cyrilzakka/clinical-trials huggingface dataset:
Pattern of Admission of Children With COVID-19 Admitted in Assuit University Children Hospital.

A novel coronavirus was identified following a cluster of cases of pneumonia in Wuhan, China, in December 2019. It rapidly spread as an outbreak there. On the 23rd of January 2020, it was announced that the outbreak constituted apublic health emergency of international concern. Few weeks later, virus spread was recorded worldwide and was announcedas a pandemic by WHO in March 11, 2020.Global spread included Egypt, and the first case was recorded inEgypt onFebruary 14, 2020.Diagnosis of COVID-19 depend on a case definition of suspected and confirmed case.

Implementation of case definition depend on the clinical presentation of the case and on laboratory test as well asradiological finding.The cases will be stratified according to these collective data to different grades of severity.

Mild cases are either asymptomatic or symptomatic with Leucopenia and/or lymphopenia with no radiological evidence of pneumonia (upper respiratory tract illness ± one of the following symptoms: fever \< 38, cough,GIT symptoms, myalgia and/or arthralgia).

Moderate cases include patients with leucopenia and/or lymphopenia with clinical and radiological evidence of pneumonia, including fever \> 38 °Cwith or without cough and tachypnea (respiratory rate \> 60 breaths/min forinfants \< 2 months, \> 50 breaths/min for infants 2-12 months, \> 40 breaths/min for children 1-4 years, \> 30 breaths/min for children older than5 years old), and the condition may be associated by moderate to severe dehydration.

Cases are considered as severe and critically ill if any of the following is present: - O2 saturation ≤ 92% despite escalating O2 therapy to maximal allowed 6 L/min - O2 saturation ≤ 90 % at room air - If the patient in septic shock, confused or hemodynamically unstable despite fluid resuscitation - If respiratory manifestations are combined with other organ failure - Chest radiography \> 50% lesion or progressive lesion within 24-48 hrs.

Children may play a major role in community-based viral transmission. Available data suggest that children may have more upper respiratory tract involvement (including nasopharyngeal carriage) rather than lower respiratory tract involvement.

The decision of the site of management either at home or in hospital depends on the clinical presentation, requirement for supportive care, potential risk factors for severe disease, and the ability of the patient to self-isolate at home. Supportive treatment including sufficient fluid and calories intake, and additional oxygen supplementation should be used in the treatment of children infected with COVID-19. The aim is to prevent ARDS, organ failure, and secondary nosocomial infections. If bacterial infection is suspected, broad-spectrum antibiotics may be used.


Eligibility Criteria:
Inclusion Criteria:

* All the patients from birth up to 18 years old admitted with suspectedor confirmed cases of covid-19 in AUCH.

Exclusion Criteria:

* : Any patient not suspected or confirmed to have COVID-19
Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG.

At University Medical Centre Ljubljana (UMCL; Slovenia), the investigators use electroencephalography (EEG) in wakefulness and sleep for diagnostic and therapeutic purposes in children with (suspected) epilepsy. Since epileptiform activity can only be detected during sleep in some patients and because children with intellectual disabilities have sometimes problems with cooperation, EEG in induced sleep is required.

In this study, the investigators will enroll 150 children who need EEG recorded in their sleep. The investigators will compare safety and efficacy of the two active substances, one of which will be given in two possible routes. Fifty children will receive melatonin in the form of a syrup orally, 50 children will receive dexmedetomidine intranasally in the form of a nasal spray, and 50 children will receive dexmedetomidine sublingually. The investigators will monitor the following parameters: the time in which the child falls asleep, vital functions during sleep (blood pressure, blood oxygen saturation, respiratory rate frequency and heart rate frequency), the impact on the technical implementation of EEG, the depth of sleep and waking time. All parents will give their written consent for their child to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 1 and 20 years
* Referral for EEG in sleep
* Children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form

Exclusion Criteria:

* Children that were unable to follow the study protocol were excluded during the study
EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses

The objective of this paired cohort study is to evaluate the diagnostic accuracy of Endoscopic Ultrasound-fine needle aspiration (EUS-FNA) with rapid onsite evaluation (ROSE) compared to EUS-fine needle biopsy (EUS-FNB) without ROSE. If EUS-FNB without ROSE is shown to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic lesions, this study has the potential to make EUS-guided tissue acquisition more economical (with elimination for the need for cytopathology staff onsite) as well as provide core histological specimen without sacrificing the overall diagnostic yield.

Endoscopic ultrasound (EUS) guided fine needle aspiration (EUS-FNA) is the primary technique for tissue acquisition for pancreatic lesions. Despite widespread adoption of the techniques, the diagnostic yield of EUS-FNA for pancreatic lesion is highly variable, with sensitivities ranging from 64-95%, specificities ranging from 75-100% and overall diagnostic accuracy ranging from 78-95%.

Despite its mainstay as the primary technique for tissue acquisition, EUS-FNA has several limitations. The standard EUS-FNA does not routinely provide core biopsy specimen with preserved tissue architecture, which is required for immunohistochemical staining and for definitive diagnosis of conditions, such as lymphoma, gastrointestinal stromal tumors, Immunoglobulin G (IgG)-4-associated lymphoplasmacytic sclerosing pancreatitis. Furthermore, the diagnostic yield of EUS-FNA is highly dependent on the availability of bedside cytotechnologist or cytopathologist for rapid onsite evaluation (ROSE), which increases the overall cost required to perform EUS-FNA.

Recently, multiple dedicated EUS fine needle biopsy (FNB) needles have been developed to obtain core specimens. Early small studies have shown promising results with these EUS-FNB needles.

The objective of this paired cohort study is to evaluate the diagnostic accuracy of EUS-FNA with ROSE compared to EUS-FNA with ROSE. Participants will be assigned to the arms. If EUS-FNB without ROSE is shown to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic lesions, this study has the potential to make EUS-guided tissue acquisition more economical (with elimination for the need for cytopathology staff onsite) as well as provide core histological specimen without sacrificing the overall diagnostic yield.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age referred for EUS-guided biopsy for pancreatic mass lesions

Exclusion Criteria:

* Refusal to consent form
* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Uncooperative patients
* Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
* Medically unstable for sedation
* Entirely cystic lesions
* Lesions inaccessible to EUS
Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study

This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study.

The purpose of this study is to determine the short-term and long-term impact and effectiveness of the CHI SJC program. The CHI SJC program has not been studied to determine program effectiveness. The investigators intend to follow families and their children until the children in the study graduate from high-school or turn 19 years of age.

The study, as a template, uses the eight outcome domains listed and described in the Home Visiting Evidence of Effectiveness website (http://homvee.acf.hhs.gov/outcomes.aspx). These eight domains are:

* Child development and school readiness
* Family economic self-sufficiency
* Maternal health
* Reductions in child maltreatment
* Child health
* Linkages and referrals
* Positive parenting practices
* Reductions in juvenile delinquency, family violence, and crime

The investigators expect to observe significant differences among the two groups with respect to the primary outcome domains listed. The investigators expect study group members randomized to the CHI SJC program will perform better on the eight outcome domains.

Other hypotheses include:

Other Hypotheses:

Hypothesis 1. Randomization to CHI SJC will be associated with higher quality functioning and better child health and well-being.

Hypothesis 2. Randomization to CHI SJC will result in more connections to community resources.

Hypothesis 3. Randomization to CHI SJC will result in improved indications of maternal health and positive parenting practices.

Hypothesis 4. Randomization to CHI SJC will be associated with higher measures of family economic self-sufficiency.

Hypothesis 5. Randomization to CHI SJC will be associated with increased school readiness and school progress and attainment.

Hypothesis 6. Randomization to CHI SJC will be associated with reductions in juvenile delinquency, family violence, and crime.

The study will collect outcome data in the same way and, at the same time, from treatment and control group members. Data collection will primarily be comprised of a set of self-report questionnaires and a review of administrative records that target the outcome domains described earlier. Study group members will be assessed at baseline, 6 months, 12 months, 18 months, 24 months, 3 years, 5 years, 8 years, 12 years, 15 years, and at high-school graduation or 19 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Must be first-born child of one of the parents.
* Child must be 3-months of age or less at the time of enrollment.
* At the time of enrollment family must live within the 3 county area covered by the program.

Exclusion Criteria:

* Children older than 3-months.
* Children who are not the first-born child of one of the parents.
Clinical and Laboratory Profile of Myasthenia Gravis in Children At Sohag University Hospitals

This study includes clinical and laboratory studies of patients with Myathenia gravis at Sohag Neurology outpatient clinic of pediatric department

All patients in this study were subjected to the followings:

(A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental history: neurological evaluation Family history. Mode of delivery

(B) Thorough clinical examination: General examination including general look, vital signs and anthropometric measurements.

Scale system include gross motor function and muscle power(Quantitative Myasthenia Gravis Scale) \[36\] detailed neurological examination including motor ,sensory and reflexes. (C) Investigations:

1. Electrophysiological testing:

   EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes.

   NCS: including repetitive nerve stimulation test (r NST)
2. laboratory studies: Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS.

   Thyroid function tests :
3. Imaging:

   CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
4. molecular studies (when possible).

Eligibility Criteria:
Inclusion Criteria:

* All patients from 1 month to 16 years confirmed diagnosis of myasthenia gravis by neurological and laboratory data.

Care giver accept to participate in the study.

Exclusion Criteria:

* Failure to obtain informed consent. Other neurological and neuromuscular disorders. Age above 16 years.
A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® to Control the Early Morning BP Rise (SURGE II)

The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.

The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.

Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability


Eligibility Criteria:
Inclusion Criteria:

* Patients male or female between 18 and 80 years of age
* Patients with mild to moderate essential hypertension
* Patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment

Exclusion Criteria:

* Pre-menopausal women who have no birth control, who are pregnant or nursing
* Patients with advanced hepatic impairment or advanced renal impairment
* Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
* Patients with any type of relevant arrhythmia according to the assessment of the investigator
* Patients with any valvular disease with hemodynamic repercussion
* Patients receiving chronic administration of oral anticoagulants or digoxin
* Patients with known hypersensitivity to any component in the formulation of Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide
* Patients with previous history of angioedema associated with angiotensin converting enzyme (ACE) inhibitors
* Patients with severe, uncontrolled hypertension or any form of secondary hypertension
* Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
Stellate Ganglion Block

The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing esophagectomy, pneumonectomy, or lobectomy aged 18-85.

Exclusion Criteria:

* Patients who have an exclusion to regional anesthesia.
* Patients who have exclusion to stellate blockade.
* Patients who are pregnant assessed via self-report or pregnancy test if they have taken one
Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma

Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma

A total of 6 blocks of Nivolumab+DA-EPOCH-R are planned for all patients regardless of stage and other risk factors. Nivolumab 40 mg (Day 2), Rituximab 375 mg/m2 (Day 1) and Prednisolone 60 mg/m2 (Days 1-5) are administered at constant unchangeable doses. Other drugs are administered at starting doses (Etoposide 50 mg/m2 (Days 1-4), Doxorubicin 10 mg/m2 (Days 1-4), Vincristine 0,4 mg/m2 (Days 1-4) and Cyclophosphamide 750 mg/m2 (Day 5). These starting doses are adjusted further according to standard principles of DA-EPOCH-R.

Eligibility Criteria:
Inclusion Criteria:

* Age from 0 years to 17 years 11 months

  * Established on the basis of histological and immunohistochemical studies, the diagnosis of PMLBL (the presence of programmed death-ligand on tumor cells is not necessary)
  * Lack of specific therapy for lymphoma
  * Signed informed consent

Exclusion Criteria:

* Age \>18

  * History of specific therapy for lymphomas.
  * Drug intolerance
Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)

Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study we are recruiting patients to receive the drug NPL-2003, which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are taking in a 12-week open label study.


Eligibility Criteria:
Inclusion Criteria:

* Primary DSM-IV Diagnosis of OCD
* Currently on a stable and adequate dose of SRI (or history of prior SRI or CBT treatment meeting criteria for adequate trial)
* Patients not currently receiving an SRI or CBT will be included if they have undergone a prior SRI or CBT trial and they report no interest in pursuing another DRI or CBT trial at this time. Patients who have been on SRIs in the past must be free of SRIs for at least 6 weeks prior to participation
* Y-BOCS score of greater or equal to 16
* Physically health and females must be using effective contraception
* Sufficient severity of symptoms to warrant additional augmentation treatment
* Able to provide consent

Exclusion Criteria:

* Ongoing treatment with other antibiotics and/or Accutane. Patients with lupus erythematosus
* Patients planning to start CBT during the study period or those who have begun CBT within the past 8 weeks
* Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder or other psychotic disorder
* Current major depressive disorder (patients must be free of the disorder for 3 months prior to enrollment). HAM-D must be \<18.
* Judged clinically to be at risk of suicide (suicidal ideation, severe depression or other factors
* Current eating disorder
* Severe renal insufficiency
* Documented history of hypersensitivity or intolerance to tetracycline antibiotics
* Concomitant use of anti-coagulant drugs, antacids, iron, calcium, magnesium, aluminum, zinc sales. Note:Concomitant psychotropic medications such as antipsychotics and benzodiazepines will be permitted as long as they have been stable for at least 4 weeks and remain stable during the course of the study.
* Current ETOH/drug abuse or dependence disorder of dependency in the past 3 months
* Female patients who are either pregnant or nursing
Early Strength Training After Hip Fracture Surgery

Patients treated surgically for a hip fracture have a need of rehabilitation for the regain of former functional skills. Despite an optimized fast track in-hospital rehabilitation program it has been found that patients with hip fracture within 2 weeks after the hip fracture loose more than half of their muscle strength in the fractured limb compared to non-fractured limb. New studies including patients with total hip arthroplasty and strength training applied early after surgery has shown promising results regarding prevention of loss of muscle strength. No similar study has been found including patients with hip fracture.

The purpose of this study is to examine the feasibility of progressive knee-extension strength training of the hip fractured limb, starting Day 1 after surgical treatment for a hip fracture and proceeded every weekday during their hospital stay.

The study will include 20 patients surgically treated for a cervical hip fracture and 20 patients surgically treated for an intertrochanteric or subtrochanteric fracture. All patients are admitted from their own home. Age 60 years or older.

Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT (2014) Feasibility of Progressive Strength Training Implemented in the Acute Ward after Hip Fracture Surgery. PLoS ONE 9(4): e93332. doi:10.1371/journal.pone.0093332

Eligibility Criteria:
Inclusion Criteria:

* Hip fracture diagnosed patients age ≥60 years, admitted to the acute hip fracture unit.
* Medial femoral neck fracture, pertrochanteric fracture or subtrochanteric fracture.
* Ability to speak and understand the Danish language.
* Cognitively well-preserved and able to give personal informed consent no later than by 5th post surgical day.
* Home-residing and with an independent pre-fracture ability to walk equal to New Mobility Score at ≥ 2 indoor.

Exclusion Criteria:

* Multiple fractures
* Postsurgical restrictions of mobilization
* Patient not accepting participation in relevant exercise therapy
* Fracture caused by cancer metastases
* Terminal illness
* Neurological impairment e.g. hemi paresis.
Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission

This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.

At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.

Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-65 years
* ability to understand the study procedures and sign the informed consent
* ulcerative colitis diagnosed at least 6 months before
* no previous exposure to anti-TNFs
* Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
* steroid-dependent disease
* women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation

Exclusion Criteria:

* Crohn's disease or undetermined colitis
* active infections or previous infections not completely resolved at baseline
* malignancies in the previous 5 years
* suspected latent tuberculosis infection
* every other potentially harmful clinical condition, in the opinion of the investigator
* patients with moderately to severe heart failure (NYHA class III/IV)
* hepatic or renal failure
* pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
* not permitted concomitant medications