cyrilzakka/clinical-trials huggingface dataset:
Cognitive Assessment and Brain Function Evaluation in Patients With Non-alcoholic Fatty Liver Disease

The purpose of this study is to explore the relationship between Non-alcoholic fatty liver disease and cognitive impairment and evaluate the effect of metabolic surgery or lifestyle intervention on cognition.

Previous research has shown that Non-alcoholic fatty liver disease (NAFLD) is associated with an increased risk of cognitive impairment. Even though there are many noninvasive tests available, a liver biopsy is still required for the accurate diagnosis of NAFLD. However, there are now few studies on cognitive function in patients with NAFLD based on pathological diagnosis. On one hand, in the cross-sectional study, biometric measurements, cognitive assessment, magnetic resonance imaging (MRI) results are analysed to explore the differences among control subjects and NAFLD patients undergoing liver biopsy. One the other hand, in the longitudinal study, changes in cognitive scales and MRI results in NAFLD patients both at baseline and 12-48 months after intervention are collected to investigate whether surgical intervention and weight control benefit brain function.

Eligibility Criteria:
Inclusion Criteria:

* \>6 years of education
* right handed

Exclusion Criteria:

* consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females)
* with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis
* with thyroid diseases
* in a state of anxiety or depression
* inability to complete cognitive function scales
Using the Composite Immune Risk Score to Assess and Modulate the Patient's Post-transplant Immune Reconstitution.

To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.

This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients must be ≥ 16 years of age;
* 2) Patients receiving haploidentical allo-HSCT;
* 3) Patients have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

* 1) Tandem transplantation or multiple transplantations;
* 2) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
* 3) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.

The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* pregnancy.
* Other.
Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia

The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI


Eligibility Criteria:
Inclusion Criteria:

* aphasia assessed by Aachener Aphasie Test (AAT) \> 6 month after moderate TBI
* Age: 18 - 80 years
* right handedness

Exclusion Criteria:

* dementia or other neurological diseases
* History of severe alcoholism or use of drugs
* Severe psychiatric disorders such as depression, psychosis (if not in remission)
* Severe untreated medical problems such as cancer
Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases

The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions.

The main questions it aims to answer are:

Question 1: Clarify the clinical characteristics and prognostic factors of various diseases (MS, NMOSD, MOGAD, etc.) within IIDD in the Chinese population.

Question 2: Analyze the relationship between biomarkers and the occurrence, progression, and prognosis of CNS IIDD cases in our hospital.

Participants will

1. Receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus, without additional special interventions.
2. Receive clinical evaluation, follow-up, and management from dedicated neuroimmunology specialists.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);
2. The clinical syndrome of the attack meets one of the following: MS, NMOSD, MOGAD, ADEM, clinically isolated syndrome, demyelinating encephalopathy, demyelinating myelitis, or brainstem encephalitis (see below A-E);
3. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. History of tumors or diagnosis of central nervous system tumors;
2. Infectious lesions of the central nervous system;
3. Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain/spinal cord;
4. Non-compliance with treatment and follow-up.
Intervention to Promote Weight Loss in Latinas At-risk for Diabetes

The overarching goal of this project is to develop and test a behavioral intervention delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.

The goal of the proposed research is to compare two evidence-based strategies for preventing type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC) among Latinas in a "real world" setting. The aims of this study are to 1) develop a protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic markers-hemoglobin A1C, fasting lipids, blood pressure-from baseline to 1 year between at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC) groups; and 3) understand the social and cultural context surrounding weight-related behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas assigned to PLI and metformin will have greater weight loss (primary outcome) and greater improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Latino ethnicity
* Spanish fluency
* Age ≥20 years
* BMI ≥25 kg/m2
* And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item questionnaire and hemoglobin A1C ≥ 5.6%)

Exclusion Criteria:

* Hemoglobin A1C ≥ 6.5%
* Current or planned pregnancy during the study period
* Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease)
* Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV)
* Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).
Prevalence of Self-reported Premenstrual Syndrome and Analysis of Somatic and Psychoemotional Symptoms

In Brazil there are few published studies that study, the prevalence, symptoms and the population's knowledge about the premenstrual syndrome of women of reproductive age, and that correlate these data with the sociodemographic conditions of these women. In addition, given the complexity of the diagnosis of PMS, the prevalence of PMS in the Brazilian female population may be lower than the self-reported and published in these works, since not all women who believe they suffer from PMS fully comply with the criteria contemplated in the consensus for diagnosis of PMS. In this sense, this study aims to analyze the prevalence and intensity of frequent symptoms of PMS reported by the Brazilian female population. The information generated with this study may help to rethink behaviors to improve the health and quality of life of these women, as well as offer tools for decision making related to the need for early and effective treatment of PMS, whose disorders are associated with both the fall present and future quality of life for women, as well as all of their family, social and professional coexistence.

In Brazil and Latin America there are still few published studies that study, the prevalence, symptoms and the population's knowledge about the premenstrual syndrome of women of reproductive age, and that correlate these data with the sociodemographic, socioeconomic and sociocultural conditions of these women .

In the investigator's view, this study brings value not only to contribute to the understanding and demystification of PMS by society in general, but also for the professionals who assist these women. The data currently used in Brazil, and which are frequently used to guide public health policies, are mostly the result of research carried out in other countries, and which may not correspond to the national reality.

The information generated with this study may help to rethink behaviors to improve the health and quality of life of these women, at this stage in which comprehensive attention to the health and needs of this population should be given, often providing contraceptive methods that offer, as a benefit relief of symptoms related to PMS. The data from this research may also offer tools for decision making related to the need for early and effective treatment of PMS, whose disorders are associated with both the decrease in the present and future quality of life for the woman, as well as all of her family life, social and professional.

Eligibility Criteria:
Inclusion Criteria:

* Data from questionnaires that integrate the anonymous secondary database generated in the period between 20/02/2019 and 03/20/2020, of female participants aged between 20 and 49 years, in which all necessary information has been filled out according to the participant's profile.

Exclusion Criteria:

* The present study does not include exclusion criteria
Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement

The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Desire enhancement of his/her vermilion borders and/or vermilion mucosa Cupid's bow, philtral columns, perioral lines, and oral commissures may also be treated
* Have a baseline score of Minimal of Mild, as assessed by the Investigator according to the 4-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked)
* Have established a realistic Lip Fullness treatment goal that Investigator agrees is achievable

Exclusion Criteria:

* Have undergone cosmetic facial, lip or perioral procedures \[e.g., face-lift or other surgeries which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\] anywhere in the face or neck, or BOTOX® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. Note: Prior treatment with Hyaluronic Acid fillers and/or collage is allowed, provided the treatment was administered not less than 6 months prior to study entry
* Have ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
* Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to local anaesthesia agents, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study
* Are pregnant, lactating, or planning to become pregnant at any time during the study
* Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Have a history of or currently suffer from autoimmune disease
* Have a history of treatment with interferon for chronic hepatitis C
* Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDs (e.g. aspirin, ibuprofen) or other substances known to increase coagulation time (e.g. herbal supplements with garlic or Gingko Biloba) within 10 days of undergoing study device injection. Note: Study device injection may be delayed as necessary to accommodate this 10-day wash out period
Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK

This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer

The initial purpose of the study is to determine the largest amount of ensartinib that can be safely given to humans. An expansion phase will be conducted to assess the preliminary anti-tumor activity in ALK-positive non-small cell lung cancer once the recommended Phase 2 dose has been established.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy
* For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations positive by FISH or IHC
* Eastern Cooperative Group ECOG) Performance Status score of 0 or 1
* Adequate organ system function
* Male patients willing to use adequate contraceptive measures; female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures
* Measurable disease per RECIST
* Willingness and ability to comply with the trial and follow-up procedures
* Written informed consents are required to indicate that the patients are aware of the investigational nature of the study

Exclusion Criteria:

* Current use of anticancer therapy.
* Use of an investigational drug within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib
* Any major surgery, radiotherapy, or immunotherapy within the last 21 days.
* Chemotherapy regimens with delayed toxicity within the last 4 weeks.
* Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
* Prior stem cell transplant
* Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib or to the active ingredient of ensartinib
* Prior use of ALK TKIs with the exception of crizotinib
* Primary CNS tumors or meningeal metastasis
* Pregnant or breastfeeding female
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib
* Clinically significant cardiovascular disease.
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
* Concurrent condition evaluated by investigator would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled
* Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye

The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes (LSC-Exo) in alleviation of dry eye symptoms

Dry eye is among the most prevalent chronic conditions in ophthalmology, significantly impacting quality of life and presenting a public health challenge that cannot be overlooked. Current treatment options primarily consist of artificial tear replacement, anti-inflammatory therapies, and local immunosuppressive treatments, which mainly focus on alleviating discomfort and other symptoms associated with the ocular surface. However, with the rapid advancements in regenerative medicine, ophthalmologists are exploring innovative approaches to treat dry eye. Chronic dry eye can result in corneal damage and potential vision loss. Recent studies suggest that therapeutic exosomes delivered as eye drops can enhance the immune microenvironment of the cornea and alter the ocular surface\&#39;s microenvironment for better outcomes.

Exosomes are membrane vesicles secreted by parental cells, which can mediate the transfer of RNA, protein, DNA and other functional molecules of the parent cell between other cells and regulate the function of target cells. The therapeutic potential of Limbal Stem Cell Exosomes has been studied by our department. We found that LSC-Exo can alleviate the symptoms of dry eye in the animal study. At present, we plan to clarify its efficacy in a clinical research.

The main objective of this study is to evaluate the alleviation of Dry Eye symptoms in patients which are resist to conventional treatment by tear drops. The assessment will be done after LSC-Exo treatment by measuring Ocular Surface Index Score (OSDI), and the second objective include the measurement of inflammatory and pro-inflammatory cytokines in tear of patients, tear secretion amount, tear break time, the areas stained by fluorescent, ocular redness, tear meniscus and best corrected visual acuity.

Approximately 30 patients will be recruited. The treatment group will receive artificial tears for 2 weeks to normalize the baseline, followed by intervention of LSC-Exo 10ug/drop, four times a day for 30 days. The follow-up visit will be 12-weeks and the progression of dry eye will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complaints of burning or itching or feeling of a foreign body in the eye
* Moderate and severe dry eye severity
* Age between 18-70 years

Exclusion Criteria:

* Previous history of eye surgery
* Any disease that suppresses the immune system
* Pregnancy and breastfeeding
* Eyelid abnormalities
* Use of eye drops in the past year except artificial tears and lubricating ointments
* Use of systemic drugs that affect the tear film in last three months
* Use of contact lenses in the last three months
An Interactive Smartphone Application to Motivate Smokers to Quit

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking.

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking. The intervention has been designed based by a team of scientist, taking principles of change behaviour into consideration. The application incorporates daily reminders, gamification, and models of habit formation to engage users. It will support participants to reflect on their smoking in a holistic manner through questions and activities.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Living in Ontario, Canada.
* Current smoker who indicates they are not interested in quitting within the next 30-days.
* Have access to and regularly use a smartphone with internet access.
* Read, write, speaks English or French.
* Available and willing to participate in follow-up assessments over the next 6 months.
* Able to provide consent.

Exclusion Criteria:

* Planning on quitting smoking within the next 30-days.
* Cognitively impaired or experiencing acute psychiatric illness that would alter their ability to participate.
* Institutionalized at a retirement home, nursing home or long-term care facility.
* Has morbid illness which will prevent completion of 6-month follow-up (e.g., receiving palliative care).
* Participating in another smoking cessation program
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.

Researchers plan to evaluate the feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).


Eligibility Criteria:
Inclusion Criteria

* 18 years or older
* Non- valvular Paroxysmal Atrial Fibrillation

Exclusion Criteria

* Non-English speaking
* Has previously been evaluated by a cardiologist or electrophysiologist
* Mitral Stenosis
* Presence of Artificial Heart Valve
* Severe valvular disease (any)
* Physical disability that would preclude technology use, safe and adequate exercise performance
* Hearing or Visual Impairment that would preclude technology use
* History of fall one or more times in the last year
* Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg
* Known aortic dissection
* Severe resting arterial hypertension (SBP \>200 mmHg or diastolic BP \>110mmHg) upon enrollment (obtained during clinic visit)
* Mental impairment leading to inability to cooperate with study procedures
* Untreated high degree atrioventricular block
* Atrial fibrillation with rapid ventricular rate (Resting heart rate at enrollment visit \>110) upon enrollment (obtained during clinic visit)
* History of cardiac arrest, sudden death
* MI or cardiac surgery complications of cardiogenic shock and/or congestive heart failure (CHF) and/or signs/symptoms of post-procedure ischemia
* Left ventricular ejection fraction \<40%
* Clinically significant depression
* Presence of implanted cardiac device
* Incomplete revascularization procedure
* Pregnancy
* Previous open-heart surgery
* Unsafe to participate in the program as per treating clinician