cyrilzakka/clinical-trials huggingface dataset:
My Interprofessional Care Team for Adherence and Research Engagement Disparities

MI-CARE is an innovative coordinated care team intervention to improve medication adherence and blood pressure derived from research findings that build on existing clinical practice. Designed with an eye toward sustainability, MI-CARE incorporates billable pharmacist and CHW services for patients with low medication adherence and high burdens of chronic illness and preventable consequences. MI-CARE offers interprofessional team care with comprehensive expertise and complementary skill sets that mitigate the silo effect of specialized medicine to deliver primary care to diverse, high-risk populations experiencing disparities in hypertension.

MI-CARE is a practice-based randomized controlled trial (RCT) to test the effectiveness of a comprehensive, individually- and culturally-tailored intervention for high-risk patients with hypertension, polypharmacy, and low adherence. MI-CARE leverages the specialized expertise of a clinical pharmacist together with a community health worker (CHW) who will serve as a cultural broker and patient navigator to address individual, clinical, social-cultural, and structural barriers to adherence.

This comprehensive and tailored, coordinated care intervention aims to improve medication adherence and hypertension outcomes among African-American, Latino, and Vietnamese immigrant patients. The proposed practice-based RCT is designed to meet the following specific aims:

Aim 1: Implement MI-CARE, an innovative, tailored adherence intervention delivered by a pharmacist and CHW team.

Aim 2: Determine the short- and long-term effectiveness of MI-CARE by assessing pre- to post-intervention changes in a) medication adherence (proximal outcome) and blood pressure (BP, distal outcome), and b) other comorbid health outcomes (e.g., HbA1c, BMI) using a randomized controlled trial.

Aim 3: Identify factors associated with MI-CARE effectiveness including a) tailored intervention features, b)medication beliefs, c) barriers to adherence, d) intervention dose, e) health literacy and f) cultural group.

The investigators will follow an intention-to-treat randomized design using a waitlist control with 230 African-American, and Latino patients with hypertension and low (\<85%) medication adherence. Data collection via pill count, self-report, electronic health record, and clinical measures will assess medication adherence, BP, and other factors at baseline (pre-intervention) and at 6 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years;
2. self-report cultural identity as African-American, or Latino;
3. speak English, or Spanish;
4. have medication-treated hypertension;
5. use ≥5 chronic medications;
6. have hypertension medication adherence \<85%; and
7. able to provide informed consent.

Exclusion Criteria:

1. if project staff conclude that a candidate participant is unable to comprehend the informed consent process (because he/she offers an inappropriate response to consent questions); or
2. if the candidate is hostile or unwilling to follow project protocols.
Implementation of Online Mindfulness-Based Stress Reduction Tailored for People with Multiple Sclerosis

This project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. We will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings.

Participants will be asked to take part in an 8-week MBSR course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years \</= 60 years
2. Diagnosis of MS or related condition (Clinically Isolated Syndrome, Neuromyelitis Optica Spectrum Disorder, Chronic Inflammatory Demyelinating Neuropathy)
3. Able to understand spoken and written English
4. Willing to take part in an MBSR course

Exclusion Criteria:

1. Cognitive impairment (\<26 on the Montreal Cognitive Assessment)
2. Severe active mental health impairment (psychosis, suicidality)
3. Medical instability (terminal/life threatening inter-current illness)
Generalizing TESTPILOT to New Single Family Room NICUs

Complex service interventions are neither smooth nor easy in any transitioning healthcare facility. Simulations performed in the new environment reinforce patient safety by uncovering safety threats, enabling their correction, and orienting hospital staff. This study expands upon patient safety successes at several institutions to measurably enhance patient safety at upcoming new inpatient facilities.

Prior to opening the nation's largest single family room NICU in 2009, Women \& Infants Hospital developed TESTPILOT: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing. The investigators simulated a functional NICU. 164 latent safety threats (LST) were identified without exposing a single neonate to risk. Practical changes were made to a) verbal and written communication protocols, b) admissions workflows, c) rapid team responses, d) family centered care e) scripting, f) facilities, g) supplies and equipment, and h) staffing and training issues.

"Generalizing TESTPILOT" studies how learnable and applicable this simulation-based methodology is at other institutions. Six institutions have successfully implemented TESTPILOT-NICU as of 2015. The investigators hypothesize implementations will succeed across a spectrum of care delivery structures, simulation experience and magnitudes of culture change, resulting in a broad blueprint for integrating simulation into transitioning healthcare services. Our goals include:

1. Share lessons learned and support local simulation teams in their preparations;
2. Quantitatively demonstrate improvement in system readiness and staff preparedness at each institution
3. Assess saturation of latent safety threats over successive TESTPILOT implementations, resulting in a blueprint for similar transitions.

During Phase I the investigators standardized, refined and validated survey instruments with NICU staff and process experts. Phase II includes implementation of TESTPILOT at 15 institutions over three years. The Principal Investigator recruits each institution and guides them through the methodology, typically lasting six to eight months. Each institution's Co-Investigator and core simulation team recruits local staff for simulation, LST discovery and resolution, and survey completion.

Eligibility Criteria:
Inclusion Criteria:

* NICUs transitioning during the study period will be recruited.
* Active NICU staff at each institution will be encouraged to participate without regard to age, gender, race, pregnancy or health status.
* The participants will be a representative sample of the overall staff, which includes primarily women in most NICUs.

Exclusion Criteria:

* Institutions unable to commit resources for simulation preparation, latent safety threat correction, or study reporting requirements
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)

Exclusion Criteria:

* Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
* Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
* Use of antacids \[except for study supplied Gelusil®\]
* Need for continuous anticoagulant therapy (blood thinners)
* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
* History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
* Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
* Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy
Impact of Microvascular Inflammation on Kidney Allograft Outcome

Graft microvascular inflammation poses a significant challenge to successful kidney transplantation due to its heterogeneous clinical presentation. There is a critical need to unravel the clinical significance of newly defined allograft microvascular inflammation phenotypes in the Banff 2022 classification and assess the implications of these new phenotypes on kidney transplant precision diagnostics and patient risk stratification.

Antibody-mediated rejection is a major cause of graft failure in kidney transplant recipients, with allograft microvascular inflammation serving as the hallmark histological lesion of antibody-mediated graft injury. However, the frequent occurrence of graft microvascular inflammation in the absence of circulating anti-HLA donor-specific antibodies highlights the incomplete understanding of the mechanisms underlying this inflammation. This heterogenous presentation poses a significant challenge in the clinical setting, as current treatment strategies often prove ineffective, hindering the improvement of allograft and patient care. The Banff 2022 classification update has reappraised lesions of microvascular inflammation, identifying new diagnostic phenotypes of microvascular inflammation. However, the clinical significance of these phenotypes is yet to be determined.

The aims of this study are:

1. To determine the impact of the revised Banff 2022 Classification on the diagnostic classification of phenotypes related to microvascular inflammation, compared to previous Banff 2019 Classification.
2. To assess the association of microvascular inflammation phenotypes with kidney allograft survival.
3. To assess the association of microvascular inflammation phenotypes with disease progression, defined by transplant glomerulopathy occurrence (cg and subsequent antibody-mediated rejection episodes.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.

Exclusion Criteria:

* Missing data for a rejection-related diagnosis according to the 2019 and 2022 Banff classification.
Observation of Non-technical Skills in the Pre-hospital Care in the Czech Republic

The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (e.g. communication, decision making, situational awareness etc.) in the real practice and how well they use them.

The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (teamwork and team leading, communication, decision making, situational awareness and task management) in the real practice and how well they use them. According to the observations of individual crews by field supervisors the use of non-technical skills will be compared between different groups (e.g. resuscitation, trauma, medical problems, non-emergency situations etc.). The comparison between the collaborators of the study is not the subject of the study.

Main hypothesis: The EMS crews are using all of the aspects of non-technical skills appropriately.

The field supervision is also the limitation of the study because it is done by different observers / supervisors, the observation therefore might by affected by subjective feelings. To minimise the subjective view of the situation all of the field supervisors undergo a uniform training of non-technical skills and how to observe and evaluate them.

Eligibility Criteria:
Inclusion Criteria:

* EMS called
* More than 2 crews on the scene
* Field supervisor present

Exclusion Criteria:

- TEAM tool not filled completely
Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.

This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years,
* recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
* patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
* all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.

Exclusion Criteria:

* patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,
* patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
* patients with previous history of malignancy,
* patients with significant hematological or metabolic laboratorial abnormalities.
Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study

Targeted population:

Sleep apnea patients at high cardiovascular risk newly treated by CPAP

Hypothesis:

Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

Study procedures:

The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, CPAP compliance, side effects and residual events.

Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.

An interim analysis will be performed when 300 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 78 years
* Men and women
* AHI \> 30 / hour
* Patient with high cardiovascular score (\>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
* Patient affiliated to the National health insurance
* Willingness to use a telemonitoring system

Exclusion Criteria:

* Central sleep apnea syndrome
* Previous CPAP treatment with respiratory support for sleep respiratory trouble
* Cardiac failure with left ventricular ejection fraction lesser than 40%
* Hypercapnic chronic respiratory failure (daytime PaCO2 \> 50 mmHg)
* Terminal disease
A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept

The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.


Eligibility Criteria:
Inclusion Criteria:

* Subject has rheumatoid arthritis (RA), is both abatacept- and belatacept-naïve, and is an eligible candidate to start a course of treatment with abatacept in accordance with the product label
* Subject is willing and able to comply with study visits and procedures
Phenotypic Characterization of Alveolar Macrophages 2016 (Caract-Aires-2016)

The aim of the study is to investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from patients with non-infectious lung diseases.

Although alveolar macrophages (AMs) represent the main immune cell population in the human lungs, consensus on their phenotypic characterization is still missing.

Current translational protocols use human AMs obtained by invasive methods (broncho-alveolar lavage and lung biopsy) or differentiate macrophages from blood monocytes cultured in the presence of growth factors such as macrophage colony-stimulating factor (M-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF). The group has already published the phenotypic and functional comparison of human blood monocyte-derived macrophages differentiated with M-CSF or GM-CSF. Aim of this study is to use a multi-staining flow cytometry (FACS analysis) to better characterize the phenotype of AMs isolated from broncho-alveolar lavage fluids of patients affected by non-infectious lung diseases. The FACS profiles of AMs will be further compared to the phenotypic profile of blood monocyte-derived macrophages differentiated in the presence of GM-CSF or M-CSF. The results of this study will allow to define the most valid in vitro model of AMs in a non-infectious setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by non-infectious lung diseases and for whom a broncho-alveolar lavage is scheduled for their medical care in the pulmonary division
* Patient Information leaflet provided
* Written informed consent of the patient

Exclusion Criteria:

* A suspected respiratory infection
Intraocular Steroid After Cataract Surgery Study

The use of one dose of an antibiotic and steroid injected into the eye at the end of cataract surgery is as safe and effective as the post operative use of eyedrops after cataract surgery.

This prospective randomized controlled trial included 80 eyes of 40 patients having routine phacoemulsification of cataract. Patients between 40 and 80 years of age who met enrollment criteria, required cataract surgery in both eyes, and agreed to participate, were enrolled in the study over a nine month period in 2006 at the office of one cataract surgeon. Eyes were randomly assigned to receive either the eye drop or injection protocol on the initial consultative visit. All surgery was preformed by one surgeon (JGS) using topical anesthesia, the Infiniti phacoemulsification system (Alcon) and an Acrysof SN60WF (Alcon) intraocular lens. The fellow eye was operated upon using the same technique and instrumentation two weeks later and was assigned to the group opposite the first eye. All eyes were examined by the operating surgeon at days 1, 8, 15, 30 and 90 postoperatively with uncorrected visual acuity, best corrected visual acuity, intraocular pressure, corneal edema, anterior chamber cell and flare recorded.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for patients to enter the study included age 40 to 80 years, clinically significant cataract in both eyes, the patient's willingness to enter the study and have cataract surgery preformed on each eye in a sequentially within a two or three week time frame.

Exclusion Criteria:

* Exclusion criteria included a history of glaucoma, retinopathy of any type, pseudoexfoliation, other significant ocular co morbidity and systemic diabetes.
Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C

The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.

Randomized clinical trial comparing rates of RVR, eRVR, EOT and SVR during standard treatment with Pegylated Interferon-Alfa plus Ribavirin compared to the same treatment supplemented with B12 and vitamin D during the treatment period.

Patients assigned to the vitamin supplementation group will receive the standard treatment of Pegylated Interferon-Alfa plus Ribavirin for 48 weeks together oral Vitamin D and intramuscular Vitamin B12. The control group will receive the same regimen of peguilated alfainterferon plus ribavirin for 48 weeks without any vitamin supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR
* Pegylated Interferon-Alfa treatment naïve
* Liver biopsy with Metavir F2 or less
* Cognitive capacity to understand and sign the informed consent

Exclusion Criteria:

* HBV or HIV co-infection
* Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3
* Creatinin ≥ 1.5 mg/dL
* Severe cardiopathy
* Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding
* Conditions that, according to the investigator's judgement, preclude participation in the study, including clinical, cognitive or behavioural conditions