cyrilzakka/clinical-trials huggingface dataset:
Serial PET MPI in Patients Undergoing Cancer Treatment

This study aims to evaluate the effects of cardiotoxic cancer therapies on myocardial blood flow (MBF) and perfusion in a prospective sample of VA patients.

Up to 60 patients who will be newly initiating chemotherapy are going to be prospectively evaluated using PET myocardial perfusion imaging (MPI) for chemotherapy-induced cardiotoxicity by quantifying MBF and perfusion. Patients will be grouped into 3 categories:

1. Patients undergoing chemotherapy with anthracycline containing regimen.
2. Patients undergoing chemotherapy with VEGF inhibitor containing regimen.
3. Patients undergoing chemotherapy with immune check point inhibitor containing regimen.

Patients will undergo PET MPI at 3 different time points:

1. Baseline PET MPI within 1 month prior to initiation of the chemotherapy regimen.
2. PET MPI at the middle of the chemotherapy regimen.
3. PET MPI within 1 month following completion of the chemotherapy regimen.

For PET MPI, the investigators will evaluate for abnormalities such as new perfusion defects, decreases in stress myocardial blood flows and decreases in myocardial flow reserves.

All study patients will also be analyzed using the following tests:

1. Echocardiogram with strain analysis within +/- 1 week of each PET MPI
2. Serology - high sensitivity troponin, cardiac C-reactive protein (CRP), brain-type natriuretic peptide (BNP), fasting lipid panel, complete metabolic panel, and complete blood count within +/- 1 week of each PET MPI study.
3. 12-lead ECG with each PET MPI study.

Eligibility Criteria:
Inclusion Criteria:

* Veterans Affairs oncology patients who will be initiating chemotherapy
* Ability to give consent

Exclusion Criteria:

* Prior chemotherapy
* Prior coronary revascularization (percutaneous coronary intervention, coronary artery bypass grafting)
* Anyone with previous invasive or CT (computed tomography) angiogram demonstrating any lesion ≥ 50% stenosis
* Known cardiomyopathy defined as rest ejection fraction \< 50%
* History of heart and/or another organ transplant
* Pregnancy or breast-feeding status
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).


Eligibility Criteria:
Inclusion Criteria:

* Is a candidate for mitral valve repair with cardiopulmonary bypass
* Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
* Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
* Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
* Anatomic and general suitability

Exclusion Criteria:

* Prior mitral valve surgery
* Concomitant cardiac procedures
* Other cardiac procedures within 3 months
Effectiveness of Augmented Reality in the Teaching of Health University Students.

The exponential growth of new technologies has meant that the educational field has had to update itself. From the educational point of view, there are some studies that have promoted the implementation of new technologies. These facts have raised the need to implement augmented reality in the university environment, especially among students of health sciences. The use of augmented reality can mean a new approach to teaching by teachers and better learning by students. Objetive: To compare the degree of usability of the two augmented reality applications and to analyse the academic performance of the control group and the experimental group at the Universities of Cadiz and Malaga. The existence of significant differences and relationships between the two variables will be observed.

This research has followed the SPIRIT statement and the ethical and legal aspects of the Principles of the Declaration of Helsinki. An intervention was carried out using two augmented reality applications in the subject of General Procedures in Physiotherapy II at the Universities of Malaga and Cadiz.

Eligibility Criteria:
Inclusion Criteria:

* Students who belong to the degree of Physiotherapy and who are enrolled in the subject General Procedures in Physical Therapy II.

Exclusion Criteria:

* Non-university students.
* Non-university students from outside the health care field.
Liver-PILP First-in-Man

The purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.

The objective of this Medical Device Study, is to demonstrate the feasibility of the liver PILP intervention.

The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
2. Unresectable metastatic disease predominant in the liver

Exclusion Criteria:

1. More than 60 % tumor involved liver tissue
2. Abnormal vascular anatomy
3. Severe atherosclerosis
4. Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries
5. Short suprahepatic vena cava segment (\< 1.5 cm)
6. One or both jugular veins are occluded
7. Other severe, concomitant diseases regarding the subject status
Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?

Open appendectomy has been used in the treatment of appendicitis, which is among the most common emergency pathologies worldwide, since the end of the 19th century. In the 20th century, laparoscopic appendectomy came to the fore and the frequency of use increased gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the best way to perform each procedural step. One of these steps is the trocar entry areas. In this study, investigator's aim is to compare the trocar entry areas, which are various reports in the literature, and to find the localization with the optimal usage area. 140 patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four groups and included in the study. Demographic data, peroperative findings, complications, length of stay and post-operative VAS values of the patients were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent laparoscopic appendectomy

Exclusion Criteria:

patients who underwent open surgery and did not want to be involved in the study process
Investigation of the Effect of Central Sensitization (CS) on Steroid Injection Response in Rotator Cuff Lesion

The goal of this clinical trial is to learn whether pretreatment central sensitization presence affect shoulder steroid injection resuls in patients with rotator cuff pathology.

The main questions it aims to answer are:

1. Is central sensitization associated with decreased treatment response?
2. Do the clinical features of patients with central sensitization differ from those of those without? Participants will be applied a shoulder injection and the treatment response will be monitored.

Shoulder pain is one of the most common musculoskeletal complaints and its prevalence varies between 7-26%. One of the most common sources of pain in these patients is subacromial impingement syndrome leading to rotator cuff pathology. In patients with shoulder pain, one of the factors associated with the persistence of pain in different etiologies, especially subacromial impingement syndrome, is reported as central sensitization (CS). CS can be summarized as an increase in the response of neurons located in the central nervous system to sub-threshold stimuli. In a meta-analysis of patients with shoulder pain, a decrease in pressure pain threshold was found in 29-77% of patients, and CS in 11-24%. There is increasing data showing that CS negatively affects response to different treatments, including surgery and injections. One of the most frequently used treatments in subacromial impingement syndrome is subacromial/intra-articular shoulder injection. Although various factors have been identified in the prediction of shoulder injection results, the effect of pain sensitization on these procedures is unknown. In this study, it is planned to investigate the effect of the presence and severity of pretreatment central sensitization on the results of the shoulder injection in patients with a rotator cuff lesion or subacromial impingement.

Eligibility Criteria:
Inclusion Criteria:

* Rotator cuff pathology confirmed clinically and radiologically (USG/MRI)
* Failure to respond to medical/physical treatment
* Agree to participate in the study

Exclusion Criteria:

* Shoulder trauma and history of previous shoulder surgery
* History of injection to the painful shoulder in the last 3 months
* Use of centrally acting drugs (antidepressants, pregabalin, gabapentin and myorelaxant etc.)
* History of active cancer, systemic inflammatory disease, and infection
* Pregnancy
Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia

Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.


Eligibility Criteria:
Inclusion Criteria:

* For cases :

  * right-handed patient
  * ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex
  * Rankin score estimated prior stroke must be equal to 0 and after stroke \<3 (at inclusion).
* For participants control : right-handed patient

Exclusion Criteria:

* For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of\> 2 (periventricular or subcortical) - Contraindications to MRI
* For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment
CT Scalar Localization

Comparing the location of cochlear implants to level of retained hearing.

Subjects who have undergone cochlear implant surgery will have a CT scan to determine the exact anatomical location of the implant. This location will then be compared with audio testing levels and operative reports to determine any advances in implantation technique that would result in more preserved hearing

Eligibility Criteria:
Inclusion Criteria:

* Currently scheduled for a cochlear implant or currently have a cochlear implant
* 18 years of age and over
* Male and female
* Capacity to consent for patients will be determined by review of the medical history of subject at screening and in concert with the referring physician. Consent will be signed after all questions have been answered and the participant indicates they understand

Exclusion Criteria:

* Younger than 18 years of age
* Current criteria for cochlear implantation
* Currently pregnant, all females will be asked to take a urine pregnancy test if of child bearing age, unless you cannot become pregnant
Decompressive Craniectomy Following Trauma

A prospective clinical trial on trauma patients with increased intracranial pressure(ICP) applied for decompressive craniectomy to lower ICP

Traumatic brain injury (TBI) remains a major health problem across the globe . Intracranial pressure (ICP) following TBI can be elevated due to increasing mass effect from hematomas, contusions, and diffuse brain swelling. Decompressive craniectomy (DC) is a surgical procedure which involves removing a large part of the skull (bone flap) out to make more room for the swollen brain.Mass lesions can be acute subdural hematoma (ASDH), intraparenchymal, brain oedema, or a combination thereof. The most frequent indication for a DC is an acute subdural hematoma (ASDH). The first modern use of DC following TBI was done by Harvey Cushing in 1908. Cushing treated head-injured patients with a subtemporal DC and he reported a substantial reduction in mortality. The management of TBI progressed significantly in the 21st century due to advances in neuroimaging, prehospital management, neurointensive care, neuroanaesthesia, and rehabilitation. This led to a renaissance of interest in DC for improvement patient conditions. One of the serious concerns regarding DC is that it may reduce mortality, but increase the subset of patients with severe disability and persistent vegetative state. The discrepancy in published outcome may, to some extent, be explained by difference in patient selection, indications, timing , and technique of surgery. In terms of surgical consideration regarding DC, it is now well accepted that the dura mater has to be opened and the minimum diameter of unilateral DC should be around 11-12 cm. Skull reconstruction (cranioplasty) after improvement of neurological state is recommended. Decompressive craniectomy provides additional space for the swollen brain and can effectively reduce ICP, thereby mitigating the risk of herniation. However, despite the positive effect of DC on uncontrollable intracranial hypertension, the effect of surgical decompression in mortality and overall functional outcome following TBI remained controversial.

Eligibility Criteria:
Inclusion Criteria:

* All Patients with signs of increased intracranial tension (subdural hematoma, brain edema, intracerebral hematoma) after trauma diagnosed clinically, radiologically, and resistant to medical decompression.
* Age: up to 60
* Midline shift more than 5 mm.
* GCS \> 8

Exclusion Criteria:

* Age: more than 60
* Old trauma
* Unfit for surgery (ex: cardiac patient)
* GCS \< 8
* Midline shift less than 5 mm.
* Unwillingness to participate in the study.
Comparison of a Web-based Advance Directive to a Standard Advance Directive

This study will compare a web-based advance directive to a standard advance directive.

Patients with GI and thoracic malignancies will be randomized to either a standard paper advance directive or the web advance directive (Ourcarewishes.org). Patients will be approached in the Cancer Center and provided the AD information to complete on their own. They will complete a survey at enrollment and a follow up survey administered by email. The primary endpoint will be proportion with new documentation in the EHR at 8 weeks. Second endpoints will include the change in satisfaction with end-of-life plans, AD acceptability, self-reported rates of completion, self-reported rate of sharing with their preferred surrogate decision-maker, proportion with new documentation of preferred decision-maker in the chart, and qualitative feedback. Patients in both groups will receive follow up reminder emails encouraging them to complete the advance directive.

Eligibility Criteria:
Inclusion Criteria (any of the following)

* Pancreatic cancer, any stage except stage 0 (C25),
* NSCLC, stage IIIA or higher (C34),
* SCLC, any stage (C34),
* Colon cancer, stage IIIB or greater (C18),
* Rectal cancer, stage IIB or greater (C21),
* Esophageal cancer (adeno or squamous), any stage (C15),
* Stomach cancer, stage IIB or greater (C16),
* Gallbladder cancer, stage I or greater (C23),
* Cholangiocarcinoma, any stage (C22.1),
* HCC, any stage (no plan for transplant) (C22.0),
* Malignant carcinoid of GI tract, stage IV (C7A.019).

Exclusion criteria:

* Does not have an active patient portal (MyPennMedicine) account,
* Does not use email at least once per month,
* Has already completed a living will,
* Does not speak fluent English,
* Unwilling to be contacted by email,
* Determined to be too ill or inappropriate for participation by patient's oncologist.
Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients

Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* COPD patients who survived after an episode of acute hypercapnic respiratory failure
* Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 \> 55 mmHg and pH \> 7.35

Exclusion Criteria:

* Age \> 85 years old
* Non- COPD causes of respiratory failure
* Obstructive sleep apnea excluded by polysomnography
* Adverse psychosocial status
* Serious co-morbidity
Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department

The study is collecting data along with other academic institutions regarding the accuracy of ocular ultrasound in diagnosing retinal detachment.

This is a prospective, cross-sectional study to assess the utility of point of care ultrasound in the diagnosis of ocular complaints in the emergency department (ED) with specific focus on the accuracy of diagnosis when compared to that of a blinded ophthalmologist. Ocular complaints represent between 2% and 3% of ED visits (Walker et al, 2011). This percentage may include vision-threatening diagnoses including retinal detachment, which can occur in 3-4% of patients presenting with ocular complaints (Alotaibi et al, 2011). However, the equipment and expertise required to adequately assess for conditions such as retinal detachment are limited in busy emergency departments due to the time consuming and challenging nature of the examination. Incorporating the use of an ultrasound could provide a more available, focused, and timely assessment.

Eligibility Criteria:
Inclusion Criteria:

Clinical suspicion for retinal detachment Age \>18 years of age Ophthalmology Consult

Exclusion Criteria:

Concurrent ocular trauma Ruptured globe Pregnancy \< 18 years of age No ophthalmology consult
Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)

Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.

The main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.


Eligibility Criteria:
inclusion criteria :

* Small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
* At least one first- or second-degree relative with a small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
* Agreement to participate to the study exclusion criteria :
* Subjects unable to provide consent
Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis

Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Disease course in SSc-ILD is highly variable: patients can experience stable disease, slow or fast progression. Prevention of ILD progression now represents a key objective of SSc-ILD management. The understanding of the course and patterns of SSc-ILD progression is necessary, as reliable prediction tools that allow the stratification of the risk of progression. We aimed to identify the longitudinal trajectories of ILD in SSc patients using latent class mixed models and to examine their associations with SSc characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
* Patients with interstitial lung disease on HRCT chest
* Patients with PFT at ILD diagnosis and at least 1 PFT evaluation during follow-up

Exclusion Criteria:

* Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)
A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 20 years at the time of informed consent
* Japanese patients with type 2 diabetes
* Patients who have HbA1c ≥ 7.0% and \< 10.0%

Exclusion Criteria:

* Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
* Patients receiving or requiring treatment with insulin
* Patients with a body mass index (BMI) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2
* Patients with clinically evident renal impairment (estimated glomerular filtration rate \[eGFR\] of \< 45 mL/min per 1.73 m2) or clinically significant renal disease
* Patients with fasting plasma glucose ≥ 240 mg/dL
SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases

This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin,
* Patients who had reached the age of majority in their countries, at baseline,
* Patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis),
* Patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded

Exclusion Criteria:

* Cause of chronic liver disease other than viral, ALD or NAFLD ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...)
* Any systemic, viral hepatitis and HIV co-infection