cyrilzakka/clinical-trials huggingface dataset:
Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Alzheimer's disease (AD) has a detrimental impact on cognitive functions. Based on pilot studies results in patients with neurodegenerative brain diseases the investigators aim for promoting the brain plasticity and improving cognition by noninvasive brain stimulation (NIBS) in healthy young, healthy aged and subjects with mild cognitive impairment due to AD. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. Different new brain targets, cognitive tasks and stimulation protocols will be tested and optimized for specific subject groups. Design of a functional MRI (fMRI) - repetitive transcranial magnetic stimulation (rTMS) - fMRI study will enable us to explore and identify effect of age, presence of the disease and genetic risk factor (APOE4) on repetitive transcranial magnetic stimulation (rTMS)-induced changes in cognition and related brain connectivity/activations. The study results will improve our understanding of healthy and pathological brain aging and will provide novel information about the usefulness of NIBS in specific subject groups. These results will have an important impact on future non-pharmacological treatment strategies.

Intensified intermittent theta-burst stimulation (iTBS) protocol will be applied in the MCI study group. A two-parallel-group, randomized, placebo controlled design will be used. Ten MCI subjects will be stimulated in a week-long therapeutical sessions. Other ten MCI subjects will be stimulated with the same protocol using sham stimulation. The investigators will study the change in subjects immediately after and again at a two-weeks follow-up visit after the end of the last stimulation session.

Eligibility Criteria:
Inclusion Criteria:

* amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011)

Exclusion Criteria:

psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by MRI that might present with cognitive decline

* a cardio pacemaker or any MRI-incompatible metal in the body
* epilepsy
* any diagnosed psychiatric disorder
* alcohol/drug abuse
* lack of cooperation
* presence of dementia
The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.

This study looks at the effects of weight loss in people who have heart failure with reduced ejection fraction (HFpEF) and are overweight or obese.

The main questions it aims to answer are whether weight loss in this group of people improves:

* The heart's shape and how well it pumps blood
* The person's quality of life and how much they can exercise

Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits.

Each study visit may involve measurements including:

Symptom and quality of life questionnaires Body measurements such as height and weight Blood tests Ultrasound scans of the heart (echocardiogram) Magnetic Resonance Imaging (MRI) scans of the heart 6 minute walk test Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care.

The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure determined by left ventricular ejection fraction 20-45%
* Body mass index \> 27.5kg/m\^2

Exclusion Criteria:

* Contraindications to magnetic resonance imaging
* NYHA class IV
* Pregnancy, planned pregnancy or lactating
* Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
* Any other conditions which may potentially compromise the safety or scientific validity of the study
Intervention to Bridge the Evidence-based Gap in Stroke Care Quality

The purpose of this study is to evaluate whether a multifaceted quality improvement intervention can improve the adherent rate of individual and composite of evidence-based performance measures for patients with acute ischemic stroke within the first 7 days of symptom onset and reduce the incidence of a new clinical vascular event, disability, and all-cause mortality at discharge and long term clinical outcome.

Study population:

patients with acute ischemic stroke who were admitted to the hospital within 7 days after the initial symptom onset.

Program:

There are multifaceted quality improvement interventions including:

1. Evidence-based clinical pathway
2. Standard operating procedures (SOP) of performance indicators
3. A quality coordinator
4. Monitoring and feedback system of performance measures

Endpoints:

Primary outcome:increase of adherence of evidence based treatment in clinical practice; Secondary outcome: total mortality, disability, and major cerebrovascular events

Eligibility Criteria:
Inclusion criteria:

* Older than 18
* Ischemic stroke within 7 days of the index event
* Direct admission based on physician evaluation or arrival through the emergency department
* Ability of patient or legally authorized representative to provide informed consent for 3, 6,and 12 months after initial symptom onset
* Eligible events were confirmed by brain ct or mri within7 days after the onset of symptoms

Exclusion criteria:

* Patients refuse to participate in this study
Diagnostic Tools for Parkinson's Disease

The study aims to identify genetic variants associated to Parkinson's disease through the analysis of exome-sequencing data of familial cases and controls. The identified variants will be used to generate a diagnostic tool for the identification of genetic risk profiles.

1. Clinical evaluation of PD patients and relatives
2. High throughput analysis of genetic variants in genome exomes
3. Genotype-phenotype association testing
4. Identification of genetic risk variants for PD

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to L-dopa (levodopa)

Exclusion Criteria:

* Previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on CT or MRI, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders.
Screening for Lysosomal Acid Lipase Deficiency

The primary outcome of this study is the development of a clinical profile of pediatric patients with LAL-D, which will enable the Sponsor to provide more focused guidance to the medical community as to which pediatric patients should be tested for LAL-D.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient is ≥ 2 to ≤ 16 years of age at the date of informed consent. (Note: Female patients who are of childbearing potential or are pregnant may participate in this study.)
2. Patient or patient's parent or legal guardian (if applicable) consents to participation in the study. If the patient is of minor age, he/she is willing to provide assent where required per local regulations, and if deemed able to do so.
3. Patient meets all components of Criterion A and/or Criterion B below.

Criterion A: Patient has dyslipidemia, defined as having at least one of the following lipid abnormalities based on a local laboratory result obtained within 3 months prior to the date of informed consent (or at the screening visit, as applicable):

LDL-c ≥ 130 mg/dL HDL c ≤ 40 mg/dL (male patients) or ≤ 50 mg/dL (female patients) Note: For patients receiving a lipid-lowering medication (LLM), the patient must have been on a stable dose of the LLM for at least 4 weeks prior to the serum lipid result.

AND

Patient has at least one of the following liver or spleen abnormalities:

Hepatomegaly, as determined by the investigator based on a physical examination or imaging procedure; Splenomegaly, as determined by the investigator based on a physical examination or imaging procedure; ALT \>75 U/L or ALT \>1.5x the upper limit of normal (ULN) (based on age- and gender-specific normal ranges of the local laboratory performing the assay) within 3 months prior to the date of informed consent (or at the screening visit, as applicable).

Criterion B: Patient has steatosis (microvesicular or mixed macro/microvesicular), hepatic fibrosis, and/or cirrhosis of unknown etiology, as determined from a liver biopsy performed within the previous 3 years. (Note: For patients who have received a liver transplantation, the liver biopsy results must have been obtained prior to the date of the liver transplantation.)

Exclusion Criteria:

1. Patient has a confirmed cause of liver disease other than LAL-D.
2. Patient has genetically confirmed heterozygous familial hypercholesteremia or other secondary causes of hypercholesterolemia.
3. Patient has current evidence of neurological dysfunction and/or a history of neurological dysfunction within one year prior to the date of informed consent.
4. Patient has been previously screened for LAL-D and found to have normal enzyme activity based on the reference range of the laboratory performing the assay.
5. Patient is currently receiving treatment with sebelipase alfa (Kanuma) or has previously participated in a clinical study with sebelipase alfa (Kanuma).
Pericardial Histopathology and COVID-19 Seropositivity

This prospective study aims to investigate the association between pericardial histopathologic inflammation grades (acute, chronic, or absent) and COVID-19 seropositivity in adult patients undergoing first-time isolated coronary artery bypass grafting (CABG). Pericardial tissue samples were collected during surgery and evaluated histopathologically, while preoperative COVID-19 serological testing was performed. The primary outcome is to determine whether COVID-19 seropositivity is associated with the severity of pericardial inflammation. Patients with prior cardiac surgery, active COVID-19 infection, systemic inflammatory diseases, chronic immunosuppressive therapy, or malignancy were excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years
* Undergoing first-time isolated coronary artery bypass grafting (CABG)
* Availability of pericardial tissue sample for histopathological analysis
* Preoperative COVID-19 serological testing performed
* Written informed consent obtained

Exclusion Criteria:

* Previous history of cardiac surgery (e.g., prior CABG, valve surgery)
* Concomitant cardiac procedures during the same operation (e.g., valve repair, aortic surgery)
* Active COVID-19 infection at the time of surgery (positive PCR test)
* Known autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis)
* Chronic immunosuppressive therapy (e.g., steroids, biologics)
* Known malignancy at the time of surgery

Insufficient or inadequate pericardial tissue sample for histopathological assessment
Efficacy of XP20B Following Bunionectomy Surgery

The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* having undergone bunionectomy surgery
* having achieved the requisite level of pain

Exclusion Criteria:

* pregnant or lactating
* history of substance abuse
* clinically significant condition or lab abnormality
* taken any prohibited medications
* gastrointestinal bleeding or history of
Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer

The study is a single center phase II trial. The purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-PD-1 antibody Followed by chemoradiotherapy in locoregionally advanced hypopharyngeal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years;
2. Hypopharyngeal squamous cell carcinoma confirmed by histopathology;
3. No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system );
4. At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been treated;
5. Provide tissues for biomarker analysis;
6. ECOG PS 0-1;
7. Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10\^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10\^9/L, albumin ≥ 28g/L, total bilirubin \< 1.5×ULN at diagnosis or after biliary drainage, ALT and AST \< 5×ULN, BUN、CREA\<1.5×ULN, creatinine clearance rate ≥ 45ml/min;
8. Contraception during the study;
9. At least 12 weeks of life expectancy;
10. Willing to join the study and sign informed consent.

Exclusion Criteria:

1. Allergic to any component of carrelizumab, cisplatin and other platinum drugs;
2. Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy in the past;
3. Received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment;
4. Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer;
5. Have corticosteroids (\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting;
6. Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 1 year；
7. Have severe infections (CTCAE\> Grade 2) occurred within 4 weeks before the first use of the study drug;
8. Have active autoimmune diseases, autoimmune diseases, but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes with stable doses of insulin; vitiligo or cured childhood asthma/allergies;
9. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
10. A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia;
11. Active tuberculosis, having antituberculosis therapy at present or within 1 year;
12. Have active hepatitis B (HBV DNA ≥2000 IU/mL or 10\~4 copies/mL) and hepatitis C;
13. Have other uncontrollable comorbidities;
14. Knowing a history of psychotropic drug abuse, alcohol or drug abuse;
15. Pregnant or breastfeeding, or expect to become pregnant during the clinical trial period.
The Efficacy and Safety of Anticoagulation in Chinese Patients With Non-ST Segment Elevation Acute Coronary Syndrome

The primary objective of the EASY-CHINA Registry is to describe the clinical epidemiology of Chinese patients with NSTE-ACS, to evaluate their current anticoagulation management in China, and the resources used for it.

Non-ST-elevated acute coronary syndromes (NSTE-ACS)are the leading cause of emergency medical care in the USA. In China, these syndromes have also become the major causes of morbidity and mortality and account for several thousands of death and hospitalizations annually. Anti-platelet drugs, anticoagulants and intervention therapy for high-risk NSTE-ACS patients may increase bleeding events while reducing ischemic coronary events. There are some evidences supporting the association between hemorrhagic complications and short- and long-term mortality. Therefore, future advances in antithrombotic therapy for NSTE-ACS need to focus on reducing ischemic event rates without increasing hemorrhagic complication rates. In this general framework, there is the need for an appropriate adoption of the available evidences concerning therapeutic strategies, specifically the use of the different antithrombotic strategies, in real world patients in order to further improve their outcomes.The primary objective of this study is to describe the clinical epidemiology of Chinese patients with NSTE-ACS, and to evaluate their current management in China. This study will be an observational survey, thus zero interference is emphasized throughout it. No randomization, blinding or special treatment will be assigned for the subjects. Issues concerning the care of subjects are completely left to the discretion of investigators in order to collect the real-world information about the pharmacological treatments for NSTE-ACS patients in china.

Eligibility Criteria:
Inclusion Criteria:

* with symptoms of UA or MI without persistent ST elevation and at least 1 of the following additional criterias: 1)troponin T or I or CK-MB above the upper limit of normal,2)electrocardiogram (ECG) changes compatible with ischemia (ie, ST depression at least 1mm in 2 contiguous leads or T-wave inversion \>3 mm),3)any dynamic ST shift or transient ST elevation
* Must be willing to signed informed consent
* age from 21-80 years
* without pregnancy or under contraception

Exclusion Criteria:

* age\<20 or \>80 years
* any contraindication to anticoagulant
* hemorrhagic stroke within 12 months
* indication for anticoagulation other than ACS
* prior enrollment in anticoagulants trials in ACS
* revascularization procedure performed for the qualifying event in one month
* severe renal insufficiency (ie,serum creatinine\>=3 mg/dL or 265umol/L)
* pregnancy or breast-feeding women
* life expectancy\<6 months
* enrollment in other medicine trials in 3 months
* with mental illness or uncooperative
Study of Methicillin-resistant Staphylococcus Aureus (MRSA) Isolated From Infected Patients in Brazil

This project has as general objective to determine if there is any Methicillin-resistant Staphylococcus aureus (MRSA) strain disseminating in the hospital of Belo Horizonte. If this is the case, the investigators will determine if this is an international known strain by typing it by PFGE and MLST.

The detection of mecA gene will be performed by PCR. Their susceptibility profile to several drugs will also be accessed and it will be possible to compare the response to those drugs commonly in use to that of Daptomycin, a new drug available in Brazil.

It will be screened for reduced susceptibility to vancomycin by Macromethod Etest (MET) in order to search for VISA or hetero-VISA. Also, due to the discussions at the literature about mutations in genes that are said to be responsible for reduced susceptibility to vancomycin, the investigators will sequence these genes in all PFGE type strain of this study looking for mutations already described to compare to the screening results.

Multidrug resistant and virulent MRSA strains have been disseminating worldwide and few alternatives of treatment for diseases caused by this pathogen are available. In this study, 36 isolates from colonization or different clinical specimens from infected patients of the Hospital Rizoleta Tolentino Neves will be analyzed. These results will provide important data for doctors and nurses, such as whether there is any strain dissemination or not in the hospital what could suggest an outbreak. It will be performed molecular typing by pulsed field gel electrophoresis (PFGE) and multilocus sequence typing (MLST). The investigators will evaluate the efficiency of several antimicrobials and the frequency of h-VISA and VISA among the Brazilian MRSA. Besides, the investigators will verify the presence of mutation in genes that are involved in resistance mechanisms of VISA. According to the strains profile present in the hospital, if this is suggested that there is a dissemination of some strain, the health professionals can start a more rigid infection control measures in order to decrease the number of cases of nosocomial infection, decreasing the time of hospitalization of patients and, consequently the cost for the hospital.

Eligibility Criteria:
Inclusion Criteria:

* MRSA from infection sites
* MRSA from colonization of the patients who already was infected by MRSA during the time of the study

Exclusion Criteria:

* MRSA from colonization of a patient who has not infection caused by MRSA
Follow-up of Anterior Cruciate Ligament Reconstruction

Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.

In this study, a collect data of patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction in order to evaluate the clinical, functional and morphological results of this intervention, in order to improve the management of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction

Exclusion Criteria:

* None
Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury

The overall objective is to obtain an initial assessment of the value of using \[18F\]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD):

* Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events.
* Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits.
* Aim 3) Assess the pharmacokinetics of a bolus infusion of \[18F\]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of \[18F\]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas.
* Aim 4) Correlate MR images with \[18F\]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all.
* Aim 5) Correlate \[18F\]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).


Eligibility Criteria:
Inclusion Criteria:

* Subjects are 18 years of age and older, except AD subjects who are 60 to 90 years of age.

Exclusion Criteria:

* A subject will not be eligible for inclusion in this study if any of the exclusion criteria for PET/CT or MRI studies applies. A negative STAT quantitative serum hCG pregnancy test is required on the day of the PET/CT scan before female subjects of childbearing potential can participate. Any woman of childbearing potential, who is seeking to become pregnant, is breastfeeding, or who suspects she may be pregnant will not be enrolled in the study.