cyrilzakka/clinical-trials huggingface dataset:
Recombinant Anti-tumor and Anti-virus Protein for Injection Plus Xeloda in Treatment of Metastatic Colorectal Cancer

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.

This is a Phase Ⅱ exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.

All patients will receive recombinant anti-tumor and anti-virus protein for injection and capecitabine.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 18 years.
* Pathologically confirmed metastatic adenocarcinoma of the colon or rectum. All other histological types are excluded.
* Failure of Second-Line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(Subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.Subject received last-line treatment not including capecitabine.
* At least one measurable lesion according to the RECIST criteria that has not been previously local treated. Minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral CT or NMR.Malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral CT.
* ECOG performance status 0, 1 or 2.
* Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Prior treatment with novaferon.
* Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
* Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
* Patient who were allergic to Interferon-α or who had interferon-α antibody.
* Patients with uncontrolled central nervous system (CNS) metastases.
A Pilot RCT on the Effect of ExAT on Teacher Burnout and Stress

The objective of this pilot randomized controlled trial is to evaluate the effects of Expressive Art Therapy on reducing burnout and stress symptoms among Hong Kong's primary and secondary school teachers.

The proposed study is a pilot randomized controlled trial. Prior to all study procedures, 90 participants (i.e., primary and secondary school teachers) will be recruited to complete an online informed consent with telephone support. Eligible participants will be randomly assigned to either the Expressive Arts Therapy group (ExAT group) or the waitlist control group (WL group) in a ratio of 1:1. The ExAT group will receive the Expressive Arts intervention via face-to-face workshops for 2 consecutive weeks (2 hours per session). There are a total of 3 batches (around 15 participants per batch) for the intervention. Participants in this group will be in touch with their inner selves and inner resources via body movement, writing and music. There will be visual art creation as a conclusion for integrating the body and mind. The art products would be placed in their workplace for stress regulation. The WL control group will not receive any intervention during the study, but they will receive self-help art therapy materials after the whole study procedure. The outcome measures include burnout, stress, depressive, and anxiety symptoms, as well as insomnia symptoms, physical activity, health-related quality of life, and the intervention acceptability at baseline, immediate post-treatment, and 4-week follow-up assessments by completing the same questionnaire set.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged \>/=18
2. Able to read Chinese (verbal expression in Chinese or English)
3. With qualified teaching cert. (degree holder)
4. Willing to provide informed consent and comply with the trial protocol
5. Teacher work in primary or secondary school in Hong Kong

Exclusion Criteria:

1. Current involvement in psychological treatment program for stress and / or burnout reduction
2. A change in psychotropic drugs or over-the-counter medications that target mood within 2 weeks before the baseline assessment
3. A Patient Health Questionnair-9 (PHQ-9) item 9 score \> 2 indicating a serious level of suicidal risk
Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine after single and multiple oral dosing to healthy Chinese men and women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young Chinese men or women
* Between 18 and 45 years of age (extremes included)
* BMI between 18.5 and 24 kg/m2 (extremes included)
* Body weight ≥45 kg.

Exclusion Criteria:

* Pregnant or lactating.
* Previously been dosed with vortioxetine
* The subject has taken any investigational medicinal products within 3 months prior to the first dose of IMP (investigational medicinal product)

Other protocol defined inclusion and exclusion criteria may apply
BEFORE Decision Aid Implementation Study

Fertility is of great importance to young women with cancer. Concerns about the ability to become pregnant after cancer treatment may influence treatment decisions and fertility decision-making is challenging. Despite these challenges, there is a lack of fertility decision support tools. Our team developed the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aid for young breast cancer patients in Canada. This study aims to evaluate the implementation of the BEFORE decision aid in hospital settings through a stepped wedge cluster randomized trial.

The investigators will conduct a stepped wedge cluster randomized trial to sequentially implement the BEFORE decision aid in clinical settings that are currently recruiting young breast cancer patients for the Reducing the bUrden of Breast cancer in Young women (RUBY) Study (www.womensresearch.ca/ruby-study/).

For this trial 24 participating RUBY sites were grouped into 14 clusters (1 to 3 sites per cluster). The decision aid intervention will be sequentially rolled out over the course of 48 weeks to all clusters. None of the clusters will be switched from control to intervention during the first 6 weeks of the study to establish a baseline. Then two clusters will move from the control to the intervention every 6 weeks (called a 'step'). There will be 7 steps total during the study period. At the end of the 7th step all clusters (i.e., participating RUBY sites) will have received the decision aid intervention. The time-point of when the clusters will be switched from control to intervention will be randomized.

The data collection includes obtaining secondary data collected as part of the RUBY study from all patient participants who were enrolled in RUBY during the study period. The primary outcome is the number of patients reporting that fertility tools were recommended to them, based on RUBY participant responses to a 3-month fertility questionnaire. The investigators hypothesizes that following the implementation of the decision aid intervention a 20% difference will be observed, from 10% in the control to 30% in the intervention, in the number of patients who report that someone in their care team recommended a fertility tool.

Eligibility Criteria:
Inclusion Criteria:

* Young females diagnosed with histologically-confirmed breast cancer will be eligible to participate if they:

  1. are age =18 years and prior to their 41st birthday;
  2. are able to provide verbal informed consent and complete the interviews in English or French;
  3. completed the 3-month fertility questionnaire as part of the RUBY Study.
Evaluation of Caries Prevention Based on Genetic Etiology and Risk.

Dental caries affects billions of people worldwide and involves saliva immunodeficiency, commensal pathogen and exposure (lifestyle) causal subtypes of the disease. Up to 85% of adolescents in Swedish and other low prevalence populations are caries-free while the remaining 15% show high, recurrent caries activity. Accordingly, there is a lack of cost-effective risk assessment and prevention tools for personalized oral care. This randomized adaptive clinical trial (RCT) evaluates both caries prevention based on genetic etiology and risk, as a consequence of saliva immunodeficiency genes specifying individuals as susceptible or resistant to caries, and the effect of intensified versus selfcare traditional prevention on the two groups.

This is a protocol for a multicenter risk assessment and intervention study (PRECARIES) with an adaptive component. The study design comprises a prescreen of 2000 adolescents of which 520 will be included in the RCT study part with adolescents undergoing ordinary orthodontic treatment with multibrackets at the Public Dental Service. The orthodontic treatment allows for rapid caries development and improved discrimination between susceptible versus resistant individuals. The children are genotyped into two risk groups; genetic susceptible and non-susceptible children that are assigned to intensive or traditional standard prevention. The clinical outcomes will adaptively be measured at different time points (0, 6, 12 and months) as caries lesions at different teeth and surfaces using tactile, visual and X-ray bitewing, clinical photos and quantitative laser fluorescence (QLF). Secondary outcomes will be inflammation at the gingival margins and pocket depth at debonding of the orthodontic appliances. Questionaires are collected as well as biological samples; swab-dna, whole and parotid saliva and microbiota. Human and microbiota geno-and protein typing involves in and ex house platforms adaptively.

Eligibility Criteria:
Inclusion Criteria:

- undergoing orthodontic treatment with fixed multibrackets appliance in the upper and lower arch

Exclusion Criteria:

* impacted canines
* agenesis in the frontal region
* maxillofacial surgery
Improving Medication Adherence in Hypertensive Patients

The study team is proposing a single arm intervention to test the effect of an electronic intervention on medication use among individuals with a prescription for hypertension/high blood pressure. The investigator proposes that technology like text messaging, email, web applications and mobile apps with proven, nurse intervention scripts, will lead to significant, cost-effective improvements in hypertension medication use.

The intervention will incorporate a scalable electronic intervention using Email/Web Apps and Short Message Service (SMS)/Mobile Web Apps. The study team will examine the participants' responses to the electronic encounters in the technology-only intervention throughout the 3-month study timeframe.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the primary care clinic for the past 6 months
* New or existing prescription for hypertension
* Poorly controlled mean systolic blood pressure (SBP) in the last 12 months (\>140/90 Hg)

Exclusion Criteria:

* Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 3 months,
* Diagnosis of metastatic cancer;
* Active diagnosis of psychosis or dementia documented in medical record;
* Does not have access to the appropriate technology required
* Is not willing to use said device to receive notifications for the study;
* Does not live independently (assisted living or nursing home residents) or otherwise institutionalized or receiving home health care
* Severely impaired hearing, vision or speech (unless technological aides allow them full functionality)
* Planning to leave the area or change primary care clinics prior to the anticipated end of participation;
* Unable to read and understand spoken English
* Participation in another cardiovascular disease (CVD) study
* Another household member enrolled in study;
* Arm size \> 50cm
Caries Cognition and Identification in Adults

This study will evaluate the effect of the International Dental Federation (FDI) criteria, compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for evaluation of caries lesions around restorations in permanent teeth, in the outcomes related to oral health of adults, in a randomized clinical trial.

The study will consist of a randomised controlled trial of two parallel groups. One group will correspond to adults who will receive the diagnosis and indication of treatment according to the standard criteria, following the FDI criteria to classify the restorations marginal conditions and the presence of secondary caries (traditional group). And the other group will receive a diagnosis and treatment decision according to a minimal intervention approach, using as reference the detection criteria "Caries Associated with Restorations or Sealants" (CARS) - ICCMS (International Caries Classification and Management System) - conservative group). Patient evaluations will be performed yearly after 12 months. The primary outcome will be the number of surfaces restored with the need for new interventions. Secondary outcomes will be the impact of oral health on quality of life and cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients seeking dental treatment at the School of Dentistry;
* Age between 18 and 60 years;
* Patients who present at least one restoration of composite resin or amalgam to posterior and/or anterior teeth.

Exclusion Criteria:

* Patients who refuse to participate in the research;
* Patients included in other surveys that involve restorations or are in systematic attendance at another clinic or service;
* Patients who present systemic conditions or chronic diseases that require differentiated care and follow-up - these will be referred to the specific services available at the Faculty of Dentistry;
* Patients who reside in other locations and who can not return for periodic follow-up of the interventions.
User Experience of a Mobile Application

To evaluate the user experience of the use of the different modules / trackers in the mobile application in recording primary caregiver reported outcomes of infants

Using a questionnaire to collect overall user experience, frequency of usage, feedback of each module in the mobile application

Eligibility Criteria:
Inclusion Criteria:

1. Infants from birth to ≤ 12 months of age.
2. Primary caregiver should have access to the internet and a smartphone or tablet to access the mobile application.
3. Primary caregiver should be able to comprehend the content in the mobile application and complete the questionnaires in English.
4. Primary caregiver takes care of the infant more than 50% of the time

Exclusion Criteria:

* Incapability of the primary caregiver to access the mobile application using a smartphone or tablet with internet
A Novel Magnetic Needle Using Iron Oxide Nanoparticles for the Detection of Leukemia

The purpose of this study is to determine if the magnetic needle, in combination with magnetic nanoparticles can accurately identify minimal residual disease in leukemia patients.

The ability to reliably detect Minimal Residual Disease (MRD) in leukemia patients allows oncologists to predict patient outcome and to monitor the efficacy of therapy which is critical to improving care. MRD can be used to identify high risk patients who cannot be identified by conventional high risk features, a presence of \< 0.1% MRD has been shown to be one of the best predictors of 5-year remission, with 70% of patients with ≥ 0.1% relapsing. In addition to providing predictions of relapse, MRD has been shown to provide a sensitive measure of early treatment response, an independent predictor of good outcome. While the presence of MRD is indicative of patient outcome, the detection of the presence of MRD provides an opportunity to modify treatment and potentially increase survival. Studies are currently underway to use MRD detection in modifying chemotherapeutic treatment and timing of stem cell transplant in leukemia patients. Development of a low cost and easily accessible MRD detector has the potential to expand the number of patients for which MRD testing is available. Expansion of the patient population is a necessary step to large scale testing of MRD detection as both a predictive factor of patient outcome and as a potential modifier of patient treatment. It is expected that increased MRD testing would lead to improved prediction of patient outcomes and increased sensitivity of testing of treatment response. MRD testing in the general patient population could be used to test treatment response and allow oncologists to modify treatment regiments leading to reduced patient mortality and improved medical outcomes.

Eligibility Criteria:
Group: Leukemia Patients

Inclusion Criteria:

* Suspected diagnosis of Leukemia
* Requiring bone marrow biopsy for standard care

Exclusion Criteria:

* unable to consent for entrance into the study

Group: Non-leukemia Patients

Inclusion Criteria:

* Requiring bone marrow biopsy for standard care

Exclusion Criteria:

* unable to consent for entrance into the study
* Leukemia diagnosis
Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy

The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.

Immunotherapy is now an option in the treatment of malignant pleural mesothelioma. A French study, Mesothelioma Avastin plus Pemetrexed-cisplatin Study 2 (MAPS 2), prospective in 2nd line or more, found 40% and 52% disease control rate with respectively an anti-PD1 antibody or a combo of anti-PD1 and Cytotoxic T-Lymphocyte-Associated protein 4 (anti-CTLA4). Safety was rather good with 14% and 26% grade 3-4 in the Nivolumab and combo group respectively.

Thanks to this trial and data from the literature, Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy became an option in the treatment of malignant pleural mesothelioma, after validation by a multidisciplinary meeting.

The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received anti-PD1/PDL1 immunotherapy outside of a clinical trial in terms of efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age,
* Diagnosis of malignant pleural mesothelioma affirmed by the anatomo-pathological analysis report of a histological sample of the tumour (re-read by MESOPATH).
* Patient who has received at least one injection of anti-PD1 or anti-PDL1 antibodies

Exclusion Criteria:

* Explicit refusal by the patient to collect data
Aim High: Readiness & Meeting the Standards in Military Pre-Recruits

The primary objective of the proposed study is to complete a comprehensive needs assessment of the Louisiana National Guard (LANG) Youth Challenge Program (YCP) in the YCP leadership and junior cadet population related to nutrition, fitness, sleep, and mental health and resilience. Results of this needs assessment will further inform the development of the intervention skills training program.

The secondary objective of this work is to provide a scalable, integrated physical and mental optimization training program that would be integrated into relevant systems and maintained over time as a core tool for young individuals readying themselves to join the Army. The program would include an environmental intervention approach as well as nutrition, physical activity, sleep, and stress reduction/positive coping guidance.


Eligibility Criteria:
Inclusion Criteria:

* Must be either staff, cadre, or cadets in the YCP program.

Exclusion Criteria:

* Not staff, cadre, or cadets in the YCP program.
Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery

This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). The study will compare outcomes between two groups: patients receiving care under the rapid recovery protocol and those following the standard institutional care.

Primary Objective:

Compare postoperative hospital stay between the rapid recovery group and the usual care group.

Secondary Objectives:

Assess morbidity and mortality between both groups.

Evaluate patient satisfaction using validated tools.

Analyze incremental costs associated with both approaches.

Assess healthcare teams' learning progression regarding the protocol (Kirkpatrick method).

Evaluate adherence to rapid recovery protocol metrics by healthcare teams.

Measure changes in patient safety culture among healthcare professionals.

Hypothesis:

The null hypothesis assumes no difference in hospital stay between the two groups. The alternative hypothesis suggests that the rapid recovery protocol will reduce hospital stay compared to the standard care. Previous findings from Mejia et al. (2022) indicated a 40% reduction in postoperative hospital stay (from 13 to 7.8 days) for cardiac surgery patients under a rapid recovery protocol at the Heart Institute (InCor HCFMUSP).

This trial will provide critical insights into the applicability of enhanced recovery after surgery (ERAS) principles in cardiac surgery within the context of public healthcare, aiming to improve outcomes and optimize resource use.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
* Signed informed consent form (ICF)

Exclusion Criteria:

* Emergency patients
* Severe ventricular dysfunction (ejection fraction \<30%)
* Renal impairment (creatinine clearance \<30 mL/min)
* Atrial fibrillation or need for oral anticoagulation
* Moderate-to-severe anemia (hematocrit \<32%)
* STS risk score \>4%
* Patient and/or family disagreement with the protocol
* Failure to sign the informed consent form