cyrilzakka/clinical-trials huggingface dataset:
Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis

Symptoms, such as cough and shortness of breath, are common among patients with pneumoconiosis. Depression and anxiety can be elicited by the symptoms, while avoidance of daily activities is believed to reduce trigger of symptoms. The lung function is then declined and the risk of having stroke and heart failure is increased. The objectives of this 2-arm waitlist pilot randomized controlled trial are to test the effects and feasibility of an acceptance-based educational program among patients with pneumoconiosis. 80 participants will be recruited from community centers and randomly assigned to intervention group or waitlist-control group in a ratio of 1:1. The 6-week group-based educational program will be provided to the intervention group first, then the waitlist-control group. The program consists of 4 sessions integrated with acceptance components and care of pneumoconiosis. Their psychological health, healthy lifestyles, and cardiometabolic profiles will be assessed at baseline, week 6, and week 14. Data will be analyzed using a statistical package. The feasibility of the program will be evaluated by interview. The findings of this study can inform the integration of acceptance-based intervention into pneumoconiosis management in Hong Kong, and future study on chronic progressive lung diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Ethnic Chinese who is able read and speak Chinese.
2. Adults aged 18 or over.
3. Taking compensation for pneumoconiosis.

Exclusion Criteria:

1. Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
2. Those who are unable to give written consent.
Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas

Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative, inflammatory, or degenerative still constitute a major medico-surgical challenge due to the particular anatomy of the spinal cord. Indeed, the spinal fibers (whether they have a sensory or motor function) are all condensed in an extremely small volume. To date, there is no reliable technique to know the precise position of the spinal tracts specifically involved in the sensory and motor functions of the upper and lower limbs.

The purpose of this study is to evaluate the feasibility for differentiating spinal tracts by tractography from a cerebral Diffusion tensor imaging (DTI) Magnetic Resonance Imaging (MRI) sequence (associated with an anatomical sequence) by performing a stitching process with spinal cord DTI MRI sequence, in healthy subjects. The criterion of differentiation of the tracts will be assessed by highlighting already known cerebral tracts (cortico-spinal fibers, spinothalamic, posterior cord) and which will be monitored at the spinal level.


Eligibility Criteria:
Inclusion Criteria:

* patient\> 18 years old
* Healthy volunteer
* Social insured in France
* Patient who signed the informed consent of the study

Exclusion Criteria:

* Medical or surgical history of disease that may affect the central nervous system, or the spine
* History of spine or spinal cord trauma.
* Spinal osteoarthritis which can lead to a medullary hyper signal.
* Contraindication to MRI: claustrophobia, pace-maker, defibrillator, metallic foreign bodies, etc.
* Subjects benefiting from legal protection (curatorship, guardianship or safeguard of justice).
* Pregnant and / or breastfeeding woman.
Prognostic Markers of Patients With STEMI

To analyze the relationship between the clinical data and the outcomes of STEMI patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ST-segment elevation myocardial infarction(STEMI).

Exclusion Criteria:

* Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases,or any other malignancy.
* Pregnant women.
* Severe hepatic dysfunction.
* Uncontrolled hypertension.
Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).

The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaining popularity in scientific literature as a viable alternative to salvage catheter ablations. Considering the scarcity of data from prospective trials and concern about the safety of the treatment method, this trial seeks to determine whether Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT) meets the expected safety requirements for clinical use.

Eligibility Criteria:
Inclusion Criteria:

* Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
* Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment.
* At least one episode of monomorphic VT registered in electrophysiological examination.
* Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment).
* Patient must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

* Heart failure requiring inotropic treatment or mechanical assistance
* Arrhythmia due to cardiac channelopathy
* Reversible source of arrhythmia
* NYHA (New York Heart Association) stage IV hearth failure
* Hearth infarction or cardiac surgery in last 3 months
* Life expectancy \<6 months
* Polymorphic VT
* Pregnancy
* Prior radiotherapy to the thoracic region (relative contraindication)
* Failure to induce VT during electrophysiological examination
Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

Preterm Birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, particularly across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU). This study will attempt to identify and rectify provider and patient related barriers to TVU screening implementation.

Preterm birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, and especially across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU) measurement of cervical length. However, several unique provider and patient related barriers for implementation of this screening limit the widespread uptake of this evidence based practice in Appalachian KY. The investigators propose to adopt a dissemination and implementation science approach using the Consolidated Framework for Implementation Research (CFIR) as the guiding framework for identification of key areas of knowledge deficits as well as attitudes, practices and perceived barriers among prenatal care providers and patients in eastern KY towards TVU cervical length screening using a mixed - methods design. This will be utilized to develop a multifaceted implementation strategy best suited for addressing and overcoming barriers identified by the target population in eastern KY. The investigators anticipate that such an implementation strategy will likely include an educational component targeting obstetric care providers and patients in addition to hands-on TVU cervical length evaluation as well as telemedicine support and surveillance. Three community based sites (Hazard, Morehead and Ashland, KY) will be recruited for implementation of this multi-component pilot program focused on community engagement and outreach targeting obstetric providers and their patients. At the end of the pilot implementation phase, acceptability of the study intervention and feasibility of implementation will be evaluated along with a preliminary assessment of effectiveness of implementation.

Eligibility Criteria:
Inclusion Criteria: Participant

* Female Sex
* Prior history of preterm birth (for initial set of interviews), no preterm birth history required for intervention feedback
* Current pregnant status

Exclusion Criteria: Participant

* Male Sex

Inclusion Criteria: Provider

* Certified as obstetric/gynecologic provider
A Patient-centered Approach to Successful Community Transition After Catastrophic Injury

Shepherd Center is bringing a more patient-centered focus to educational, peer-support, and technology resources offered to patients with spinal cord injury and their families and is evaluating these changes.

Approximately 740 patients have provided information about healthcare utilization following inpatient rehabilitation. This information will help Shepherd Center staff follow utilization trends and plan programs targeted at the high-use areas.

Research efforts are transforming the educational, peer-support and technology resources offered to patients and their caregivers, and evaluating how these changes help improve outcomes, including building patients' sense of self-efficacy - the belief that they can effectively manage their own care. Goals of the three focus areas include:

A. Patient and Family Education Revamp patient education modules for bladder management, skin management, and medical complications management to follow the chronic disease self management approach that replaces didactic lectures with participant-focused problem solving discussions led by peers (persons with SCI). Multiple baseline implementation approaches will be evaluated in interrupted time series analyses.

B. Peer mentoring and peer-led self-management training The peer mentor randomized clinical trial is reported separately on clinicaltrials.gov and not repeated here.

C. Patient and family web portal Shepherd Center, along with our collaborators at Craig Hospital in Denver, Colorado, are developing an engagement portal to provide a mechanism for patients to manage all aspects of injury following rehabilitation discharge and share information with other providers and caregivers.The portal will become a standard part of rehabilitation care and discharge planning for all Shepherd Center patients - starting first with patients with spinal cord injuries and later expanding to others. Stakeholders will be actively involved in providing feedback about portal usability and content so that the product continues to meet their needs.

Eligibility Criteria:
Inclusion Criteria:

* patient receiving inpatient rehabilitation at Shepherd Center following spinal cord injury
* discharge to community setting

Exclusion Criteria:

* discharge to non-community setting
* patient without spinal cord injury at Shepherd Center
Acute Kidney Injury After Craniotomy

The aim of this study was to investigate the incidence, risk factors and prognosis of acute kidney injury (AKI) in critically ill patients after craniotomy.

This was a prospective, single-center, cohort study that included adult patients who were admitted to the ICU of Beijing Tiantan Hospital from January 2017 to December 2018 after craniotomy and had a stay in the ICU for ≥ 24 hours (patients with preoperative AKI were excluded). Data collected included patient demographics (age, gender, underlying diseases, baseline serum creatinine, etc.), primary diagnosis, perioperative information, disease severity scores, as well as the occurrence of hypernatremia and hyperchloremia within 48 hours after ICU admission. For patients with AKI, pre-AKI sepsis and shock, and the recovery of renal function were recorded. All patients were followed until discharge, and information about prognosis was recorded. Multivariate regression analysis was used to identify the risk factors of AKI.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent craniotomy
* admitted into ICU ward and the ICU length of stay ≥24h

Exclusion Criteria:

* Age\< 18 years;
* Patients with pre-existing acute kidney injury (AKI) and chronic kidney disease undergoing long-term renal replacement therapy (RRT) .
Optimization of the Isolation Protocol for Extracellular Vesicles (EVs) From Human Follicular Fluid

Background: Extracellular vesicles (EVs) are membrane-bound vesicles found in all biological fluids, containing various regulatory molecules, including microRNAs (miRNAs). It has been suggested that the EVs in human follicular fluid (the fluid surrounding the oocyte within the ovary) play a crucial role in oocyte development through these miRNAs. However, several methods exist for isolating these EVs from follicular fluid. Before further research can be conducted on the pathophysiology and potential diagnostic and therapeutic applications of these EVs and their content, the optimal isolation technique must be determined for future studies.

Each method has its advantages and disadvantages, and the purity and efficiency may vary between species and different biological fluids. There are only a limited number of studies comparing the various techniques for application in human follicular fluid.

Objective: This study will compare the three most commonly used techniques for isolating EVs: size-based, sedimentation-based (differential ultracentrifugation), and buoyancy-based isolation techniques.

Methodology:

In this prospective study, follicular fluid will be collected from four patients undergoing transvaginal oocyte retrieval following ovarian stimulation at Ghent University Hospital. Patients over 40 years of age or with endometriosis, adenomyosis, or PCOS (polycystic ovarian syndrome) will not be included in this study. During the oocyte retrieval procedure, follicular fluid will be collected from 2-4 oocytes per patient. Since follicular fluid is not used in the patient's treatment (residual material), it does not affect the treatment.

After collection, the three isolation techniques will be applied to each sample. The techniques will be compared in terms of purity (absence of contamination) and efficiency (EV concentration) using transmission electron microscopy, nanoparticle tracking analysis, and western blotting.


Eligibility Criteria:
Inclusion Criteria:

* Patients planned for an oocyte retrieval at Ghent University Hospital.

Exclusion Criteria:

* Diagnosis of endometriosis/adenomyosis
* Diagnosis of PCOS (Polycystic Ovary Syndrome)
* Macroscopic blood contamination at oocyte retrieval
High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction

Patients with suspected acute coronary syndrome account for a tenth of all presentations to the Emergency Department and up to 40 per cent of unplanned hospital admissions. The majority of patients do not have a heart attack (myocardial infarction), and may be safely discharged from the Emergency Department.

The investigators propose to evaluate whether the use of the HighSTEACS pathway in patients with suspected acute coronary syndrome reduces length of stay and allows more patients to be safely discharged from the Emergency Department. This pathways utilizes high-sensitivity cardiac troponin I testing and will rule out myocardial infarction if troponin concentrations are \<5 ng/L on presentation, with further testing indicated at 3 hours only in those presenting early or with troponin concentrations between 5 ng/L and the 99th centile.

In six secondary and tertiary centres across Scotland, the investigators will introduce the pathway as part of a stepped wedge cluster randomized controlled trial. Sequential hypothesis testing will evaluate the efficacy and safety of the pathway. The primary efficacy end-point will be length of stay from time of presentation until final hospital discharge and the primary safety end-point will be survival free from type 1 or 4b myocardial infarction or cardiac death from discharge to 30 days. The study population will consist of those patients with cardiac troponin concentrations within the normal reference range (\<99th centile) at presentation.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with suspected acute coronary syndrome
* High-sensitivity cardiac troponin I measured as part of routine clinical care

Exclusion Criteria:

* Patients who are not resident in Scotland
* Patients with ST-segment elevation myocardial infarction
* Patients presenting to hospital in cardiac arrest
* Patients with presentation high-sensitivity cardiac troponin I concentrations greater than sex-specific 99th centile thresholds
The Effect of Beta-glucan in Non-Small Cell Lung Cancer

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.

Beta-glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. Imucell WGP is extracted from food-grade baker's yeast, which is permitted for use in food by the U.S. Food and Drug Administration (FDA). Studies in animals have shown that Imucell WGP helps trigger white blood cells to destroy cancer cells. Other animal studies combining Imucell WGP with anti-cancer medications have shown greater tumor regression and tumor-free survival.

Eligibility Criteria:
AIM 2:

Inclusion Criteria:

* suspected or definitive diagnosis of non-small cell lung cancer (NSCLC)
* treatment naive or no treatment within 6 months prior to enrollment
* able to swallow pills
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
* absolute neutrophil count (ANC) at least 1500/microl
* able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* history of hypersensitivity reactions attributed to beta-glucan
* currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy
* presence of an uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

AIM 3:

Inclusion Criteria:

* resectable non-small cell lung cancer (NSCLC), as determined by a thoracic surgeon
* treatment naive
* able to swallow pills
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* must be an operative candidate
* absolute neutrophil count (ANC) at least 1500/microl
* able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* history of hypersensitivity reactions attributed to beta-glucan
* currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy
* presence of an uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Baby Friendly Initiative Implementation: Maternity Staff Experiences

This qualitative, case study will explore the experiences of maternity staff in England when implementing the World Health Organisation and Unicef Baby Friendly Initiative (BFI) standards within a maternity organisation.

A range of maternity staff over 4 UK NHS hospitals will be recruited and interviewed by one chief investigator regarding their experiences of working with the BFI standards in their daily professional practice.

Eligibility Criteria:
Inclusion criteria

* Maternity staff who have had training in and with experience of working with the BFI.
* Senior neonatal staff working in the maternity unit.
* Maternity unit management.
* Staff in specialised infant feeding roles at local hospitals.
* Student midwives on placement at main study hospital site.
* English speaking.

Exclusion criteria

* Maternity staff with no BFI experience.
* Medical staff.
* Community maternity staff.
* Community nurses and health visitors.
* Student nurses.
Rhizomelic Chondrodysplasia Punctata Registry

The goal of this registry is to collect medical information on individuals with rhizomelic chondrodysplasia punctata and closely related conditions. The study team hopes to learn more about these conditions and improve the care of people with it by establishing this registry.

The goal of this registry is to collect information on individuals with rhizomelic chondrodysplasia punctata (also called RCDP). This registry will enable detailed natural history studies of RCDP, with the hopes that identification of risk factors will allow for preventative treatments and thus a better quality of life for individuals with these diagnoses.

This study is limited to chart review, after signed informed consent obtained. There will be no additional visits or time in clinic because of participation in this registry. This study involves only the collection and storage of data extracted from the medical record. Records that may be requested and reviewed as a part of this study include but may not be limited to: specialist evaluations, surgical reports, results of blood and urine tests, genetic testing, x-rays, CT/MRI imaging. There are no special procedures, visits, or expectations of the individual as a result of participation in this registry. No one will be asked to have any specific testing for the sole purposes of this research.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RCDP or closely related conditions by metabolic and/or genetic testing

Exclusion Criteria:

* Not meeting diagnosis of RCDP or closely related conditions by study team physician review of prior metabolic and/or genetic testing
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection

To evaluate the clinical safety of different doses of MEDI-507 through day 33.

To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.

Eligibility Criteria:
Inclusion Criteria:

* Renal allograft recipients receiving their first or second allograft
* Age over 18
* Maintained on conventional immunosuppression
* Completed informed consent document

Exclusion Criteria:

* Known hypersensitivity to MEDI-507
* More than two renal allografts
* Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial
* Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert)
* Any of the following clinical settings or diagnoses posttransplant:

pregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection

* Having received OKT3, tacrolimus, or antilymphocyte globulin during the current allograft
* Less than 10 ml/hr average urine output over 4 hours since the end of surgery
Pharmacokinetics Study for Probucol

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.

Eligibility Criteria:
Inclusion criteria

* Korean
* Male
* Age from 20 to 40 years at time of informed consent
* BMI more than 19.0 and less than 25.0
* Subjects who meet the following criteria at the time of the screening
* Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values

Exclusion criteria

* History or clinical evidence of significant medical history
* Present or previous significant drug allergy to any prescription or OTC medication