cyrilzakka/clinical-trials huggingface dataset:
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis

This is a 4-week open-label study in which subjects will be assigned to receive tapinarof cream, 1% once daily for 4 weeks. At the end of the 4-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old
* BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy.
* vIGA-AD score of ≥ 3 at screening and baseline (pre-dose)
* Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
* Capable of giving written informed consent
* Negative pregnancy test at Baseline (Day 1)

Exclusion Criteria:

* Immunocompromised at screening
* Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
* Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
* Screening total bilirubin \> 1.5x ULN
* Current or chronic history of liver disease
* Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
* Subjects who would not be considered suitable for topical therapy
* Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
* History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
* Pregnant or lactating females
* History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation
* Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Cancer and Aging Resilience Evaluation in Older Adults with Hematologic Malignancies: the CARE-Heme Registry

The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.

All participants will be invited to participate in a patient reported geriatric assessment questionnaire as well as an objective physical function testing. This includes the Short Physical Performance Battery (SPPB) that evaluates lower extremity performance and muscle strength assessment via hand grip dynamometer. Participants will also complete a 12 item modified version of PRO-CTCAE. This will be administered by trained research staff at the time of study enrollment. Repeat CARE instruments (Follow-up GA questionnaire and Physical Function test) will be administered after the baseline visit to measure changes in patient reported outcomes at 3 months, 6 months, and one year. A one-time blood or saliva sample will be requested and obtained at baseline or a follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients are ≥50 years of age.
* Patients have a biopsy proven diagnosis of Hematologic Malignancy (Multiple Myeloma, AL Amyloidosis, Waldenstrom's Macrogloblunemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic syndromes, Myeloproliferative Neoplasm, Acute/Chronic Myeloid Leukemia, Acute/Chronic Lymphoid Leukemia).
* Patients have appointments at UAB including if they are an inpatient or other clinic locations.

Exclusion Criteria:

* Individuals who are \<50 years old.
* Patients who do not read and/or speak English will not be eligible for this study as many of the questionnaires are not validated in other languages. No exclusions will be made based on gender, ethnicity or race.
Impact of Sleep Quality on Outcomes After Cardiac Surgery

Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.

The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease


Eligibility Criteria:
Inclusion Criteria:

* Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery

Exclusion Criteria:

* Not willing to give consent
* Preoperative sleep medications use
* Preoperative psychological disorders, on mechanical ventilation for \>12hrs, dementia, cerebrovascular accident
The Effect of Extract of Green Tea on Obese Women and Obese Related Hormone Peptides

The aim of this study is to examine the therapeutic effect of green tea extract on obese women and the correlation analysis between traditional Chinese medicine syndrome and obese related hormone peptides.

Obesity has become a noticeable and worldwide public health problem recently. According to the WHO survey in 2005, 1.6 billion and 400 million adults were found overweight and obese, respectively. In Taiwan, there are more than 30% found overweight in the national survey in 2009. Compare with the ones done in 1999 and 2005, a rising trend of the prevalence of obesity is found. Furthermore, the incidence and prevalence of obesity are also increasing worldwide, especially in the developing and newly industrialized nations. In addition, obesity is related to some chronic diseases, like diabetes mellitus, hyperlipidemia and cardiovascular diseases, which are major lethal health concerns in Taiwan and many developing countries. Taken together, obesity emerges as an important issue lately. The aim of the study is to evaluate the therapeutic effect and safety of green tea extract on demographic characteristics and obesity-related hormone peptide of obese women and to establish an obesity Traditional Chinese Medicine (TCM) syndromes questionnaire, which will undergo well assessing of reliability and validity. Second, we intent to utilize the TCM syndromes and Quality of Life (SF-12, WHO) questionnaire to 200 obesity women for the correlation analysis of TCM syndromes, obesity related hormone peptides and quality of life. The results of this study are expected to assess the effect and safety of green tea extract on obese women and improve the scientific diagnosis of TCM with a quantitative measurement by this questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 60 years old women
* Chinese
* body mass index (BMI) \> 27 kg/m2
* waist circumference (WC) \> 80 cm
* willing to participate in and fill out the questionnaires for this trial.

Exclusion Criteria:

* GPT \> 80 U/L, serum creatinine \> 2.0 mg/dl
* breast feeding or pregnancy
* heart failure
* acute myocardial infarction
* Stroke
* any other conditions not suitable for trial as evaluated by the physician
Physical Fitness and Bone Structure Evaluation in Preschool Children

Several studies have shown a high association between physical fitness and present and future health. Two of the main epidemics of the industrialized world are obesity and osteoporosis, diseases that could be prevented with early interventions from childhood. Both, physical activity and physical fitness have shown an association with these diseases, but tools for assessing them in early ages are still in development. Moreover, there is a lack of physical fitness reference values in preschool children and the relation of pathologies with physical fitness in these ages is still to be demonstrated. Therefore, through a simple and precise methodology displayed in the school and adapted for the younger we intend to: Provide a combination of safe and precise field tests to evaluate health related physical fitness in preschool children. Analyze body composition, risk of overweight, obesity and low mineral density and their relation with physical activity. The evaluation of these health-related physical fitness variables in early ages is of great interest to clinic and public health.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 3 to 5 years old

Exclusion Criteria:

* Unhealthy
* Taking drugs affecting bone
Mental Health Associations With Vitiligo

This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with vitiligo compared to controls and to evaluate whether the relative risks may vary by different ethnicity.

This study has two primary outcomes 1) Prevalence and incidence of mental health condtions in people diagnosed with vitiligo compared to matched controls and 2) Primary care and secondary healthcare utilisation in patients diagnosed with vitiligo and having a prevalent depressive conditon compared to matched controls. In addition, the study examines risk of time off work and unemployment in people diagnosed with vitiligo compared to matched controls.

Eligibility Criteria:
Inclusion Criteria:

* All eligible adults ≥18 (as at date of vitiligo diagnosis for cases or start of follow-up for controls) registered with GP practices contributing data to OPCRD between January 1, 2004 and December 31, 2020, were eligible for inclusion in the study.

Exclusion Criteria:

* People with less than 1 year of follow up available
Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference

Chronic liver diseases (CLDs) represent a major worldwide public health burden. Worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases. CLD is most of the time an asymptomatic, progressive, and potentially fatal disease. With its complications it becomes one of the major causes of mortality worldwide. Globally, hepatitis B virus and hepatitis C virus, alcoholic liver disease and non-alcoholic steatohepatitis, are the most important causes of liver disease.

The diagnosis of liver lesions remains an important issue for these patients. The prognosis and management of liver disease greatly depends on the amount of liver fibrosis. In early stages, it is the main factor predicting long-term outcome of these patients. The liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment, although a wide spectrum of noninvasive tools are now commonly used as a surrogate to the liver biopsy. It includes direct and indirect serum markers of liver fibrosis, but also several imaging-based methods, including transient elastography (FibroScan®, Echosens, Paris, France).

Even if the liver fibrosis is the key pathological feature of progressive liver disease, the accumulation of excessive hepatic triglyceride, hepatic steatosis, is today recognized as an important factor in the pathogenesis of a number of CLD. The magnetic resonance imaging (MRI) techniques are sensitive to steatosis and show interesting diagnostic performances, especially the MRI using the proton density fat fraction (MRI-PDFF) which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1H Magnetic Resonance Spectroscopy and with histological grade, across several studies. Therefore, this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis. Echosens has developed an ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™).

Echosens is working on improving the diagnostic accuracy of the CAP measurement performed with the FibroScan. This protocol is set-up to compare the diagnostic performances of the first generation of the CAP and the second generation of the CAP to the reference, the MRI-PDFF, in patients with CLD, all etiologies combined.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years of age
* Patient must be able to give written informed consent
* Patient affiliated to a social security system
* Patient with a chronic liver disease, all etiologies

Exclusion Criteria:

* Vulnerable patient
* Pregnant women
* Patient with presence of ascites
* Contra-indication to MRI
Effect of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Stroke

Individuals older than 60 years old, discharged after suffering brain stroke with referral to the rehabilitation outpatient clinic, will be assessed for orthostatic balance. Patients with positive Romberg test are invited to participate in the trial. Participants will be randomized to either the current rehabilitation protocol or to an supplemental intervention focused on oculomotor and gaze stability exercises to be applied at home for three weeks. Participants will be assessed with standardized, validated tools.

The study aims to evaluated the effect of a home program of oculomotor and gaze stability exercises on improvement the balance in stroke patients.

Individuals older than 60 years old, discharged after suffering brain stroke and referred to the neurologic rehabilitation outpatient clinic, will be assessed for a neuro-motor deficits. Patients will be consider eligible if they had positive Romberg test (disorder of orthostatic balance) and they will be invited to participate in the trial. Patients with previous balance problems will be excluded.

Participants will be allocated in two intervention groups through block randomization, either the current rehabilitation protocol or to an supplemental intervention focused on oculomotor and gaze stability exercises to be applied at home for three weeks. Participants will be assessed with Motor Assessment Scale, Berg Balance Scale and Timed Up and Go Test.

Eligibility Criteria:
Inclusion Criteria:

* Stroke diagnosis 3 to 15 months before recruitment
* Balance deficits (positive Romberg)
* Patients able to walk 3 meters without assistance with or without an assistive device

Exclusion Criteria:

* Balance problems previous to the index stroke
* Severe osteo-articular lesions that compromise the ability to perform the proposed exercises
* Previous exposure to oculomotor or gaze stability exercises
Study Evaluating Mitoxantrone in Multiple Sclerosis

The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Secondary progressive MS in an active stage
* EDSS between 3 and 6

Exclusion Criteria:

* Benign or primary progressive MS
* Patients with cardiac risk factors
* Patients who have already received mitoxantrone
AI Prediction of Gastric Cancer Response to Neoadjuvant Chemotherapy

This study seeks to develop a deep-learning-based intelligent predictive model for the efficacy of neoadjuvant chemotherapy in gastric cancer patients. By utilizing the patients' CT imaging data, biopsy pathology images, and clinical information, the intelligent model will predict the post-neoadjuvant chemotherapy efficacy and prognosis, offering assistance in personalized treatment decisions for gastric cancer patients.

This study seeks to develop a deep learning model to predict the outcomes of neoadjuvant chemotherapy in patients with gastric cancer. Leveraging participants' CT scans, biopsy pathology images, and clinical profiles, this model aims to forecast the effectiveness of post-neoadjuvant chemotherapy and the subsequent prognosis, thereby aiding in individualized treatment choices for these participants.

Data Collection: The investigators will gather data from 1,800 retrospective cases and 200 prospective cases from multiple hospitals. The retrospective data will be divided into training and testing sets to train and validate the model, respectively. The model's performance will subsequently be evaluated using the prospective dataset.

Clinical Information: This encompasses the participant's gender, age, tumor markers, staging, type, specific treatment plans, pre and post-treatment lab results, etc.

Imaging Data: CT imaging data taken within one month prior to the neoadjuvant chemotherapy, with at least the venous phase CT imaging included.

Pathology Data: Pathology images from a gastric tumor biopsy stained with Hematoxylin and Eosin (HE) taken within one month prior to treatment.

TRG Grading: Based on the pathology report of the surgical samples using the Ryan TRG grading system.

Prognostic Endpoints: The recorded endpoints are a 3-year progression-free survival (PFS) and a 5-year overall survival (OS). All deaths due to non-disease factors are excluded from the prognosis analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Pathologically diagnosed with advanced gastric cancer in accordance with the American AJCC's TNM staging standards;
* Have not undergone any systematic anti-cancer treatments before neoadjuvant chemotherapy and have not had surgery for local progression or distant metastasis;
* Received standard neoadjuvant chemotherapy as recommended by the clinical guidelines, and have documented treatment details;
* CT imaging and biopsy pathology images strictly taken within one month prior to starting neoadjuvant treatment;
* Patients possess comprehensive preoperative clinical information and post-operative TRG grading.

Exclusion Criteria:

* Patients whose CT or pathology images are unclear, making lesion assessment infeasible;
* Patients diagnosed with other concurrent tumors.
Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring

1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon.
2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported.
3. The complication rates of the flap and oncological safety were studied.

Operative time and complication rate are employed to analysis the learning curve of the ms-Tram and DIEP surgery,which is meaningful for the new microsurgeon training.

Buried flap without the implatable doppler is very common condition all over the world, and the complication rate was evaluated as evidence of reliable of the validated monitoring protocol.

Complication rates were considered as different before and after the platue of the learning curve. Within the study of the learning curve, complication rates were reported.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients with age \> 18 years
* Received autologous abdominal free-flap breast reconstruction (including muscle-sparing free TRAM or DIEP)

Exclusion Criteria:

* Breast conserving patient
* Implant-based breast reconstruction
A Novel/Common Approach for Temporalis Muscle Thickness Measurement

The aim of this study is to propose a new measurement point for temporal muscle thickness (TMT) that can be similarly localized in computerized tomography (CT) /magnetic resonance imaging (MRI) and ultrasonography (USG), and to evaluate the reliability and consistency of these measurements.

Recently, temporal muscle thickness (TMT) has been proposed as a new marker of whole-body muscle function. In addition, TMT has been shown to be a useful parameter for estimating skeletal muscle mass. Measurement of temporal muscle mass with CT and MRI has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. However, the literature indicates that USG can also be used to measure temporal muscle thickness. The recommended measurement points for CT, MRI, or USG in the studies performed to date depend on the particular imaging modality, and it does not seem possible to use them interchangeably. The aim of this study is to propose a new TMT measurement point that can be localized in a similar way in CT /MRI and USG, and to evaluate the reliability and agreement of these measurements.

Eligibility Criteria:
Inclusion Criteria:

* Referral to the radiology department for an MRI or CT scan

Exclusion Criteria:

* Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
* Vulnerable populations (patients with a terminal illness, people living in nursing homes, unemployed or poor people, people in need of urgent medical care, children, people unable to consent, etc.).