rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
Status: Not yet recruiting

The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.

Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?

Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories [ no visible lesion, diffuse changes, discrete visible lesion]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 years or above (no upper limit) Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all). Diagnostic bi-parametric or multiparametric MRI Diagnostic systematic biopsy +/- targeted biopsy A histological diagnosis of localised prostate cancer Patient chosen active surveillance  Exclusion Criteria:  On active surveillance for greater than 9 months prior to screening date. Contraindication to MRI or gadolinium contrast Previous hip replacement to both hips Contraindication to performing a biopsy guided by a transrectal ultrasound probe - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: Due to disease type, prostate cancer is only found in male. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation
Status: Not yet recruiting

This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing; Male or female ≥ 40 years and < 80 years old； History of atrial fibrillation or atrial flutter, or newly diagnosed atrial fibrillation or atrial flutter during the screening period, as documented by Holter ECG or 12-lead ECG at the time of screening or within 12 months prior to screening.  Exclusion Criteria:  Patients with a mechanical heart valve; Rheumatic mitral stenosis or moderate to severe non-rheumatic mitral stenosis; Atrial fibrillation or atrial flutter is caused by reversible causes, or successful ablation has been converted to sinus rhythm, or cardioversion or ablation surgery is planned during the study; Concomitant poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100mmHg) at screening; Those who are allergic to the trial drug or any component of the trial drug; Unstable or severe liver, renal, cardiovascular, psychiatric, neurological, endocrine, hematological and other diseases at the time of screening, and the investigator judges that it is not suitable to participate in the study; Females who are pregnant or lactating. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
Status: Not yet recruiting

The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Patients must have a confirmed diagnosis of MS, NMOSD, MOGAD, CIS or RIS. Patient (or patient's legal representative) has previously signed and dated an informed consent form (ICF) for the secondary use of their data, or assent form. Alternatively, the secondary use of the patient's data is allowed following Institutional Review Board (IRB)/Ethical Committee (EC) approval in accordance with national and local subject privacy regulations.  Exclusion criteria:  Patients under 18 years of age will be excluded. Other unspecified reasons that, in the opinion of the Investigator or Joint Steering Committee, make the patient unsuitable for participation in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study will include patients with a confirmed diagnosis of MS (Thompson et al., 2018), CIS, RIS, NMOSD (Wingerchuck et al., 2015), or MOGAD (Banwell et al., 2023). No other specifications are included. We envision a database that captures the diversity and heterogeneity of the population, in order to address factors influencing disease worsening that have not been investigated yet or have only been investigated to a very limited extent in previous studies. - SamplingMethod: Probability Sample
AI-Predicted Disease Trajectories in Diabetes: A Retrospective Study
Status: Not yet recruiting

The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis: Individuals with a confirmed diagnosis of T1DM or T2DM, as indicated by their EHR labels or a history of glycated hemoglobin levels and medication usage consistent with diabetes management. Age: Patients of all ages are considered, with subgroups possibly defined for more detailed analysis (e.g., pediatric, adult, senior). Treatment history: Both patients who are newly diagnosed and those with an established history of diabetes treatment, including insulin and oral hypoglycemic agents, are included to capture a broad spectrum of disease trajectories.  Exclusion Criteria:  Incomplete records: Patients with incomplete medical records that do not provide sufficient information on their diabetes diagnosis, treatment history, or follow-up data are excluded. Other significant diseases: Individuals with comorbid conditions that could significantly alter the natural history of diabetes or its management (e.g., end-stage renal disease not related to diabetes, active cancer treatment) might be excluded to ensure the study focuses on the diabetes trajectory. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The study population comprises individuals diagnosed with Diabetes Mellitus, encompassing both Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM). This population is identified through medical records housed within the Electronic Health Record (EHR) system, specifically utilizing data generated by the Smart Digital Clinic Software (Meteda) since its inception in our hospital environment. - SamplingMethod: Probability Sample
SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia
Status: Recruiting

This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient must have suspected T1RC/HGD and scheduled for a local endoscopic en-bloc resection. The rectum is defined as the area between the linea dentata and 10cm ab ano. Age > 18 years old Patients should be capable and willing to give signed informed consent before study specific procedures.  Exclusion Criteria:  Prior participation in this study Previous administration of SGM-101 Patients with a history of anaphylactic shock Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Aurora Test for ART Donor Patients (AURORA-Donor)
Status: Recruiting

This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist & hr-FSH with GnRH Agonist trigger, 2) Progesterone & hr-FSH with GnRH Agonist trigger.

Eligibility:
- EligibilityCriteria: Inclusion Criteria Donor:  Patients are 18 to 35 years old BMI between 17-30 Regular menstrual cycles AFC > 8 Patient profile in compliance with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent) Patients' stimulation: GnRH Antagonist & hr-FSH with GnRH Agonist trigger or Progesterone & hr-FSH with GnRH Agonist trigger Patients agree that the oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study  Exclusion Criteria Donor:  BMI < 17 or > 30 Extreme irregular menstrual cycles (<20 days or >40 days) AFC < 8 <8 MII on previous egg retrieval Women with history of poor oocyte maturation or known maturation defect or unexplained failure in previous treatments Patients that fail to comply with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)  Inclusion Criteria Recipient:  Patients applying for ART egg donation with fresh/frozen sperm from the partner or frozen donor sperm. With eSB-FET in modified natural cycle or an HRT cycle. Patients are from 18 to 50 years old. Patients will be treated by ICSI (intracytoplasmic sperm injection) and eSB-FET (elective Single Blastocyst Frozen Embryo Transfer) Recipient patients agree that the donors' oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study  Exclusion Criteria for oocyte Recipients  Patient included in any other prospective study. BMI < 17 or > 35 Severe uterine factor: Multiple myomectomy, multiple fibroids, major uterine malformation (unicorn, septum), Asherman Sd, severe adenomyosis Repeated Implantation Failure or Repeated Pregnancy Loss after euploid Single Blastocyst Transfer Severe male factor: Abnormal Caryotype or FISH, severe OAT / Cripto-Azoospermia, DNA Fragmentation >50% after medical treatment TESE / TESA (testicular sperm extraction/aspiration) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult - StudyPopulation: Donor's for this study must be between 18 and 35 years of age, and compliant with SEF directive for egg donation. Only patient with at least 6 MII will be included in the study. - SamplingMethod: Non-Probability Sample
Efficacy Of Hiatal Closure For GERD
Status: Recruiting

The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 - 50 years Able to provide informed consent BMI <30 Hiatal defect <4cm on esophagram pH testing requirement: pH <4 for >5.5% Surgical candidate for hiatal closure only  Exclusion Criteria:  Vulnerable subjects (children, prisoners, pregnant women) will be excluded. - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: The estimated annual number of subjects enrolled prospectively in the study is 20. The recruitment goal is 40. The research team will screen all patients that are being followed-up at the gastrointestinal surgery clinic at the UCM. - SamplingMethod: Non-Probability Sample
Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis
Status: Not yet recruiting

The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children between the ages of 2 and 12 diagnosed with autism spectrum disorder are eligible to participate in the study. Informed consent from parents or legal guardians is a prerequisite.  Exclusion Criteria:  Challenges that may impact study outcomes include coexisting medical conditions. Severe behavioral issues that may impede participation. Difficulties in obtaining informed consent, posing obstacles to comprehensive research endeavors. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 2 Years - MaximumAge: 12 Years - StdAgeList: Child - StudyPopulation: This study examines the impact of dietary habits on oral health among children with Autism Spectrum Disorder (ASD). It assesses how specific dietary choices correlate with oral health outcomes, including dental caries and periodontal disease. Key findings highlight the significance of diet in oral health management for autistic children, underscoring the need for specialized dietary advice and oral care strategies. The research aims to inform caregivers and healthcare professionals about the importance of monitoring and adjusting dietary habits to improve oral health in the ASD pediatric population. - SamplingMethod: Non-Probability Sample
The Effect of the Inclusion of Soybean Flour on Glycemic Responses
Status: Recruiting

Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.

In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female between 21-45 years of age All races/ethnicities Body mass Index (BMI) > 25 kg/m2 and <40 kg/m2 (i.e., overweight and obesity, excluding severe obesity) Fat %: > 30% for female or > 20% for male  Exclusion Criteria:  Currently smokes or quit smoking nicotine cigarettes, vapes or E-cigarettes for less than 6 months ago Pregnant, breastfeeding, menopausal Hemoglobin: <11g/dl for female and <13g/dl for male Blood donation in the past 8 weeks Gluten intolerance (Gluten allergy, wheat allergy, celiac disease), Soy intolerance or allergy Presence of malabsorption syndrome History of bariatric surgery Presence of inflammatory intestinal disease, liver, or kidney disease Diabetes (fasting glucose level >126mg/dl or plasma glucose level 2h after glucose challenge >200 mg/dl) or taking medicines to treat diabetes Polycystic ovary syndrome (pcos) Untreated hypertension Taking any medication that might affect glucose metabolism or the results of our study History of cancer <5 years ago Abnormalities in the metabolic panel test (e.g., liver enzymes >2 times the upper limit). Seizures - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 45 Years - StdAgeList: Adult
Transitional Care Model for Patients With Stroke
Status: Recruiting

Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being at least 18 years old, being admitted in neurology department for at least 24 to 48 hours, Not having cognitive impairment as measured by the Montreal cognitive assessment (score ≥ 23), Being able to communicate in Indonesia, having the ability to provide informed consent, Being willing to participate in this study during hospitalization and 8 weeks after hospital discharge  Exclusion Criteria:  Have potentially biased information, such as being unable to provide informed consent due to cognitive impairment, Having major speech and language problems or aphasia that prevent them from participating in the study, Having serious psychiatric disorders or other with terminal disease requiring active treatment, and Being discharged to a nursing home or welfare institution. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children
Status: Not yet recruiting

Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  School children aged (6 to15) years old. Children with or without previous dental experience.  Exclusion Criteria:  Refusal of participation. Children with a mental or physical disability - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 15 Years - StdAgeList: Child - StudyPopulation: A group of Egyptian children aged between 6-15 years attending a public school in Fayoum - SamplingMethod: Probability Sample
Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
Status: Not yet recruiting

This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  confirmed intrahepatic cholangiocarcinoma with Resectable tumor lesion no contraindications to surgery with high risk of tumour recurrence No prior systemic therapy for intrahepatic cholangiocarcinoma. ECOG Performance Status of 0 or 1 Child-Pugh Class: Grade A  Exclusion Criteria:  History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment Known genetic or acquired hemorrhage or thrombotic tendency Thrombosis or thromboembolic event within 6 months prior to the start of study treatment Cardiac clinical symptom or disease that is not well controlled Hypertension that can not be well controlled through antihypertensive drugs - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction Syndrome (SMDS)
Status: Not yet recruiting

The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  bodyweight ≥ 12 kg native (not surgically replaced) ascending aorta diagnosed with SMDS with confirmed ACTA2 mutation disrupting arginine 179 females with negative urine pregnancy test must agree to use acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study  Exclusion Criteria:  Individuals who have undergone surgery to replace aneurysmal or dissected ascending and root aortic tissue with a graft. Additional medical conditions that impair the patient's ability to participate in the study. Known allergy or sensitivity to niacin or nicotinamide riboside. Prior consumption of niacin or nicotinamide riboside supplement within the prior eight weeks. Failure to provide informed consent. Inability to tolerate PET/CT imaging and echocardiography without sedation. Concurrent participation in another intervention trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Single-operator Versus Double-operator in Single-Balloon Enteroscopy
Status: Recruiting

Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age greater than eighteen years; Suspected small bowel disease with proposed enteroscopy  Exclusion Criteria:  patients with a history of small bowel surgery; patients who fail to perform bowel preparation as required; patients at high risk for esophageal varices with risk of bleeding; patients who have not planned a deep small bowel examination before enteroscopy, such as a lesion clearly located in the duodenum, proximal jejunum or terminal ileum; patients who are in extremely poor physical condition and are not suitable for general anesthesia, as defined by an ASA score greater than 3; Pregnant or lactating women; Inability to provide written informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult