cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Intervention to Support Clinicians' Firearm Safety Counseling Behaviors

The goal of this clinical trial is to assess the efficacy of REACH Firearm Safety in a sample of pediatric residents. The main question it aims to answer are:

Do residents who have completed REACH Firearm Safety have increased documentation in the electronic medical records for screening and counseling for safe firearm storage?

Participants will be asked to engage in a virtual reality curriculum (REACH Firearm Safety). Researchers will compare the REACH Firearm safety group to a group of participants who complete an abbreviated online training.

The American Academy of Pediatrics urges pediatricians to counsel parents on the dangers of childhood access to firearms and restrict access through safe storage practices. However, evidence suggests that most pediatricians do not provide firearm-related counseling in real-world clinical practice. This is notable as firearm-related injury is now the leading cause of death in children aged 1-19 years in the United States. Virtual reality (VR) is a type of simulation-based medical education that allows users to interact with virtual environments and characters in a seemingly realistic way. Investigators developed Resident Education And Counseling on Household (REACH) Firearm Safety, a VR curriculum to allow pediatricians to practice screening and counseling on firearm safety. The objective of this proposal is to assess the efficacy of REACH Firearm Safety, along with key implementation metrics, to justify and inform scale and distribution of the training approach. To achieve the objective, Investigators will: (1) Conduct a multi-site two-arm randomized controlled pilot study assessing the efficacy of REACH Firearm Safety and (2) Measure acceptability, appropriateness, fidelity, feasibility, and cost of implementation of REACH Firearm Safety. The proposed research is significant and innovative because it is the first rigorous effort to evaluate the efficacy of VR as a training platform to teach communication skills related to firearm safety counseling.

Eligibility Criteria:
Inclusion Criteria:

* Resident with continuity clinic at either Kentucky Clinic South, University of Kentucky (UK) Internal Medicine and Pediatrics group, CCHMC Hopple Street Neighborhood Health Center, or University of Cincinnati (UC) Hoxworth Medicine-Pediatrics Clinic

Exclusion Criteria:

* Resident unable to read or speak English
* Resident with continuity clinic outside of inclusion criteria clinics
Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T

The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. Atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* CRT-D indication according to current ESC guidelines (NYHA III/IV; QRS≥120ms; LVEF≤35%; Expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of AV nodal ablation or ventricular rate ≤60bpm at rest and ≤90bpm on exercise)
* Permanent atrial fibrillation
* Patients planned to be implanted with BIOTRONIK Lumax 640/740 HF-T
* Patients planned to be implanted with BIOTRONIK LinoxSmart S DX right ventricular lead (or successors)
* Patient eligible for programming of DX functionality according to the physicians' decision
* Patient is willing and able to comply with the CIP and provided written informed consent
* Patient accepts Home Monitoring® concept and has sufficient GSM/GPRS coverage

Exclusion Criteria:

* Patients with any contraindication to CRT-D therapy
* Patients listed for heart transplantation
* Life expectancy less than 12 months
* Pregnant or breast-feeding women
* Patients under the age of 18
* Patients with limited contractual capability
* Participation in any other clinical study
Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.

Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).

Eligibility Criteria:
Inclusion Criteria:

* Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation).
* Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious.
* Clinically stable (within the previous month).
* Patients without previous NonInvasive Mechanical Ventilation treatment.

Exclusion Criteria:

* Clinical exacerbation.
* Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio \< 70% or Sleep Apnea-Hypopnea Syndrome
Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction

Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the present cohort study is to investigate whether ACEi therapy reduces the rate of periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention (PCI) among patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. metabolic syndrome
2. elective percutaneous coronary intervention with angiographically successful stent implantation

Exclusion Criteria:

1. acute coronary events
2. renal failure
3. needed the use of IV glycoprotein IIb/IIIa receptor inhibitors were excluded
4. left main coronary artery disease
5. chronic total occlusion
6. high levels of baseline CKMB or troponin
7. any contraindication of aspirin, clopidogrel or ACEi treatment
Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration

The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.

This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.

Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.

Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential or males
* 18 to 45 years of age
* Judged by the Principal Investigator to be healthy on the basis of medical history and a pre-study physical examination including 12-lead electrocardiogram (ECG), 24-hour Holter ECG, vital signs and blood and urine laboratory assessments.

Exclusion Criteria:

* Females of childbearing potential
* Clinically significant disease
* Clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
PTLD: Multicentric Retrospective Study

This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD.

The aim of the study is to analyze the clinical features and survival of patients who received a PTLD diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by PTLD, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments.

This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. Retrospective data will be collected for all cases of PTLD diagnosed during a 10 years period since 1st January 2011 to 31th December 2021.

The following clinical characteristics of the patient at the time of PTLD diagnosis and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of PTLD obtained from a biopsy sample (availability of stocked biopsy sample is requested but not mandatory);
* age over 18 years at time of diagnosis of PTLD;
* previously subjected to allogeneic transplantation (both SOT and HSCT);
* diagnosis of PTLD obtained in 10 years' time frame (from 01/01/2011 to 31/12/2021);
* free and voluntary written informed consent (included unreachable subjects according to Art. 36 UE Regulation 2016/679 and to the current Italian Privacy Regulation).

Exclusion Criteria:

* Patients not meeting the above-mentioned inclusion criteria.
Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size.

The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method performed pecutaneously in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety of the method.

This trial is an open-label, double-arm study. Twenty patients diagnosed with pancreatic cancer will be treated in this trial, ten recieving imILT treatment and ten recieving standard chemotherapy. The study is estimated to be carried out during a time period of 21 months.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of non-resectable pancreatic adenocarcinoma by form of either locally advanced disease (stage II-III) or of stage IV disease with hepatic metastasis (staging according to UICC 2009)
* Locally advanced disease shall have a lesion diameter less than 4cm
* If stage IV disease, the patient shall have only liver metastasis, with less than 5 in number, each one less than 4 cm in diameter
* The patient is a candidate for standard chemotherapy (as described at point 5.1)
* Age between 18 and 80 years, males and females
* Anticipated compliance with treatment and follow-up
* Have given informed verbal and written consent to participation in the trial
* Have stable and adequate haematologic, renal and hepatic functions:

  1. Hemoglobin ≥9 g/dL
  2. Platelet count ≥75 x 109/L
  3. International normalized ratio (INR) ≤1.7
  4. WBC count ≥2 x 109/L
  5. Absolute neutrophil count (ANC) ≥1 x 109/L
  6. Albumin ≥2.8 g/dL, total bilirubin ≤3.0 mg/dL (51.3 μmol/L); ALT, AST ≤5 times upper limit of normal (ULN)
  7. Serum chemistries sodium, potassium, and calcium within normal limits (WNL)
  8. Serum creatinine \<2.0 mg/dL or creatinine clearance \>60 mL/min according to Cockroft-Gault formula
* At least a part of the tumour can be treated with imILT without damage to adjacentvital structures
* Have an ECOG performance status \<2 (Karnofsky\> 60%)

Exclusion Criteria:

* HIV 1 or 2 positive
* Active autoimmune disease which is judged to reduce an anti-tumour immune response
* Pregnancy or breast feeding
* Have known bleeding disorder that cannot be managed accordingly with the protocol rules, such severe acute or chronic liver failure, other genetic blood diseases not properly managed prior to treatment or other any disease treated with anticoagulant or anti-platelet medication that cannot be interrupted prior to treatment
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients

The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney transplant recipients

Between four (4) months and 14 months after receiving a kidney transplant and, per standard of care (SOC), having been placed on an immediate-release (IR) tacrolimus immunosuppressant regimen, participants in this study will undergo cognitive and motor function testing and have a blood sample collected (BASELINE). Half of the participants will then be randomly converted to extended-release (XR) tacrolimus (Envarsus® XR) while the other half will remain on IR tacrolimus for the duration of the study. Both the IR and XR groups will repeat the cognitive and motor function testing and have a blood sample collected at 6, 12, and 24 weeks Post-BASELINE. A practice version of the cognitive and motor function tests will be administered no more than 60 days prior to the baseline visit (Pre-BASELINE). Alternate versions of the cognitive and motor tests will be used at each Post-BASELINE testing session to control for possible practice effects.

The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney transplant recipients.

The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used. Measurement of drug concentration will be the dependent variable.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female kidney transplant recipient;
2. 18-65 years of age;
3. receiving a kidney transplant from a living or deceased donor;
4. if female, premenopausal and heterosexually active, must be using two forms of highly effective birth control (at least one of which must be a barrier method) which includes consistent and correct usage of established oral contraception, established intrauterine device or intrauterine system, or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, starting at screening and throughout the study period and for 90 days after the final study drug administration;
5. written informed consent to participate in the study

Exclusion Criteria:

1. younger than 18 years of age;
2. older than 65 years of age;
3. Non-native level English speaker;
4. pregnant women
5. breastfeeding women
Dentin Hypersensitivity Following Non-surgical Periodontal Therapy With Hand or Ultrasonic Instruments

Periodontal instrumentation aims to remove plaque and calculus from the root surface. Both manual and ultrasonic instruments have been used for such decontamination; however, establishing a healthy periodontium can result in adverse effects, such as dentin hypersensitivity. The aim of this study was to evaluate the effects of hand or ultrasonic instrumentation on dentin hypersensitivity in patients undergoing non-surgical periodontal treatment. For this controlled clinical trial of a "split mouth" design, 14 patients were selected with homologous teeth in the incisor to premolar region and probing depth ≥ 5 mm on the buccal aspect of the teeth. One side (control) was instrumented with hand instruments and the other side (test) with ultrasonic instruments. Dentin hypersensitivity was assessed in the baseline and during the follow 4 weeks after treatment, with a periodontal probe scratching the root surface and with an air jet. The patient's response was detected by a visual analog scale (VAS) of 10 cm.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with chronic or aggressive periodontitis, according to the American Academy of Periodontology classification15, requiring non-surgical periodontal treatment in at least two quadrants. These quadrants should present two contralateral and homologous teeth in the incisor to premolar region with probing depth ≥ 5 mm and bleeding on probing on the buccal surface.

Exclusion Criteria:

* presence of systemic illness or medication use (six months preceding the research), which could influence the response to periodontal treatment,
* performance of periodontal treatment including subgingival instrumentation in the six months preceding the study,
* performance of treatment for dentin hypersensitivity in the three months previous to the study,
* presence of periapical or pulpal changes,
* being under orthodontic treatment,
* smoking and
* pregnancy.
Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer

EFFICACY OF NEOADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE IN POMENOPAUSAL WOMEN WITH ER-POSITIVE BREAST CANCER.

Flavia Morales-Vásquez, Horacio Noé López Basave.

Background: Neoadjuvant Hormonal Therapy (HT) is being used increasingly to downstage locally advanced and large operable breast cancer. Following this treatment, inoperable breast cancer often becomes fully respectable and tumors requiring mastectomy may be successfully removed by breast-conserving surgery (BCS).

Methods: Recruit postmenopausal women with ER(+) and/or PgR (+) breast cancer (BC) T2,N1-2 to T3,N0-1 were assigned to HT with anastrozole 1 mgr daily for 4 months.

The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound. Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women who had primary breast cancer, histological confirmed, through a core needle biopsy, and who{s tumors positive for estrogens receptor ER/PR.

Clinical stage IIB or IIIA Tumor assessable by clinical exam, mammogram or and ultrasound Adequate functional bone marrow Documented evidence adequate renal function and liver function Life expectancy for six months Written inform consent

Exclusion Criteria:

* Prior treatment with letrozole or tamoxifen uncontrol disorders patients with instable angina or uncontrol cardiac disease patient with bilateral breast tumors patients elegies for conservative breast surgery Inflammatory breast cancer o distant metastases Other concurrent malignancies, except carcinoma with in situ cono biopsy of uterine cervix or adequate treat skin cancer no melanoma concomitant cancer treatment such as chemotherapy, immunotherapy biological modulators, endocrinotherapy, biphosphonates therapy and radiotherapy.

Concomitant treatment with steroids Others research drug whiting the last 30 days and concomitant use of research drugs History non compliance with medications schedules and patients consider potential unreliable.
Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows:

* decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.;
* increasing the flexible ureteroscope tip deflection lower pole stones availability;
* decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber;
* increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter

RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days.

A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females \> 18 y.o.;
* Radiologically confirmed (CT) kidney stone;
* Stone size from 10 to 20 mm.

Exclusion Criteria:

• Multiple (more than 3) kidney stones \> 5 mm
The Effect of an Education Module to Reduce Weight Bias Among Healthcare Professionals in a Private Hospital Setting

Although scientific bodies have recognized obesity as a disease, obese people are often stigmatized, facing discrimination, and accusations that they are responsible to their condition due to their lack of willpower by healthcare professionals. However, experimental research to reduce weight bias among healthcare professionals is lacking, and published studies to date are methodologically flawed, including lack of randomization, lack of control group and small sample size.

The study is designed to evaluate the effect of a comprehensive online education module on knowledge about obesity and weight bias in a convenience sample in a private hospital setting.

This is an interventional study conducted among all Assuta Medical Centers healthcare employees including physicians, bariatric surgeons, nurses, dietitians, social workers, physiotherapists, pharmacists, imaging department technicians, laboratory workers, patient services assistants and medical secretariats. Participants who will confirm their consent to participate in the study, will be randomized into two arms: intervention vs. control (with no intervention). The study intervention will include an online 15-minute educational module which will be based on relevant literature and expert opinion and will include four sections: a) Knowledge about obesity; b) Weight bias definition and impact; c) Strategies to reduce weight bias; d) A short quiz. At baseline, one week and one-month post intervention, both groups will respond to an anonymous on-line survey on knowledge about obesity and weight stigma. Moreover, data on demographic parameters of study participants will be collected.


Eligibility Criteria:
Inclusion Criteria:

* All Assuta Medical Centers healthcare employees will be recruited to the study

Exclusion Criteria:

-