cyrilzakka/clinical-trials huggingface dataset:
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years with diabetic macular edema
* Diagnosis of diabetes mellitus types 1 or 2
* Best corrected visual acuity of 19-68 letters
* Retinal thickness \> 250 micron by OCT
* Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

* Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
* Any ocular surgery within the last 3 months
* Retinal laser treatment within the last 3 months
* History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
* Any lens opacity which impairs visualization of the posterior pole
Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥10 years of age at the time of consent.
* Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies.
* Negative urine pregnancy test for all female participants.

Exclusion Criteria:

* Previous vaccination with any meningococcal serogroup B vaccine.
* Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
* Any confirmed or suspected human immunodeficiency virus infection.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment.
* Current chronic use of systemic antibiotics.
* Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab).
* Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
Midazolam Whole Body Physiologically Based Pharmacokinetic Model

This study investigates what independent variables may influence Midazolam Pharmacokinetics in critically ill patients.

This study has three specific aims:

1. to create a Midazolam PBPK model based on anthropometric and physiopathological data from enrolled patients;
2. to estimate cerebral and systemic Midazolam concentrations;
3. to assess independent variables about Midazolam pharmacokinetic in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* ICU admittance
* Caucasian
* Clinical indication of least 72h of continuous sedation with Midazolam
* MAP between 60 - 150 mmHg, even if obtained with amine support
* informed consent obtained

Exclusion Criteria:

* Any endocranial lesion, spontaneous or induced
* PaCO2 \> 60 mmHg or \< 30 mmHg
* PaO2 \< 50 mmHg
* Pregnancy
* Anuria
* Any transplantation
* Severe hepatic failure (Child C)
* Life expectancy \< 72h
* Ketoconazole and antiretrovirals in therapy
Blind Tracheal Intubation Through Supraglottic Airway Devices

Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation \&ventilation, less hemodynamic stress response and less postoperative complications. These advantages encourage the use of a proper SAD as a conduit for endotracheal intubation in stressful conditions. This study will be carried out to compare the Air-QTM Blocker and LarysealTM Pro for blind tracheal intubation during elective ophthalmic surgeries under general anesthesia. Intubation through SAD can be performed using a fiber-optic bronchoscope or blindly. Blind intubation is meaning that the tube is inserted through SAD without direct visualization of the airway. Success rate of blind intubation ranges between 15% and 97%, mostly depending on the type of used SAD, patient characteristics and operator skills. The availability of blind intubation through SAD is important in cases of difficult intubation (either anticipated or unanticipated) especially if fiber-optic is not available, so that SAD will be convenient for untrained personnel.

The laryseal pro could provide rapid and secure airway management and improve patient safety with gastric access reducing the risk of pulmonary aspiration, in addition to speeding up the ETT tube placement with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance, and elevates the epiglottis for easy, trauma-free ETT tube or bronchoscope insertion. According to the manufacturer: all these features of laryseal pro allow quick easy first time insertion success. As, the laryseal pro is being of shorter breathing tube and smaller cuff in comparison to Air-Q Blocker, so the laryseal pro is expecting to be more amazing than the Air-Q Blocker especially for the new trainers regarding the total insertion time of the endotracheal tube and success rate. Jatin et al. 2021reported that Air-Q Intubating Laryngeal Airway resulted in significantly more success rate and ease of intubation as compared to Ambu Aura Gain. Andrzej et al. 2018 stated that success rate of blind intubation through Air-Q was 75% when compared to 80% in I-gel group. In contrary, there are limited studies available in literature on blind tracheal intubation through the laryseal pro.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-55 years old.
2. ASA I\&II.
3. Both sexes.
4. El-Ganzouri Airway Score \< or =2

Exclusion Criteria:

1. History of upper respiratory tract infections.
2. History of obstructive sleep apnea (OSA) or STOP Bang-Score \> 4.
3. Potentially full stomach (trauma, morbid obesity BMI\> 35 Kg/m2, pregnancy, history of gastric regurgitation and heart burn).
4. Esophageal reflux (hiatus hernia).
5. Coagulation disorders.
Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

The present study grounds on the absence of evidence-based treatment in individuals with dyslexia. At this topic, the present study will explore the potential effect of transcranial direct current stimulation (tDCS) over parieto-occipital brain regions, cerebral areas usually disrupted in individuals with dyslexia. tDCS will be administered without concomitantly training.

Therefore, the investigators hypothesized that active tDCS over parieto-occipital areas will enhance reading skills in children and adolescents with dyslexia. On the contrary, sham tDCS (placebo) over parieto-occipital areas will not have significant effect on reading. Further, both active and sham tDCS will be safe and well-tolerated.

The study design is randomized stratified, cross-over, double-blind, placebo-controlled.

Children and adolescents with dyslexia will be selected and randomly assigned to two different groups: 1. Active tDCS over parieto-occipital areas + sham tDCS over parieto-occipital areas (Active-Sham tDCS); 2. Sham tDCS over parieto-occipital areas + active tDCS over parieto-occipital areas (Sham-Active tDCS).

In this project, the investigators will work to understand whether a brain-based intervention, with the use of tDCS without combined training, can enhance reading in individuals with dyslexia.

The protocol will allow the investigators to:

1. Testing the efficacy of stand-alone tDCS in enhancing reading in individuals with dyslexia;
2. Testing the critical role of brain regions (parieto-occipital areas) usually involved in reading and disrupted in dyslexia;
3. Predicting outcomes based on reading-related skills;
4. Investigating the safety and tolerability of tDCS;

The overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in dyslexia.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with dyslexia (DSM-5, APA 2013)
* IQ ≥ 85

Exclusion Criteria:

* Having a comorbidity with an important medical conditions;
* Having neurological diseases;
* Having Epilepsy o family history of epilepsy;
* Receiving a treatment for dyslexia in the previous three months before the baseline screening;
Phototoxicity Test of Dapsone Gel in Healthy Volunteers

This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.


Eligibility Criteria:
Inclusion Criteria:

-Healthy adults.

Exclusion Criteria:

* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
* Sensitivity to adhesive bandages or tape.
Human Urinary Biomarker for Orange Juice Consumption

Human urinary metabolic profiling showed to be very successful to elucidate biomarkers linked to geographic origin and specific food consumption patterns (Holmes and Loo et al.: Human metabolic phenotype diversity and its association with diet and blood pressure. Nature 2008:1-6). It was possible to identify urinary metabolites directly linked to animal vs. vegetable protein intake. This is very valuable for future population studies, where diet is an important lifestyle factor but food questionnaires are time-consuming and expensive. Moreover, miss-reporting is a very common problem.

Our hypothesis is to find the same biochemical marker for orange juice as we already found in a preceding nutritional studies where participants recorded orange consumption.

To elucidate the citrus fruit biomarker it needs to be ensured that all volunteers do not consume citrus fruits and foods potentially containing similar ingredients. Therefore it is necessary to ask volunteers to refrain from these foods by giving them dietary restrictions. Extensive literature research showed that some foods (such as grain legumes and brie cheese) may contain the same compound, but in much smaller amounts.

Days 1-3 will be on open diet but with dietary restrictions (no alcohol, cheese, fruits, ethnic foods such as Chinese and Indian food, grain legumes such as beans, lentils, peas and peanuts, and all kinds of sprouts (such as cress or alfalfa)). On day 2 a glass of orange juice (200ml) will be consumed in addition to the open diet. Urine collection will continue and stop on day 4 at 10 am.

During the study to minimise variation in biomarker excretion due to other beverages the participants beverage intake will be restricted to water and coffee.

All urine samples will then be analysed using high resolution NMR spectroscopy and mass spectrometry. Mathematical data analyses as well as the visual examinations of the NMR spectra will also be carried out to validate the presence of citrus fruit biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* male/female
* aged 18-45 years
* non-smoker
* BMI 18-25 kg/m2

Exclusion Criteria:

* regular drug intake
* regular food supplements intake
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

The purpose of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among patients with moderate and severe aortic stenosis in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).

Residents of Southeast Minnesota over 75 years of age with an inpatient or outpatient diagnosis of moderate or severe aortic stenosis will be consecutively identified using an automated bi-weekly review of the echo lab calendar (on Mondays and Fridays) at Mayo Clinic Rochester (MCR) and Mayo Clinic Health System (MCHS) sites. Participants will be consented to undergo venipuncture, urine collection and 99mTc-PYP SPECT/CT imaging to rule in/out the diagnosis of TTR-CA. Hence, the prevalence of TTR-CA will be defined. To place this prevalence in perspective of the global aortic stenosis cohort in the community, a rigorous screening log will be maintained to allow generation of a comprehensive CONSORT diagram. Importantly, baseline characteristics of patients who qualify for our study but decline to consent will still be collected provided that consent for use of their records for medical research had previously been granted.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County)
* Age ≥ 75 years
* Current diagnosis of moderate or severe aortic stenosis by most recent (within 6 months at most) echocardiogram as defined by:

  * Moderate AS: 1.0 cm2 \< aortic valve area (AVA) ≤ 1.5 cm2
  * Severe AS: AVA ≤ 1.0 cm2

Exclusion Criteria:

* Any cardiac surgery or major chest trauma within 4 weeks of PYP scan
* Myocardial infarction within 4 weeks of PYP scan defined by typical angina, EKG changes and significant change in serial troponins. (Note that chronic troponin elevation is extremely common in cardiac amyloidosis).
* Prior or current exposure to Plaquenil (Hydroxychloroquine)
Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability

The CoNoR study aims to assess whether the use of the LiMAx test and the HepaT1ca pre-operative planning magnetic resonance scan impact upon technical resectability decision-making in colorectal liver metastases (CLM).

The CoNoR Study will occur via 4 workstreams:

1. Systematic review of all published criteria for colorectal liver metastases (CLM) technical resectability (systematic review protocol published on PROSPERO database: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=136748
2. Expert interviews: Interviews with liver surgeons and radiologists to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools
3. Online questionnaire: Online international questionnaire of liver surgeons to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools, in additional to identifying clinical scenarios in which these tools may be of greatest benefit
4. Online case-based survey: Recruitment of 10-20 participants with 'difficult decisions' regarding technical resectability, and consent to use results from pre-operative assessments to create anonymised online case-based survey. Participants will consent to have two additional pre-operative assessments: the LiMAx tests and the HepaT1ca magnetic resonance scan. These results from these additional tests will also be used in the online survey, We will recruit international liver surgeons to complete this online survey, where they will be asked to provide an opinion on technical resectability for each individual case scenario, and to specify their operative plan, both before and after seeing the results of these novel assessment tools. We will assess for change in decision-making on resectability, and change in operative plan after seeing these test results. We will also assess for level of agreement between liver surgeons on each scenario, and identify where they difficult decisions persist.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 16 years of age with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases
2. Discussion at regional hepatobiliary multidisciplinary team meeting
3. Hepatobiliary surgical opinion that their case represents a potentially difficult decision regarding technical resectability
4. Ability to provide written informed consent

Exclusion Criteria:

1. Presence of a medical or psychiatric condition impairing the ability to give informed consent
2. Presence of any other serious uncontrolled medical condition
3. Patients under 16 years old
4. Contra-indications to magnetic resonance scanning
Internet Based Cognitive Behavior Treatment for Alcohol Problems

The purpose of this study is to determine whether internet based cognitive behavior therapy might be effective in the treatment of alcohol problems.

A 12 week Internet based self help program based on cognitive behavioral therapy and relapse prevention is tested among Internet help seekers as well as among patients seeking help in addiction care.The design is a one armed pilot study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, self efficacy, craving, as well as depression and quality of life. 20 participants are recruited entirely online from an open access website and 20 participants are recruited through information given to them at an addiction clinic. All participants have access to the same self help program and have access to a licensed psychologist who guides the person all the way through the program.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* access to the Internet
* problematic alcohol use defined as ≥ 16 p or more for men and ≥ 14 p or more for women in the Alcohol Use Identification Scale

Exclusion Criteria:

* not adequately fluent in Swedish
* reading or writing impairment if this is so severe as to affect treatment
* ongoing psychological treatment with content similar to the treatment being studied
* suicide risk defined as ≥ 4 p på MADRS-S Q 9 or through a telephone interview with clinician
* severe depression defined as MADRS-S ≥ 30 p
* somatic or psychiatric conditions that are contraindicated for the treatment such as psychosis, bipolar disorder (depressive or manic phase), severe post traumatic stress disorder.
* has during the last 3 weeks begun using medication for alcohol problems or other psychiatric disorder
Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis

The study aims at defining the role of soluble CD95 Ligand in the physiopathology of the non-infectious uveitis. Soluble CD95 Ligand might have a prognostic interest as well as potential for the discovery of new therapeutic strategies

Non-Infectious active uveitis is a severe inflammatory ocular disease which can expose to the blindness. Actually, the knowledge of the physiopathology of uveitis stay poorly. CD95 Ligand (CD95-L) belongs to a TNF (tumor necrosis factors) receptor family. It knows to play a preponderant role to maintain the eye immune privilege. In particular conditions depending on immunologic environment, CD95-L has pro-inflammatory properties and can interact with Th17 lymphocytes and neutrophils, two cells implicated in non-infectious uveitis. The hypothesis is that s-CD95-L levels might be a prognostic factor in non-infectious uveitis and the study of the molecular mechanisms involved could provide new therapeutic targets.

This study will recruit 100 patients with non-infectious uveitis followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected during to assess s-CD95-L. Fundamental research will be realized on patients' sample to evaluate underlying molecular mechanisms.

Clinical and biological disease activity, treatment and outcomes will be studied in correlation with s-CD95-L to describe their potential prognostic role. Patients will be followed at regular intervals, accordingly to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-infectious uveitis according to the SUN (Standardization of the Uveitis Nomenclature) working Group;
* Age ≥ 18 years;
* being affiliated to health insurance,
* willing to participate.

Exclusion Criteria:

* Pregnant or breastfeeding women,
* patient under legal protection measure ,
* poor understanding of the French language
Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

After preterm birth mothers often suffer from hypogalactia. Herbal galactogogues can be used in order to increase milk production. In this double-blind, randomized, placebo-controlled clinical trial the effect of Silitidil, an extract from milk thistle, on the postpartal milk production in mothers of very premature newborns is investigated.

Mothers of preterm infants born at a gestational age \<= 32 wg are asked to participate in this double-blind, randomized, placebo-controlled interventional trial, where they will receive a preparation of the herbal galactogogue Silitidil or placebo over an intervention period of 3 weeks. The influence of the galactagogue will be investigated by monitoring daily milk production before, during and 1 week after cessation of the intervention. As secondary outcome parameters weight gain, the progress of enteral feeding, and the percentage of human milk feeding on total enteral feeding volumes will be monitored in the newborn infants. Also the breast milk composition (in terms of fatty acids, protein and carbohydrates content) will be investigated and compared between study groups. Saliva and urine probes will be collected at specific time points to survey hormonal reactions during the various phases of lactation and the relation of maternal hormone levels on milk production.

Eligibility Criteria:
Inclusion Criteria:

* mothers after preterm birth \<= 32 weeks of gestation
* Age of the newborn 1 - 5 days
* Human milk feeding intended

Exclusion Criteria:

* Ingestion of other galactagogues
* maternal chronical disease requiring therapy (e.g. severe hypothyreosis, preexistent arterial hypertension, Type I or 2 Diabetes, chronic inflammatory bowel disease, severe bronchial asthma, pollinosis)
* medication influencing prolactine levels
* Mastitis at time of enrollment
* mammary tumors or surgery influencing milk production
Role of Gut Microbiome in Cancer Therapy

This study examines how gut microbiome can affect cancer therapy in cancer patients undergoing cancer therapy or stem cell transplant. The human microbiome affects the way some cancer drugs are metabolized in the human body. Information from this study may help doctors improve the way cancer treatment is delivered, and increase its effectiveness and success.

PRIMARY OBJECTIVE:

I. To correlate gut microbiome with specific cancer diagnoses and the clinical response (efficacy), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.

OUTLINE:

Patients undergo collection of blood and stool samples and have their medical records reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-99
* Diagnosis of cancer and undergoing cancer therapy or scheduled to start cancer therapy or undergoing stem cell transplant for any hematological condition

Exclusion Criteria:

* Unable to provide informed consent
* Vulnerable adults