cyrilzakka/clinical-trials huggingface dataset:
Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers

Latino children experience higher rates of obesity compared to non-Hispanic white children, especially in low-income communities. Optimal feeding strategies in early life, avoidance of screen time and longer sleep duration may lower the risk of obesity. Family financial hardship is also associated with short- and long-term health risks, including behavioral and mental health problems, and toxic stress which contributes to elevated risk of common chronic conditions over the life course. This proposal aims to pilot test two interventions to promote optimal health outcomes in Latino infants. Study participants will meet with a health educator after well child visits at 2-weeks, 2-, 4-, 6-, 9- and 12-months. Half of the parents will receive education on obesity prevention. The other half will receive financial education and case management using an established financial coaching approach. Parents will also receive text messages that reinforce educational content. The objective of this study is to determine the acceptability and feasibility of offering these interventions in the well-child setting. Study investigators also seek to determine the preliminary efficacy of these interventions on infant and parent health outcomes including dietary intake, screen time, sleep duration, health related quality of life and financial stress.


Eligibility Criteria:
Inclusion Criteria:

* Study investigators will recruit parents who self-identify as Latino and their newborn infants
* Infants must be born at Zuckerberg San Francisco General Hospital (ZSFG)
* Infants must be singletons
* Parents must intend to receive primary care for their infant at Zuckerberg San Francisco General Hospital
* Parents must speak Spanish (but may also speak English)

Exclusion Criteria:

* Infants with birth weights less than 2500 grams
* Infants born prior to 37 weeks and 0 days gestation
* Infants with any medical condition that significantly affects feeding, such as infants who are unable to feed by mouth
* Infants with any medical condition that is known to be associated with failure to thrive or specialized nutritional needs
* Infants in foster care
* Infants for whom the primary caregiver is not the infant's mother or father
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed VIN (only usual type, formerly VIN 2-3)
* Visible, measurable lesion(s)
* Contraception (for premenopausal women)

Exclusion Criteria:

* Evidence of invasion
* History of cancer or severe inflammatory dermatosis of the vulva
* Pregnancy, lactation
* Immunodeficiency
* Any treatment for VIN within the previous three months
* Known hypersensitivity to imiquimod
Study of Gut Microbiota in Primary Immune Deficiency, Possibly Associated With Inflammatory Bowel Disease

Some Primary Immune Deficiencies can be associated with an inflammatory bowel disease, mimicking Crohn disease : the Chronic Granulomatous Disease (CGD), the XIAP deficiency, and the TTC7A deficiency.

This inflammatory bowel disease is frequent but inconstant, raising questions about other factors contributing to the disease. The aim of our study is to analyze, describe and compare the gut microbiota of patients with those primary immune deficiency, with or without intestinal disease.

The investigators can expect, in the long term, to compare on a same patient, the gut microbiota evolution, and to assess the role of gut microbiota modifications on the onset of an inflammatory bowel disease.

The investigators will include patients (adults or children), with Primary Immune Deficiency (CGD, XIAP or TTC7A deficiencies), and they will collect feces samples from them.

In parallel, as control groups, patients with no inflammatory bowel disease and no primary immune deficiency will be included, and also patients suffering from Crohn's disease without known primary immune deficiency.

The laboratory collaborators will then realize analyzes on the microbiota collected for all patients.

The study team will then analyze the microbiota composition of the different types of patients, and try to identify some factors, associated with the appearance of an inflammatory disease on these patients.

Eligibility Criteria:
Inclusion Criteria (Patients with one of the 3 specific PID mentioned above):

* Presenting a Primary Immune Deficiency (CGD, XIAP ou TTC7A deficiency) with or without inflammatory digestive disease

Inclusion Criteria (Control patients without one of the 3 specific PID mentioned above):

* No antibiotic treatment in the month preceding the inclusion

Exclusion Criteria (all patients):

* Patients having a received a gene therapy or a Hematopoietic stem cell transplantation
Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope

Fluorescent lifetime microscopy has emerged as a useful tool to study fluorescent lifetimes in vitro. Fluorescence lifetime represents the average amount of time a fluorophore remains in the excited state following excitation and depends on the fluorophores molecular environment. Fluorescence lifetime ophthalmoscopy (FLIO) is a technique which can quantify fluorescence lifetimes in the human retina in vivo. The purpose of this study is to investigate fluorescence lifetime characteristics in the human retina by using a FLIO. The investigators hypothesize that FLIO will allow to identify areas of retinal metabolic stress such as ischemia by detecting changes in fluorescence lifetimes.

Background

Ophthalmic imaging has made considerable progress in the last years. Especially the introduction of optical coherence tomography and the scanning laser ophthalmoscope has helped to understand the structural changes underlying various retinal diseases. However, the appearance of structural changes during retinal disease often represents irreversible functional loss with only limited treatment options. In order to prevent loss of vision, retinal diseases should ideally be diagnosed before structural changes occur. This can be achieved by imaging metabolic changes of the retina as most retinal diseases such as age related macular degeneration or diabetic retinopathy are associated with distinct metabolic changes, mainly related to oxidative stress.

Recently, a novel device for imaging fluorescent lifetimes of the retina in vivo, the fluorescent lifetime ophthalmoscope (FLIO), has been developed. This device is able to measure fluorescence lifetimes in the retina on a macroscopic level and may be able to shed new light on metabolic diseases of the retina.

Objective

To define fluorescence lifetime characteristics in healthy patients and patients with various retinal diseases.

Methods

The investigators will use a novel device, the fluorescence lifetime ophthalmoscope (FLIO) to investigate fluorescence lifetimes in the human retina.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be willing to give written informed consent
* Healthy volunteers 18 years of age or greater
* Patients 18 years of age or greater
* No significant media opacities

Exclusion Criteria

* Opacities of ocular media excluding detailed observation of the retina
Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up

The prevalence of obesity is steadily growing in many parts of the world in order to reach epidemic proportions. Changes in signaling pathways state of hunger and satiety contribute to the increase in obesity and metabolic syndrome. Currently, the white adipose tissue, also is considered a secretory tissue by producing numerous adipokines involved in a chronic state of inflammation, which may interfere with the neuroendocrine regulation of energy balance that affect the weight loss process. The bariatric surgery is recommended as the most effective tool in the treatment and control of morbid obesity. The study population will consist of patients undergoing bariatric surgery of type Roux-en-Y gastric bypass. The study was performed in Clinical Hospital of the Federal University of Paraná (UFPR). This is a prospective cohort study with follow up of 6 and 24 months. The aim of this study is to assess the effects of weight loss after bariatric surgery associated anthropometric characteristic, metabolic changes (glucose, cholesterol profile,hepatic enzymes, Fibroblast growth factor- 21(FGF-21), blood pressure), the profile of adipokines pro/anti-inflammatory (adiponectin, interleukin-6 (IL-6),interleukin-10 (IL-10), C reactive protein (CRP), plasminogen activator inhibitor-1 (PAI-1), tumor necrosis factor alpha (TNF-α), intercellular adhesion molecule-1 (ICAM-1), resistin, frizzled-related protein 5 (SFrp5) and neuroendocrine regulation of energy balance (leptin, neuropeptide Y (NPY) , alpha-melanocyte stimulating hormone (α-MSH), melanin-concentrating hormone (MCH) and agouti-related peptide (AgRP), as well as the quality of life in obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Age range 20-59 years
* BMI ≥ 40 kg/m2
* BMI ≥ 35 kg/m2 with comorbidity recognised by National Institutes of Health.

Exclusion Criteria:

* Patients in use of insulin
* Patients in use of Immunosuppressant
* Anti-inflammatory and/or immunosuppressant therapies
* Any malignancy
* Chronic kidney or liver disease
* Obesity caused by an endocrine disorder
* Patients with psychiatric disorders
* Smoker or alcohol dependence
* Patients with rheumatoid arthritis and/or autoimmune
Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

Patients with neovascular age-related macular degeneration (AMD) scheduled to receive intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10 seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be conducted immediately after and 15 minutes after the injection, to assess for pain.

All patients scheduled to receive intravitreal Ranibizumab for the treatment of neovascular AMD will be evaluated for inclusion into the study. After a positive evaluation, the study will be explained to the patient, the Letter of Explanation reviewed with the patient and informed consent approved if patient agrees to participate. Demographic data of sex and age will be recorded. As well the number of previous intravitreal injections will be recorded ( none, 2 - 5 and \> 5 ). A nurse will then proceed to select an opaque envelope from a box of identical envelopes. The envelope will contain the topical anesthetic agent to be used. The randomization code linking each patient to their anesthetic will be stored in a secure location, and only accessed at the completion of the trial. The anesthetic procedure will be performed by someone other than the surgeon who will perform the IVT injection. After a minute of the anesthetic application, the surgeon, blinded to the anesthetic intervention, will perform the IVT injection of Ranibizumab. Immediately following the injection, a blinded observer will first explain the Pain Questionnaire, and then conduct it. Also at this time, the physician who performed the injection will complete the Wong-Baker Pain Questionnaire. The patient will then be asked to wait in a room for an additional 15 minutes, where the same observer will return and the Pain Questionnaire will be conducted a second time.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 50
2. Scheduled to receive Ranibizumab for neovascular AMD

Exclusion Criteria:

1. History of pars plana vitrectomy
2. Any major surgery within the prior 28 days, or one planned within next 6 months
3. History of thromboembolic event
4. Previous known allergic response to topical anesthetic(s) (lidocaine, tetracaine, cocaine)
Refractive Surgery and Optive Compatibility Study

To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 and over
* Patients undergoing refractive surgery

Exclusion Criteria:

* Concurrent ocular conditions or pathology that could affect patient's ability to complete study
* Concurrent use of topical medications other than study medications
* Use of systemic medications with ocular drying sequelae:

  * Antihistamines
  * Decongestants
  * Antispasmotics
  * Antidepressants
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices

The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP) and Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing surveys (questionnaires) for the accessory medical devices by the investigators.

The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP) and Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing surveys (questionnaires) for the accessory medical devices by the investigators.

A survey (questionnaire) of each accessory medical device should be completed by investigator in order to assess safety of the accessory by success of implantation procedure, occurrence of adverse events during implantation procedure or as late term effects resulting from implantation procedure, user harm related to the accessory, procedure, reported device deficiencies related to the accessory. The Surveys (questionnaires) also include questions related to performance, usability and compatibility with devices and other accessories. Subjects should be treated according to instructions-for-use of the implants and accessories and according to clinical routine. The devices must have been used exclusively by physicians who are experienced in cardiac catheterization techniques and who are experienced in using the products in the process of interventional operations.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use for accessory medical devices and cardiac implant devices.

All subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included

Exclusion Criteria:

* Exclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use and if applicable in the corresponding protocol of the investigation on the Occlutech implant devices.
Effect of a Preparation Video on Preoperative Anxiety in Children Undergoing Dental Treatment Under GA

The present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under General Anesthesia (GA).

This randomised controlled trial, conducted at King Abdullah University Hospital (KAUH) over an eight-month period from February to October 2023, focused on children aged four to seven years undergoing comprehensive dental treatment under GA. Participants were randomly assigned to either the control group or the study group. Participants in the control group received the standard care provided upon arrival at the Day Case Unit (DCU) at KAUH, involving only a verbal explanation of the anaesthesia induction process. In contrast, on the night before the surgery, participants in the study group were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home. Additionally, all parents watched the video alongside their children and provided positive comments on its content. The primary outcome assessed was the children's preoperative anxiety measured by modified Yale Preoperative Anxiety Scale (m-YPAS) and Visual Facial Anxiety Scale (VFAS), allowing for an evaluation of the intervention's impact.

Eligibility Criteria:
Inclusion Criteria:

* Children who are healthy, with American Society of Anesthesiologists (ASA) Grade 1 and 2 status.
* Age 4-7 years.
* Children undergoing GA for the first time who require comprehensive dental rehabilitation.

Exclusion Criteria:

* Presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities.
* Presence of visual or auditory disability.
* Participants who refuse to answer subjective scales due to heightened anxiety levels.
* Participants with no access to internet services.
* Presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety.
The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping

To assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.

Ultrasound can provide a multi-directional scan of the femoral head and neck junction, and the range of evaluation is larger than that of the intraoperative c-arm. The study was to assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the forming of the femoral head and the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hip pain;
* Cam type (alpha Angle \> 50°) impingement and glenoid labrum laceration

Exclusion Criteria:

* Previous hip surgery;
* Patients with subosseous cystic degeneration of synovitis
A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

The purpose of this study is to assess the transfer of fospropofol and its active metabolite, propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a needed procedure.

E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.1 It is a water-soluble, phosphono-O-methyl prodrug of propofol. Upon IV injection, the inactive fospropofol undergoes metabolism, most notably by alkaline phosphatase enzymes, to yield the active metabolite (propofol), phosphate, and formaldehyde. Formaldehyde is quickly converted to formate in vivo, and formate is further metabolized by a folate-dependent mechanism.

Eligibility Criteria:
Inclusions:

* Lactating women undergoing a needed procedure expected to last between approximately 10 to 45 minutes
* Subjects should be between 6 weeks and 8 months postpartum
* Lactation must be well-established in subjects
* Subject's infants must be full term and able to bottle-feed
* Infants should be predominantly breast milk fed and should not receive more than one bottle of formula per day

Exclusions:

* Subjects who are pregnant
* Subjects undergoing a breast procedure (eg, biopsy, abscess drainage, etc.)
* Subjects who are not willing to temporarily refrain from nursing their children during the 0-24 hour breast milk collection interval.

(Subjects may resume nursing following this interval).
Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma

An open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2) peptides in patients with relapsed follicular lymphoma.

Follicular lymphoma (FL) is the the most common of the indolent lymphomas, with an incidence in Denmark of 220 per year. In 90% of the cases the disease is incurable why the treatment strategy often is watchful waiting until significant signs of progression or transformation. After chemotherapy, maintenance therapy is often used to increase disease control.

The microenvironment and immune escape mechanism are believed to play a major role in the persistence of the lymphoma. One escape mechanism is the PD-L1 and PD-L2 molecules expressed in the microenvironment of follicular lymphoma inhibiting the T-cells. By stimulating the T-cells to attack PD-L1 and PD-L2 expressing cells we hope to hamper the immunosuppressive tumor environment and establish immune tumor control.

10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented FL grade I-IIIa, with no sign of current transformation. Patients cured of transformed lymphoma are eligible.
* A minimum of one line of induction therapy. Maintenance rituximab can continue along with the vaccination
* At least partial response to the latest standard treatment
* A minimum of 4 weeks since last treatment
* Age ≥ 18
* ECOG performance status of 0 or 1
* Life expectancy ≥ 12 weeks
* Adequate hematologic and end-organ function

Exclusion Criteria:

* Progression with the presence of at least one GELF criteria or transformation at inklusion time.
* Other active malignant diseases
* Significant medical condition per investigators judgement e.g. severe Asthma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.
* Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis
* Serious known allergies or earlier anaphylactic reactions.
* Known sensibility towards Montanide ISA-51
* Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
* Pregnancy