cyrilzakka/clinical-trials huggingface dataset:
PLAN Intervention to Enhance Engagement of Latino Cancer Patients in Advanced Care Planning

This trial tests whether Planning for Your Advance Care Needs (PLAN) intervention works to enhance Latino patients' understanding of and engagement in advanced care planning. The PLAN intervention may be an effective method to help people with cancer plan for and talk about advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.

ARM II: Patients receive usual care.

After completion of study treatment, patients are followed up at 1 week and then at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Identifying ethnically as Latino.
* Locally advanced or metastatic cancer and/or have experienced disease progression on at least first-line chemotherapy.
* Ability to provide informed consent.

Exclusion Criteria:

* Not fluent in English or Spanish.
* Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of \>= 6 to be delivered by trained study research staff during screening).
* Too ill or weak to complete the interviews (as judged by interviewer).
* Currently receiving palliative care/hospice at the time of enrollment (to allow prediction of \[advanced care planning\] ACP).
* Children and young adults under age 18.
* Patients deemed inappropriate for the study by their treating oncologist.
Playing Games to Learn About Children's Vaccines Project

This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of two strongly recommended vaccines with suboptimal uptake rates: Human papillomavirus (HPV) and COVID-19 in vulnerable and underserved youth aged 11-14.

The study objectives are:

Objective 1: Assess feasibility (participation rate, retention, involvement, satisfaction) of two game-based interventions targeting HPV and COVID-19 vaccination.

Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention; Arm 2: COVID-19 game-based intervention; Arm 3: usual care). The investigators will explore patterns of pre- to post-intervention change in theoretical mediators and vaccine intent, and explore levels of vaccine intent and uptake in 90 parent-child dyads of unvaccinated youth aged 11-14.

Eligibility Criteria:
Inclusion Criteria:

* Child sample: Individuals who (1) are aged 11-14 years, (2) have not received the 1st dose of HPV or COVID-19 vaccine, (3) can speak and read English, and (4) when approached, both parent and the child indicate that they do not plan or cannot decide whether the child will receive the HPV or COVID-19 vaccine.
* Parent sample: Individuals who (1) are the parent/caregiver of the participating child, (2) agree to participate in the research activities. If more than one child in the same family is eligible for the study, the oldest one who has not received the HPV or COVID-19 vaccination will be recruited.

Exclusion Criteria:

* Individuals who do not meet inclusion criteria or refuse to provide consent/assent.
Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

Tranexamic acid has been used to reduce bleeding and transfusion for years. Randomized studies showed its efficacity in orthopedic surgery, trauma and post-partum hemorrhage. Few data were available for other types of surgery and the safety profile of tranexamic use was nor clearly established. In april 2022, the results from the POISE-3 (Perioperative Ischemic Evaluation - 3) trial was published in the New England Journal of Medicine. This stdy clearly demonstrated in 9535 patients undergoing non-cardiac surgery, that the use of tranexamic acid significantly reduced not only perioperative bleeding, but also transfusions. The safety profile of tranexamic acid was very good in this trial. This publication was rapidly followed by editorials in major anesthesia journals, calling for "safe surgery" with a systematic use of tranexamic acid in the population studied in the POISE-3 trial. A literature review was done with a formal presentation at Erasme University Hospital, again with the call for a systematic use in appropriate patients.

In this study, the adherence to these recommendations will be tested. All patients operated between october 1st 2022 and december 31 st 2022 will be included. For every patient, it will be determined if this patient should have received tranexamic acid according to the results of the POISE-3 trial and wether this patient really did get tranexamic acid. Primary endpoint will be the percentage (%) of patients correctly treated according to the POISE-3 recommendations. A second primary endpoint will be the comparison with patients operated between October 1st 2021 and december 31st 2021; that means before the publication of the recommendations. The difference between both populations will be tested with a Chi-square test. Secondary outcomes wil be bleeding and transfusion in the correctly treated population compared with an eventually not correctly treated population.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery either between oct 1st 2021 and dec 31st 201 or oct 1st 2022 and dec 31st 2022
* noncardiac surgery
* expected to require at least one overnight hospital admission after surgery
* at risk of perioperative bleeding

Exclusion Criteria:

* cardiac surgery
* intracranial neurosurgery
* creatinine clearance \< 30 mL/min (Cockcroft-Gault equation)
* chronic dialysis
* history of seizure disorder
* recent (\< 3 months) stroke, myocardial infarction, acute arterial thrombosis, venous thromboembolism
* fibrinolytic condition following consumption coagulopathy
* subarachnoid hemorrhage within 30 days before surgery
* women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia

Vitamin D deficiency is a commonly observed health problem in the world. With a role in many chronic diseases and especially lung diseases, the importance of vitamin D deficiency in anesthesia management is increased. This research aims to investigate whether there is a correlation between the respiratory complications occurring in patients under general anesthesia and preoperative vitamin D levels.

This study included 95 adult cases aged from 18-65 years operated under general anesthesia. The cases had total 25-hydroxyvitamin D (25OHD) levels identified in blood samples before the operation. Patients given routine general anesthesia and postoperative monitoring procedures were assessed in terms of respiratory complications during anesthesia induction, extubation, anesthesia recovery and the first 24 hours postoperative.

This research observed that patients with low preoperative 25OHD vitamin levels encountered respiratory complications related to general anesthesia more often. Especially in the early postoperative period there is a very significant difference between complications and low 25OHD vitamin levels. Our study results show that low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia causing severe morbidity and mortality increase. The results lead to the consideration that optimizing vitamin D levels in the preoperative period for patients undergoing general anesthesia may aid in reducing complications.

Eligibility Criteria:
Inclusion Criteria:

- American Society of Anesthesiologists I - II risk classification, healthy adult surgery cases

Exclusion Criteria:

* Thoracic surgery, those with severe respiratory, neuromuscular or endocrine system diseases, those with difficult intubation, morbid obesity, using vitamin D supplements and those who smoked
Acceptability of Depo-subQ in Uniject

This is an observational study to assess the experience of current depot medroxyprogesterone acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject and offer recommendations for the introduction of this method.

This is an observational study to assess the experience of current depot medroxyprogesterone acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject and offer recommendations for the introduction of this method.

A total of 560 participants will be enrolled in the study in the following groups:

360 participants (120 in Uganda and 240 in Senegal) who are current DMPA IM clients who seek re-injection of DMPA from either community health workers (CHWs) or clinic-based providers; and are 18-40 years of age; received their most recent DMPA injection no more than 13 weeks prior to enrollment in the study \[16\].

Up to 100 participants (50 in Uganda and 50 in Senegal) current DMPA IM clients who meet the inclusion/exclusion criteria but do not want to receive the injection with Depo-subQ in Uniject and are willing to complete a short questionnaire

80 CHWs (40 in Uganda and 40 in Senegal) and 20 clinic-based providers (from Senegal only) who are trained to give Depo-subQ in Uniject as part of this study

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* In general good health (the participant verbally reports she feels well)
* Using DMPA continuously for at least six months prior to enrollment in the study (i.e., had at least two previous injections)
* Received their most recent DMPA injection no more than 13 weeks prior to enrollment in the study at the study clinic or from a family planning provider involved in the study (Senegal only)
* Received their most recent DMPA injection no more than 13 weeks prior to enrollment in the study from a family planning provider involved in the study (Uganda only)
* Desires to be re-injected with DMPA
* Willing to sign an informed consent document
* Willing to provide contact information and be interviewed three months after enrollment.
Basilar Artery International Cooperation Study

Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.

Objective: Evaluate the efficacy and safety of IAT in addition to best medical management (BMM) in patients with basilar artery occlusion.

Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.

Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar occlusion.

Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone. IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.

Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.


Eligibility Criteria:
Inclusion criteria

* Symptoms and signs compatible with ischemia in the basilar artery territory.
* Basilar artery occlusion (BAO) confirmed by CTA or MRA.
* Age 18 years or older (i.e., candidates must have had their 18th birthday).
* If IVT is considered as part of best medical management, IVT should be started within 4.5 hours of estimated time of BAO. (Estimated time of BAO is defined as time of onset of acute symptoms leading to clinical diagnosis of BAO or if not known last time patient was seen normal prior to onset of these symptoms).
* Initiation of IAT should be feasible within 6 hours of estimated time of BAO.

Exclusion criteria

* Pre-existing dependency with mRankin ≥3.
* Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
* Patients who require hemodialysis or peritoneal dialysis.
* Other serious, advanced, or terminal illness.
* Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated.
* Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
* Informed consent is not or cannot be obtained.

Imaging exclusion criteria

* High-density lesion consistent with hemorrhage of any degree.
* Significant cerebellar mass effect or acute hydrocephalus.
* Bilateral extended brainstem ischemia.
A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS)

The study objective is to develop and test a Measure of Drug Self-Management for use in clinical settings among patients with hypertension and diabetes.

While medication non-adherence is a highly recognized public health and patient safety concern, it is rarely assessed in a routine and consistent manner in clinical settings. With the aging of the US population and rising rates of chronic disease, an increasing number of adults are being prescribed multi-drug regimens that require greater self-management skills. Despite the complexity of medication use, adherence has most commonly been measured as a limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has, over time, simplified how we think of prescription (Rx) medication use and directed attention away from the full range of tasks associated with effective Rx self-management. The field of health literacy research has deconstructed these tasks in considerable detail in recent years, and can offer insight into a more comprehensive measurement of patients' outpatient Rx use.

There is a clear need for a brief, yet inclusive, measure of adherence that can be used in clinical settings to routinely assess patients' use of complex Rx regimens. Such an assessment could be used to guide clinicians in addressing specific patient challenges to safe and appropriate medication use. In response to this need, our study proposes to develop a new assessment of medication self-management. This unique measure will utilize health literacy best practices to promote patient comprehension and ease-of-use; it will also be tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the tool will be available in both English and Spanish to support use among diverse patient populations. Our study aims are to:

1. Develop and refine a Measure of Drug Self-Management (MeDS) prototype.
2. Inform the content, structure and delivery of the MeDS through targeted discussions with patients, providers and information technology specialists.
3. Test the reliability and validity of the MeDS among patients with diabetes and hypertension

H1: The MeDS will strongly correlate with other self-report adherence measures.


Eligibility Criteria:
Inclusion Criteria:

* be ≥ 18 years old,
* have a diagnosis of diabetes and hypertension,
* be prescribed 3 or more drugs to treat these conditions,
* speak English or Spanish as their primary language,
* have primary responsibility for administering their own medications,
* be a registered UNC patient.

Exclusion Criteria:

* severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation.
Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis patients who will be receiving their first kidney transplant
* Weight over 88 pounds (lbs.)

Exclusion Criteria:

* Very high cholesterol levels
* Obesity
* Organ donor over 65 years of age if living; over 60 years of age if cadaveric.
Couples Lived Experience

This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad.


Eligibility Criteria:
Longitudinal Portion

Inclusion Criteria:

1. Community dwelling older adult aged 65 years or older
2. Must speak English as the study measures are not validated in other languages.
3. Must express intent to commit to ongoing participation in longitudinal study with assessments every 6 months for 3 years,
4. Is part of a couple and their spouse/partner is also willing to participate in the project. All couples, regardless of sexual orientation or gender preference are eligible to participate
5. Both members of the couple must cohabitate at the time of enrollment.
6. Must have stable internet connection and capability to stream video with audio.
7. A subset of the longitudinal study participants (selected at random) will be invited to be participate in a focus group upon completion of the last (3 year) quantitative assessment. These participants must be willing to have their comments recorded.

Exclusion Criteria:

1. Any individual with a prior diagnosis of schizophrenia or other psychotic disorder.
2. Individual is unable to complete the informed consent process
3. Any individual with a prior diagnosis of a chronic disabling medical condition that would make it impossible to participate in a focus group via Zoom or WebEx.
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. With a life expectancy of ≥12 weeks.
5. With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
7. Adequate laboratory parameters during the screening period.

Exclusion Criteria:

1. Active brain metastases.
2. Prior treatment with a KRAS G12D inhibitor.
3. Palliative radiotherapy was completed within 14 days before the first dose.
4. Have poorly controlled or severe cardiovascular disease.
5. Subjects with active hepatitis B or active hepatitis C.
6. Known allergy to the study drug or its components.
7. Pregnant or lactating women.
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with chronic PsA pulmonary infection.

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and tolerability of BX004-A in CF subjects with chronic PsA pulmonary infection. The study is divided into two parts, a single-ascending and multiple-dose phase (Part 1) and a multiple dose phase (Part 2). Subjects in both parts will be included in a 6-month safety follow-up. A Data Safety Monitoring Board will monitor safety in both parts. The purpose of the study is to evaluate safety and tolerability of BX004-A, and whether BX004-A reduces the PsA burden in the sputum of CF subjects with chronic PsA pulmonary infection. Clinically stable CF subjects with a confirmed diagnosis of CF and chronic PsA pulmonary infection will be enrolled.

Eligibility Criteria:
Key Inclusion Criteria:

* Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
* Age ≥ 18 years
* FEV1 ≥ 40% predicted
* Clinically stable lung disease
* Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.

Key Exclusion Criteria:

* Known hypersensitivity to bacteriophages or excipients in the formulation.
* Receipt of prior bacteriophage therapy within the 6 months prior to Screening
* Recovery of Burkholderia species from respiratory tract within 1 year prior to screening
* Currently receiving treatment for allergic bronchopulmonary aspergillosis
* Currently receiving treatment for active infection with non-tuberculous mycobacteria
* History of severe neutropenia
* History of lung transplant
* History of solid organ transplant
* Acquired or primary immunodeficiency syndrome
* Initiation or change in CF modulator therapy less than 3 months prior to screening
* Pregnant or breastfeeding female