cyrilzakka/clinical-trials huggingface dataset:
The Effect of Poverty on Psychological Well-being of Children

The aim of this study is to explore the impacts of poverty and income disparity on the psychological well-being of Hong Kong Chinese children.

It is well documented that poverty has a negative impact on the physiological well-being of children in the West. There is an imperative need for health care professionals to develop and evaluate interventions to promote the psychological wellbeing of children living in poverty. First, however, it is crucial to assess and understand how the impact of poverty, in particular the impact of income disparity, affects the psychological wellbeing of Hong Kong children before any intervention to promote it can be planned, developed, or evaluated. Unfortunately, while much public concern about poverty has concentrated on children's physical development, the impact of poverty and income disparity on their psychological well-being remains relatively underexplored. Because the cultural context in which they live is drastically different from that of Western children, the way that Chinese children view the nature and meaning of poverty, as well as their responses to it and to any psychosocial interventions, will in all likelihood differ considerably from those of Western children. Hence, the aim of this study is to explore the impacts of poverty and income disparity on the psychological well-being of Hong Kong Chinese children.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese pupils from Grades 5 and 6 of the elementary schools in Hong Kong
* be able to read Chinese and speak Cantonese
* had to live and go to school in the same district

Exclusion Criteria:

* Children with chronic illness or identified cognitive and learning problems
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin

The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.

Participants receiving low-to-moderate-dose statins were randomized in a 1:3 ratio to receive subcutaneous placebo or evolocumab and enrolled sequentially into one of 5 dose-escalation cohorts:

1. Evolocumab 14 mg/placebo once weekly (QW) × 6 doses
2. Evolocumab 35 mg/placebo once weekly (QW) × 6 doses
3. Evolocumab 140 mg/placebo every 2 weeks (Q2W) × 3 doses
4. Evolocumab 280 mg/placebo every 2 weeks (Q2W) × 3 doses
5. Evolocumab 420 mg/placebo every 4 weeks (Q2W) × 2 doses.

Participants receiving high-dose statins were randomized 1:3 to receive subcutaneous placebo or evolocumab 140 mg every 2 weeks × 3 doses (Cohort 6).

Participants diagnosed with familial hypercholesterolemia (HeFH) were randomized 1:2 to receive subcutaneous placebo or evolocumab 140 mg every 2 weeks × 3 doses (Cohort 7).

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 70 years (inclusive) at the time of screening with hyperlipidemia
* Body mass index (BMI) ≥18 and ≤ 35 kg/m\^2 at the time of screening
* Low-density lipoprotein cholesterol (LDL-C) level of 70-220 mg/dL (inclusive) at screening as measured by direct assay
* For Cohorts 1-5: On a stable dose of rosuvastatin (Crestor) \< 40 mg/day, atorvastatin (Lipitor) \< 80 mg/day, or simvastatin (Zocor) 20-80 mg/day for ≥ 1 month prior to enrollment and expected to remain on this dose for the remainder of the study
* For Cohort 6: On a stable dose of rosuvastatin (Crestor) 40 mg/day or atorvastatin (Lipitor) 80 mg/day for ≥ 1 month prior to enrollment and expected to remain on this dose for the remainder of the study
* For Cohort 7: Diagnosis of heterozygous familial hypercholesterolemia, based on a score of ≥ 9 points using the World health Organization (WHO) criteria

Exclusion Criteria:

* Diagnosis of homozygous familial hypercholesterolemia
* History of heart failure, coronary artery bypass graft, or cardiac arrhythmia
* History of acute coronary syndrome (e.g. myocardial infarction, hospitalization for unstable angina) or percutaneous coronary intervention, within 12 months prior to enrollment
* Planned cardiac surgery or revascularization
* Known aortic, peripheral vascular or cerebrovascular disease (including history of stroke or transient ischemic attack)
* Diabetes mellitus with any of the following:

  1. known microvascular or macrovascular disease
  2. HbA1c \> 8.0% at screening
  3. use of any hypoglycemic medication other than metformin
* Uncontrolled hypertension (systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 90 mmHg) either on or off therapy at screening or at baseline
Sophie Pilot Implementation and Assessment

Evidence-based interventions using cognitive behavioral therapy (CBT) and self-management education have been demonstrated to effectively treat symptoms of depression and improve the quality of life in populations with chronic illness. Research indicates that CBT is the most effective psychosocial treatment for depression; as effective as pharmacotherapy and as effective as adding another medication for patients who do not respond to one antidepressant alone. Despite the existence of proven efficacious treatments for depression, however, fewer than half of patients for whom depression treatment is indicated receive the services they need. Access barriers (i.e., transportation, insurance coverage), limited clinician availability (i.e., long waitlists, difficulty finding a provider), and competing (and time-consuming) medical priorities contribute to inadequate depression treatment for individuals with serious chronic illness. In this research the investigators will conduct a pilot randomized trial to compare results from implementation of two CBT strategies iHope and Sophie.

A pre-implementation pilot study will be conducted with 20 adult patients diagnosed with advanced (Stage 3 or 4) cancer who screen positive for moderate depression and are receiving care at the Solomont Center for Hematology and Medical Oncology at Boston Medical Center (BMC) with the following specific aims:

1. Using the Consolidated Framework for Implementation Research (CFIR) as a guide, design a pilot implementation strategy for introducing the Sophie CBT system and iHope system into the clinical context of care (Months 1-4)
2. Conduct a pre-implementation pilot study with randomization of 20 cancer patients who screen positive for depression and/or anxiety into two arms with Sophie CBT or iHope telemedicine (10 participants each) to: a) assess the feasibility, acceptability, and appropriateness of implementing the Sophie CBT and iHope interventions in an ambulatory cancer treatment center and b) evaluate the potential impact of the Sophie CBT and iHope interventions on measures of depression, anxiety, coping, and quality of life for cancer patients with comorbid depression (Months 5-10)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stage 3 or 4 cancer receiving care at Solomont Cancer Center
* GAD score \>10 AND/OR positive screening for moderate to severe depressive symptoms (PHQ-8\>9).
* Comfortable using tablet, phone and computer
* Has telephone access
* Speaks English
* Lives in greater Boston area

Exclusion Criteria:

* Patients without the capacity to provide informed consent
* Ongoing substance use disorder
* Patients with Schizophrenia and Dementia
Asthma Exacerbation and Helium-3 MRI

The goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs at different times of an attack. These three stages are immediately after the attack, 1 month later and 4-6 months later.

Asthma is a pulmonary disorder that affects millions of people each year. The exact method of exacerbation is still under some discussion. Currently there is no cure for the disorder but treatment is of a wide variety.

This study is meant to image the asthmatic lung at various time points post exacerbation. Since pulmonary imaging is currently limited to radiation techniques, this method will allow exacerbated images without the unnecessary exposure to radiation.

Eligibility Criteria:
Inclusion Criteria

* At least 18 years old
* Able to speak and read English
* Acute asthma exacerbation, defined as requirement for hospitalization or emergent outpatient visit, and treatment with high dose corticosteroids ( 40mg prednisone or equivalent)
* FEV1 \< 80% predicted on the day of MRI
* Attending physician agrees that patient is safe to participate on the day of the MRI scan

Exclusion Criteria

* Evidence of pneumonia, based on chest radiograph obtained within 24 hours of enrollment (if performed)
* Documented fever or requirement for antibiotics
* Unable to hold breath for 10 seconds
* Active smoker or history of at least 10 pack years cigarette smoking
* Chest radiograph with active pulmonary disease, except for changes expected with asthma (hyperinflation, subsegmental atelectasis)
* Admission to ICU
* For inpatients: contraindication to leaving hospital room for MRI as determined by Attending physician and RN on day of MRI
* Any other concurrent active pulmonary disease or other unstable or active medical condition (including suspected active coronary ischemia, acute bleeding), as determined by Attending physician
* Pregnancy as self reported
* Need for cardiac monitoring
* Need supplemental oxygen at an amount of 4L/min or a facemask
Effects of Green Tea on Body Weight Reduction and Gut Microbiota

The investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut microbiota.

After screening obese subjects who met the inclusion and exclusion criteria, the investigators randomly assigned the two treatment arms and one placebo arm at 1:1:1 ratio. At baseline, anthropometric and biochemical evaluations were conducted including body weight, body composition (DXA and Fat CT), lipid profiles, and liver function test. The tablets were supplied to each participants under double-blind conditions. The investigators obtained blood and stool samples both baseline and final visit at 12 weeks. For improving compliance for treatments, the investigators checked diary for lifestyle and drug compliance every 6 week.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-60 years
* BMI 25-35 kg/m2
* Abdominal obesity (Waist circumference): Male \>90 cm, Female \>85cm

Exclusion Criteria:

* Cardiovascular events within 3 months
* uncontrolled hypertension (\>160/100 mmHg)
* Diabetes mellitus
* Dyslipidemia under statin therapy
* TSH\<0.1 uU/ml or\>10 uU/ml
* Elevated creatinine level (twice higher than upper normal limit)
* Elevated AST/ALT level (three times higher than upper normal limit)
* Pregnancy, lactation
Engaging Fathers for Effective Child Nutrition and Development in Tanzania

This study aims to evaluate the independent and combined effectiveness of engaging both mothers and fathers in bundled parenting and nutrition behavior change packages on early child nutrition and development.

The overall aim of EFFECTS is to develop, implement, and evaluate nutrition and parenting interventions that will be delivered by community health workers in the Mara region of Tanzania. We will use a 2x2 factorial cluster randomized controlled study design, plus a local standard of care control group, to evaluate the effectiveness of EFFECTS on the primary outcomes of early child nutrition and development. In total, there will be five study arms: nutrition intervention with mothers, nutrition intervention with mothers and fathers, bundled nutrition and parenting intervention with mothers, bundled nutrition and parenting intervention with mothers and fathers, and a local standard of care control. We hypothesize that an intervention approach that engages fathers will benefit the primary outcomes; a bundled nutrition and parenting package will benefit the same primary outcomes; and that the combined intervention approach - that both engages fathers and bundles nutrition and parenting messages - will have additive benefits on the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Household has a child aged 0-18 months at study enrollment
* Child has a mother/female caregiver with a male partner
* Mother, father, and child anticipate remaining in the study area for the duration of the study
* The mother, and father where appropriate, is willing to participate in a peer group for the duration of the intervention, receiving full knowledge of the amount of time they are expected to contribute to this study.
* Both mother and father provide informed consent.
* Fathers have to be present in household with mother/child 10 months out of the year

Exclusion Criteria:

* None (only those households not meeting all the above criteria will be excluded from the study)
Interference Screw Mectascrew-C Postmarket Study

An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.

This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction.

Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).

The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.

The treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged 16-60 yrs
* Pre-operative MRI confirming the ACL or PCL rupture
* Scheduled for surgical reconstruction of ACL or PCL
* BMI\>18 and \<35 kg/m2
* Ability to give informed consent by signature

Exclusion Criteria:

* Age under 16 or over 60 yrs
* Degenerative osteopathies
* Local bone tumors
* Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician
* Systemic diseases and metabolic disorders that may compromise the outcome of the surgery
Factors Influencing Physiological Hyperopia in Children

The trend of myopia in children and its low age is a major social and public health problem in China. More seriously, retinopathy associated with high myopia has become the number one cause of irreversible blinding eye disease in adults in some parts of China. Physiological hyperopia has a protective effect on preventing the onset of myopia, and is one of the strongest predictors of myopia on its own, which is significant in curbing myopia from occurring at a younger age and preventing the development of high myopia before adulthood. However, it is not yet known how the physiological hyperopia changes in childhood, the stage at which the critical inflection point occurs, which key factors lead to the rapid fading of the physiological hyperopia and progression to myopia, and the strength of its effect. In the early stage of the study, the research group established a prospective cohort of preschoolers based on natural population sampling, which included a total of 2109 preschoolers aged 3-6 years from 22 kindergartens in a district in Beijing, and completed a 2-year follow-up, obtaining exploratory results on the changing pattern of physiological hyperopia and key influencing factors in younger children. The group will add new samples to the existing whole cohort sampling cohort and adopt the design scheme of prospective nested case-control study to determine the changing trend of fading trajectory of physiological hyperopia in school-age children, key inflection points and key risk factors, so as to provide new techniques for the prevention and control of childhood myopia.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 6-9 years old, male or female;
2. Good cooperation in examination;
3. Parents cooperate and sign the informed consent form;

Exclusion Criteria:

1. Children with a history of drug allergy;
2. Pediatric patients with heart disease, cranial trauma or epilepsy, Down syndrome, or glaucoma will be excluded from the cohort.
Somatic Mutation in Chronic Liver Disease

Deaths from chronic liver disease are rising in the UK and around the world. The leading causes are alcohol-related liver disease, metabolic-dysfunction associated steatotic liver disease (MASLD, formerly known as 'non-alcoholic fatty liver disease') and viral hepatitis. Chronic liver disease puts people at significantly increased risk of liver cancer, which in the UK has a 5 year survival of under 15%. Little is understood about how liver cells acquire genetic changes, called somatic mutations, as they progress from healthy cells, to disease, to cancer development. This study aims to investigate these somatic mutations across different causes of chronic liver disease, and different stages of liver disease. The investigators hope this will help us to understand how different insults to the liver put the liver cells under different pressures, resulting in varying genetic changes. By understanding these changes specific to disease aetiology and stage, novel genetic targets may be identified which assist to focus research in identifying specific prognostic, diagnostic and therapeutic tools in chronic liver disease, and improve outcomes for patients.

Tissue, surplus to clinical requirement, from patients were undergoing liver biopsy, liver resection or liver transplantation (tissue sampling from explanted liver) collected by collaborators at University of Texas Southwestern will undergo genomic sequencing at the Wellcome Sanger Institute.


Eligibility Criteria:
Inclusion Criteria:

Pre-collected cohorts of liver tissue collected from adults (male and female) with consent and ethical approval for use in research.

Exclusion Criteria:

Anything outside of the above including samples other than liver tissue, samples where there is no consent or ethical approval for use in research and/or samples from children.
Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort

Lupus nephritis (LN) is one of the main manifestationsin SLE patients, having an important impact on morbidity and mortality. Renal biopsy is the "gold standard" for the diagnosis of LN, however, it is an invasive technique, not free of complications,which is not recommended to be performed serially as a follow-up tool for patients with LN. Searching for biomarkers in SLE has been the subject of interesting research, although results have not always been relevant. Multiple biomarkers have been studied in different locations (soluble markers in blood, urine and biological fluids),of different nature(autoantibodies, genetic markers of "kidney damage") looking atdiagnostic and/orprognostic features. In recent years, several biomarkers have been developed that seek to find an association with pathological patterns, with pathogenic mechanisms and with a non-invasive diagnosis of different glomerulopathies, allowing the identification of prognostic subgroups in each type of kidney disease, while predicting response to treatment and/or recurrence. To date, double-stranded anti-DNA antibodies (anti-dsDNA) and serum complement are the only non-invasive routine biomarkers for monitoring renal activity in patients with LN. However, these markers are only the reflection of the immune activity of the disease and they are not markers of renal damage or poor prognosis. For all the above, the purpose of this study is, in a case-control study, to evaluate simultaneously serum (ANA, anti-dsDNA, anti-C1q, anti-cardiolipin IgG and IgM, anti-ß2GPI IgG and IgM, anti-phosphatidylserine/prothrombin antibodies, and anti-DFS70 antibodies) and urinary biomarkers, and the presence of anti-DFS70 antibodies, in a multiethnic cohort of patients with SLE such as the cohort of GLADEL, and assess its possible correlation with various socio-demographic, clinical and serological manifestations of the disease.

In subgroup of patients, transcriptome studies will be performed using RNA from blood and tissue to identify possible transcriptional signatures.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a diagnosis of SLE will be included. Patients should meet at least one ofthe classification criteria: ACR 1982/1997 (1) and/or SLICC 2012 (2) to determine the efficacy of calcineurin inhibitor-containing treatment regimens in LN cohorts by ethnic groups.
* Age ≥18 years old.
* Patients and controls that volunteer toparticipate and sign the informed consent

Exclusion Criteria:

* Patients with other systemic autoimmune diseases or overlap syndrome (rheumatoid arthritis, systemic sclerosis, dermatomyositis, systemic vasculitis and others).
* Patients who have urinary infection, pregnancy or have a history of hepatitis B, C or HIV virus infection.
* Those patients presenting with antiphospholipid syndrome (APS) associated with lupus will not be excluded from the study.