cyrilzakka/clinical-trials huggingface dataset:
Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation

the investigator will evaluate the change in endothelial cell count in eyes implanted with the iris-claw phakic Artisan lens for treatment of moderate to high myopia using specular microscopy

Iris-fixated phakic intraocular lenses (pIOLs) are used worldwide to correct high myopia, hyperopia, and astigmatism. It is used to correct high degrees of myopia in patients for whom laser excimer refractive surgery is not indicated.

The Artisan lens is designed to minimize the contact between the iris and the IOL resulting in less halo and glare from the prism effect.

Several clinical studies show that the visual results of the Artisan lens are stable and predictable. Artisan phakic IOLs provides precise predictability.

There have been concerns that the anterior chamber lens could damage the endothelial cell layer because of its proximity to the cornea. The manufacturer advises using the Artisan lens only in eyes with an ECD greater than 2000 cells/mm2 and an ACD greater than 2.6 mm.

Corneal endothelium is metabolically active and responsible for keeping the corneal stroma in its usual dehydrated state of 70% water.

loss of endothelial cells from increasing age, trauma, disease, or corneal surgery can reduce the density of endothelial cells and affect the ability of the endothelium to maintain it's primary function.

Alterations in the corneal endothelium depend on surgical technique and style; although endothelial cell loss is mainly the result of surgical trauma, continuous endothelial cell loss can occur. Late corneal decompensation often occurs in the absence of direct intraoperative endothelial trauma. These complications can be explained by the toxic effect of inflammatory mediators on the corneal endothelium.

Specular microscopy is used to view and record non-invasively the image of the corneal endothelial cell layer.

Eligibility Criteria:
Inclusion Criteria:

* an age greater than 20 years, stable myopia with a variation in spherical equivalent of less than -0.50 diopter (D) during the 12 month preoperative period, a normal anterior segment with an ACD (i.e., the area between the corneal endothelium and the central anterior lens capsule) greater than 3.00 mm, an endothelial cell count of 2000 cells/mm2 or greater, no corneal, pupil, or iris abnormalities; and no history of glaucoma and chronic or recurrent uveitis , having contraindications to laser in situ keratomileusis based on pachymetric data or other corneal shape characteristics, and an intraocular pressure of 20 mm Hg or less.

Exclusion Criteria:

* an ACD less than 3.0 mm, history of ocular surgery, glaucoma, chronic uveitis, or preexisting ocular pathologic features or abnormalities.
A Virtual Ward to Reduce Readmissions After Hospital Discharge

The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge.

We will conduct a pragmatic, randomized controlled trial to evaluate a new model of care for high-risk medical patients after discharge from hospital. This new model of care has two key elements. First, we will use the LACE index (see citation below for details) to identify patients who are at high risk of readmission or death after hospital discharge. These patients will be randomized to either the Virtual Ward or usual care on the day of discharge. Although patients being cared for in the Virtual Ward will reside at home, they will benefit from a hospital-like interdisciplinary team, a shared set of notes, a single point of contact, round-the-clock physician availability and increased co-ordination of specialist, primary and home-based community care for several weeks after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Discharge from medical service
* LACE score greater than or equal to 10
* Age greater than or equal or 18
* Resident in Toronto Central Local Health Integration Network catchment area
* Patient or designate able to speak English well enough for follow up telephone calls

Exclusion Criteria:

* Previously enrolled in study
* Discharged to a rehabilitation or complex continuing care facility
Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib

The study was a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS) who initiated alpelisib at least 24 weeks before the cut-off date at a MAP site. The study cut-off date was 09-Mar-2020.

Patient-level data were abstracted from medical charts of all eligible patients at all participating sites. Study completion date refers to the last date data was extracted.

Information from patients treated with alpelisib was used to describe the efficacy and safety of alpelisib in PROS patients.

The index date (baseline) is defined as the date of alpelisib initiation. The study period is the period from the index date up to the most recent data available at the time of the cut-off date.

The maximum follow-up was 187 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient (adult or pediatric) is ≥ 2 years of age
* Patient has a physician confirmed/documented diagnosis of PROS
* Patient has a documented evidence of a mutation in the PIK3CA gene
* Patient's condition was assessed by the treating physician as severe or life threatening and treatment was deemed necessary
* Patient has been treated with at least one dose of alpelisib, initiated on or before 23-Sep-2019 (i.e. at least 24 weeks before the cut-off date of the 09-Mar-2020)
* Patient has medical chart history available during enrollment in the Novartis MAP
* Patient (or parent/guardian in case of pediatric patient) consented to participate in the study (as required by local ethics regulations) Inclusion criteria for MAP enrollment (assessed at the time of alpelisib initiation)
Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.

Acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there are limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive Sequential CAR-T Cells Targeting CD5/CD7 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ CD7+ relapsed or refractory acute leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent; Patients volunteer to participate in the clinical trial;
* Diagnosis is mainly based on the World Health Organization (WHO) 2008;
* Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;
* Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);
* The expected survival period is greater than 12 weeks;
* ECOG score ≤2;
* Age 2-60 years old;
* HGB≥70g/L (can be transfused);
* Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.

Exclusion Criteria:

* Patients declining to consent for treatment
* Prior solid organ transplantation
* One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;
* History of severe pulmonary dysfunction diseases;
* Severe infection or persistent infection cannot be effectively controlled;
* Severe autoimmune disease or congenital immunodeficiency;
* Active hepatitis;
* Human immunodeficiency virus (HIV) infection;
* Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).
Success of Inferior Alveolar Nerve Block in Women Taking Selective Serotonin Reuptake Inhibitors

To evaluate the success of inferior alveolar nerve block (IANB) for mandibular molars with irreversible pulpitis in women under treatment with selective serotonin reuptake inhibitors (SSRIs).

Seventy patients with a diagnosis of symptomatic irreversible pulpitis in one mandibular molar were assigned to either SSRI users or SSRI non-users groups. SSRIs users were 45 women who take SSRIs referred for endodontic treatment from a psychiatric clinic to the clinic of the endodontic department of Isfahan University of Medical Sciences. SSRIs non-users were 45 women who did not take SSRIs referred for endodontic treatment to the same dental clinic. The protocol of the study was approved by the Ethics Committee of the university (no. 394867). Written informed consent was obtained from all the patients. The level of anxiety of the patients was determined by using the Corah Dental Anxiety Scale. The patients registered their baseline pain severity using a Heft-Parker visual analogue scale (HP-VAS). Two standard IANBs (1.8-mL cartridges) of 2% lidocaine with 1:100,000 epinephrine (Darupakhsh, Tehran, Iran) were administered to each patient. Fifteen minutes after injection, the teeth were isolated. Access cavity preparation was started. The patients was instructed by the same operator to mark his or her pain experienced during the access cavity preparation.

Eligibility Criteria:
Inclusion Criteria:

* vital mandibular molar tooth
* diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

* younger than 18 years old
* history of significant medical conditions
* allergies to local anesthetics or sulfites
* pregnancy
* active sites of pathosis in area of injection
* inability to give informed consent
A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor

The purpose of this study is to determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET).

Hypothesis: Pre-SMA LF r-TMS will result in a \>30% reduction in tremor as measured by the TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the pre-SMA effects tremor in patients with ET.

Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing pre-SMA output, and improving motor control, as determined shortening of the delay in the second agonist burst, seen in ET patients. At conclusion of this study expect to have sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of pre-SMA r-TMS in ET.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 of age
* Meet the diagnostic criteria for essential tremor with visible upper limb tremor
* Must be either on stable medications to treat tremor for 30 days, or no medications to treat tremor

Exclusion Criteria:

* History of seizures
* History of chronic pain conditions
* Any metal in their body above their shoulders
* Use of medications that lower seizure threshold including:

  * broad classes of drugs such as tricyclic antidepressants
  * anti-psychotics
  * neuroeptics
  * thyroid medications and stimulants
* Use of any medications that cause tremor, Pregnancy
Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso

MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso.

The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include :

1. A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain.
2. A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.

Objectives :

Main objective :

To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is significantly greater than 75% (reference value of the national program in BF).

Secondary objectives :

* To ensure the mortality rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 3% (reference value of the national BF program).
* To ensure the default rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15% (reference value of the national BF program).
* To ensure the non-response rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 8%.
* To ensure the hospitalization rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15%.
* To ensure the coverage rate of the program increases by 30% after the year the integrated protocol was introduced (specific protocol annexed).
* To estimate the relapse rate of the integrated protocol for treatment of acute malnutrition.
* To compare RUTF rations per child of the integrated protocol compared to the national protocol

Methods :

The study population will include all acutely malnourished children aged between 6 and 59 months seeking consultations at all of the health centers in Yako District between January 2017 and December 2017.

The study will be implemented in Burkina Faso's Yako District, which includes 54 health centers.

Eligibility Criteria:
Inclusion Criteria:

* Being between 6 and 59 months old
* New admission
* Acute malnutrition defined as follows:

  * MUAC\<125mm
  * MUAC\> 125mm AND WHZ (Z-score) \<-3 (WHO standard)
  * Edema
* Resident in the study area (Yako district)
* Signed informed consent of the mother or the child's guardian

Exclusion Criteria:

* Children allergic to milk, peanuts and / or RUTF
Brain Mechanisms of Juvenile Fibromyalgia

This study evaluates whether differences exist between adolescent females with juvenile-onset fibromyalgia and healthy controls in processing of pain and emotion at the neural level as assessed by functional magnetic resonance imaging (fMRI). The study includes a longitudinal component to evaluate changes in neural processing of pain and emotion before and after different treatment strategies.

Juvenile-onset fibromyalgia (JFM) is a chronic, widespread pain condition that primarily affects females. Previous work has shown increased sensitivity to painful and non-painful sensory stimuli in adults with fibromyalgia, as well as brain processing abnormalities associated with these stimuli. These abnormalities in adults are highly predictive of fibromyalgia status (as opposed to healthy status) in adults. Although JFM has some similar symptoms and features to fibromyalgia in adults, the neural mechanisms of JFM may be partially different, given the moment of sharp brain development characterising JFM. fMRI scans will be completed before and after different treatments for JFM (e.g. neuromuscular training + cognitive behavioral therapy, graded aerobic exercise) to investigate the effects of treatment on brain measures related to pain, fatigue and emotion processing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Juvenile Fibromyalgia (by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology criteria)
* Right handed
* Functional Disability Index score ≥ 7, indicating at least mild disability
* Stable medication regimen for 3 weeks prior to MRI scan

Exclusion Criteria:

* Non-MRI compatible metal objects in the body (including braces, permanent upper retainers)
* Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematosus)
* Major psychiatric diagnoses (e.g. bipolar disorder, obsessive compulsive disorder, schizophrenia) or documented developmental delay
* Taking opioid pain medication
Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries

This study will fill important knowledge gaps in the availability of best practices that use innovative methods to integrate the cognitive and vocational needs of students with TBI who will be transitioning from 2- and 4-year postsecondary education to employment. Best practices exist from the assistive technology (AT) field to help people compensate for cognitive impairments, and from the vocational rehabilitation (VR) field to enhance employment outcomes for individuals with disabilities. However, these practices have not been integrated to provide needed supports and services to improve the employment outcomes of students with TBI. The study's goal is to expand the availability of innovative practices by testing the efficacy of a technology-driven, long-term, and resource-rich individualized support program that merges assistive technology for cognition and vocational rehabilitation practices. The end products will include technology application guidelines, training and procedural manuals, and resource information that rehabilitation professionals and students with TBI can utilize to enhance technology and mentoring proficiency, academic success, self-determination, and long-term career success for students with TBI.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of TBI
* Enrolled in a degree program at two-year and four-year colleges or universities
* Live within a 60-mile radius of Kent, Ohio

Exclusion Criteria:

* No exclusion criteria will be applied
Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes

study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2 diabetes. To this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg).

In men subjects with type 2 diabetes treated with diet and exercise with or without metformin treatment as an antidiabetic agent, a standardized mixed meal test will be served with or without administration of sitagliptin (100mg).

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men with type 2 diabetes diagnosed according to ICD10
* Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. Metformin therapy should not exceed 2 grams daily
* Age 20-75 years
* HbA1c ≤80 mmol/mol
* BMI: 20-40 kg/m2

Exclusion Criteria:

* Liver disease or ALAT three times above upper reference range
* Diabetic nephropathy (GFR \< 50 mL/min/1.73 m2 or albuminuria)
* Proliferative diabetic retinopathy
* Treatment with any glucose-lowering medication except metformin
* Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months.
* Previous surgery on the gastrointestinal tract
* Larger surgical intervention during the last 12 weeks
* Treatment with oral steroids or thiazide diuretics
* Treatment with digoxin
* Smokers
* Participation in another study the last 4 weeks
* Paracetamol intolerance
Patient Reported Outcomes in Living Donor Lung Transplantation

The purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.

In Japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. However, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. Therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* New donors for living donor lung transplantation

Exclusion Criteria:

* Inability to obtain informed consent
Epidemiology of TNBC in Asyut Clinical Oncology Department

Epidemiological Study about behavior of TNBC in Clinical oncology department in 8 y in Asyut university hospital

Breast Cancer )BC) is the most Common malignancy in women in 2020, there were 2.3 million women diagnosed with breast cancer and 685.000 deaths globally. Breast cancer rates are 88% higher in developed countries compared to developing countries .

TNBC represents accounts for approximately 24% of all breast cancer in 2020 .While in Egypt it accounts for 11.05% according to Egyptian national BC (5). By gene expression profiling ,4 subtypes of TNBC emerged : luminal androgen receptor (LAR), mesenchymal stem-like (MSL), immunomodulatory (IM), basal-like (BL1 and BL2) . Most of cases are advanced with median survival about 14 months . Brain and visceral organs represent common sites of distant metastasis . So it is considered the worst prognosis . In addition , chemotherapy is only option in treatment with no available targeted options for decades. Now we have Immunotherapy (IO ) and PARP inhibitors in neoadjuvant (NAT) and metastatic setting For example : Key note 355 which add Pembrolizumab in NAT which lead to marked improvement in pathological complete response ( PCR ) And in high risk patient and have marked results in disease and event free survival(8) .Poly (ADP-ribase) poly merase -1 (PARP-1) inhibitors appear to particularly effective in BRCA 1/2 mutation carries (9) .As reviewed by rodleret al. emerging data suggest that BRCA 1/2 carriers with TNBC disease may respond favorably to cisplatin therapy .

Eligibility Criteria:
Inclusion Criteria:- Age ≥ 18

* Male or female
* Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology
* Adjuvant or metastatic

Exclusion Criteria:- Have other type of malignancy

* HER2 , ER, PR positive
Mometasone vs Budesonide in CRS With Polyposis

The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis with nasal polyps
* Absence of active infection at start of study

Exclusion Criteria:

* Diagnosis of chronic rhinosinusitis without nasal polyps
* Diagnosis of recurrent acute bacterial rhinosinusitis
* Previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries)
* Cystic fibrosis or ciliary dyskinesia
* Allergy to corticosteroids
* Pregnant or lactating women
* Contra-indication to intranasal steroids