cyrilzakka/clinical-trials huggingface dataset:
Exercise and Neurocognition in Adults Relative to ApoE Genotype

The current project is a single-blinded, double-arm, 6-month randomized controlled trial aiming to assess the effects of a integrated intervention program on neurocognitive function with respect to event-related potential in adults aged 45-70 years. Additionally, the potential impacts of apolipoprotein epsilon-4 alleles and the brain-derived neurotrophic factor will be explored.

The current randomized clinical trial is designed to examine (1) whether a 6-month integrated intervention program (IIP) consisting of multiple exercise modalities, meditation, and social interaction could benefit neurocognitive function (e.g., inhibition) in middle-aged and older adults; (2) whether components of ERP will be influenced by the integrated intervention program; and (3) whether apolipoprotein E (ApoE) genotypes (ApoE e3/e4, ApoE e4/e4, ApoE e2/e2, ApoE e2/e3, ApoE e2/e4, and ApoE e3/e3), physical fitness, and brain-derived neurotrophic factor (BDNF) will influence the effects of an integrated intervention program on neurocognitive function and components of ERPs.

The study will randomly assign 100 eligible participants to either the IIP group or the control group in a 1:1 ratio. The IIP group will engage in 150 min of exercise per week, which consists of one 90-min on-site session and multiple online sessions, for 6 months. The control group will be invited to attend one 60-minutes online educational course per week for 6 months.

The neurocognitive function, the components of ERP, ApoE genotype, physical fitness, and BDNF will be assessed at the baseline (Baseline-Assessment) and the end of the 6-month intervention (Post-Assessment).

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected-to-normal vision
* Able to speak and read Chinese
* Scores of Mini-Mental Status Examination \>= 25
* Physical Activity Readiness Questionnaire score \< 0
* Able to conduct the exercise with moderate intensity
* Provide informed consent

Exclusion Criteria:

* Diagnosed or self-reported cognitive problems (e.g., mild cognitive impairment or dementia)
* Diagnosed or self-reported physical disease (e.g., untreated hypertension and chronic heart disease, stroke, brain tumor, musculoskeletal disorders, other exercise contradictions)
* Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
* Diagnosed or self-reported neurodegenerative disease (e.g., Alzheimer's disease or other dementias, Parkinson's disease (PD) and PD-related disorders, Huntington's disease)
* History of alcohol or drug abuse
* History of chemotherapy
* Traveling consecutively for three weeks or more during the study
* Unwillingness to be randomized to one of the two groups
* Currently participating in another study trial
Efficacy Of Copper To Reduce Acquisition Of Microbes and Healthcare-acquired Infections

CONTEXT: Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality. Commonly touched items in the patient care environment harbor microorganisms that may contribute to HAI risk. Thus, reduction in the surface bioburden may be an effective strategy to reduce HAI. Inherent biocidal capabilities of copper surfaces offer a theoretical advantage to conventional cleaning, as disinfection is continuous rather than episodic.

OBJECTIVE: Determine whether placement of copper-alloy surfaced objects in an intensive care unit (ICU) reduce risk of HAI.

DESIGN: An intention to treat study where patients are sequentially placed into rooms with or without copper-alloy surfaced objects.

SETTING: The ICUs of three hospitals, a tertiary academic hospital, an academic cancer center, and a Veteran's Administration Medical Center.

PATIENTS: Any patient 18 years of age or older who required admission to an ICU at a study hospital is eligible for placement into a study room if available.

INTERVENTION: Placement of copper-alloy surfaced objects in an ICU room. MAIN OUTCOME MEASURE: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.


Eligibility Criteria:
Inclusion Criteria:

patients 18 years and older requiring admission to an ICU at one of the study sites were eligible

Exclusion Criteria:

* less than 18 years of age or
* pregnant
Hetrombopag for Low/Intermediate-1 Risk MDS With Thrombocytopenia

Myelodysplastic syndrome (MDS) is a kind of clonal myeloid tumor. The major manifestation is decrease of tri-lineages of blood due to ineffective and abnormal hematopoiesis, some of which can progress to acute myeloid leukemia. According to the international prognosis scoring system (IPSS) of MDS, about 10% low/intermediate risk-1 MDS patients have severe thrombocytopenia (PLT \< 30 × 109/ L). These patients have both decreased platelet count and platelet dysfunction, resulting in a high risk of bleeding. In the new prognostic score, such as IPSS-r, the degree of thrombocytopenia is regarded as a poor prognostic factor. Platelet transfusion is mainly used in the treatment of this kind of patients. The indications of transfusion include bleeding events or severe platelet count reduction (\< 10 × 109 / L). However, platelet transfusion can only lead to short-term platelet elevation, while repeated transfusion increases the possibility of infection and ineffective platelet transfusion. TPO is a newly discovered hematopoietic promoting factor, which can specifically bind to the TPO receptor on the cell and participate in the regulation of proliferation, differentiation, maturation and division of megakaryocyte to form functional platelet. The efficacy and safety of the TPO receptor agonists eltrombopag and romiplostim in the treatment of thrombocytopenia in low/intermediate risk-1 MDS patients have been successfully confirmed in foreign studies. Hetrombopag is a new kind of a TPO receptor agonists which is highly specific platelet stimulating factor. At present, there is no large report on the application of Hetrombopag in such patients. The purpose of this study is to explore the short-term and long-term therapeutic effect and safety of Hetrombopag on low/intermediate risk-1 MDS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed MDS, IPSS low / intermediate risk-1
2. In the 4 weeks before inclusion, the average value of platelets was ≤ 30 × 10e9 / L, or \< 50 × 10e9 / L with bleeding events
3. Patients with EPO due to anemia and G-CSF due to severe neutropenia can be included, and the dosage will not change during trial
4. ECOG 0-2 points
5. Able to sign informed consent

Exclusion Criteria:

1. Pregnant or lactating
2. IPSS intermediate risk-2 / high risk MDS
3. More than 5% of myeloblasts in bone marrow
4. Myelofibrosis
5. Previous transplantation or ATG treatment within 6 months
6. Previous use of TPO or other TPO receptor agonists
7. Active infection or tumor
8. Thromboembolic or hemorrhagic disease
9. Serious heart disease, including unstable angina, congestive heart failure, arrhythmia, 1-year history of myocardial infarction
10. Baseline liver and kidney function: ALT / ASL over than 3 times normal upper limit, TBIL over than 2 times normal upper limit, and creatinine over than 2 times normal upper limit
Outcome of Facial Palsy Following Rehabilitation

Retrospective case series,the aim of this study is to assess the outcome and rate of complications in patients with facial palsy following rehabilitation, a retrospective study.

Data from all patients presenting to the outpatient clinics of the Physical Medicine, Rheumatology and Rehabilitation Department. Faculty of Medicine, Alexandria University in the past 3 years will be collected. The outcome and complications from rehabilitation of facial palsy will be recorded.

Primary Outcome: complications of Facial palsy following rehabilitation. Confidentiality of all records will be ensured.

Eligibility Criteria:
Inclusion Criteria:

* all patients with primary idiopathic peripheral facial palsy

Exclusion Criteria:

* all patients with secondary causes of facial palsy
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2

The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response at the site of Candin intradermal injection in the presence of a targeted immune pathway inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight of no less than 50 kilograms (kg)
* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example, nicotine patch) for 3 months prior to screening
* Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) coronavirus disease 2019 (COVID-19) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to administration of study intervention
* A woman must be: a) not of childbearing potential; or b) of childbearing potential and practicing a highly effective method of contraception (failure rate of less than \[\<\] 1 percent \[%\] per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 4 months after study intervention administration - the end of relevant systemic exposure. The investigator should evaluate the potential for contraceptive method failure (example, noncompliance, recently initiated) in relationship to the study intervention administration

Exclusion Criteria:

* History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances
* Known allergies, hypersensitivity, or intolerance to Candin or its excipients
* Has an active, acute or chronic infection
* has a history of psychiatric disorders (depression, suicidal ideation and/or behavior including suicides)
* Has had prior exposure to belimumab or other B-cell activating factor (BAFF) inhibitors, such as tabalumab, atacicept, and telitacicept
MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Recently, MRI technics have demonstrated their sensibility to the different processes involved in MS. Particularly, MRI has evidenced that the pathological process of MS is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. In the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. Moreover, MRI has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. Despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. The present project aims to depict the main determinants of physical but also cognitive disability in patients with MS. To do this, a longitudinal study including 70 patients with MS using different MRI markers known to be sensitive to the different pathological aspects of MS will be performed. The relationships between these markers and the progression of disability will be assessed. Identification of the main pathological underpinnings of irreversible disability of MS will provide the most relevant therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Major patient,
* Patient affiliated to a health insurance plan
* Patient having signed free and informed consent after receiving detailed, understandable and honest information,
* Patient with multiple sclerosis according to the criteria of Polman 2010

Exclusion Criteria:

* Patients with the usual contraindications to MRI (pace-maker, agitation, metal splinters, claustrophobia etc.)
* Patients at risk of non-compliance on examination: impaired understanding, confusion, involuntary movements, poor tolerance of prolonged supine
* Patients with known allergy to gadolinium
* Patients with renal insufficiency
* Patients unable to give their consent: disorders of the comprehension, disturbances of vigilance, confusion ...
* Pregnant and breastfeeding woman
* Patients with a history of neurological or psychiatric pathology
* Patients under guardianship or curatorship
A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects

This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.


Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntarily participated in the study and signed the informed consent form (ICF);
* 2. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
* 3.Body mass index \[BMI= weight (kg)/height (m) 2\] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；

Exclusion Criteria:

* 1. Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;
* 2. Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;
* 3. Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;
* 4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;
* 5. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.
Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.

according to protocol

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Age between 18 and 65 years
* Body Mass Index in the range of 18.5 to 29.9 kg/m2

Exclusion Criteria:

* Acute or chronic illnesses (high blood pressure, heart disease, diabetes, kidney disease, liver disease, alcohol dependence, etc.)
* Taking medication (except oral contraceptives)
* Pregnancy or breastfeeding
* Food intolerances or allergies to mushrooms and dairy products
* Smokers
* Visits to solariums or previous holidays in southern countries or in the Alps or other high mountains
* Participation in another study
* Blood donation during the last 2 months before the start of the study
* Dieting
* Severe weight loss or weight loss (≥ 3 kg) within the last month
Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or cells of patients with abdominal aortic aneurysm (AAA). Researchers will compare participants receiving evolocumab injections to participants receiving placebo injections to see how the tissue and cells of the aorta are affected by changes in LDL-C levels.

After being informed about the study and its potential risks, all patients giving informed consent will undergo a baseline visit and be randomized to received either evolocumab 140mg subcutaneously or placebo. This baseline visit includes a vital signs assessment, laboratory tests, medical history and medication review, a pregnancy test (if applicable), and training on how to perform drug injections. Participants will receive 3 doses/autoinjectors of study drug or placebo and be instructed to perform injections every 14 days starting 5 weeks prior to their scheduled AAA repair. If the baseline assessment occurs 5 weeks prior to their scheduled AAA, the first injection will be performed during this visit. Participants will have the option of coming back to the site for injections 2 and 3 or perform these injections at home under telehealth supervision. At the time of open AAA repair, participants will repeat laboratory tests and have a sample of aneurysm tissue taken. Participants will then have a follow up phone call 4 weeks after AAA repair to assess for any adverse events. At the conclusion of the study investigators will examine gene expression and protein levels in the aortic tissue to determine the impact of LDL-C lowering with evolocumab.

Eligibility Criteria:
Inclusion Criteria:

1. Abdominal aortic aneurysm (AAA) requiring open surgical repair
2. Age \> 18
3. Provision of signed and dated informed consent form
4. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Prior use of a PCSK9 inhibitor (evolocumab, alirocumab, inclisiran) within 6 months of the baseline visit
2. LDL-C \< 40 mg/dL (within 3 months of baseline visit)
3. Known allergy to PCSK9 inhibitor
4. Aortic dissection
5. Vascular connective tissue disorders
6. Type I-III or V Thoraco-abdominal Aortic Aneurysm
7. Vasculitis or inflammatory aneurysm
8. Pregnant or lactating women
9. Poorly controlled diabetes (A1C \> 10%)
10. Chronic kidney disease Stage 4/5 or End Stage Renal Disease (ESRD) on hemodialysis (HD)
11. Liver Disease (alanine transaminase \[ALT\] or aspartate aminotransferase \[ALT\] \> 3.0 x upper limits of normal) (within 3 months of baseline visit)
12. Known latex or naturally rubber allergy
13. Treatment with another investigational product within 30 days or 5 half-lives of the investigation drug before consent (whichever is longer) that would have an impact on endpoints associated with this trial.
14. Any other condition that the Investigator feels prohibits participants' ability to comply with study or follow up.
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet

Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown. In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different bending angles.

intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients require nasotracheal intubation

Exclusion Criteria:

* fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status
A Tolerability Assessment Study of Three Wash Products in Infants

This will be a single centre, evaluator blind, randomized, parallel group, stratified, two week study in healthy participants. The clinical study is designed to provide reassurance that the formulations developed for children and babies with mild to moderately dry skin and for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the target population, babies and young children with dry skin.


Eligibility Criteria:
Inclusion Criteria:

* Participants up to 18 months of age at the screening/baseline visit with good general health and no major physical disabilities
* Parent/legal guardian reported dry skin
* Voluntary written informed consent form by parent/legal guardian as an evidence to understanding of the study and willingness to participate

Exclusion Criteria:

* Allergy/intolerance or hypersensitivity to the study material or any of their stated ingredients
* Participant with skin condition that warrants medical intervention, current episode of eczema/atopic dermatitis or has had an episode in the 3 months prior to screening, not regular use of moisturizers (variable application frequency)
* Use of oral corticosteroids/immunosuppressive medication within 4 weeks or topical corticosteroids/topical anti-itch products within 2 weeks of baseline
* Child in Care; participants' previous participation in this study/another clinical study/receipt of investigational drug within 30 days of the screening visit
* Parent/legal guardian aged 18 years or under, employee of the sponsor or the study site or members of their immediate family
* Participant living in the same household of an already enrolled participant
Impact of Ibis on Patients With Advanced COPD

The purpose of this research is to determine if Ibis™, a digital therapeutics solution developed by Senscio Systems, reduces the emergency room visits and hospitalizations of patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Gold Stage II with a CAT Score above 19
* Gold Stage III/IV with a CAT Score above 14

Exclusion Criteria:

* Cognitive or physical impediments that inhibits patients from interacting with our digital therapeutics platform.
Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection

This prospective non-randomized controlled trial aims to determine whether autotransfusion of red blood cells salvaged before liver resection is associated with the recurrence-free survival in patients with hepatocellular carcinoma.

Preoperative and intraoperative blood salvage autotransfusion is used in various surgical procedures. However, because of the risk of reinfusion of salvaged blood contaminated by tumor cells, the use of autotransfusion in hepatocellular carcinoma (HCC) patients undergoing liver resection is controversial. The critical points include whether tumor cells can be cleared by autotransfusion, whether autotransfusion increases the risk of recurrence or metastasis, and what are the indications for autotransfusion. Moreover, some other issues are still not addressed. For example, is it warranted to take the risk of tumor dissemination by using autotransfusion to avoid allogeneic blood transfusion? Do the remaining tumor cells after additional filtration by leukocyte depletion filters still possess potential tumorigenicity?

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent liver resection;
* Diagnosis of hepatocellular carcinoma confirmed by postoperative histopathology;
* Level of preoperative hemoglobin ≥110 g/L;
* Child-Pugh class A or B liver function;
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

Exclusion Criteria:

* A history of other malignancies;
* History of active autoimmune or immunodeficiency diseases;
* Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;
* Loss to follow-up.