cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation

In order to keep our immune systems healthy over our lifetime, certain cells in the bone marrow and lymph nodes called stromal cells nurture the immune cells and protect them from damage. Stromal cells and blood cells communicate using a protein called SDF1a. The investigators think that cancer cells including lymphoma and multiple myeloma can trick the stromal cells into helping them avoid damage from chemotherapy by using SDF1a.

Plerixafor is a drug developed to block the effects of SDF1a and has been approved by the Federal Drug Administration (FDA) for use in humans to help release blood stem cells from the bone marrow for use in transplantation. The use of plerixafor to interrupt communication between stromal cells and cancer has not been approved by the FDA and is experimental.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Subjects must have documented, relapsed/refractory or high-risk primary lymphoid malignancy
* Subjects must have evidence of residual disease prior to transplant, but need not have measurable or strictly evaluable disease
* Subjects must be eligible candidates for high dose chemotherapy with either BEAM or single-agent melphalan preparative regimens and autologous stem cell transplantation at Tufts Medical Center (See Appendix B for anticipated transplant schedules)
* Subjects must be able to provide informed consent to the research procedure

Exclusion Criteria:

* Uncontrolled infection
* Active heart disease as evidenced by myocardial infarction within 6 months, uncontrolled arrhythmia, or angina.
* Creatinine clearance estimated \< 50 ml/min.
* HIV infection or evidence of active chronic hepatitis
* Unable or unwilling to comply with required study procedures
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion

The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are limited by reperfusion injury. In animal models, nicorandil, a hybrid of an ATP-sensitive K+ (KATP) channel opener and nitrates, reduces infarct size, so the Japan-Working groups of acute myocardial Infarction for the reduction of Necrotic Damage by a K-ATP channel opener (J-WIND-KATP) designed a prospective, randomized, multicenter study to evaluate whether nicorandil reduces myocardial infarct size and improves regional wall motion when used as an adjunctive therapy for AMI.

Twenty-six hospitals in Japan are participating in the J-WIND-KATP study. Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous nicorandil or placebo. The primary end-points are (1) estimated infarct size and (2) left ventricular function. Single nucleotide polymorphisms (SNPs) that may be associated with the function of KATP-channel and the susceptibility of AMI to the drug will be examined. Furthermore, a data mining method will be used to design the optimal combined therapy for post-myocardial infarction (MI) patients.

It is intended that J-WIND-KATP will provide important data on the effects of nicorandil as an adjunct to PCI for AMI and that the SNPs information that will open the field of tailor-made therapy. The optimal therapeutic drug combination will also be determined for post-MI patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-79 years
2. Chest pain of more than 30 min
3. 0.1 mV ST-segment elevation in 2 contiguous ECG leads
4. Admission to hospital within 12 h of symptom onset
5. First episode of AMI
6. Candidates for PCI

Exclusion Criteria:

1. History of old myocardial infarction
2. Left main coronary artery stenosis
3. Severe liver and/or kidney dysfunction
4. Suspected aortic dissection
5. History of coronary artery bypass graft
6. History of allergic response to drugs
7. Severe hypovolemia
8. Right ventricular infarction
Right Ventricular Metabolism in Pulmonary Arterial Hypertension

The purpose of this study is to use non-invasive imaging to determine the metabolic phenotype of the right ventricle in patients with pulmonary arterial hypertension across a spectrum of disease severity.

Current medical therapy for pulmonary arterial hypertension (PAH) is aimed at reducing pulmonary vascular resistance (PVR) but not ameliorating right ventricular (RV) failure, the major cause of death. There are no RV-specific therapies currently available for PAH, in part because the pathophysiology of RV failure is poorly understood.

The investigators hypothesize that the RV in PAH develops a distinct metabolic pattern characterized by increased glycolysis, impaired oxidative metabolism and lipid deposition, which are associated with RV failure.

Specific Aim 1. To test the hypothesis that the RV in human PAH exhibits lipid deposition, increased glycolysis and impaired fatty acid oxidation. The investigators will measure RV oxidative metabolism and glycolysis in PAH patients and controls using positron emission tomography 11C acetate and \[18F\]fluoro-deoxy-D-glucose imaging and measure myocardial lipid accumulation using magnetic resonance spectroscopy imaging.

Specific Aim 2. To test the hypothesis that an abnormal RV metabolic profile is associated with RV dysfunction and reduced exercise capacity in PAH. PET and MRS findings will be correlated with RV function, patient exercise capacity and a blood metabolic profile.

Eligibility Criteria:
Inclusion Criteria:

* Heritable or idiopathic PAH
* 18 years or older
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Type 1 diabetes mellitus
* Prednisone use
* PAH associated with any condition other than idiopathic or heritable
* Implanted ferromagnetic material incompatible with MRI
Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China

The primary objective is to determine sensitivity, specificity, positive predictive value and negative predictive value of a bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) for colorectal cancer and advanced precancerous neoplasm(including advanced adenoma and advanced serrated lesions) screening, using colonoscopy as the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination.

The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test (FIT) assay, both with respect to cancer and advanced precancerous neoplasm. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

This study is a multi-center diagnostic test led by the National Clinical Research Center for Digestive Disease (Shanghai) (Department of Gastroenterology, Changhai Hospital, Navy/Second Military Medical University), which is conducted at about 30 digestive endoscopy centers nationwide in China, with the expectation of including approximately 4,800 patients. Subjects willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for stool DNA test and commercially available FIT assay. The basic characteristics of subjects, bowel preparation method and quality, and related information of colonoscopy are recorded in detail. Colonoscopy and histopathologic examination are used as reference.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 to 85 years old, the gender is not limited
2. Willing to provide written consent
3. Able to provide stool sample

Exclusion Criteria:

1. Unwilling to provide stool samples
2. Subject with contraindications for bowel preparation or colonoscopy
3. Subject with known colorectal polyps but not removed
4. Subject with inflammatory bowel disease
5. History of colonoscopy within 1 year
6. History of colorectal cancer
7. History of hereditary colorectal cancer syndrome (including polyposis)
8. Active lower gastrointestinal bleeding
9. Pregnancy
10. Subject taking anticoagulants such as aspirin and warfarin, or who have coagulopathy
11. Subject clinically highly suspected with gastrointestinal cancer
12. Other conditions deemed not suited for the study by investigators

Elimination Criteria:

1. Ask to withdraw from the study
2. Unable to get a stool sample
3. Invalid stool samples to test
4. Poor or inadequate bowel preparation
5. Failed to complete the colonoscopy
Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

The Canadian Australasian Randomized Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease (CARSK) will test the hypothesis that eliminating the regular use of non-invasive screening tests for CAD AFTER waitlist activation is not inferior to regular (i.e., annual) screening for CAD during wait-listing for the prevention of Major Adverse Cardiac Events. Secondary analyses will assess the impact of screening on the rate of transplantation, and the relative cost-effectiveness of screening.

Cardiovascular disease is the commonest cause of death while on the kidney transplant waiting list and after transplantation. Current standard care involves screening for coronary artery disease prior to waitlist entry, then every 1-2 years, according to perceived risk, until transplanted. The aim of screening is two-fold. Firstly to identify patients with asymptomatic coronary disease to enable either correction, by bypass surgery or angioplasty, or removal of the patient from the list, with the ultimate aim of preventing premature cardiovascular mortality at the time of, or soon after kidney transplantation. Secondly, from a societal perspective, to prevent mis-direction of scarce donor organs into recipients who experience early mortality. This current screening strategy is not evidence based, has substantial known and potential harms, and is very costly. Two major issues of uncertainty require addressing in sequence: (1) whether to periodically screen asymptomatic wait-listed patients for occult coronary artery disease; and (2) whether to revascularise coronary stenoses in asymptomatic patients prior to transplantation. The CARSK study seeks to address the first of these 2 issues.

CARSK aims to

1. Test the hypothesis that after screening for wait list entry, no further screening for coronary artery disease (CAD) is non-inferior to the current standard care which is screening all asymptomatic wait-listed patients for CAD at regular intervals.
2. Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.

Eligibility Criteria:
Inclusion Criteria:

1. adults aged 18 years of age or older
2. Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
3. expected to require further screening for CAD prior to transplantation (by current standard of care);
4. able to give consent;
5. anticipated to undergo transplantation more than 12 months from date of enrolment

Exclusion Criteria:

1. patients with signs or symptoms suggestive of uncontrolled cardiac disease such as unstable coronary syndromes, decompensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease;
2. patients who "on-hold" for transplantation due to a medical problem;
3. patients with other solid organ transplants;
4. multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates);
5. patients with planned living donor transplant;
6. patients unable to give consent.
Nitrites in Acute Myocardial Infarction

The research question to be addressed is "Does a 2.5 - 5 minute systemic intravenous injection of sodium nitrite administered immediately before opening of the infarct related artery result in significant reduction of ischaemia reperfusion injury in patients with first acute ST elevation myocardial infarction (MI)?"

There are estimated to be 125,000 acute myocardial infarctions (heart attacks) in the UK every year. Although substantial progress has been made in reducing the infarct size by prompt opening of the infarct related artery (with thrombolytic therapy or percutaneous coronary intervention (PCI)), effective therapy to further reduce the infarct size would substantially reduce the risk of the patient subsequently developing heart failure.

There is a growing body of evidence from studies in animals that the use of nitrites may help in reducing the infarct size, although this has not been tested in man.

In this phase 2/3 study, the investigators propose to investigate the effect of sodium nitrite injection on infarct size. Eligible patients will be males aged 18 and over and females aged 55 and over, presenting within 12 hours of the onset of chest pain, who are suitable for treatment with percutaneous coronary intervention. Those who give verbal agreement to take part will receive a 2.5-5 minute injection of sodium nitrite (or placebo) immediately prior to the blocked artery being opened with percutaneous coronary intervention.

Eligibility Criteria:
Men aged ≥18 years, women aged ≥55 years, and women \<55years who are sterilised, or have had a hysterectomy or have effective contraception and thus where there is no possibility of them being pregnant; presenting within 12 hours of the onset of chest pain who have ST segment elevation of more than 1mm elevation in limb leads or 2mm elevation in two contiguous chest leads or new left bundle branch block (LBBB) and for whom the clinical decision has been made to treat with primary PCI will be eligible for enrolment. Occlusion of the culprit related artery (TIMI grade 0 or TIMI grade 1) will also be required for inclusion. Eligible patients will be of North European descent.

Exclusion criteria

* Historical or ECG evidence of previous myocardial infarction
* Patients with prior coronary artery bypass grafting (CABG)
* Prior revascularization procedure where this procedure (PCI) was performed in the same territory as the current infarct
* Known or suspected pregnancy
* Contra-indications to MRI
* Patients with cardiac arrest or cardiogenic shock
* Patients with left main coronary occlusion
* Patients with known moderate to severe renal failure (estimated GFR \< 30mls/min), or liver failure
* Patients with prior thrombolysis for this event
* Patients with such Left Main disease which after PCI of their culprit lesion (culprit lesions may be located in the LAD or LCx or RCA) are likely to require CABG within the time course of the study period (6 months).
Breast 3DUS ABUS System Comparison

This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients who are scheduled for screening ABUS
* Adults Patients who are scheduled for short term follow-up with ABUS.
* Must be at least 18 years of age or older.
* Must be proficient in English (reading/writing).

Exclusion Criteria:

* Patients with breast implants.
* Patients with contraindication for ABUS.
* Patients who cannot tolerate ABUS.
Insomnia Interventions in Cancer Survivors

This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.

The purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. Moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including African-Americans, Latinos and Caucasians. The results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* age 18 and over
* diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic
* receiving treatment at one of the outpatient offices of the MD Anderson Cancer Center at Cooper
* Self reported insomnia
* Not currently taking any medications to treat insomnia
* No medical or psychological condition that would prevent successful protocol completion in the opinion of investigator.
Weight-bearing Exercise for Trans-tibial Amputees

A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).

Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.

Eligibility Criteria:
Inclusion Criteria:

* trans-tibial amputation,
* fitted with first trans-tibial prosthesis,
* independent mobility for 50m with or without assistive aid,
* Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5,
* ability to follow the instructions, Mini Mental State Examination (MMSE) \> 25,
* no severe visual problems, ble to see computer screen,
* willing to participate.

Exclusion Criteria:

* bilateral lower limb amputation or any other level of unilateral lower limb amputation,
* not candidates for prosthetic fitting.
Clinical Trial Phase I/II Prospective, Open Nonrandomized for Treatmen of Postoperative Air Leak After Lung Resection in High Risk Patients Through the Administration of Mesenchymal Autologous Cells

The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded)
* Patients class C or D on the risk scale of air leak Patients included in the study must meet all inclusion criteria.

Exclusion Criteria:

Patients with any of the following exclusion criteria may not be included in the clinical trial:

* Those considered by the investigator are not on a good position to tolerate the procedure
* Clinical criteria and anesthetics that contraindicate surgery
* Uncontrolled severe disease
* Pregnant women
* Patients infected with hepatitis B, hepatitis C, syphilis and HIV + virus
* People who are taking a drug under clinical investigation or participated in any study under clinical investigation (or an authorized product) within 30 days prior to randomization
* The absence of informed consent or revocation thereof
ECT/Succinylcholine: Biochemical, Serum and Cardiovascular Changes

This study will be conducted to determine the pharmacodynamics, cardiovascular and biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT). This is a single center, prospective, study in patients who will be receiving ECT as indicated and prescribed by their psychiatrist. The study will be performed twice on each patient, 48-72 hours apart during consecutively scheduled ECT procedures.

Patients will receive the anesthetic that is traditionally given which includes appropriate doses of succinylcholine. Serum potassium and creatinine phosphokinase (CK) levels will be determined pre and post anesthesia; serum and urine myoglobin will be determined post anesthesia. Vital signs data \[i.e., heart rate (arrhythmias) and arterial blood pressure\] will be compared pre and post anesthesia. In addition patients will be asked about the presence of muscle pain (myalgia) 1 hour before discharge from the recovery room and the following day post ECT.

Eligibility Criteria:
Inclusion Criteria:

1. A male or non-pregnant female aged 18 years and older
2. American Society of Anesthesiologists physical status 1, 2, 3
3. Scheduled to undergo electroconvulsive therapy under general anesthesia
4. Have given written informed consent

Exclusion Criteria:

1. Pregnant or nursing
2. Any patient in the study investigators opinion who may not be suitable for research.
Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)

The goal of this interventional study is to develop and assess the effectiveness of a peer-led digital health program (MYCardio-PEER) for primary prevention of cardiovascular disease (CVD) in a low-income community at-risk of CVD.

The main questions it aims to answer are:

* Is MYCardio-PEER effective in improving knowledge, lifestyle behaviors and CVD biomarkers of a low-income community at-risk for CVD?
* Is there an association between MYCardio-PEER participants' adherence and satisfaction, with effectiveness and sustainability of the program?

Participants will attend the 8-weeks MYCardio-PEER program with their peer leaders, supplemented with face-to-face components. Participants will then be followed up for another 12 weeks, during which peer leaders and researchers will have minimal contact with the participants. Participants who have been allocated into the control group will receive printed documents with standard tips on dietary and lifestyle management for CVD, where they will be encouraged to maintain regular calorie intake and expenditure and perform regular exercise.


Eligibility Criteria:
Inclusion Criteria:

* Mentally sound man/woman of at least 30 years old
* Monthly household income of less than RM3,710 or receiving government aid for low-income community
* Literate with a fair command of the Malay language
* Have mobile device connected to the Internet
* Willing to attend 8 weeks of intervention and be followed up for another 12 weeks during the maintenance phase.
* Have been confirmed to have a moderate or high risk for CVD based on the Framingham General CVD Risk Score

Exclusion Criteria:

* Pregnant, lactating or intend to become pregnant during the study period.
* Any other pre-existing conditions or severe complications that could compromise the ability to adhere to the study program.
* Enrolled in other studies.