cyrilzakka/clinical-trials huggingface dataset:
Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk

There are currently no minimally invasive techniques for the measurement of lipopolysaccharide (LPS) and Apo-B48 that can be used in samples collected in field settings. In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.

The primary objectives of this pilot study are to a) determine whether postprandial LPS and ApoB48 levels can be assessed in finger prick blood of both lean subjects and obese subjects; and b) compare postprandial LPS and ApoB48 levels assessed in venous blood and blood collected through a finger prick test.

This study is an observational pilot study in which postprandial LPS and ApoB48 will be assessed before and after ingestion of a high fat load in 5 lean and 5 obese subjects in the age range 18-70 years.

Samples will be collected under fasting conditions and in response to a high fat challenge test (1, 2, 4 and 6 hours post ingestion).

The risks for participation are very small if not negligible. No adverse effects of the high fat challenge were reported previously. Consumption of high amounts of saturated fat may cause some GI discomfort. Blood sampling will be performed via a cannula and the insertion can be a painful and may cause a bruise. Finger prick might also give a short pain sensation and small bruises. The amount of blood that is drawn from participants is relatively small (total 37.5 ml) and is therefore within acceptable limits. There are no direct benefits for the participants. In the BIOLOGIC study we include both lean subjects and obese subjects as we expect differences in postprandial responses related to differences in chylomicron production and LPS levels. Therefore it is important to explore these biomarkers in both target groups. This study can therefore be regarded as group-related, non-therapeutic research.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Living in the surroundings of Wageningen (max. 25 km)
* Stable body weight for past 6 months
* Suitable veins for insertion of cannula
* BMI 18.5-22 kg/m2 (lean subjects)
* BMI ≥ 30 kg/m2 (obese subjects)

Exclusion Criteria:

* Use of cholesterol-lowering medication (e.g. statins)
* Use of diabetes medication (e.g. insulin, metformin)
* Use of antibiotics or anti-inflammatory medication (e.g. NSAIDS such as ibuprofen)
* Known allergy for any of the food components used in the study (milk, cream, sugars)
* Blood clotting disorders
* Current smokers
* Alcohol consumption of \> 21 units per week
* Participation in another clinical trial at the same time
* Being an employee of Wageningen Food \& Biobased Research
Evaluation of a Perceptual Learning Module on Spinal Ultrasound Among Residents.

This medical education research project aims to evaluate the impact of a directed perceptual learning module (PLM) on spinal sonoanatomy. Following a demographic questionnaire, participants will be exposed to a tutorial explaining the necessary theoretical foundations for the PLM as well as the functioning of the PLM interface. A pre-test involving selecting the best image from a video sequence depicting spinal sonoanatomy will be administered to all participants. Participants will then be randomized into two groups and exposed to video sequences in the same manner as during the pre-test, with immediate feedback in the intervention group and no feedback in the control group. The video sequences presented will be the same between the two groups. Finally, a post-test will be administered immediately and remotely after exposure to the PLM. The time window corresponding to the best image will be predefined by an expert and compared to the resident\&#39;s value. The difference in feedback exposure between the two groups will not be revealed to limit biases.


Eligibility Criteria:
Inclusion Criteria (participants) :

* To be a first, second, third, or fourth-year resident in the anesthesiology program at the Université de Montréal.
* Not having experience in spinal ultrasound (defined as not having performed more than 5 spinal ultrasounds, whether accompanied or not).
* To be familiar with ultrasound.
* Consenting to participate in the study.

Inclusion Criteria (experts) :

- Having used spinal ultrasound in clinical practice or taught it within the last year.

Exclusion Criteria (participants) :

* Refusal to consent
* Not meeting the inclusion criteria.
Re-Energize Fontan

Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With \>1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* 8-19 years of age
* Fontan palliation
* Ability to fast overnight
* Cardiac clearance to exercise by primary cardiologist
* Presence of an adult at home during exercise sessions for patients \<14 years old
* English-speaking patient.

Exclusion Criteria:

* NYHA Class IV (severe heart failure)
* Acute illness within the past three months
* Active protein losing enteropathy (albumin \<2.5 mg/dL)
* Implanted pacemaker
* Cognitive delay deemed severe enough to inhibit the ability to follow the exercise
Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event

This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).


Eligibility Criteria:
Inclusion Criteria:

* Present with a recent history of an ACS event based on the disease diagnostic criteria between 30 and 330 days prior to enrollment, and who state that they are supposed to be taking daily aspirin and maintenance dose 75-mg clopidogrel.
* Are of a legal age (and at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent before entering the study.

Exclusion Criteria:

* Left main coronary artery stent or left anterior descending (LAD) bifurcation stent.
* Have any form of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) planned to occur during the study (from signing consent through the final visit).
* Have undergone CABG or PCI within 30 days of entry into the study.
* Receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
* Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
* Have any of the following: history of ischemic or hemorrhagic stroke intracranial neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack (TIA), have a body weight less than 60 kilograms (kg).
Effect of EMDR in the Treatment of Fibromyalgia

The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.

The main questions it aims to answer are:

* Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?
* Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?
* Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia?

Background: In addition to pharmacological treatments, psychotherapeutic approaches are recommended for the treatment of fibromyalgia. There is a suggestion that Eye Movement Desensitization and Reprocessing (EMDR) therapy may be effective. This study aims to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients through a Randomized Controlled Study (RCT).

Material and methods: The sample for this study comprises 79 individuals diagnosed with fibromyalgia. Participants were randomly assigned to two groups: the 'Treatment as Usual' (TAU) group and the TAU+EMDR group. Prior to the study and at six different time points (before starting the study, at the end of the 5th, 10th, and 15th sessions, 1 month later, and 3 months later), participants completed assessments, including the Fibromyalgia Impact Questionnaire (FIQ), Visual Analog Scale (VAS), Fibromyalgia ACR 2010 Diagnostic Criteria (Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Trauma Symptom Checklist-40 (TSC-40).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of fibromyalgia,
2. Age between 18-65,
3. Compliance with routine medical fibromyalgia treatment,
4. Cognitive and technical competence to meet the working conditions,
5. Volunteering to participate in the study.

Exclusion Criteria:

1. Receiving any psychotherapy,
2. Presence of psychiatric disorders such as Schizophrenia or Bipolar Affective Disorder, c) No other physical and psychological targets apart from trauma needing to be addressed before fibromyalgia pain (e.g., suicide, domestic violence, etc.),

d) Presence of an organic cause that can cause pain.
Effects of Cyclosporine A on Pancreatic Insulin Secretion

Our primary aim is to investigate if cyclosporine A reduces insulin secretion.

Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Renal failure patients on dialysis which is planned to receive a renal transplant

Exclusion Criteria:

* Age below 18 years or above 75 years
* Pregnancy
* Breast feeding mothers
* Diabetes mellitus /WHO criteria)
* Dialysis treatment less than 2 months
* Serious coronary heart disease
* Unstable angina pectoris
* Recent acute infarction (less than 3 months)
* Non-compensated heart failure
* Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.
Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
2. Have progressive disease during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
3. Have measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. Have confirmed programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% in tumor tissues tested by the central lab.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Key Exclusion Criteria:

1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
2. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
3. Evidence of complete esophageal obstruction not amenable to treatment.
4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pulmonary Rehabilitation Program in COPD Patient

This study was designed in order to evaluate the compliance of a pulmonary rehabilitation program using a wearable device and the application effect of the program according to the characteristics of each patient, in COPD patients.

Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and airflow limitation. Symptoms of COPD often restricts exercise capacity and activities of daily life of patients. Accordingly, patients with symptomatic COPD have reduced health-related quality of life, which leads to substantial socioeconomic burden.

In order to overcome the limitation associated with COPD pharmacotherapy, the need for a combination of nonpharmacologic therapies, including pulmonary rehabilitation has been suggested constantly. Pulmonary rehabilitation is a method of relieving respiratory distress symptoms through exhalation and inspiratory training, improving exercise ability and contributes in improving lung function and overall quality of life.

Nevertheless, compliance of pulmonary rehabilitation in daily life is low in most COPD patients. Thus, we applied wearable device to detect and evaluate application, compliance and effectiveness pulmonary rehabilitation program in COPD patients, according to the patients' characteristics. Moreover, we sought to use the results of this study as a basic data to establish a strategy for a customized education program for each patient that can be applied to non-face-to-face digital therapeutics in the future.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients 18 years of age or older
* ECOG PS (Eastern Cooperative Oncology Group Performance Status) \<2
* Smart phone user
* Those who understand the contents of the questionnaire and agree to the research

Exclusion Criteria:

* Patients with history of lung cancer surgery
* Patients with bronchiectasis, severe tuberculosis destroyed lung, active pulmonary tuberculosis, non-tuberculous mycobacterial lung disease (NTM), and idiopathic interstitial pneumonia
An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer

The goal of this observational research is to assess the real-world clinical utility of PYLARIFY PET through evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA/PET scan.

Participants will be enrolled at their physician's office at the time of referral for PYLARIFY PET and will be followed for up to 5 years. Data concerning their prostate cancer diagnostics and treatment will be collected at 6-month intervals.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all the following inclusion criteria:

1. Biological male at birth ≥ 21 years of age
2. Histopathological confirmed prostate adenocarcinoma
3. Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2:

   1. Cohort 1:

      Patients who are newly diagnosed with prostate cancer (and have suspected metastases per the physician's discretion per standard of care assessment) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET for identification of suspected metastases.

      OR
   2. Cohort 2:

   Patients who have previously received treatment for prostate cancer and are referred to undergo PYLARIFY PET or have received PYLARIFY PET for suspected recurrence of prostate cancer (based on an elevated PSA) within 60 days of consent to enroll in the registry
4. Life expectancy ≥ 6 months as determined by the investigator
5. Able and willing to provide informed consent and comply with the protocol requirements.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not eligible for enrollment in this study:

1. Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFY
2. Patients who have histological evidence of neuroendocrine prostate cancer (NEPC) (small cell/ductal variant)
3. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety of compliance of the patient to produce reliable data or completing the study.
Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.

PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.

OBJECTIVES:

Primary

* Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide.

Secondary

* Evaluate the tolerability.
* Compare the duration of response.
* Compare local progression-free survival.
* Compare overall survival.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
* Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.

After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Unresectable disease or patient refused surgery
* Must have brain metastases

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Liver transaminases ≤ 1.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No carcinomatous meningitis
* No history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
* No other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment
* No contraindications to treatment with temozolomide
* No psychological, familial, social, or geographic situations that preclude clinical follow up
* No patient deprived of liberty or under guardianship

PRIOR CONCURRENT THERAPY:

* No prior brain radiotherapy
* At least 10 days since prior chemotherapy