cyrilzakka/clinical-trials huggingface dataset:
New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening

The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body.

Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.

In a previous trial (ISRCTN96071600) the investigators tested on 2400 women, compliance with self sampler device (PantaRhei Devices, Zeist, the Netherlands).

With this study the investigators analyze the response to two channels of transmission of the device (a model of device easier, and less expensive than the previous), such as screening for colon cancer.

The shipment of the device at home and taking on a local pharmacy. Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).

Eligibility Criteria:
Inclusion Criteria:

All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall

Exclusion Criteria:

does not meet inclusion criteria
Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths

twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate \& compare bone formation \& implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths.

group one will receive 8mm implant lenght while group two will receive 10mm implants.


Eligibility Criteria:
Inclusion Criteria:

* patient with atrophic maxilla \& pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge
* both sexes

Exclusion Criteria:

* patients with systematic diseases that may affect normal healing
* sinus pathology
* heavy smokers more than 20 cigarettes per day
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography

This study is aimed at creation and validation of a vitreous haze scoring system using ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and quantification of inflammation will be done to create the scoring scale.

Patients with uveitis may present with Vitreous Haze (VH) resulting in obscuration of fundus details. VH is composed of cells and protein exudation and results in decrease visual acuity.The degree of VH is an important indicator of disease activity, severity and response to therapy in patients with uveitis. Color fundus images are commonly used to objectively document VH.

Eligibility Criteria:
Inclusion Criteria:

* • Ability to provide written informed consent and comply with study assessments for the full duration of the study

  * Age 18 -90 years
  * Diagnosis of uveitis

Exclusion Criteria:

* • Patients with posterior segment complications including retinal detachment, choroidal detachment or hemorrhage

  * Patients with any intraocular foreign body or displaced intraocular lens
  * Patients with silicon oil filled eye or with gas tamponade.
  * Patients with vitreous hemorrhage
  * Patients with media opacity including visually significant cataract that precludes grading of VH based on fundus photography
Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at base line and after 6 months of treatment.

The Aim of this work was to study the effect of Magnesium as add on therapy on clinical seizure control in drug resistant idiopathic epilepsy and IQ.

Eligibility Criteria:
Inclusion Criteria:

* Children with drug resistant idiopathic epilepsy

Exclusion Criteria:

* Structural, Metabolic, Infectious and Unknown etiology epilepsy
* Any neurological disease other than epilepsy
* Any nutritional disorder
* Any other systemic diseases (including Renal disease, Cardiac arrhythmia)
* Drug intake other than antiepileptic drugs (AED)
Impact of Excision Margins on Survival and Recurrence Rate in Patients With Thick Melanoma (>2mm)

Objective: To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.

Background: Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.

Methods: The investigators will conduct a retrospective population-based survey in patients with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins in the investigators center. For both groups, the patients' charts reviewed for data including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness, tumor type, presence of ulceration, findings of sentinel nodes, local recurrences, locoregional metastases, disease free survival and overall survival were calculated for both groups.

Background

Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.

Objective

To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.

Methods

The investigators will conduct a retrospective population-based survey in patients with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins in the investigators center. For both groups, the patients' charts reviewed for data including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness, tumor type, presence of ulceration, findings of sentinel nodes, local recurrences, locoregional metastases, disease free survival and overall survival were calculated for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed melanoma
* Safety margin 1 cm or 2 cm
* Tumor thickness according to Breslow \>2mm

Exclusion Criteria

* Safety margin less 1 cm
* Unclear safety margins
Optical Coherence Tomography Angiography in Myopic Patients

The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.

High myopia is defined as a refractive error equal to or more than -6 D, and/or axial length equal to or more than 25.5 mm².Axial elongation of the globe and subsequent stretch of the retina leads to sight threatening complications.

Quantitative measurements of retinal vasculature in the healthy eye have been reported using several in vivo and in vitro techniques, including confocal microscopy, fluorescein angiography (FA), and swept-source optical coherence tomography (ssOCT) angiography.

The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.

This cross-sectional prospective study included 75 eyes of 54 patients, they were recruited from the outpatient clinic of ophthalmology department of El-Minia university hospital.They were divided into two groups, group A included 25 normal eyes of 25 patients. Group B included 50 myopic eyes of 30 patients.

All patients subjected to history taking and full ophthalmological examination in addition to axial length measurment before performing OCTA.

Eligibility Criteria:
Inclusion Criteria:

* • Highly myopic subjects, defined as those with spherical equivalents (SEs) of -6 or more, with axial length greater than 26.5 mm.

Group B individuals were chosen among healthy age-matched controls.

Exclusion Criteria:

* • Patients younger than 18 years old, or older than 45 years.

  * Any patient with macular pathology (e.g. diabetic retinopathy, hypertensive retinopathy, dystrophy)
  * Myopic patients with any vitro-retinal abnormalities (e.g. choroidal neovascular membrane (CNVM), foveoschisis,macular hole)
  * Patients who underwent previous intra ocular surgical procedures.
  * Patients with previous history of intraocular injections.
  * Glaucomatous patients.

Exclusion criteria to the images that has been captured:

* - Low signal strength index (less than 50).
* - Presence of blink artefacts.
* - Poor fixation leading to motion or doubling artefacts.
* - Media opacity obscuring view of the vasculature.
* - Segmentation error due to cystoid macular oedema or epi-retinal membrane, among others.
Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation

This randomized clinical trial studies how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation. Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.

PRIMARY OBJECTIVES:

I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.

SECONDARY OBJECTIVES:

I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation.

II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

TERTIARY OBJECTIVES:

I. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the study population.

II. To evaluate relationship between cytochrome P450 family 24 (CYP24), 27B1, single-nucleotide polymorphism (SNPs) and serum 25(hydroxy \[OH\]) vitamin D response to oral D3 supplementation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cholecalciferol orally (PO) once daily (QD) for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.

ARM II: Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.

After completion of study treatment, patients are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Willingness to comply with study guidelines
* Willingness and ability to consent
* 25(OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 month would be used

Exclusion Criteria:

* History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue
* Creatinine \> 2.0 mg/dL
* Corrected serum calcium level of \> 10.5 mg/dL (serum corrected calcium = serum calcium + 0.8\[4-serum albumin\])
* Most recent PSA value more than 18 months ago
* Prior or current therapy for prostate cancer
* Documented history of nephrolithiasis within the past 5 years
* Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible
* Patients cannot take any additional vitamin D supplementation during study treatment; patients taking \> 2000 IU per day prior to treatment will be ineligible
The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients

The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system.

Anaemia is one of the most common comorbidities among patients hospitalized in intensive care units. Hospital-acquired anaemia (HAA) is a newly developed anaemia that occurs during hospitalization in patients who were not anaemic prior to admission. Patients with HAA have a higher risk of developing complications such as infections, muscle weakness, and neurocognitive developmental disorders; an increased incidence of blood and blood product transfusions (and related complications); longer hospital stays, and higher morbidity and mortality. According to available data, the incidence of anaemia in adults hospitalized in the ICU ranges from 40 to 74%. There a feq data describing anemia in critically ill pediatric patients, with the estimated incidence being up to 50%.

The etiology of HAA is multifactorial and is related to the severity of the underlying disease (sepsis, coagulation disorders, bleeding, renal failure, malnutrition, bone marrow suppression, decreased erythropoietin production, etc.). Another factor contributing to the development of anaemia in critically ill patients is iatrogenic blood loss caused by blood draws for laboratory testing.

In addition to the standard blood collection method, closed-loop sampling (in-line sampling) can also be used, with studies in adult patients showing a reduction in the amount of blood drawn, ranging from 20 to 80% after its implementation.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for the study.
* Patients with established intravenous access: CVC (Central Venous Catheter), CICC (Centrally Inserted Central Catheter), PICC (Peripherally Inserted Central Catheter), MVC (Midline Venous Catheter), venous port, from which blood can be drawn.
* Anticipated length of stay in the ICU more than 24 hours

Exclusion Criteria:

* Age outside the specified range.
* Peripheral venous access only.
* Anticipated length of stay in the ICU less than 24 hours.
* Organ donors.
* Lack of consent from the legal representative/patient.
Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion

The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.

SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to LLETZ cone, which is performed with a large loop electrode.

The treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone . When the transformation zone contains squamous precancer and is completely ectocervical and therefore full visible, excision or destruction is an effective and relatively straightforward therapeutic entity. However in a small proportion of women a cone biopsy is necessary. A cone biopsy often requires the excision of 20-30 mms of endocervical canal.

Interventions.

1. The standard procedure, LLETZ - cone (Large Loop Excision of Transformation Zone cone biopsy), is performed with a large loop electrode of 20-25 mm depth. The activated loop was applied to the cervix outside the lateral margin of transformation zone and brought slowly to the controlateral margin with the objective to acquire 20-25 mm up the canal.
2. The experimental intervention is SWETZ (Straight Wire Excision of Transformation Zone), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease. The activated wire was used as a knife, fashioning a cone with desired dimensions.

This technique may be able to excise the endocervical transformation zone with a lower rate of morbidity and incomplete excision rate than LLETZ cone biopsy.

The hypothesis to be tested in this trial is that SWETZ is superior to LLETZ cone in the management of endocervical pre-invasive disease.

Eligibility Criteria:
Inclusion Criteria:

* Incompletely visible transformation zone in women with High grade Squamous Intraepithelial Lesion (HSIL)
* Suspicion of microinvasive carcinoma or occult invasive carcinoma
* Suspicion of glandular disease

Exclusion Criteria:

* Pregnancy
* Coagulation disorders
* Cervicitis were present
* Refusal to participate in the study
Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40

Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* patients who are undergoing thyroid operation belong to ASA class 1 or 2

Exclusion Criteria:

* patients who are belongs to ASA class 3 or more,
* patients who have underlying complicated cardiovascular or psychological disease.
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration

St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed, will provide better pain control.

Each patient enrolled on this study will have three different anesthetic combinations for three different procedures, in order to determine which combination worked best for each child.

The study focusses on the following primary aims:

* To compare 0.5 mg/kg versus 1.0 mg/kg of fentanyl to control pain in patients who have a BMT/LPIT procedure in the context of propofol anesthesia and topical anesthesia with EMLA or L•M•X 4™cream (or when necessary, lidocaine for injection).
* To compare placebo versus fentanyl (0.5 mg/kg or 1.0 mg/kg) in these same patients. The first BMT/LPIT for which patients receive any fentanyl will be used in this comparison.

The study focusses on the following secondary aims:

* To determine which dose regimen ensures best conditions to perform bone marrow aspiration (lack of motion) and maintains hemodynamic and respiratory stability as indicators of adequate levels of analgesia during bone marrow aspiration.
* To evaluate the safety and complications for each dose regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bone marrow aspiration (unilateral), with lumbar puncture and intrathecal chemotherapy.
* Age 2 to 17 years
* ASA I-III
* Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma in remission or on the day of anticipated remission procedures occurring at the end of remission induction.
* Patients must have three anticipated bone marrow aspirates and lumbar punctures with intrathecal chemotherapy remaining in their treatment

Exclusion Criteria:

* Newly diagnosed patients
* Patients with low platelet count (less than 50000)
* Patients undergoing bone marrow biopsy in addition to bone marrow aspiration
* Age less than 2 years or over 17 years
* ASA IV-V
* Patients taking opioid medication for pre-existent pain for more than 2 weeks at the time of the procedure
* Neurological impairment that would increase susceptibility to opioids (Down's syndrome)
* Clinical contraindications for general anesthesia (large mediastinal mass) or specific use of propofol, Fentanyl, EMLA, L•M•X 4™ or Lidocaine for injection
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 20 open-label subjects enrolled for Type B-Lupus Nephritis.

Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product.

Eligibility Criteria:
Type A Cohort Key Inclusion Criteria:

1. Is male or female, age ≥ 18 and ≤ 75 years
2. Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE
3. Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
4. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
5. Restricted SLE treatments are stable and/or washed out
6. During Screening, has adequate hematologic function

Type B Cohort Key Inclusion Criteria:

1. Is male or female, age ≥ 18 and ≤ 75 years
2. Has a diagnosis of SLE
3. Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V)
4. Has a urine protein to creatinine ratio of \> 1000 mg/g
5. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment
6. Has adequate hematologic function
7. Restricted SLE treatments are stable and/or washed out
8. Most recent eGFR ≥ 40 mL/min/1.73m2
9. Has evidence of serologic activity

Key Exclusion Criteria:

1. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
2. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
3. Active TB or a positive TB test