cyrilzakka/clinical-trials huggingface dataset:
Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI

The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).


Eligibility Criteria:
Inclusion Criteria:

1. Men or Women;
2. 18-64 years of age with an incomplete or complete acquired traumatic SCI;
3. Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification);
4. The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10).
5. Must have previous experience with consuming cannabis and or cannabinoids.

Exclusion Criteria:

1. Current drug (DAST-10: \>6) or alcohol abuse (AUDIT: \>10);
2. Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
3. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
4. History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event;
5. Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners;
6. Current pregnancy. Pregnancy will be evaluated using a pregnancy test during the first study visit. Female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study;
7. Have a history of renal or hepatic disease: or
8. Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
9. Have elevated serum transaminases (ALT or AST) above the ULN: or
10. Have elevated total bilirubin above the ULN; or
11. Take valproate, due increased risk of liver enzyme elevation; or
12. Currently using strong CYP2C19 and CYP3A4 inducers; or
13. Have suicidal ideation (subjects should be screened for suicidal ideation); or
14. Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
15. Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.
16. Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.
Efficacy and Safety of Multisite Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left ventricular (LV) dysfunction with ejection fraction (EF)\<35%., moderate to severe congestive heart failure and wide QRS in ECG. Positive response presents as improvement in quality of life, decrease in congestive hrat failure symptoms and signs, improvements in echocardiographic measurements and longer survival. About 30% of the patients do not respond to this treatment.

A decrease in clinical response to CRT is expected in patients with those predictors: advanced age, male, ischemic etiology of cardiomyopathy, Non-LBBB pattern in ECG, lack of mechanical dyssynchrony, large scar in LV, congestive heart failure stage IV, and non-cardiac co-morbidities (lung disease, pulmonary hypertension, renal failure and diabetes).

There are few solutions to increase the rate of clinical response to CRT, for example: endocardial pacing of LV or pacing a few simultaneous sites on LV. A study that investigated a method of simultaneous pacing on LV of patients with congestive heart failure and LBBB with QRS\>150ms has shown major improvement of cardiac contraction (increased dP/dtmax) compared to a single pacing site over a postero-basal or lateral wall site).

Implantation of pacemaker leads- one in right ventricle (RV) and two over LV, i.e. multisite cardiac resynchronization therapy (MSCRT), has a few potential advantages, compared to conventional CRT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe LV dysfunction, severe heart failure (NYHA FC III-IV and at least one hospitalization for congestive heart failure in the past 3 months before inclusion) on optimal medical treatment and that have narrow complex QRS or RBBB. These patients have an indication for ICD implantation.
2. Patients with conventional indications for CRTD implantation and EF\<25%, QRS\>150ms and severe heart failure (NYHA FC\>III).
3. Patients with an indication for pacemaker implantation and an expected high rate of pacing (complete AV block or prior to AVN ablation) and a wish to avoid RV pacing (example: severe TR).
4. Patients with refractory ventricular tachycardia and severe LV dysfunction (EF\<35%) that continue to have VT episodes despite antiarrhythmic drugs and despite recurrent VT ablations. Those patients have indication for ICD.
5. Patients with conventional indications for CRT but during implantation the anatomy is such that the site of implantation is not optimal (QRS\>200ms). In these cases we will add an electrode in the opposite branch of the coronary sinus.

Exclusion Criteria:

Pregnancy

* Patients included in another study
* Patients that have other solutions that could avoid implantation (medications, ablation, etc
Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis

A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.

Using temporally resolved computed tomography images, the patient-specific geometry of the stenosed aortic valve during peak systole is reconstructed. Using this geometry, the projected area of the aortic valve's orifice (AVA) is calculated. Additionally, the left ventricular geometry is reconstructed for the complete heart cycle. Using the information of the left ventricular volume change, the patient-specific flow profile and peak-systolic flow (Q)is calculated. Using this information, the pressure gradient is calculated using a power law estimation of the form PG = a \* AVA\^b \* Q\^c. The model generation and parameter fit is described in \[1\].

To validate this model, retrospective data of patients receiving a catheter-based replacement of the aortic valve (TAVI) is collected. For those patients, CT images are already acquired for treatment planning and the invasive pressure measurements are performed during replacement of the aortic valve. Therefore, no additionally steps are required. Using the CT images the patient-specific aortic valve area ad flow rate are calculated. This information is then used for estimation of the pressure gradient using the power law model. The catheter-based pressure gradient is calculated as the difference between the peak-systolic pressure in the left ventricle and the ascending aorta before implantation of the prosthesis.

\[1\] Franke et al.; Towards improving the accuracy of aortic transvalvular pressure gradients: rethinking Bernoulli; Medical \& Biological Engineering \& Computing (2020); https://doi.org/10.1007/s11517-020-02186-w

Eligibility Criteria:
Inclusion Criteria:

* aortic valve stenosis
* treatment via TAVI
Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents

Carotid intima-media thickness (CIMT) is a marker for detecting endothelium dysfunction, and has become a non-invasive method that is very useful in detecting and evaluating subclinical atherosclerosis in obese children and adolescents. This method is very useful in visually detecting and monitoring changes in the intima and its medial thickness, and can also evaluate changes within the arterial wall in the absence of localized plaque. Previous research that was conducted found an increase in CIMT diameter in 44 of 59 obese adolescents. Obesity has a risk of increasing the diameter of CIMT which carries the risk of atherosclerosis. Obesity accompanied by insulin resistance, and metabolic syndrome has a greater risk of atherosclerosis. Currently, the prevalence of obesity in adolescents is increasing. Interleukin 18 is a group of interleukin 1 whose levels increase in chronic inflammatory processes such as obesity, metabolic syndrome, and type 2 diabetes mellitus. IL-18 levels increase in obesity with increased CIMT.

Assessment of cardiovascular risk in obese adolescents is still a challenge for health practitioners, to prevent cardiovascular complications in obese adolescents which can cause sudden death at a young age. It is necessary to assess changes in the cardiovascular system that can be identified early by knowing the CIMT diameter. However, there is no definite reference value so the CIMT can be used as a reference for the occurrence of subclinical atherosclerosis in obese adolescents. In the previous study, CIMT was not examined in non-obese adolescents, so the cut-off for CIMT in non-obese was not known. Therefore, we have the opportunity to research to determine the thickness of CIMT and determine the cut-off value of CIMT which is at risk of experiencing early atherosclerosis in the obese adolescent population.

This research is a cross-sectional study with an analytical observational to examine Carotid Intima-Media Thickness (CIMT) in normal adolescents compared to obese adolescents. The research population was obese adolescents aged 13-18 years who study in Junior and Senior High School in Surabaya and Sidoarjo. The samples were research subjects, namely obese teenagers who met the inclusion criteria and exclusion criteria. The selection of research samples was carried out randomly. The number of research samples was based on previous research with adolescent subjects, obtaining a minimum sample size of 50.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents (obese and normal)
* Aged 13-18 years old
* Not Smoking
* Not consumed alcohol and drugs

Exclusion Criteria:

* Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders
* consuming steroids or hormone therapy
A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.

This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).

Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Malignant bile duct stricture.
* Increased bilirubin.
* Duct stricture is ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).
* Not an operative candidate.

Exclusion Criteria:

* Unable to obtain consent.
* Unable to tolerate procedure.
* Suspected benign bile duct stricture.
* Candidate for potentially curative surgical intervention.
* Previous metallic biliary stent.
* Previous bile duct surgery.
the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort

To explore the effect of different drugs and infusion ways on degree of postoperative comfort.Patients undergoing spinal neoplasm surgery receive different patient controlled analgesia(PCA) drugs postoperatively,one group is sufentanil,the other is hydromorphone. Then each drug group will be divided into two subgroups according to the infusion way,intravenously,subcutaneously. During the patient controlled analgesia period, patients' degree of comfort,pain score,sleep quality, the degree of side reaction will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II .

Exclusion Criteria:

* history of severe heart, hepatic or renal disease,
* history of chronic pain condition or opioid use,
* body mass index (BMI) ≤18 or ≥30 kg/m2,
* alcohol or drug abuse,
* relevant drug allergy,
* inability to properly describe postoperative pain,
* inability to use PCA pump.
The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.

Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.


Eligibility Criteria:
Inclusion Criteria:

* Patients (with female age \< 40 years)
* Patients undergoing a 1st oocyte retrieval for an IVF/Intracytoplasmatic Sperm Injection (ICSI) treatment
* Patients planned for an embryo transfer on day 3.
* Patients with supernumerary embryos of sufficient quality for freezing/vitrifying on day 3.
* Fresh personal (own oocytes)
* One inclusion in the study per patient.

Exclusion Criteria:

* Patients undergoing a 2nd or higher ranked oocyte retrieval after a fresh cycle with failed pregnancy.
* Female age ≥ 40 year
* Patients with Preimplantation Genetic Diagnosis (PGD)
* Patients with donor oocytes
* Patients with positive serology whose embryos may not be frozen.
* Patients planned for a transfer on day 2 or day 5.
* Patients receiving assisted hatching in the embryo transfer in the frozen cycles.
* Patients who have been included in the study before.
Autologous Stem Cell Transplant for Multiple Sclerosis

Multiple sclerosis is an autoimmune disease. We are studying whether high dose chemotherapy and autologous stem cell transplant can replace the autoreactive immune system and if this reduces clinical inflammatory disease in the central nervous system (CNS). A second goal is to examine whether there is long-term stabilization or improvement in disability scores if the inflammatory disease is controlled.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years
* The diagnosis of active multiple sclerosis with relapses or progression and sustained accumulated impairment, made by a neurologist expert in the field
* Patient considered at high risk of progression
* EDSS Cerebellar Functional score greater than or equal to 3 OR EDSS Pyramidal Functional score greater than or equal to 3
* EDSS between greater than or equal to 3 and less than or equal to 6
* Evidence of current disease activity
* Evidence of progression or continued relapses or worsening MRI after at least one year of therapy with interferon-B1, glatiramer acetate, Mitoxantrone, or other conventional dose immunosuppressive drug therapy
* If a patient has previously received a cytotoxic agent (Mitoxantrone, Cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study
* MRI brain scan that satisfies the MRI criteria of Paty or Fazekas for the diagnosis of multiple sclerosis
* No evidence of hepatic inflammation or fibrosis

Exclusion Criteria:

* Patients with primary progressive multiple sclerosis
* Patients with cardiac, renal, pulmonary, hepatic or other organ impairment that would limit their ability to receive dose intensive immunosuppressive therapy including high dose chemotherapy and ASCT
* Patient with any active or chronic infection
* Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
* Patients with a previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
* Patients whose life expectancy is severely limited by another co-morbid illness
* Patients with evidence of myelodysplasia or other non-autoimmune cytopenia
* Patients having received a cytotoxic agent within one month of enrolling in this study
* Pregnancy or risk of pregnancy. This includes patients that are unwilling to practice active contraception during the time of chemotherapy
* Patients with hypersensitivity to rabbit proteins
* Patients unable to give written informed consent in accordance with research ethics board guidelines
* Patients having previous exposure to natalizumab or alemtuzumab.
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control group).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥21 years
2. Evidence of lumbar multifidus muscle dysfunction
3. Intractable Chronic Low Back Pain that has persisted \>6 months resulting in pain most of the days in the past 12 months
4. Failed therapy including pain medications and physical therapy
5. Not a candidate for spine surgery
6. Low Back Pain NRS of ≥6 and ≤9
7. Oswestry Disability Index score ≥30 and ≤60
8. Willing and capable of giving Informed Consent
9. Able to comply with this protocol
10. On Optimal Medical Management per the Investigator

Exclusion Criteria:

1. Contraindicated for the ReActiv8 System
2. BMI \> 35
3. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
4. An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery
5. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee
6. Any condition unrelated to CLBP which, in the opinion of the Investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy
7. Surgical and other procedure exclusions
8. Psycho-social exclusions
9. Protocol compliance exclusions
10. General exclusions
Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

The reasonable combination of macronutrients including carbohydrates, proteins and fat, is the basis of rational diet and beneficial to treatment of metabolic diseases including obesity and diabetes. Endocrine hormones play pivotal roles in regulation of nutrients metabolism and energy homeostasis. However, the dynamic metabolism following the consumption of macronutrients and the relationship between various metabolites and endocrine hormones during these procedures yet to be adequately explained nowadays. Therefore, in this study, the investigators selected glucose, protein, fat and mixed meal tolerance test (MMTT) for the loading tests, endocrine hormones and metabolites were detected to profile the molecular changes in the plasma. The investigators aimed to explore the nutrient processing patterns of various macronutrients and determine the interaction between metabolic hormones and metabolites.


Eligibility Criteria:
Inclusion Criteria:

1. Those who agree to participate in the study and sign informed consent.
2. Age between 20 and 65 year.
3. Fasting plasma glucose \< 7.0mmol/l, and 2-hour postprandial plasma glucose \< 11.1mmol/l.
4. BMI \> 18 kg/m2.

Exclusion Criteria:

1. History of diabetes.
2. Pregnant or lactating women.
3. The subjects had not received oral/systemic corticosteroids for 7 consecutive days during the last 6 months.
4. Subjects were taking medication known to affect glucose metabolism.
5. Subjects who take strong inhibitors of cytochrome P450 (CYP)3A4/5, for example, ketoconazole, azanaway, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin.
6. Patients with either of the following characteristics of severe hepatic disease:

   i. Two consecutive abnormal hepatic function results during recent four weeks, with ALT or AST three times the upper limit of the institutions normal reference ranges.

   ii. Hepatic excretion dysfunction (eg. hyperbilirubinemia) and/or synthesis dysfunction, or other decompensated liver disease.

   iii. Acute viral hepatitis, autoimmune hepatitis, and alcoholic hepatitis
7. Patients with moderate and severe renal impairment, and end-stage renal disease (serum creatinine \> 194.5 mmol/L, or serum potassium \> 5.5 mmol/L).
8. New York Heart Association (NYHA) functional class III or IV congestive heart failure.
9. History of acute or chronic pancreatitis.
10. History of gastrointestinal disorders: gastroenterostomy, enterectomy, ileus and intestinal ulcers.
11. Subjects with previously diagnosed malignancy within the past 5 years.
12. Any other reasons that the investigator considered inappropriate to participate in the study.
Upper Limb Thrombosis Associated With Midline Catheter

The patients admitted in hospital who had midline catheter inserted in upper limb are followed-up for the presence of complications related to catheter introductions. The symptoms and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography examination. In the selected group of asymptomatic patients sonography examination is done 8 to 10 days after cathether insertion in order to detect the incidence of the asymptomatic thrombosis

The patients admitted in hospital who had midline catheter inserted in upper limb are followed-up for the presence of complications related to catheter introductions. The symptoms and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography examination. The age, gender, principal diagnosis, the vein were midline catheter is inserted and number of vein punctures for catheter insertion are recorded. Afterward the patients are treated in the ward and the possible complications are recorded. The main concern is about the incidence of upper limb thrombosis. All the complications are recorded as well as date when they has appeared. The statistical analysis is done in order to evaluate the incidence of upper limb symptomatic thrombosis, the duration since insertion to thrombosis manifestation ańad its associations with age, gender, principal diagnosis, selected vein, its size and number of punctures is analysed.

In the selected group of the asymptomatic patients 8 to 10 days after midline insertion upper limb sonography is done in order to detect the presence of the asymptomatic upper limb thrombosis and the same type of analysis as for symptomatic thrombosis is undertaken.

Eligibility Criteria:
Inclusion Criteria:

* The patients admitted to University Hospital suffering from disease when venous access is required for period longer than 5 days or with insufficient peripheral venous access

Exclusion Criteria:

The patients who need another type of venous access, e.g. central venous access