rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium
Status: Not yet recruiting

Objectives The transparent surface of the eye, called the cornea, plays a crucial role in transmitting light to the retina and in protecting the eye. On its external surface, the cornea is composed of a constantly renewing multistratified epithelium. This mechanism is fueled by stem cells located in the limbus (the transition zone between the cornea and the sclera). Limbal Stem Cell Deficiency (LSCD) is characterized by a decrease or cessation of epithelial renewal and neovascularization of the cornea. Consequently, the cornea loses its integrity and transparency. This visually impairing condition is currently in a therapeutic impasse as only autologous limbal or allogeneic corneal grafts are viable options, but they pose significant risks to patients.

Studies have shown that the oral cavity contains stem cells that can be isolated, cultured, and transdifferentiated into limbal stem cells (LSCs). However, to date, these studies are limited, and no protocol has been validated. In this study, the advantage of the accessibility of the oral cavity is used to develop a protocol for differentiating cells from the oral mucosa into limbal stem cells (LSCs) for use in a future clinical trial with patients.

Methodology This prospective monocentric study will be conducted on patients from the ophthalmology department of the Montpellier University Hospital who have an indication for conjunctival reconstruction. After obtaining consent from the patients, cells from the oral wall will be sent to the tissue bank of the Montpellier University Hospital, where they will be cultured. Finally, the transdifferentiation steps will be analyzed by the "Eye" research team at the Institute of Neuroscience in Montpellier, which is collaborating on the project. The investigators have established objective factors to assess the success of the developed protocol based on the literature : (i) > 3% of stem cells in primary cultures, (ii) <10% aborted colonies, (iii) Expression of LSC markers (Pax6, Krt14, p63).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Presenting an indication for conjunctival reconstruction using oral mucosa (for example because of a recurrent pterygium, conjunctival carcinoma or ocular burn) Written consent to participate in this research  Exclusion Criteria:  Chronic infection (HIV, hepatitis, tuberculosis, Lyme disease) Oral pathology which could affect the health of the oral mucosa tissue according to the opinion of the investigating doctor Uncontrolled systemic disease Pregnant or breastfeeding - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
Status: Recruiting

A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.

The specific hypotheses include:

Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients
Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation.
Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments
Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Liver cirrhosis as diagnosed by imaging and/or clinical data, including pathology  Exclusion Criteria:  Any contraindication to PET, as in attached screening form Any contraindication to MRI, as in attached screening form Any contraindication to gadolinium-based contrast agent, including allergy to gadolinium, as in attached screening forms. Pregnancy Breast feeding. Cumulative radiation exposure for research studies during the prior 12 months, combined with the exposure from this study, > 50 mSv Inability to fit in the scanner: weight > 300 lbs or BMI > 33 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Fifty-five subjects will be recruited. All subjects recruited for the study will be able to withdraw from the study at any time.  Healthy Volunteers: The investigators will not be recruiting or enrolling healthy volunteers in this study. Patients with liver cirrhosis: Fifty-five (55) - SamplingMethod: Non-Probability Sample
Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients
Status: Recruiting

Current guidelines recommend the inititaion of noradrenaline and if shock is refractory, then vasopressin should be administered. Data indicate that the earlier use of vasopressin may improve survival. Two large randomized controlled trial failed to prove a survival benefit from the early use of vasopressin. The present study will investigate the effect of an early initiation protocol of vasopressin (as the first vasoconstrictor drug) on the degree of multiorgan failure improvement and also on the course of sepsis (if in septic patients) versus early initiation of noradrenaline as first vasoconstrictor drug in hemodynamically unstable patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  • Shock (mean arterial pressure <65 mmHg) after initial resuscitation with fluids  Exclusion Criteria:  Patients under 18 years of age. Known heart failure (ejection fraction &lt;35%) Recent acute myocardial infarction Pulmonary embolism - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
ERP Plus Improv Group Therapy for OCD (IMPROVE Study)
Status: Recruiting

The goal of this study is to pilot test a novel group therapy intervention for adults with OCD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 18 years of age Ability to speak and understand English Clinical diagnosis of obsessive-compulsive disorder (OCD)  Exclusion Criteria:  Current active suicidality Medical or psychiatric illness that could interfere with study participation - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis
Status: Recruiting

AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.

This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches.

The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V.

Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.

Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult subjects with biopsy proven lupus nephritis Class III or IV either with or without the presence of Class V according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, who failed or did not respond to previous standard of care treatment approaches A kidney biopsy must be performed < 24 weeks prior to the screening visit or during the screening period. Eligible subjects must have evidence of active disease on renal biopsy based on the modified NIH Lupus Nephritis activity and chronicity indices. Eligible subjects must have detectable anti-double stranded DNA antibody titers for enrollment.  Exclusion Criteria:  Known past or current malignancy other than inclusion diagnosis Known clinically significant cardiac disease Known past or current clinically significant lung disease, including: Current use of tobacco products Subjects with a history of HBV infections are considered ineligible - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography
Status: Not yet recruiting

In this study, it is planned to determine the effect of virtual reality applied to women before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals applying for breast cancer screening will first be randomly divided into experimental and control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the experimental group before the mammography procedure. A relaxing video will be watched with virtual reality glasses and the mammography will be performed. At the end of the mammography, the relevant forms will be applied to the individuals again. The control group will not be subjected to any additional application that will continue with the applied routine.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Having applied for mammography for screening purposes, having no communication problems, being over 18 years of age, not having a history of breast cancer voluntarily agreeing to participate in the study  Exclusion Criteria:  Being screened for breast cancer having vision or hearing problems being under 18 years of age. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Only female applicants will be included due to breast cancer screening. - MinimumAge: 18 Years - MaximumAge: 69 Years - StdAgeList: Adult, Older Adult
The Effect of Diabetes Coaching on Distress and Diabetes Self-Management
Status: Not yet recruiting

This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.

The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteering to participate in the study, Having been diagnosed with Type 2 diabetes for at least 1 year, Being between the ages of 18-65, No communication problems, Being literate, Being able to use a phone (home or mobile phone), Lack of diagnosis of psychiatric disease, Not receiving hospital treatment due to acute problems, Not to be involved in another study involving a similar intervention during the research period  Exclusion Criteria:  Being diagnosed with type 1 diabetes, Type 2 diabetes diagnosis period is less than one year, Being under 18 years of age, over 65 years of age, Being pregnant, Having a diagnosis of psychiatric disease, Not agreeing to participate in the research - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients
Status: Not yet recruiting

This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The participant is a physician (one of the following specialties: Neurology, Intensive Care, Internal Medicine, Emergency Medicine) The participant practices medicine at the University Hospital Basel The participant has signed informed consent and agrees to be recorded (audio and video) during the study.  Exclusion Criteria:  None. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Physicians from different medical specialties (including neurologists, intensivists, internists, and emergency medical doctors) with different duration of clinical experience working at the University Hospital Basel. - SamplingMethod: Non-Probability Sample
Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion
Status: Recruiting

Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age ≥ 18 years imaging diagnosis of large vessel occlusion CT excluded intracranial hemorrhage signed informed consent form by the patient himself or his legal representative  Exclusion Criteria:  severe bleeding or known significant bleeding tendency severe organ dysfunction life expectancy of less than 90 days presence of other conditions that the investigator considers inappropriate for enrollment - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients with ischemic stroke due to large vessel occlusion。 - SamplingMethod: Non-Probability Sample
Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children
Status: Not yet recruiting

Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.

Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.

Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.

Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.

Patient Population: young infants from 0 to 6 months of age

Intervention: There will be two groups:

Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.

Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.

Outcome: Contamination rate and feasibility of both urine sampling techniques

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Hemodynamically stable infants. Require urine collection as part of their work-up in the emergency department. Age 0 to 6 months.  Exclusion Criteria:  Parental refusal. Unstable hemodynamically young infants. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 6 Months - StdAgeList: Child
One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations
Status: Recruiting

to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients must present with at least four posterior primary compound proximal caries involving two surfaces, specifically occluso-mesial or occluso-distal cavities, with a corresponding International Caries Detection and Assessment System (ICDAS) score of 4 or 5. The buccolingual width of the lesion should be approximately less than two-thirds of the intercuspal distance. Teeth to be restored must be in normal occlusion with the natural antagonist teeth. Vital teeth with no signs of pulpal inflammation or pathological lesions. Normal periodontal status and good oral hygiene. Good likelihood of recall availability.  Exclusion Criteria:  Patients with proximal cavities that extend beyond two surfaces or have a lesion buccolingual width greater than two-thirds of the intercuspal distance, or requiring cusp coverage. Partly erupted or endodontic treated teeth. Poor oral hygiene or severe periodontitis. Absence of neighboring or antagonist teeth. Patients with known allergy to any component of the study materials. Patients with unstable medical conditions. Patients with known unavailability to attend recall visits. Pregnant or lactating females. Patients with heavy para-functional habits, fractured, or visibly cracked teeth. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult
Epilepsy Learning Healthcare System (ELHS)
Status: Recruiting

The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding".

The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  In order to be eligible to participate in this registry-based research study, an individual must meet all of the following criteria:  Patient is in an established care relationship with the ELHS site  Exclusion Criteria:  An individual who meets any of the following criteria will be excluded from participation in this registry-based research study:  Patients who are not currently in nor expect to be in an established care relationship with the ELHS site (for example, patients who are being seen at the center for a second opinion only). Patients who do not, after diagnostic evaluation, meet criteria for a diagnosis of epilepsy will not be analyzed in epilepsy-specific population groups. However, these non-epilepsy patients will not be excluded from the registry. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: People of all ages diagnosed with epilepsy by a physician and in an established care relationship, and their families and caregivers. - SamplingMethod: Probability Sample
Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients
Status: Not yet recruiting

No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eligible patients were 18 years or older. Confirmed diagnosis of breast cancer. Patients completed adriamycin and cyclophosphamide (AC) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with G-CSF support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.  Exclusion Criteria:  Patients with signs and symptoms of grade 2 or 3 bone pain at baseline. Patients receiving famotidine in the previous 72 hours. Patient receiving any antihistaminic in the previous 72 hours. Hypersensitivity to famotidine or loratadine. Patient receiving opioid or adjuvant analgesic. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult