rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Status: Not yet recruiting

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.

Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.

All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.

The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.

The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female patients ≥18 and <65 years of age at baseline Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.  Exclusion Criteria:  Presence of clinical findings suggestive of Crohn's disease. Planned surgical intervention  Prior/Concomitant Therapy:  any previous exposure to etrasimod including participation in the etrasimod clinical program. any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine or tioguanine) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator. Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the local approved label and independent from the decision to enroll the patient in this study. - SamplingMethod: Probability Sample
CRP and Lung Ultrasound in Respiratory Evaluation
Status: Not yet recruiting

Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.

This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old Clinical suspicion of LRTI defined as acute illness lasting less than 21 days, with cough as the main symptom, accompanied by at least one other lower respiratory symptom (such as sputum production, dyspnoea, difficult breathing, or chest pain) without any other explanation for the clinical picture. Ability to read, understand and willingness to give written consent to participate in the study.  Exclusion Criteria:  Patients who have been treated with antibiotics during the last 14 days up to inclusion. Patients with hemodynamic instability or that need emergency medical care due to the current clinical condition. Previous diagnosis of lung or pleural cancer. Thoracic surgery within the past 60 days. Lung interstitial diseases. Patients who refuse to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with lower respiratory tract infections attending Primary Care centres in Lleida. - SamplingMethod: Non-Probability Sample
Vaginal Fluid Collection for Detection of Endometrial Cancer
Status: Recruiting

The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women ≥18 years of age. Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN. Women whose planned surgical intervention (if any) includes hysterectomy, D&C, or hysteroscopic resection.  Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.  -  Exclusion Criteria:  Patient with recurrent and/or previously treated EC. Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment. Prior hysterectomy. Current known pregnancy diagnosis. Prior or current biopsy and histopathology-proven cervical cancer. The presence of concomitant biopsy and histopathology-proven cervical dysplasia. Any prior pelvic or vaginal radiotherapy. Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years. Chemotherapy within the past 5 years. Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study will enroll women ≥18 years of age with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia, or endometrial intraepithelial neoplasia (EIN) presenting for management of their endometrial pathology. - SamplingMethod: Probability Sample
Stool Sample Collection Study
Status: Recruiting

The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant is a person ≥18 years of age. Participant has a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.  Exclusion Criteria:  Participant has actively bleeding hemorrhoids. Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer). Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years. Participant has a history of any inflammatory bowel disease. Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes. Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.  Individual has a condition the Investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Men and women 18 years or greater with a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. - SamplingMethod: Probability Sample
Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy
Status: Recruiting

The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  children of both sexes age 5-15 years affected by isolated GH deficiency according to the criteria provided by note 39 AIFA for this pathology (short stature: ≤ -3 DS or ≤ -2 DS; growth rate/year ≤ -1.0 DS per age and sex evaluated at a distance of at least six months; GH peak at two different pharmacological stimulation tests < 8 ng/ml).  Exclusion Criteria:  - presence of organic hypothalamic-pituitary pathologies (diagnosed through encephalic NMR). - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 15 Years - StdAgeList: Child - StudyPopulation: Children with isolated growth hormone deficiency - SamplingMethod: Probability Sample
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
Status: Not yet recruiting

This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study.

The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).

120 patients will be enrolled and randomized in two groups:

the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®)
the control group "Placebo Group," with oral administration of the placebo.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 years or older, Scheduled to undergo surgical intervention through vitrectomy, Aphakic or pseudophakic patients, Experiencing rhegmatogenous retinal detachment affecting 2 quadrants or more, Presenting with macula OFF (raised macula) for 7 days or less before the onset of symptoms, Has signed a consent form, Affiliated with a health insurance plan.  Exclusion Criteria:  Patients who have previously undergone vitrectomy for retinal detachment, Patients with vitreous hemorrhage or any other associated retinal pathologies, Monophthalmic patients, Women of childbearing age without effective contraceptive methods, Pregnant or lactating women, Hypersensitivity to the active substance, bile acids, or any of the excipients in Ursolvan® (see §6.1.1 of this protocol), Patients with peptic ulcers, acute or chronic liver disease, acute infection or inflammation of the gallbladder or bile ducts, recurrent gallstones, or obstruction of the bile ducts (common bile duct or cystic duct obstruction), Patients with radiopaque calcified gallstones, Patients with severe pancreatic disorders, Patients with Crohn's disease, ulcerative colitis, or other intestinal diseases that may alter the enterohepatic circulation of bile acids, Patients on oral treatment with cholestyramine, colestipol, antacids containing aluminum or magnesium hydroxide and/or smectite (aluminum oxide), cyclosporine, ciprofloxacin, nitrendipine, or dapsone, Patients with galactose intolerance, Lapp lactase deficiency, or glucose and galactose malabsorption syndrome (rare hereditary diseases), Patients participating or in the exclusion period following an interventional research with the use of prohibited medications in this study, Patients under protective custody. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users
Status: Recruiting

The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Practicing rehabilitation professional whose client population includes wheelchair users. Willing and able to attempt practicing wheelchair skills Access to a spotter(s) Access to an Internet-ready device with video capabilities. Speaks English  Exclusion Criteria:  1) Confident in teaching (Self-Efficacy on Assessing, Training, and Spotting [SEATS] item score = 5) and able to complete (WST-Q capacity item score = 2) >50% of skills targeted by the training intervention. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
4AP to Delay Carpal Tunnel Release (CTR)
Status: Not yet recruiting

The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with non-traumatic carpal tunnel syndrome without any other confounding diagnosis (e.g. cubital tunnel syndrome, cervical nerve compression) Standard of care EDX testing within 6 months of study enrollment Cognitive ability to report sensory and motor deficit during examination. Able to complete twice daily dosing of 4-AP for the entire 6 week treatment period. Adults subject aged 18-90 Ability to give written informed consent. Capable of safely undergoing electrodiagnostic testing (EDX). Availability for all study visits.  Exclusion Criteria:  Inability to complete twice daily dosing during 6 week treatment period. History of multiple sclerosis, stroke or any other diagnosed neurological disorder History of hypersensitivity to AMPYRA® or 4-aminopyridine Current use of aminopyridine medications, including other compounded 4-AP Suspected renal impairment based on the Choyke questionnaire. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Toric Intraocular Lens Implantation in Pediatric Cataract
Status: Recruiting

To evaluate the visual and refractive outcomes after a IOL implantation in pediatric eyes with cataract and preexisting corneal astigmatism

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Visually significant cataract; Corneal astigmatism more than 1.25 diopters; Children aged ≥ 6 years and < 18 years.  Exclusion criteria:  Patients with a corneal diameter less than 9 mm; Presence of corneal scarring; Irregular astigmatism; Intraocular pressure more than 25 mm Hg; Active inflammatory process of the eyeball or signs of a previous episode of inflammation; Traumatic, subluxated, or complicated cataract; Persistent Fetal Vasculature; Diseases of the optic nerve or macula that may limit visual potential; History of previous intraocular surgeries; Performing posterior capsulorhexis intraoperatively. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia
Status: Recruiting

This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Structural heart disease (SHD) defined as left ventricular dysfunction (LVEF < 55%), or right ventricular dysfunction (FAC <35%) or presence of ventricular scar, pathological hypertrophy, wall bulging or inflammatory conditions. Optimized medical treatment for the underlying SHD ICD or CRT-D recipient ≥ 1 episodes of sustained or treated (with either anti-tachycardia pacing or shock, internal or external) monomorphic VT (MMVT) resistant to at least one invasive VT ablation attempt, unless contraindicated or deemed at high risk. Reason for lack of ablation must be specified  Exclusion Criteria:  Age < 18 or > 85 years. Inability to provide informed consent. Acute myocardial infarction or recent primary coronary intervention or cardiac surgery (<3 months) Primary electrical disease (e.g. long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome). Reversible and/or treatable cause of VT (e.g., drug-induced or intoxication) ICD electrode malfunction or ICD readings outside reference range Pregnancy or breast feeding Patients with polymorphic VT/VF - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial
Status: Not yet recruiting

Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type  Exclusion Criteria:  individuals diagnosed with dementia, cognitive impairment or chronic pain; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult