rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes
Status: Not yet recruiting

The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Those who agree to participate in the study and sign informed consent; Diagnosis of type 1 diabetes mellitus (ADA2024); Age of 18~65 years; Dependent on exogenous insulin therapy (CSII), the treatment plan remains unchanged within 2 months (the type of insulin cannot be changed, and the dose can be adjusted according to plasma glucose); Body mass index (BMI) of 18~24 kg/m2; HbA1c ≤9.5%; Random C-peptide ≥200pmol/L.  Exclusion Criteria:  Honeymooners with type 1 diabetes mellitus; Women who are pregnant or plan to become pregnant; Patients who are vegetarians; Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-IV inhibitors, etc.); Patients who are users of glucocorticoids within 30 days; History of severe food allergy; Patients with acute complications such as DKA; Patients with gastroparesis, inflammatory bowel disease and other complications; Patients with large albuminuria and renal insufficiency; Patients with uncontrolled hyperthyroidism and hypothyroidism; History of heart disease, coronary heart disease and arrhythmia; Serious of liver dysfunction (ALT or AST>1.5 times the upper limit of normal); History of malignant tumors, uncontrolled other immune system diseases, uncontrolled infections; Alcohol abuse, mental disorders or other conditions unfit to be an observer in drug tests; Patients with any disease likely to interfere with study participation or evaluation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
iLookOut Micro-learning to Improve Knowledge Retention
Status: Not yet recruiting

This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age or older  Exclusion Criteria:  Younger than 18 years of age - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy
Status: Not yet recruiting

The goal of this study is to test the safety and feasibility of a change in management approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg allergy will have egg introduced via a gradual and graded home based approach known as an "egg ladder" supervised by a dietitian. The main questions this study aims to answer are how safe and feasible are home-based dietitian-led "egg ladders" as a treatment pathway to achieve tolerance of egg for newly diagnosed infants with egg allergy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  infants aged greater than 4 months and less than 12 months of age diagnosed by an RCH allergist with IgE- mediated egg allergy in conjunction with a positive skin prick test (SPT) or specific immunoglobulin E (sIgE) to egg white has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf  Exclusion Criteria:  any history of severe food induced anaphylaxis. Defined as reaction requiring 2 doses of intermuscular adrenalin Physician diagnosed recurrent wheeze Not commenced or unable to eat solid food prescribed beta-blocker medication - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 4 Months - MaximumAge: 12 Months - StdAgeList: Child
Efficiency of Verbal Intelligent Tutor Instruction in Neurosurgical Simulation
Status: Not yet recruiting

At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education.

In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of three groups (one control and two experimental). Group 1 (control) will be provided with verbal AI tutor feedback based on the ICEMS error detection. Group 2 will be tutored by a human instructor who will receive ICEMS error data and deliver verbal instruction identical to that which the AI tutor delivers. Group 3 will be tutored by a human instructor who will be provided with ICEMS data but may deliver feedback as they feel is appropriate to correct the error.

The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee response to instruction and overall surgical performance. Evaluating trainee responses to AI instructor verbal feedback as compared to feedback from human instructors will allow for further development, testing, and optimization of the ICEMS and other AI tutoring systems.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Medical students who are actively enrolled in medical school at any Quebec institution who do not fit the exclusion criteria. Premedical students who are actively enrolled in medical school at any Quebec institution who do not fit the exclusion criteria.  Exclusion Criteria:  Prior use of the NeuroVR (CAE Healthcare) simulator. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
French Validation of the AdT-Physio Scale
Status: Not yet recruiting

The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.

participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires. - SamplingMethod: Non-Probability Sample
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)
Status: Not yet recruiting

The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age 21-55 fluent in English diagnosis of mood, anxiety, or traumatic stress disorder clinically elevated repetitive negative thinking outpatient status 6-week stability if taking selective serotonin reuptake inhibitor (SSRI) medications willing to take a pregnancy test on the dates of the MRI scan to confirm pregnancy status. own a smartphone  Exclusion Criteria:  past year diagnosis of severe alcohol or moderate or greater substance use disorder lifetime history of psychotic or bipolar I disorder acute suicidality necessitating immediate clinical intervention neurodegenerative or neurodevelopmental disorders history of moderate or severe traumatic brain injury or other known neurological condition sensory deficits that would preclude completing tasks conditions unsafe for completing MRI scanning (e.g., metal in body) current pregnancy currently receiving psychosocial treatment currently receiving psychiatric pharmacotherapy, except SSRIs - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 55 Years - StdAgeList: Adult
Application of Auriculotherapy in ERAS of TKA for KOA
Status: Not yet recruiting

To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis that complies with OA; Age ≥ 18 years old, regardless of gender; Improve preoperative knee joint X-ray and lower limb CT examination; The patient's auricles are intact and there are no contraindications such as damage, redness, swelling, bleeding, or infection that are not suitable for ear acupoint therapy.  The subject/guardian is able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form (ICF)  Exclusion Criteria:  Individuals with contraindications for TKA surgery; Patients with severe deep vein thrombosis in the affected limb; A history of knee joint surgery, trauma, or fractures in the affected limb may affect the evaluation of this project and surgical safety; The subjects are in an immunosuppressive state, suffering from autoimmune diseases or immunosuppressive disorders; Pregnant or lactating women; Patients who are known to have excessive alcohol or drug abuse; The researchers believe that it is not suitable for participants in this clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Robot-Assisted Training Versus Standard Training in Ischemic Stroke
Status: Not yet recruiting

The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.

The main hypothesis of the study is:

Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training.

Eligibility:
- EligibilityCriteria: Inclusion:  Ischemic apoplexia. Chronic state (>6 months post-stroke). Subacute rehabilitation terminated (subacute phase defined as until 6 months post-stroke).  Moderately-severely impaired:  Modified Rankin Scale Score 3-5. Scandinavian Stroke Scale Leg Motor Function Score 0-4. Approved by referring doctor  Exclusion:  Prior stroke, TIA, SAH Severe fatigue making study completion improbable. Cognitive deficits impeding study participation. Inability to walk independently pre-stroke. Recurrence of cardiovascular/cerebrovascular accidents. Pre-existing neurological diseases or ongoing cancer treatment. Refusing group allocation. Concurrent participation in another clinical trial potentially interacting with the present trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Palmitoylethanolamide for Chronic Inflammatory Pain Conditions
Status: Not yet recruiting

The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.

Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Chronic Inflammatory Pain of greater than 3 months duration and greater than or equal to 5/10 intensity that has not responded to other conservative therapies such as rest, ice, compression or other oral medications.  Exclusion Criteria:  Severe allergy to any specific food component such as nut, egg or soy - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures
Status: Recruiting

Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  above the age of 21 years' old medically fit with prior denture experience either maxillary or mandible partial dentate partial edentulism with stable occlusion  Exclusion Criteria:  History of maladaptation to denture use With maxillofacial or mandible bone defect(s) Known allergic reaction to cobalt chromium metal - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
PCORI II: Improving Postpartum Maternal Outcomes
Status: Not yet recruiting

The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.

Eligibility:
- EligibilityCriteria: Inclusion Criteria for Postpartum Women:  Admitted to the Roper St. Francis HealthCare Postpartum Unit following delivery of a live birth. Postpartum woman within approximately 1 week of delivering a live birth. Aged 18-45 years old. Insured by Medicaid.  Exclusion Criteria for Postpartum Women  Plans to relocate outside of SC anytime during the postpartum year. Plans to discontinue Medicaid health insurance during the postpartum year. Speaks a language other than English or Spanish. Incarcerated/pending incarceration during peripartum period. Currently institutionalized. Enrolled in current MUSC study funded by PCORI (#Pro00123833).  Inclusion Criteria for Obstetric Providers and Hospital Administrators  - OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women; or hospital administrator working in a delivery hospital in SC and job responsibilities relate to the postpartum unit.  Exclusion Criteria for Obstetric Providers and Hospital Administrators  Less than 1 month of LTWP experience if involved in the hospital where participants are recruited from. Unable or unwilling to commit to completing surveys or an interview. Speaking a language other than English or Spanish. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Postpartum woman within approximately 1 week of delivering a live birth. Aged 18-45 years old. - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Feasibility Evaluation of a Dance Fitness Program
Status: Not yet recruiting

The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ages 20-39 years Have an infant 0-12 months old Self-report clearance from provider to engage in physical activity following birth Structured Clinical Interview for Diagnostic Statistical Manual-5-Research Version (SCID-5-RV) diagnosis of major depressive episode (MDE) with onset during pregnancy or 12 months following childbirth Edinburgh Postnatal Depression Scale (EPDS) score of 10 or above English speaking OULA-naïve If on first-line treatment for depression; antidepressant dose must be stable for 6 weeks; psychotherapy duration of treatment must be at least 4 weeks  Exclusion Criteria:  Unable to be physically active Current pregnancy SCID-5-RV diagnosis of bipolar disorder, schizophrenia, or current substance use disorder Active suicidal attempt or plan identified on the SCID-5-RV Suicide attempt in the past 6 months Concurrent participation in another group dance fitness format No access to Internet via computer, tablet, or smart phone - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 39 Years - StdAgeList: Adult
Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
Status: Not yet recruiting

The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:

To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.
To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).
To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy with diagnosis of peptic ulcer  Exclusion Criteria:  Inappropriate gastric mucosal biopsy conditions such as hemodynamic instability, coagulopathy or severe thrombocytopenia or massive bloody content in gastric cavity or duodenum Previous history of gastric surgery such as partial or total gastrectomy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients aged 18 years or older, who present with upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy, receiving a diagnosis of peptic ulcer, will be recruited and enrolled. The exclusion criteria include patients with inappropriate gastric mucosal biopsy conditions, such as hemodynamic instability, coagulopathy, severe thrombocytopenia, or the presence of massive bloody content in the gastric cavity or duodenum. Additionally, individuals with a previous history of gastric surgery, such as partial or total gastrectomy, will be excluded. - SamplingMethod: Non-Probability Sample
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Status: Recruiting

The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.

The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).

The above criteria define 'high metastatic volume' disease with the following parameters

≥ 4 bone metastases, including at least one outside the spine and pelvis
Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of new-onset prostate neoplasia (any risk category according to EAU guidelines). Histological confirmation of disease by prostate biopsies. Absence of neuroendocrine differentiation Low volume of metastatic disease defined according to CHAARTED study criteria (< of 4 bone metastases, absence of visceral metastases) Patients without previous treatment of primary malignancy (e.g. previous radical prostatectomy, previous RT) Patients treated with systemic therapy (ADT as monotherapy or in combination) for less than 6 months prior to enrolment Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patients eligible for local treatment of primary malignancy and concomitant systemic therapy Signature of informed consent  Exclusion Criteria:  Inability or unwillingness to give written informed consent High volume metastatic disease defined according to CHARTEED criteria ECOG performance status > 1 Patients included in other clinical trials Contraindications to hormone/systemic therapy administration Previous treatment of primary tumour (RP, RT or other treatment of primary tumour) - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with a diagnosis of new-onset oligo-metastatic prostatic neoplasia are included in the study. The definition of oligo-metastatic neoplasm is based on the CHARTEED criteria (less than 4 metastases, absence of visceral metastases).  All patients should undergo staging by conventional imaging techniques (total body bone scintigraphy, CT abdomen with mdc) or with PET-CT (choline or PSMA) and multiparametric prostate MRI to assess the local extension (clinical stage) of the disease, surgical resectability of the disease and radiotherapy planning.  In addition, individual cases should be discussed in the multidisciplinary oncology group of the enrolling centre. The choice of treatment type will be based on the decision of the multidisciplinary team and the patient's preferences. - SamplingMethod: Probability Sample