cyrilzakka/clinical-trials huggingface dataset:
CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers

The purpose of the study is to examine the efficacy of educational materials to promote hepatitis C virus (HCV) screening and colorectal cancer (CRC) screening uptake among adults born between 1945-1965.


Eligibility Criteria:
Inclusion Criteria:

* Born between 1945 and 1965 and up to age 75
* No personal history of colorectal cancer (CRC) or current presumptive colorectal cancer symptoms (e.g., unresolved rectal bleeding or abdominal pain/bloating)
* No personal history of hepatitis C virus (HCV) or liver cancer
* Able to read, write, speak, and understand English or Spanish
* Not currently enrolled in another CRC screening or a HCV screening study
* At average risk for CRC (that is, no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC)
* Not currently up-to date with CRC screenings
* Not having previously completed HCV screening
* Able and willing to complete a phone interview
* Able to provide informed consent
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors

This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

Aim:

The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.

Methods:

The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.

Eligibility Criteria:
Inclusion Criteria:

* Female patients from the Catalan Institute of Oncology
* Aged 18 to 75
* Body mass index (BMI) of 25 kg•m-2 or more
* Completed chemotherapy and/or radiotherapy for breast cancer during the 6 months preceding recruitment

Exclusion Criteria:

* First cancer, tumours of stage IIIB and above
* Morbid obesity (BMI ≥40 kg•m-2)
* Any condition that could not permit to follow the diet and PA intervention offered
Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis

Critically ill patients are at risk of developing a sudden decrease of kidney function which may be detected by a decrease in urine output or is diagnosed on the basis of blood tests for substances normally eliminated by the kidney, primarily creatinine.

Because it takes about 24 hours for the creatinine level to rise, even if both kidneys have ceased to function, better markers are needed.

This trial is investigating if the marker urinary dickkopf-3 (uDKK3) allows an early prediction of a sudden decrease of kidney function.

Urinary dickkopf-3 (uDKK3), a stress-induced renal tubular epithelium-derived glycoprotein, has been identified as a biomarker predicting persistent kidney dysfunction.

In this prospective observational trial in patients at high risk of developing acute kidney injury we will assess whether urinary dickkopf-3 serves as a predictor of acute kidney injury.

Patients of the intensive care units of Saarland University Hospital will be surveyed for up to two years after their admission to the intensive care unit.

The progression of the estimated Glomerular Filtration Rate and uDKK3 will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated on the intensive care units of Saarland University Hospital.

Exclusion Criteria:

* Patients on renal replacement treatment before admission to the intensive care unit.
* Patients with chronic kidney disease stage CKD G3b or below.
* Known kidney disease.
* Kidney transplantation.
* Intoxications leading to dialysis treatment.
* Participation in other clinical trials.
Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria

The aim of this non-interventional study is to assess oral vinorelbine dose schedules (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of treatment under routine conditions in Germany together with the underlying reasons for the respective chosen schedules.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient with regard to the pseudonymized documentation and processing of his/her disease data
* Legally capable male or female NSCLC patient or legally capable female MBC patient; in both situations: ≥ 18 years of age (no upper limit)
* Presence of any of the following two tumor entities:

  * Advanced NSCLC (stage III or IV)
  * Anthracycline- and taxane-resistant MBC (stage IV) in women
* Planned systemic chemotherapy and planned regimen with oral vinorelbine in any palliative setting (decision on treatment must have been made before inclusion in this study); included treatments:

  * Monotherapy or any combination therapy with oral vinorelbine
  * Inclusion of patients with hybrid-treatment involving i.v. and oral vinorelbine in one treatment cycle is allowed

Exclusion Criteria:

* Presence of any contraindication with regard to oral vinorelbine treatment (and with regard to i.v. vinorelbine in case of hybrid-treatment) according to the respective Summary of Product Characteristics (SmPC)
* Oral vinorelbine based palliative treatment already ongoing or planned oral vinorelbine starting dose of \>60 mg/m2
* Presence of a Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 2
* Simultaneous participation in an interventional clinical trial
Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.

Phase 1, multi-center, open-label, dose-escalation study to:

* Evaluate the safety profile and MTD of RP-6306 with gemcitabine to establish the RP2D and schedule
* Characterize the PK and pharmacodynamics of RP-6306 with gemcitabine
* Assess preliminary anti-tumor activity associated with RP-6306 with gemcitabine

Eligibility Criteria:
Inclusion Criteria:

* Male or female and ≥18 years-of-age at the time of informed consent.
* ECOG Performance status 0 or 1.
* Locally advanced or metastatic resistant or refractory solid tumors.
* Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
* Measurable disease as per RECIST v1.1.
* Ability to swallow and retain oral medications.
* Acceptable hematologic and organ function at screening.
* Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
* Resolution of all toxicities of prior therapy or surgical procedures.
* Life expectancy ≥12 weeks after the start of the treatment

Exclusion Criteria:

* Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study drug.
* History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
* Patients who are pregnant or breastfeeding.
* Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
* Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
* Major surgery within 4 weeks prior to first dose of RP-6306 and gemcitabine.
* Uncontrolled, symptomatic brain metastases.
* Uncontrolled hypertension.
* Moderate or severe hepatic impairment
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
The Use of Palliative Non Invasive Ventilation in Acute Respiratory Failure. OVNI Study.

The purpose of this study is:

* to estimate the frequency of the use of non invasive ventilation
* to estimate the frequency of the use of palliative non invasive ventilation
* to evaluate the impact of non invasive ventilation
* to propose some recommendations

The purpose of this study is:

* to estimate the frequency of the use of non invasive ventilation
* to estimate the frequency of the use of palliative non invasive ventilation
* to evaluate the impact
* to propose some recommendations

Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory failure
* hospitalization in ICU
* age \>= 18 years

Exclusion Criteria:

* Patients who have already participated to OVNI
Improving African American Glaucoma Patient Involvement in Visits and Outcomes

This is a research project about services provided to African American patients with glaucoma. The goal of the project is to improve communication between providers and African-American patients about glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* African American
* Age 18 or older
* Able to speak and read English
* Mentally competent to participate
* Not blind (are at least 20/400 in their better seeing eye)
* On one or more glaucoma medications
* Report being less than 80% adherent to their glaucoma medications on a Visual Analog Scale

Exclusion Criteria:

* \< 18 years of age
A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults

This is a 3-arm controlled trial. The participants are caregivers of the community-dwelling dependent older adults. There will be around 105 participants to be recruited and randomly allocated into 3 groups. Caregiving training group will receive a evidence-based caregiving training delivered via home visit of community nurse. Caregiving training plus family resilience group will additionally receive a structured family resilience intervetion. Control group will receive usual community health care service by nurses. The primary outcomes are caregiving ability, family resilience and psychological distress, and the secondary outcomes are caregiving burden, resilience, coping, social support, and quality of life the caregivers and the older adults. The measurement will be conducted four times at baseline, after, 1-month and 3-month after intervention.


Eligibility Criteria:
Inclusion Criteria:

* ①The degree of disability of the caregiver is moderate to severe activity of daily living score above;

  * The primary caregivers are≥18 years old ;

    * The primary caregivers bear the most important care task during care, and the continuous care time are≥3 months ; -④The psychological pain thermometer score of the primary caregivers are≥5 points (the previous cross-sectional survey results showed that when the psychological pain thermometer score of the primary caregivers in disabled elderly are 5 points, the highest Youden index is obtained, and the sensitivity, specificity, positive predictive value, and negative predictive value are also high. Therefore, participants with scores above 5 points are screened as potential research subjects ); -⑤No cognitive impairment or language expression disorders; -⑥The primary caregivers have smart phones and can use them skillfully, and have access to the Internet; -⑦Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

* ①Currently participating or having received intervention from other healthcare teams within the past three months;

  * There are paid personnel such as nannies participating in the care.

    * Those who voluntarily withdrew from the research process;

      * During the research process, due to significant adverse events (such as death) involving disabled elderly individuals or primary caregivers, they were unable to continue participating in the study.
PCV10 Reactogenicity and Immunogenicity Study - Malindi

The World Health Organization has recommended that developing countries should incorporate pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine childhood immunization schedule in 2010. In the areas of Kenya that have been designated to monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed for use in children up to 2 years of age, but its use as a primary series in children over age 12 months has not been evaluated. This study will assess the immunogenicity and reactogenicity of PCV10 first administered at an age of 12-59 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 12-59 months
* Written informed consent

Exclusion Criteria:

* Current febrile illness (temperature \>38.5°C)
* Previous receipt of any pneumococcal vaccine
* Previous receipt of a DTP-containing vaccine after the 1st year of life
* Previous receipt of hepatitis A vaccine
* Severe malnutrition (mid upper arm circumference \<11.5 cm) or other serious medical condition (e.g., malignancy, AIDS, tuberculosis)
* Seizures within the previous 6 months or progressive neurological illness
* Known allergies to vaccines or vaccine components
* Resident in the Kilifi Demographic Surveillance area
* Intention to leave the study area in the next 6 months
Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.

This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Women with a history of stage I-IIIa invasive breast cancer
* History of hormone-receptor positive cancer (either ER + or PR + or both)
* Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
* Are experiencing AIMSS

Exclusion Criteria:

* Unable to read or understand English
* History of psychiatric disability affecting informed consent or compliance with drug intake
* Malabsorption syndrome or inability to take oral medication
* Has less than 7 months of AI therapy remaining
Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

As human life expectancy increases, the prevalence of degenerative osteoarthritis of the knee joints is steadily rising, leading to a significant surge in the frequency of total knee arthroplasty (TKA). However, research on sarcopenia in the population that comprises the primary recipients of these orthopedic joint surgeries has been notably lacking. Since the release of the 2019 Consensus update on sarcopenia by the Asian Walking Group for Sarcopenia (AWGS) in 2020, research on sarcopenia has gained momentum in various domains. Yet, as previously mentioned, the field of orthopedics still lags behind in investigating sarcopenia. Therefore, it is believed that establishing the relationship between sarcopenia and surgical outcomes in the elderly, who are the primary targets of orthopedic joint replacement surgery, could offer insights to further enhance the results of joint replacement surgeries.


Eligibility Criteria:
Inclusion Criteria:

* A woman aged 60 or older who is undergoing TKA due to degenerative osteoarthritis of the knee joint at the our institution.

Exclusion Criteria:

1. Male
2. Under 60 years of age
3. Patients with a history of rheumatoid arthritis, traumatic joint disease, and post-infection joint disease
4. Patients who cannot undergo tests for muscle weakness diagnosis A. Patients unable to walk B. Patients unable to stand alone due to conditions like cerebral palsy or brain disorders C. Patients unable to use muscle strength
5. Patients considered inappropriate for recruitment in this study based on the judgment of the research team.
Comparison of Elution Swab (ESwab) and Amies Transport Swabs for Screening Patients for Methicillin Resistant Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) Colonization

1.To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the detection of Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) in colonized patients and to determine whether nasal cultures alone is sufficient for detection of MRSA isolates in hospitalized patients. 2.To assess patient comfort in the use of the ESwab vs. Amies Transport swab for screening patients for methicillin resistant Staphylococcus aureus and vancomycin-resistant Enterococcus.

MRSA is a major cause of nosocomial and life threatening infections. Infections with MRSA have been associated with a significantly higher morbidity, mortality and costs than methicillin-susceptible S. aureus (MSSA).1 Selection of these organisms has been greatest in the healthcare setting; however, MRSA have also become more prevalent in the community.2 To control the transmission of MRSA, the Society for Healthcare Epidemiology of America (SHEA) has recommended guidelines, which include an active surveillance program to identify potential reservoirs and a rigorous infection control program to control the spread of MRSA. Accurate identification of patients colonized with MRSA is essential in managing the transmission of the organism. It is currently unknown whether the currently utilized collection rayon swab is the optimal swab in detecting colonized patients The purpose of this study is to directly compare whether Eluted (ESwab) swab is superior to the currently utilized rayon swab in identifying MRSA/VRE colonized patients.

Eligibility Criteria:
Inclusion Criteria:

* Hospitallized patients known to be colonized with MRSA/VRE

Exclusion Criteria:

* Unable to provide informed consent
Visco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy

comparing outcomes of Visco-Circumferential-Suture-Trabeculotomy in primary congenital glaucoma to trabeculotomy

prospective randomized interventional study conducted on infants below the age of 2 years with PCG attending the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University were recruited to compare the long-term surgical outcomes of this proposed technique (VCST) and rigid probe VT in patients with PCG.

Eligibility Criteria:
Inclusion Criteria:

* infants below the age of 2 years with PCG

Exclusion Criteria:

* patients older than 2 years on presentation
* eyes with previous surgery
* eyes with secondary glaucoma
* eyes diagnosed as anterior segment dysgenesis syndrome
Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot

Evaluation of cardiac and extra cardiac vascular defects associated with Tetralogy of fallot in pediatric patients, regarding frequency and types of anomalies with assesment of multidetector computed tomography diagnostic value.

Tetralogy of Fallot (TOF) is the most common complex cyanotic congenital heart disease (CHD), with a prevalence of 3.5-9%. Almost all pediatric patients born with TOF can now expect to survive to adulthood because of advances in its surgical treatment. In addition to the four diagnostic criteria of TOF that include ventricular septal defect, right ventricular hypertrophy with outflow tract obstruction, and overriding aorta, other extra-cardiac vascular anomalies are frequently coexist . These may involve pulmonary, aortic, and coronary arteries with or without valve abnormalities, aorto-pulmonary vessels, and vena cava connections, is crucial for surgeons in the formulation of surgical strategies. Trans-thoracic echocardiography (TTE) is the initial classical procedure done for these patients, as it can demonstrate heart structure and estimate intra-cardiac pressures, gradients, and contractile functions as well as blood flow direction across any heart defect and emphasizing coronary vessels integrity. However, many extracardiac vascular defects associated with different heart diseases cannot be detected accurately by TTE; consequently, heart catheterization with its invasive complications was widely used for confirming these abnormalities before surgery. Recently, the evolution of multi-slice or multi-detector computed tomography (MDCT) with its multi-planar information, lower doses of radiation, short scanning time, and easy availability suggested it to be a non-invasive reliable diagnostic method for detection of different malformations in pediatric patients with complex CHD. Thus, effective imaging modalities are required to provide a thorough preoperative anatomic description of the associated extracardiac vascular anomalies in pediatric patients with TOF in order to improve surgical planning and outcomes. In recent years, multi-detector computed tomography (MDCT) has become regarded as a reliable non-invasive tool for delineating various anomalies in patients with complex CHD. Few studies have focused on the preoperative evaluation of associated cardiac and extracardiac vascular anomalies in pediatric patients with TOF using MDCT, especially not large case series studies. In this study, we aim to investigate the diagnostic performance of MDCT for assessing associated cardiac and extracardiac vascular abnormalities in patients with TOF.

Eligibility Criteria:
Exclusion criteria

* Non-surgical patients
* Patients with unstable clinical conditions
* Renal insufficiency
* Hypersensitivity to iodinated contrast.

Age range of included patients:

All pediatric patients less than 18 years were included. All patients underwent MDCT and TTE preoperatively. All associated cardiac and extracardiac vascular abnormalities and their percentages will be recorded.