cyrilzakka/clinical-trials huggingface dataset:
Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics

This trial aims to evaluate the impact of clinical pharmacists' pharmacogenomics-guided choice and statin titration for managing hyperlipidaemia.

The central hypotheses of this trial are (1) clinical pharmacists' pharmacogenomics-guided choice and titration of statins will lead to a more significant reduction in LDL-c; (2) lower incidence of myopathies with the use of statins for hyperlipidaemia management over 12 months compared to usual care by doctors alone. Active follow-up and titration should occur over the first six months. However, the participants will be followed up to 12 months to confirm the sustained LDL level attainment.

The primary aims are:

* The changes in Low-Density Lipoprotein cholesterol (LDL-c), total cholesterol, triglycerides (TG), and high-density lipoprotein cholesterol (HDL-c) levels, and
* The incidence of myopathies over 12 months.

The secondary aims include:

* Characterisation of the pharmacogenomic relationship between serum levels of statins (and their metabolites) with the changes in LDL-c levels and incidence of myopathies over six months
* Economic outcomes include but are not limited to the cost-effectiveness of pharmacogenomic testing in attaining LDL-c targets
* Change in health-related quality of life over 12 months is measured using the EuroQoL 5-Dimension 5-Level questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Participants between 21 and 75 years old
* Participants who are planning to start on statin\* medication or whose LDL-c goals have not been met, per Appendix B.
* Participants who are able to communicate in English, Chinese or Malay.

Participants who are planning to start or will be started on the following doses are eligible: atorvastatin 10-80 mg/day, rosuvastatin 10-40 mg/day, or simvastatin 10-40 mg/day within the last two to four weeks before enrolment

Exclusion Criteria:

* Participants who are statin-intolerant or in whom statins are contraindicated
* Participants on a statin dosing schedule of every other day (EOD)
* Participants administered on potent Cytochrome P450 3A4 (CYP3A4) or Cytochrome P450 2C9 (CYP2C9) or OATP inhibitors or inducers.
* Participants on evolocumab and alirocumab prior to enrolment
* Participants with documented diagnosis of psychiatric conditions
* Participants requiring palliative care, end-of-life care, or those with a life expectancy of less than one year
* Pregnant and lactating women
* Participants with complaints of myalgia or muscle weakness at baseline, before the commencement of statin
* Participants who are unable to swallow a whole statin tablet
Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy \[i.e., nicotine replacement therapies (NRT)\], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.

We will conduct a two-arm randomized controlled trial among Latinos who smoke and do not meet the recommended levels of physical activity (N=408). Participants will be recruited via community-based efforts and randomly assigned in a 1:1 ratio to Actívatexto (a mobile intervention that promotes both smoking cessation and physical activity) or Decídetexto (a mobile intervention that solely promotes smoking cessation). All participants will be provided with nicotine replacement therapies and a Fitbit Versa 4 device. Participants in both groups will complete a baseline assessment at enrollment and follow-up assessments at Months 3 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Hispanic and/or Latino
* Know how to read and speak English and/or Spanish
* Be ≥ 18 years of age
* Not meet the recommended levels of physical activity (150 minutes of moderate to vigorous physical activity)
* Smoke cigarettes at least 3 days per week
* Be interested in quitting smoking in the next 30 days
* Have a cellphone with text messaging capability
* Know how to utilize text messages
* Be willing to wear a wearable device daily to monitor physical activity
* Be willing to complete all study visits

Exclusion Criteria:

* Use of tobacco products other than cigarettes in the past 30 days (including e-cigarettes)
* Being pregnant or breastfeeding
* Plan to move from their current residence in the next six months
* Another household member enrolled in the study
* Unable to become more physically active or engage in a fitness appraisal
Process and Effect Evaluation of the KickAsh! Intervention

The goal of this evaluation study is to evaluate the KickAsh! intervention, an intervention aiming to prevent smoking initiation in adolescents living in vulnerable socioeconomic situations. This intervention will be implemented in youth social work organisation that offer sport and/or recreational activities for these adolescents. Youth workers will act as implementers of the intervention.

The main aim of this study is to evaluate the effect of the intervention, whether it does or does not produce change in the smoking initiation behaviour of adolescents (= effect evaluation). Secondly, the study aims to evaluate the implementation process to generate more understanding concerning why the intervention does or does not produces change. Therefore, it will be investigated how the intervention was implemented, what exactly was implemented, in which context the intervention was implemented... (= process evaluation)

For the effect evaluation adolescents will be asked to fill in a questionaire at three time points. For the process evaluations interviews and focus groups will be organised with the adolescents and youth workers respectively.

Two groups will participate to this study: one group existing of organisations where the intervention will be implemented (=intervention group), and one group where the intervention will not be implemented (= control group).


Eligibility Criteria:
Inclusion Criteria:

* Aged between 10 and 15 years old
* Participate in activities offered by a youth social work organisation during the implementation period
* Have sufficient understanding of the Dutch language

Exclusion Criteria:

* Not participating in a youth social work organisation
A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions

The goal of this R21 study is to explore the feasibility and preliminary efficacy of individualized cognitive prescriptions (CogRxs) in improving engagement in healthy behaviors and other outcomes in middle-aged AAs and to gain feedback on future implementation of the program.

A pre-post experimental design will be used, in which 150 AA participants aged 50-65 will complete a baseline assessment of cognitive testing and data-driven assessment of deficiencies across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity). Participants will be randomized to either: psychoeducation + CogRx, psychoeducation only, or no contact control. The psychoeducation and CogRx groups will receive general psychoeducation on dementia prevalence, prognosis, and risk factors, while the CogRx group will also receive personalized information on their risk factor profile and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home. Motivational reminders as well as adherence and self-efficacy questions will be administered via text-messaging over the 3-months. Participants will return for 3-month and 6-month follow-ups. Specific Aim 1 (proximal outcomes) is to determine whether the CogRx condition is superior to psychoeducation alone in improving engagement in healthy lifestyle behaviors. Specific Aim 2 (distal outcomes) is to compare the three conditions on a brief battery of cognitive and psychological measures. The Exploratory Aim is to gather feedback for future implementation of this program, including cultural considerations, barriers and facilitators to engagement, and likelihood of continuing the program.

Eligibility Criteria:
Inclusions:

* Must be African American
* Must be age 50 to 65
* Must have a working cell phone with unlimited texting
* Must be ambulatory

Exclusions:

* No neurological (including dementia diagnosis) or severe psychiatric (e.g., schizophrenia or bipolar disorder) disorders
* No insomnia
* Telephone Interview for Cognitive Status (TICS) score ≤20
The Evaluation of MyPreOp, an Online Preoperative Assessment Tool

This pilot study will intend to assess the feasibility and acceptability of MyPreOp (online pre-operative assessment tool). The study will aim to assess the quality of the MyPreOp assessment in comparison to standard practice of a nurse led face to face assessment. The investigators will also assess the acceptability of MyPreOp amongst patient participants and staff participants.

MyPreOp is a patient online pre-assessment tool that has been developed as a means of an alternative to the current existing model of a nurse led pre-assessment service.

This pilot study will intend to assess the feasibility and acceptability of MyPreOp. The study will primarily evaluate the quality of the MyPreOp assessment in comparison to standard practice of a nurse led assessment. The investigators will also assess the acceptability of MyPreOp amongst patient participants and pre-assessment nurses and anaesthetists.

Participants will be recruited directly from the pre-assessment clinic. Consenting participants will alternate undergoing either the MyPreOp assessment or the nurse assessment first. Participants will complete the MyPreOp assessment on a computer device at the hospital. Participants will also complete a nurse led pre-assessment process as per standard practice. Following the completion of both the MyPreOp assessment and the nurse assessment, participants will be asked to complete a satisfaction questionnaire about their experience of using MyPreOp, together with further questions about their home internet access, usage and their preference of electronic or nurse led assessments.

Similarly pre-assessment nurses will review a random sample of MyPreOp assessments and complete a questionnaire about their views of the MyPreOp assessment summary and recommended actions.

The MyPreOp assessments will be compared with the nurse assessments through an independent adjudication process. Nominated adjudicators will be Consultant Anaesthetists with regular clinical duties in the pre-assessment clinic. Adjudicators will not be blinded with respects to the assessments so that the manner in which the patient data is presented can also be compared as well as the data itself. Adjudicators will assess the performance of the MyPreOp assessment in two domains, medical history and recommended investigations, and assign them into graded categories of over or under assessment, with or without clinical significance.

Eligibility Criteria:
Inclusion Criteria:

* All patients due to see a pre-assessment nurse on that day
* Read and able to write English
* Lucid patients with mental capacity

Exclusion Criteria:

* Patients unable to understand spoken or written English.
* Not able to see a pre-assessment nurse on the same day
* Patients too unwell or confused to be able to complete the questionnaire.
* Patient refusal.
Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).


Eligibility Criteria:
Inclusion Criteria:

* Participants newly treated with ibrutinib for first line or relapsed CLL (treatment is being initiated or has been initiated within the last 8 days as a maximum)
* Participants agreed to follow the individual physical activity intervention (IPAI)
* Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet
* Participants with Internet access at home and email address
* Participants agreed to wear a connected watch 24 hours a day for all the duration of the study

Exclusion Criteria:

* Pregnant participants or planning to become pregnant while enrolled in this study
* Participants with inability or deemed unsafe to practice physical activity
* Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit
* Participants who are currently involved in an interventional study
* Participants with probable difficulties in using the digital tool autonomously
Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to Cataract Surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.

Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).

Eligibility Criteria:
Inclusion Criteria:

* Only one eye per participant
* Clinically significant cataract
* Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
* Open chamber angle with Schaffer grading three to four in at least two quadrants

Exclusion Criteria:

* Previous glaucoma surgery, including cyclodestructive procedures.
* Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
* Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
* Unable to participate and make written consent due to another medical condition.
Clinical Significance of Leukocyte Cell Population Data in Patients with Myeloproliferative Neoplasms (MPNs)

Myeloproliferative neoplasms (MPNs) are a group of clonal hematopoietic disorders which categorized according to the World Health Organization (WHO) into Philadelphia Chromosome positive (Ph +ve) including chronic myeloid leukemia (CML) and Philadelphia Chromosome negative (Ph -ve) like essential thrombocythemia (ET), polycythaemia vera (PV), and primary myelofibrosis (PMF) .

the aim of the study is to Detection of leukocyte cell population data in patients with MPNs and Relation between leukocyte cell population and patients' clinical status.

MPNs are characterized by sepsis, thrombosis, myelofibrosis and leukemic transformation as critical complications of the disease. Most recently, the MPNs have been described as "Inflammatory Diseases" because the chronic inflammation being identified as a key factor in the development and progression of the disease . It is characterized by persistent activation of immune cells, elevated leukocyte and platelet counts, release of various mediators, DNA and tissue damage . Consequently. when neutrophils are activated by different stimuli, they undergo degranulation and release neutrophil extracellular traps (NETs) and microparticles, leading to thrombosis in MPNs by blocking blood vessels . Monocyte and its distribution are also a simple marker of activation useful for early sepsis detection .

The leukocyte cell population data (CPD) are parameters used to provide quantitative information on the morphological and functional characteristics of leukocytes. CPD assessment involves measuring neutrophil and monocyte forward scatter (Z axis) for cell size and side scatter (X axis) for internal complexity. Additionally, fluorescence intensity (Y axis) for DNA/RNA content and cell population variability (dispersion width) can also be evaluated.

Therefore, assessing of these parameters in the context of sepsis and thrombosis as a complication of MPNs helps to understand how these conditions interact at the cellular level and provides insights into morphological changes and abnormal leukocyte distribution for early detection and management .

Eligibility Criteria:
Inclusion Criteria:

* Patients with MPNs according to the recent WHO classification.

Exclusion Criteria:

* Patients with other types of myeloid neoplasms and/or not fulfil the WHO criteria for MPNs diagnosis.
Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence

The purpose of this study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ HD Accommodating IOL
* Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
* Use of systemic or ocular medications that may affect visual outcomes
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* History of ocular trauma
* History of ocular surgery other than that required for inclusion in this study
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
* Subjects who may be expected to require retinal laser treatment or other surgical intervention
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity

Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between blood pressure and arterial stiffness in HFpEF patients with different levels of obesity.

Before the 21st century, Heart failure with preserved ejection fraction (HFpEF) was considered as a disease with simple diastolic dysfunction, but after the 21st century, HFpEF was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Other studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between blood pressure and arterial stiffness in HFpEF patients with different levels of obesity.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged \>=18years old;
* Diagnosed with HFpEF.

Diagnostic criteria including:

1. left ventricular ejection fraction ≥50%；
2. with the symptoms and/or signs of heart failure；
3. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
4. at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction

Exclusion Criteria:

* LVEF less than 45% at any time;
* Severe liver failure;
* Other causes of shortness of breath, such as severe pulmonary disease or severe chronic obstructive pulmonary disease;
* Primary pulmonary hypertension;
* Severe valvular disease of the left heart;
* Chronically bedridden or incapacitated;
* Age \<18 years old.
Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

Coronary endarterectomy (CE) combined with coronary artery bypass grafting (CABG) can be the final option for achieving complete revascularization in diffuse coronary artery disease patients. Since the exposure of subendothelial tissue to the blood flow after CE, the coagulation cascade can be activated, resulting in the increased risk of graft failure. Therefore, anticoagulation with warfarin in this group of patients might be beneficial. However, evidence is limited. This study aims to compare the clinical outcomes between dual antiplatelet therapy with or without warfarin after CE+CABG.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with diffuse coronary artery disease undergoing CE+CABG during the study period.
* No contraindications for both dual antiplatelet therapy and anticoagulation therapy with warfarin.
* Must be able to swallow tablets after the surgery.

Exclusion Criteria:

1. Patients with high bleeding risk (HAS-BLED ≥ 3);
2. Patients undergoing concomitant aortic valve or mitral valve surgery, or undergoing cardiac surgery for the second time;
3. Emergency surgery;
4. Serum creatinine \>130μmol/L, or significant liver dysfunction (elevated ALT and/or AST);
5. History of digestive or urinary tract bleeding, active gastric bleeding caused by gastric ulcer, or postoperative new-onset gastric bleeding;
6. History of hemorrhagic stroke, or platelet dysfunction;
7. Allergic or with contraindication to any of aspirin, clopidogrel or warfarin;
8. Participated in other clinical trial for drug or device within 30 days;
9. Pregnant or planning to be pregnant.