cyrilzakka/clinical-trials huggingface dataset:
Assessment of Coronary Plaque Composition

The investigators' hypothesis is that local activation of the endogenous Lipoprotein-associated phospholipase A2 (Lp-PLA2) plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, this study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.

The present study will be a substudy of our National Institute of Health (NIH) funded and Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary endothelial function.

The substudy will allow the investigators to also examine the additional endpoint of lipid core content of atherosclerotic plaques and hence plaque vulnerability. Plaque lipid composition will be measured using the LipiScan or LipiScan IVUS catheter (InfraReDx Near Infrared Spectroscopy (NIRS) System with or without intravascular ultrasound (IVUS) capability) at baseline and again at 6 month following Lp-PLA2 inhibition.

The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.

Eligibility Criteria:
Inclusion Criteria:

* patients age \> 18 years and \< 85 years
* referred to our cardiac catheterization laboratory for coronary vasomotion testing- subsequently found to have coronary endothelial dysfunction.

Exclusion Criteria:

* heart failure ejection fraction \<40%,
* unstable angina
* myocardial infarction or angioplasty within 6 months prior to entry into the study
* use of investigational agents within 1 month of entry into the study
* patients who require treatment with positive inotropic agents other than digoxin during the study
* patients with cerebrovascular accident within 6 months prior to entry the study
* significant endocrine, hepatic or renal, disorders, local or systemic infectious disease within 4 weeks prior to entry into study
* pregnancy or lactation
* mental instability
A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma

To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed HCC
* Age 18-75 years old
* ECOG PS 0-1
* Child Pugh A-B7
* Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
* At least one measurable lesion (RECIST 1.1)
* Enough organ and bone marrow function
* Expected survival time≥12 weeks
* Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol

Exclusion Criteria:

* Severe complications due to primary liver disease
* No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
* Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
* Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
* Autoimmune immune disease
* History of HIV
* Prognent women
* The presence of any serious or uncontrolled systemic disease
* Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
Feasibility Trial of a Lifestyle Intervention for CHR-P

The present study will assess the feasibility and social validity of an adjunctive health promotion group for youth and clinical high risk for psychosis (CHR-P). Youth participating in treatment at the Center for the Assessment and Prevention of Prodromal Sates (CAPPS) will be invited to participate in a weekly, adjunctive, closed psychoeducation group focused on sharing health promotion strategies and increasing health behaviors (e.g. improved sleep habits, increased participation in physical activity).

The aim of the group will be to provide psychoeducation on lifestyle risk and protective factors for youth at risk for psychosis (i.e. experiencing subthreshold psychosis symptoms). Topics covered will include psychoeducation, goal setting, stress management, sleep, physical activity, substance use, and nutrition. Evidence-based strategies to decrease risk factors and promote protective lifestyle factors for mental illness will be reviewed. Group leaders will utilize a motivational interviewing approach to facilitate the group.

The group will complete nine weekly group sessions. The goal of our research is to 1) determine the feasibility of a novel group-based health promotion intervention, 2) assess the social validity of the group, 3) measure the effects of the intervention on stress, sleep, physical activity, substance use, and nutrition, and 4) measure preliminary effects on symptoms and functioning.


Eligibility Criteria:
Inclusion Criteria:

1. between 13 and 17 years old
2. able to sign and provide informed consent (assent for minors)
3. meet criteria for CHR-P using the Structured Interview for Psychosis-Risk Syndromes (SIPS).
4. Must have a primary caregiver willing to participate who speaks fluent English

Exclusion Criteria:

1. current or lifetime DSM-5 psychotic disorder
2. impaired intellectual functioning (IQ \<65)
3. history of neurological disorder
4. traumatic brain injury (≥7 on TBI screening tool)
5. significant substance use that makes CHR-P diagnosis ambiguous
Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.

Upper GI Hemorrhage (UGIH) causes significant morbidity and mortality, although endoscopic hemostasis has revolutionized management of these patients. Despite standard endoscopic treatment and high dose proton pump infusions, 25% - 30% of high risk patients with UGIB from ulcers or other non-variceal UGI lesions (NVUGI) had recurrent bleeding in a recent RCT and cohort studies by our group. Potential risk factors for NVUGI rebleeding were large ulcers (≥ 15 mm), fibrotic bases, Dieulafoy's lesions, anastomotic ulcers, coagulopathies, cirrhosis, other severe co-morbidities and residual arterial blood flow under stigmata of recent hemorrhage (SRH) after endoscopic treatment. Such patients with rebleeding after standard endoscopic hemostasis usually required angiography (by interventional radiologists-IR) or surgery for definitive hemostasis. A new, large, FDA approved, over-the-scope hemoclipping device (OTSC® System OVESCO Endoscopy, Tübingen, Germany) can capture larger amounts of tissue and underlying arteries than standard hemoclips and potentially can improve endoscopic hemostasis of such bleeding lesions.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient or a surrogate.
* Clinical evidence of severe UGIB.
* Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy.
* Severe upper GI bleeding.
* Life expectancy of at least 30 days based on lack of severe or terminal comorbidity as judged by the generalist or subspecialist caring for the patient.

Exclusion Criteria:

* Patients who are do-not-resuscitate (DNR) that is not reversible, uncooperative, refuse to participate, or are unable to give consent personally or through a legal surrogate.
* Active GI malignancy, under treatment but not in remission.
* Acute hypovolemic shock that is unresponsive to transfusion of 5 or more units of red blood cells (RBC's) or requires continuous intravenous vasopressor infusion for blood pressure support.
* ASA (American Society of Anesthesiology) class V or higher, moribund, or with a very poor prognosis and expected survival \<30 days.
* Severe coagulopathy or thrombocytopenia despite attempted reversal with transfusion of blood products (e.g persistent International Normalized Ratio \[INR\] \>2.0, platelet count \<20,000, a Partial Thromboplastin Time \[PTT\] greater than 2x upper limit of normal).
* Absolute contraindication to urgent endoscopy (such as suspected perforated viscus, or peritonitis).
* Stricture of the esophagus or pylorus that can not be dilated or precludes passage of a diagnostic sized endoscope and/or the GI endoscope with an 11, 3a OTSC device attached.
Transitioning Young Patients' Health Care Trajectories

The project aims to transition the approach used to care for children with complex conditions and care pathways into a more holistic and coordinated model. The traditional model where specialists independently treat single diseases, makes joint and coordinated decisions about patients with multiple and unclear conditions difficult. In particular there is a gap between mental and somatic services.

In preparation for re-designing the care model, several pre-studies are conducted, both a register study and a collection of user reported experiences. Built on the results, we have invented multi-disciplinary teams of complementary competences including paediatricians, psychologists, and physiotherapists to meet the patient and family. The study includes:

* To implement the new team intervention in a clinical case-control study
* To scientifically evaluate the intervention
* To systematise lessons learned in regard to potential spread across systems and patient groups Children 6-16 years together with family and professionals will constitute the team. The assessment aims to clarify the patient's condition through shared decision making and to develop a treatment plan for the child. It is a clinical randomised controlled trial where TpT children will be compared to children following treatment as usual. It includes a one year follow-up regarding a set of evaluation domains: provider perspectives, user-centred experiences and outcomes, as well as health care outcomes.

200 children with multi-referrals will be invited to either intervention or treatment as usual at their third or more referral to Haukeland university hospital.

In the intervention group the child and family will meet a complementary team of professionals for more than two hours aimimg to get a clarification of the patient's condition and giving coping strategies for their condition. Outcome defined as better mental health and quality of life as well as increased school attendence are some of the measures being collected. These outcomes will be compared to the control group after 12 mth.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-16 years,
* Previous referred to specialist health care service for 3 or more times, including mental health service as well paediatric service.

Exclusion Criteria:

* Not within age range
* Less than 3 referrals
Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

This study will evaluate patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. This is a single center, prospective case-series study. The investigators are going to evaluate Corrected Distance Visual Acuity (CDVA), disease activity, retinal and choroidal thicknesses and number of injection per year, during a twelve month follow up. The aim of this study is to verify if the combined therapy can act on the insult induced by the pachychoroid and on the neovascular lesion itself in this sub-population of patients with PCV in pachychoroid,

This study evaluates patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. Inclusion criteria are the presence of haemorrhagic or exudative PCV diagnosed by Optical Coherence Tomography (OCT) and Indocyanine Green Angiography (ICGA) and the mean central choroidal thickness \> 250 µm. Exclusion criteria comprehend ocular comorbidity, previous cardiovascular events and different ocular surgical procedures form cataract surgery. Participants undergo a thorough ophthalmic assessment that included best corrected visual acuity (CDVA), slit lamp biomicroscopy and dilated funduscopic examination. OCT, OCT-Angiography (OCT-A), ICGA and Fluoresceine Angiography (FA) were performed for all patients. The 12-month follow-up foresee monthly revaluations of the above measurements, excluding FA, repeated only on clinical judgement. CDVA will be measured using LogMAR. Choroidal and retinal thicknesses will be automatically measured by digital software OCT- integrated (IMAGEnet). All patients will be treated with a loading dose of Aflibercept combined with PDT within the first 7 days of the first intravitreal therapy. The spot size is calculated by adding 1000 μm to the greater linear dimension of the lesion. No additional therapy will be performed during follow-up unless signs of reactivation.

Eligibility Criteria:
Inclusion Criteria:

* presence of haemorrhagic or exudative PCV diagnosed by OCT and ICGA
* Mean central choroidal thickness \> 250 µm

Exclusion Criteria:

* ocular comorbidity
* previous cardiovascular events
* different ocular surgical procedures form cataract surgery
Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease

The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.

The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe pain, loss of mobility and function of the ankle
* Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
* At least six months of conservative treatment for severe ankle conditions
* Bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
* Willing and able to give informed consent

Exclusion Criteria:

* Patients who have not reached skeletal maturity
* Active or prior deep infection in the ankle joint or adjacent bones
* Prior arthrodesis at the involved site
* History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
* Obesity (weight greater than 250 lbs)
* History of current or prior drug abuse or alcoholism
* Any physical condition precluding major surgery
* Prior surgery and/or injury that has adversely affected the ankle bone stock
* Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
* Insufficient ligament support
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery

Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing 1-2 levels primary spine surgery ≥18 years old

Exclusion Criteria:

* Chronic opiate users
* More than 3 levels or revision spine surgery
* Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s)
* Allergy/hypersensitivity to acetaminophen
* Patients that have used acetaminophen during the 24 hours before their scheduled surgery

Subjects who were unable to communicate in English were further excluded because of their inability to complete the postoperative questionnaires
Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo

This study aims to validate a machine learning model that stratifies the risk of stroke in patients who present to the emergency department with dizziness or vertigo.

This is a cross-sectional, hospital-based study, with no randomization procedure. Over a 21-month period, approximately 600 subjects will be enrolled. The study will assess the risk of stroke in each patient using a machine-learning model. To detect ischemic or hemorrhagic stroke, each patient will undergo a non-contrast brain magnetic resonance imaging study. The predictive performance of the machine-learning model will be evaluated in terms of accuracy, precision, recall, F1 score, and area under the receiver operating characteristics curve.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to the emergency department with dizziness or vertigo
* Aged ≥ 20
* Dizziness or vertigo lasting for at least 1 hour and \< 7 days
* Persistent dizziness or vertigo at the time of the examination at the emergency department

Exclusion Criteria:

* Having 5 or more prior episodes similar in quality, intensity, and duration to the current symptoms, with at least one episode more than a year prior and one within the past year
* Having frank stroke-like symptoms or signs, such as hemiparesis, facial asymmetry, dysarthria, dysphasia, ataxia, gaze palsy
* Consciousness disturbance, Glasgow coma scale \< 13
* Severe dementia
* Recent stroke within 3 months
* Dizziness or vertigo thought to be the result of head injury, hypotension, medication/drug intoxication, hypoglycemia, electrolyte imbalance, anemia, hepatic encephalopathy, hydrocephalus, etc
* Concomitant head or neck trauma
* Severe degenerative cervical spondylosis
* Having contraindications to magnetic resonance imaging examination
Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.

Abdominal aortic aneurysms are a leading cause of death in the United Kingdom. Surveillance programmes and pre-emptive surgical repair are lifesaving. Traditional open surgical repair is associated with major perioperative morbidity and mortality and there has been a move towards minimally invasive Endovascular Aneurysm Repair (EVAR), which reduces these early risks. However, the cost effectiveness and long-term clinical effectiveness of EVAR is undermined by concerns of durability due to the development of endoleaks and late aneurysm rupture secondary to progression of native aortic aneurysm disease and stent graft failure. It has previously been demonstrated that 18F-Sodium Fluoride Positron Emission Tomography can predict progression of aneurysm disease and is associated with greater rates of abdominal aortic aneurysm expansion and the future risk of rupture or surgical repair.

The investigators here wish to examine whether 18F-Sodium Fluoride on Positron Emission Tomography uptake (i) is increased in patients with endoleaks or related complications, (ii) can prospectively predict the likelihood of developing endoleaks in patients undergoing EVAR, and (ii) is a feasible approach to select patients for EVAR with a reduced future risk of stent graft failure and re-intervention. The investigators believe that there is a compelling scientific rationale for this approach with major translational potential to better select subgroups of patients for EVAR and ultimately improve their outcome.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of AAA as defined by the European Society of Vascular Surgery guidelines on the management of aorto-iliac artery aneurysms, and having undergone endovascular repair within the recommended Instructions For Use (IFU) by the manufacturer. \['Endoleak' and 'No Endoleak groups only\]
* Complication will be defined as any type of endoleak or stent graft migration \['Endoleak' group only\].
* A diagnosis of AAA requiring endovascular repair OR a diagnosis of juxtarenal AAA requiring fenestrated endovascular aneurysm repair as defined by the European Society of Vascular surgery guidelines on the management of aorto-iliac artery aneurysms and planned EVAR or fenestrated EVAR surgery. \['pre-EVAR' group only\]
* Minimum age: 50 years. No maximum age.
* Retain capacity for informed consent

Exclusion Criteria:

* The inability of patients to undergo PET/CT scanning
* Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
* Major or untreated cancer
* Pregnancy
* Allergy or contra-indication to iodinated contrast
* Inability or unwillingness to give informed consent
* Life-expectancy of less than two years
* Known history of connective tissue disease