cyrilzakka/clinical-trials huggingface dataset:
Short Therapy for Febrile UTI in Childhood

Febrile urinary tract infections (UTIs) are common in children, but there is no consensus concerning the duration of the antibiotic treatment. Current recommendations include the use of an oral antibiotic, chosen between amoxicillin and clavulanic acid or a third-generation cephalosporin (ceftibuten), for a minimum of seven to a maximum of 14 days. In an antibiotic overuse-sparing model, proper evaluation of a shorter therapy in the treatment of febrile UTI in childhood is lacking.

The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children.

The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood, contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 3 months to 5 years;
2. Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) in two consecutive urine samples collected by bladder catheterization or clean catch (19). The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge\> 105 CFU /ml as per the Recommendations of the Italian Society of Pediatric Nephrology (SINePe) (19).

Exclusion Criteria:

1. "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate dehydration with the need for intravenous antibiotic therapy)
2. Presence of an inserted urinary catheter
3. Immunodeficiency
4. Hypersensitivity to the active substance or other beta-lactam antibiotics
5. Any antibiotic treatment received in the previous 15 days.
6. Presence of another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.)
7. Presence of neurological bladder
8. Presence of phenylketonuria or glucose-galactose malabsorption
9. Intestinal malabsorption
10. Poor compliance
11. History of jaundice or liver failure positive
PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE

A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime/avibactam (CAZ/AVI) alone or with CAZ/AVI plus fosfomycin (FOS) for infection due to carbapenem-resistant Enterobacterales (CRE) (KPC and/or OXA-48).

Gram-negative infections, particularly those caused by carbapenem-resistant Enterobacterales (CRE), have a dramatic impact on patient survival. Despite the introduction of new drugs in the last years have improved the outcome of patients with CRE infections, mortality and relapse rates are still relevant, especially in patients with high-risk source as pneumonia, and those in which the attainment of optimal exposure could be reduced by underlying renal disease. The use of combination regimen in these scenarios has been proposed. However, a standardized approach is still missing. Since several in vitro studies have highlighted the synergistic effect of fosfomycin (FOS) with different antibiotic classes, including cephalosporins such drug could be an appealing option in combination therapy for the management of CRE infections.

In particular, the primary aim of the study is to assess the probability of achieving a pre-defined target of efficacy in patients treated with ceftazidime/avibactam (CAZ/AVI) and/or FOS according to different modes of drug administration in patients with CRE infections.

Secondary aim is to assess the association between plasma drug concentration of both CAZ/AVI and FOS and patient response.

Eligibility Criteria:
Inclusion Criteria:

* Signature of the informed consent
* Age ≥ 18 years
* Adult patients treated for ≥ 48 hours with CAZ/AVI or CAZ/AVI plus FOS for a microbiologically documented CRE infection

Exclusion Criteria:

* Polymicrobial/mixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs
Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.

Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10mg / kg bolus followed by continuous infusion of 1 mg / kg / h until the end of the procedure and patients receiving placebo in similar arrangements.

Besides the impact on the volume of intraoperative bleeding the incidence of postoperative wound dehiscence in the first week and the incidence of oronasal fistulas after 1 month were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital

Exclusion Criteria:

* Preoperative hemoglobin lower than 10 mg / dl or platelet count less than 100,000 / mm3 ;
* Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
* History of bleeding disorders in first-degree relatives;
* Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
* Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
* Known allergy to tranexamic acid.
Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway

The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via lipid peroxidation, the induction of oxidative DNA damage and the formation of protein adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO synthases. Several studies suggest that the overproduction of this free radical and the subsequent excessive exposure to oxidative conditions have a potential pathogenetic implication, which due to the reduction of sperm motility. The present study was conducted to study the effect of Zn supplementation on the levels of NO synthase and arginase in semen of patients with asthenozoospmia.

Previous studies suggest that high concentrations of NO play an injurious consequence on spermatozoa kinetic characteristics. These studies reported that NO may react with superoxide or hydrogen peroxide, resulting in the production of peroxinitrite, hydroxyl radical, or singlet oxygen, which cause oxidation of sperm membrane lipids and thiol proteins. NO also may inhibit cellular respiration by nitro-sylation of heme in mitochondrial enzymes, aconitase, and glyceraldehyde phosphate dehydrogenase, leading to a reduction of adenosine triphosphate and that is due to loss of motility of spermatozoa.

Eligibility Criteria:
Inclusion Criteria:

* the presence of asthenozoospermia in the semen sample.

Exclusion Criteria:

* the absence of endocrinopathy,
* varicocele, and
* female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels
Implementation of a Psychoeducational Intervention in New Mothers

The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. Additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals.

Researchers will compare "Usual Care" (standard postnatal care provided by professionals from the Sexual and Reproductive Health Service) with "Intervention group" (usual care plus two psychoeducative intervention WWWT sessions) to see if the "WWWT intervention" is better than "Usual Care" at preventing postpartum depression and anxiety disorders in new mothers.

Participants will:

* Take baseline questionnaires at 2-4 weeks postpartum
* Take usual care or usual care plus two psychoeducative intervention WWWT sessions within the first 6 weeks postpartum
* Take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up
* Take a brief anonymous self-report survey (only those participants taking the WWWT intervention)


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women
* Given birth a healthy, full-term baby in the preceding 2 weeks
* Receiving postpartum healthcare at Atenció a la salut sexual i reproductiva (ASSIR) of Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
* Over 18 years of age
* Give consent to participate in the study

Exclusion Criteria:

* If are unable to complete the questionnaires due to language or literacy barriers
OCS Liver DCD Trial

Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Eligibility Criteria:
Inclusion Criteria:

* Registered primary liver transplant candidate
* Age ≥ 18 years
* Obtained informed consent

Exclusion Criteria:

* Acute, fulminant liver failure
* Prior solid organ or bone marrow transplant
* Ventilator dependent on day of transplant/donor organ offer
Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia

The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children.

The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. These tools utilize magnetic fields to visualize the heart without using radiation. The purpose of this study was to determine if these 3D mapping tools could reduce radiation exposure during SVT ablation procedures could be performed using these 3D tools.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/=8
* Weight \>/=25kg
* Structurally normal heart (no major cardiac defects)
* History of SVT
* No prior history of cardiac surgery or ablation

Exclusion Criteria:

* Congenital Heart Disease
* Prior history of cardiac surgery or ablation
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
* Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
* Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening
* Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and Day 1
* Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
* Must have completed the week 52 treatment for the optional open-label long-term extension period

Exclusion Criteria:

* Nonplaque psoriasis at Screening or Day 1
* Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis
* History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
* Active fibromyalgia
* Received an approved or investigational biologic therapy for the treatment of PsA or PsO

Other protocol-defined inclusion/exclusion criteria apply
Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.

Zinc, a micronutrient, appears to have anti-viral properties with various mechanisms of action depending on the concentration Zinc supplementation has been reviewed extensively for use in the common cold, and has been shown to reduce the duration of symptoms. In-vitro studies have shown zinc can inhibit RNA-dependent RNA polymerase (RdRP) in coronavirus, which is typically a conserved region in the viral genome. In-vitro experiments have also shown that lung epithelium in a zinc depleted state can become susceptible to apoptosis and loss of barrier function, increasing permeability, which can lead to acute respiratory distress syndrome (ARDS).

If a patient can travel to St. Francis Hospital they can have a COVID test on site at a designated St. Francis testing location. The COVID test will be resulted via a rapid Covid (Point of Care device) or at a local lab.

Patients who are unable to travel to St. Francis Hospital or one of the outpatient practices, will be allowed to enroll remotely. Patients are eligible to enroll within 72 hours of a positive Covid-19 test result. Study medications will be mailed to the patient overnight after being enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand informed consent.
* High initial clinical suspicion by physician based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by confirmation of COVID-19 diagnosis
* Any gender
* Age 60 years and older
* Age 30-59 years with one or more of the following:

  * abnormal lung exam
  * abnormal oxygen saturation \<95%
  * abnormal Chest X-ray or chest CT
  * persistent fever \>100.4 degrees Fahrenheit
  * one of the following co-morbidities: hypertension, diabetes mellitus, history of coronary artery disease, chronic kidney disease (CKD), asthma, COPD, current or former smoker, or morbid obesity (Body Mass Index ≥35)

Exclusion Criteria:

* Severe COVID-19 requiring admission for inpatient treatment
* Need for any oxygen supplementation
* Need for mechanical ventilatory support
* History of oxygen supplementation dependency
* History of cancer with ongoing chemotherapy or radiation therapy
* Known hypersensitivity to zinc
* Severe renal disease: Glomerular Filtration Rate \<30ml/min
Children's Lifestyle, Diet, and Exercise Intervention - CHILDREN's Project

Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score (aICH) in children enrolled in New York City elementary schools.

Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score (aICH) in children enrolled in New York City elementary schools. This study will enroll children of ages 5 to 6 and teachers from participating schools. Participating schools will be randomized to an intervention group or a control (non-intervention group). The SI! Program intervention will incorporate a comprehensive vision of cardiovascular health promotion that encompasses four basic components: body and heart, physical activity, healthy diet, and emotional management. The intervention will take place at baseline and a reintervention will take place at 2 years-follow up. The research team will assess an adapted version of the Ideal Cardiovascular Health (aICH) score (that includes body-mass-index Z-score, physical activity, diet, sleep time and smoking exposure) and the Knowledge, Attitudes, and Habits (KAH) score. The aICH will be evaluated at baseline, 2 years and 4 years follow-up; the KAH will be evaluated at baseline and after the first intervention, and prior and after the second intervention. The research team will also study the influence of factors in parents (socioeconomic and health-related variables), teachers (stress, teaching motivation, and health status), and the environment (pollution, housing, and neighborhood conditions) through parent/caregiver questionnaires, teacher questionnaires, publicly available data, and pollution data sourced from NASA satellites.

Eligibility Criteria:
Inclusion Criteria:

* NYC Elementary school Kindergarten Children
* Parents and teachers of participating children

Exclusion Criteria:

* Children who are Wards of the State
* Children or parents who cannot provide legally effective consent
The Role of Focus Strategies on Pilates

Aims of the randomized controlled study is compare to the effects of external and internal focus strategies, commonly used in Pilates, on participants' reaction time and performance metrics. Conducted over an 8-week Pilates program at Alanya Alaaddin Keykubat University, we plan to include 25 participants in each focus group. Participants in the external focus group will use equipment to perform exercises, while the internal focus group will perform exercises with attention to body positioning.

The primary aim of this study is to examine the difference in effects between 8-week internally and externally focused Pilates exercises on the performance of young sedentary individuals. A secondary aim is to investigate the effects of internally and externally focused Pilates exercises on the physical characteristics and reaction time of young sedentary individuals.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged between 18 and 30 years who have no musculoskeletal disabilities and are willing to exercise were included in the study.

Exclusion Criteria:

* Had any cardiovascular or musculoskeletal condition that would prevent them from exercising,
* Had an acute pain history of 5 or more on the visual analog scale in the past week,
* Had a systemic disease that would prevent exercise,
* Had a BMI of 30 or above,
* Had any issues that would hinder their ability to perceive or understand verbal commands, or had hearing problems.
Does Metabolic Syndrome Exist in Anorexia Nervosa?

The purpose of this study is to examine whether body fat distribution changes that occur with weight gain in women recovering from anorexia nervosa are transient or persistent, and if they are associated with other features of Metabolic Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea) (restricting or binge eating/purging subtype)
* Female
* Age 18-40
* Medically stable
* Participation in inpatient or daypatient treatment sufficient to restore patient to a BMI of at least 19.5kg/m²

Exclusion Criteria:

* Additional Major Axis I disorder (including substance abuse or dependence
* On daily prescription medication (including oral contraceptives)
* History of suicide attempt or other self-injurious behavior within the previous 6 months
* Significant current or past medical illness,including diabetes mellitus, heart disease
* Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry or recent metallic ink tattoo
HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients

Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).


Eligibility Criteria:
Inclusion Criteria:

* BMI 18\~23 kg/m2
* Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
* Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts

Exclusion Criteria:

* Using embryos from donor oocytes
* Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
* Moderate or severe endometriosis
* Untreated unilateral or bilateral hydrosalpinx
* Uterine adenomyosis, uterine myoma (submucous,intramural myoma \>4 cm),\>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus
Vital Signs Monitoring in Rehabilitation Center Patients

Some patients unable to return home from hospital due to physical or mental illness will be discharged to a rehabilitation home to restore strength and rehabilitate. This study attempts to examine if it is possible to continuously monitor the vital signs in patients discharged to a rehabilitation center and whether wearable devices will detect more abnormal vital signs than the rehabilitation facility, as well as complication and readmission rates.

Patients who are ready to leave the hospital but are deemed unable to return home are discharged to a rehabilitation center to regain strength and performance.

Vital signs are only measured when deemed necessary at the rehabilitation center, in contrast to hospital wards, where vital signs are measured intermittently and manually every 8-12 hours.

Wearable devices that continuously monitor a patient's vital signs may be able to detect patients who are deteriorating, as abnormal vital signs often precede a physiologic decline This study aims to determine whether it is possible to continuously monitor patients discharged to a rehabilitation center and detect more abnormal vital signs than measurements from the rehabilitation center. By attaching three wearable devices to 20 patients, we wished to record the vital signs for up to 96 hours, documenting abnormal vital signs as well as complications - and readmission rates.

Eligibility Criteria:
Inclusion Criteria:

* discharged to the rehabilitation center after surgery or; diagnosed with ischemic heart disease, chronic heart disease, apoplexia cerebri, chronic obstructive pulmonary disease, or diabetes.
* Inclusion less than 72 h from rehabilitation admission

Exclusion Criteria:

* Unable to give informed consent
* Implanted pacemaker or cardioverter-defibrillator
* allergic to plaster, plastic, silicone