cyrilzakka/clinical-trials huggingface dataset:
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation

The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the production over time of several inflammatory markers.

Inflammation is an important biological process initiated by the immune system in response to injury, irritation or infection. Prolonged or chronic inflammation is involved in the etiology of several diseases such as cardiovascular disease (CVD), diabetes, rheumatoid arthritis, cancer, and neurodegenerative diseases such as Alzheimer disease. The evidence base clearly demonstrates benefits of diet in ameliorating inflammation and reducing the burden of chronic disease. With respect to marine-derived omega-3 fatty acids and various markers of inflammation related to cardiovascular disease (CVD), both population studies and randomized controlled supplementation trials have yielded mixed results.

Some studies have demonstrated a dose-response relationship between dietary eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) and increased membrane (phospholipid) EPA and DHA. Red blood cell (RBC) EPA + DHA content has been proposed as a potential, modifiable marker for coronary heart disease (CHD) risk. It is well established that these fatty acids are precursors of series-3 prostanoids, thromboxanes, 5-series leukotrienes, and novel lipid mediators such as resolvins and protectins that have anti-inflammatory effects. We hypothesize that nutritionally-relevant intakes of omega-3 fatty acids are able to blunt the usual response to an inflammatory stimulus. We propose to test this hypothesis using both in vivo (i.v. endotoxin challenge) and ex vivo (endotoxin-stimulated monocytes) models in a 6-month, dose-response study with marine-derived omega-3 fatty acid supplements in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and non-pregnant/lactating women between the ages of 20 and 45
* BMI \>19.9 and \<30.0
* Able to give written informed consent and willing to comply with all study- related procedures.

Exclusion Criteria:

* Previous history of heart disease or diabetes
* Renal Insufficiency
* Chronic anti-inflammatory use
* Systolic blood pressure \< 90
* Individuals currently using tobacco products or have done so in the previous 30 days
* Individuals taking Omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month.
Multimodal Study of the Human Brain Epilepsy Tissue

The TIPI2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy.

The aim of the study will be to identify new pathophysiological pathways. For this purpose, the investigators will investigate with a multimodal approach blood and brain samples from patients undergoing a surgery for focal drug-resistant epilepsy. The adult patients will be enrolled either during the pre-surgical evaluation or right before the surgery.

This study aims to investigate blood and brain samples from patients with drug-resistant epilepsy in order to identify new pathophysiological biomarkers.

The investigators will first conduct multimodal research, including:

* electrophysiological analyses
* immunohistochemistry and genetic studies
* biochemistry analyses

Samples will be stored at -80°C for future research.

Patients will undergo a follow-up evaluation within the 36 months following the surgery. New clinical data and biological samples will be collected then.

Eligibility Criteria:
Inclusion Criteria:

* 18 yo or above
* patients with a focal drug-resistant epilepsy
* patients hospitalized for a pre-surgical evaluation or for an epilepsy surgery
* consent obtained from the patient, or legally authorized representative
* affiliated to a social security system

Exclusion Criteria:

* None
The Italian Transthyretin Amyloidosis Web-Network

The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.


Eligibility Criteria:
Inclusion Criteria:

1. Suspected diagnosis of systemic and localized amyloidosis;
2. age .18 years;
3. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
4. planned (or ongoing) follow-up at participating center.

Exclusion Criteria:

1. Diagnosis of light chain (AL) amyloidosis
DC Vaccine Combined With CIK Cells in Patients With SCLC

The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously preclinical research with DC combined with CIK cells, the investigators plan to perform the clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed diagnosis of Small- Cell Lung Cancer
* Age \>18 years at time of consent
* Received standardized treatment of Small-Cell Lung Cancer
* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* No severe viral or bacterial infections
* Predicted survival \>3 months

Exclusion Criteria:

* Clinically relevant diseases or infections (HBV, HCV, HIV)
* Females who are pregnant or nursing
* Immunosuppressant treatment
* Currently participating in another clinical trial
* Unfit for participating in this clinical trial in investigators' opinions
Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that laparoscopic colon resection would result in fewer incisional hernias, prospective studies demonstrate a similar incidence to open surgery. Observational studies suggest that the rate of incisional hernia after laparoscopic colon resection may be reduced with the use of a transverse compared to a midline extraction incision. However, no randomized trails are available, and a midline extraction incision for hemicolectomy remains the standard current approach. The investigators hypothesize that the use of a lower abdominal transverse muscle splitting incision for specimen extraction in laparoscopic colon surgery will result in fewer incisional hernias compared to a midline periumbilical extraction incision.


Eligibility Criteria:
Inclusion Criteria:

* scheduled laparoscopic partial colectomy where an abdominal extraction incision is planned

Exclusion Criteria:

* previous laparotomy
* rectal resection or anastamosis
* planned pfannenstiel extraction incision
* single site surgery
* planned or performed stoma
* BMI \>35 kg/m2
* ASA 4-5
Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Postoperative delirium (POD) is a common complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing selective awake craniotomies.
* Age ≥18 years.
* Obtain written informed consent.

Exclusion Criteria:

* 1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA\< 18).
* 2.Preoperative psychotropic medication within one year.
* 3.BMI≤18 or ≥30 Kg/ m2
* 4.Pregnant or lactating women.
* 5.History of traumatic brain injury or neurosurgery.
* 6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
* 7.Severe hepatic or renal dysfunction.
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*02 Disease Controlled Advanced Non-small Cell Lung Cancer

The investigators previously identified a novel HLA-A\*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung cancer. In this clinical study, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*0201 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers.

The investigators previously identified a novel HLA-A\*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies, but who do not have any options for additional standard ones to prevent .future relapse of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. NSCLC whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease.
2. ECOG performance status 0-2
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*0201
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
Study of Subjects With Diabetic Foot Ulcer (DFU)

Foot ulceration is a common and costly complication of diabetes. GSK1278863 is a topical drug, which is being developed to treat wounds associated with DFU. The aim of this study is to explore the symptoms and impacts of DFU from the subject perspective and to elicit in-depth information about DFU signs and symptoms, impacts on functioning and health-related quality of life (HRQoL). Adult DFU subjects with current or recent (within last six months) neuropathic foot ulcers will be eligible to participate in this prospective, cross-sectional interview study. Approximately 20 DFU subjects will be recruited from up to three clinical sites. Potential subjects will be pre-screened and then contacted to gauge interest in the study. Interested subjects will be screened and eligible subjects will consent to release contact information to research staff. Research staff will contact the subject to schedule interviews. This study will include concept elicitation interviews over the telephone or in-person by trained and experienced interviewers. In-person interviews will be conducted in a private room at the clinical site. All interviews will be conducted in English and will be guided by semi-structured interview guides. All subjects will provide written consent prior to the start of the interview.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female, 18 years of age or over
* Has a diagnosis of type 1 or 2 diabetes
* Has a diagnosis of neuropathic foot ulcer with minimal, if any, ischemia present (Ankle-Brachial Index \[ABI\] \>=0.6 or transcutaneous oxygen \[TcPO2\] \>35 millimeter of mercury \[mmHg\])
* Wagner grade 1 or 2
* Currently receiving treatment for a diagnosis of diabetic foot ulcer or have had an active foot ulcer healed within the last 6 months
* Is not currently enrolled in a clinical trial for DFU
* Is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
* Is willing and able to participate in the study which includes a 60 minute interview
* Willing to have interview audio-recorded
* Speaks English as primary language

Exclusion Criteria:

* Subjects who does not meet the inclusion criteria
* Has diagnosis of critical limb ischemia
* Has ulcers that have exposure of tendon, bone, or joint capsule (Wagner grade \>2)
* Has osteomyelitis or gangrenous ulcers
* Is currently enrolled in a clinical trial for DFU
* Is unwilling or unable to sign an informed consent document indicating that they understand the purpose and procedures of the study
* Is unwilling or unable to participate in the study which includes an interview of up to 60 minutes in duration
A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants

Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 to ≤ 45 OR ≥ 60
* Ability to provide pre-vaccination venous blood sample

Exclusion Criteria:

* History of clinically significant medical conditions
* Immunomodulative therapy
* Acute infection
Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis

Objectives of Medical Research:

Separation of LDL and HDL from blood samples of patients with high LDL and / or low HDL who have developed atherosclerotic disease with similar patients who have no evidence of atherosclerosis.

Lipidomics and proteomics will examine whether there is a difference in lipid and protein composition and lipoprotein composition. If there are any changes in expression level or the composition of proteins or metabolites that make up lipoproteins, the investigator will try to figure out the mechanism responsible for these changes and their role in the metabolic process. the investigator will seek therapeutic measures through which these mechanisms can be inhibited and thus inhibit the development of sclerosis or even retraction.

Participants:

Participants who are found suitable during their visit to the Lipid Institute Clinic or during hospitalization at the Sheba Medical Center will receive an explanation of the study, will be asked to sign a consent form.

A medical history will be taken, the participant will be asked to fill out a nutrition questionnaire (FFQ) and a 5 cc blood sample will be taken from each patient

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants with LDL levels less than 130 mg / dl without evidence of atherosclerosis or wall thickening of the carotid artery according to an ultrasound imaging of the carotid artery at the Lipid Institute and unknown for atherosclerosis or cardiovascular disease in the background.
* Participants with LDL levels above 160 mg / dl, with no evidence of atherosclerosis or wall thickening of the carotid artery according to an ultrasound - IMT of the carotid arteries performed at the Lipid Institute and unknown for atherosclerosis or cardiovascular disease in the background.
* Participants with LDL levels above 160 mg / dl, where evidence of atherosclerosis or wall thickening of the arteries can be found by ultrasound imaging of the carotid artery that is performed at the Lipid Institute or known for atherosclerosis or cardiovascular disease in the background.

Exclusion Criteria:

* Patients with triglyceride values above 300 mg%, HDL lower than 30 mg%, APOB greater than 150 mg% or LPa higher than 70 mg% will not be included in the study
The Effects of Core Stabilization Exercises on Respiratory Functions, Trunk Muscle Endurance and Postural Stabilization in Individuals Taking Basic Acting Education,

The aim of the study is to investigate the effects of a 8-week, core stabilization exercise program on respiratory functions, muscle trunk endurance and postural stabilization in individuals taking basic acting education. The main question it aims to answer is:

the effects of a 8-week, core stabilization exercise program on respiratory functions, muscle trunk endurance and postural stabilization in individuals taking basic acting education

The aim of the study is to investigate the effects of a 8-week, core stabilization exercise program on respiratory functions, muscle trunk endurance and postural stabilization in individuals taking basic acting education. The respiratory functions were assessed by the spirometer. Trunk muscle endurance was assessed by Fleksor Trunk Endurance Test (FTET), Biering Sorenson Test (BST) and Lateral Bridge Test (LBT). Postural stabilization was evaluated by Flamingo Balance Test (FBT) and Y Balance Test (YBT). The participants were randomly divided into two groups as Exercise Group (EG) and Control Group (CG) . Both people in EG and CG were taken diaphragmatic training program according to BAE. The core stabilization exercise program was administered for EG, twice a week, 45 minutes a day and for a 8-week duration.

Eligibility Criteria:
The inclusion criterias of this study are;

* Being volunteer
* whose ages between 18-40 years
* whose taking basic acting education course at DC Kozmos Art Academy

Volunteers were excluded from the study if the following conditions will be presented:

* chronic respiratory disease,
* back pain within the last two months,
* pregnancy,
* refusal to sign the informed consent document.
PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study

This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.

The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.

Eligibility Criteria:
Inclusion Criteria:

* Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
* Negative workup for distant disease
* \> 18 years of age
* Pre-treatment workup completed including:
* history and physical
* CT or MRI of the abdomen and pelvis
* endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
* if female of child-bearing age, negative pregnancy test
* Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
* Informed consent reviewed and signed

Exclusion Criteria:

* Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
* Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
* ANC ≤ 1,500/cubic mm³
* Platelet count ≤ 100,000/mm³
* ALT and AST ≥ 2.5 times upper level of normal (ULN)
* Alkaline phosphatase ≥ 2.5 times ULN
* Total bilirubin ≥ 1.5 times ULN
* Creatinine clearance \< 50 mL/min
* Creatinine ≥ 1.5 times ULN
* Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness
* Not deemed a surgical candidate
* Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix
* Previous pelvic radiation therapy
* History of severe reaction to gadolinium
* Inability to tolerate MRI (e.g., inability to lie flat for \> 1 hour)
* Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
* Body Mass Index (BMI) \> 35
* Pregnant or lactating female
Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female at least 18 years of age
* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily (OD) or BID with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* Body mass index (BMI) equal or below 40.0 kg/m\^2

Exclusion Criteria:

* Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidase inhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) or GLP-1 receptor agonists within 12 weeks prior to screening (Visit 1)
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and monoamine oxidase (MAO) inhibitors
* Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
* Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the investigator's opinion could interfere with the results of the trial
* Previous participation in this trial. Participation is defined as screened.
* Known or suspected hypersensitivity to trial products or related products