rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV
Status: Recruiting

The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Self-identify as Latino/Latina/Latinx/Hispanic; adults 18 years and over; with HIV infection confirmed by standard laboratory results available in the medical record; 6 or more months from initial entry into care with a medical provider who can prescribe HIV antiretroviral treatment; receiving HIV primary care at Jackson Memorial Hospital or Thomas Street at Quentin Mease Health Center/Harris Health System; and medical record evidence with last viral load (VL) indicating viral non-suppression (HIV RNA ≥200 cpm) within 90 days of assessment of eligibility, as it is typical for providers to obtain laboratories prior to a clinic visit in preparation for counseling.  Exclusion Criteria:  Lacks capacity to consent (measured by a validated screener), plans to move out of the county in the next 6 months, or currently participating in an HIV intervention study with ongoing follow-up. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Exercise Training Study Before Bariatric Surgery
Status: Not yet recruiting

The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).

Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.

Researchers will compare the effects of walking before bariatric surgery on:

Insulin sensitivity (diabetes risk factor)
Health of blood vessels
Rate of complications after surgery
Weight
Body Fat
Fitness level

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI: 35 - 45 kg/m2. For adults of Asian race or descent, the BMI cutoff is between 25-27.5 kg/m2 to be considered for surgery and thus will be considered for inclusion in this study. Considered sedentary based on self-reported inactivity of < 2-3 x/week of MVPA within previous 3 months before enrollment. Able to walk without use of assistive device, such as cane or walker for ≥ 10 minutes. Surgery approved within 6-9 months of initial visit. Signed approval from study physician (Dr. Catherine W. Varney; Medical PI of study) that participant is capable to participate. Willingness to accept group randomization assignment.  Exclusion Criteria:  Any serious medical conditions, such as cancer; history cardiovascular disease of stroke, heart attack, or heart failure; type 1 diabetes mellitus; severe psychiatric illness (such as severe depression); kidney disease. Autoimmune diseases such as lupus, multiple sclerosis, Graves' disease, or rheumatoid arthritis. HIV or tuberculosis. Currently taking medications that lead to significant weight loss (e.g., semaglutide; tirzepatide, etc). Resting SBP > 150 mmHg, DBP > 100 mmHg. Current pregnancy or plans to become pregnant during intervention. Plans to be away from the Charlottesville, VA area for > 1 week during intervention or plans of relocating during the intervention. Any medical or health condition (e.g., musculoskeletal, orthopedic, or neurological conditions) that is contraindicated for safe exercise testing and training. Previous weight-loss surgeries or revisions - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma
Status: Not yet recruiting

Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.

To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.

The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women aged 18 and over Patient with glaucoma followed in the ophthalmology department of Nantes University Hospital mean visual field deficit (MD) >10dB  Exclusion Criteria:  Retinal vascular pathology (moderate to severe non-proliferative diabetic retinopathy, complicated diabetic retinopathy, OVCR/OBVR, OACR/OBAR, NOIAA...) Non-glaucomatous optic neuropathy, neurological pathology leading to visual field deficit (stroke with HLH, quadranopsia, chiasmatic Sd...) PPR (retinal PanPhotocoagulation), retinal cerclage Retinal pathology leading to visual field impairment (e.g. retinitis pigmentosa) AMD and other macular pathologies that can lead to central visual field deficits Significant environmental disorders impairing retinal imaging (e.g. active uveitis, dense cataract) Loss of fixation point preventing visual field formation Pregnant or breast-feeding women Protected adults under guardianship or curatorship with unreliable visual fields (false positives and false negatives > 33%) with an uninterpretable OCTrnfl or OCTa (artifact, low quality score) - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients followed at Nantes University Hospital for advanced glaucoma (MD>10dB in visual field) who had peripapillary angiography OCT, OCTrnfl and visual field at their follow-up consultation. - SamplingMethod: Non-Probability Sample
Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms
Status: Not yet recruiting

Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  No neurological deficits (Markwalder score ≤1); Unilateral or bilateral cSDH; Subdural Hematoma width ≤ 20 mm; midline shift ≤ 7mm; Independent functional status with mRS score ≤ 2 prior to symptom onset; Likely compliance of the participant in attending follow-up examination.  Exclusion Criteria:  Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma; Contraindications to angiography (end stage chronic renal disease, any sign of anatomical variations that could make MMA embolization unsafe, pregnancy); Life expectancy < 1 year; Patients with any kind of ventricular derivation catheter. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease
Status: Not yet recruiting

The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease.

The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients at least 18 years old Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450  On stable dosing of any therapy for at least 4 weeks prior to treatment initiation. Including:  Steroids (9 mg or less of budesonide, 20 mg or less of prednisone) Mesalamines Immunomodulators Biologics Other medications for IBD (inflammatory bowel disease)  Exclusion Criteria:  Antibiotic usage within one month prior to initiation of blinded fluconazole treatment Antifungal usage within one month prior to initiation of blinded fluconazole treatment Known allergy to fluconazole Patients with known hepatic disease or cirrhosis Patients taking medications known to interact with fluconazole and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc Pregnant or lactating women Severe Crohn's disease defined by a PRO-2 (2-item patient-reported outcome) score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician Patient with symptomatic stricturing Patient with pouchitis or an ostomy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
Status: Recruiting

This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer.

Eligibility:
- EligibilityCriteria: General Inclusion Criteria:  Willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blood draw Diagnosis of HER2+, HR+ (for cohort R1) or triple negative breast cancer (for cohort T1) as per local assessment Availability of an archival tumor tissue (most recent pre-treatment tumor tissue is preferred) Unequivocally growing tumor lesion (progressive lesion) that is accessible for resection, excision or core needle biopsy Discontinuation of prior anti-cancer treatment outlined below should not be longer than 4 weeks from participation in this study  Inclusion criteria for participants in the cohorts studying acquired resistance  Participant had undergone regular monitoring for disease progression as per local practice (preferably every 3-6 months) while on most recent breast cancer therapy Accessible tumor lesion that newly appeared or a lesion that started to regrow while the participant was at least 6 months on therapy  Inclusion criteria for participants in the cohort studying primary resistance  Accessible tumor lesion that continued to increase in size or a newly appearing lesion (as confirmed by routine tumor assessment) while treated for at least 4 weeks but less than 6 months on therapy  Exclusion Criteria:  Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders) Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study Participant has started treatment with subsequent anti-cancer therapy Participants whose progressive tumor lesion that is targeted for biopsy/resection is in the bone Discontinuation of treatment was due to a reason other than disease progression - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients
Status: Not yet recruiting

To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults over 19 years old Brain disease patients hospitalized in the rehabilitation medicine department of our hospital and receiving exercise therapy 5 times a week Patients with a functional ambulatory category (FAC) score of 0-4 After receiving a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to follow the precautions.  Exclusion Criteria:  Those who have suffered prior to participating in the study Those in good physical condition, such as unstable conditions in the state system, coordination system, problem system, and endocrine system, and those with cerebrovascular disease Other cases of investigation without participation in this study - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
A Study of BND-35 in Participants With Advanced Solid Tumors
Status: Not yet recruiting

This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy Histologic confirmation of malignancy Measurable disease per RECIST v1.1 Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1 Participants must have adequate organ function as defined by laboratory tests Part 1: Following tumor types: Breast cancer, cholangiocarcinoma, colorectal cancer, adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, melanoma, ovarian cancer, renal cell carcinoma, pancreatic adenocarcinoma, soft tissue sarcomas  Exclusion Criteria:  Active, known or suspected autoimmune disease Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications Brain or leptomeningeal metastases Known history of positive test for HIV or known AIDS Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) Participants after solid organ or allogeneic hematopoietic stem cell transplant History of life-threatening toxicity related to prior immune therapy History of life-threatening toxicity related to prior cetuximab or other anti-epidermal growth factor receptor antibodies (for Sub-Part 1C) Unstable or deteriorating cardiovascular disease within the previous 6 months Any major surgery within 4 weeks of study drug administration Prior immune therapy treatments, unless at least 4 weeks have elapsed from last dose Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from last dose Use of other investigational drugs within 28 days Prior treatment with immunoglobulin-like transcripts (ILT3)-targeting agents Administration of a live attenuated vaccine within 28 days - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
Status: Recruiting

The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :

• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject is indicated for a NON emergent PCI. Patient presents with a compromised ejection fraction of less than 35%, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of >33). Clinicians decide to perform PCI during ECMO support. Informed consent  Exclusion Criteria:  ST elevation myocardial infraction. Pre procedure cardiac arrest within 24 hours. Subject in cardiogenic shock. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery.
Status: Recruiting

Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy, recreationally active males and females age 18-40 will be recruited for this study. A pre-participatory screening will assess physical activity readiness, medication use, and activity level to determine eligibility.  Exclusion Criteria:  Individuals will be excluded if they: 1) have any musculoskeletal injuries that could be made worse by participating in this study (e.g., sprain or strain of lower limb), 2) have documented medical conditions (i.e., hypertension, asthma, heart disease, diabetes) or exhibit signs and symptoms of medical conditions, and/or 3) are taking any medication that would interfere with the interpretation of our results. These include but are not limited to, anti-inflammatory drugs, antibiotics, anti-hypertensives, and any medicine controlling the digestive system. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities
Status: Not yet recruiting

While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Caregivers of a child who is empaneled at Denver Health (e.g. had 1 well child visit in last 18 months) Child will be aged 6 months to 5 years during the influenza season in which the trial will be conducted (season 1: 10/1/24-3/31/25; season 2 (if needed): 10/1/25-3/31/26) Child has no medical contraindications to vaccination (e.g., severe allergy to one of the vaccine ingredients, history of Guillan-Barre Syndrome)  Exclusion Criteria:  - Caregivers whose first language is not English - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort
Status: Not yet recruiting

The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age from 20 - 50 years ASA (The American Society of Anesthesiologists) I or II, undergo percutaneous nephrolithotomy (PCNL)  Exclusion Criteria:  Patients with history of psychotic illnesses Opioid users Bladder obstruction, Benign prostatic hyperplasia Overactive bladder (OAB) defined as frequency _3 times at night or _8 times within 24 hours. - HealthyVolunteers: No - Gender: Male - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult
Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment
Status: Not yet recruiting

This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis of the the scalp planned treatment of actinic keratoses of the scalp with Tolak® Olsen grade I or II  Exclusion Criteria:  known or documented intolerance to any of the ingredients of Tolak® or Lipikar Urea 30% treatment of actinic keratoses in the treatment area within the past 3 months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.) suspected invasive squamous cell cancer in the treatment area chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult