cyrilzakka/clinical-trials huggingface dataset:
Pressure Pain Tolerance in Relation to Balance and Strength in Children

Sickle cell disease (SCD) is the most frequent life-threatening genetic hemoglobinopathy in the world and occurs due to the synthesis of abnormal hemoglobin S (HbS).Cells with sickle cell hemoglobin are stiff and sticky. When they lose their oxygen, they form into the shape of a sickle or crescent. This can cause pain and tissue damage. Significant decrease in exercise capacity was seen in sickle cell anemic children. In the absence of a guidelines that can guide the prescription of exercise in SCD children. This study is a step for determine the forms of prescription of pain on the balance and muscle strength to build up in future studies a safety of physical exercises for children with sickle cell anemia and improve their functional abilities.

Sickle cell anemia is a serious life-limiting and potentially life-threatening condition that causes disruption in the lifestyle of the affected child. Pain is a common and severe symptom of sickle cell disease (SCD) and is the major reason that patients seek health care services. Some researchers supported the fact that an important impairment in balance control and muscle strength in children with sickle cell disease due to pressure pain tolerance problems and other factors. Significant decrease in exercise capacity was seen in sickle cell anemic children. The altered muscle function and balance observed in SCD children may collectively be the result of pressure pain tolerance impairment. As your physical fitness improves, your body becomes more efficient at getting oxygen into the bloodstream and transporting it to the working muscles. Along this observational correlational study design; Eighty children from both sexes will be participated in this study. Forty normal healthy children will be selected from primary governmental schools at Alexandria governorate and forty children with sickle cell anemia will be selected from Alexandria University Students Hospitals For evaluation of muscle strength hand held dynamometer (Lafayette) is one of the best methods to detect the muscle strength. It is an ergonomic hand-held device for objectively quantifying muscle strength

Eligibility Criteria:
Inclusion Criteria:

* Age range range was 9-14 years old.
* Could follow given instructions.
* Children with Sickle cell anemia were medically stable, and take their medications regularly.
* Children with Sickle cell anemia had experience of chronic pain that lasts more than 6 months.
* All children with Sickle cell anemia have average weight, height, and body mass index based on their age percentiles.
* All normal healthy children did not participating in regular sport activities, particularly including lower limb strengthening.

Exclusion Criteria:

* Defined cardiovascular or respiratory disorders.
* Renal failure.
* Myocardial infarction, mainly within last month.
* Unstable angina.
* Recent thoracoabdominal surgery.
* Thoracic or abdominal aneurysm or current pneumothorax.
* Painful vaso-occlusive crises.
* Muscular contractures, Joints' stiffness, or deformities.
* Neuromuscular problems i.e., myositis or peripheral neuropathy.
Dextenza for Corneal Crosslinking

This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The study will enroll patients age 13 and up with progressive keratoconus (KCN) who are scheduled for bilateral epithelial off corneal collagen cross-linking (CXL) with Photrexa. A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

  1. Progressive keratoconus as defined by increasing astigmatism and/or keratometry on corneal topography or tomography or increasing cylindrical error on refraction
  2. Patients requiring general anesthetic for the procedure
  3. Preoperative central corneal thickness of \>= 400 microns

Exclusion Criteria:

* History of acute hydrops in treated eye
* History of pre-existing severe corneal scarring in the treated eye
* History of pre-existing glaucoma in the treated eye
* History of or pharmaceutical treatment of glaucoma or ocular hypertension and history or current spikes in intraocular pressure (IOP) in either eye.
* History of pre-existing ocular inflammation or infection (conjunctivitis, keratitis, uveitis, or retinitis) in treated eye
* Active infectious systemic disease
* Obstructed nasolacrimal duct in the study eye(s)
* Patients with a nasolacrimal duct smaller than 0.4 mm or greater than or equal to 1.0 mm.
* Patients with stenosis to the location where the insert will be placed should be excluded from the study, as the study team would not engage in surgical procedures to expand or surgically correct that region
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* Patients being treated with immunosuppressants and/or oral steroids
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
RELATIONSHIP OF LUMBOPELVIC MUSCULATURE WITH FUNCTIONAL TESTS IN NON-PROFESSIONAL ATHLETES WITH LUMBAR DISC HERNIATION

This is a control-case study. It has been designed to determine if there is a relationship between the cross sectional (thickness), through RUSI ultrasound, of the abdominal muscles, lumbar and hip muscles with the results of the functional tests, to determine its relevance in patients with low back pain and / or ciatalgia and lumbar disc herniation in non-professional athletes. The secondary objectives of the study will be to know if there is a relationship between the results of ultrasound measurements and functional tests with the result of the disability questionnaires, the amount of pain and its location, as well as determine the relevance, depending on the results of ultrasound measurements and test of the presence or not of a lumbar disc herniation.


Eligibility Criteria:
Inclusion criteria:

* Age 18 to 55 years of age.
* Sports practice equal to greater than three hours per week.
* No low back pain or ciatalgia in the last 12 months.

Exclusion criteria:

* Traumatic process or surgery in the lower back or lower limb in the last year.
* Alterations of the skin or local infection in the area to be examined or that impedes the ultrasonographic measurement or performance of the functional tests.
* Peripheral or central neurological pathology.
* Psychiatric pathology and / or cognitive alterations.
* Inflammatory and tumor diseases.
* Alterations that prevent the understanding of the indications and / or the performance of the tests.

Group selection criteria:

* Group 1(group without low back pain): No low back pain or ciatalgia in the last 12 months.
* Group 2 (low back pain group): History of at least one episode of low back pain and / or ciatalgia in the last 12 months lasting no longer than three months and diagnosis of hernia lumbar disc using MRI.
Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System

The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations . The device used in this study is designed to assist the physician in guiding the needle towards the suspected area. This device does not change the procedure of liver biopsy or ablation. The only difference is that a small adhesive pad is placed on the skin and a miniature video camera is attached to the end of the needle. This camera does not enter the body.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
* Subjects scheduled for clinically indicated CT guided percutaneous needle placements in the liver who meet the desired target population described above.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures.
* Verified home address and phone number to facilitate study follow-up.

Exclusion Criteria:

* Significant coagulopathy that cannot be adequately corrected.
* Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
* Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
* Subjects who are uncooperative or cannot follow instructions.
* Mental state that may preclude completion of the study procedure.
* Pregnant or nursing female subjects.
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Exclusion Criteria:

* Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.

Other protocol-defined inclusion/exclusion criteria may apply.
iBeat Wristwatch Validation Study

The iBeat Study is a single-center, prospective, unblinded validation of the photoplethysmography (PPG) and tissue oximetry (TO) signal waveforms recorded from a wrist-based sensor devices.

The goal of the proposed research is to validate PPG and TO signal waveforms recorded from a wist-based sensor device, which is worn on one or both arms, during catheter ablation, device interrogation, and defibrillation threshold testing (DFT). It is a non-invasive procedure that will include placing a wrist-based sensor on subjects who consent participate. Data collected from routine clinical care devices used during these procedures (catheter ablations, device interrogations, and DFTs) will confirm data collected from the iBeat wristwatch.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years and ≤ 85 years
2. Able to understand and give informed consent.
3. Subject is presenting for the following planned procedures:

3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing).

3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)

Exclusion Criteria:

1. Age \< 21 years and \> 85 years
2. Unable to or refuse to give written informed consent
3. Unwilling or unable to wear the smartwatch device on at least one wrist
4. Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction \> 50 mm
5. New York Heart Association Class IV Heart Failure
Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis

One of the most common and serious complications in decompensated cirrhotic patients (DCPs) is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis.

Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and macrophages can also produce these proteins. The induction of SAA and CRP synthesis is triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell types, but mainly from macrophages and monocytes at inflammatory sites

Increased serum CRP and SAA levels have been found in a number of disorders, including bacterial infections, malignancies tissue injuries and tissue rejection. Therefore, new studies of early diagnosis, prevention and treatment are needed to improve clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* • Decompansated cirrhosis with ascites, defined by a combination of any of the following:

  * Laboratory findings
  * Endoscopic results
  * Ultrasound
  * Histology

Exclusion Criteria:

* Creatinine\>1.5 mg/dl
* Other infection e.grespiratory,UTI ,gastrointestinal and skin infection.
* Hepatocellular carcinoma
* Other extrahepatic malignancy e.g ; chest
* Any significant psychiatric illness or other medical comorbidity.
* Any degenerative diseases.
Safety and Efficacy Study of AI LVEF

To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of left ventricular ejection fraction compared to sonographer measurements in preliminary readings of echocardiograms.


Eligibility Criteria:
Inclusion Criteria:

* The study imaging studies will include patients who underwent imaging (limited or comprehensive transthoracic echocardiogram studies) and a LVEF was adjudicated in the echocardiography/non-invasive cardiac imaging laboratory.
* The study participants are cardiologists reading in the echocardiography/non-invasive cardiac imaging laboratory.

Exclusion Criteria:

* The study imaging studies will exclude transesophageal echocardiogram imaging.
* The study will exclude cardiologists who decline to participate
EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol

A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might interfere on measured BIS values.

The aim of this prospective randomized study was to compare, in steady state conditions, the EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels of general anesthesia.

Children will be prospectively included and randomly assigned in two groups : Propofol (P) Group or Sevoflurane (S) Group.

Steady state periods will be performed at a fixed randomized concentration between 2, 3, 4, 5 and 6 mcg/ml of stable Ct P concentration in the P group and between 1,2,3,4,5 % of FeS in the S group.

At the end of each steady-state period the BIS value was noted and the relationship between BIS and anesthetic concentrations will be studied using non linear regression. For all steady state periods, EEG traces will be reviewed to determine the presence of epileptiform signs (ES) and spectral EEG signal analysis with fast Fourier transformation (FFT) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* from five to eighteen year of age, ASA 1 or 2, scheduled for middle ear surgery

Exclusion Criteria:

* obesity (body mass index \> percentile 97); history of cardiac, pulmonary, or renal disease; known neurological or neuromuscular disorders; preoperative administration of medications known to interfere with the central nervous system
Role of Dexamethasone in Multimodal Analgesia for Postoperative Pain in Thoracic Surgery

The aim of the study is to evaluate the analgesic properties of dexamethasone and to quantify the possible associated postoperative complications, such as wound infections and hyperglycaemia, in patients who underwent lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (VATS).

We designed an observational study, aimed to evaluate the possible reduction in morphine consumption in thoracic patients, who were administered dexamethasone compared to who didn't received the drug.

The research wants to assess the presence of additional analgesic properties, besides the well known antiemetic effect, in the intraoperative administration of dexamethasone, and the possible postoperative complications, such as wound infections and hyperglycaemia.

The rational is to ameliorate the anaesthesiological management, in particular with a view to a opioid-sparing analgesia in thoracic patients.

To do so, we enrolled thoracic patients, who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (VATS).

We selected two groups: one in which patients were administered dexamethasone 8 mg at the moment of induction, and the other one in which patients didn't received dexamethasone, but ondansetron 4 mg at the end of surgery. Both groups received other antiemetic drugs based on Apfel score and multimodal analgesia, comprising loco-regional analgesia, opioids and other analgesic drugs administration.

The we checked morphine consumption and Numerical Rating Scale (NRS) values for pain in the first 24 hours after surgery.

Moreover we evaluate Post-Operative Nausea and Vomiting (PONV), intra- and post-operative blood glucose levels and wound infection.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30 kg/m2
* ASA I-III
* Lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS

Exclusion Criteria:

* Refusal by the patient to participate or patient unable to express his own consent
* Chronic therapy with medium-high doses of corticosteroids
* Chronic therapy with opioids
* METS ≤ 4, defining an overall decreased cardiovascular fitness
* Urgent or emergency surgery
* Allergy to the active ingredient of the drug used
* Kidney failure at stage III or more
* Liver failure
* Pregnancy
* Drug addiction, patients with a history of drug abuse
* Corrected Qt interval (QTc) \> 0,45 for males and 0,47 for women
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting

The purpose of this study is to describe long term (\> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.

Time perspective: Collection of historical data and longitudinal follow up. Patients will be enrolled in 2011/2012 but data will be collected from medical charts from ATV initiation date (Feb 2008 - July 2010) until July 2013 at the latest (if no ATV discontinuation, or death, or lost to follow up).

Non probability sample:

* Specialized HIV management centers will be contacted in order to recruit about 15-20 sites per country.
* Each site will have to enroll an average of 8-12 consecutive patients (min:5; max:30) fulfilling the inclusion/exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female HIV patients ≥ 18 years old at ATV/RTV initiation treatment date
* Outpatient seen in routine consultation whatever the reason, between January 1st 2011 and March 31st 2012
* Commencing an ATV/RTV-based regimen including at least 2 nucleoside reverse transcriptase inhibitors (NRTI) after February 1st 2008 and before July 31st 2010, regardless of the current ARV treatment ongoing at enrollment visit

Exclusion Criteria:

* Patient exposed to or who began ATV/RTV prior to February 1st 2008, or after July 31st 2010 or without a known start date for ATV/RTV therapy
* Exposure to more than 4 weeks of any ARV prior to initiation of ATV/RTV treatment
* Participation in a clinical trial with ATV at the time of or after initiation of ATV/RTV-based regimen
Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV

It is unclear whether children with HIV and severe acute malnutrition can be started on highly active antiretroviral therapy (HAART) safely while they are still malnourished and the manner in which this therapy should start. This study will examine the safety, efficacy, and metabolism of children started on HAART while still severely malnourished.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected about to start on HAART for the first time
* 6-59 months old

Exclusion Criteria:

* also being treated for TB
* other chronic illness (e.g., congenital heart disease, cerebral palsy)
Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand

Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand

Primary:

To assess the prevalence of specific FGIDs (infant regurgitation, infantile colic and functional constipation) and related signs and symptoms in infants and toddlers in Thailand, according to information provided by the parents.

Secondary:

To assess the impact of FGIDs (Infant regurgitation, Infantile colic and functional constipation) and related signs and symptoms of infants and toddlers on the quality of life (QoL) of parents/caretakers and family, according to information provided by the parents.

Exploratory:

To assess treatments and practices employed in real-life to manage FGIDs according to the Rome IV criteria (infant regurgitation, infantile colic, and functional constipation) and related signs and symptoms in infants and toddlers, according to information provided by the parents.

Eligibility Criteria:
Inclusion Criteria:

1. Parent of otherwise healthy infants and/or toddlers from one of the age groups: 3±1 months, 6±1 months, 9±1 months, 12±1 months, or 18±1 months
2. Parent answering the online survey questionnaire attends to the child more than 50% of the time
3. Informed consent from one or both parents (according to local laws) and/or legal guardian.
4. Parent should have reliable access to the internet and a reliable device such as a computer, tablet or smartphone to complete the online survey questionnaire

Exclusion Criteria:

1. Parent who is not adequately comfortable in the language in which the online survey questionnaire will be completed
2. Inability of the parent to answer the survey questionnaire online.
3. Infants and Toddlers who underwent surgery under general anesthesia