cyrilzakka/clinical-trials huggingface dataset:
Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study

RITA-MI aims to develop of a novel therapeutic concept to target the immune response in patients with acute myocardial infarction (MI) by depleting B-cells with a single injection of Rituximab which is approved for clinical use in cancer, autoimmune disease and inflammatory conditions. The goal is to re-purpose the drug, and translate the discovery into benefit for patients at high risk of cardiovascular events. Rituximab is expected to limit infarction size and improve the healing process, as complementary to other therapeutic strategies.

The applicants intend to perform a clinical study in patients with acute myocardial infarction (MI). The objective is to find the optimal dose (lowest dose with highest biological efficacy and best safety profile) for peripheral blood B cell depletion during the first 6 days after injection, and selective molecular signatures associated with improved heart function through analysis of peripheral blood samples.

The study rationale is to decrease the inflammatory reaction upon tissue necrosis following heart muscle ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old
* Acute anterior (left anterior descending artery) STEMI and successful primary percutaneous coronary intervention (PCI) with stent implantation in the culprit lesion during the first 24h after onset of symptoms

Exclusion Criteria:

* A previous history of STEMI
* Cardiogenic shock (systolic blood pressure \<80 mm Hg, unresponsive to fluids, or necessitating catecholamines), electrical instability or severe congestive heart failure
* Residual severe proximal bystander disease awaiting inpatient revascularisation
* Corrected QT interval (QTc) \> 500 msecs using Bazett's formula
* Hematologic abnormalities (hemoglobin \<10 g/dL or hematocrit \<30%, platelet cell count of \<100 x103/μL, white blood cell count \<4 x103/μL)
* Hypogammaglobulinaemia (defined as \<3g/L of IgG)
* Renal failure (estimated GFR by the MDRD formula \< 45 ml/min/1.73m2);
* Known hepatic failure or abnormal liver function tests at baseline (ALT \> 2 x ULN).
* Active or recurrent hepatitis (type B).
* Known HIV infection
* Current or previous tuberculosis (Chest X-Ray)
* Current infections
* Presence or history in the previous five years of an ongoing cancer, except in situ cancer of the cervix or basal cell carcinoma
* Any oral or intravenous immunosuppressive treatment (other than concomitant 100 mg methylprednisolone), disease modifying drugs, or other immune modulatory monoclonal antibodies or immunodepleting therapy at any time
* Allergy to rituximab or one of its excipients
* Expected need for vaccination with a live attenuated vaccine during the study including incomplete vaccination courses.
* Known or suspected pregnancy at screening or lactating woman
* Women of childbearing age unless confirmed by direct questioning that they are reproductively sterile or post-menopausal
* Participation in other clinical trials
* Inability to comply with study procedures
The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries

Emergence agitation is a post anesthetic phenomenon that develops in the early phase of general anesthesia recovery,The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .

While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Especially, our clinical impression is that nasal surgical patients admitted to the postbanesthesia care unit (PACU) have suffered emergence agitation more frequently than other surgical patients, possibly due to a sense of suffocation during emergence from anesthesia.

preoperative counselling and repeated verbal stimulation of orientation may serve as a simple and easily applicable strategy to reduce emergence agitation after general anaesthesia .

There have been studies looking into the effect of pre-operative counselling on individual aspects internationally like anxiety, BMI, serum cholesterol , length of stay , pain .( Six trials were identified and have produced conflicting findings. Some trials have demonstrated the effects of preoperative education on improving physical and psychosocial recovery of cardiac patients, while others found no evidence that patients' anxiety is reduced or of any effect on pain or hospital stay) .

To our knowledge there was no study investigating the impact of preoperative counselling on postoperative agitation following nasal surgeries, The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* Patients undergoing nasal surgery
* American Society of Anesthesiologist (ASA) I or II physical status.
* Between 18 and 65 years of age.

Exclusion Criteria:

* ● Patients with communication difficulties.

  * ASA Ⅲ and Ⅳ patients.
  * Mentally retarded patients.
  * In-ability to postpone anti-coagulation medications.
  * Central or peripheral neurological disease.
  * Drug or alcohol abuse.
  * Localized infection at nose.
  * Bleeding disorder (platelets count less than 100,000 or INR more than 1.4)
Effect of Antihypertensive Agents Over Sleep Apnea

Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.

This is a randomized, double-blind, clinical trial, comparing the association of Chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). The primary outcomes will be the variation of apneas/hour and blood pressure. The secondary outcomes will be adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein. The follow up will last 8 weeks. The sample size will be of 29 participants per group. The project was approved by the Ethics committee of our institution.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 40 years of age
* Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)

Exclusion Criteria:

* Low life expectancy
* Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs
* Pregnancy
* Established cardiovascular disease (myocardial infarction
* Stroke
* Heart failure)
* Use of more than one drug for hypertension
* Secondary hypertension
* Participation in other clinical trial in previous 6 months
Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness

This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Using circulating cell-free DNA (cfDNA) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. The hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.

This is a prospective observational trial evaluating CNA Rapid Sepsis Dx -novel biomarkers (CNA Diagnostics Inc.; Calgary, Canada) based on circulating cell-free DNA (cfDNA) in the blood stream to identify patients originally admitted with non-sepsis conditions who ultimately develop sepsis according to Sepsis-3 criteria within seven days of hospital presentation. This novel technology has been demonstrated to detect host-related response to infection days before clinical evidence of sepsis manifests.

The primary objective of this study is to assess the performance of the novel diagnostic assay, CNA Rapid Sepsis Dx, based on the biomarkers, drawn daily from the day of hospital presentation, to identify patients who ultimately develop sepsis according to Sepsis-3-definition within seven days of hospital presentation.

The secondary objective is to correlate the CNA Rapid Sepsis Dx with clinically relevant outcomes such as infections that otherwise do not meet Sepsis-3 criteria, intensive care unit (ICU) length of stay, hospital length of stay, fluid culture results, and hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Patient 18 years of age or older at the time of enrollment
2. Presence of any of the following high-risk features:

   * Victims of trauma with either an Injury Severity Score of ≥ 15 or a Glasgow Coma Score of ≤ 8\[2\] OR
   * Any patient undergoing high-risk surgical procedures including any emergency surgery and high risk elective surgery procedures involving the thorax, esophagus, stomach, small bowel, large bowel \[3, 4\] OR
   * Any patient being admitted to any ICU setting for any reason with no current evidence or suspicion of active infection (by primary team).\[5, 6\]
3. Able to collect sample within 24 hours of presentation to the hospital.

Exclusion Criteria:

1. Prisoners or in police custody
2. Pregnancy
3. Pre-existing infection for which patient is being treated with antibiotics as an outpatient.
4. Plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable).
5. Moribund, unlikely to survive the duration of active enrollment
6. Comfort care measures in place or ordered at time of screening OR indication from treating team that active medical care will not be pursued due to patient's condition or patient's/family's wishes.
7. Palliative care or hospice consult at time of screening.
Falls: A Marker of Preclinical AD

This longitudinal cohort study investigates cognitively normal participants with and without preclinical Alzheimer disease (AD) in order to examine: (1) the relationship between falls and functional mobility in preclinical stages of AD; and (2) a hypothesized model of central and peripheral mechanism(s) underlying falls and functional mobility in preclinical stages of AD.

Alzheimer disease (AD) is a slowly progressive neurodegenerative disease. Conversion to symptomatic AD occurs slowly over years through a series of preclinical stages marked by changes in molecular biomarkers. It is unknown whether functional mobility and falls are preclinical markers of AD.

This longitudinal clinical study evaluates a cohort of cognitively normal individuals who are currently undergoing comprehensive clinical, neuropsychological, and biomarker evaluations at the Knight Alzheimer's Disease Research Center (Knight ADRC). They receive an annual in-home evaluation of fall risks and functional mobility and prospective ascertainment of falls. Comparisons of assessments of functional mobility will be performed with regard to measures of brain pathology (i.e., amyloidosis, tau, and neurodegeneration) to allow researchers to characterize when changes in falls and functional mobility occur during preclinical stages of AD.

This study also examines the central and peripheral system mechanism(s) underlying falls and functional mobility in preclinical AD using structural equation modeling.

Eligibility Criteria:
Inclusion Criteria:

1. 65 years of age or older
2. cognitively normal (Clinical Dementia Rating \[CDR\] score of 0)

   * A pilot sub-study collecting stool will also enroll a few individuals with CDR\>0 for comparison.
3. have biomarkers (CSF), and/or neuroimaging (positron emission tomography \[PET\] and/or magnetic resonance imaging \[MRI\]) within 2 years of enrolling in this study.

Exclusion Criteria:

* History of Parkinson's disease.
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).

Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all inclusion criteria:

* Patients \>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
* Severe coronary lesion with a calcified nodule (highly recommended confirmation with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and
* Lesion to treat in a vessel between 2.5 and 4 mm

Exclusion Criteria:

Patients must not meet any criteria

* Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
* Pregnant patients
* Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
* Impossibility to maintain double antiplatelet treatment during at least 1 month.
* Life expectancy \<1 year.
* Index lesion at left main stem.
* Aorto-ostial lesion.
* Target lesion previously treated with stents or DEB.
* High thrombus burden in the target lesion (TIMI thrombus scale≥3).
Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).

The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.

Eligibility Criteria:
Inclusion Criteria:

1. A child with OW/OB (\>=85% BMI for age) aged 6-12 years
2. Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
3. The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician
4. The parent who is responsible for food preparation is willing to participate
5. The family is willing to commit to attending all treatment and assessment sessions
6. Child on a stable medication regimen (minimum of 3 months)
7. Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity.
8. Child and/or parent are not participating in another organized weight control program
9. Family owns a device that can facilitate zoom meetings

Exclusion Criteria:

1. Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed
2. Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
3. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
4. Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
5. Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration
6. Child is taking medication for the purpose of weight loss
Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty

Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.

While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.

The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.

Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

1. primary, unilateral knee arthroplasty
2. age ≥ 18 years
3. postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours

Exclusion Criteria:

1. morbid obesity as defined by a body mass index \>40 (BMI=weight in kg/ \[height in meters\]
2. chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use \>4 weeks)
3. history of opioid abuse
4. allergy to study medications
5. known renal insufficiency (creatinine \> 1.5 mg/dL)
6. pregnancy
7. incarceration
8. any known neuro-muscular deficit of the ipsilateral femoral nerve, obturator nerve and/or quadriceps muscle (including diabetic peripheral neuropathy); and inability to ambulate 30 m preoperatively.
Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension

Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second stage arrest of descent to prevent or uterine extension at the hysterectomy site.

Intravenous nitroglycerin resulting in uterine relaxation has been standardly utilized for various obstetrics conditions, e.g. breech extraction of second twin in vaginal deliveries, uterine relaxation after tachysystole in labor, prior to external cephalic version, and during difficult fetal extraction during cesarean delivery for arrest of descent in labor. Currently the use of nitroglycerin is at equipoise in obstetrics for difficult cesarean delivery after second stage arrest in labor. The clinical trial will randomize women who undergo cesarean delivery for second stage arrest in labor to receive IV nitroglycerin vs saline at the time of hysterotomy. The primary outcomes will be maternal: uterine extension, blood loss, total fetal extraction time, surgical time; neonatal: cord gases at delivery, apgar scores, admission to neonatal intensive care unit.

Eligibility Criteria:
Inclusion Criteria: women 37weeks or greater gestation diagnosed with second stage arrest of descent undergoing cesarean delivery -

Exclusion Criteria: elective, active phase arrest cesarean delivery, successful operative vaginal delivery

-
Urine Extracellular Vesicles: Non-invasive Biomarkers of Β-cell Function and Novel Therapeutic Agents in Diabetes

Diabetes mellitus is a common chronic disease with a huge socioeconomic burden worldwide. Type 1 Diabetes(T1D) accounts for nearly 95% of diabetes in pediatric age and a lifelong dependence on exogenous insulin. Its diagnosis is based on symptoms and/or autoantibodies, both identified too late to avoid the disease progress. Ideally, children should be screened whilst assymptomatic, when there is endogenous insulin production, but C-peptide and beta-cell function are starting to decline. Early diagnosis would allow interventions capable of preventing disease progress and/or to preserve beta-cell function, ultimately delaying/avoiding insulin dependence. Given their association with pathogenesis of diabetes, Extracellular Vesicles have emerged as potential biomarkers for diagnosis and progression of diabetes. This project proposes the development of a non-invasive biomarker of preclinical T1D, based on miRNA characterization in urine, allowing a timely identification of children that can benefit from preventive therapies and, in the future, to cure T1D.


Eligibility Criteria:
Inclusion Criteria:

* T1D Group: children diagnosed with T1D, according to internationally defined criteria, with at least one positive pancreatic antibody and under functional insulin.
* Genetic-related group: children without T1D, age- and sex-matched with T1D group, recruited among T1D relatives;
* Control group: children without T1D, age- and sex-matched with T1D group, recruited from general endocrinology clinics, among children without disease or genetic relation with T1D children;

Exclusion Criteria:

* Obesity, according to WHO standards for pediatrics;
* Hypertension, as ≥95th percentile according to International Consensus;
* Other auto-immune diseases;
* Diabetes in the context of syndromic features/secondary to treatments;
* Hypothyroidism, adrenal insufficiency or hypercortisolism;
* Children under somatotropin/oncologic treatment;
* Under medications affecting glucose metabolism