cyrilzakka/clinical-trials huggingface dataset:
Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.

For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping studies have shown that different languages may be localized, at least partially, in distinct microanatomical systems located within the same gross anatomical areas.

The present investigation involves both types of healthy bilinguals with carefully controlled proficiency levels, as well as bilingual patients suffering from low-grade glioma.

Functional magnetic resonance imaging data will be collected while the participants perform a picture naming task in blocked conditions for both languages (either English or French) or in switch condition (English and French). A stimulation mapping study will be conducted in the patients during awake surgery with the same tasks.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Bilingual patients with a pathology indicating an intervention in awake surgery (e.g. low-grade glioma)
* At least C1-level of the CECR in both languages
* At least 12 years of schooling (French BAC)
* Right-handed (Edinburgh test, 1971)
* Performance indicator Eastern Cooperative Oncology Group 0-2 (cf. annexe)
* Life expectation \> 6 month
* Affiliated to social insurance
* Having given informed consent

Healthy volunteers:

* French-English or English-French bilinguals with at least a C1 level (CECR) in both languages
* At least 12 years of schooling (French BAC)
* Right-handed (Edinburgh test, 1971)
* Early bilinguals: age of acquisition of both languages \< 3 years
* Late bilinguals: age of acquisition of the L2 \> 10 years

Exclusion Criteria:

Patients:

* Contra-indication for MRI
* Left-handed or ambidexter (less than +80 at the Edinburgh test - 1971)
* Mini-Mental State Examination \<26
* Patient who cannot respect the procedures, visits, exams described in the protocol
* Any other medical or psychiatric affection which renders inclusion of the patient to the study inappropriate as judged by the principal investigator

Healthy volunteers:

* Contra-indication for MRI
* Mini-Mental State Examination \< 26
* Age of acquisition of one of the language between 3 and 10 years
Statins in Children With Type 1 Diabetes and Hypercholesterolemia

Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due to chronic increase in the blood sugars and inflammation. If there is also increased in cholesterol, it creates a highly abnormal environment not fully corrected by improved control of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention and treatment, compelling in children. This grant proposal encompasses 3 separate, yet interrelated projects addressing different aspects of CVD risk in children with T1DM. Project #1: a randomized controlled trial on the safety and efficacy of a class of drugs called "statins", which lower bad cholesterol in the body, in children with diabetes and elevated bad cholesterol. We will measure changes in concentration of blood inflammatory markers and for the 1st time, correlate levels of these markers with changes in blood sugar as measured by continuous glucose sensors, instruments that measure the blood sugar continuously through a small needle under the skin. Project #2: is a laboratory study to investigate the genetics and concentration of key molecules that participate in the inflammatory cascade and atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will be compared with those in healthy controls for the 1st time. Project #3: examines the use of abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy age-matched controls. The results of these studies will likely provide important new data on the use of statins in children with diabetes.


Eligibility Criteria:
Inclusion Criteria:Project 1

* T1DM diagnosed clinically for \> 1 year
* any HbA1C
* on stable insulin therapy
* Ages: 10 - 20 years
* both genders
* BMI \< 85th percentile
* Fasting LDL-C\>100mg/dl
* Normal thyroid function

Inclusion Criteria:Projects 2 and 3

* T1DM diagnosed clinically for \> 3 year
* HbA1C \> 8%
* on stable insulin therapy
* Ages: 12- 20 years
* both genders
* BMI \< 85th percentile
* Fasting LDL-C\>100mg/dl
* Normal thyroid function

Exclusion Criteria:Projects 1,2 and 3

* Severe dyslipidemia (LDL-C \>160, TG \> 400 mg/dl)
* Smoking
* Pregnancy
* Current use of anti-inflammatory or immunomodulatory drugs, lipid lowering, antidiabetic drugs
* Patients with hypertension and/or microalbuminuria will be allowed using balanced randomization and standardized treatment
Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)

Renal failure patients were treated with linezolid (LZD) for proven or suspected infections by multiresistant Gram-positive cocci. The aim of this study is to determine if dose adjustment of LZD is needed as a function of renal impairment or not, especially that a significant component of LZD is eliminated unchanged in urine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with normal renal function (CLcr ˃80 ml/min);
* Patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine)
* Patients on long term HD with an ideal body weight of \>60 kg and a body mass index between 20 and 26 kg/m2
* Passed all the screening parameters
* Free of any drug exposure known to interfere with the pharmacokinetics or assay of linezolid for at least 10 days prior to the study
* Able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

Had a history of clinically significant organ dysfunction other than renal disease or those diseases associated with renal disease (as in case of acute RF or ESRD patients) Had physical examination or laboratory test results outside the inclusion such as; sitting systolic BP (SBP) of \>140 or \<100 mmHg, diastolic BP (DBP) \> 90 or \<60mm Hg (as in case of healthy volunteers and acute RF patients), or a pulse rate of \> 95 or \< 50 beats/min at screening; history of orthostatic hypotension; history of serious intolerance, allergy or sensitivity to linezolid ; history of blood dyscrasias; history of alcohol, smoking, or drug abuse; donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study; unable to tolerate vein puncture and multiple blood samplings; any surgical/medical condition that might alter the absorption, distribution, metabolism, excretion of linezolid ; or can't follow instructions, according to the investigator's opinion.

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A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).


Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable.
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
6. Karnofsky performance status (KPS) of 90 or more.
7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine.
2. Patients with concomitant hemorrhagic disease.
3. Pregnant or breast feeding.
4. Inability to use gastric conduit after esophagectomy because of a prior surgery.
5. Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more.
6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
Ocular Changes in Vitiligo Patients on Therapy

Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.

Chorioretinal changes associated with vitiligo therapy could address patients visual acuity and life style. Early detection of these changes can help these patients to evade such adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* vitiligo patients on systemic and local therapy that regularly visit dermatology clinic at banha university.
* normal subjects seeking regular ophthalmic examination at ophthalmology clinic at banha university.

Exclusion Criteria:

* patients with known chronic retinal diseases that may alter OCT-A parameters as age related macular degeneration and diabetic retinopathies.
* patients that refuse to participate in this study.
TESE and Non Obstructive Azoospermia

Azoospermia is complete absence of sperm in the ejaculate. It accounts for 10-15% of male infertility cases. It is classified as obstructive and non-obstructive azoospermia (NOA). NOA constitutes 60% of all cases of azoospermia. Testicular sperm extraction (TESE) for intracytoplas¬mic sperm injection (ICSI) was first introduced for treatment of obstructive azoospermia in 1993. Soon afterwards testicular sperm were retrieved successfully and used in ICSI in cases of NOA. In the NOA cases, TESE combined with ICSI has been proven to be an acceptable line of treatment. Microdissection TESE may have some theoretical benefits over conventional TESE, but uncertainty exists about its superiority. During a conventional TESE procedure, the testis is exposed through a small incision and one or multiple biopsies are taken blindly. Micro TESE was first introduced in 1999. In this technique, the tunica albuginea is widely opened and examination of the testicular tissue is carried out at 20-25× magnification under an operating microscope allowing visualization of whitish, larger and more opaque tubuli. The concept of this technique is that these tubuli are more likely to contain active spermatogenesis. also no secure clinical predictors of (SR) are demonstrated for both procedures.The recovery of spermatozoa is successful in only 50% of cases and therefore the ability to predict those patients with a high probability of achieving a successful sperm retrieval would be of great value in counselling the patient and his partner . There is no single clinical finding or investigation that can accurately predict the outcome of TESE.An unsuccessful sperm recovery has important emotional and financial implications so objective counselling based on predictive factors may offer realistic expectations for both the couple and physician.

In Assiut university

Eligibility Criteria:
Inclusion Criteria:

* All infertile males with non-obstructive azoospermia

Exclusion Criteria:

* Patient with obstructive azoospermia:

  * Normal FSH
  * Dilated seminal vesicle or ejaculatory duct
Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension (Ph-PAH)

Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH)

Each patient was educated about the benefits of PhA in PAH on the initial visit. Patients wore pedometers (Omron HJ-321-E) for 2 weeks. After PhA assessment, the patients were contacted by a physician. Patients who walked \<5,000 steps per day were recommended to increase PhA, and patients who walked ≥5,000 steps per day were recommended to maintain PhA. Patients wore pedometers for 3 months until their next visit. The primary endpoint was the number of steps after 12 weeks of the study; the secondary endpoint was the 6-minute walk test distance (6MWD), quality of life (SF-36), acceptance of the disease, and anxiety and depression level (HADS).

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years
* PAH diagnosis according to current guidelines, confirmed by right heart catheterization
* optimal pharmacological treatment
* stable clinical condition at least 3 months before inclusion in the study
* Informed consent to participate in your own

Exclusion Criteria:

* Age under 18 years
* a type of hypertension other than PAH
* a neurological or orthopedic disease that prevents walking and performing the 6-minute walk test
* mental illness that prevents cooperation and assessment of quality of life survey
* lack of consent to participate in the study
Evaluation of Cellphone Based Otoscopy in Pediatric Patients

The Cellscope is an iPhone-based otoscope that uses the iPhone camera and light source to capture HIPAA compliant images and video recordings of the external and middle ear structure. This technology allows multiple providers, at different levels of training, the ability to simultaneously exam a child's external and middle ear structures. The investigators hypothesize this device will result in improved concordance in trainee/supervisor exam findings, increase trainee confidence in exam findings, decreased antibiotic prescriptions, and fewer repeat exams by multiple providers. Thus, this study has the potential to improve physician training and examination confidence, decrease the unnecessary use of antibiotics, and improve the patient/caregiver experience in healthcare interactions.

Abstract

Concerns about middle and external ear infections and discomfort are frequent chief complaints that bring children to pediatric providers. On top of this, there are numerous non-ear complaints (e.g. head trauma) that warrant a complete evaluation of the middle and external ear structures. At present, the middle and external ear is examined with standard direct otoscopy, commonly using a handheld otoscope. Otoscopy is defined as the visualization of the external and middle ear structures, including the tympanic membrane, ossicles, middle ear fluid, ear canal, etc. The skill of otoscopy is taught early in the medical trainees' career, most often in the first or second year of medical school. This skill is further honed during the pediatric medical student clerkship and pediatric residency, however there is not an efficient and patient-centered mechanism for direct visualization and teaching of trainees. Because of this, it is nearly impossible for trainees to receive feedback on trainees' visualization and interpretation skills. Based on the investigators' experience, trainee exams are often not repeated by clinical supervisors as the trainees progress in training. When supervisors do repeat ear exams (i.e., trainee is uncertain of findings), it is challenging to determine if the trainee fully appreciates exam findings. Ear exam findings directly inform the clinical decision-making (e.g., prescribing antibiotics for acute otitis media (AOM)) and uncertainty often results in unnecessary prescribing.

Objectives

Aim 1: To establish whether a smartphone otoscope improves diagnostic accuracy of tympanic membrane (TM) pathology for trainees, compared to supervisor.

Aim 2: To determine whether smartphone otoscope improves diagnostic confidence of trainees, thereby reducing frequency of antibiotic prescriptions for AOM.

Aim 3: To determine whether there is a change in repeat exam rates by supervisors, comparing with/without Cellscope.

Aim 4: To determine whether trainees convert to traditional otoscope use during the weeks that Cellscope is available.

Eligibility Criteria:
Inclusion Criteria:

* All trainees and supervisors
* All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team

Exclusion Criteria:

* None
Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

Literature on the use of superficial cervical plexus blocks for ear surgery is sparse in general, and almost non-existent in the pediatric population. Overall, literature review supports the safety of performance of this block but there is minimal published literature on its utility despite anecdotal evidence of benefit. This study, especially its prospective randomized nature will allow for expansion of the evidence for or against addition of this block to the care of pediatric patients undergoing ear surgery. The purpose of this study is to determine if SCPB plus standard practices provides superior pain control, as measured by reduced opiate consumption, compared to standard practices alone when performed on pediatric patients undergoing surgery on the ear and mastoid process.


Eligibility Criteria:
Inclusion Criteria:

* Age: \<18 years and \>3 months
* Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy

Exclusion Criteria:

* Preoperative opiate use within the last 30 days
* Bilateral surgery
* No English speaking caregiver
* Parental/patient refusal
* Severe preoperative respiratory compromise
* Allergy to ropivacaine
* Coagulopathy: Defined by INR\&gt;1.5 or Platelet count \&lt;100k
* Current Infection at site of injection
* VP Shunt on side of surgical procedure
* Pregnant patients: determined by patient history and available laboratory data. Patients will not be required to have pregnancy testing done if not otherwise indicated.
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Systemic or oral antibiotics.
* Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.

Patients with the following conditions are included:

* AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
* Able to follow instructions regarding the use of a pastille.
* Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
* Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Systemic candidiasis.
* Hypersensitivity to nystatin.
* Suspected or proven candidal esophagitis.

Patients with the following are excluded:

* Systemic candidiasis.
* Projected survival of less than 6 months.
* Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
* Hypersensitivity to nystatin.
* Suspected or proven candidal esophagitis.
A Growth Artificial Intelligence Algorithm for leNgth and Weight Study

This is a data collection and machine learning accuracy testing project that aims to a) collect training data to enhance, by machine learning, an artificial intelligence (AI) algorithm for measuring length in infants and young children and b) test the accuracy of the AI algorithm by comparing the AI predicted length with the gold standard measured length. Images and videos will be collected by care givers and healthcare professionals, together with physical length measurements. These data will be used to train the AI algorithm and to explore potential improvements. Other data to be collected is user experience feedback.


Eligibility Criteria:
Inclusion Criteria:

1. Infants/young children aged 0 to 24 months old at enrolment;
2. Caregiver(s) have access to the internet and a smartphone or tablet to complete questionnaires, take images and videos, and upload these;
3. Written informed consent from one or both caregivers (according to local laws) or legally acceptable representative(s) aged ≥ 18 years at enrolment.

Exclusion Criteria:

1. Children unable to undergo length or weight measurements when applying standardized techniques recommended by the WHO (e.g. infants/children with structural abnormalities of the lower limbs or orthopaedic conditions (e.g. club foot, hip dysplasia)).
2. Research staff's uncertainty about the caregiver's ability or willingness to complete the study according to the instructions
Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study

The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness. The objective of this study is to create bioelectric impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of healthy persons of both genders in the age 20-70 years.

The treatment of Growth Hormone deficiency (GHD) patients with GH, has since 1994 been approved in several countries. The approval is based on studies that show positive effect on body composition, physiology, lipid profile, bone density and life quality. One often observed side effect is fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness.

By comparing the body bioelectric impedance (BIA) with an Arm Muscle Area (AMA) measurement, it is possible to determine the hydrations status of a person. This measurement is a simple and non invasive method to evaluate the GH dosages applied in the treatment of GHD persons.

The objective of this study is to create BIA/AMA reference data of healthy persons of both genders in the age 20-70 years.

Eligibility Criteria:
Inclusion Criteria:

* Healthy persons,
* Age 20- 70 years.

Exclusion Criteria:

* Cardiac implanter (pacemaker),
* Heart insufficiency, chronic venuos insufficiency,
* Use of diuretics, desmopressin, neuroleptica, antidepressants, corticosteroids, fludrocotidon,
* Obesity (BMI \> 30),
* Knowledge of changes in electrolyte or water homeostasis.