cyrilzakka/clinical-trials huggingface dataset:
Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study

The ability to label specific cells and image their natural movements in vivo would allow researchers to investigate the mechanisms of disease progression. In addition, cell-based therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells to follow their bio-distribution and biological function. Because of recent interest in stem cell treatment, several methods have been investigated for in vivo cell tracking. The investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo tracking using MRI. The investigators will use 20 healthy human volunteers to:

1. Assess the feasibility of imaging Endorem-labelled cells in vivo
2. Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age \>18 years

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI scanning (detected by safety questionnaire) including severe claustrophobia
* Inability or refusal to give informed consent
* Renal or hepatic dysfunction
* HIV/hepatitis B/ hepatitis C/ HTLV/ syphilis
* Intercurrent illness
* Blood dyscrasias
Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care

The aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.

The expected prospects are therefore maintaining surveillance around the MEOPA following his release from hospital reserves, but also to ensure that the MEOPA not an addictive potential in the context of its use in dentistry. The results of this study will in any case to secure its application for dental care.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 15 years
* Requiring dental care under MEOPA
* Not opposing, as well as his parents, his participation in the study
* Not having difficulties tracking (going on holiday, imminent change, remoteness, lack of motivation)

Exclusion Criteria:

Excluded patients are those whose dental care can be made to the vigil state, or on the contrary, will present a number of important care, justifying general anesthesia.

Also excluded will be children whose parents no longer have parental authority or whose parents are divorced or divorcing.
Adaptive Treatment Strategies for Improving Engagement With a Web-Based Smoking Intervention in Socially Anxious Smokers

This phase I trial will use a pilot sequential multiple assignment randomized trial (SMART) to examine protocol feasibility and acceptability of new components of a web-based intervention for socially anxious smokers. This study will be used to help build an adaptive treatment strategy to improve engagement with and effectiveness of the web-based intervention. Adaptive treatment strategies provide individualized sequences of intervention components to accommodate the changing needs of individuals based on their characteristics, treatment response, or engagement.

This study proposes to use a pilot SMART to help build an adaptive treatment strategy to improve engagement with and effectiveness of a web-based intervention for socially anxious smokers. At the outset of the study (Phase 1), participants will receive access to a new web-based smoking intervention (MyWebQuit) and will randomized to receive one of two text message services: 1) 1-way text messages, or 2) interactive, 2-way text messages. Those who disengage with the website in the first 5 weeks will be re-randomized to one of three re-engagement strategies: 1) re-engagement emails, 2) re-engagement interactive text messages, or 3) no re-engagement strategy. Outcomes include protocol feasibility, treatment acceptability, treatment utilization, and smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* resides in the US and anticipates remaining in the US for the duration of the study
* smokes at least 5 cigarettes per day for at least 12 months prior to screening
* desire to quit smoking within 30 days
* has at least weekly internet access
* current use of a personal email account
* current use of text messaging
* willing to receive text messages as part of this study
* screen positive for social anxiety (LSAS-SR ≥ 60)
* interested in participating in the study for themselves (versus \[vs\] someone else)
* not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
* no prior participation in one of the investigator's prior smoking cessation studies,
* comfortable reading, writing, and speaking English
* agree to the conditions of compensation
* not currently incarcerated in a prison
* willing to use the MyWebQuit program, complete study assessments, and sign an online consent form
* no other member of their same household participating in the study
Amiloride for Resistant Hypertension

To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)

The primary objective of this study was to evaluate the antihypertensive effect of amiloride added to triple antihypertensive treatment in patients with resistant hypertension and type 2 diabetes mellitus in an open-labelled, non- controlled and non-randomized interventional study.

The secondary objectives were to evaluate the additional effects of amiloride on:

* Urinary albumin excretion
* Blood pressure control, how many patients reached blood pressure control when amiloride was added to previous triple antihypertensive treatment.
* Plasminogen and plasmin excretion (ENaC activity) in the micro-and macroalbuminuric patients in the cohort.
* Urokinase plasminogen activator (uPA) activity

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with resistant hypertension (average daytime BP \>130and/or \>80 mmHg by ambulatory monitoring in spite of treatment with 3 antihypertensive drugs including a diuretic and an angiotensin coverting enzyme inhibitor (AECi) or angiotensin recpetor blocker (ARBs) and a third optional, all in optimal dosages.
* type 2 diabetes
* prior participant in a randomized controlled trial with spironolactone, but after a wash-out periods of minimum two weeks (NCT01062763)

Exclusion Criteria:

* Office blood pressure (BP) \>180/110 mmHg
* daytime average BP by ambulatory monitoring \> 170/85 mmHg
* heart failure (NYHA III-IV) Cardiac arrythmia HbA1C \> 10% severe dyslipidemia known or with signs of secondary hypertension estimated glomerular filtration rate (eGFR) \<50ml/min per 1.73 m2 prior intolerance to spironolactone or amiloride fertility without oral contraception pregnancy lactation
FAmily Engagement Strategy for Coordinated Specialty Care

Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.

The overall goal of this mixed-methods, clustered stepped-wedged designed study is to examine the effectiveness of a family peer implemented in coordinated specialty care programs at engaging family members in services. The use of a family peer is anticipated to increase family member participant's feelings of connectedness, self-efficacy, and motivation which will in turn improve family member participants engagement in scheduled coordinated specialty care services such as family psychoeducation.

Recruitment will consist of dyads compromised of a family member support person and a corresponding individual receiving coordinated specialty care services. Recruitment will occur over two waves, the attention control condition (ACC) and the FAMES condition. The ACC will last for 18 months and will recruit 225 participant dyads during which time family member participants will be contacted weekly for 12 weeks where they will be provided with positively framed messaging, educational materials around psychosis, tips for addressing relevant concerns in areas such as communication and de-escalation, and a list of community-based and online resources and events. The FAMES condition will last for 30 months and will recruit 225 participant dyads during which time family member participants will receive a modified cultural formulation interview, brief check-ins, psychoeducation, and will have access to an online community.

Recruitment will take place at nine coordinated specialty care programs across four states (Washington, Oregon, Tennessee, and New Mexico) which have been randomized to a clustered stepped wedge program design.

Eligibility Criteria:
Inclusion Criteria:

* Family member/support person of an individual enrolled in coordinated specialty care services for equal to or less than 6 months.
* 18 years of age or older.
* During the active implementation period (FAMES) did not participate in the attention control condition.

Exclusion Criteria:

* If they do not understand the consent process.
* If they do not speak and/or understand English or Spanish.
Predictors of Recurrence for High Risk Endometrial Cancer Patients

This study will analyze whether there is any difference in recurrence and survival rates among the patients who received different adjuvant therapies.

The incidence of endometrial cancer is gradually increasing nowaday. The postoperative treatment of high-risk endometrial cancer is also inconsistent. Besides, the recurrence of high-risk endometrial cancer is high.The investigators retrospective study will analyze the factors associated with recurrence of endometrial cancer, especially for different adjuvant therapies.

Eligibility Criteria:
Inclusion Criteria:

* All patients with high risk stage I endometrial cancer and all patients with stage II and stage III endometrial cancer and who underwent therapy in Far Eastern Memorial Hospital from 2009/01/01\~2019/09/17.

Exclusion Criteria:

* Patients with stage I endometrial cancer do not have high risk factors.
A Health Action Process Approach Online Intervention for People With Multiple Sclerosis

The purpose of this study is to implement the person-centered internet-based Health Action Process Approach to promoting physical activity in people with Multiple Sclerosis (i.e., eHAPA-MS online intervention) and assess the intervention's effectiveness and adherence.


Eligibility Criteria:
Inclusion Criteria:

* are 18 years old and above;
* any type of multiple sclerosis
* have not maintained 30 minutes of MVPA accumulated per day for 2 days of the week during the previous 6 months;
* be relapse-free for the past 30 days;
* show low risk for contraindications of physical activity indicated by no more than a single 'yes' response on the Physical Activity Readiness Questionnaire;
* be able to walk with or without an assistive device;
* are willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period;
* have a reliable Internet access.

Exclusion Criteria:

* have a score \>14 for the leisure score index of the Godin Leisure-Time Exercise Questionnaire;
* No computer or mobile device access with the internet.
* Patient determined disease steps (PDDS) Score = 7 i.e., using a wheelchair or scooter most of the time, or PDDS Score = 8 being bedridden.
* Anyone living outside of the United States of America.
* Anyone who is unable to speak, read and write in English.
* not willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period.
Comparison of Core Strength Training Using Stable Versus Unstable Surfaces

This study will address the scarcity of research and the variations in recommendations regarding core strengthening and stability programs. As physical fitness is a major concern of individuals and mostly people refer gym for fitness enhancement, this study will thus provide a guideline for effective core strength training program

Male clients, aged 19 to 44 years, coming to the gym for strength training will be purposively selected based on the inclusion criteria and then randomly assigned into two groups. They will undergo a series of pre-intervention tests that would assess their strength using Bourbon TMS and standing long jump tests; flexibility using stand and reach test; balance using Y balance test; coordination using jumping sideways test and speed using 20-m sprint test. After initial assessment, they will be advised and demonstrated for curl-up, side-bridging and quadrupled exercises. The experimental group will perform these exercises on Thera-Band© Exercise Ball while the control group will perform the same exercises on gym floor. The clients will have sessions on preferably the first day and 4th day of the week but is subject to their attendance at the gym. There will be interval assessments at 2nd and 4th week based on the tests mentioned above to record changes at these intervals. After 6 weeks of bi-weekly sessions, the clients will undergo post-intervention tests that will be the same as pre-intervention tests.

Eligibility Criteria:
Inclusion Criteria:

* Male clients
* Male adults with age 19-44 years
* Regular gym attendance with at least two gym workout session per week

Exclusion Criteria:

* Recent history of injury or illness
* Clients coming to gym for other exercises (endurance training, cardiovascular training)
Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease

The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* best corrected visual acuity in both eyes of at least +0.7
* six-month documented history of dry eye disease
* as least mild severity in 1 of the 5 dry eye symptoms
* corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15)

Exclusion Criteria:

* permanent conjunctival goblet cell loss or scarring conditions
* ongoing contact lens wear
* current topical ophthalmic medication use
A Multicentre Clinical Test of the Ultracore Repose® Mattress to Prevent Pressure Ulcers Cat. II-IV in Nursing Homes

A mixed method desgin study will be conducted to study pressure ulcer incidence Cat. II-IV (including deep- tissue injury,unstageable), not associated with the use of medical devices, on the Ultracore Repose® mattress (Frontier therapeutics Ltd) and to study differences in caretakers' experiences and perceptions when using the Ultracore Repose® mattress versus the Repose overlay mattress®

Quantitative part:

Before the start of the study, nurses on the participating wards will be educated by the researcher about skin observation, pressure ulcer classification, risk assessment, risk assessment, and use of the Ultracore Repose® mattress (Frontier therapeutics Ltd).

Skin assessment and risk assessment are performed on a daily basis by the staff nurses. Reliability testing will be done by the researcher on a weekly basis and without pre-announcement. Reliability checks and compliance with the protocol will be completed by the researcher as well as the collection of additional data.

Qualitative part

Three focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress).The researcher will encourage group interactions to capture the data and to provide a more comprehensive understanding of experiences and perceptions of using the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress). Non-verbal communication will also be captured in each focus group.

Eligibility Criteria:
Inclusion Criteria:

* High risk of pressure ulcers (Braden score \< 12) and/or pressure ulcer category 1
* Bedbound (\> 8 hours in bed) or chair bound (\> 8 hours in chair)
* Aged \> 65 years

Exclusion Criteria:

* Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer
* Expected length of stay \< 2 weeks
* End of life care
* Medical contraindication for use of static air support devices
The Effect of Time-restricted Eating on Liver Metabolism

Numerous studies have established the role of nutrition on obesity and its related metabolic diseases, which together affect a billion individuals worldwide. Evidence indicate that meal timing regulates numerous metabolic processes suggesting that meal time manipulation may be a simple intervention against obesity and its metabolic diseases. Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-10 h/day with no energy intake the rest of the day. In rodents, TRE significantly decreases hepatic steatosis and dyslipidemia, while it supports a healthier hepatic cellular content even without caloric restriction, potentially by alternating activation of nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on liver health in people is not clear. Accordingly, we will conduct a randomized controlled trial in people with overweight/obesity and hepatic steatosis to determine the effect of 9 h TRE for 12 weeks, on key metabolic outcomes in liver health: 1) intrahepatic triglyceride content using magnetic resonance imaging; 2) de novo lipogenesis during fasting and postprandial conditions using administration of deuterated water in conjunction with mathematical modeling. The proposed study will enable us to determine the effect of meal timing on metabolic function in people with NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* age 25-75 years
* men and women
* body mass index 25-45 kg/m2
* clinical diagnosis of NAFLD
* self-reported habitual eating period more than or equal to 14 h per day.

Exclusion Criteria:

* shift worker, recent or expected travel crossing time zones
* fasting \>12-h/day more than once a week

  \*\> once a week no food intake after 18:00
* habitually waking up before 04:00 and sleeping before 22:30
* unstable weight (\>5% change in the last 2 months)
* diabetes mellitus or alcoholic liver disease
* sleep disorder
* history of or current eating disorder
* cancer in last 5 years
* conditions that render subject unable to complete all testing procedures
* use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued
* smoking or illegal drug use
* pregnant or breastfeeding
* having metals in the body
* cognitive impairment
* gastrointestinal or bariatric surgery that affects nutrient digestion and absorption unable to grant voluntary informed consent or comply with the study instructions individuals who are not yet adults (infants, children, teenagers)
* individuals that are unable to lie motionless on the MRI scanner for an hour or \*have tattoos or tattooed eyeliner
* alcohol abuse
* prisoners
The Effects of Dietary Nitric Oxide and Anthocyanins on Anaerobic Exercise Performance

The purpose of this graduate student research study is to investigate the effects of nitrate from beetroot powder with additional anthocyanins from tart cherry on exercise performance in healthy Loma Linda University students utilizing the Wingate Anaerobic test on stationary bike.

A randomized controlled double-blind crossover study with a baseline and two interventions. On day 1 (baseline), all subjects will have a lactate fingerstick measurement before and after the Wingate protocol. A random subsample (1/3 of subjects) will have 10 milliliters (2 teaspoon) of blood drawn for determination of serum allantoin. Subjects will then be equipped with a pulse oximeter and a heart rate monitor after which they will perform the Wingate Anaerobic test protocol. The protocol includes: 4 minutes of warm up, 3 seconds of warm up sprint with weights, 1-minute relaxed cycling, 2-minute rest, then 10 seconds cycling without weights. This will be followed by 30 seconds sprint with weights and end with 2 minutes of relaxed cycling. A post-activity blood draw will be performed for another 10 milliliters (2 teaspoon) of blood from the same one-third of subjects previously sampled. After baseline data collection, subjects will undergo a 1-week washout (avoiding high antioxidant foods) after which they will be randomized to treatment groups. On day 9, subjects will begin supplementation with nitrate from beetroot powder with additional anthocyanins, or nitrate from beetroot powder with a placebo for 7 days. On day 15 the subject will again repeat the same procedures as day 1, followed by another week of washout. They will supplement again on day 23 and repeat the same procedure as the first intervention on day 29.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Loma Linda University students aged between 21 and 35 years old
* Willing to abstain from caffeine, mouthwash, chewing gums, and high antioxidant foods during the week of supplementation.

Exclusion Criteria:

* Diabetic
* having salivary gland disorder, cardiovascular disease or orthopedic injuries
* pregnant or breastfeeding
* taking NSAIDS
* have an allergy to anthocyanins and/or beetroot
* women who are on their menses
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets

The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).


Eligibility Criteria:
Inclusion Criteria:

* Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.

Exclusion Criteria:

* Inability to have blood drawn for the screening lab tests
* Received methotrexate or folate supplement within the last 24 hours
* Pregnant or lactating females
* Inability to swallow a pill
* Hemoglobin less or equal to 8 gm/dl
* Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator
* Weight \< or = 16 kg
A Prospective Registry to Enable Collection of Standardized Routine Care Oncology Patient Data

This is an observational registry for patients at participating oncology centers. The data collection includes but is not limited to baseline variables, treatments given and outcome data. Patient surveys are also included. The aim of the study is to generate rich and standardized data for patients and to help enable more patients participate in clinical trials and contribute to research and development.

This is an observational registry for patients at participating oncology centers. The data collection includes but is not limited to baseline variables, treatments given and outcome data. Patient surveys are also included. The aim of the study is to generate rich and standardized data for patients and to help enable more patients participate in clinical trials and contribute to research and development.

Eligibility Criteria:
Inclusion Criteria:

Be a patient at a site (oncology) participating in the Registry Be at least 18 years old Be able and willing to provide signed informed consent

Exclusion Criteria:

Prisoners/imprisonment at time of screening for eligibility Patients who cannot consent without utilization of a legally authorized representative