cyrilzakka/clinical-trials huggingface dataset:
Dialysis Catheter Caps Case Feasibility Study

The purpose of this research is to evaluate patient comfort and ease of an investigational device called Catheter Caps Case (C3) attached to the hemodialysis catheter over a 15-minute period. You have been asked to take part in this research because you have been identified as a dialysis patient with a hemodialysis catheter.

Tunneled hemodialysis catheters are commonly used to administer dialysis to patients with kidney failure to remove excess fluid and waste from the blood. Traditionally, the maintenance and protection of these catheters involves the use of gauze and tape to secure the catheter and cover the double lumen and caps. While this method is widely practiced, it has several drawbacks that can affect both patient outcomes and healthcare efficiency.

Firstly, the use of gauze and tape can be uncomfortable for patients. The adhesive nature of the tape can cause skin irritation and allergic reactions, in addition the gauze can impede visualization of the entire length of the catheter. Additionally, the process of routine changing gauze and tape is time-consuming for healthcare providers and can increase the risk of catheter dislodgment during or catheter caps disconnection during removal of tape gauze combination.

Another significant concern is infection control. Gauze and tape do not provide an optimal sterile barrier, which can lead to an increased risk of catheter-related bloodstream infections (CRBSIs). These infections are associated with prolonged hospital stays, higher hospital healthcare costs, and increased patient mobility and mortality.

The catheter caps case was developed to address these issues by providing a more secure and sterile alternative to gauze and tape. The case is designed to cover the catheter's double lumen and end caps, offering added protection and stability. Its innovative design aims to reduce the risk of accidental dislodgement, enhance infection control, and improve overall patient comfort by eliminating the need for gauze and adhesive tape.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with tunneled dialysis catheter that will not be removed in the next 90 days.
2. Patients from the home dialysis program or in-center (outpatient dialysis) patient population.
3. Patients who are age 18 years or older

Exclusion Criteria:

1. Patient-delayed graft function (DGF)
2. Acute kidney injury patients
3. Patients with non-tunneled catheter
4. Allergies to the BioMed Elastic 50A Resin
Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

The main objective of the study is to evaluate the diagnostic performance of the XL probe for estimating degree of liver fibrosis/cirrhosis in obese patients \> 28 kg/m² with various liver diseases in patients with chronic liver disease scheduled for a liver biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient of at least 18 years of age
* Patient able to give written informed consent form
* Patient with a BMI superior or equal to 28kg/m²
* Patient scheduled to have a liver biopsy within 1 month after the enrollment or with a liver biopsy performed within 6 months before the enrollment.
* Patient for which abdominal ultrasound is technically possible

Exclusion Criteria:

* Unable or unwilling to provide written informed consent
* Confirmed diagnosis and/or history of malignancy, or other terminal disease
* Patients with clinical ascites
* Pregnant women
* Patient with a BMI \< 28 kg/m²
* Patients with any active implantable medical device (such as pacemaker or defibrillator)
* Transplanted patient and patient with heart disease
* Refusal to undergo a liver biopsy
Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area

In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis at the health service provision level. Diagnosis is also important when malaris endemicity is low - most fevers are not caused by disease. These two issues mean that most malaria and fevers are not adequately treated, even though the drugs may be effective; many patients who do not have malaria are treated for the disease, and patients with malaria may get the wrong treatment for their species. The study aims to test the effectiveness of employing rapid diagnostic tests and will study the effect on correct treatment.

The study will randomly assign diagnostic methods, either with clinical diagnosis, field microscopy or rapid diagnostic tests. The study will take place in 22 clinics in Eastern and Northern Afghanistan, both areas with low transmission of predominantly vivax malaria. They differ in their locations and their current standard diagnostic methods.

The study will examine the result of the diagnostic test in the clinic against the result of reference slides and PCR to estimate the number of cases correctly treated in each arm. This will be a measure of the effectiveness of diagnosis (and the physicians response to the diagnosis) and be influential in considering modalities for diagnostic delivery

Eligibility Criteria:
Inclusion Criteria:

* Any patient where the clinician\* considers malaria in the diagnosis - either prescribing an antimalarial or would request a malaria test if available or referring for diagnosis of malaria elsewhere.
* Patient, or parent/guardian, gives informed consent to the study.

Exclusion Criteria:

* Patients with a result from another facility
* Patients referred on for diagnosis in the private sector
* Patients the clinician decides to treat presumptively without requesting a test (defined as treating prior to randomisation)
* Where the clinician requests microscopy specifically due to clinical need prior to randomisation will not be randomised in the trial, but will be noted as part of the study and a reference slide and clinical information will be taken following consent.
RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms

This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC-associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.

This design seeks to evaluate each intervention relative to the Active Comparator. The BrainHQ (alone) arm is important because the intervention is commercially available, accessible, relatively inexpensive, and does not require trained personnel to administer. BrainHQ has been also been proven effective in other studies of cognitive dysfunction such as studies in aging, mild cognitive impairment, traumatic brain injury, among others. The BrainHQ + PASC CoRE arm and the BrainHQ + tDCS arms are suspected to provide cognitive improvements beyond BrainHQ alone through different mechanisms. Both PASC CoRE and tDCS have extensive prior use and have demonstrated utility in improving aspects of cognitive function in other clinical settings..

Participants will be randomized to one of the intervention appendices that are actively enrolling at the time of randomization. Intervention appendices may be added or removed according to adaptive design and/or emerging evidence. Various interventions will be studied.

Participants will be randomized equally across the five arms:

1. Active Comparator (video games)
2. BrainHQ
3. BrainHQ + PASC CoRE
4. BrainHQ + tDCS-active
5. BrainHQ + tDCS-sham

Eligibility Criteria:
Inclusion Criteria:

1. See NCT05965752 for RECOVER-NEURO: Platform Protocol level inclusion criteria which applies to this appendix

Exclusion Criteria:

1. See NCT05965752 for RECOVER-NEURO: Platform Protocol level exclusion criteria which applies to this appendix

Additional Appendix (Sub-study) Level Exclusion Criteria:

1. Presence of metal objects in the head or neck
2. Skin disorders or skin-sensitive areas near tDCS stimulation locations that would interfere with electrode placement or increase the risk of stimulation-induced damage, at the investigator's discretion
The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. Neuronostics will use findings from the trial to improve user experience of the Neuronostics platform (the tool which clinicians use to obtain a BioEP score from EEG and the aligned report). The data coming from the trial will also enable Neuronostics to iterate the BioEP algorithms and so improve future performance.

Neuronostics will conduct a two-arm randomised control trial with two groups: (i) Usual Care, (ii) Usual Care + BioEP score and report. In this context, usual care involves clinical/ patient history, eye-witness accounts and any standard tests ordered (electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), blood tests etc.). Investigators will recruit adults attending first seizure clinics where there is a suspicion that epilepsy is the causing symptoms and so a first EEG is recommended. Participants will be sourced from 10 sites. The trial duration will be 1 year recruitment, and 2 year follow up period.

Randomisation: Consenting individual patients will be randomly assigned to either Usual Care or Usual Care + BioEP in a 1:1 ratio. Randomisation will be stratified by centre, with eligible and consenting participants allocated in random blocks. The allocation schedule will be generated by the trial statistician, and concealed from the clinicians assessing eligibility and recruiting patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and above) presenting with first suspected seizure(s)
* Able to give informed consent
* Patient receives EEG following clinicians' decision to refer for an EEG based on clinical history and seizure description taken during first seizure clinic.

Exclusion Criteria:

* Participants unable to tolerate an EEG test so no EEG data were gathered
* Participants with a known hepatic/renal encephalopathy
* Participants that upon history taking have a clear clinical diagnosis of a physical condition other than epilepsy (e.g. vasovagal syncope)
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening

This clinical trial evaluates the patient reminders and self-referrals via online patient portals and text messaging (PReVenT) intervention for improving adherence to breast cancer screening. Though no doctor referral is required for mammography, adherence to screening mammograms remains low. Barriers to screening mammography can include things like forgetfulness, low motivation, high cost, or lack of knowledge. Patient reminders and self-scheduling assistance may overcome some of these barriers by increasing patients' awareness, motivating them to schedule their mammogram, and improving access by removing the need for a healthcare provider to order the exam. The PReVenT intervention uses online and text-message based patient-reminders and self-referral assistance to increase adherence to breast cancer screening.

PRIMARY OBJECTIVES; I. Compare the screening mammogram (SM) completion rates between PReVenT and enhanced usual care (EUC) arms at 6 months.

II. Describe patient's experience with the PReVenT intervention using mixed methods stratified by completion of SM.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive usual care as well as a portal message reminder to schedule a SM and a callback link if they need assistance. Participants who have not or do not schedule their SM at the time of the first reminder receive a reminder text-message one week later with a link to receive assistance with scheduling.

ARM II: Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating.

After completion of study, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 50-74 years
* Active online patient portal account
* Mobile phone number listed in the electronic medical record (EMR)
* At least one primary care visit in our healthcare system between 2015 and 2021
* No screening mammography performed in our healthcare system in the last 2 years

Exclusion Criteria:

* Because of limited research team and patient portal language at this time, non-English speaking patient will be excluded
* Personal history of breast cancer or prior mastectomy
* Participants who already have an upcoming SM scheduled within or outside of Emory Healthcare
* Patients who had a screening mammography at an outside facility within the prior 2 years
* Patients with severe comorbidities at the time of the study (in palliative care or hospitalized at the time of the study)
* Participants who are cognitively impaired or have with history of Alzheimer's disease or dementia
Association of Vitamin D, Parathyroid Hormone and Fibroblast Growth Factor-23 With Infarction-related Arrhythmia in Patients With Acute Myocardial Infarction

To investigate the effect of vitamin D deficiency on the development of arrhythmia in patients with acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* age ≥20 years
* diagnosed with acute myocardial infarction (confirmed by cardiac enzyme and EKG)
* subjects who agreed with informed consent

Exclusion Criteria:

* previous history of arrhythmia before onset of acute myocardial infarction
* currently taking anti-arrhythmic drugs
* severe condition of comorbid diseases that can cause more serious effects on patients than acute myocardial infarction does (e.g., cancer, cerebrovascular diseases, acute bleeding etc.)
Impact of Bean Polyphenols and Phytic Acid on Iron Absorption

Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have the potential to alleviate iron bioavailability problems associated with PA. These plants have normal phosphate levels, but reduced PA phosphate due to various modifications of the biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA concentration without any defects in terms of growth and yield.

Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the development of a variety which has the potential to improve the iron status of bean consuming populations.

The following study will evaluate the relative impact of PA and PP on iron absorption from beans by comparing iron absorption from four different bean varieties. Iron absorption from a bean with normal PA concentration and high PP concentration will be compared to iron absorption from a bean with normal PA and low PP concentration as well as to two lpa varieties, one with high and one with low PP concentration.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, non-lactating women
* Between 18 and 40 years
* Below 65kg

Exclusion Criteria:

* Metabolic, chronic and gastro-intestinal disease
* Long-term medication
* Blood donation within 6 month before the study
Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence

Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence.

The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

Urinary stress incontinence is defined as leakage of urine during stress (cough, lough, sneezing, coitus, heavy lifting, physical activity). Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence.

The CARE study has examined the efficacy of preventive BURCH RETROPUBIC URETHROPEXY among women who underwent abdominal sacrocolpopexy. According to this study, the BURCH procedure reduced the rate of post surgery urinary stress incontinence. The authors recommend to offer those women the preventive surgery. Those results cannot be relied on when considering vaginal wall repair by the vaginal approach.

The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

Eligibility Criteria:
Inclusion Criteria:

* women with vaginal wall prolapse grade 2 and more
* no contraindication to vaginal wall repair or tvt-o
* No stress incontinence

Exclusion Criteria:

* urinary tract malformations
* past urinary stress incontinence surgical procedure
* UDI - question 17 or 18 - positive answer
* Occult urinary stress incontinence
Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)

The purpose of this study is to determine new multiscale signatures for the prediction of head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for overall survival.

The clinical study is devoted to the validation of a decision support system for HNC patients management in the frame of a H2020 project.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Histologically confirmed diagnosis of oral cavity, oropharynx, larynx, hypopharynx squamous cell carcinoma
* Clinical stage III and IV
* Patient candidate for curative treatment: ± surgery ± radiotherapy ± chemotherapy
* Adequate archival pre-treatment tumor specimen available (FFPE macrodissected sections)
* Availability of baseline diffusion-weighted imaging (DWI) - Magnetic Resonance Imaging (MRI) acquisition (non-TRACE ) with more than 3 b-values (ranging from 0 (included) to 1000 s/mm2), and a field map acquisition.
* MRI images, T1 and T2 weighted, (slice thickness lower than 3 mm), head and neck in a single volume, and/or CT scan of the head and neck performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast
* Male or female ≥ 18 years old

Exclusion Criteria:

* Any previous haed and neck cancer.
* Patients with previous malignancies in the last 5 years before treatment for head and neck cancer, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
* Any previous malignancy that was treated with surgery and or radiation of the head and neck region.
* Histological type other than head and neck squamous cell cancer (nasopharynx, salivary glands and sinus nasal cancer are excluded).
Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.


Eligibility Criteria:
Inclusion criteria:

1. Patients ≥ or equal to 18 years of age.
2. Suspected or documented diagnosis of dermatofibrosarcoma protuberans (DFSP). Patients with suspected diagnosis of DSFP must have DFSP confirmed by pathology at the local institution prior to dispensing and the start of imatinib.
3. Patient is medically able to undergo surgical resection of the DFSP and resection of the DFSP is recommended for clinical management of the disease.
4. Patient has at least one site of measurable (macroscopic) disease.
5. Performance status 0, 1 or 2 Eastern Cooperative Oncology Group (ECOG) (see Section 7.1).
6. Adequate end organ function, defined as the following:

   total bilirubin \< 1.5 x institutional upper limit of normal (ULN), SGOT and SGPT \< 2.5 x UNL, creatinine \< 1.5 x ULN, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L.
7. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
8. Written, voluntary informed consent.

Exclusion criteria:

1. Patients who will receive radiation therapy to the site of DFSP prior to resection.
2. Patients with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
3. Female patients who are pregnant or breast-feeding.
4. Patients who have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) that may worsen because of imatinib.
5. Patients who have known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
6. Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection.
7. Patients who have received chemotherapy within 4 weeks prior to study entry.
8. Patients who have had a major surgery within 2 weeks prior to study entry. Incisional biopsy or partial excision of dermatofibrosarcoma protuberans to establish the diagnosis and/or to collect pretreatment tumor tissue does not qualify as major surgery.