head or eye trauma with inclusion of metal fragments, cardiac pacemaker, arrhythmic heart disease, hearing implants, implantation of drug delivery devices, piercings or tattoos with metallic ink. Pregnancy status - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult
Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain
Status: Recruiting

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 20-65 years Postpartum ≥ 3 months Pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold) Pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause) At least 2 positive findings of 6 pain provocation tests for pelvic pain Score of Active Straight Leg Rise (ASLR) test > 0  Exclusion Criteria:  being pregnant or actively trying to get pregnant having known causes of pelvic girdle pain, such as fractures and rheumatism having undergone lumbar, pelvic, gynecologic or obstetric surgery having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy having cancer having cardiovascular disease being diagnosed as having a psychiatric disease active infection or infectious disease in the pelvis or abdomen having experience with structured and supervised core or trunk exercise training programs. - HealthyVolunteers: No - Gender: Female - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Virtual Game Simulation on Nursing Students' Physical Examination Skills
Status: Not yet recruiting

The project is unique in that it will use virtual game simulation, a new learning method, and it will address the physical examination skills of nursing students, an area that has not been researched before. In the project, a randomized controlled research design with a pretest-posttest control group will be used. The population will consist of 200 second-year students enrolled in the Physical Examination in Nursing course at Necmettin Erbakan University, Faculty of Nursing, Department of Nursing, in the 2024-2025 Fall Semester. 120 students from the population who meet the research inclusion criteria will be randomly assigned to control (n=60) and experimental (n=60) groups according to their general academic success score. In collecting data; Introductory characteristics form, skill checklist for physical examination of the heart, skill checklist for physical examination of the abdomen, skill checklist for physical examination of the respiratory system and an evaluation form for the effect of virtual game simulation on skill practice for physical examination will be used. In the project, three different virtual game simulations will be developed for physical examinations of the heart, abdomen and respiratory system. During the fall semester, theoretical and laboratory demonstration applications will be carried out by the project team. A pre-test will be administered to all students, and then virtual game simulations will be made available to students in the experimental group for three weeks. Then, the virtual games will be closed to the students and a post-test will be administered to the experimental and control group students. After the final test application, virtual game simulations will be made available to students in the control group. In pre- and post-test applications, students will practice physical examination skills on simulated patients at three different stations (heart, abdomen and respiratory system) and will be evaluated by the project team according to skill checklists. After the skill evaluations, the students in the experimental group will be given a form to evaluate the effect of the virtual game simulation for physical examination on skill practice and will be asked to fill it out.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Taking the Physical Examination course in Nursing for the first time, Having access to the Internet, Volunteering to participate in the research.  Exclusion Criteria:  Not participating in in-class and out-of-class processes regarding the heart, abdomen and respiratory system, Not participating in one of the steps of the research (pre-test, playing virtual game simulations, post-test) Wants to leave the research. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 25 Years - StdAgeList: Adult
Using Games in Teaching Nursing History
Status: Not yet recruiting

Innovative learning methods can be used in teaching nursing history. One of the most preferred among these methods is learning through games. It is known that today's Generation Z students prefer active learning methods and want to learn by having fun instead of learning by rote. It is reported that learning through games improves students' knowledge and skills and increases retention. One of the methods of learning through games is the "tell me" game. The "Tell Me" game involves the narrator explaining the words prepared specifically for the subject to a group of students without using prohibited words. Other students in the group try to know the word explained. Thus, both the student narrator and the student trying to know actively use their critical thinking and decision-making skills. This research aims to determine the effect of the tell-all game used in teaching nursing history on students' learning and opinions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Taking the nursing history and deontology course for the first time, Agreeing to participate in the research.  Exclusion Criteria:  Graduating from a health-related high school or university, Having difficulty in speaking and understanding Turkish, Not participating in any of the research steps (theoretical training, explain game, topic repetition, pre-test, post-test), It means wanting to leave research. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 24 Years - StdAgeList: Adult
Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis
Status: Recruiting

introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared.

Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Inclusion criteria for the early RA group:  To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria Being 18 years or older Being followed up with a diagnosis of RA for less than 1 year (early RA)  Inclusion criteria for the RA group:  To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria Being 18 years or older  Exclusion Criteria:  Presence of other rheumatic disease Presence of malnutrition Recent surgical history, Stroke history, Pregnancy, Presence of prosthesis or metal implant, Presence of a pacemaker, Patients over 140 kg - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: In the planned single-center study, patients with clinically confirmed RA and early RA diagnosed who applied to Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinic will be included in the study after their consent is obtained. - SamplingMethod: Non-Probability Sample
Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking.
Status: Recruiting

This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery, and to determine which solution is more effective. Additionally, we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who were diagnosed with lumbar spinal stenosis need to undergo posterior lumbar decompression with fusion surgery.  Exclusion Criteria:  People who are allergic to disinfectants (Providine or CHG) The surgical site has been operated before. Patients under active infection status. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up
Status: Recruiting

Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.

The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.

The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  A male or female patient of legal age with suspected ALS (bulbar or spinal) who meets the criteria for "possible", "probable" or "definite" ALS according to the Awaji criteria Able to give informed consent to participate in the research Enrolled in a Social Security plan  Exclusion Criteria:  Pregnant or breastfeeding woman Severe progressive pathology other than ALS. Comorbidities with another neurological disease altering motor skills. Contraindication to trans-cranial magnetic stimulation: epilepsy, pacemaker, intracranial ferromagnetic foreign body (clip, aneurysm, implants)... Chronic alcoholism Cognitive disorders or major incapacity making it impossible to understand the study and sign an informed consent (fronto-temporal dementia, psychiatric conditions of psychotic type, language disorders) Refusal to participate. Patients under legal protection (guardianship, curators, safeguard of justice) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain
Status: Not yet recruiting

Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults at least 18 years of age. Scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone.  Exclusion Criteria:  Pregnancy Incarceration Morbid obesity (body mass index greater than 40 kg/m2 Contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria, or Reynaud's syndrome. Investigator opinion that the potential subject is a poor candidate for this trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Personal Recovery Based Psychoeducation For Schizophrenia
Status: Not yet recruiting

This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively. The program's effectiveness will be evaluated through a randomized controlled research design. The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation. In this context, the following hypotheses have been formulated.

Research Question:

1) Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission?

Hypotheses:

H0a: Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission.

H0b: Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission.

H0c: Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission.

H1a: Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission.

H1b: Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission.

H1c: Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of schizophrenia, Age between 18 and 65, Willingness to participate in the study, At least 6 months in remission, Literacy, No hearing or comprehension problems.  Exclusion Criteria:  History of alcohol or substance abuse (excluding nicotine), Presence of comorbid neurocognitive disorders. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer
Status: Recruiting

Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients (≥ 18 years old); Suspected or newly diagnosed malignant tumor patients; Patients who underwent 18F-FDG and 18F-FAPI PET scans within one week; Patients who are able to provide informed consent forms (signed by participants, parents, or legal representatives) and consent forms in accordance with the guidelines of the Clinical Research Ethics Committee.  Exclusion Criteria:  Pregnant women; Scanned images with poor image quality due to factors such as body movement; Patients with mental illness or other unsuitable conditions for examination, poor compliance, etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "EligibilityCriteria" colymn. - SamplingMethod: Probability Sample
Lower Silesia Culotte Bifurcation Registry (LSCBR).
Status: Recruiting

The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.  Exclusion Criteria:  Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study includes a retrospective analysis of subjects who underwent PCI in two cooperative cardiac centers in the Lower Silesia region between April 2012 and January 2024. Data from the participating centers on all PCIs performed during these periods were prescreened for bifurcation lesions with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based on the judgment of the cardiac team or on a specific clinical indication (persistent ischemia, unwillingness to accept alternative treatment options, presence of significant angiographic CAD suitable for PCI). The decision to perform PCI with the two-stent technique was left to the operator's judgment based on clinical and angiographic characteristics. - SamplingMethod: Non-Probability Sample