cyrilzakka/clinical-trials huggingface dataset:
Nudging High Emergency Department Utilizers to Consider Non-emergent Healthcare Resources

The goal of this campaign is to reduce unnecessary ED visits by providing patients who are high ED utilizers (with a visit of any acuity) with alternative resources to manage their health outside of the ED. In this campaign, patients will be randomized to receive one of two types of outreach following discharge aligned with the goal. Outreach may occur via (1) a phone call from a Geisinger Community Health Worker (CHW) or Community Medical Assistant (CMA); current standard practice or (2) an interactive chatbot message providing similar information and questions to those provided by the CHW/CMA. The study team will measure whether ED use differs across patients in different outreach conditions. The study team will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions.


Eligibility Criteria:
Inclusion Criteria:

* Geisinger Health Plan insurance or KACO membership
* Any PCP or no PCP
* Visit of any acuity
* 4 or more ED visits in the past 6 months

Exclusion Criteria:

* Institutionalized
* Cannot be contacted via the communication modality being used in the study (i.e., SMS), due to insufficient/missing contact information in the electronic health record or because the patient opted out
* Admitted to hospital
* Eloped from ED
* Left ED without being seen
* Deceased prior to messaging
* Qualifies for more intensive care management due to higher-level category of complexity
Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for sedatives and analgesics in the immediate post-operative period in children who underwent surgical correction of complex congenital heart disease

The hypothesis the investigators want to verify is that the reduced administration of sedative drugs (opioids and benzodiazepines) in children undergoing cardiac surgery, reduces the side effects of the drugs themselves, such as respiratory depression (reduction of mechanical ventilation) and the onset of withdrawal symptoms while maintaining an adequate analgo-sedation.

The study is an unblinded randomized controlled study. It will involve 60 children aged \> 1 and \< 24 months sedated and mechanically ventilated after corrective or palliative surgery of congenital heart disease on cardiopulmonary bypass with Aristotle score \> 8.

Dexmedetomidine infusion will be started upon arrival in the CICU and continued until the time of discontinuation of morphine.

Eligibility Criteria:
Inclusion Criteria: age \< 24 months but \> 30 days, Aristotle score \>8, elective procedures in cardiopulmonary bypass -

Exclusion Criteria: atrioventricular block prior to the start of infusion; vasoactive inotropic score on arrival to the CICU\>30; brain malformations orbone, muscle or neuromuscolar disease; pleural effusion or pneumothorax prior to the study; hepatic or renal failure

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Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients

This is a first-in-human dose-titration and open-label extension study to assess safety, tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 45 skipping.

This is a randomized, placebo-controlled dose-titration study to assess safety, tolerability, and pharmacokinetics of 4 dose levels of SRP-4045 in genotypically confirmed advanced-stage DMD patients with deletions amenable to exon 45 skipping.

After completion of the dose-titration portion of the study and SRP-4045 is determined to be safe, all patients will be evaluated on open-label SRP-4045 for the duration of the study.

Safety, including adverse event monitoring, routine laboratory assessments, and cardiac testing will be monitored through the duration of the dose-titration and open-label portions of the study.

Clinical efficacy will be assessed at regularly scheduled study visits via quality of life questionnaires and tests of pulmonary and upper extremity function through the duration of the dose-titration and open-label portions of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Genotypically confirmed DMD (amenable to exon 45 skipping).
* Stable cardiac and pulmonary function.
* Limited or no ambulation.
* On a stable dose of oral corticosteroids for at least 24 weeks OR has not received corticosteroids for at least 24 weeks.

Exclusion Criteria:

* Current or previous treatment with the experimental agents SMT C1100 (BMN-195) or PRO045.
* Other experimental treatment in the past 12 weeks.
* If on cardiac medication, must be on a stable dose for the past 12 weeks.
* Major surgery within the past 3 months.

Other inclusion/exclusion criteria apply.
Detection of Periapical Lesions on Dental Panoramic Radiographs Based on Artificial Intelligence

Dental periapical damages can have various reasons and is reflected by a radiolucent lesion on complementary imaging: angulated retro-alveolar (RA) radiographs, dental panoramic radiographs, and three-dimensional imaging such as computed tomography (CT) or cone-beam computed tomography (CBCT).

For the radiographic detection of these deep periodontal lesions, the dental panoramic represents a first approach commonly performed with relatively low radiation. The investigation can be followed by retroalveolar radiology imaging that are more localized and more precise. However, using these techniques, the detection rates of these lesions are low (20% and 36% respectively), it is necessary to use three-dimensional tomographic investigation to be more discriminating (69%). The gold standard imaging for detection of these lesions is CBCT followed by retroalveolar radiography (\~2x less sensitive than CBCT) and panoramic radiography (\~2x less sensitive than RA). Although not a full-thickness radiograph, the dental panoramic has the advantage of being more commonly performed while being less radiating than CBCT and giving a global view of the dental arches on a single image.

The detection of periapical lesions is done after a clinical assessment and a visual appreciation of the complementary examinations.

The aim of this project is to improve the detection of periapical lesions, by developing an algorithm able to identify them on a panoramic dental radiograph. This algorithm is based on a deep learning system trained with reference data including panoramic dental imaging and CBCT with an acquisition interval of less than 3 months. The model is based on a previous work, will improve the quality of the initial data (using CBCT), using innovative artificial intelligence algorithms (transfer learning).

The final objective of the research is to improve the early diagnosis of periapical lesions, which would allow a better and faster care of these lesions namely at early stages. This represents a major public health interest since these lesions can be responsible for multiple local and regional pathologies (osteomyelitis, cervico-facial cellulitis, thrombophlebitis, cerebral abscesses...) or even more serious general pathologies (cardiac pathologies, cardiovascular diseases, diabetes, renal diseases, tendinopathies...). For certain target groups such as the military and high-level athletes, this research would make it possible to improve the assessment carried out before medical aptitude or club transfer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had CBCT and panoramic dental imaging with less than 3 months between the two examinations

Exclusion Criteria:

* Patients who refused to participe in the study.
"Ventricular Tachycardia Ablation Registry".

Catheter ablation of Ventricular Tachycardias is a well-established approach in clinical practice in patients with Implantable Cardioverter Defibrillator (ICD) implanted. Previous studies have shown a significant reduction in appropriate shocks (\~ 20%) and a significant reduction in hospitalizations for cardiovascular reasons (\~ 12%) in patients with ischemic heart disease treated with ablation. Recent works have also shown the effectiveness of the ablation procedure using as procedural target the reduction of late potentials. However, actually it is necessary to have an homogenize and accepted mapping scheme in Sinus Rhythm to ablate Ventricular Tachycardias related to scar substrate in patients with:

* Previous MI
* Previous myocarditis
* Arrhythmogenic Right Ventricular Dysplasia (ARVD)
* Idiopathic Dilated Cardiomyopathy (IDCM)

Scope of the registry is to collect data during cardiac mapping in Sinus Rhythm in patients indicated for Ventricular Tachycardia ablation, that will be performed per clinical practice, by using the St. Jude Medical EnSiteTM PrecisionTM mapping system.

The objective of the present registry is: to assess the acute and long-term efficacy of the strategy of substrate abolition (abolishment of complex and late potentials) guided by electroanatomic mapping with Precision software.

This is an Italian multicenter, observational, prospective and retrospective registry.

Data will be collected during enrollment/baseline, procedure, pre-discharge and during the follow-up visits according to the standard practice of participating centers, with mandatory visits at 6 and 12 months. Data can also be collected retrospectively, prior informed consent of the patient.

The planned enrollment duration is approximately 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an implanted ICD
* Patients with indication to Ventricular Tachycardia Ablation procedure, supported by EnSite Precision 3D mapping system (previous MI, myocarditis, ARVD, IDCM)
* Age 18 years or more
* Able to provide an informed consent to participate to the registry and available to respect the assessments described in the protocol

Exclusion Criteria:

* Contraindication to anticoagulants
* Presence of thrombi
* Presence of Mitral and Aortic prosthetic valve
* Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
* Pregnant or nursing
* Ventricular Tachycardia caused by reversible pathology
* \< 1 Year life expectancy according to the investigator
* Contraindication to the use of ablation/diagnostic catheters or to cardiac catheterism
High Dose SBRT for Abdominal-Pelvic Lymph Nodal Lesions in Oligometastatic Patients

This is a prospective, multicentric, phase II and feasibility study aimed to address early and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.

The purpose of this prospective, multicentric, phase II study is to determine the feasibility of Stereotactic Body Radiation Therapy in stage IV selected oligometastatic patients, by looking at acute and late toxicity. Investigators also want to verify what is the impact of local control in irradiated metastatic foci in the context of the systemic disease, how local control can affect disease free survival and overall survival, and moreover quality of life of patients treated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* WHO performance status ≤ 2
* Histologically-proven of primary cancer disease
* M1 stage with primary cancer site radically treated with complete response/resection or stable. No other site of disease in progression (a maximum of 3 lymph node sites of disease to treat)
* Diameter ≤ 5 cm
* Abdomen/pelvic site
* Informed consent.

Exclusion Criteria:

* Patients were required to have not brain metastases or bone metastases.
* Patients with a life expectancy of \>3 months.
* Any serious disease contraindicated radiation therapy
* Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial. Additionally, patients were excluded from the trial if they were receiving any systemic chemotherapy during radiotherapy, although hormonal therapy was allowed.
Intertransverse Process Block for Postoperative Acute Pain After Coronary Bypass Surgery

This prospective, randomized controlled trial aims to evaluate the effect of bilateral intertransverse process block (ITPB) on acute postoperative pain in patients undergoing coronary artery bypass grafting (CABG) via median sternotomy. Patients will be randomly assigned to receive either ITPB or placebo (saline) injection prior to surgery. Postoperative pain scores, opioid consumption, and recovery quality will be assessed during the first 24 hours following extubation.

Coronary artery bypass grafting (CABG) is associated with significant postoperative pain due to sternotomy and tissue manipulation, which may impair recovery, increase opioid consumption, and prolong hospital stay. Regional anesthesia techniques are increasingly used as part of multimodal analgesia strategies to minimize opioid-related side effects. The intertransverse process block (ITPB) is a novel regional technique that targets the dorsal rami of spinal nerves and may provide effective bilateral analgesia in thoracic procedures with a favorable safety profile.

This prospective, randomized, triple-blind controlled study aims to investigate the effect of preoperative bilateral ITPB on postoperative acute pain, opioid consumption, and recovery quality in adult patients undergoing elective CABG via median sternotomy. Patients will be randomized to receive either ITPB with 0.25% bupivacaine or a placebo (saline) injection under ultrasound guidance. Postoperative outcomes, including Numeric Rating Scale (NRS) pain scores, rescue analgesic use, total opioid consumption, and Quality of Recovery-15 (QoR-15) scores, will be collected within the first 24 hours following extubation. The results of this study may support the incorporation of ITPB into routine analgesia protocols for cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Elective coronary artery bypass grafting (CABG) via median sternotomy planned
* Able to provide written informed consent
* Able to communicate symptoms reliably with the research team

Exclusion Criteria:

* Emergency CABG surgery
* Infection or open wound at the injection site
* Coagulopathy
* Hepatic or renal failure
* Reoperation cases
* Incomplete or missing data
Duration of Vitamin D Stores After Prolonged Vitamin D Substitution

Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues. The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such storage which may potentially be of vital importance when intake or solar exposure is limited. In the present study we will include 76 subjects who have participated in an intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of type 2 diabetes, and who have completed the study after 5 years or who have been excluded because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D during the following year without vitamin D substitution, which will be measured in the present study. If our hypothesis is correct, that vitamin D can be stored in significant amounts when the supply is abundant; current advice on vitamin D supplementation mainly during winter should be changed to "year around" in order to build up sufficient stores for the months without sufficient sun light.


Eligibility Criteria:
Inclusion Criteria:

* previously participated in a vitamin D study

Exclusion Criteria:

* pregnancy
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients

The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Familial adenomatous polyposis
* 18 years of age or older
* 5 or more adenomas of colorectum or ileum

Exclusion Criteria:

* Female patient of child bearing age not on effective birth control pills
* Pregnant women
* White blood cell (WBC) count less than 4000
* Platelets (Plts) less than 100,000
* Blood urea nitrogen (BUN) greater than 25
* Creatine greater than 1.5
* Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
* Malignancy
* Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
* Patient on warfarin or anti-platelet drugs
Uptake of Comprehensive Eye Examination Trial

1. To evaluate a educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong.
2. To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong.

A comprehensive eye examination includes visual acuity, slitlamp exam, pupil exam, intraocular pressure, gonioscope lens and 90D lens with slitlamp exam fundus. A number of eye diseases are irreversible at on early stage. Both glaucoma and diabetic retinopathy(DR)are frequently asymptomatic until significant, often-irreversible, damage to the vision has already occurred. It has been estimated that only 10% of persons in India with glaucoma are diagnosed, and the Handan Eye Survey reports that only 10% of persons with diabetes in rural areas of China have received diabetic eye care. In order to deliver effective care for DR and glaucoma in areas with limited resources, education of patients and interventions to promote compliance among patients will both be needed.

Eligibility Criteria:
Inclusion Criteria:

* age ≥40 years who have never had a comprehensive eye examination

Exclusion Criteria:

* inability to join informed consent
Navigating the Clinical Research Process for Lymphoma

Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of lymphoma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future lymphoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of lymphoma
* Participant must be 18 years of age or older
* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

For this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. The hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. Success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years with a history of cancer.
2. Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.
3. Clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction.
4. Ability to understand a written informed consent form, and willing to sign it prior to study registration.

Exclusion Criteria:

1. Patient \<18 years.
2. Without a personal history of cancer.
3. Existing cardiomyopathy diagnosed after cancer diagnosis.
4. Documented cognitive impairment.
5. Patient or patient representative who is unable and unwilling to sign the informed consent form.
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

  * Single serum total testosterone concentration \< 250 ng/dL, or
  * Two consecutive serum total testosterone concentrations \< 300 ng/dL (determined at least one week apart during the screening period).
* Has a BMI ≥ 22 kg/m2 and \< 35 kg/m2.