cyrilzakka/clinical-trials huggingface dataset:
Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score

Appendicitis is the most common abdominal disease requiring surgery in children. The risk of developing appendicitis during a lifetime is reported to be 8.7% for boys and 6.7% for girls. Despite its high incidence, there are still diagnostic difficulties. The overall negative appendectomy rate among all children is suggested to be 8.4%, but in children under 6 years of age, the rate has been reported to be as high as 56.7% . The diagnosis of acute appendicitis is considered to be especially challenging in children due to difficulties in communication and examination.

The diagnostic difficulties result in increased risks of both negative appendectomies and a delayed diagnosis, both leading to increased morbidity, more complications, longer hospital stay, and higher costs. These risks are further increased in the younger children. The doctor delay is a known cause contributing to late diagnosis in young children. Other studies, with patients under 3 years and 4 years of age, have found parent delay to contribute as well to the late diagnosis. Our clinical experience, confirmed by the literature, shows that the younger children with acute appendicitis deviate from the typical presentation and clinical findings observed in older children with acute appendicitis.

The use of a clinical score, based on patient history and examination, is one way to possibly improve the diagnostic procedure. There are several available scores. In this systematic review, Pediatric Appendicitis Score (PAS) were considered the most reliable. Pediatric Appendicitis Score is the only score specifically developed for children, composed by Samuel in 2002 when analyzing children between 4 and 15 years of age. Pediatric Appendicitis Score has been validated and recommended by some authors, but only one of these studies has included children less than 4 years of age.

We hypothesized that PAS could be helpful in diagnosing young children with appendicitis and that we would find both parent delay and doctor delay contributing to the often late diagnosis in this age group. The aims of this study were to (1) evaluate Pediatric Appendicitis Score in children, operated on for suspected appendicitis, with respect to Pediatric Appendicitis Score sensitivity, specificity, positive predictive value, and negative predictive value; (2) investigate if there was a delay in diagnosing appendicitis; and (3) identify factors responsible for the possible late diagnosis in younger children In order to improve the diagnostic accuracy of acute appendicitis, ultrasound, computed tomography and post-appendectomy histopathological examination have been used as clinical aids in cutting down the rate of negative appendectomy without increasing morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Children (1-15 years old) coming to hospital with abdominal pain and diagnosed provisionally as acute appendicitis .

Exclusion Criteria:

1. Children below 1 year old or above 15 years old.
2. Complicated appendicitis ( mass or abcess ).
3. Patient with recent history of any abdominal surgeries.
Clinical Validation of a Combinatorial Pharmacogenomic Approach in Major Depressive Disorder

Major depressive disorder (MDD) is a common, chronic, debilitating mood disorder causing serious functional impairment and significantly decreased quality of life. Pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial because of antidepressants ineffectiveness or side-effects. This causes suffering for patients and their families and significantly contributes to pushing up costs for healthcare services. Precision medicine in psychiatry might offer to clinicians the possibility to tailor the treatment according to the best possible evidence of effectiveness and tolerability for each subject. In this context our study aims to carry out a clinical validation of a combinatorial pharmacogenomics (PGx) test in an Italian MDD patient cohort with an advocacy license independence.

Our study is a prospective single-blind randomized controlled clinical observational trial enrolling 300 MDD patients. Patients referred to psychiatric services due to the failure and/or the onset of adverse effects of their current treatment for receiving a new antidepressant. Eligible participants with a primary diagnosis of MDD according to DSM-5 criteria and a Hamilton Depression Rating Scale (HAM-D17) with a score \> 14 are randomized to TGTG group (Treated with Genetic Test Guide) or TAU group (Treated as Usual). For all subjects, buccal brush for DNA is collected. The primary outcome is the reduction in depressive symptomatology as measured by HAM-D17. The secondary outcomes involve a range of scales that assess MDD symptoms and social functioning outcomes. The assessment is performed at four timepoints: baseline and 4, 8, and 12 weeks. This project represents the first randomized controlled clinical trial in which is tested whether a non-commercial PGx test improves outcomes in a MDD naturalistic cohort. Moreover, the identification of new genetic variants associated with non-response or side effects will improve the efficacy of the test leading to a further cost-saving.


Eligibility Criteria:
Inclusion Criteria:

* A current diagnosis of unipolar depression according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
* An Hamilton Depression Rating Scale (HAMD-17) score \>=14
* Caucasian ethnicity.

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Examination MMSE \<24)
* Neurological disorders
* Diagnosis of MDD with psychotic features, bipolar I and II disorders, schizophrenia spectrum and other psychotic disorders, obsessive-compulsive disorder, post-traumatic stress disorder
* Substance abuse in the last 3 months
* Comorbidity with personality disorders (cluster A and/or B); pregnancy
* Comorbidity with other severe medical illness.
Genetic Variants in Linear Localized Scleroderma

The purpose of this study is to investigate the genetic architecture of Linear Localized Scleroderma (LLS) (linear morphea) by whole exome sequencing.

At present the etiology of LLS is unknown, but a genetic background is suspected. Although LLS clearly classifies as a mosaic disorder, its genetics and protein machinery remain to be understood.

We are going to use a tailored approach to identify the genetic factors of LLS. In the first phase of the study we will investigate the genetic architecture in LLS. WES will analyze whole protein coding DNA in skin samples of 50 consenting LLS patient. The aim is to identify the key genes associated with LLS. In the second phase of the study subsequent functional experiments will be performed. Based on the identified candidate genes, knockdown and overexpression models will be created with relevant cell lines (fibroblasts) to identify the biological consequences and confirm the functional relevance of the identified genetic mutations in LLS. Further the protein network active in LLS will be investigated (proteomic analysis).

The described basic genetic studies combined with functional experiments will lay the groundwork for treatment trials to provide possibly novel treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 5 years of age with well phenotyped LLS
* Affecting their head and / or face "termed " en coup de sabre " type LLS or Hemiatrophia faciei or Parry-Romberg syndrome, with or without therapy
* Affecting any site of the body except the head or face, with or without therapy

Exclusion Criteria:

* Patients with signs of systemic scleroderma
* Patients with localized scleroderma (morphea) other than the linear type ("plaque-type", "morphea profunda", "generalized morphea") Patients with diagnosed gadolinium induced scleroderma Patients with post-irradiation scleroderma Patients with missing consent
Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition

Pre-operative weight loss can reduce the risk intra- and post-operative complications but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

Bariatric surgery is an important treatment strategy for obese patients having failed multiple diet-induced weight loss attempts. On the other hand, severly obese patients have also a high risk of both intra- and post-operative complications. Pre-operative weight loss can reduce these risks but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

Eligibility Criteria:
Inclusion Criteria:

* patient candidate to laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy) after multi-disciplinary pre-operative evaluation
* Availability to long-term post-operative follow-up
* Normal kidney function serum creatinine ≤ 1,2 mg/dL and glomerular filtration rate ≥ 90 mL/min
* Normal liver function (aspartate amino-transferase and/or alanine amino-transferase and/or gamma glutamyl transferase \< 2 x N)
* written informed consent

Exclusion Criteria:

* age \<18 or \>60 anni
* serum creatinine \>1,2 mg/dl
* liver failure (Child-Pugh ≥ A)
* insuline-dependent diabetes mellitus
* atrioventricular block with QT \> 0,44 ms
* Cardiac arrythmias
* Moderate-severe cardiac failure
* Hypokaliemia
* Chronic diarrhoea or vomitus
* 12-month previous cardio-vascular disease
* pregnancy and/or lactation
* current/previous neoplastic disease
* psychiatric disorders
* know gastro-intestinal diseases
* other controindications to enteral nutrition
* moderate-severe hypo-albuminemia (\<3.0 mg/dL)
* 6-month previous diet-induced weight loss
* intragastric balloon
* unavailability to planned measurements
The iCARE Study: Education Modules for Fracture Prevention

A large proportion of older adults living in long term care homes are frail and have osteoporosis. With age, there is a gradual and progressive decline in bone quality and quantity and an increase in frailty, which is associated with increased fracture risk. Additionally, fractures pose a significant burden to the health and quality of life of long term care residents and contribute to high healthcare costs. Despite the high prevalence of osteoporosis, falls, and fractures in long term care, the management of osteoporosis is not optimal among long term care residents at risk of fracture. The aim of this study is to co-design a service provision (i.e., PREVENT - Person-centred Routine Fracture PreEVENTion) with healthcare providers in long term care and to determine the feasibility of implementing PREVENT in long term care settings.

Fractures pose a significant burden on health, quality of life, and mortality of older adults in long term care (LTC) and contribute to high health care costs. PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture. The purpose of the iCARE study is to create a fall and fracture educational program (i.e., PREVENT) for LTC healthcare providers to deliver routine assessments for the management and treatment of osteoporosis. The benefit of such a guide may help to reduce the devastating impact of fractures in older adults residing in LTC homes. The aim of this pilot study is to: 1) determine feasibility and 2) adaptations through facilitators and barriers. Before a larger trial can be implemented to determine the effectiveness of the PREVENT Program in practice, the iCARE study seeks to determine the feasibility of implementing PREVENT in practice and identify strategies to tailor the program to the individual long term care home and care team through design thinking solutions.

Eligibility Criteria:
Organizational Level Inclusion Criteria:

Five long LTC homes in Ontario that

* Have a minimum of 70 residents
* Are publicly owned and private for-profit and private not-for-profit homes in both urban and rural sites

Individual Level Inclusion Criteria:

* At least one internal champion
* Five Professional Advisory Committee (PAC) care teams from five long term care homes in Ontario that provide osteoporosis care to residents.
Eplerenone and Extracellular Adenosine Formation

Various studies have reported cardioprotective effects of mineralocorticoid receptor (MR) antagonists in the setting of an acute myocardial infarction. In a recent animal study, the protective effect of MR antagonists on infarct size was completely abolished in CD73 knock-out and adenosine A2b receptor knock-out mice, and by co-administration of adenosine receptor antagonists in rats. These findings suggest that extracellular formation of adenosine is crucial for this protective effect and that MR antagonists stimulate extracellular adenosine formation by the enzyme CD73.

To investigate whether eplerenone promotes adenosine receptor stimulation by activating CD73, the investigators will measure forearm blood flow in response to various dosages of dipyridamole with the use of plethysmography. Dipyridamole increases the extracellular endogenous adenosine concentration by inhibition of the ENT transporter and induces local vasodilation. Therefore, the vasodilator effect of dipyridamole accurately reflects extracellular adenosine formation by the CD73 enzyme.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 18-40 years
* Healthy
* Written informed consent

Exclusion Criteria:

* Smoking
* Hypertension (Blood pressure \>140 mmHg and/or \>90 mmHg - SBP/DBP-)
* Hypotension (Blood pressure \<100 mmHg and/or \<60 mmHg -SBP/DBP-)
* Diabetes Mellitus (fasting glucose \> 6.9 mmol/L or random \> 11.0 mmol/L in venous plasma)
* History of any cardiovascular disease
* Angina pectoris
* History of chronic obstructive pulmonary disease (COPD) or asthma
* Alcohol and/or drug abuse
* Concomitant use of medication
* Renal dysfunction (MDRD \< 60 ml/min/1.73 m2)
* Liver enzyme abnormalities (ALAT \> twice upper limit of normality)
* Serum potassium ≥ 4.8 mmol/L
* Fasting total cholesterol \> 6.0 mmol/L
* Second/third degree AV-block on electrocardiography
Short-term Behavior Change With Pedal Desk Installation

The purpose of this investigation is to evaluate participant use of a dedicated office pedal desk with and without behavioral support.

For this pilot study the investigators will identify and recruit up to 20 full time Pennington Biomedical staff members employed in sedentary jobs (i.e., report mostly sitting during working hours). The sample size is limited by the number of pedal desks being built for this pilot study and the need for timely data generation. Although the investigators can stagger starts as needed, all participants must intend to be on campus for the subsequent 6 weeks after they start the intervention. Two cohorts of 10 participants will complete the three 2-week conditions in the following order: 1) SELF-DIRECTED use where participants have access to their daily recorded data but will not have any other form of feedback or goal-setting; 2) FACILITATED use where participants are provided with their daily recorded pedal desk data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount; 3) FACILITATED use with PEDOMETER where participants will be provided with their daily recorded pedal desk and step count data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount and increase their step count by 3,000 steps/day compared to baseline. Participants will be asked to pedal at a sustainable and self-selected pace while using the pedal desk.

Eligibility Criteria:
Inclusion Criteria:

* Be a full-time employee at Pennington Biomedical Research Center
* Be between 21 and 65 years of age
* Primarily sit while at work
* Work from a private office/cubicle

Exclusion Criteria:

* Weigh more than 250 pounds
* Have physical limitations that prevent performance of pedaling motions
* Plan to be away from work for the 6 weeks of the intervention
* Be pregnant
* Have a pace maker and/or metal joint replacement
* Plan to be away from work for the 6 weeks of the intervention
Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation

Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis and implantation outcomes.

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding the Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2ng/ml) as a growth factor that have multi-ways to might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between two arm of the same culture media and the same culture condition. One arm with Cytokines and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Eligibility Criteria:
Inclusion Criteria:

* all patients

Exclusion Criteria:

* over 40 years
Sevoflurane in Electroconvulsive Therapy

The purpose of the study was to investigate the effects of different doses of sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles

Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Study included 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia

Exclusion Criteria:

* Pregnancy
* Cerebrovascular disease
* Epilepsy
* Unstable cardiovascular disease
* Chronic obstructive pulmonary disease; and
* Renal or hepatic failure
Immunologic Markers for the Differential Diagnosis Between Uveitis-TBC and Uveitis-SARC (TBC-SARC)

Today there are no tests that allow to make a precise differential diagnosis between uveitis from presumed tuberculous origin and uveitis by sarcoidosis. Therefore, with this study, investigators aim to identify, in the aqueous humor and in the blood of participants (patients that suffering from one of these two forms of uveitis) the presence of immunologic markers that distinguish between uveitis of tuberculous etiology and uveitis by sarcoidosis.

Both tuberculosis and sarcoidosis are chronic, multi-systemic and granulomatous pathologies that have very similar pulmonary and extra-pulmonary manifestations, and even in the case of ocular involvement it has been shown that many features of intraocular TB can also be found in participants with ocular sarcoidosis.

In this monocentric observational study investigators are asking to the participants with granulomatous uveitis, in which a tuberculosis or sarcoidosis origin is suspected and who will have undergo paracentesis of the anterior chamber, to grant part of the aqueous humor and a blood sample for this study.

The collected samples will be analyzed as follow:

1. Determination of the concentration of various cytokines, chemokines and growth factors in aqueous humor and in the plasma.
2. Analysis of the mononuclear cells ( T helper lymphocytes CD3+ (CD3 is the acronym of cluster of differentiation 3: a glycoprotein found on the surface of immune cells) and CD4+ ((CD4 is the acronym of cluster of differentiation 4), T cytotoxic lymphocytes CD3+ CD8+ (CD8 is the acronym of cluster of differentiation 8) , B lymphocytes CD19+ (CD19 is the acronym of cluster of differentiation 19), Natural killer lymphocytes CD56+ (CD56 is the acronym of cluster of differentiation 56) and CD3- and monocytes CD14+ (CD14 is the acronym of cluster of differentiation 14) present in the aqueous humor by cytofluorimetry.
3. Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
4. Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells in aqueous humor with epitopes of tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of uveitis of tuberculous etiology or patients with diagnosis of uveitis of suspect sarcoidosis or patients with diagnosis of uveitis of undifferentiated origin (tuberculosis/sarcoidosis)

Exclusion Criteria:

* Patients suffering from non-granulomatous uveitis.
Antibiotics During Intrauterine Balloon Tamponade Placement

The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.

The investigators will perform a randomized, controlled trial of women who have had a postpartum hemorrhage and received an intrauterine balloon tamponade.

Patients who are candidates for study enrollment will be identified on Labor \& Delivery or in the Maternal-Fetal Care Unit. Patients who give consent will be randomized by random number generator to receive either antibiotics (Group A) or no antibiotics (Group B).

If the patient is randomized to Group A, she will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.

If the patient is randomized to Group B, she will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Able to give consent
* Gestational age \> 24 weeks
* Postpartum
* Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours
* Primary obstetrician amenable to proceeding with either method of management during the study period.

Exclusion Criteria:

* Age \< 18 years old
* IBT removed within 2 hours of placement
* Chorioamnionitis
* Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes