cyrilzakka/clinical-trials huggingface dataset:
Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors

This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, the Young, Empowered \& Strong (YES), to standard therapy in managing symptoms in adolescent and young adult breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. The YES portal may improve the quality of life of young breast cancer survivors. The YES portal may help manage symptoms and provide useful information/resources.

PRIMARY OBJECTIVES:

I. To determine the efficacy of the YES intervention compared to usual care in improving quality of life (QOL), as measured by the Quality of Life in Adult Cancer Survivors (QLACS) at 6-months (primary outcome).

II. To determine the efficacy of the YES intervention compared to usual care in reducing specific adolescent and young adult (AYA) breast cancer (BC) concerns and symptoms at 6-months.

III. To determine the sustainability of the effects of YES on AYA concerns, symptoms, and QOL at 9 months, after the completion of the 6-month active intervention period.

EXPLORATORY OBJECTIVE:

I. To explore potential moderators and mediators of intervention efficacy, and to explore the potential effects of the intervention on inflammatory and other biomarkers including genetic profiles.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients receive access to the YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.

GROUP B: Patients receive usual care for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. After 9 months, patients may also receive access to the YES portal for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 15-39 years at diagnosis of a stage 0-III breast cancer
* Within 3 years of breast cancer diagnosis
* No known evidence of breast cancer recurrence (local or distant) or second primary breast cancer
* No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)
* Able to speak, understand and read English
* Cognitively able to complete the study requirements
* Ability to access medical records from treating hospital
* Willing to provide cell phone number and/or email address, and willing to receive email and/or text messages from the study team either with their own smartphone or one provided by the study team if they do not have their own to use
* Pregnant survivors are also eligible for this protocol, given that fertility and pregnancy are important AYA issues

Exclusion Criteria:

* Individuals under age 15 or over age 42
* Stage IV or metastatic breast cancer
* Males with breast cancer are not being recruited to this protocol. In the AYA age group, only a miniscule proportion of breast cancers occur in males. For this reason, the YES portal intervention materials have been targeted for young women
Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People

The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 27 and 35 kg/m2 (included),
* Aged 30 to 60 years old (included),
* Stable weight: no variation of 3 kg in the las 3 months,
* Signed the consent form,
* Able to follow the study,
* Health insured.

Exclusion Criteria:

* History of coronary disease (in the last 6 months),
* Progressive illness at the time of the study (cancer, neurodegenerative disease...),
* Diabetics (treated or not),
* Fasting blood total cholesterol equal or over 2.5 g/L (treated or not),
* Fasting blood triglycerides equal or over 2.0 g/L (treated or not),
* Fasting blood glucose equal or over 1.26 g/L,
* Peripheral neuropathy (polyneuritis, diabetic neuropathy) or central neuropathy (hemiplegia),
* Infectious cutaneous condition or allergies (to the contact point of the device),
* History of stroke,
* Severe heart disease,
* Epilepsy,
* Reduced motility,
* Diagnosed eating disorder,
* Followed a diet in the last 90 days in order to lose weight,
* Took weight loss assistance drug (Orlistat) in the last month or is likely to take one during the study,
* Psychiatric disorder incompatible with the study,
* Mental illness,
* Neurological disorder,
* Chronic somatic disease,
* Addiction or nicotine withdrawal,
* Under psychoactive drug ,
* Alcool consumption over 3 glasses a day,
* Pregnant or breastfeeding women,
* Women that are likely to get pregnant during the study,
* Is unable to understand or follow the protocol
* Is deprived of liberty
* Is under judicial protection
Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary rehabilitation are promising in improving life quality, disease symptom and outcomes. But there's not standard algorithm in China so far. The study aims to compare the effectiveness of these interventions and develop an intervention algorithm of anxiety and depression in COPD.


Eligibility Criteria:
Inclusion Criteria:

* Stable COPD patients with mild or moderate anxiety and depression

Exclusion Criteria:

* Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
* Patients with tumor history during past 5 years
* Patients with COPD exacerbations during past 4 weeks
* Participants in clinical trials
* Patients in pregnancy or breastfeeding
* Patients unable to complete questionaire independently
* Patients older than 80 years old
* Patients receiving long-term domiciliary oxygen therapy
Efficacy and Safety of Pitavastatin in a Real-world Setting

The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.

This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.

Exclusion Criteria:

* Patients with hypersensitivity to pitavastatin
* Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in
* Patients with severe liver failure or biliary obstruction and patients with cholestasis
* Patients who are receiving cyclosporine
* Myopathy patients
* Pregnant women or women of childbearing age and lactating women
* Children
* Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose
* Patients deemed inappropriate by the investigator
A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Prevalence of Persistent COVID-19 in Punta Arenas, Magallanes and Chilean Antarctic Region

This cross-sectional observational study aims to determine the prevalence of Persistent COVID-19 in 282 individuals in Punta Arenas, Magallanes and Chilean Antarctic Region. Persistent COVID-19 is a complex array of symptoms that persist or emerge for more than 4 weeks beyond SARS-CoV-2 infection. Recent studies suggest that up to 80% of survivors may develop chronic multi-organ dysfunction due to persistent inflammation and immune dysregulation, making it an ongoing public health concern worldwide.

The study aims to (1) describe and establish the frequency of physical and psychological signs and symptoms in adult patients who have tested positive for COVID-19, (2) identify individuals who meet the WHO case definition of Persistent COVID-19 in Chile, (3) explore risk factors associated with persistent COVID-19 to guide intervention strategies, and (4) explore inflammatory and molecular biomarkers associated with persistent COVID-19.

The research project utilizes a stratified random sampling with a mixed-methods embedded design. In the first phase, individuals diagnosed with COVID-19 will be recruited and followed up to complete the study's sample universe. A sociodemographic survey, blood sampling (including complete blood count, biochemical profile, immunoglobulin mutational status analysis, and analysis of inflammatory biomarkers), and a battery of psychological tests will be administered. In the second phase, kinesiology studies and medical consultation and evaluation will be conducted to determine if individuals have Persistent COVID-19 and to derive them to the healthcare network. In the final follow-up phase, participants diagnosed with Persistent COVID-19 will be invited to undergo musculoskeletal and respiratory assessments to complete the diagnosis of symptoms associated with the pathology.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Individuals must be included in the COVID-19 monitoring database by the SEREMI of Health in Punta Arenas between July 2022 and July 2023.
* Patients able to give informed consent.

Exclusion Criteria:

* Age \< 18 years
* Any physical, mental, immunosuppressive, or social condition that, in the investigator's judgment, might interfere with the completion of the baseline assessments and evaluations.
* Individuals who are digitally illiterate and do not have access to nearby networks to support them during the process.
WMT for Autism Spectrum Disorder (ASD)

Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Intestinal microbial disturbance is common in children with ASD. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "gut-brain-microbiota axis". We intend to explore the role of Washed Microbiota Transplantation in improving symptoms of children in autism spectrum disorder; To study the potential etiological mechanism of autism spectrum disorder.

Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (WMT). Washed microbiota transplantation (WMT) can significantly reduce FMT-related AEs by removing parasite eggs, fecal particles, and fungi through a series of automated washing procedures. This study aims to evaluate the efficacy and safety of FMT for ASD. Patients received repeated WMT with fecal from healthy donors. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 3 month post transplantation. This study sought to evaluate the efficacy of washed microbiota transplantation (WMT) in children with ASD and explore the role of washed bacteria transplantation in improving ASD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Children who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for at least 3 months.
* Age 3-14years.
* Received WMT

Exclusion Criteria:

* their guardian could not understand the questionnaires or provide informed consent.
* diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis)
* had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc.
* accompanied with other life-threatening disorders required emergency treatment.
* used antibiotics or probiotics three months before WMT.
Early Identification and Treatment of Rare Cardiomyopathy Cohorts

This study aims to further develop an imaging-guided cohort of rare cardiomyopathies based on the existing database. The investigators will standardize the construction of a cohort that integrates a clinical data repository, serum biobank, myocardial tissue bank, and imaging database. In the current cohort, the investigators will systematically screen for biomarkers indicative of pathological changes in challenging cardiomyopathies. Multidimensional data will be integrated to establish and optimize a heart failure risk assessment model, which will then be validated in a prospective cohort. The effectiveness of the model in assessing different risk groups will be evaluated, with the goal of achieving precise prevention of heart failure from the source.

To answer what are the key clinical questions of patients with rare cardiomyopathies resulted in high risk of adverse outcomes and requiring intensified treatment, this study will systematically refine and expand the cohort. This study will combine multimodal imaging with clinical data, blood samples, myocardial tissue samples to retrospectively identify biomarkers associated with pathological changes in rare cardiomyopathies; thereby to integrate multi-dimensional data to develop and validate a prognostic risk assessment model and evaluate the effectiveness of treatments guided through prospective randomized controlled trials by this model. Ultimately, this study aims to offer an integrated solution for the diagnosis and treatment of rare cardiomyopathies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old.
* Patients preliminarily diagnosed with heart failure and scheduled to receive drug therapy after being evaluated by cardiology departments.
* No history of structural heart disease, and the Framingham score \&amp;lt;5 (for patients with the Framingham score ≥5, coronary artery disease will be excluded by coronary angiography/coronary CT/exercise platelet).
* Creatinine clearance ≥50ml/min (Cockcroft-Gault formula).
* LVEF ≥50% assessed by Echocardiography.
* QT interval \&amp;lt; 470 ms.
* Providing written informed consent.

Exclusion Criteria:

* Presence of acute/chronic renal impairment (GFR \&amp;lt;50/ml/min/1.73m2).
* History of cardiovascular disease such as confirmed coronary artery disease, valvular disease, cardiomyopathy, congenital heart disease, and heart failure.
* Presence of contraindications to CMR.
Method Optimization for the Quantification of the NAD

Method optimization for the quantification of the NAD metabolome in human whole blood, and evaluation of baseline inter and intra-subject variability.

Whole blood from healthy participants will be collected to optimize analytical method based on liquid chromatography tandem mass spectrometry (LC-MS/MS) for the analysis of the NAD metabolome in biological samples. Parameters such as collection volume and anti-coagulants will be investigated for optimal quantification. Moreover, inter- and intra-subject variability of NAD metabolite levels in whole blood will be evaluated. Plasma and urine will also collected for method development and variability measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women (based on anamnesis),
2. Age between 18 and 55 years,
3. Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 28 kg/m2.

Exclusion Criteria:

1. Pregnant or lactating women
2. Sick or with a strong cold
3. With vitamin B3 supplementations or under low carbohydrate of ketogenic diet
4. Under prescribed chronic medication, except contraceptive pill.
Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.

The first purpose of this study is to evaluate the safety of treating pancreatic cancer with surgery to remove cancerour tissue.

Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
* Subjects must be \>/= 18 years of age at time of informed consent.
* Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection.
* Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG).
* Subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for Pancreatic ductal adenocarcinoma（PDAC）.
* Subjects with estimated survival \> 12 weeks.

Exclusion Criteria:

* Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody or any other immune therapy for pancreatic ductal adenocarcinoma.
* Known hypersensitivity or allergy to the active substance or to any of the excipients of SJ-neo006, Camrelizumab, Gemcitabine, Abraxane.
* Actie, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
* Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
* Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
* New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysthythmia, or electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
* History or autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease.
* Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.
Cerebral Oxymetry at Elective Coronary and Valve Surgery.

Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.


Eligibility Criteria:
Inclusion Criteria:

* Patient age under 80.
* Patients should undergo elective coronary artery bypass grafting surgery (ACB) or heart valve surgery (AVR or MVR).
* The patient must be admitted at least 18 years of years.

Exclusion Criteria:

* Damage to the frontal lobes corresponding to the area where SCO2 monitored.
* Patients in pharmacological studies.
* Patients with known intracranial vascular anomalies or cerebral aneurysms.
* Patients with known neurological disease.
* Patients with known undergone cerebral insult, TIA or carotid stenosis.
"UroMonitor Trial" in Spinal Cord Injury.

This study aims to determine if a non-functioning UroMonitor device can be safely inserted, monitored, and removed in patients with SCI.

This prospective, observational study will be conducted with 10 patients with chronic thoracolumbar SCI who are already undergoing routine UDS studies as part of their care. Following their routine UDS, a non-functioning UroMonitor device will be inserted and removed after 3 hours. Participants' symptoms will be monitored after the UroMonitor is inserted, following the 3 hour monitoring period, and again after UroMonitor removal. A second cystoscopy will be conducted for research purposes after removal to examine the urethra and bladder for any irritation or trauma. During insertion and removal, the urologist will document the time required for insertion and any difficulties encountered

Eligibility Criteria:
Inclusion Criteria:

1. Cervical or Thoracolumbar (T2-L1 spinal level) spinal cord injury with AIS A, B, C, or D severities of injury.
2. Age 17-75.
3. At least 1 year post-injury.
4. At least one prior urodynamics study in the past 12 months that has objectively documented abnormalities on bladder function consistent with an upper motor neuro lesion.
5. History of neurogenic bladder symptoms requiring some form of intervention (e.g. clean intermittent catheterization, condom catheter)

Exclusion Criteria:

1. Lumbar injuries (L2-S1 spinal level) where the injury is primarily to the cauda equina and not to spinal cord.
2. History of autonomic dysreflexia (such individuals are excluded to minimize the chance of inducing autonomic dysreflexia with device insertion).
3. Active urinary tract infection.
4. Past urethral or bladder reconstruction surgery
Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis

To investigate the effects of quadriceps strengthening on the adductor moment in individuals with medial knee OA and whether quadriceps strengthening has a different effect on the adductor moment in individuals with and without knee malalignment

Although quadriceps strengthening is the cornerstone of physiotherapy management, recent evidence suggests that high quadriceps strength in patients with malaligned knees may increase OA progression.

This study investigates the effects of quadriceps strengthening on the adduction moment in patients with medial knee OA with and without malalignment. 107 participants with and without varus knee malalignment were recruited and randomised into an exercise or a control group. Participants in the exercise group were taught five quadriceps strengthening exercises by a project physiotherapist to be performed five days a week for twelve weeks at home. The exercises were:

1. Quadriceps exercise over fulcrum using ankle weight
2. Straight leg raise exercise using ankle weight
3. Long arc knee extension exercise in sitting using ankle weight
4. Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
5. Knee extension exercise with isometric hold at 60° knee flexion using an elastic band.

Each exercise was performed at 2x10 repetitions for the first 2 weeks and 3x10 repetitions thereafter.

Participants visited the physiotherapist 7 times at Week 1, 2, 3, 4, 5, 7 and 10. They were given the ankle weights and elastic band to bring home and instructed about the repetitions and weights to use by the physiotherapist, who also checked and progressed their exercises. The average duration of the physiotherapy sessions was 30 minutes. To monitor compliance, each participant was given an exercise instructions sheet and kept a training diary to record the exercises they had done.

The control group received no intervention.

Eligibility Criteria:
Inclusion Criteria:

* Pain in the knee
* Osteophytes on knee x-ray
* Self-reported pain on the inner aspect of the study knee
* Osteophytes in the medial compartment of the knee joint and
* Medial joint space narrowing greater than lateral joint space narrowing on x-ray

Exclusion Criteria:

* Knee surgery within the previous 6 months
* History of lower limb joint replacements
* Systemic arthritic conditions such as rheumatic or psoriatic arthritis
* Valgus knee deformity (\> 5º)
* Inability to walk without the use of walking aids
* Intending to start a lower limb strengthening program in the next 3 months
* Seeking or currently receiving physiotherapy for OA knee