cyrilzakka/clinical-trials huggingface dataset:
Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Infectious keratitis are favored by the circumstances causing the small trauma of the corneal epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome rheumatoid arthritis, or much more frequently wearing contact lenses. If the majority of infectious keratitis are favourable, some lead to serious injury of the cornea, or even corneal perforation which result an endophthalmitis. This unfavourable evolution may lead to blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. This negative evolution is encountered while the infectious keratitis due to tedious germs of difficult diagnosis such as nontuberculous Mycobacterial, fungal infections, fungal keratitis, amoebic keratitis, and certain viral keratitis. The microbiological diagnosis of routine is based on the systematic search for pathogens tedious from invasive sampling of cornea by vaccinostyle. We set up a new non-invasive corneal swab diagnostic method.

Primary Purpose: Compare the ability diagnostic of non-invasive sampling swab corneal versus the gold standard, (invasive vaccinostyle uptake) for the systematic search for pathogens tedious in corneal specimens.

Hypothesis:

The diagnostic strategy using a microbial testing of cornea method has a sensitivity of 90% and a specificity of 80% or more over the policy diagnostic using a sampling by vaccinostyle method.

Primary outcome measures: Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.

Eligibility Criteria:
Inclusion Criteria:

* Patient is more than 18 years old.
* Patient with a prescription of a microbiologic diagnostic of keratitis
* Patient who do not declined to have his medical records reviewed for research
* Patient with health insurance

Exclusion Criteria:

* minor patient (\<18 years).
* Pregnant or breastfeeding women.
* Major Patient under guardianship.
* Patient in vital emergency.
* Private Patient liberty or under court order.
* Patient refusing to sign the informed consent form
Diffusion MRI for Pancreatic Adenocarcinoma

The detection of small liver metastases represents a major challenge during the staging process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT represents the established imaging modality for selecting patients with pancreatic adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients undergoing a surgical procedure are finally found to have an unresectable disease because of arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a better contrast resolution for soft tissue and liver imaging, and thus leads to a better detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in patients with potentially resectable PA may improve the selection process of candidates for curative pancreatic resection by increasing the detection of LM undiagnosed by traditional preoperative work-up


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 year old,
* no general contraindication for pancreatic surgery,
* pancreatic mass suspected or demonstrated to be a pancreatic adenocarcinoma,
* CAP CT of excellent technical quality showing a pancreatic tumor deemed resectable or border line (portal and/or superior mesenteric venous circumferential involvement \< 180°
* Resectability confirmed by a medical/surgical multidisciplinary review,
* if neoadjuvant therapy was applied, patients were included in the study: only the second evaluation will be considered.
* informed consent prepared and signed.

Exclusion Criteria:

* locally advanced pancreatic adenocarcinoma (involvement \> 180°in circumference of superior mesenteric venous (SMV) or portal vein, superficial vein thrombosis, superior mesenteric artery (SMA) involvement \< 180°)
* unresectable tumour (circumferential involvement \> 180 ° of the SMA, involvement of the celiac artery, thrombosis of the portal vein or vena cava, or complete VMS thrombosis
* metastasis of any organ visible on thoraco-abdominopelvic CT scan
* time lag exceeding 21 days between diffusion-weighted MRI and surgery
* contraindication for an MRI
Identifying and Characterizing Preclinical MS

The purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease.

The purpose of this study is to try and learn how to identify multiple sclerosis (MS) before it causes any neurologic symptoms. By the time MS causes symptoms, the disease has often been causing damage under the surface for years. Because early treatment of MS helps prevent long term disability from the disease, the investigators are hypothesizing that if MS could be detected (and treated) before symptoms start, the disease might be preventable.

The investigators believe that people who go on to develop MS have changes in their immune systems long before they have symptoms. Some of these changes might be in "hidden" parts of the body, like lymph nodes or fat tissue. The investigators want to study people who have risk factors for MS to try and learn to detect very early signs of disease.

Study procedures will include:

All study participants will undergo a blood draw and an oral swab; they will also complete baseline questionnaires All study participants will be contacted approximately once per year and asked to complete some additional questionnaires All study participants may be asked to donate repeat blood/oral swab specimens or stool specimens over time on an ad hoc basis Study participants who agree will undergo additional optional procedures to study the immune system in different parts of the body.

The optional procedures include:

Lumbar punctures (to obtain spinal fluid) Tonsil biopsy Fat biopsy (to obtain fat cells) Lymph node biopsy (to obtain lymph node tissues with immune cells) Traditional brain MRI Low-field (portable) brain MRI

One in-person visit is required. There will also be annual phone/email contact, which may take up to 30 minutes The required in-person visit will take approximately 1 hour total. Anyone who agrees to donate follow up biospecimens, undergo a procedure, or undergo an MRI will have additional in-person visits Optional visits for donating biospecimens, having a procedure or getting an MRI may take longer (up to 3 hours), depending on what is happening during the visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Having one or more risk factors for multiple sclerosis, including one or more of the below:

  * Individuals known to have a radiologically isolated syndrome
  * Individuals with a family history of multiple sclerosis (first degree family member)
  * Individuals with personal risk factors, which are known to include smoking, obesity, Epstein Barr virus infections, Vitamin D deficiency, genetic risk score

Exclusion Criteria:

* Currently pregnant
* Diagnosis of multiple sclerosis or any ongoing, systemic autoimmune disease
* Ongoing treatment with immunosuppressive medications
PTEN Hamartoma Tumor Syndrome Pediatric Patient Registry

PtenTurkiye.org' is a national ( Turkish), web-based registry for PTEN Hamartoma Tumour ( PHTS) syndrome established in 2022. It is designed to increase awareness, gather scientific knowledge by collaboration and increase data accessibility, collect high-quality data on the epidemiology, genetic background and natural history of PHTS especially for pediatric patients so that more accurate follow up guidelines can be recommended.

There is a limited understanding of the natural history of childhood-onset PTEN Hamartoma Tumour Syndrome (PHTS) as a cancer predisposition syndrome. Patient registries are important for longitudinal follow up of these patients. Our aim is to create a Turkish registry especially for pediatric PHTS patients, but registry is open to adult PHTS patients as well.

The purpose is to engage families with children with PHTS in the data-sharing process to accelerate research and drug development and share their experiences with other families as a support if they agree to do so. The registry is open to both adults and children with PHTS.

Most pediatric patients with PHTS have autism spectrum disorders, developmental delays and/or intellectual deficiencies. Patient registry will help us see if they are getting appropriate behaviour interventions. There is no consensus on the guidelines for cancer surveillance in children. The investigators will follow these patients according to 'pediatric follow-up protocol for PTEN (Phosphatase and tensin homolog) mutated children' created by Ciaccio et al. Patient registry will also help if these guidelines are sufficient or need improvements.

Once the individual or their parent/guardian has consented to participate in the registry, the researchers will collect their past and current medical, familial, and other necessary demographic information from their medical records and face to face interviews. The investigators will follow up patients every 6 months or earlier if needed. The investigators will do thorough physical and dysmorphological exam (using autism research exchange dysmorphology check list). For patients with autism and other behavioral problems, the investigators will refer them to child and adolescent psychiatry clinics for evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have clinical findings of PHTS and have mutation in PTEN gene ( VUS included if show clinical findings) and agree to participate in the study

Exclusion Criteria:

* Patients who do not have clinical findings of PHTS and do not have mutation in PTEN gene and do not agree to participate in the study
Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)

Primary:

* Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using infusion nurse and patient measured physical, quality of life (QOL), respiratory, laboratory, and disability assessments in patients with Primary Immunodeficiency Disease (PIDD).

Secondary:

* Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured outcomes.
* Change in IVIg/SCIg dose timing effects measured outcomes.
* Change in patient status is reflected in measured outcomes.
* Assess the value to physicians from collected outcomes data.
* Identify types of patients by response to IVIg/SCIg therapies (well maintained, problematic, etc.).
* Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease state, co-morbidities, and demographics.

This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting PIDD adult and assenting pediatric subjects who receive infusion services from BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC). Subjects meeting all inclusion criteria who have provided informed consent/assent for trial participation will have validated, physician-prescribed, standard-of-care outcome measures, and Ig administration information recorded during normal home infusion visits. There will also be standard-of-care questions captured within some outcome measures recorded during normal home infusion visits that may be at a frequency and/or combination which may not be considered routine clinical care by some physicians who treat for this medical condition. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any form of Primary Immunodeficiency Disease
* Age at enrollment ≥ 7
* Sign informed consent/assented to participation
* Ability to read and write English
* Understanding of study procedures and ability to comply with study procedures for the entire length of the study
* Receiving Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
* Have been on or is between doses of Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
* Being considered to be prescribed Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
* Determined to be eligible for infusion services by BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC.) in collaboration with the patient's prescribing physician

Exclusion Criteria:

* Children (age ≤ 6 years)
* Prisoners, and other wards of the state
* Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by the study participant's caregiver
Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a nutraceutical preparation on early markers of cognitive impairment, in patients affected by arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Males or females between 40 and 65 years of age;
* Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1 hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP 160-179 mmHg; DBP 100-109 mmHg).

Exclusion Criteria:

* Previous acute myocardial infarction (AMI);
* Previous stroke and/or transient ischemic attack (TIA);
* Diabetes mellitus;
* History of atrial fibrillation or other severe arrhythmias;
* Severe cardiovascular diseases;
* Renal pathologies (creatinine \> 1.4 mg/dL);
* Preexisting psychiatric pathologies;
* Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis, Parkinson, Alzheimer, neuromuscular pathologies, epilepsy;
* Diagnosis of dementia;
* Depression;
* Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs, hypnoinducing drugs, cognitive stimulators.
Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial

Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards.

The protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. The children will wear an Oculus headset and be exposed to the foods through this virtual reality tool, enhancing their engagement and willingness to try new foods in a fun and immersive way.


Eligibility Criteria:
Inclusion Criteria:

* Food selectivity upon parental referral
* Child with diagnosis of autism

Exclusion Criteria:

* presence of other medical disorders
A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV retinitis.

Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.

Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.

Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication: Required:

* Primary CMV treatment.

Patients must have:

* AIDS.
* Active CMV retinitis.
* At least one photographable lesion of one-quarter or more optic disc area in size.
* Undergoing primary treatment for CMV retinitis that is not contraindicated with MSL 109.
* Visual acuity in at least one eye of 3 or more letters on Early Treatment Diabetic Retinopathy Study ( ETDRS ) chart at 1 meter distance ( Snellen equivalent 5/200 ). Note:
* Exceptions may be made if visual acuity impairment is possibly reversible and there is at least light perception in that eye.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Retinal detachment not scheduled for surgical repair.
* Media opacity that precludes visualization of the fundus.
* Active medical problems sufficient to hinder study compliance.

Concurrent Medication:

Excluded:

* IVIG.
* CMV immune globulin ( CMVIG ).
* Interferon alpha.
* Interferon gamma.
* Interleukin-2 ( IL-2 ).

Drug or alcohol abuse sufficient to hinder study compliance.
A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage

The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.

i- Verify the study inclusion and exclusion criteria at visit 1.

ii- Inform patients (verbally and in writing) and their caregivers (when considered necessary and with the patient's consent) of the characteristics of the study and confirm their agreement to participate by signing the informed consent document.

iii- Assist with patient assessment, record the information in the case report form. Based on the data we get from the case report form, assign the patient to the experimental or control group by stratified randomization.

ⅳ- At visit 2 to obtain blood sample from peripheral vessel and analyze the density of CECs,sCD40L and hs-CRP by flow cytometry (FCM), ELISA and particle-enhanced turbidimetric immunoassay.

ⅴ- All patients are given aspirin 100mg/qd orally and the experimental group given ticagrelor 90mg/bid while the control group clopidogrel 75mg/qd for 30 days.

ⅵ- At visit 3 repeating step ⅳ and making comparison on numbers of CECs and CD40L between the two groups, and finish a statistic analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.
2. A previous or new diagnosis of type 2 diabetes mellitus, document by one of following criteria:1）Hemoglobin A1c of ≥6.5% at diagnosis;2) Fasting plasma glucose (FPG) ≥126mg/dL (7.0 mmol/L);3) Two-hour plasma glucose≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);4) with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose≥200mg/dL (11.1 mmol/L)( confirmed by repeat testing)
3. A previous or new diagnosis of stable CAD according to ICD 10 for at least 6 months, document by following criteria: 1) Stable angina; 2) No AMI or NSTE-ACS within 1 month;and(or) 3) EKG with ischemic ST-segment and(or) T-wave change; and(or)4) coronory artery stenosis ≥50% viewed by coronary CTA or coronary angiography
4. No medication history of clopidogrel/ticagrelor for at least 1 months
5. Female or male, and any race, aged≥18 years, not pregnant.

Exclusion Criteria:

1. Blood pressure\>160/100 mm Hg;
2. Hypercholesterolemia(LDL-c \>240mg/dl);
3. Hemoglobin A1c ≥ 10%;
4. Platelet count less than 10\*10\^9/L or hemoglobin \<10 g/dL;
5. Intolerance or allergy to clopidogrel/ticagrelor or any of the excipients;
6. Patient with known inflammatory conditions or those on anti-inflammatory drug therapy;
7. Second and third degree atrioventricular block;
8. chronic obstructive lung disease or asthma;
9. Creatinine\>2 mg/dl;
10. Malignancy;
11. Moderate or severe hepatic impairment;
12. History of intracranial haemorrhage;
13. Active pathological bleeding;
14. Pregnancy or lactation;
15. Any condition that increases the risk for noncompliance or being lost to follow-up;
16. Medicine history of potent CYP3A4 inhibitor(ketoconazole, clarithromycin,etc.);
17. No provision of informed consent.
Opioid Free Anesthesia for Laparoscopic Cholecystectomy

The goal of this interventional study is to check the efficacy of Erector Spinae block as Opioid Free Anesthesia for Laparoscopic Cholecystectomy. Laparoscopic Cholecystectomy is a commonly performed day care procedure. Being a day care procedure the anesthetic technique employed should provide adequate analgesia, allow early mobilization of patient and should mitigate nausea and vomiting which occurs quite frequently in this surgical population. If these goals are achieved patients can be discharged early from hospital setting and this leads to overall cost benefits.

One of the commonest presentations to surgical department is the abdominal pain caused by gall stones. The procedure of choice for treatment of cholelithiasis is Laparoscopic Cholecystectomy; a day care surgical procedure. This is performed under General Anesthesia with Endotracheal tube. During the surgery, anesthetist provides multi-modal analgesia in the form of opioids, NSAIDs and paracetamol. The commonly used Opioids in our setting include Morphine, Fentanyl and Nalbuphine. Opioids provides excellent analgesia but are associated with a number of side effects such as sedation, euphoria or dysphoria, respiratory depression, nausea, vomiting and increase in smooth muscle tone of the gut. These side effects can significantly impair the recovery in post-operative period, leading to prolong hospital stay. As a result opioid free anesthesia could be a suitable alternative to conventional opioid anesthesia for laparoscopic cholecystectomy. By avoiding the adverse effects of opioids; Opioid free anesthesia can lead to early recovery and discharge from the hospital.

One way to provide opioid free anesthesia is by utilizing loco-regional techniques. One of the loco-regional technique which has shown some benefit in laparoscopic cholecystectomy is erector spinae block. However in the available literature the block was utilized for providing post-operative analgesia in laparoscopic cholecystectomy. This Randomized Control Trial will check the efficacy of Erector Spinae Block in providing intra-operative as well as post operative analgesia in patients undergoing laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age: 16 years to 80 years.
* American Society of Anesthesiologists (ASA) class: I and II.
* Elective Laparoscopic Cholecystectomy under General Anesthesia.
* Duration of surgery being less than 1h

Exclusion Criteria:

* ASA class III or above
* Neuromuscular disease
* Body mass index \>35 kg/m2
* known allergy to drugs used in the study
* Ischemic Heart disease, Cardiac Failure, Liver and renal insufficiency
* Intra-operative conversion from laparoscopic to open procedure.