cyrilzakka/clinical-trials huggingface dataset:
Analysis of Deep Brain Nuclei LFP and Cortical EEG Signals During the Recovery From General Anesthesia

The correlations of deep brain nuclei firing and cerebral cortex activity during recovery from general anesthesia is unclear. In this study, the local field potential (LFP) from the deep brain nuclei and the scalp electroencephalogram (EEG) of the frontal cortex were recorded from patients undergoing deep brain stimulation (DBS) surgery during the recovery from general anesthesia, in order to explore the changes and relevance of deep brain nuclei firing and cortex activity during the recovery of consciousness from general anesthesia .

The recovery of consciousness during the emergence from general anesthesia is an important part of general anesthesia. Previous studies have found that the recovery of consciousness is not a passive process of drug metabolism, but involves the activation of functional neural networks in the brain. However, the temporal-spatial dynamics of different brain regions, including deep brain nuclei and the cortex, during recovery from general anesthesia have not been elucidated.

At present, thanks to the perceptible function of the new generation of deep brain stimulation (DBS) equipment, the local field potential (LFP) of deep brain nuclei can be recorded in real time during the patient's recovery from general anesthesia after DBS surgery. This study will simultaneously record the electrophysiological signals of the patient's deep brain nuclei LFP and cortical EEG signals, and analyze the differences and correlations between the deep brain nuclei LFP and the cortical EEG characteristics during recovery from general anesthesia. This provides evidence for understanding how subcortical deep brain nuclei are involved in the recovery of general anesthesia, and provides clues for solving the mystery of consciousness.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* ASA (American Society of Anesthesiologists) classification I-III
* Those who meet the indications for DBS surgery
* Right-handed with normal listening and speaking abilities
* The patient signs the informed consent form and cooperates with the researchers

Exclusion Criteria:

* Patients with cognitive impairment \[Montreal Cognitive Assessment (MoCA) score less than 26 points\];
* Patients with severe depression \[Beck Depression Inventory (BDI-II) score greater than or equal to 25 points\];
* Patients with important organs dysfunction, such as heart, lungs, liver, and kidneys; or patients with unstable vital signs;
* Patients who are expected to enter the ICU after surgery;
* Patients who are alcoholic, alcohol dependent or drug dependent;
* Patients who have received general anesthesia one month before surgery, patients who are known to be allergic to general anesthetics;
* The DBS surgery exceeds 4 hours;
* Patients who are pregnant.
Incretin Hormone Antagonism After Bariatric Surgery

Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.


Eligibility Criteria:
Inclusion Criteria, surgery groups:

* Age \> 18 years
* RYGB or SG operation \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion

Inclusion Criteria, control group:

* Age \> 18 years
* no former RYGB- or SG operation
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol, fasting plasma glucose \< 6.1 mmol/l and no history of diabetes

Exclusion Criteria:

* Thyrotoxicosis or inadequately treated hypothyreosis
* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations

Matching between groups

* Age
* Sex
* BMI at inclusion and for surgery groups also pre-surgery BMI
Correlation Between Perioperative EEG Features and Delirium After General Anesthesia

The goal of this observational study is to compare the perioperative EEG characteristics and the incidence of short-term cognitive dysfunction in patients with postoperative delirium and non-postoperative delirium after elderly (\> 65 years old) patients undergoing major gastrointestinal surgery under general anesthesia. The main question it aims to answer are: • The correlation between postoperative cognitive dysfunction and postoperative EEG features was evaluated.• To analyze the correlation between EEG characteristics and clinical risk factors of delirium after major abdominal gastrointestinal surgery under general anesthesia in elderly patients.Participants will collect EEG before and after operation and collect the incidence of postoperative cognitive function to explore the mechanism of postoperative delirium and predict postoperative cognitive dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Education level in primary school or above;
2. Age ≥65 years old, gender is not limited;
3. Good communication ability, language expression ability, mental state and consciousness state;
4. Preoperative simple mental state scale score ≥27 points;
5. no history of craniocerebral diseases;
6. For patients who plan to choose abdominal surgery under general anesthesia, the operation time is expected to be about 2h-4h;
7. ASA anesthesia grade I \~ III;
8. No general anesthesia contraindications;
9. Sign informed consent voluntarily;

Exclusion Criteria:

1. Relative contraindications of general anesthesia: patients with serious heart and lung function diseases, drug allergy history, etc.
2. Patients with a history of mental illness or long-term psychiatric drugs (dementia, schizophrenia), chronic analgesic drug use history, alcoholism history and cognitive dysfunction;
3. any cerebrovascular accident occurred within 3 months, such as stroke, transient ischemic attack (TIA), etc.
4. Diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular disease, diabetic nephropathy);
5. Chronic hypoxia and carbon dioxide storage, such as chronic obstructive emphysema;
6. a long history of alcohol abuse;
7. Unable to cooperate to complete the test, the patient or family rejected the participant.
Weight Set-Point and HDL Concentration in Runners

To investigate the differences in diet, fat cell morphology and lipoprotein metabolism in previously- overweight and naturally lean men and women who ran and who lived sedentary lifestyles in order to better understand the relationship between lipoprotein metabolism and weight set-point.

BACKGROUND:

The elevated high-density lipoprotein (HDL) cholesterol concentrations of long distance runners has been ascribed almost exclusively to increased muscle lipoprotein lipase. Based on data collected in cross-sectional and longitudinal studies, the investigators proposed an alternative theory: long-distance runners had the HDL-cholesterol metabolism of men who were below their sedentary weight rather than the HDL-cholesterol metabolism of lean sedentary men who were at their usual sedentary weight. In other analyses, they found that the most significant determinant of male runners' plasma HDL-cholesterol concentrations was the difference between the runners' greatest weight and their current weight. HDL- cholesterol levels were highest in runners who had lost the most weight, i.e., highest in those who were presumed to be the furthest below their weight set-point

The study was a result of a Program Announcement (PA) released in October, 1994 on Physical Activity and Cardiopulmonary Health. The PA was jointly sponsored by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research.

DESIGN NARRATIVE:

In this cross-sectional study, runners and sedentary men and women were measured for lipoprotein cholesterol, triglycerides, polyacrylamide gel electrophoresis of HDL and low-density lipoprotein subclasses, apolipoproteins A-I and B, intravenous fat clearance rate, post-heparin lipoprotein lipase and hepatic lipase, adipose tissue lipoprotein lipase, cholesteryl ester transfer activity, diet, percent body fat, and regional adiposity. It was hoped that the survey would confirm or reject the weight set-point hypothesis, provide a possible explanation of the lipoprotein differences between male and female runners, and elucidate the mechanism for the lipoprotein changes that occur during exercise-induced weight loss.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome

This is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the treatment of adults with Tourette syndrome.

The investigators propose a 12-week, investigator-initiated, open-label trial of a therapeutic combination of Dronabinol and PEA in 18 adults with Tourette syndrome. Participants will receive Dronabinol and PEA in combination for the duration of the trial. The goal for this pilot study is to (1) provide initial safety, feasibility and tolerability data on both Dronabinol and PEA in a TS population and (2) provide data in order to make a more informed decision regarding the appropriate sample size and design of a larger clinical trial to prove efficacy (i.e. sample size and trial duration in large efficacy trial of the Dronabinol/PEA combination in TS).

Eligibility Criteria:
Inclusion Criteria:

* Adult between 18-60 years of age
* Meet DSM-5 criteria for the diagnosis of Tourette syndrome
* Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline
* On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial
* Accepted method of birth control

Exclusion Criteria:

* Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ\<70)
* Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.
* Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
* Taking any co-medications (over the counter or prescription), food supplements/additives which can have a drug interaction with dronabinol or PEA.
* Positive pregnancy test or drug screening test
* History of cannabis dependence
* Significant Medical Comorbidity
* History of hypersensitivity to any cannabinoid or sesame oil
The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience

Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. Other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.

This prospective observational study of women with hypertensive disorders of pregnancy (gestational hypertension or preeclampsia) seeks to evaluate a number of markers of maternal postpartum well-being, including maternal mood, breastfeeding, cognitive function, maternal-infant attachment, maternal perception of control, and postpartum pain between women who did and did not receive magnesium prophylaxis in the peripartum period.

This project will include 300 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 34 weeks gestation, have a singleton pregnancy, and have been diagnosed with a hypertensive disorder of pregnancy (either gestational hypertension or preeclampsia). Women will be exposed to magnesium for the indication of preeclampsia at the discretion of their obstetric provider.

Intrapartum baseline magnesium serum levels will be drawn for all women. For women who are receiving a magnesium infusion, serum magnesium levels will be repeated during the magnesium infusion (after receipt of the bolus infusion). For women who elect to receive neuraxial analgesia, CSF will be obtained and central magnesium levels drawn at the time of epidural placement.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review. Surveys will be administered to assess potential confounders of depression. A baseline self-reported depression survey, the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) will be administered followed by a structured clinical interview for diagnosis (SCID), the gold standard for psychiatric research diagnosis. Women will be contacted at two weeks and again at six weeks postpartum and the QIDS-SR will be administered. For women with positive screens, a phone-based MINI will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant or immediately postpartum women
2. Age 18 and over
3. Singleton gestation
4. Diagnosis of hypertensive disorder of pregnancy
5. Gestational age of at least 34 weeks
6. English-speaking

Exclusion Criteria:

1. Women not meeting the above criteria
2. Prior receipt of magnesium during pregnancy
3. Intrauterine fetal demise or neonatal demise
4. Chronic hypertension
A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

This is a dose escalation study that will assess the safety and efficacy of LCL161 in combination with weekly paclitaxel in adult patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

Patients with breast cancer must have a histologically or cytologically confirmed diagnosis of disease that has metastasized or is resistant to therapy.

Patients with ovarian cancer must have histological evidence of recurrent epithelial ovarian, fallopian tube or peritoneal cancer.

Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia Male or female patients 18 years or older ECOG performance status 0-1 Life expectancy greater than 12 weeks Measurable disease as determined by RECIST v1.0 Patients must give written informed consent and comply with the protocol

Exclusion Criteria:

For patients with breast cancer:

Concurrent Her2-directed or anti-estrogen therapy

For patients with ovarian cancer:

Primary refractory disease, defined as progression during initial treatment with a platinum- and taxane-containing regimen.

Prior treatment with weekly paclitaxel. More than two chemotherapy regimens given in the relapse setting. Evidence of a documented bowel obstruction within six months of study entry Patients with unresolved peripheral neuropathy, nausea, vomiting, or diarrhea ≥ CTCAE Grade 2 Any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities.

Patients with impairment of GI function or GI disease that may significantly alter the absorption of LCL161 Patients who have undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of procedure.

Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive β-HCG laboratory test (\> 5 mIU/mL).

Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C (HIV and hepatitis testing are not mandatory).

Other protocol-defined inclusion/exclusion criteria may apply
Feeding the Rainbow to Investigate Endothelial Dysfunction

The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 18-65
* in good health by the absence of exclusion criteria on standardized medical history interview
* willingness to be randomized
* willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days

Exclusion Criteria:

* children \<18 years
* current use of carotenoid supplements (not including typical multivitamins containing beta-carotene)
* current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract
* current use of aspirin, statins or regular (\>2 per week) use of NSAID medications
* current smoking or past smoking greater than 3 packs total or currently living with a smoker
* excessive alcohol intake (\> 3 drinks per day) or history of alcoholism
* known exposure to asbestos
* autoimmune disease
* hemachromatosis
* history of gallbladder disease including gall stones or gall bladder removal
* pre-diabetes, metabolic syndrome or diabetes (1 or 2)
* established cardiovascular disease (arrhythmia, heart failure, hypertension treatment or untreated stage II hypertension (≥160/90; stage II technically diastolic ≥100mmHg, will maintain diastolic cutoff of 90mmHg), past MI or stroke)
* renal or liver disease (viral hepatitis, non-alcoholic steatohepatitis "fatty liver")
* acute infection except viral colds
* residual injury/pain/limitation from trauma
* chronic musculoskeletal disorders including osteoarthritis requiring pain medications
* psychiatric disorders that would impair completion of research tasks
* allergies to supplied foods
* anyone on a medically-prescribed diet
* \>3.5 servings fruits/veggies per day
* inability to consume entire study Control meal w/in specified timeline (30 minutes)
* current pregnancy or breast feeding
* refusal to participate in blood draws following the control meal.
Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students

The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence.

The aims of this study are (1) to test feasibility \& acceptability of screening for AUD symptoms/alcohol misuse and recruitment among college students, and (2) to test preliminary efficacy of PST-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* Male and female college students aged 18-25 yr
* English-speaking
* Current alcohol use more than or equal to 2 days/week via phone screening
* Completion of AUDIT screening and meet criteria for (past year) mild, moderate or severe AUD during AUDADIS-5 interview
* Completion of written informed consent
* Interested in cutting back alcohol intake or changing his/her drinking
* Baseline screening study visit

Exclusion Criteria:

* Participation in past 6 months in AUD or substance use treatment
* Current use of medications used to treat AUD (e.g., naltrexone)
* Lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
* Current use of psychoactive drugs
* Not currently enrolled in college
* Not interested in cutting back alcohol intake or changing his/her drinking
* Pregnancy or intention to become pregnant
TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus

This is a phase 2, randomized, open-label, single-center study that will assess the efficacy of TriCalm Hydrogel®, a topical gel containing strontium, for treating pruritus related to immune checkpoint inhibitors (ICIs).

Pruritus is a common immune-related adverse event of immune checkpoint inhibitors (ICI).

This is a phase 2, randomized, open-label, single-center study that will assess the efficacy of TriCalm Hydrogel®, a topical gel containing strontium, for treating pruritus related to ICIs. Topical strontium salts have been found to reduce the duration and severity of histaminergic and nonhistaminergic pruritus. The investigators hypothesize that TriCalm Hydrogel® will be effective in reducing the severity of immunotherapy-related pruritus and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older.
2. Patients receiving ICIs for hematologic or oncologic malignancies at the Moores Cancer Center Infusion Center at UC San Diego. ICIs include CTLA-4 inhibitors (ipilimumab), PD-1 inhibitors (cemiplimab, nivolumab, pembrolizumab) and PD-L1 inhibitors (atezolizumab, avelumab, durvalumab).
3. Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI.
4. Preexisting use of oral antihistamines and/or GABA analogs more than 7 days prior to study entry are allowed.

Exclusion Criteria:

1. Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis).
2. Initiation of any new oral or topical antipruritic medications and/or systemic corticosteroids within 7 days prior to study entry.
3. Presence of open wounds on the skin.
4. Presence of pruritus on the face.