cyrilzakka/clinical-trials huggingface dataset:
Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy

This study will investigate whether there is an association between insulin resistance and cardiac function in children with dilated or hypertrophic cardiomyopathy. This study will also investigate whether there is an association between FGF21 and cardiac function in children with dilated or hypertrophic cardiomyopathy and whether this is mediated through greater insulin resistance and/or through independent effects.

Although pediatric cardiomyopathy is rare, the condition is severe and life-threatening. The main focus of this proposed study will examine whether insulin resistance is correlated with decreased cardiac function which will hopefully pave the way for future clinical trials using medications that sensitize insulin such as metformin or glucagon-like peptide-1 (GLP-1 agonists) as possible therapeutic agents. The exploratory piece of this study will investigate a novel therapeutic target by determining whether FGF21 has any direct effects on cardiac function and whether it interacts with insulin resistance in altering cardiac function. Patients with cardiomyopathy normally undergo ECHO as part of routine evaluation and follow up and is standard of care. At this time, there are no official guidelines for pediatric patients with cardiomyopathy to undergo oral glucose tolerance testing (OGTT) and thus it is not part of the standard of care. Based on findings from this study, the investigators hope to justify performing an OGTT on pediatric patients with dilated or hypertrophic cardiomyopathy and incorporate the procedure in future practice guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dilated or hypertrophic cardiomyopathy
* Pubertal (Tanner 2 breast in females or testicular volume ≥ 4mL in males)
* Permission by the primary cardiologist of the patient for enrollment in the study

Exclusion Criteria:

* Prior diagnosis of diabetes and treatment with anti-diabetes medication
* Neuromuscular disorder
* Inborn error of metabolism
* Malformation syndrome
* Clinically unstable based on the assessment of the primary cardiologist caring for the patient
* inability of parent/legal guardian to provide informed consent
* non-English speaking
Vitamin D Levels in Adolescent Idiopathic Scoliosis

This study aims to estimate the prevalence of vitamin D insufficiency among patients with adolescent idiopathic scoliosis, to calculate the differences in serum vitamin D levels, Cobb angles, spinal bone mass densities, and serum alkaline phosphatase levels between genders in the sample, and to assess the possibility of a correlation between any of these factors in those surgical patients.

Adolescent Idiopathic Scoliosis (AIS) is a major public health problem and despite its relative rareness, it reduces the quality of life. It is three-dimensional deformity where there is a lateral curving of the spine. The prevalence rate is 0.47-5.2%. The degree of the spinal curvature is evaluated by the Cobb angle. A Cobb angle of more than 10-15° is considered pathological. AIS occurs mostly in adolescents between 10 and 25 years of age, and is more prevalent among females.

Scoliosis is considered severe and requires surgical intervention when the Cobb angle exceeds 40o.

The etiology of AIS is still unknown. Genetic and non-genetic factors have been attributed to cause AIS. Among non-genetic factors is bone mineral density (BMD), as bone quality plays an important role in the derangement of bony mechanical stability. The prevalence of AIS with osteoporosis is approximately 20-38%. Osteoporosis is known to lower the bone strength.

Vitamin D plays an essential role in maintaining a healthy mineralized skeleton. It helps with calcium absorption, and patients with a deficiency of Vitamin D can have difficulties in producing new bone and maintaining their bone strength.

In this study, the prevalence of vitamin D insufficiency among patients with AIS was evaluated. Gender differences in serum vitamin D levels, Cobb angles, BMD, and serum alkaline phosphatase levels were measured. Further correlation of Vitamin D with Cobb angles, BMD, and serum ALP levels was also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* AIS patients of either gender
* Aged between 10-25 years old
* Had Cobb angles of 40o or more (i.e. requiring corrective surgery)
* Had their serum vitamin D levels measured prior to their corrective surgery.

Exclusion Criteria:

* Patients with non-idiopathic scoliosis (such as congenital or neuromuscular condition)
* Younger than 10 years
* Older than 25 years of age
* Who did not have their serum vitamin D levels present on the system.
Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies

The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.

GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Male or female
* Measurable or evaluable solid tumor malignancy
* Relapsed, refractory, locally advanced, or metastatic disease
* Disease refractory to or not amenable to standard therapy
* Karnofsky performance status 70-100%
* Life expectancy 3 months or greater

Exclusion Criteria:

* Pregnant or lactating women
* Primary central nervous system(CNS) malignancy or active CNS metastases
* Hematologic malignancy
* Chemotherapy within 4 weeks prior to study
* Mitomycin C, nitrosoureas within 6 weeks prior to study
* High dose chemotherapy with stem cell support within 6 months prior to study
* Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study
* Systemic hormonal therapy within 4 weeks prior to study
* Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
* Radiotherapy within 4 weeks prior to study
* Significant cardiovascular disease
* Serious/active infection
* Major surgical procedures within 2 weeks
Cardiac Rehabilitation for Heart Event Recovery (HER)

The purpose of this study is to compare women's cardiac rehabilitation program adherence across three program models.

Heart disease is the leading cause of morbidity and mortality for women in Canada. Cardiac rehabilitation (CR) is an outpatient secondary prevention program composed of structured exercise and comprehensive education and counseling. CR participation results in lower morbidity and mortality, among other benefits. Unfortunately, women are significantly less likely to adhere to these programs than men. While the traditional model of CR care is a hospital-based mixed-sex program, women are the minority in such programs, and state that these programs do not meet their care preferences. Two other models of CR care have been developed: hospital-based women-only (sex-specific) and monitored home-based programs. Other than through our controlled pilot testing of 36 patients, women's adherence to these program models is not well known.

CR4HER is a 3 parallel arm pragmatic RCT designed to compare program adherence to traditional hospital-based CR with males and females, home-based CR, and women-only hospital-based CR. Power calculations based on our pilot study suggest a sample size of 261 patients is needed to detect a difference in adherence by program model using ANCOVA. Participants are female CAD, acute coronary syndrome, percutaneous coronary intervention, bypass surgery, or valve surgery inpatients recruited from 5 hospitals. Also, female patients referred to participating cardiac rehabilitation (3) centres with one of the aforementioned diagnosis will be approached to participate. The primary outcome variable is program adherence operationalized as CR site-reported percentage of prescribed sessions completed by phone or on-site, as reported by a staff member who is blind to study objectives. Secondary outcomes are exercise capacity operationalized as VO2peak on a graded stress test, and exercise, dietary, smoking and medication adherence behaviours measured in hospital and 1 week post-CR. By identifying the CR program model which results in the greatest adherence for women, we can optimize their participation and potentially their cardiac outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Documented coronary artery disease and/or acute coronary syndrome diagnosis and/or revascularization (coronary bypass graft or angioplasty) and/or valve surgery
* Work or reside in Greater Toronto Area
* Proficiency in English language
* Written approval to participate in CR by the patient's cardiac specialist or general practitioner
* Eligible for home-based CR

Exclusion Criteria:

* musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric condition, or any serious or terminal illness not otherwise specified which would preclude CR eligibility based on CR guidelines
* physician deems patient not suitable for CR at time of intake exercise stress test
* planning to leave the area prior to the anticipated end of participation
* being discharged to a long-term care facility
* participation in another clinical trial with behavioral interventions
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline

Goals: 1. To check for frequency and type of arrhythmia in patients undergoing a medical procedure under local anesthesia 2. To examine whether the addition of adrenaline to local anesthesia affects the incidence of arrhythmias

Rationale: Determining the frequency and type of arrhythmia will help determine the need for monitoring and the type of monitoring required during procedures under local anesthesia.

Patients will undergo the prescribed medical procedure using local anesthesia. Patients will be randomized into two groups: Group 1 - Local anesthesia of lidocaine and arterial blockage on the arm; Group 2 - Local anesthesia with lidocaine and adrenalin.

The amount and type of anesthetic used shall be recorded. In addition to the routine monitoring performed today (use of non-invasive blood pressure gauge and oxygen saturation), the patients will be connected to a cardiac holter monitor prior to the start of the surgical procedure and until they are released from the recovery room. Upon completion of the monitoring, the results of the holter test will be transmitted to the electrophysiology unit and analyzed to detect arrhythmias. There will be a registration of side effects reported by patients, which can result from arrhythmias (palpitations, dizziness, fainting, CPR). In patients in whom arrhythmias are detected, the type of arrhythmia and if it was accompanied by clinical symptoms will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who undergo hand surgery using local anesthesia at Assuta Ashdod Hospital

Exclusion Criteria:

* Patients with a known medical history of cardiac arrhythmia
Renal Stone Treatment Global Registry

This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.

Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.

Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.

New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.

Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.

Eligibility Criteria:
Inclusion Criteria:

* Patient at the age of 18 or above

Exclusion Criteria:

* Patient is unable to give consent
Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.

Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
* a history of at least two Raynaud's events during a typical winter day
* must be willing to apply creams to fingers
* must be willing to undergo cold temperature exposure
* must be willing and able to stop certain medications
* must be willing to use effective contraception, if applicable

Exclusion Criteria:

* had a Raynaud's attack that required hospital or clinic intervention
* has allergies to nitroglycerin or topical medication ingredients
* has a history of migraine or chronic pain
* has an unstable medical problem that could interfere with the study
* had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
* used any investigational drug in the past 4 weeks
* has significantly abnormal laboratory tests
* had certain major surgeries in the past 6 months
* has skin lesions on certain parts of the fingers
* women who are pregnant or nursing
Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)

Rectal biopsies from IBS patients or healthy subjects will be taken.

Biopsies will be used for:

1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and real time PCR (Polymerase chain reaction);
2. culturing biopsies

On the basis of these observations, the general aim of the study is to move a significant step forward in the current knowledge on human ENS (enteric nervous system) in IBS by establishing a live imaging method to record enteric nerves activity in small intestinal biopsies from humans. This development is unique in its kind as not other research groups have reported successful live recordings with calcium imaging in this preparation.

In particular, the investigators aim:

1. to develop and validate the technique to measure activity in human enteric nerves in the submucous plexus isolated from rectal biopsies from healthy subjects and IBS patients;
2. to characterize this nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia;
3. to investigate whether the biopsies of IBS patients secrete more modulators/cytokines compared to healthy subjects and their potential to activate neurons.
4. to evaluate the influence of different food constituents (cow"s milk, wheat, yeast, gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell activation/degranulation in biopsies of IBS patients compared to healthy subjects.
5. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS patients and healthy volunteers by the use of metabolic profiling


Eligibility Criteria:
Inclusion Criteria:

* IBS patients (based on ROME III Criteria)
* Healthy subjects

Exclusion Criteria:

- All subjects with not IBS related complaints
The Analysis of Thyroidectomy and Parathyroidectomy

To analyze surgery or not, different surgical methods, timing of surgery, and alternative managements for patients of thyroid or parathyroid disease.

Utilizing our institutional database, tissue bank, and electronic medical charts to surgery or not, different surgical methods, timing of surgery, and alternative managements for patients of thyroid or parathyroid disease.

Eligibility Criteria:
Inclusion Criteria:

* age more than 20 years
* thyroid or parathyroid disorder
* willing to receive management at National Taiwan University Hospital (NTUH)

Exclusion Criteria:

* age less than 20 years
MRI of the Liver With Eovist

The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.

Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC.

This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.

Eligibility Criteria:
Inclusion Criteria:

* known hepatocellular carcinoma
* undergoing MRI of the liver

Exclusion Criteria:

* Contraindication to MRI with IV contrast
The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)

The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral NMN combined with DC cells injection in patients after tumor surgery, and evaluate the biological age of adults, TCR diversity, SiRT1 expression level, SF-36 quality of life, OS, antigen specific immune response (TAA), cytokines and so on. In this study, 20 postoperative tumor patients who meet the entry and excretion criteria were recruited to explore the clinical potential of NMN combined with DC cell vaccine.


Eligibility Criteria:
Inclusion Criteria:

* 1. 18-80 years old, weight ≥ 40kg.
* 2. Patients with malignant solid tumors diagnosed by histology or cytology, who underwent radical resection and completed standard postoperative adjuvant therapy.
* 3. Estimated survival time ≥ 6 months.
* 4. ECOG score 0-1.
* 5. Adequate venous channels, there is no contraindication for peripheral blood monocyte collection.
* 6. Good function of organs and bone marrow.

Exclusion Criteria:

* 1. Diabetes.
* 2. Premenopausal or menopause \<1 year.
* 3. Persons who have received hormone replacement therapy within the past 6 months.
* 4. Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
* 5. Unstable weight (\>3% change during the last 2 months before entering the study).
* 6. Significant organ system dysfunction or disease.
* 7. Polycystic ovary syndrome.
* 8. Major psychiatric illness.
* 9. Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study.
* 10. Metal implants.
* 11. Persons who consume \>14 units of alcohol per week.
* 12. Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients with Solid Tumours

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
* 2. Age 18 to 70 years old;
* 3. Patients with advanced solid tumours who have been diagnosed with: failure of standard treatment, no standard treatment, or inaccessible to standard treatment;
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 12 weeks;
* 6. Good function of vital organs;
* 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
* 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment