cyrilzakka/clinical-trials huggingface dataset:
Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2

This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries.

This study will test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of encouraging pantries to use SWAP traffic light labels on pantry shelves and increase the healthfulness of foods chosen by pantry clients. The study design is a 12-month cluster RCT of 30 Greater Boston Food Bank partner pantries comparing a basic SWAP implementation strategy (control, n=15) with a BE-enhanced SWAP implementation strategy (intervention, n=15). Primary outcomes assessed at 6 and 12 months will be implementation of the SWAP program within pantries and improvement of client food choices and dietary quality. At the end of 12 months, the BE-enhanced SWAP implementation strategy will be adapted, updated, and offered to the 15 pantries assigned to control (waitlist) at baseline. The 15 intervention pantries will be followed without further intervention.

Eligibility Criteria:
Inclusion Criteria:

* Food pantries enrolled in the study will be partner agencies of the Greater Boston Food Bank that are maximum client choice, are located within approximately 1 hour driving time of Boston (for logistical feasibility), and are not actively using traffic-light nutrition ranking.
* Food pantry clients that complete assessments must be 18 years or older and speak English or Spanish.

Exclusion Criteria:

* Food pantries that are not affiliated with the Greater Boston Food Bank and are not maximum client choice.
* Food pantry clients that do not speak English or Spanish.
Navigated Repetitive Transcranial Magnetic Stimulation in Improving Motor Rehabilitation in Participants With Brain Tumors

This trial studies how well navigated repetitive transcranial magnetic stimulation works in improving motor rehabilitation in participants with brain tumors. Navigated repetitive transcranial magnetic stimulation may help improve patients' lost motor function after surgery.

PRIMARY OBJECTIVES:

I. Determine feasibility of conducting 10 sessions of navigated repetitive transcranial magnetic stimulation (nrTMS) during the post-surgical rehabilitation time period.

EXPLORATORY OBJECTIVES:

I. Explore the effects of the nrTMS training program on motor recovery. II. Explore changes in cortical activity: electroencephalographic (EEG) activity including event-related potentials (ERPs) and motor evoked potentials (MEPs) will be assessed from baseline to end of treatment (EOT).

OUTLINE:

Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.

After completion of study, participants are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain tumors associated with the motor cortex
* Understand and read English, sign a written informed consent, and be willing to follow protocol requirements
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Motor impairment must be related to the surgical procedure or the tumor itself (in the opinion of the treating physician)
* Patients who are within 7 days of brain tumor resection associated with the motor cortex
* Eligibility for the nrTMS treatment will be based on motor ability and will be determined postoperatively by the surgeon

Exclusion Criteria:

* Patients who are taking any antipsychotic medications
* Patients who have ever been diagnosed with bipolar disorder or schizophrenia
* Patients with a history of stroke
PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease

Among patients with ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Myocardial infarction (MI) with non-obstructive coronary artery disease (MINOCA) accounts for 5-20% of patients with MI and preferentially affects women. MINOCA pathogenesis is varied and may include atherosclerotic plaque rupture, plaque erosion with thrombosis, vasospasm, embolization, dissection or a combination of mechanisms. Other patients may have clinically unrecognized myocarditis, or takotsubo syndrome masquerading as MI. Among patients referred for coronary angiography for the evaluation of stable ischemic heart disease, non-obstructive CAD is present in up to \~30% of men and \~60% of women. Stable ischemia with non-obstructive coronary arteries (INOCA) may be due to coronary microvascular dysfunction in up to 40% of these patients. Our understanding of mechanisms of MINOCA and INOCA remain incomplete. Coronary inflammation has been hypothesized as a potential mechanism contributing to coronary spasm in MINOCA and microvascular disease in INOCA.

The PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease (POINT-NOCAD) study is a single-center diagnostic, observational study enrolling men and women with MINOCA or INOCA who are planned to undergo (or underwent) clinically indicated coronary angiography. The research plan is to evaluate coronary inflammation, as measured by the perivascular coronary fat attenuation index from non-invasive coronary computed tomography angiography (CCTA), in patients with MINOCA and INOCA.

Eligibility Criteria:
Inclusion Criteria:

* Adult age ≥18 years referred for clinically indicated coronary angiography
* Stable ischemic heart disease OR acute myocardial infarction as the indication for coronary angiography

Exclusion Criteria:

Clinical Exclusion criteria:

* Estimated glomerular filtration rate \< 45 mL/min
* History of allergic reaction to iodinated contrast media
* Pregnancy

Angiographic / Post-Cath Exclusion criteria:

* Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
* Allergic reaction to iodinated contrast media
Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks
* Experiencing more than mild joint pain/symptoms
* 21 or older
* have permission from physician to engage in moderate intensity physical activity

Exclusion Criteria:

* Undergoing chemotherapy and/or radiation therapy at any time during the study period
* Scheduled for major surgery during the study period
* Presently engaged in high levels of physical activity on a daily basis
* Less than 21 years of age
* Unable to walk or engage in moderate intensity physical activity
Salt Sensitivity Hypertension and Lens Opacities

Salt-sensitive hypertension (SSH) accounts for about the half of all Hypertension (HT) cases .In SSH, Na+/K+-ATPase activity is impaired. Impaired Na+/K+-ATPase activity in the lens epithelium results in cortical opacities in the peripheral equator of the lens.

This study analyzed 305 patients with hypertension aged between 40 and 80 years and 124 non-HT controls. A total of 163 patients with HT who were admitted to the emergency service at least once with a minimum increase of 10% in their systolic and diastolic blood pressure after consuming salted food met the eligible criteria for HT and were included in the SSH group. A total of 142 patients who were previously diagnosed with HT but had no previous history were considered non-SSH. Two researchers examined the presence of cortical lens opacities biomicroscopically using the diffuse, direct, Scheimpflug, and retroillumination from fundus methods.

The number of patients with hypertension (HT) worldwide is estimated to reach 1.56 billion by 2025.HT accounts for almost 50% of deaths due to stroke and coronary artery disease. Salt-sensitive hypertension (SSH) accounts for about the half of all HT cases. Na+ /K+-ATPase activity is impaired in patients with SSH . Impaired Na+ /K+-ATPase activity in the lens epithelium results in cortical opacities in the peripheral equatorial region of the lens.A definite diagnosis of salt sensitivity is difficult, expensive, and associated with low patient compliance. Salt sensitivity is a risk factor for cardiovascular mortality and morbidity regardless of blood pressure and for other diseases such as asthma, gastric carcinoma, osteoporosis, and renal dysfunction. The present study is the first to investigate the potential of using lens opacity to predict SSH.

The transparency of the whole lens is largely based on epithelial cell permeability and Na+ /K+-ATPase activity. Circulation is activated by Na+ /K+-ATPases, which are present at 20-fold normal concentrations, particularly in the equatorial than in the anterior epithelial cells.

The mechanisms associated with SSH pathogenesis, such as signaling pathways involving Src family kinase (SFK), endothelin, connexin, brain natriuretic peptide (BNP), aldosterone, transient receptor protein V4 (TRPV4) ion channel, with-no-lysine kinase-Ste20-like proline/alanine rich kinase/oxidative stress-responsive kinase 1 (WNK-SPAK/OSR1), and Ras-related C3 botulinum toxin substrate (Rac1) , are important to the physiology of the lens epithelium. Compelling studies suggest that inhibition of these pathways may facilitate opacity.

Eligibility Criteria:
Inclusion Criteria:

Salt Sensitivity Hypertension patients Non-SSH, salt-resistant HT (SRH) patients Control patients without HT, aged 40-80 years.

Exclusion Criteria:

Cataracts Diabetes Mellitus Smoking Hypo/hypercalcemia Hyperparathyroidism Eye trauma Coronary artery disease Cardiac failure Renal failure

-
The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening

Wuchuan Osteoarthritis Study is a population-based longitudinal study of natural history of knee osteoarthritis and its risk factors. At baseline and follow-up visits, IPA-Q questionnaire and a radiographs at tibiofemoral (TF) joints will be taken in order to assess the relationship between physical activity and radiographic osteoarthritis worsening.

1025 residents aged ≥ 50 years will be recruited using door-to-door enumeration in randomly selected rural communities in Wuchuan, China, and will be followed in 3 years. At baseline and follow-up visits, subjects will complete a home interview (including, but not limited to, socio-demographic factors, physical activity level using IPA-Q questionnaire,WOMAC questionnaire) and have a weight-bearing posteroanterior semiflexed view of radiographs at tibiofemoral (TF) joints. Radiographic osteoarthritis (ROA) worsening for a knee is defined if its Kellgren and Lawrence (K/L) grade increases by at least 1 grade except for the change from 0 to 1 during follow-up. The relationship between level of physical activity and ROA worsening will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. people aged 50 or over
2. Wuchuan permanent resident population

Exclusion Criteria:

1. patients with rheumatoid arthritis
2. the disabled
3. patients with mental disorders
4. laid up for malignant tumor
5. people who live or work outside for more than half a year
Potential Role of Gum Arabic as Immunomodulatory Agent Among COVID 19 Patients

To study the efficacy of Gum Arabic as an immuno modulator and anti-inflammatory agent among COVID 19 seropositive patients..Half of participants will receive Gum Arabic and the other half will receive placebo

Randomized placebo controlled trial including COVID 19 seropositive patients will be treated with 30 gram per day for 4 weeks, compared to placebo group treated for the same duration in positive COVID 19 patients.

Blood samples will be taken first at base line level, after two weeks and after the intervention after satisfying the inclusion and exclusion criteria. The main objective is to assess the effect of Gum Arabic (acacia Senegal) on immune system among COVID-19 patients. The outcome of this project understand SARS-CoV-2 immune response in COVID patients and the effect of Gum Arabic (Acacia Senegal) consumption to counteract progression of the disease

Eligibility Criteria:
Inclusion Criteria:

* COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed)

Exclusion Criteria:

* Intubated patients on parental treatment
Implications of Wearing a Fat Suit

This study examined how wearing a fat suit might lead individuals to experience the negative effects of weight based stigmatization, including psychological, behavioral, and physiological consequences. It also aimed to test using the fat suit as a possible intervention tactic to reduce weight stigma.

The goal of this study was to understand how embodying a stigmatized domain might elicit the same consequences investigators see in victims of weight stigma. Participants were randomly assigned to either manipulate their weight through wearing a fat suit prosthesis or to a control condition where they wore the same clothing that was on the fat suit but in their own size. Outcome variables were cortisol reactivity, psychological well-being, and food and drink consumption. Additionally, this study tested whether wearing the fat suit might serve as an effective weight stigma reduction effort.

Eligibility Criteria:
Inclusion Criteria:

* Participants had to be registered in the UCLA Department of Psychology Subject Pool.

Exclusion Criteria:

* No specific exclusion criteria.
Grounding Effect on Alzheimer's Disease

The investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.

Grounding refers to having direct contact with the Earth, such as walking barefoot or lying on the ground. Research has found that grounding can improve inflammation, free radical damage, blood pressure, sleep quality, pain, stress, mood, and wound healing. However, there has been no re-search on the effect of utilizing grounding for patients with Alzheimer's disease (AD). Thus, in this study, the investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.

Patients with mild AD were enrolled in the study. The electrochemical analyzer CHI 1205b was employed to check the electrochemical signals at acupoints KI1 and GV16. The investigators used the Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory-II (BDI-II) to evaluate sleep quality, anxiety, and depression, respectively, at weeks 0 and 12.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with dementia, and CDR ≥ 0.5
* aged \> 50 years,
* sit with bilateral bare feet on the grounding mat
* able to answer the questionnaire
* able to sign the informed consent adequately.

Exclusion Criteria:

* aged less than 50 years
* inability to sit with bilateral bare feet on the grounding mat
* currently taking anti-oxidative health supplements or anti-inflammatory medicine.
Mesothelioma and Radical Surgery 2

Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2500 people in the UK are diagnosed with mesothelioma each year and the median survival is approximately 8.5 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 40-60 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. Patients will be followed up by phone at regular intervals for 2 years. Patients will be asked to complete and return a Quality of Life Questionnaire at these time points.

MARS 2 also includes an optional 'Information study', where consenting patients may be interviewed or have their consultations audio-recorded. The aim of the Information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.


Eligibility Criteria:
Inclusion criteria:

1. 16 years of age or over
2. Tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasic mesothelioma
3. Disease confined to one hemi-thorax based on CT assessment
4. Disease deemed surgically resectable
5. Fit for surgery
6. Capacity to provide written informed consent to participate in the trial

Exclusion criteria:

1. Severe shortness of breath (this is defined as an Eastern Cooperative Oncology Group (ECOG) status ≥ 2, or if lung function tests are performed: pre-operative forced expiratory volume after one second (FEV1) or transfer factor of the lung for carbon monoxide (TLco) less than 20%)
2. Serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure)
3. Severe heart failure (this is defined as NYHA III or IV or if an echocardiogram is performed an ejection fraction less than 30%)
4. End stage kidney failure requiring dialysis
5. Liver failure (e.g. encephalopathy and/or coagulation abnormalities)
6. Prisoner
7. Patient lacks capacity to consent
8. Existing co-enrolment in another interventional clinical trial that aims to improve survival
Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis

We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Because of the similarities between the inflammatory processes found in asthmas and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should respond to Xolair, just as asthma.

We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Since Xolair has been shown to be effective in asthmatic subjects with evidence of atopy and elevated IgE, we will limit our study to patients with chronic sinusitis and these parameters. The primary objective is to determine if Xolair decreases mucosal thickness on CT scan after 6 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 75 years of age
* Chronic sinusitis as defined by symptoms for greater than 12 weeks despite treatment.
* Paranasal sinus CT scan showing evidence of chronic sinusitis.
* Positive skin or RAST test to an inhalant allergen.
* Serum total IgE between 30 and 700 International Units/ml.
* Body weight less than 150kg.
* Impaired quality of life as measured by the Rhinosinusitis Disability Index (RSDI).

Exclusion Criteria:

* Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
* Known sensitivity to Xolair
* Patients with severe medical conditions that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
* Use of any other investigational agent in the last 30 days.
* No measurable disability on the RSDI.
* Immunocompromised patients or patients with ciliary disorders.
A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)

The objectives of this prospective observational study is to explore 1-year clinical response via both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) after initiation of adalimumab therapy in AS patients from routine clinical practices in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Participants with confirmed AS.
* Participant will start adalimumab as treatment
* Participant must provide the written authorization form and agree to provide personal and/or health data prior to the entry into the study.

Exclusion Criteria:

* Participant has been treated with any investigational drug or biologic within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit.
* Participants who fulfill any of the contraindications as per Humira label in Taiwan.
Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound

Treatment of extensive deep burn residual wounds is a common problem in burn plastic surgery. Due to bacterial invasion, excessive maturation of granulation tissue, poor abrasion resistance of new epithelium, and coexistence of wound healing and dissolution can lead to delayed wound healing. Residual wounds rarely heal spontaneously and are prone to recurrence. Mesenchymal stem cells (MSC) boost tissue repair through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1 have been found in MSC conditioned media (MSC-CM), and play a role in promoting tissue repair and regeneration.Our previous animal experiments have confirmed the role of MSC-CM in regulating wound inflammation, repairing damaged repair cells and promoting wound regeneration. In here, we will evaluate the safety and effectiveness of mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound.


Eligibility Criteria:
Inclusion Criteria:

Patients with thermal burns are all residual wounds that have not healed after 1 month; The distance between adjacent residual wounds of the same patient is greater than 10cm; Patients signing informed consent -

Exclusion Criteria:

Patients with severe heart, lung, liver, kidney, blood and mental system diseases; Combined with diabetes, hypertension and malnutrition; Patients with shock, severe systemic infections, and pregnant or lactating women. -
Short Daily Hemodialysis and Online HDF: Which One is Better?

1. To compare the efficacy of

1. Short Daily Hemodialysis
2. Online HDF in term of adequacy of dialysis.

The investigators intend to compare the efficacy between these modalities of treatment in terms of adequacy and also other parameters such as calcium-phosphorus balance and hematocrit

Eligibility Criteria:
Inclusion Criteria:

* stable ESRD
* KT/V \> 1.2 for thrice weekly or \> 1.8 for twice weekly

Exclusion Criteria:

* Inadequate vascular access flow rate
* Concurrent medical illnesses
* History of non-compliance