cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients and its higher sensitivity when compared to procainamide infusion (the conventional drug used in the USA). As a substudy it proposes to apply this test to early ARVC cases in order to evaluate if ECG changes similar to those seen in Brugada Syndrome could be unmasked by flecainide iv.

Brugada Syndrome is an inherited arrhythmogenic disease responsible for life-threatening arrhythmias and sudden cardiac death in young individuals with structural normal heart.

It is characterized by a peculiar ECG pattern, but this pattern could be intermittent. The infusion of sodium channel blockers (flecainide, ajmaline, procainamide) is used to unmask a concealed ECG pattern, thus providing an essential contribution to the diagnosis of this condition.

In the current clinical practice in USA, only procainamide is used for diagnostic purposes; however in Europe only ajmaline and flecainide, available as iv formulations, are widely used. European and Japanese studies have demonstrated that the use of flecainide harbors less risks of adverse events in patients and may have a higher accuracy in unraveling the presence of the disease.

In the present study the investigators propose to use flecainide infusion test in the Cardiovascular Genetics Program at NYUMC, in order to assess its sensitivity and specificity in diagnosing the disease and compare the incidence of adverse events to that observed during procainamide use.

Additionally, the investigators propose to extend the study protocol to patients with a suspect diagnosis of Arrhythmogenic Right Ventricular Tachycardia (ARVC), due to the possible overlap between the two conditions.

The study has the following aims:

1. To demonstrate the higher sensitivity and specificity of flecainide iv infusion compared to procainamide infusion for the diagnosis of Brugada Syndrome.
2. To demonstrate that flecainide is equally safe or safer than procainamide to use for diagnosing Brugada Syndrome.
3. To demonstrate that flecainide has high sensitivity and specificity in diagnosing also some patients with early stage Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC).

Eligibility Criteria:
Inclusion Criteria:

* Suspect diagnosis of Brugada Syndrome or ARVC
* Idiopathic ventricular fibrillation and suspect concealed Brugada syndrome
* Family history of Brugada Syndrome
* Family history of unexpected cardiac sudden death

Exclusion Criteria:

* Type 1 Brugada Syndrome ECG
* Pregnancy
* History and/or evidence of ischemic cardiomyopathy
* Recent myocardial infarction
* Allergy or known adverse reaction to flecainide
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the impact of ear pain on sleep and other daily activities.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months of age.
* Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
* Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
* Agree to refrain from water immersion of the ears during the conduct of the entire study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
* Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
* Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
* Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
* Prior otologic surgery within 6 months of study entry in the affected ear(s).
* Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.
* Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.
* Other protocol-defined exclusion criteria may apply.
Quality Improvement Intervention in Colonoscopy Using Artificial Intelligence

Quality measures in colonoscopy are important guides for improving the quality of patient care. But quality improvement intervention is not taking place, primarily because of the inconvenience and expense. To address the difficulties above, we used artificial intelligence for quality control of colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 80;
* agree to give written informed consent.

Exclusion Criteria:

* patients with the contraindications to colonoscopy examination;
* patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
* patients with prior failed colonoscopy and high suspicion of polyposis syndromes, IBD and typical advanced CRC;
* patients refused to participate in the trial;
* the colonoscopyprocedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
* the colonoscopy procedure have to be terminated due to complications of anaesthesia.
Post-CA Neuroprotection With Magnesium

The purpose of this pilot interventional study is to collect preliminary data on administering magnesium sulfate as a neuroprotective medication in patients who achieved Return of Spontaneous Circulation (ROSC) following Cardiac Arrest (CA). The primary aims are to assess the feasibility and safety of administering magnesium and measure serum markers of neuronal injury at prespecified time points in the post-cardiac arrest period. Because this is a pilot study with a limited sample size, the primary objective is to evaluate the precision and stability of the collected measures to inform the design and formal analysis in a larger trial.


Eligibility Criteria:
Inclusion Criteria:

* Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved \<2 hours prior to recruitment

Exclusion Criteria:

* Age \< 18 years or \> 85 years
* Traumatic cardiac arrests
* Unsustained ROSC (\<20 minutes)
* Patient who is responsive/able to follow motor commands within 1 hour of achieving ROSC
* Plan for withdrawal of life support within 72 hours of ROSC
* Known pregnant women at the time of the cardiac arrest
* Known prisoners at the time of the cardiac arrest
* Subjects who have a medical o social condition that would make them inappropriate for the study based on the PI's or clinical team judgement.
The Effect of Using a Kaleidoscope on Fear and Pain in Children

The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data.

Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:

The research was conducted between March 2022 and December 2023 as a randomized controlled experimental study. The study population consisted of patients who sought treatment at the Orthopedics Polyclinic and Emergency Department of Erzurum Atatürk University Health Research and Application Center. These patients were referred to the orthopedics clinic and diagnosed with fractures, such as humerus, wrist, finger, tibia, femur, and ankle fractures, for which plastering was performed as treatment. Specifically, the study included children aged 6 to 12 years. The sample size for the study was determined through a power analysis and ultimately consisted of a total of 70 children, with 35 children assigned to both the control group and the kaleidoscope group. The children in the kaleidoscope group were exposed to a kaleidoscope, while the control group received no intervention beyond routine medical practice. To collect data, the researchers utilized an "Introductory Information Form," the "Wong-Baker Faces Pain Rating Scale," and the "Children Fear Scale." The data were analyzed using percentage distributions, mean, standard deviation, chi-square test, and independent groups t-test. Throughout the research, ethical principles were strictly followed.

Eligibility Criteria:
Inclusion Criteria:

* Being a child in the 6-12 age group,
* The child's willingness to participate in the study,
* The parent's volunteering to participate in the study,
* Absence of intellectual disability of the child and parent,
* The child and the parent speak Turkish and are open to communication.

Exclusion Criteria:

* The child has a chronic disease that can cause pain,
* The child has used analgesics within 24 hours before admission to the hospital,
* The child has visual impairment.
Study of Denosumab in Subjects With Giant Cell Tumor of Bone

To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)

To determine how safe denosumab is in treating subjects with GCTB

Eligibility Criteria:
Inclusion criteria:

* Pathologically confirmed GCTB within 1 year before study enrollment
* Measurable evidence of active disease within 1 year before study enrollment
* Subjects with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR subjects whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
* Karnofsky performance status equal or greater than 50% (ie, Eastern Cooperative Oncology Group status 0, 1, or 2)
* Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone \[eg, humerus with closed growth epiphyseal plate\]) equal or greater than 12 years of age
* Skeletally mature adolescents must weigh at least 45 kg
* Before any study-specific procedure is performed, the appropriate written informed consent must be obtained

Exclusion criteria:

* Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
* Concurrent bisphosphonate treatment
* Known or suspected current diagnosis of underlying malignancy including high grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
* Known or suspected current diagnosis of non GCTB giant cell-rich tumors
* Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease
* Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
* Active dental or jaw condition which requires oral surgery, including tooth extraction
* Non-healed dental/oral surgery
* Planned invasive dental procedure for the course of the study
* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
* Subject has known sensitivity to any of the products to be administered during dosing
* Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
* Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment
* Female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Effects of My Diabetes Care on Patient Outcomes

The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care (MDC), to evaluate its effect on clinical outcomes.

484 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 242 will be assigned to the intervention (My Diabetes Care) embedded within an existing patient web portal, My Health at Vanderbilt at Vanderbilt University Medical Center or Patient Gateway at Brigham and Women's Hospital. 242 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt or Patient Gateway without the My Diabetes Care (MDC) application. Potentially eligible patients will be invited to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap). Outcomes data will be collected from patients at four time points: baseline (T0), three-month follow-up (T1), three-month follow-up (T2), six-month follow-up (T3), and twelve-month follow-up (T4). At each time point, study participants will complete questionnaires electronically via email using REDCap, participants' hemoglobin A1C level will be assess via home A1C test kits, and participants' diabetes health data will be abstracted from their electronic health record. Participants will be randomized to the intervention or control arm after their baseline data is collected.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Age 18-75 years old
* Currently taking at least one medication for diabetes
* Be a patient at Vanderbilt University Medical Center (VUMC) or Brigham and Women's Hospital (BWH)
* Able to speak and read in English or Spanish
* Have reliable access to a smartphone, tablet, or computer with internet access
* Active patient web portal account (My Health at Vanderbilt at VUMC or Patient Gateway at BWH)

Exclusion Criteria:

* Receiving dialysis,
* Pregnant or planning to become pregnant within the next year,
* Living in a long-term care facility.
Gold Against Pains From Osteoarthrosis in the Knee

Gold implantation around arthritic joints is a very popular treatment - but the effect has never been controlled.

Randomization between

1. Gold (4 x 3 berlocks, injected under local anesthesia) and
2. Sham operation - only local anesthesia Functional and pain measures reported through the next 6 months.

Eligibility Criteria:
Inclusion Criteria:

Arthrosis in knee joint

Exclusion Criteria:

Need for NSAID
Obstetric Life Support, a Curriculum to Effectively Resuscitate Pregnant Patients Experiencing Cardiac Arrest.

The objective of the study is to determine if Obstetric Life Support Program (OBLS) has an effect on the confidence and skills knowledge in participants.

Enrolled participants with healthcare experience will be randomized to intervention with an electronic curriculum and instructor-led course or placebo first and then will be crossed over to receive the intervention. Participants will undergo assessments pre and post intervention, as well as repeat assessments after three washout periods separated by six months each.

Eligibility Criteria:
Inclusion Criteria:

PH

1. All genders
2. EMS healthcare providers of all levels including basic, advanced, paramedics; firefighters, law enforcement officers, and trainees in any of these programs.
3. 18 years old or older
4. Ability to read, write and speak in English

IH

1. All genders
2. Emergency medicine providers (ED, FP, ICU) surgeons (OB), anesthesiologists, trainees of GME, and nurses from ED, FP, ICU/NICU, or OB/L\&D.
3. 18 years or older
4. Ability to read, write and speak in English

Exclusion Criteria:

1. Participants included in the pilot-testing sessions
2. Participants from other medical specialties not listed in the inclusion criteria.
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents

The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have compiled a database of more than 300 subjects that completed diagnostic testing for GER in the 1970's, 1980's, and 1990's. Subjects are being contacted initially by mail using a previously approved recruitment letter. Subjects that fail to respond to this recruitment letter are called by phone. In each case, contact information has been abstracted from the Children's Hospital database. Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. Subjects receive no compensation for their participation in this study. Subjects will be compared to controls. Controls will complete the same questionnaire as the subjects. Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. Controls will receive $25 to participate in the study.


Eligibility Criteria:
Inclusion Criteria for Subjects:

* Patients who were evaluated for GERD at the age of 12-17 years, inclusive at Children's Hospital, Boston or Massachusetts General Hospital
* Positive for GERD per biopsies or pH probe results

Exclusion Criteria for Subjects:

None

Inclusion Criteria for Controls:

* No GI diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,Hirschsprung's disease
* Date of birth is within 1 year of a subject's date of birth
Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.

The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.

Nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar Puncture or Myelogram
* Peripheral Intravenous access available in the veins on the dorsal region of the hand
* The informed consent signed by the legal responsible of the child allowing the participation in the study

Exclusion Criteria:

* Relative or absolute contraindications use of propofol and excipients
* Contraindications to the patient undergo general anesthesia or sedation with drug
* Allergy derived from egg or soy
* Use of pre-medication
* Patient receiving psychotropic drugs
* Use of opioid within 24 hours
* The responsible for the children unable to decide for his participation
* The severity of the condition wich compromises vital functions such as ventilation and hemodynamic balance
* Liver cancer which compromises its function
* Changes in the blood tests
* Others comorbidities in the investigator opinion
Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB)After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm

The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy which is booming in the management of aortic stenosis. It concerns patients who have a high surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch Block (LBBB) is one of the most frequent complications of this procedure and represents an important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent pacing in 5 in 15 % of the cases in 1 year.

De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation. However, there are no predictive elements of these conductive disorders. Besides, the incidence and the deadline of appearance of this AV disorders are not established. It seems relevant to propose a new stratification based on ECG and endocavitary data. The monitoring of the conductive disorders is allowed by remote monitoring thanks to the implantation of a pacemaker or an implantable holter allowing to determine the incidence and the deadline of appearance of high grade AV conduction disorders.

The aim of this protocol is to study the appearance of the high grade AV conductive disorders at 12 months by monitoring for patients with a de novo LBBB after TAVI from an adapated algorithm to the risk and based on an early electrophysiological evaluation.

The recruitment of patients takes place in each cardiology department. The project is submitted to the Ethics Committee .

The patients are informed about this study by the investigator. After a reflection period and an answer to the possible questions, the patient is included. The informed consent is signed.

Every patient included with a de novo LBBB, persistent that is observed beyond 24 hours after the TAVI procedure, will benefit from an endocavitary electrophysiological exploration . According to the meditative delay of conduction, a pacemaker will be implanted in case of delay lengthened HV (\> 70 ms) or of infrahissian block, in the opposite case the implantation of an holter with remote monitoring will be made.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 year's old
* Patient implanted by a percutaneous biological aortic valve according to the recommendations of the European society of cardiology according to the guidelines of ESC 2012
* Life expectancy upper 1-year-old
* Sinusal rhythm
* Patient with a de novo LBBB post-TAVI persitent and observed beyond 24 hours after the procedure of TAVI.

Exclusion Criteria:

* Patient with a pacemaker pre-TAVI
* Patient with LBBB pre-procedure
* Pregnancy
* Permanent atrial fibrillation