cyrilzakka/clinical-trials huggingface dataset:
Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI

Left ventricular remodeling can still occur after primary percutaneous coronary intervention (PCI). Global longitudinal strain (GLS) assessment has been used as a predictor of left ventricular remodeling. Coenzyme Q10 is known for its anti-inflammatory and antioxidant properties, which may help reduce cardiac remodeling. This study aims to determine the effect of CoQ10 administration after myocardial infarction as an adjunct to standard therapy on left ventricular remodeling, assessed through changes in GLS values.

Researchers will compare Coenzyme Q10 to a placebo to see if Coenzyme Q10 has a greater effect on improving left ventricular GLS values in patients with ST-Elevation Myocardial Infarction undergoing primary percutaneous coronary intervention.

This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with Acute STEMI post primary PCI who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive coenzyme Q10 100mg/12hours. Patients randomized to the other treatment group will receive a placebo. It is expected that the patients of the treatment group with the coenzyme Q10 will have a greater improvement of their GLS.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 - 80 years
* Agree to participate in the study
* Patients with a diagnosis of Acute Myocardial Infarction with ST-Segment Elevation (AMI-STE) with onset \< 12 hours who underwent primary percutaneous coronary intervention (PCI)
* Successful primary PCI on the culprit lesion (residual stenosis \< 20%, TIMI flow III)
* Received standard medication therapy according to guidelines (Guideline-Directed Medical Therapy; GDMT) achieved during hospitalization
* Sinus rhythm at the time of echocardiographic examination

Exclusion Criteria:

* Patients who routinely consume CoQ10 prior to the study
* Patients with hemodynamic conditions of Killip class III-IV and NYHA class III-IV
* Patients with a history of previous acute myocardial infarction
* Patients with a history of previous PCI or fibrinolytic therapy
* Patients with a history of previous coronary artery bypass surgery
* Patients with heart valve disease greater than moderate severity
* Patients receiving warfarin therapy
* Patients with a diagnosis of isolated right ventricular infarction
* Patients with inadequate echocardiographic image quality (poor echo window)
Intradermal Injection of Anti-CTLA-4 in Patients With Stage I/II Melanoma

This study evaluates the clinical safety and tolerability, and the immunological effects of local intradermal injection of tremelimumab in patients with clinical stage I/II melanoma patients undergoing a sentinel node biopsy (SNB). Patients will be treated by local intradermal injections around the excision site of the primary tumor with escalating doses of 2, 5, 10 or 20 mg tremelimumab.

Although of limited therapeutic value, the SLN procedure has proven a useful prognostic tool for the assessment of melanoma relapse and mortality risk. Moreover, the SLN is of great value for the assessment of immunological interventions for melanoma. Since early melanoma development is accompanied by impaired immune effector functions primarily in the SLN, there is a strong rationale for therapeutic immune modulation of the SLN aimed at strengthening cellular immune functions.

The investigator now propose a phase I dose escalation study to administer intradermally a single clinical dose of tremelimumab/anti-CTLA-4 locally at the primary tumor excision site of patients with clinical stage I/II melanoma. Such a single local administration aimed at conditioning of the SLN should allow for the use of relatively low anti-CTLA-4 dosages without excess risk of autoimmune effects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Clinical stage I/II melanoma patients, planned to undergo a sentinel lymph node biopsy (SNB)
* ECOG performance status 0 or 1
* White blood count (WBC) ≥ 3 x10\^9/L
* Platelet count ≥ 100 x10\^9/L
* Hemoglobin ≥ 6.5 mmol/L
* Serum creatinine ≤ 2.5 x ULN
* Total serum bilirubin, AST, ALT and LDH ≤ 2x ULN

Exclusion Criteria:

* Non-oncology vaccine therapy used for prevention of infectious diseases (up-to) 4 weeks prior and/r 8 weeks after any dose of tremelimumab
* Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist
* Uncontrolled infectious disease including negative testing for HIV, HBV, HCV
* Autoimmune disease
The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy

To explore the impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen.


Eligibility Criteria:
Inclusion Criteria:

* 1. Scheduled painless gastroscopy examination and treatment

  2. Age 60-75 years old

  3. ASA grade Ⅰ-Ⅱ

  4. The respiratory tract is unobstructed and there is no difficult airway

  5. No history of allergy to etomidate and cyclopropofol

  6. Participants with normal heart, liver, lung, and kidney functions

  7. Able to complete the QoR-15, MMSE, and HADS scale assessments

  8. lnformed consent, voluntary participation in the trial, and signed by the patient informed consent

Exclusion Criteria:

* 1. Participants with concurrent dysfunction of major organs.

  2. Participants with a history of mental illness and abuse of sedative drugs

  3. Participants with allergies or contraindications to the study drugs

  4. Participants with severe visual, auditory, or speech communication impairments

  5. Participants with acute gastrointestinal inflammation or obstruction

  6. History of uncontrolled diabetes, hypertension, and hypotension

  7. Participants with malignant tumors, severe hyperkalemia, bronchial asthma, or excessive obesity (BMI \&gt; 30kg/m2)

  8. Participants with aneurysmal vascular diseases of the thoracic and abdominal aorta, intracranial and peripheral arterial vessels.

  9. Unable to cooperate with the QoR-15, MMSE, and HADS scale assessments
An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.

Phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.

Eligibility Criteria:
Inclusion Criteria:

* Obese with BMI ≥30 kg/m2
* Type 2 diabetes mellitus
* HbA1c of 7-11%
* Fasting glucose \<15.5 mmol/L
* Treated with diet and exercise alone or with a stable regimen of metformin, sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, SGLT-2 inhibitor or any combination of these agents
* Female subjects must be surgically sterile, post-menopausal or using long-acting contraception, which includes intrauterine devices or use of an implanted or injectable contraceptive

Exclusion Criteria:

* Current or recent use of insulin
* Severe hypoglycemia within the prior 6 months
* Metabolic disorders or genetic disorders linked to obesity (e.g., Prader-Willi Syndrome)
Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good results in pain relieve and local control, However,the longterm of efficacy and safety of this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.

Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. WHO scores 0-2;
2. The primary lesion was confirmed by pathology or cytology;
3. The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy;
4. The metastatic lesion was limited in 3 consecutive vertebral bodies;
5. The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded;
6. The enhanced MRI scan of involved vertebral bodies was required in the 2 weeks before radiotherapy;

Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

1. Leukocytes ≥ 3.0 x109/ L;
2. Absolute neutrophil count (ANC) ≥ 1.5 x109/ L;
3. Platelet count ≥ 100 x109/ L;
4. Hemoglobin (Hb) ≥ 9g/ dL;
5. Total bilirubin ≤1.5 x the upper limit of normal (ULN);
6. Alanine aminotransferase (ALT) ≤ 3 x ULN;
7. Aspartate aminotransferase (AST) ≤ 3 x ULN;
8. Serum creatinine ≤ 1.5 x the ULN;
9. Signed informed consent;

Exclusion Criteria:

1. There were significant changes in the shape of the vertebral body (the height of the vertebral body was compressed≥ 50%) or the vertebral body was unchanged but the volume of the dissolving bone was≥ 50% and could lead to serious bone adverse events;
2. There were \>3 consecutive vertebral bodies involved;
3. Spinal cord compression has occurred;
4. The gap between tumor and spinal cord was less than 3mm;
5. The metastatic area previously received radiation;
6. Pregnant and Nursing women;
7. Uncontrolled co-morbid illnesses;

9.refused to signed informed consent;
Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

Children undergoing anesthesia are often very frightened by the experience. This can lead to bed wetting, nightmares and stranger anxiety that can last for weeks. Moreover, this can influence their future experiences with anesthesia and surgery. The investigators believe the presence of a parent via video might work better as parental fear is not transferred to the child. The investigators also believe that parents who are coached on how to assist their child during anesthesia will have a better impact. As such the investigators are carrying out this study to assess whether parents who are coached and are present in either video or physical form will be more effective in reducing anxiety at induction of anesthesia.

The investigators' goal in this study is to investigate the effects of virtual parental presence and coaching of parents on anxiety in children at induction of anesthesia. The primary hypothesis is virtual parental presence during induction of anesthesia is superior to physical parental presence during induction of anesthesia in reducing anxiety in children at induction of anesthesia. The secondary hypothesis is that the coaching of parents modulates the effect of physical or video parental presence at induction anesthesia on children's anxiety.

Eligibility Criteria:
Inclusion Criteria:

1. Children from ages 18 months to 12 years old
2. American Society of Anesthesiologists physical status I, II or III
3. No previous exposure to anesthesia or surgery
4. Same Day surgery
5. English speaking parents and child

Exclusion Criteria:

1. Children with developmental delay
2. Children with psychological / emotional disorders
3. Children with language barrier
4. Previous anesthetic or surgical experience
5. Children whose eyes will be closed following surgery
6. Children on sedative or psychoactive medication
7. History of allergy to medications in our study
8. Children with expected difficult intubation
9. Children presenting for emergency surgery
10. Family history or personal history of malignant hyperthermia / risk of malignant hyperthermia
11. Consent not obtained or withdrawal of consent
12. Children who are violent during induction of anesthesia
13. Cancellation of surgery
Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide

The objective of this clinical study, randomized, crossover is to evaluate the pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide) Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp \& Dohme) by comparing the serum concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.

The pharmacokinetic profile of the drug will also be assessed by comparing the serum concentration of active metabolites following:

* O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT
* carboxylic acid (E-3174, LS-CA): active metabolite of LS

Eligibility Criteria:
Inclusion Criteria:

1. Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
2. Age between 18 and 55 years, regardless of sex, clinically healthy and present laboratory parameters within normal limits;
3. BMI ≥ 18.5 and ≤ 30.

Exclusion Criteria:

1. Participation in clinical trials in the 12 months preceding the survey;
2. History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide and / or any other ingredients of medicines;
3. Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results;
4. Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
5. Acute illness during the 07 days preceding the start of the study;
6. Chronic disease that determine drug delivery, such as hypertension, diabetes or any other that requires continuous use of any medicine, including use of vitamins, mineral supplements and OTCs (over-the-counter);
7. Having made regular use of medication in the last 02 weeks before the onset of the study. The use of any medication that does not interfere with the physician's judgment on the pharmacokinetics of the drug under study, will not be considered as an exclusion criterion.
8. Use of medications that interact with any medications association;
9. History of or current use for at least 12 months of tobacco;
10. Current or previous history (under 12 months) of illicit drug use;
11. At the discretion of the Principal Investigator of the study.
Effect of Electrical Stimulation (DC Polarization) to the Brain on Memory

This study will test the effect of direct current (DC) brain polarization (the application of a very weak electrical current to the brain) on learning and memory. Earlier studies have shown that DC polarization can temporarily improve the ability of healthy people to think of certain words. This study will explore whether it can also temporarily improve learning and memory.

Healthy people 18 years of age and older may be eligible for this study. Subjects participate in two experimental sessions at the NIH Clinical Center. The first session lasts about 1 hour; the second session, on the next day, takes about 10 minutes.

At the beginning of the first session, electrodes are placed on the subject's head and arm for brain stimulation. The current may be turned on for 25 minutes, or only very briefly (sham stimulation). Subjects are not told which type of stimulation they are receiving. No stimulation is applied in the second session.

During the sessions subjects are asked to complete the following tasks that will help elucidate the effects of polarization:

* Read a list of words and remember them. Later they will try to repeat the words from memory.
* Look at a series of designs and remember them. Later they will try to draw the designs from memory.
* Push a button on a keyboard when they see a specific item (for example, when the number 7 appears).
* Generate as many words as they can think of that begin with a particular letter of the alphabet.

Subjects may be videotaped for some or all of the time during the sessions.

OBJECTIVE: The principal objective is to establish whether DC polarization of left lateral prefrontal cortex can enhance verbal memory.

STUDY POPULATION: 75 healthy volunteers over the age of 18 will be enrolled.

DESIGN: The study is a double-blind parallel study with three arms: anodal polarization, cathodal polarization, and sham treatment.

OUTCOME MEASURES: The primary outcome measure is performance on the WMS-III Word Lists test. Secondary outcome measures, testing for effects of DC polarization on basic information processing and non-verbal memory, respectively, are the CalCAP and WMS-III Visual Reproduction Test. The Verbal Fluency Test will be administered prior to stimulation and 24 hours post-stimulation to screen for other residual effects of the polarization on the stimulated region.

Eligibility Criteria:
* INCLUSION CRITERIA:

Healthy volunteers over age 18. Pregnancy is not an exclusion.

EXCLUSION CRITERIA:

Any history of a central nervous system illness or other behavioral disorder.

Broken skin in the area of the electrodes.

Uncontrolled medical problems, such as diabetes mellitus, hypertension, airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.

Presence of metal in the cranial cavity.

Holes in the skull made by trauma or surgery.
Augmenting Cognitive Training In Older Adults

A two-phase adaptive randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and could enhance neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance neurocognitive function, brain function, and functional outcomes from CT, with combined CT and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12 months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs. active cognitive tasks will predict individual response to tDCS.


Eligibility Criteria:
Inclusion criteria:

1. Age 65 to 89 years; this age group was selected because it is at high risk of age-related cognitive decline and have a sufficiently long life expectancy to participate in the study.
2. Evidence of age-related cognitive decline in the Cognitive Training assessment defined by performance below the 80th percentile.
3. Ability to participate in the intervention and attend training sessions; willingness to be randomized to either treatment group.

Exclusion criteria:

1. Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
2. Evidence of cognitive impairment (as defined by NACC UDS performance below 1.5 standard deviations on age/sex/education normative data in at least one cognitive domain).
3. Past opportunistic brain infection.
4. Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
5. Unstable (e.g., cancer other than basal cell skin) and chronic (e.g. severe diabetes) medical conditions.
6. MRI contraindications (e.g., claustrophobia, metal implants).
7. Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
8. Currently on GABA-ergic or glutamatergic medications, or on sodium channel blockers.
9. Left-handedness.
Case Managers for CVD Risk Reduction in HIV Clinic

The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.

Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum delivered over 24 weeks \[intervention arm\], or the educational pamphlets alone \[control arm\]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from patients to assess the efficacy of the intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL).

Eligibility Criteria:
Inclusion Criteria:

* In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months
* On antiretroviral therapy
* 2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of either hypertension or hyperlipidemia
* English literate (able to speak and read at a 6th grade level)
* Subjects must have the capacity to give legally effective consent.

Exclusion Criteria:

* Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease