cyrilzakka/clinical-trials huggingface dataset:
Nitrite in Hypertrophic Cardiomyopathy (HCM) Study

Inorganic nitrate, which is found at high levels in green leafy vegetables, is reduced to nitrite by bacteria in the mouth, swallowed, and absorbed in the stomach into the blood. Studies have shown that increasing the blood levels of nitrite improves the way that muscles use oxygen and energy during exercise, and potentially blood flow.

Some people (\~1 in 500) suffer from a type of genetic heart condition known as hypertrophic cardiomyopathy (HCM). This condition means that the muscle in the heart does not use energy well and becomes larger than average, meaning that they have to tap into the heart's 'energy reserves'. It is not known if nitrite has the same beneficial effects on heart muscle as on other muscles in the body. Our study will explore the mechanism by which nitrite may improve the function and energy status of the heart in HCM.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 18 and 80 years.
* Able to provide informed consent.
* Able to understand basic instructions in English.
* A diagnosis of hypertrophic cardiomyopathy based on conventional transthoracic echocardiogram guidelines: left ventricular wall thickness \>1.5cm in the absence of sufficient alternative cause.
* Exercise limited by symptoms on exertion (NYHA Class II symptoms or greater).
* PeakVO2 \<80% on baseline CPEX.
* The absence of resting LV outflow tract obstruction (peak gradient \<30 mm Hg) on TTE.

Exclusion Criteria:

* Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety or influence the study outcome.
* Contraindications for undergoing MRI.
* Hypotension with a systolic blood pressure \<90mmHg.
* Severe anaemia with a plasma haemoglobin level \<8.0g/dL.
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency measured at screening in males of African, Asian or Mediterranean decent.
* Female subjects of childbearing potential.
* Haemodynamically significant valve disease.
* Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease.
The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Duchenne Muscular Dystrophy

The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with Duchenne muscular dystrophy.

The main questions it aims to answer are:

* What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with Duchenne muscular dystrophy?
* Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not?

Participants will:

* Receive education on how to wear and use the shoulder orthosis.
* Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues.

Researchers will compare Duchenne muscular dystrophy patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Duchenne muscular dystrophy (DMD) through genetic testing
* Older than 10 years old
* Brooke scale score of 2-5
* Shoulder abduction muscle strength grade below 3

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Brooke scale score of 1 or 6
* Cognitive impairment to the extent that limits the use of the shoulder orthosis
A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.

This study is being conducted to evaluate the safety and efficacy of Chimeric antigen receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In the research, the investigators design a novel CAR consists of a EpCAM targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. The infusion dose is (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation. The way of infusion is vascular interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to 30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory EpCAM positive cancer.
2. KPS \> 60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 80 years.
5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.
6. Acceptable organ function Hematology:

   * Absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim.
   * White blood cell (WBC) (\> 2000/mm\^3).
   * Platelet count greater than 50,000/mm\^3.
   * Hemoglobin greater than 9.0 g/dl.
7. No other serious diseases(autoimmune disease, immunodeficiency etc.).
8. Adequate cardiac function (LVEF ≥ 40%).
9. No other tumors.
10. Patients volunteer to participate in the research.

Exclusion Criteria:

1. Allergic to cytokines.
2. Uncontrolled active infection.
3. Acute or chronic GVHD.
4. MODS.
5. Treated with T cell inhibitor.
6. HIV affected.
7. Pregnancy.
Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates

Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC).

Enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B. Both the groups will receive appropriate management for their morbidities as per existing NICU protocols. Both the groups will be followed up till 37 weeks of gestation where in their neurobehavioral assessment will be performed using Neurobehavioural assessment of preterm infants score.

In both the groups all the baseline data regarding antenatal factors will be recorded in a predesigned proforma such as age, gravid, Gestational age, Chorioamnionitis, Prenatal steroids, Multiple pregnancy, maternal comorbidities (preeclampsia, gestational diabetes mellitus), mode of delivery etc.

Eligibility Criteria:
Inclusion Criteria:

* All stable preterm very low birth weight babies not on invasive mechanical ventilation
* Hemodynamically stable
* Parental consent

Exclusion Criteria:

* Babies with major congenital anomalies
* Asphyxia (Apgar score \<3 at 5mins).
* Acute bilirubin encephalopathy
* Hypoglycemia at enrollment
* Clinical Chorioamnionitis(fever \> 100.4 ◦ f , uterine fundal tenderness, maternal tachycardia (\>100/min), fetal tachycardia (\>160/min) and purulent or foul amniotic fluid )
* History of birth trauma
The First Jordanian PCI Registry: Events at 1 Year

The investigators will look at the short- (in hospital) and long- term ( 1 year)outcome in consecutive patients who undergo stent implantation and angioplasty in Jordan.

1. Voluntary registry of consecutive patients undergoing Percutaneous coronary intervention (PCI).
2. Patients will be treated according to the treating cardiologists' discretion. No randomization of any medication or stent.
3. Baseline data on admission will be collected (cardiovascular risk factors, blood lipids, ect).
4. PCI procedure details and complications will be documented during the index admission.
5. Outcome events (death, MI, revascularization, stent thrombosis) will be evaluated at 1, 6, and 12 months by clinic visits or phone calls.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive PCI patients
* Arab nationality

Exclusion Criteria:

* less than 18 year of age
Motion Correction of Positron Emission Tomography (PET) Data Using Amplitude Gating

Objectives:

Evaluation of an amplitude based gated Positron Emission Tomography (PET) data acquisition system for all GE Discovery Positron Emission Tomography/ Computed Tomography (PET/CT) scanners.

Routine PET/CT scans are taken while patients are breathing normally. The motions made by breathing can reduce the image quality of the scan. Minimizing the effects of this motion by taking the images and processing the scans differently may improve the image quality.

The PET/CT Scan:

If you agree to take part in this study, an elastic belt will be placed around your lower chest/upper abdomen before your routine PET/CT scan. This belt is used to track your breathing motion. This information will be used to help process the scan.

Your PET/CT scan will be performed as usual. During the scan, researchers will focus on your lower chest/upper abdomen (areas that experience breathing motion). Having to focus on this area might extend the scan by up to 10 minutes.

The additional scan time will not increase your radiation exposure since only PET scanning will be performed.

Length of Study:

Your participation on this study will be complete when your scheduled PET/CT scan is complete.

This is an investigational study. The imaging focused on your lower chest/upper abdomen during the scan is investigational.

Up to 26 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with lung or liver lesions measuring 0.5-2cm in diameter will be considered.
2. Patients that are scheduled to be imaged in the PET/CT suite at the Mays Building will only be considered.

Exclusion Criteria:

1. Pediatric patients (younger than 18 years) will be excluded.
2. Patients that cannot tolerate being scanned for an additional 10 minutes with arms above their head will be excluded.
Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy

This pilot study will take place at Health Sciences North (HSN) in Sudbury. Patients will be identified and screened for inclusion into the study once referred to a general or colorectal surgeon for resection of their rectal cancer. This may occur before or after preoperative chemoradiotherapy (CRT) but randomization will take place after CRT.

The main question of this study is whether or not delaying surgery after preoperative CRT increases disease-free survival. The standard 6-7 week waiting period will be compared to 10-11 weeks, which was the time-frame identified in the Dutch Surgical Colorectal Audit as increasing the likelihood of pCR the most. This trial will also be able to determine if an increased waiting interval increases the rate of sphincter-preservation, local recurrence, and pCR. While similar to the GRECCAR-6 trial, our primary outcome is disease-free survival (a more clinically relevant outcome) and is the first North American clinical trial of this nature.

To maximize the utility of this trial, immunohistochemical staining will be performed on pre-CRT tumor samples to prospectively validate the scoring system proposed by Hur et al. \[28\] The question being whether or not expression of these biomarkers can predict which patients will experience pCR and disease-free survival.

The pilot will be constructed as a prospective, open-label clinical trial, with patients being randomized to undergo surgery at 6-7 weeks or 10-11 weeks after completion of preoperative CRT. The intention is that once preliminary data is available, other centres in Ontario will be recruited. This will not only help answer our research question, but also create a large, prospective database of rectal cancer patients. The Primary outcome (disease-free survival) will be assessed at 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* T3/4N0M0 or TxN+M0 rectal cancer below or at the peritoneal reflection, confirmed on clinical exam, histology, pelvic MRI, and CT chest/abdo
* Patients who have completed a CRT protocol for the above tumor at HSN
* Informed consent given
* Surgical resection with TME planned

Exclusion Criteria:

* Metastatic disease
* Failure to complete preoperative CRT
* Unable to give free and informed consent
* Unable to comply with the requirements of the study
* Previous malignancy other than nonmelanoma skin cancer, papillary or follicular thyroid cancer
* Inflammatory bowel disease
* Hereditary colorectal cancer
Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension

This study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy


Eligibility Criteria:
Inclusion Criteria:

* At Visit 3, mean seated diastolic blood pressure (SeDBP) ≥ 95 mmHg and \< 110 mmHg, AND mean seated systolic blood pressure (SeSBP) ≥140 mmHg and \< 180 mmHg
* At Visit 4, mean SeDBP ≥ 90 mmH
* No significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system

Exclusion Criteria:

* Patients with known or suspect secondary hypertension
* Unstable angina
* History of acute myocardial infarct, or PTCA or surgical cardiac procedures 3 months before entry into this study
* Prior or current congestive heart failure (NYHA grade III or IV), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease
* Arrhythmia of clinical significance
* Bilateral renal artery stenosis, isolated renal artery stenosis, post kidney transplantation
* Acute glomerular nephritis
* Gout sufferers, even with the normal serum uric acid at entry
* Retinal hemorrhage /exudate
* Type 1 diabetes mellitus
* Uncontrolled type 2 diabetes mellitus
* Hypovolemia
* Patients with autoimmune disease
Study for the Clinical Roadmap and Prognosis of Pulmonary Artery Sarcoma.

This is an observational study in which patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

This is an observational study covering mainland China, and patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Computed tomography pulmonary angiography indicated that there were intraluminal defects
* Malignant histopathology was sarcoma
* Informed consent form was signed

Exclusion Criteria:

* Life expectancy was less than 3 months due to diseases other than pulmonary artery sarcoma
* Expected inability to complete follow-up
Westlake Gut Microbiome Study

The Westlake Gut Microbiome study is a prospective cohort study. This project aims to characterize the gut microbiome among Chinese populations from different regions of China, and explore the relationships between gut microbiota and human health. Human fecal samples will be collected from the participants and muli-omics detection and analysis will be performed.

In the first phase of the study (also a pilot study), the investigators will create a longitudinal datasets from a students-based cohort in Westlake University. Information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations such as blood glucose, body composition and electroencephalogram will be examined, and biological samples including blood, saliva, urine and feces, will be collected.

In the second phase, the investigators will expand to include eligible participants from at least 10 provinces of China, which are located at different regions. Similar to the procedures in phase 1 stage, information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations will be performed, and biological samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

Participants or her/his legal guardian are able to report the antibiotics use during the past 3 months; Participants or her/his legal guardian are able to understand and respond to the online questionairs; Participants or her/his legal guardian are able and willing to collect the biological samples as instructed; Participants or her/his legal guardian are able and willing to provide written informed consent; -

Exclusion Criteria:

Those with serious fundamental diseases or infectious diseases; and those with other conditions that not suitable to participate in this study, as considered by the investigators.

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Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients

Does vaccinating hemodialysis patients with Twinrix® (combination vaccine against hepatitis A and hepatitis B) result in a difference in hepatitis B antibody response in comparison to the monovalent hepatitis B vaccine? Hepatitis B infection is an important cause of mortality and morbidity. Current standard vaccination practices have low efficacy levels in patients (eg. hemodialysis patients) who are most susceptible of infection. Efficacy of the two regiments will be studied.

Hepatitis B virus (HBV) is a human pathogen that causes acute and chronic liver infection. Immunosuppression may be associated with more frequent persistent infection and HBV infections in renal dialysis patients can become chronic. The routes of transmission of the virus is well established; direct percutaneous inoculation of virus via exchange of contaminated blood, blood products, body fluids, and hemodialysis. The Center for Diseases Control and Prevention (CDC) recommends immunization in high-risk groups, including hemodialysis patients. Ninety to ninety five percent of healthy, immunocompent adults develop protective anti-hepatitis B surface antibody (anti-HBs) with a primary series of hepatitis B vaccination, but the overall efficacy in renal dialysis patients is much lower. The proportion of hemodialysis patients who develop a seroprotective antibody even with higher doses of vaccination is a median 64% (range: 34-88%).

Reports suggest that combined vaccination of hepatitis B and hepatitis A (Twinrix®: combination vaccine containing inactivated hepatitis A and recombinant hepatitis B) may improve immunogenicity in healthy individuals. In one study, comparing Anti-HBs geometric mean titres (GMT) at month 6 of the series, subjects receiving the combined vaccine showed a statistically significant higher response than those who obtained the monovalent vaccines. Other studies also reflect the same trend at varying points in the vaccination series.

Currently, there are 426 patients in the hemodialysis program at St. Joseph's Healthcare in Hamilton and 324(76%) patients are susceptible to HBV infection.

Our study will determine if the improved immunogenicity observed with combined HAV and HBV vaccine will increase the efficacy of HBV vaccine in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients
* Age greater than or equal to 18
* Able and willing to give informed consent
* Undetectable Anti-HBs Ab level

Exclusion Criteria:

* Presence of hepatitis BsAg, hepatitis BcAb
* Treatment with IVIg (intravenous immune globulin) within the last 6 months
* Hypersensitivity to components of either vaccine
* Contraindication to intramuscular injections
Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.

The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients\&#39; sensation.

Eligibility Criteria:
Inclusion Criteria:

* Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
* Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
* Subject is ≥ 18 years old.
* Subject is not pregnant or nursing.
* Subject is willing and capable of giving informed consent.

Exclusion Criteria:

* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
* Subject is incapable of understanding or responding to the study questionnaires.
* Subject is incapable of understanding or operating the patient programmer handset.
Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes

The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.


Eligibility Criteria:
Inclusion Criteria:

* Adult active duty personnel between 18 and 50 years of age with best corrected visual acuity of 20/20 or better.

Exclusion Criteria:

* Patients not meeting above stated age criteria
* Females that are pregnant or lactating (non pregnant females of childbearing potential will have pregnancy test prior to participating in study)
* History of serious ocular, neurological, cardiovascular disease
* History of severe systemic disease
* History of arrhythmias or high blood pressure
* Patients currently taking any type of ocular or systemic medications except multivitamins.
* Patients with abnormal pupil shape, Addie's pupil, anisocoria, or abnormal pupil defect.