cyrilzakka/clinical-trials huggingface dataset:
Development of a Novel Asian Mediterranean Diet and Its Acceptability in NAFLD

The goal of this pre-intervention study is test the acceptability of Asian version of the Mediterranean diet to NAFLD patients.

The main question\[s\] it aims to answer are:

1. Whether Asian version of the Mediterranean diet that retains the nutritional composition and can be developed by mapping the components of the Mediterranean diet and finding substitute ingredients commonly eaten in Southeast Asia.
2. Whether the 4-week menu cycle of newly developed novel Asian Mediterranean diet is acceptable among Singaporean local population.

Participants will participate in taste test sessions to find out if the Asian Mediterranean diet meals are acceptable to people with NAFLD.

Numerous studies have shown that Mediterranean diet decrease the risk of cardiovascular disease, metabolic syndrome, cancer and overall mortality characterized by being low in saturated fats and animal protein, high in antioxidants, fibre and monounsaturated fatty acids, and with an adequate omega-3 to omega-6 fatty acid balance.

Recent studies have proved that adherence to a Mediterranean diet is beneficial for non-alcoholic fatty liver disease (NAFLD) as it provides antioxidants and anti-inflammatory nutrients that slows the development of hepatic steatosis.

However, adhering to the Mediterranean diet can be difficult for people of Southeast Asian cultural backgrounds to follow, as food items used in traditional Mediterranean diets may not be readily available or frequently used in local cuisines.

It is therefore the aim of this study to first map out the nutritional composition of the traditional Mediterranean diet, derive substitute ingredients, and then develop an Asian version of the Mediterranean diet that can be accepted and easily adopted by the Asian population while retaining the beneficial nutritional characteristics.

Following this, NAFLD patients will be recruited for the sensory evaluation of the Asian Mediterranean diet. Specifically for this study, the researchers are keen to focus on a clinical condition (i.e. NAFLD) that has been demonstrated to reap positive effects from adopting a Mediterranean diet. As such, this is a pre-intervention study with a focus on development and evaluating its acceptability among NAFLD patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NAFLD, as determined clinically by imaging evidence of hepatic steatosis on ultrasound/CT/MRI

Exclusion Criteria:

* Secondary causes of NAFLD (e.g. medication-induced)
* Unstable body weight (variation \>5% within the preceding 3 months)
* Current use of weight loss medications
* Other liver diseases (viral hepatitis, auto-immune or cholestatic liver disease, Wilson's disease, hemochromatosis, alpha-1 anti-trypsin deficiency)
* Unstable diabetes (HbA1c \>8.5%)
* Renal failure
* Inability to provide informed consent
* Pregnancy and lactation
* Problems with tasting and smelling
* Food allergy/intolerances/restrictions
SmartWatch ECG Evaluation Trial I

This is a single-center, non-randomized study to collect validation data for submission to the Food and Drug Administration (FDA) to support a 510(k) device clearance for a smartwatch ECG.

1. Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.
2. Compare the ECG waveforms from the Smartwatch to the GE and KardiaMobile devices to demonstrate equivalence in terms of cross correlation (correlation coefficient \>.95) and RMS Difference (\<10 microvolts).
3. Compare the algorithmic determination from the Smartwatch ECG to those of the GE and KardiaMobile to demonstrate equivalence.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years of age.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
* Being seen in the OU Cardiac Electrophysiology Outpatient Clinic.

Exclusion Criteria:

* Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
* Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).

\*Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation

For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).Pelvic laparoscopy and ovarian biopsy To be examined histologically. All procedures were performed under general anesthesia the utero-ovarian ligament was stabilized with the round biopter introduced through the other. The round metal biopter 5 mm in diameter with an inner protective trocar.

The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. The round biopter was removed, and a grasper was introduced to recover the excised tissue.

Ovarian biopsy specimens were fixed in 10% formalin and embedded in paraffin forming tissue blocks. Two sections, 4μ thick were cut from each block. One was stained with routine haematoxylin and eosin (H\&E) stain while the other was immunostained with anti-Leukocyte Common Antigen (LCA).

For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

Eligibility Criteria:
Inclusion Criteria:

* Woman under age of 40y.

  * Infertility.
  * History of oligomenorrhea or amenorrhea for 1 year or more FSH level \>20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).
  * History of thyroid dysfunction, postpartum thyroiditis and or thyroid surgery.
  * Symptoms or signs suggestive of thyroid dysfunction or goiter.
  * Family history of thyroid dysfunction or goiter.
  * Presence of thyroid antibodies or other antibodies.
  * Type 1 Diabetes Mellitus.
  * Prior irradiation to head and neck

Exclusion Criteria:

* Women above 40 yrs.

  * Follicle stimulating hormone (FSH) less than 20mIU/mL
  * Women using hormonal treatement, exposed to radiation to abdomen or pelvis, chemotherapy, or ovarian surgery.
Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

The purpose of this study is to determine whether temsirolimus is effective in the treatment of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)

Temsirolimus is an inhibitor of the mammalian target of rapamycin (mTOR), a crucial regulator of cell cycle progression. It was approved in the treatment of advanced renal cell carcinoma. Temsirolimus demonstrated also antitumor activity in a variety of other human cancer models, such as gliomas, rhabdomyosarcomas, neuroblastomas, prostata and breast cancer through induction of apoptosis or inhibition of proliferation. A similar effect was noted in HNSCC cell lines.

This is the first study evaluating the efficacy and safety of temsirolimus in platinum/cetuximab-refractory HNSCC.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent must be given prior to study inclusion
* Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
* Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy
* Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion
* Cetuximab must have been included in at least one prior line of therapy
* Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy
* At least one measurable lesion according to RECIST (Version 1.0) criteria
* Age \> 18 years
* ECOG performance status 0-2
* Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment
* If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose
* Willingness and ability to comply with the protocol
* Adequate bone marrow function, liver and renal function

Exclusion Criteria:

* Live expectancy less than 3 months
* Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
* Participation in a clinical trial within the last 30 days prior to study treatment
* Serious illness or medical condition other than the disease under study
* Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons
* Pregnancy or breast feeding
* Known allergic/hypersensitivity reaction to any component of the treatment
* Concurrent treatment with oral anticoagulants
* Uncontrolled diabetes: fasting serum glucose \> 2.0 ULN
* Active or uncontrolled infection
Bioavailability of Folic Acid Fortified Bread

Folic acid is the synthetic form of vitamin folate. Because of its high stability and bioavailability, it is the form of folate added to bread in Canada to reduce birth defects. There are health concerns about long-term folic acid consumption. Another form of folate, L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic acid.

The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.

See above.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Not taking a folic acid containing supplement

Exclusion Criteria:

* Adults who have medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, or psychiatric illness
* Adults who are taking medications known to interfere with folate metabolism (i.e. phenytoin, sulphasalazine, methotrexate)
* Adults with wheat, milk allergy or lactose intolerance
* Adults with known B12 deficiency
* Adults who consume more than 1 alcoholic drink/day on average (1 drink=12 oz beer, 5 oz wine or 1.5 oz spirits)
* Women have been pregnant during the year previous
* Women planning a pregnancy in the next year
* Women who believe they may become pregnant during the study
* Women who have had a known previous neural tube defect affected pregnancy
* Adults who are unable to provide informed consent
Patient-Centered Care and Asian Americans

Liver cancer and hepatitis B are health disparities for Asian Americans, and hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive for viral hepatitis. Technology, specifically mobile applications, can provide a flexible and efficient way to address these challenges. This project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in San Francisco.

The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile app for use on a tablet computer to increase hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis.

Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.


Eligibility Criteria:
Inclusion Criteria:

* ages 18+ years
* identifies as Asian
* Asian American, Chinese, or Vietnamese
* speaks English, Chinese (Cantonese), or Vietnamese
* does not have an electronic health record (EHR)-documented HBV screening test (defined as a hepatitis B surface antigen \[HBsAg\] test).
* we select Chinese and Vietnamese because those are the 2 most common languages spoken by limited English-proficient Asian Americans

Exclusion Criteria:

* dementia or any conditions precluding understanding informed consent or using a touch screen with audio
Improving Lactation Success in Black Mothers of Critically Ill Infants

Racial disparities result in Black infants in the neonatal intensive care unit (NICU) receiving less breast milk (BM) than White and Hispanic infants.1 BM improves infant health yet mothers of critically ill infants produce insufficient amounts to provide these benefits which is likely due to inadequate daily breast pumping frequency. Black mothers face unique challenges to frequent breast pumping including returning to work earlier, working in facilities with inadequate lactation support, and limited privacy for breast pumping at home. Therefore, the objective of this pilot study is to determine the feasibility and potential benefits of using a discreet, hands-free, wearable breast pump with an associated App that tracks pumping frequency and BM production to increase lactation success in Black mothers of infants admitted to the NICU. Specific aims include (1) evaluate the feasibility of a discreet, hands-free, wearable pump in Black mothers of critically ill infants to increase pumping frequency and BM production and (2) assess whether results indicate a signal of effectiveness supporting a subsequent adequately powered randomized clinical trial (RCT). Following delivery, 40 Black mothers of critically ill infants will be randomized to one of two groups. Group 1 will be provided a discreet, hands-free, wearable breast pump with an associated App and Group 2 will be provided a standard mechanical breast pump with no associated App. Results will be used to revise the intervention and study processes and to estimate outcome measurement variability and effect sizes needed for sample size calculations for an adequately powered RCT.


Eligibility Criteria:
Inclusion Criteria:

* Mothers self-identified as Black
* \> 18 years of age
* English speaking
* Stated intent to provide breast milk to her infant
* Rate their level of commitment to pumping breast milk for their infant for at least 3 weeks as 3 or greater or a 1-5 point Likert scale
* State they are available for an approximately 30 minute education session prior to hospital discharge
* Infant not expected to be stable enough to bottle/breastfeed for \> 21 days
* Access to a mobile phone and able to download app.

Exclusion Criteria:

* Known illicit drug use
* Breast reduction or augmentation
* Positive HIV status
* Infant not expected to live \> 7 days following delivery
* Has pacemaker
Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.

Previous studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.

Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.

Beneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.

Eligibility Criteria:
Inclusion Criteria:

* 18- 80 years old patients
* Patients undergoing thoracic surgery
* Patients undergoing upper abdominal surgery

Exclusion Criteria:

* Severe Aortic Valve stenosis
* Active Neurologic Disease
* Allergy to lidocaine or bupivacaine
* Allergy to iodine-based contrast
* Cutaneous Disorders at epidural insertion site
* Preoperative impaired coagulation status
* Pregnancy
Understanding immunE-related toXicities by multifACeT Profiling

A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.

The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.

Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.

IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18 years or older
* Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy

Exclusion Criteria:

* Medical or psychological condition that would preclude informed consent
* Planned participation in a drug trial receiving investigational agents
* Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.
* Subjects unable to comply with the study or sample schedule.
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Written informed consent obtained prior to study entry

Exclusion Criteria:

* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* History of any previous JE vaccination (e.g. JE-VAX®)
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Any acute infections within 2 weeks prior to enrollment
* Known or suspected HIV Infection
* Pregnancy, lactation or unreliable contraception in female subjects
The Effect of Psychoeducation on Cognitive Emotion Regulation and Negative Emotional Symptoms

This research was planned to determine the effect of cognitive behavioral approach-based psychoeducation on the cognitive emotion regulation strategies and negative emotional symptom levels of emerging adults who experienced an earthquake. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.After the pre-test applied to the experimental and control groups, a 9-session cognitive behavioral approach-based psychoeducation program will be applied to the experimental group.Following this application, post-test and one-month follow-up tests will be administered to both groups and the effectiveness of the psychoeducation program will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being in the 18-29 age group,
* Being at least a primary school graduate,
* Being exposed to/having experienced the Kahramanmaraş earthquake and living in the center of Osmaniye.

Exclusion Criteria:

* Having a hearing or speech disability that makes it difficult to answer surveys,
* Participating in a similar psychoeducation program,
* Presence of any psychiatric disorder and receiving treatment