cyrilzakka/clinical-trials huggingface dataset:
HepaSphere™ Microspheres Prospective Registry

HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015.

The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.

This prospective, post-market study was designed to evaluate the median overall survival (MOS) of subjects with metastatic colorectal cancer (mCRC) to the liver treated with HepaSphere Microspheres loaded with the chemotherapeutic agent irinotecan. This treatment process is referred to as transarterial chemoembolization (TACE).

Subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior TACE for this indication were considered for study participation. Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. All study subjects were in one cohort and were not blinded to treatment.

Per protocol, all subjects completed a baseline visit to collect medical history information, lab assessments, and have a baseline MRI. Following this baseline visit subjects were to have two TACE cycles (i.e., TACE Cycle 1, TACE Cycle 2), with TACE Cycle 2 occurring within 2-4 weeks following TACE Cycle 1. A TACE cycle is defined as one TACE procedure for subjects with unilobar disease or two TACE procedures for subjects with bilobar disease (i.e., one for each lobe of the liver). Following completion of TACE Cycle 1 and TACE Cycle 2, additional TACE cycles could be performed at the investigator's discretion for residual or new disease.

When subjects had completed two TACE cycles and were no longer indicated for further TACE cycles (at the investigator's discretion), they entered follow-up. The study ended and analysis began when all enrolled subjects had (1) completed two-year (24 months) follow-up from the date of TACE Cycle 1, (2) been deemed lost to follow up, or (3) died, whichever occurred first.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or radiologically confirmed colorectal cancer metastases to the liver
* Patient is able to have either CT or MRI imaging
* Hepatic tumor burden ≥50% of total tumor burden
* Hepatic tumor burden ≤50% of total liver volume
* Not suitable for treatment by resection or percutaneous ablation at time of TACE treatment
* Life expectancy ≥ 3 months
* WHO performance status ≤ 2

Exclusion Criteria:

* Previous treatment with any form of hepatic transarterial embolization
* Total bilirubin ≥ 3.0 mg/dL
* Any contraindication for irinotecan administration
* Partial or complete thrombosis of the main portal vein
* Cardiovascular or respiratory failure
* Any other condition deemed exclusionary by the Investigator
The Effect of Precede-Proceed Model Based Simulation Experience in Needlestick and Sharps Injuries Among Nurses

Healthcare workers are exposed to many important risks that will negatively affect their health in their working environment. Among these risks, the most important threat is needlestick injuries. Needlestick injuries in healthcare workers with work-related injuries among studies, and the prevalence of injury remains high. In a study conducted by Gheshlagh et al. (2018), the prevalence of needlestick injuries in health workers was found to be 42.5%. It has been shown in studies conducted that the most common decision needlestick injuries among health workers are in nurses. In preventing injuries, preventing, and controlling negative behaviors related to the safe use of needlestick tools is among the most important strategies. In addition, the use of evidence obtained from interventional studies to prevent needlestick injuries in protection programs also plays an important role in prevention.

The importance of frequent and regular education about the subject has been mentioned especially in the studies conducted to prevent injuries. The World Health Organization (WHO) has published gold standards in the education of nurses and has recommended the use of electronic learning and simulation methods in the programs of nursing schools for learning and teaching according to these standards. It is important to use evidence-based practices to increase quality and competence by creating realistic clinical environments in nursing education. In this context, it is possible to use simulation-based experiences for educational purposes without exposure to infection control and employee safety in the clinical field.

In a study conducted by Nakamura et al. (2019), it was found that a simulation-based training program was effective in infection control. Due to the limited number of studies aimed at protecting the health of healthcare workers and controlling infection, more simulation-based studies are needed in this area. In addition, conducting model-based studies in developing behavior in health workers will also increase success. One of these models, the Precede-Process Model, is an important guide for users in assessing the social, epidemiological, behavioral, and environmental spheres of society for planning and evaluating programs. In summary, the aim of the study is to evaluate the effect of the Precede-Process Model-based simulation training program on preventing needlestick injuries in nurses who are the occupational group most exposed to injury.


Eligibility Criteria:
Inclusion Criteria:

* 0-1 years of experience in the profession,
* Nurses who volunteered to participate in the study,

Exclusion Criteria:

* Nurses who graduated from Acıbadem Mehmet Ali Aydınlar University
* Nurses who have worked in the profession for more than one year
Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Transplantation patients treated with sirolimus (Rapamune).

Exclusion Criteria:

* Patients must be able to give informed consent.
Effect of Vibratory Expiratory Pressure on Pulmonary Function After Lung Resection Surgery

Postoperative airway clearance and recovery of pulmonary function after lung resection is critical in patients undergoing pulmonary resection surgery. The investigators hypothesized that vibratory positive expiratory pressure using the Acapella device may improve pulmonary function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients between 20 and 65 years old
* undergoing video-assisted thoracoscopic lung resection surgery for suspicious lung cancer
* admission to intensive care unit in extubate state
* with intravenous patient-controlled analgesia

Exclusion Criteria:

* body mass index of less than 15 kg/m2 or more than 30 kg/m2
* history of respiratory tract infection within 3 months
* emergency surgery
* preoperative supplemental oxygen or ventilator care
* preoperative PaO2 of less than 70 mmHg or PaCO2 of more than 50 mmHg
* preoperative FEV1 of less than 30% of predicted value
* unconsciousness or neuromuscular disease
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe obstructive sleep apnea (AHI 15 to 60).
* Cannot or will not tolerate CPAP treatment.
* Body mass index (BMI) between 25 and 40
* Able to read, understand, sign and date the written informed consent form
Posture Correction Exercises for Forward Head Posture in Chronic Smartphone and Laptop Users

This study aims to compare different posture correction exercises to see which is most effective in improving forward head posture (FHP) in people who frequently use smartphones and laptops. FHP occurs when the head leans forward, putting extra strain on the neck and shoulders, leading to discomfort and pain. With the increasing use of digital devices, many individuals experience posture-related issues without realizing their long-term effects. This study will assess the impact of specific exercises, such as chin tucks and neck isometric holds, in realigning the head and relieving discomfort. The research will involve 56 participants aged 18-40 who use their devices for at least 2-3 hours daily. Participants will perform targeted exercises over four weeks, and improvements in posture and pain levels will be measured using a standardized scale. The study aims to determine whether structured posture correction exercises can help alleviate FHP and improve overall well-being in frequent digital device users.

This study focuses on understanding and improving Forward Head Posture (FHP), a common problem seen in people who frequently use smartphones and laptops. FHP occurs when the head moves forward beyond its natural alignment, causing excessive strain on the neck, shoulders, and upper back. It can lead to pain, stiffness, headaches, and long-term postural problems. With the increasing use of digital devices, more people-especially young adults-are experiencing FHP without realizing its impact on their health. This study aims to compare different posture correction exercises to determine which is most effective in reducing FHP and associated discomfort. People often use smartphones and laptops for long hours without paying attention to their posture. Research shows that prolonged device use can cause poor posture habits, leading to musculoskeletal issues over time. If left untreated, FHP can contribute to chronic neck pain, reduced mobility, and even long-term spinal problems. This study is important because it will help identify simple exercise-based solutions that can improve posture and reduce discomfort. The findings can benefit smartphone and laptop users by promoting awareness and encouraging healthy posture habits.

Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be recruited into the study.
* Demographic criteria; age from 18-40 years both male \& female.
* Smartphone usage for minimum of 2-3 hours daily from last one year
* Willingness to participate.
* No previous treatment for forward head posture.

Exclusion Criteria:

* Participants who fall in this category would be excluded of the study.
* Spinal deformities
* Spinal injuries
* Existing neurological conditions
* Pregnancy due to possible posture changes.
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years old (inclusive), regardless of gender.
2. Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology,.
3. At least one measurable tumor lesion according to RECIST v1.1.
4. ECOG performance score of 0-1.
5. Life expectancy ≥ 12 weeks.
6. Adequate bone marrow and organ function.
7. Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.

Exclusion Criteria:

1. Patients with active central nervous system ( CNS ) metastases.
2. Spinal cord compression not be cured by surgery or radiotherapy.
3. Subjects with uncontrollable tumor-related pain.
4. Clinically uncontrollable the third space effusion.
5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
6. Received \> 30Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
7. Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
8. Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
9. History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.
10. Serious cardiovascular and cerebrovascular diseases.
11. Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
12. History of immunodeficiency, including HIV test positive.
13. Active hepatitis B or hepatitis C infection.
14. History of severe allergic reactions to any component of any study drug to be accepted.
15. Known history of alcohol or drug dependence.
16. Mental disorders or poor compliance ;
17. Pregnant or lactating women.
The Menus of Change Health and Heart Benefits for University Students

The goal of this cross-sectional study is to investigate the health benefits of the Menus of Change in undergraduate university students, by comparing 2 groups: Students eating in the Menus of change catered halls, versus students eating outside the Menus of change meal plan. The main question it aims to answer is:

What are the effects of the menus of change on other vascular outcomes, namely blood pressure? What are the effects of the menus of change on other health markers?

The Menus of Change (MoC) is an example of behaviour change that was created by The Culinary Institute of America (CIA) and Harvard TH Chan School of Public Health. This initiative is based on a set of around 24 core principles, mainly promoting and serving 'healthy, sustainable, and delicious' food in restaurants and foodservice operations. The University of Reading has successfully implemented the MoC across the campus and in students' accommodations. However, MoC is not implemented across all campus halls.

To date, most of the studies performed in relation to the MoC had explored techniques to encourage students towards healthier, more sustainable diets. Very little research focuses on the associated health outcomes and hence the impact on health of the eating pattern laid out in the MoC principles.

Therefore, this project aims to investigate the health impact of the menu of change on university students, by comparing 2 groups: students eating in MoC catered halls, following the meal plan provided by the university food services, versus students who do not follow the menus of change meal plan. The primary aim will be to investigate the effect of the MoC on vascular outcomes, namely arterial stiffness, a particularly important tool in younger adults with low-moderate cardiovascular disease risk.

Secondary aims will be to investigate other vascular outcomes, namely blood pressure changes, as well as looking at other health markers, such as full blood count, lipid profile, sugar levels, liver and kidney function, and CVD related inflammatory markers. In addition, the study aims to look at the impact of the MoC on stress and anxiety levels and the differences in students' attainment between groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Home students living in university halls
* Undergraduates
* Can understand participant information sheet and willing to comply with the study design

Exclusion Criteria:

* International students
* postgraduates
* living outside the university halls
* participating in other studies
Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO) is a five-year project that tests whether delivering care using a collaborative model helps patients with both opioid use disorders and mental health disorders.

Untreated mental illness and substance use disorders are prevalent and can have devastating consequences for the individual, their families and the community. Co-occurring opioid use disorders (OUD) with either depressive disorders and/or post-traumatic stress disorder (PTSD) are of particular concern, because depression and PTSD are prevalent in people with OUD, co-occurring mental illness is linked to an increased risk for opioid misuse and overdose, and because of the high prevalence of the chronic use of prescription opioids in individuals with mental illness, a risk factor for heroin use and the development of an OUD. Primary care is an important and underutilized setting in which to provide treatment for all three disorders, because OUD, depression and PTSD are frequently co-morbid with medical conditions. However, despite the effectiveness of treatments for all three disorders, many individuals never receive treatment; and, when treatment is provided, quality is low. With the rising number of opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. Collaborative care (CC) has never been tested with co-occurring disorders (COD), despite research by our team suggesting it may be effective. CC consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In our CC model for COD (CC-COD), the CC team also includes a behavioral health psychotherapist (BHP); the evidence-based treatments supported include medications for OUD (MOUD), pharmacotherapy for depression and PTSD, motivational interviewing (MI), problem solving therapy (PST) and Written Exposure Therapy (WET).

The current study consists of a multi-site, randomized pragmatic trial in rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico and California to adapt, harmonize and then test whether CC-COD improves access, quality and outcomes for primary care patients with co-morbid OUD and depression and/or PTSD. The study will randomize 900 patients with co-occurring OUD and depression disorder and/or PTSD to receive either CC-COD or enhanced usual care (EUC).

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Receiving primary care at one of the participating clinical sites
* Has OUD and one or more specific co-occurring behavioral health disorders (depression and PTSD)

Exclusion Criteria:

* Under 18
* Does not speak English or Spanish
* Unable to consent
* Receiving both MOUD and psychotropic medication from a provider outside of the primary care health system at which the patient is enrolled
* Not receiving primary care at one of the participating clinical sites
Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

Spasticity is a common consequence of injury to the central nervous system and can be a major problem in motor function and everyday activities. A method for treating spasticity that applies low-amplitude electrical stimulation through a garment with built-in electrodes, Mollii® (Elektrodress), has been developed. The garment is to be used in combination with individualized training and the stimulation is mainly given to antagonists of spastic muscles.

The general objective of this study is to evaluate the efficacy of and costs associated with the Mollii® treatment of spasticity due to stroke or cerebral palsy.

Primary objectives are;

* to study whether treatment with the Mollii® improves function and activity
* to evaluate the cost-effectiveness of the treatment, from both a health-care perspective and a societal perspective.

Secondary objectives are;

* to study whether there are differences in treatment effect between the stroke and the Cerebral Palsy groups in a subgroup-analysis
* to assess compliance with treatment
* to report any adverse effects.

This study is designed as a double-blinded, randomized, cross-over trial (RCT). This part of the study takes 12 weeks (6 weeks of active treatment and 6 weeks of non-active treatment) and is followed by a wash-out period of 6 weeks. An uncontrolled,open phase starts after week 18, where patients are followed one year after inclusion.

30 participants with spasticity due to Stroke and Cerebral Palsy will be included.

Two centers are recruiting participants and are collecting data.

Outcome measures are chosen to reflect the different dimensions in the International Classification of Functioning, Disability and Health (ICF) and patient reported outcome measures (PROM).

Eligibility Criteria:
Inclusion Criteria:

* Spasticity due to stroke or Cerebral Palsy
* Have some preserved walking ability, with or without walking aids
* Be able to understand the treatment and instruments/interviews used
* For stroke participants, two years should have elapsed since their injury/insult

Exclusion Criteria:

* Electronic devices
* Ventriculoperitoneal shunt
* Arrhythmia
* Hearth infarction or unstable angina pectoris
* Symptomatic hyper- or hypotonia
* Cancer under treatment
* Unstable psychiatric disease
* Lung disease, affecting daily life
* Unstable epileptic disease
* Orthopedic surgery last year
* Obesity with BMI \> 35
* Infectious disease with longstanding treatment
* Pregnancy
Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan

This is a single-arm, two-visit, non-randomized, cross sectional study identified as an intervention due to the use of a single bout of aerobic exercise to assess cerebrovascular function under the NIH rules. This study is not masked and its primary purpose is to develop a basic science understanding of the relationship between cerebrovascular health and balance control with aging. This study will involve 102 individuals classified as younger adults, middle-aged adults, and older adults who are neurotypical and cognitively normal. The primary outcome from a clinical trials perspective will be cerebrovascular response to a bout of aerobic exercise (i.e. change in cerebral blood flow with the performance of aerobic exercise on a recumbent stepper exercise machine). Non-interventional outcomes will be EEG measures of cortical activity and biomechanical kinetic and kinematic data recorded during standing balance reactions, as well as biological blood samples for genomic analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age within the following 3 group age ranges, 21-30yo; middle-aged: 40-55yo; older: 65-95yo adults
* the absence of major orthopedic disability
* cognitively normal (MoCA score ≥ 26/30 in older adult group)
* vision that is 20/40 or better with or without corrective lenses, (5) the ability to consent and communicate with researchers
* English speaking
* ability to stand for 3 minutes and walk 10 meters with or without an assistive device and without the assistance of another person.

Exclusion Criteria:

* insulin-dependent diabetes
* peripheral neuropathy
* myocardial infarction or symptoms of coronary artery disease within 2 years
* congestive heart failure or class IV heart failure
* any significant sensory impairment affecting balance or cognition; visual, vestibular, or auditory impairments.