cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation

Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.

Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included

Exclusion Criteria:

* Severe peripheral arterial disease that precludes deployment of Sentinel device
* Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device
* Unable or unwilling to provide informed consent.
* Known history of dementia.
Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine

When two or more vaccines are administered concurrently, there is a concern on vaccine interaction, which can either enhance or suppress immune response to vaccine antigens. This study is designed to evaluate the immunogenicity and safety of tetanus-diphtheria (Td) and pneumococcal vaccines after concomitant administration in adults aged 50 years and older.

Vaccination would be the most effective strategy to prevent diverse infectious diseases. Actually, The World Health Organization (WHO) estimate that vaccination averts 2-3 million deaths per year. In adults, several vaccines are recommended based on age and medical conditions if they have not receive vaccination before, and lack evidence of past infection: influenza, measles-mumps-rubella (MMR), varicella, human papilloma virus (HPV), tetanus-diphtheria (Td), pneumococcl vaccines and etc. In particular, when the patient visits a vaccination clinic, Td and the pneumococcal vaccines are commonly administered at the same time. In this study, we aimed to evaluate the immunogenicity and safety of Td vaccine and PCV13 after concomitant administration in adults aged 50 years. This single-center, open label randomized trial was conducted (Clinical Trial Number - NCT02215863) at Korea University Guro Hospital from November 2013 to April 2016. Adults ≥50 years of age were randomized in a 1:1:1 ratio to receive Td + PCV13 (Group 1), PCV13 alone (Group 2) or Td alone (Group 3).

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥50 years who signed the informed consent

Exclusion Criteria:

* history of S. pneumoniae infection within the previous 5 years
* previous pneumococcal vaccination
* previous tetanus-diphtheria (Td) vaccination within the last 10 years
* known immunodeficiency or immunosuppressant use or coagulation disorders
Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma

In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).


Eligibility Criteria:
Inclusion Criteria:

* Major patients with metastatic melanoma (stage IIIC non-résécable or no surgically curable or stage IV with classification AJCC) in progression after a first-line of treatment by vemurafenib or chemotherapy, and non-eligible or non-responders to ipilimumab.

Metastases measurable by RECIST criteria. Hematologic, renal and hepatic appropriate functions. Negative pregnancy test.

Exclusion Criteria:

* Patients with symptomatic brain metastases and Performans Status (PS)\>2. Patients with carcinomatous meningitis. Pregnant or breathfeeding women. Patients with a contraindication to the metformine. HIV infection, active infection with HBV or HCV. Patients already treated with metformin in the context of diabetes.
Rectal Cancer Shared Care

The investigators propose a multifaceted rectal cancer survivorship care program involving oncology specialists, nursing support and primary care physicians. This initiative centers on regular meetings with oncology nursing support, enhanced communication and coordination of care among clinicians including primary care physicians, and an educational platform for patients regarding the late and long-term effects of cancer. Initial efforts will target rectal cancer patients specifically as they have been identified as being at high risk of having unmet needs. Once we have realized measurable, successful implementation in this population, our hope is then to expand our initiative to all colon cancer patients.

Rectal cancer is a life-altering diagnosis that can have long-lasting effects not only on one's physical health, but also their psychological, emotional and financial well-being. With advancements in both disease detection and therapeutic options, there is now a growing cohort of patients who have successfully completed active rectal cancer treatment and transitioned into post-treatment care. Unfortunately, the post-treatment phase has its own set of challenges. Lost in Transition was one of the first major publications to advocate for dedicated survivorship planning, raising awareness of the needs of cancer survivors. Since then, both the National Comprehensive Cancer Network (NCCN) and the American Cancer Society have released guidelines for survivorship care focused on prevention, surveillance, assessment, intervention, coordination of care and survivorship planning. Despite these efforts to bolster survivorship care, studies have found an average of 2.88 unmet needs among cancer survivors affecting physical, financial, educational, emotional and psychology domains. The investigators propose a multifaceted rectal cancer survivorship care program involving oncology specialists, nursing support and primary care physicians. This initiative centers on regular meetings with oncology nursing support, enhanced communication and coordination of care among clinicians including primary care physicians, and an educational platform for patients regarding the late and long-term effects of cancer. Initial efforts will target rectal cancer patients specifically as they have been identified as being at high risk of having unmet needs. Once the investigators have realized measurable, successful implementation in this population, the hope is then to expand this initiative to all colon cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years-old)
* rectal cancer patients who underwent curative intent treatment between 2019-2020 (i.e. in the last 2 years), including those who underwent surgical resection (abdominoperineal resection or restorative proctectomy with or without ileostomy) and those managed non-operatively, with chemoradiotherapy will be included.

Exclusion Criteria:

* Cannot be contacted by telephone
* Unable to read and comprehend English or French;
* Unable to give clear and informed consent.
Digital Tools for Coping With Chronic Pain

Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid psychological distress are also commonly found among individuals living with chronic pain. Often requiring a multi-modal treatment approach, a growing body of literature suggests that digital behavioral health interventions and tools may serve as promising complementary options to help individuals cope with the pain.

The research objective is to evaluate the effectiveness of the myStrength product offerings, namely the chronic pain focus area, on study participants' functional well-being over time. The research questions to be answered include the following:

1. Do study participants who are randomized to the myStrength intervention arm experience change in their self-reported ability to function, outlook on pain, and/or perception of prescription opioids.
2. Do study participants who are randomized to the myStrength intervention arm experience change in terms of their behavioral health, such as anxiety and depression levels, during the study period.

The study team hypothesizes that myStrength study participants will achieve a higher level of functioning and adopt a more positive outlook toward their pain management as compared to the waitlist control group. Self-assessments will be repeated throughout the study period to capture the inflection point of change as well as the sustainability of these changes over time.

Eligibility Criteria:
Inclusion Criteria:

1. Study participants must be 18 years of age or older
2. Self-report chronic pain lasting for at least the past 3 months but no more than 9 months (examples include lower back pain, arthritis, chronic headaches, neuropathic pain, knee pain)
3. Must have considered, have a history of, or are currently taking a prescription opioid for chronic pain (examples oxycodone (OxyContin, Percodan, Percocet), hydrocodone (Vicodin, Lortab, Lorcet), morphine (Kadian, Avinza, MS Contin), fentanyl (Duragesic), propoxyphene (Darvon), hydromorphone (Dilaudid)
4. Fluent in English and articulate Access to a laptop or mobile device to access email and the myStrength platform

Exclusion Criteria:

1. Under the age of 18
2. Chronic pain due to cancer
3. Chronic pain \<3 months or \> 9 months
4. Prior exposure to the myStrength platform
5. Self-reported history of hospitalization for mental illness or a substance use disorder
6. Receiving government benefits related to a developmental or behavioral health disability
Practice Structure on Motor Learning in Post-Stroke Patients

Background: The literature indicates that, in relation to motor learning, healthy subjects benefit more from random practice than from constant practice. However, this effect is not well known in post-stroke patients. Objective: The goal of this study was to investigate the effects of practice structure on motor learning in post-stroke patients. Methods: Participants included an experimental group (EG) of post-stroke patients: 17 males and females; and a control group (CG) of healthy individuals: 17 males and females. At the acquisition phase, all participants performed 30 trials of a coincident timing task. Nine individuals from each group practiced constantly (C) at a stimulus propagation speed of 3 mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph. Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05 (5%).

Utilized was Bassin's anticipation timer (Lafayette Instruments #50575), which is comprised of a control screen, one 1.52 m gutter with 32 diodes placed on it linearly, and a response button. The screen has a digital display, with commands that permit the operator to control the stimulus propagation speed and the preparatory interval speed. Once activated, the screen exhibits an alert signal, and, after the preparatory interval, it initiates the propagation of a luminous stimulus, lighting the 32 diodes successively. The task required participants to press the response button simultaneously with the illumination of the last diode. The digital display showed the error measure (em): that is, the difference between the illumination of the last diode and the response.

Eligibility Criteria:
Inclusion Criteria:

1. First cerebrovascular accident
2. Lesion covering the middle and the anterior cerebral artery territories
3. Presence of hemiplegia or hemiparesis
4. Mini-Mental State Examination (MMSE) score above 24 (19)
5. Sufficient attention and comprehension to perform the task
6. Absence of other associated neurological diseases.

Exclusion Criteria:

1. Acute medical problems
2. Uncorrected vision loss
3. Previous history of psychiatric admission
4. History of multiple strokes, transient ischemic attacks
5. Pathology of the less affected, ipsilateral to stroke upper extremity that would affect ability to perform the task
6. Score of 23 or less on the MMSE
7. Difficulty in comprehension of verbal command and simple instructions
8. Aphasia of comprehension.
AI Assistant for Enhancing Colorectal Cancer Screening Among First-degree Relatives of Patients: a Randomized Trial

Participants in intervention group will receive the ScreenTalk AI-based intervention consisting of 3 sessions: tailored messaging session, open dialogue session, and summary session. The primary outcome, screening uptake will be verified by medical records; and health belief will be measured at baseline, 3, 6 and 12 months.

ScreenTalk AI can automatically tailor screening recommendations based on risk and psychosocial characteristic assessments by leveraging AI-interactive speech technology. The three components of the ScreenTalk AI-based intervention are as follows: (1) tailored messaging session: to provide CRC risk and screening recommendation based on family history and health belief assessment; (2) open dialogue session: to communicate with users asking questions related to CRC risk and screening information, underpinned by the professional knowledge database and large language models; (3) summary session: to provide a picture overview for easy review. The evaluation will be guided by the RE-AIM. Quantitative measures will determine the reach, adoption, and implementation via participation rate, session adherence, completion, satisfaction rate, fidelity and cost. Screening uptake verified by medical records and health belief will be measured at baseline, 3, 6 and 12 months. Qualitative interviews will be conducted to identify the factors affecting implementation and maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 75 years or 10 years before the age at which the relative was diagnosed;
* individuals with one FDR with CRC age \<60 years or with two or more FDRs with CRC at any age;
* have not had a colonoscopy within 5 years;
* access to WeChat themselves or through close family members living in the same household;
* able to read and speak Chinese.

Exclusion Criteria:

* Have history of cancer or inflammatory bowel disease;
* have history of a hereditary syndromes (Lynch syndrome or familial adenomatous polyposis);
* recently participate in another study or previously participated in cancer risk counseling or study;
* with doctor-diagnosed psychiatric illness.
EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study

The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.

Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. These include patients with low grade dysplasia (LGD), high grade dysplasia (HGD) or residual Barrett's after a complete endoscopic resection of a lesion containing HGD or esophageal adenocarcinoma. Ablation treatment will be performed by the EndoRotor ablation device, followed by surveillance endoscopy at 3 months where the feasibility for ablation will be assessed. During the 3 months follow-up, all adverse events such as perforation, post-procedural bleeding, stricture, and pain will be registered.

The EndoRotor® System is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Age equal to or above 18 years (adult).
* Minimum (residual) Barrett's length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)
* Scheduled Barrett's ablation for:

  * Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion,
  * Residual Barrett's mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR \<50% of the circumference)
* Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.

Exclusion Criteria:

* Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
* In case of previous EMR: EMR specimen showing deep submucosal invasion (\> 500μm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins.
* In case of previous EMR: \> 50% circumference.
* Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
* Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
* Evidence of portal hypertension, esophageal varices, etc.
* An interval \< 6 weeks between EMR and EndoRotor treatment.
* An interval of \> 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia.
* Unable to undergo endoscopic procedure using sedation analgesics.
* Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.
Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma

Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. The goal of this observational study is to study the efficacy of ablation in treating iCCA by comparing its prognosis with surgery. The main questions it aims to answer are:

* Whether microwave ablation could achieve similar efficacy with liver resection in treating iCCA
* What is the risk factor for ablation or surgery in treating iCCA
* What kind of iCCA patients could receive ablation as their first-line treatment In this real-world multicenter cohort study, we will collect data of iCCA patients from hospitals who underwent microwave ablation (MWA) or liver resection (LR) for tumors within Milan criteria. Survival will be compared between patients treated by MWA or LR.


Eligibility Criteria:
Inclusion Criteria:

1. pathologically diagnosed iCCA based on the WHO classifications;
2. curative-intent liver resection or microwave ablation;
3. tumor within Milan criteria, namely single tumor ≤5cm in maximum diameter; multiple tumors ≤3 in number and each ≤3cm; no evidence of major vascular/hilar invasion, extrahepatic/lymphatic metastasis or other malignancies;
4. age ≥18 years.

Exclusion Criteria:

Patients not meeting any one of the inclusion criteria were excluded.
Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.

Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and neurological deficits in injured individuals. The limited ability of the Central Nervous System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated accidents, falls, and violence-related injuries.

Unfortunately, there is still no effective clinical treatment for SCI. In recent years, tissue engineering and regenerative medicine based approaches have been proposed as alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed promising results in several studies. Our aim is to assess and compare the safety and effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.

The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal numbers. The first groups will be treated with autologous BM-MSC, while the second group will be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging (MRI) will be performed at base line and after 12 months of the stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Complete spinal cord injury grade AIS-A or -B, or incomplete C
* At least 2 weeks since time of injury
* Cognitively unaffected
* Motivated for stem cell transplantation

Exclusion Criteria:

* Reduced cognition
* Age under 18 years of above 70 years
* Significant osteoporosis in spine and/or joints
* Pregnancy (Adequate contraceptive use is required for women in fertile age)
* Anoxic brain injury
* Neurodegenerative diseases
* Evidence of meningitis
* Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Syphilis.
* Medical Complications that contraindicate surgery, including major respiratory complications.
* Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate Magnetic resonance imaging (MRI).
* Other medical conditions which can interfere with stem cell transplantation
* Inability to provide informed consent.
COPD Assessment Test Can Predict Depression

The frequency of depression in COPD patients are substantial and early detection and prevention of depression is critical.

Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD on patients' quality of life.

In this prospective study, we will investigate the predictive utility of CAT for predicting depression in COPD patients.

This study is aimed to investigate the association between the COPD Assessment Test (CAT) and depression in stable COPD patients. Stable COPD patients will be enrolled from the tertiary hospitals. All patients will undergo lung function tests. The Korean versions of the CAT (COPD assessment test) and Patient Health Questionnaire-9 (PHQ-9) will be used to assess COPD symptoms and depressive disorder, respectively.

We will compare the depresssion frequency among GOLD classifications of airway limitation and among the four CAT groups. And. we will also investigate which items of the CAT are the strongest indicators of depression.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients who aged \> or = 40 years

Exclusion Criteria:

* acute exacerbation within 3 months
* bronchial asthma or an increase in FEV1 of more than 12% of the predicted value with the use of 400 µg of albuterol.
* other lung diseases such as bronchiectasis, interstitial lung disease, and tuberculosis-destroyed lungs.
* who denied to consent.