cyrilzakka/clinical-trials huggingface dataset:
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)

This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose. To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association.
* Hemoglobin A1c \<10.0% at screening
* Treated with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening

Exclusion Criteria:

* History of hypoglycemic events associated with seizures in the last year prior to screening
* History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening
* Previous participation in a clinical trial within the dasiglucagon program
APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer

Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.

Prospective Phase II randomized superiority study, open label, multicentric. Patients with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with Apalutamide will be randomized to receive standard systemic treatment alone or concomitant SBRT on all sites of metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed written informed consent
* Adult patients ≥ 18 years
* Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions \*, \*\*
* All lesions must be amenable to SBRT in judgment of treating radiation oncologist \*\*\*
* Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered
* Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment
* Patients should be eligible to Apalutamide treatment

Exclusion Criteria:

* Presence of visceral disease
* De novo metastatic disease
* Any contraindication to the use of Apalutamide
* Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated
Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation

A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. All patients underwent transesophageal echocardiography before and 3 months after operation, and the results were explained by two experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. All patients were examined by transthoracic echocardiography 3 months after operation to evaluate new pericardial effusion, pericardial tamponade, instrument embolization / displacement and so on. The baseline clinical and surgical features and hospitalization outcomes of patients guided by ICE and TEE were recorded and compared. Clinical endpoints include death, new pericardial effusion that does not require pericardiocentesis, tamponade with pericardiocentesis, instrument embolism / displacement, bleeding at the entry site, thromboembolic events (stroke / transient ischemic attack \[TIA\]), and renal failure requiring dialysis. The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided left atrial appendage occlusion combined with radiofrequency ablation. And try to analyze whether intracardiac echocardiography can be used as an alternative to transesophageal echocardiography in transcatheter closure of left atrial appendage. The average follow-up time was 1 year.


Eligibility Criteria:
Inclusion Criteria:

sustained AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria:

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.
Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)

To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA.

All PARADIGM study patients underwent initial and follow-up CCTA based on order from their primary physician. Demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (eCRFs) at the time of the initial CCTA and at the time of follow-up CCTA.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent two or more clinically indicated CCTA with 64-detector rows or greater for CAD evaluation
* patients underwent at least 2 year interval between the baseline and follow-up CCTA

Exclusion Criteria:

* poor image quality of CCTA
Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

To compare efficacy and safety between bilateral superficial cervical plexus block combined with intravenous sedation (RA group) and general anesthesia (GA group) for thyroid and parathyroid operations. This study evaluates postoperative numerical pain score and systemic opioid requirement within 24 hours.

According to literature review, there is limit information about efficacy and safety of thyroid and parathyroid operations under bilateral superficial cervical plexus block combined with intravenous sedation without general anesthesia. General anesthesia is commonly used for neck operations because it is easy to perform. However in high cardiovascular or pulmonary risk patients such as end stage renal disease (ESRD) patients, regional anesthesia such as superficial cervical plexus block combined with intravenous sedation have become an alternative technique for neck operations.

This study evaluate whether regional anesthesia (RA) technique can be the alternative technique for thyroid/parathyroid surgery compare to conventional technique (GA).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) grade I-III, aged over 18 years
* Elective thyroidectomy, thyroid lobectomy, parathyroidectomy

Exclusion Criteria:

* Language barrier or inability to communicate with the operating team
* Allergy to local anaesthetic
* Known substernal, retroesophageal or retrotracheal goiter
* Thyroid cancer
* Previous neck exploration or neck radiation
* Recurrent laryngeal nerve paralysis
* BMI ≥ 30
A Trial of Nadolol Plus Isosorbide Mononitrate Versus Carvedilol for the Prevention of Variceal Rebleeding

Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.

Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients have up to a 70% risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality rate. Therefore, preventive procedures are required for patients surviving an episode of acute variceal bleeding. Both endoscopic injection sclerotherapy (EIS) and propranolol have been well documented to be effective for the prevention of variceal rebleeding. In recent years, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice in the management of bleeding esophageal varices. On the other hand, the addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding. A controlled trial showed that the combination of nadolol and ISMN was better than EIS in terms of prevention of variceal rebleeding and complications. The combination of nadolol and ISMN has been shown to be better than EVL in preventing variceal rebleeding. However, our study showed a contradictory result. On the other hand, carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and ISMN with carvedilol in the prevention of rebleeding from esophageal varices.

Eligibility Criteria:
Inclusion Criteria:

1. acute or recent bleeding from esophageal varices (defined below),
2. the etiology of portal hypertension was cirrhosis, and
3. age was between 20 and 70 years old.

Exclusion Criteria:

1. association with hepatocellular carcinoma or other malignancy,
2. association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
3. had history of gastric variceal bleeding,
4. received beta-blocker within 1 month prior to entry,
5. history of contraindication to the use of beta-blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate \<55/min) or arterial hypotension (systolic blood pressure \< 90 mmHg),
6. history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt),
7. deep jaundice (serum bilirubin \> 10 mg/dl),
8. encephalopathy greater than stage II,
9. failure in control of index variceal bleeding, or
10. refused to participate in the trial.
The Role of OCTA in Patients Affected by Beta Thalassemia

To investigate, using optical coherence tomography angiography (OCTA), the retinal and choriocapillaris vascular features in patients affected by Beta Thalassemia. Moreover we analyzed the structural retinal parameters (ganglion cell complex and retinal nerve fiber layer), using optical coherence tomography (OCT) in these patients

Beta Thalassemia is one of the most common genetic hemoglobinopathy characterized by a defective β globulin chain synthesis leading to hemolysis and ineffective erythropoiesis.

The study investigated the changes in retinal and choriocapillaris vascular features using optical coherence tomography angiography, a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal and choriocapillaris blood flow.

Eligibility Criteria:
Inclusion Criteria:

* age older than 35 years
* diagnosis of Beta Thalassemia
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT and OCT-A images.

Exclusion Criteria:

* age older than 50 years
* absence of diagnosis of Beta Thalassemia
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT and OCT-A images.
Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)

This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.

1. Device description NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester composing the NEUROLAC® nerve guide, Poly(68/32\[15/85 D/L\] Lactide-Ԑ-Caprolactone) (PLCL).
2. Objective This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
3. Study design This post-market surveillance study consists of a cohort study to provide post market surveillance information regarding long-term performance and ease of use of the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in the upper and lower extremity. Sub analyses will be performed regarding demographics and medical background.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Subjects who are able to comply with the follow-up or other requirements.
3. Subjects who are ≥ 18 years old.
4. Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
5. Subjects with a positive Tinel's sign.
6. Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS questionnaire score.
7. Subjects that are indicated for surgery to treat symptomatic neuroma.

Exclusion Criteria:

1. Subjects who do not complete the informed consent.
2. Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
3. Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
4. Subjects with congenital neuropathy.
5. Insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. Use of the device over a joint is advised against.
6. Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32\[15/85 D/L\] Lactide-ε-Caprolactone) (PLCL).
8. Proximal nerve end \> 8mm.
9. Pregnancy.
Multi-Center Medication Reconciliation Quality Improvement Study

Patients often have problems after they leave the hospital, in part because errors are made in the medications they are prescribed. The goal of this project is to develop a more accurate and safe medication prescription process when patients enter and leave the hospital and implement this process at six U.S. hospitals. The investigators will measure the success of the project and develop lessons learned so this process can be applied to other hospitals.

Unintentional medication discrepancies during transitions in care (such as hospitalization and subsequent discharge) are very common and represent a major threat to patient safety. One solution to this problem is medication reconciliation. In response to Joint Commission requirements, most hospitals have developed medication reconciliation processes, but some have been more successful than others, and there are reports of pro-forma compliance without substantial improvements in patient safety. There is now collective experience about effective approaches to medication reconciliation, but these have yet to be consolidated, evaluated rigorously, and disseminated effectively.

This project's findings should provide valuable lessons to all hospitals regarding the best ways to design and implement medication reconciliation interventions to improve medication safety during transitions in care.

SPECIFIC AIMS:

Aim 1: Develop a toolkit consolidating the best practice recommendations for medication reconciliation

Aim 2: Conduct a multi-center mentored quality improvement project in which each site adapts the tools for its own environment and implements them

Aim 3: Assess the effects of a mentored medication reconciliation quality improvement intervention on unintentional medication discrepancies with potential for patient harm

Aim 4: Conduct rigorous program evaluation to determine the most important components of a medication reconciliation program and how best to implement it

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Admitted to inpatient medical or surgical services

Exclusion Criteria:

* Vulnerable populations (pregnant women, prisoners, institutionalized individuals)
* Under 18 years

Hospital staff subjects:

* Personnel directly involved in the medication reconciliation process, which depending on the site might include residents, physician assistants, inpatient attending physicians, nurses, pharmacists, and pharmacy technicians.
Better Effectiveness After Transition - Heart Failure

The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized at any of the six medical centers who are being actively treated for heart failure.

Exclusion Criteria:

* patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,
* patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,
* patients with dementia,
* patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,
* patients who do not have a working land line phone or reliable cell service,
* patients on chronic dialysis,
* patients who cannot identify a usual source of care (free clinic is acceptable) and who will not be assigned a provider upon discharge,
* patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included), percutaneous coronary intervention
* patients expected to enroll in hospice or expire after discharge,
* patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention
Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin \[1, 5, or 25 mg\], or the approved drug hydrochlorothiazide \[HCTZ\]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 2 diabetes and hypertension
* Medically stable
* On at least 1 (and up to 2) oral diabetes drugs
* And up to 2 medicines for blood pressure control

Exclusion Criteria:

* Participants with type 1 diabetes
* Heart attack
* Stroke
* Uncontrolled blood pressure
* Significant kidney disease
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia

This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients.

This study will also measure levels of drug in the blood and see how well it is tolerated. This is known as pharmacokinetic (PK) analysis.

At baseline only a small number of patients will participate in a single dose PK phase over 24 hours.

In order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.


Eligibility Criteria:
Inclusion Criteria:

* children and adolescents (aged 6 to less than 18 years) with Familial Hypercholesterolaemia
* Patients aged between 6 and less than 10 years of age must not be taking a statin medicine

Exclusion Criteria:

* History of muscle or sensitivity reactions to any statin medicines
* Current active liver disease or dysfunction (except a confirmed diagnosis of Gilbert's disease)