cyrilzakka/clinical-trials huggingface dataset:
Metabolic Risk Factors and Myocardial Oxygenation Reserve

The purpose of this study is to use MRI images using the OS-CMR technique to view the differences in the hearts of healthy volunteers and participants with a condition called Metabolic Syndrome. The objectives of this project are to compare these two groups and to view how health risks, blood test results, and the time since a Metabolic diagnosis can affect heart health.

Myocardial oxygenation changes during vasoactive breathing maneuvers, observed with oxygenation-sensitive cardiac MRI, will be identified and compared between individuals considered healthy and those fitting the criteria of the Metabolic Syndrome.

Eligibility Criteria:
Inclusion Criteria:

Patient Participants:

* Age 18-80
* Informed Consent
* Diagnosis of MetS (through at least 3 MetS characteristics (abdominal obesity, high triglyceride level, low HDL cholesterol, high systolic blood pressure, and high fasting glucose levels)

Healthy Volunteers:

* Age 18-80
* No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system
* No Smoking

Exclusion Criteria:

* General MRI contraindications\*
* Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
* Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam
Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients

This study aims to evaluate the impact of widefield OCTA-guided selective photocoagulation on the progression of diabetic retinopathy (DR) by comparing the control of non-perfusion (NP) areas, DR grading, and management of other DR lesions. The study is designed as a parallel randomized controlled trial. From February 2025 to August 2026, 30 diabetic patients attending the Ophthalmology Department of Sichuan Provincial People's Hospital will be enrolled. Using a simple randomization method, one eye of each patient will be assigned to the intervention group, while the contralateral eye will serve as the control, resulting in 30 eyes in each group. The intervention group will undergo OCTA-guided selective photocoagulation, specifically using a grid pattern (3x3) of spot laser applied once to the NP area, extending one spot diameter beyond the NP boundary. Each session will last 10-20 minutes. The control group will receive no treatment. The study will compare changes in NP area, DR grading progression, and control of other DR lesions at 3, 6, 9, and 12 months between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Type 1 or Type 2 diabetes mellitus
* Clinical dilated fundus examination and Optos imaging within 7 fields showing diabetic retinopathy (DR) lesions no more severe than severe non-proliferative diabetic retinopathy (NPDR)
* Optical coherence tomography angiography (OCTA) demonstrating non-perfusion (NP) areas greater than 1 disc diameter (PD) in both eyes
* Diabetic retinopathy in both eyes at the same stage, with the total NP area within the observed range of OCTA being comparable (difference less than 5 PD)
* Absence of other ocular diseases that could lead to the formation of retinal microaneurysms
* Absence of other ocular diseases that could lead to the formation of retinal non-perfusion areas
* No diabetic macular edema involving the fovea
* No history of retinal laser treatment
* No history of intravitreal injection therapy within the past 3 months
* No history of ocular surgery other than cataract surgery
* Ability to cooperate with all examinations and provide informed consent

Exclusion Criteria:

* Optical media opacity affecting OCTA imaging
* Patients with difficulties in cooperating with laser treatment
* Patients with renal failure, diabetic neuropathy, or severe cardiovascular diseases
* Patients who are unlikely to complete follow-ups every 3 months, as well as those residing in other provinces
* Patients requiring early PRP (conditions include: combined DME, planned cataract surgery, pregnancy planning, early PDR, poor follow-up compliance, severe vision loss in the other eye, poor glycemic control, poor renal function, or type 1 diabetes)
* FFA showing NP greater than 10 PD within the ETDRS area or a total NP area greater than 75 PD, or an ischemia index greater than 35%
Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.

Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.

Eligibility Criteria:
Inclusion Criteria:

* 17 years of age; full legal capacity to volunteer.
* Ocular examination within the last two years
* Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
* Currently wearing soft contact lenses.
* Clear corneas; no active ocular disease.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
* Monovision.
* Any ocular disease.
* Never worn contact lenses before.
* Corneal refractive surgery.
* Uses topical ocular medicine.
* Other protocol-defined exclusion criteria may apply.
Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder

The investigators hypothesize that in patients with shift work sleep disorder, armodafinil will specifically increase brain activity in the frontal cortex parallel with improvements in deficits of fundamental mechanisms of attention.

The current protocol will utilize a paradigm which is well suited to examine frontal attentional neuronal mechanisms by eliciting event related potential components known to reflect automatic stimulus detection as well as involuntary and voluntary attentional processes. The that end the proposed research has two specific aims. 1) Identify what areas of the frontal lobe and corresponding cognitive functions are impacted by excessive sleepiness in shift work sleep disorder and 2) identify specific brain areas affected by armodafinil and their role in improvement of fundamental attentional processes using a complex cognitive task targeting attentional control.

Eligibility Criteria:
Inclusion Criteria:

* Night shift workers with and without shift work sleep disorder.

Exclusion Criteria:

* Secondary condition to shift work sleep disorder.
Molecular Imaging Exploration of Ocular Angiogenic Activity and Evaluation of Its Interest in the Therapeutic Follow-up of Patients With AMD (Age-related Macular Degeneration)

The main objective of this pilot study is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

To date, no functional imaging modality has been validated to assess the level angiogenic activity of choroidal neovascularization in AMD, while the therapeutic use of antiangiogenic agents is almost systematically in the form of intraocular injections.

The therapeutic response is observed anatomically and functionally only after 6 months of treatment. Several arguments in the literature suggest that the therapeutic response occurs earlier at the molecular level, as soon as the induction phase is complete (after 3 months of treatment). The main objective of this pilot study is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18, membership of a social security scheme. Signature of informed consent,
* Subject presenting AMD with unilateral involvement, involving at least 1 Choroidal neovascularization objectified in OCT, naive to any treatment antiangiogenic.
* Initial assessment including at least OCT and measurement of visual acuity, dating from maximum 1 month at the time of PET 68Ga-NODAGA-RGD.

Exclusion Criteria:

* Pregnant or breastfeeding women, as a result of radiation protection.
* Subjects under 18 years of age and / or not affiliated to a social security scheme.
* Subjects with AMD with bilateral involvement.
* Subjects with AMD without a focus of neovascularization objectified by the classic diagnostic battery.
* Subjects having already been treated with antiangiogenic therapy.
* Subjects with any other ophthalmological pathology. Monophthalmic subjects
Effects of Flumazenil on Brain Excitability

This study will investigate the effects of the drug flumazenil on brain excitability and the drug's relationship to a natural brain chemical called GABA. Flumazenil is commonly used in hospitals to reverse the effects of a group of drugs called benzodiazepines, one of which is Valium. Benzodiazepines act by enhancing the effects of GABA.

Healthy volunteers 21 years of age and older may be eligible for this study. Candidates will be screened with a medical history and physical and neurological examinations.

Participants will have transcranial magnetic stimulation (TMS) four times on two different days, before and after receiving an intravenous (through a vein) infusion of either flumazenil or placebo (an inactive sugar solution), as follows:

TMS study 1

Drug or placebo infusion

TMS study 2 - 15 minutes after infusion

TMS study 3 - 60 minutes after infusion

TMS study 4 - 120 minutes after infusion

In transcranial magnetic stimulation, a very brief electrical current is passed through an insulated coil wire placed on the scalp. These currents stimulate the cortex (outer part of the brain). They may cause muscle, hand, or arm twitching if the coil is near the part of the brain that controls movement, or they may affect other reflexes or movements. During the study, subjects may be asked to make movements, do simple tasks or tense muscles. To record the electrical activity of muscles, electrodes will be taped to the skin over the muscles tested. In some cases, the studies will be videotaped.

Flumazenil will be infused through a catheter (thin plastic tube) attached to a needle placed in an arm vein. On one day, subjects will receive a 1-mg injection of flumazenil followed by a continuous infusion of 0.5 mg of the drug for about 30 minutes. On the other day, they will receive placebo, administered in the same manner.

The purpose of this study is to investigate the effects of flumazenil on cortical excitability in healthy human volunteers. Flumazenil acts as a potent benzodiazepine (BZP)-specific antagonist by competing at the central synaptic gamma-aminobutyric acid (GABA) receptor site. However, the relationship between GABA and flumazenil without BZPs is not well known. We plan to determine if intravenous (IV) administration in therapeutic dosage alters cortical excitability as measured by transcranial magnetic stimulation (TMS). The long-term plan is to identify a pharmacological method to reduce cortical inhibition that might be useful in stroke rehabilitation.

Eligibility Criteria:
Only healthy volunteers, who are age 21 or older.

No history of surgery with metallic implants or known metallic particles in the brain.

Patients cannot be pregnant (as tested with a pregnancy test).

Patients with a psychiatric illness are not eligible.

No history of seizures.

No cardiovascular disease or drug therapy for chronic depression.

No hypersensitivity to benzodiazepines and related drugs.

No history of drug abuse and/or chronic alcoholism.
Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data).

Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Performance status ECOG-WHO 0, 1 or 2
* Metastatic colorectal cancer Histologically proved
* signed written informed consent

Exclusion Criteria:

* previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease
* history of autoimmune disease
* patients under immunotherapy systemic treatment or immunosuppressive drugs or stopped for less than 6 months to the enrollment in this study.
* corticoids ≥ 1mg/kg
* acute or chronic infectious disease during treatment or stopped for less than six months
* other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* pregnancy, breast-feeding or absence of adequate contraception for fertile patients
* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
* patient under guardianship, curator or under the protection of justice.
Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors

This study will evaluate the impact of Short Message Service (SMS) on compliance with surveillance of patients with germ-cell tumors. Patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder SMS before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without SMS.


Eligibility Criteria:
Inclusion Criteria:

* Patient with germ cell tumor.
* Patient with a mobile phone.
* Patient on surveillance.

Exclusion Criteria:

* Testicular cancer without germ cell component.
* Prior history of other malignancy except for: cutaneous cancers excluding melanoma, superficial bladder tumor, localized prostate cancer with undetectable PSA.
* Cognitive condition that would preclude patient's understanding and completion of study procedures.
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance

Hypothesis

1. Study method achieves lower requirement for medications
2. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
3. Study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy
4. Study method improves bowel preparation and increases polyp pickup rate

Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic VA patients is being promoted (VHA directive). Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy. The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.

Methods that maintain a high success rate and good patient assessment improve overall compliance for surveillance colonoscopy. Our preliminary experience showed that patients are able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was aided by a water infusion in lieu of air insufflation method. In this group of patients, the shortened recovery time means a quick turn around of patient and a more efficient endoscopy service. Patients are able to communicate better with the staff and physician regarding their problem and discharge instructions, and not subjected to the amnesic effect of sedation. Next day follow-up of patient by telephone contact which requires commitment of staff time can be obviated.

If this randomized study confirms the success of our preliminary findings and this technique is adopted by more endoscopists, a larger number of VA patients may benefit from less sedation complications and at the same time allow for more efficient colonoscopy screening services.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 50 years old), male and female patients
* Scheduled and consented for screening or surveillance colonoscopy
* Accept randomization to the study or the conventional method
* Agree to complete study questionnaires will be considered for enrollment
* Normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2

Exclusion Criteria:

* Patients who decline to participate, are unable to give informed consent or to complete the questionnaires due to language or other difficulties will be excluded. Excluded patients will be managed by usual procedures at the Sacramento VAMC
Composition for Treating Cirrhosis and Liver Cancer (SB-1121)

The composition treats cirrhosis and hepatocellular carcinoma (Hcc) at an early stage. The product is extracted from herbs, including Adenosma glutinosum extract, Eclipta prostrata extract, Phyllanthus urinaria extract, Impatiens balsamina extract, Ascorbic acid, pyridoxine 5-phosphate, L-Arginine hydrochloride, Pregnenolone acetate. These components have participated in repairing and regenerating new liver parenchyma, preventing fibrosis cell generation, preventing liver cancer cell growth at an early stage. The composition supplements precursors which help the body strengthen antibodies and reduce the risk of inflammation, restore physiological and biochemical functions of liver cells after chronic inflammation.

The composition is fractionally extracted from herbs. Flavonoids, isoflavonoids, and pregnenolone combined with ascorbic acid, pyridoxine 5-phosphate, L-arginine act as the key compounds in the regeneration of fibrosis liver cells, remove scar tissue, stimulate and release growth hormones, prevent progression to Hcc and prevent Hcc recurrence.

The pharmaceutical ingredients involved in the composition are calculated to increase their effectiveness in preventing and curing cirrhosis and Hcc.

Currently, many preparations have been and are being studied to fight against cirrhosis and liver cancer globally. The effectiveness of this preparation is a new finding which has been proven over 5 years of follow-up.

Pregnenolone is a cortisol precursor. Cortisol plays an important role in several systems in the body, including the immune system(in the cycle of the immune system to produce B lymphocytes). This ingredient is used as a supplement to stabilize the endothelium, regulate the amount of cortisol within normal limits, and help the body produce B lymphocytes with a good response.

Kaempferol is a flavonoid that participates in cell protection against toxic proteins which were produced during prolonged inflammation; blocking the action and removing denatured proteins that change the parenchyma of liver cells. The selected flavonoids repaired the fibrotic structure of liver parenchyma after chronic inflammation. Ascorbic acid, pyridoxine 5-phosphate, and L-arginine help to facilitate biological functions in cell adhesion, synergize with flavonoids in cell membrane protection, structural repair, and liver cell regeneration.

Ascorbic acid, pyridoxine 5-phosphate act as enzymes that catalyze processes conveniently.

Eligibility Criteria:
Inclusion Criteria:

* All patients with underlying medical conditions who have been taking medications for these conditions.
* Patients with AIDS, HIV, HBV, HCV, and patients with co-infections.
* The cancer patients are stable.
* Patients with congenital or acquired immunodeficiency.

Exclusion Criteria:

* Unstable cancer patients.
* Decompensated cirrhosis.
Decision Aid for Parents of Infants With UPJO

Ureteropelvic junction obstruction (UPJO) is the most common etiology of high-grade hydronephrosis, affecting approximately 4,000-10,000 infants annually in the U.S. The goal of surgical treatment of UPJO is to minimize the risk of kidney damage associated with obstruction, which may occur in 30-60% of infants with high-grade hydronephrosis.1-However, the benefit of early surgery compared to observation and potential later surgery to preserve kidney function has not been well-defined. Consequently, surgeons differ on whether to initially treat with surgery or observation, with surgical rates in the first year of life varying from 15-50% across surgical practices. These variations are important to understand, as the decision for early surgery is not without risk. Prior studies suggest that infants treated surgically are at higher risk for readmission and reoperation. Early surgery also raises concerns about neurodevelopmental effects of anesthetic exposure.

To address this gap, the purpose of this pilot test is to develop a patient decision aid (PtDA) tool and pilot test its effect on parental understanding and engagement in the decision-making process at Children's Hospital Colorado. The proposed pilot is a necessary first step in preparation for a future multicenter hybrid effectiveness-implementation trial. This work will also be used to support future studies evaluating the impact of a PtDA on surgical variations and treatment outcomes in patients with UPJO and other complex congenital urologic anomalies.


Eligibility Criteria:
Inclusion Criteria (all of following are needed):

* parents (age 18-89 years) of children age 30 days - 2 years
* child is presenting for consultation for SFU grade 3-4 Hydronephrosis at Children's Hospital Colorado
* parents/child presenting at Urology appointment where a MAG 3 is performed or has recently been performed.

Exclusion Criteria:

* does not meet age parameters
* does not have a child with a UPJO
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event.

A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event. The investigators expect that this intervention will lead to improvement in posttraumatic guilt, shame, and PTSD symptoms as compared to an active control condition.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Endorsed prior TI experience (TIQ items A \& B)
* Elevated posttraumatic stress symptoms (PCL-5; Blevins et al., 2015)

Exclusion Criteria:

Inability to consent or complete the intervention including:

* Cognitive impairment
* Uncorrected visual or auditory impairment
* Unmedicated severe mental illness
* Imminent risk of harm to self or others