cyrilzakka/clinical-trials huggingface dataset:
Gene Expression Profiling in Subjects With Postoperative Atrial Fibrillation After Cardiac Surgery (GENEXPRO Surg)

Atrial fibrillation is a type of irregular heartbeat that is common after having heart surgery. There may be many different reasons why some people get atrial fibrillation after their heart surgery. These reasons may include that a person is older or that he/she is taking certain types of medications before surgery. Genes may also be a reason. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Some people may have genes that make it more likely for them to get atrial fibrillation after their heart surgery. This research project is being done to find out if the cells of people who develop atrial fibrillation after heart surgery are different from the cells in people who do not develop atrial fibrillation after surgery.

Atrial fibrillation is a type of irregular heartbeat that is common after having heart surgery. There may be many different reasons why some people get atrial fibrillation after their heart surgery. These reasons may include that a person is older or that he/she is taking certain types of medications before surgery. Genes may also be a reason. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Some people may have genes that make it more likely for them to get atrial fibrillation after their heart surgery. This research project is being done to find out if the cells of people who develop atrial fibrillation after heart surgery are different from the cells in people who do not develop atrial fibrillation after surgery.

This study seeks to identify regulatory events in atrial myocyte transcription and translation that are altered by germline variation

Eligibility Criteria:
Inclusion Criteria:

* Age 20-99 years
* Undergoing cardiac surgery

Exclusion Criteria:

* Prior cardiac surgery
* chest radiation
* recent chemotherapy
Effect of Rapamycin in Ovarian Aging

The investigators are proposing a prospective, randomized, double-blind, placebo-controlled pilot study assessing the ability of low-dose rapamycin to delay ovarian aging in women. Animal studies have shown the potential of rapamycin in slowing or reversing some age-associated pathways.

One of the earliest and most profound changes associated with human aging is the rapid decline in ovarian follicular activity and reproductive capacity. Beginning around age 35, fertility rates decline as the number and quality of oocytes fall, culminating in the onset of menopause around age 51. The onset of menopause has profound socioeconomic, quality of life, and health implications, including increasing the risks of cardiovascular disease, osteoporosis, cognitive decline and dementia. While human lifespan has increased, the age of menopause has remained largely unchanged, leaving more women living an ever-larger proportion of their lives in a postmenopausal state. The narrow reproductive window adds socioeconomic pressure on women to complete childbearing within a limited timeframe, or preserve their fertility with egg or embryo freezing. The investigators and others have demonstrated that rapamycin can delay ovarian aging in mice.

The purpose of this pilot study is to determine whether the same may be true in humans. Extending the reproductive lifespan will reduce the time pressure on women to complete childbearing and will allow more women to spend more of their lives in the premenopausal status and delay the negative healthy consequences of menopause.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 35-45 years
* In the menopausal transition stage -3a
* Have been unable to conceive based on diminished ovarian reserve and who have failed to develop any euploid embryos with IVF or who do not desire to conceive within the next 1.5 years
* Have regular menstrual periods (with less than 7 days of variability)
* Early follicular phase follicle stimulating hormone (FSH) levels \] \< 20 mIU/mL
* Anti-müllerian hormone (AMH) levels of \>0.1 ng/mL
* Antral Follicle Counts (AFC) of \>3

Exclusion Criteria:

* Women with irregular menstrual cycles
* Severe ovarian deficiency, or with no evidence of remaining follicles
* Kidney or liver disease
* Any significant medical disease, including cancer
* Contraindications to receiving rapamycin
Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study

The purpose of this study is to identifying the intramuscular dose equivalent to the 4mg intravenous dose and assess its safety and tolerability as a weekly injection.

The purpose of this bridging study is to advance the therapeutic development of Allopregnanolone (Allo) by using the intramuscular (IM) route of administration as an alternative to the intravenous (IV) route. In order to identify the equivalent IM dose we will conduct pharmacokinetic (PK) analysis previously informed by simulations and modeling. We will recruit a total of 12 participants, both males and females equally distributed, into this single-arm, open-label study.

PK analysis and dose finding will take place for the initial 4 weeks; some participants may not require all 4 weeks of initial dosing to establish maintenance dose. Once maintenance dose is established all participants will receive weekly administration of Allo IM until they complete 12 weeks total of Allo exposure (5 or 6 clinic visits and 6 or 7 home-nurse visits).

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Men or postmenopausal women, aged 55 years or older
* Diagnosis of MCI due to AD or mild AD
* In good general health as evidenced by medical history and with no medical contraindications to participation
* MMSE \> 20 at screen
* Caregiver willing and capable to accompany the patient to clinic visits

Exclusion Criteria:

* Daily use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the GABA-A receptor complex.
* Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy.
* Clinically significant laboratory or ECG abnormality obtained at screening visit.
* MRI indicative of significant abnormality, including but not limited to evidence of a single prior hemorrhage or infarct \>1 cm3, multiple lacunar infarcts (\>1) or evidence of a single prior infarct \>1cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (e.g. abscess or tumor).
* Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
* Is currently enrolled in a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research or observational study judged not to be scientifically or medically compatible with this study.
Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent in the treatment of breakthrough cancer pain.

Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.

This study will compare the time of onset and degree of pain relief of Nasalfent to that of Placebo. The safety of the two treatments groups (Nasalfent, Placebo) will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give consent
* Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception
* Diagnosis of cancer
* Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain
* Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication
* Able (or via caregiver)to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary
* Able to be up and about for 50% of the day or greater

Exclusion Criteria:

* Intolerance to opioids or fentanyl
* rapidly increasing/uncontrolled pain
* pain that is not cancer related
Risk Factor Analysis for Developing Metabolic Syndrome in Korean Adults

In Asia, the prevalence of metabolic syndrome have been dramatically increased. Therefore, the investigators intend to the collect the blood sample, laboratory, anthropometric, and body composition parameters prospectively to examine the risk factors of metabolic syndrome. Furthermore, the investigators will collect the data of carotid IMT and branchial ankle pulse wave velocity to clarify the metabolic risk factors of atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy people who underwent medical routine check up in Korea Health Promotion Center.
* age \> 20 years

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Stage 2 hypertension
* Severe renal or hepatic disease
The Wire-free Invasive Functional Imaging (WIFI) Study

Quantitative Flow Ratio (QFR) is a new method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.

Background:

Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG) and often in combination with measurement of fractional flow reserve (FFR) to assess the functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during maximum blood flow (hyperaemia) induced by adenosine infusion.

The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire and the cost of the wire and the drug inducing hyperaemia limits more widespread adoption.

Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections.

The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.

Hypothesis:

QFR can be assessed during CAG for stenosis interrogated by FFR

Methods:

Proof-of-concept, prospective, observational, single arm study with inclusion of 100 patients. Clinical follow-up by telephone call after one year.

A stenosis with indication for FFR is identified and at least two angiographic projections rotated at least 25 degrees around the target vessel are acquired during resting conditions. QFR is calculated on-line using the Medis Suite application and simultaneously to the operator performing the FFR measurement using I.V. adenosine. The QFR observer is blinded to the FFR measurement.

QFR is reassessed off-line by internal observer and by an external core laboratory. Both blinded to FFR results.

FFR is assessed in core laboratory by a different blinded observer

All data are entered and stored in a protected and logged trial management system (TrialPartner).

Eligibility Criteria:
Inclusion Criteria:

* Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI)
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Myocardial infarction within 72 hours
* Severe asthma and chronic obstructive pulmonary disease
* Severe heart failure (NYHA≥III)
* S-creatinine\>120µmol/L
* Allergy to contrast media or adenosine
* Stenosis in vein graft
* Ostial left main stenosis
* Severe tortuosity
* Atrial fibrillation
PET/MR in Post Stroke Cardiac Inflammation Study

Patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. The mechanisms behind these complications are not well understood. Evidence suggests that inflammation plays a central role. With the present proof-of-concept prospective cohort study, the investigators aim to demonstrate that patients develop cardiac inflammation after stroke by performing positron emission tomography (PET) magnetic resonance imaging (MRI) of the heart within 15 days after stroke. As a secondary aim, the investigators will evaluate whether post-stroke cardiac inflammation persists at 3 months after stroke. The control group will be comprised of age- and sex-matched individuals without stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years willing to cons Age ≥18 years willing to consent
* Patients with acute ischemic stroke in the right or left MCA territory, admitted to University Hospital, London Health Sciences Centre (LHSC) or evaluated at LHSC's Urgent TIA and Stroke Prevention Clinic. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on a Head CT or on diffusion weighted imaging (DWI) MRI of the brain showing restricted diffusion.
* Willing to consent.

Exclusion Criteria:

* History of known heart disease defined as known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention
* Stroke in the previous 3 months before the qualifying stroke.
* High-sensitivity Troponin-T (HS-TnT) \>100 ng/L on routine standard of care acute stroke bloodwork.
* Clinically or neurologically unstable patients as per the treating physician.
* Ongoing infection or recent infection within the previous 3 months.
* Surgery within 3 months before the stroke.
* Concurrent inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications.
* Contraindications to the use of gadolinium (e.g., pregnancy, stage IV renal insufficiency)
* Subjects will be excluded if they fail the St. Joseph's Health Care standard MRI screening questionnaire. Briefly, this questionnaire screens for: Heart Pacemakers / Wires, Aneurysm Clips, Shunt / Surgical Clips, Shrapnel / Bullets, Dentures or Metal braces, Intra-Uterine Device, Heart Valves, Ear Implants, Prostheses, Medication Patches (Nicoderm, Habitrol, Transderm-Nitro, etc.), Claustrophobia, History of a head or eye injury involving metal fragments. Patients with an eGFR \< 40 will be excluded, as impaired renal function places the patient at a higher risk for a rare reaction to Gd-DTPA, the MRI contrast agent.
Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors

To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.

To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.

HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.

Eligibility Criteria:
Inclusion Criteria:

* age \< 21 years old
* Patients with high-risk solid tumors who failed prior HDCT/autoSCT
* Patients with a suitable haploidentical donor
* High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc.
* stable disease with salvage chemotherapy after relapse

Exclusion Criteria:

* organ dysfunction(NCI common toxicity criteria grade \> 2)
* progression of disease despite salvage chemotherapy
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.

Eligibility Criteria:
Inclusion Criteria:

1. In the opinion of the Investigator, patients must have safely completed the lead-in study.
2. Patient is taking their ADT as prescribed from the lead-in study.

Exclusion Criteria:

1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:

   1. At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
   2. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
3. Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.
Cervical Spine Manipulation Affects on Balance and Proprioception

Cervical spine manipulation (CSM) is utilized by many health care practitioners in the management of patients with neck pain and headache. How CSM works is not understood however, most researchers agree that there is likely a combination of mechanical, neurophysiological and placebo effects. This study will test for possible neurophysiological effects by examining for changes in a person's ability to reposition their head and neck in space, and maintain their balance following CSM.

Consenting participants will have their proprioception tested through a joint repositioning error test for their cervical spine, and also have their balance tested through a Neurocom Balancemaster. Following these pre-intervention measures, they will receive in a random order, either a cervical spine manipulation (CSM) or a sham manipulation, and then have tests repeated to analyze for changes and differences between interventions.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals between the ages of 18 and 60

Exclusion Criteria:

* current neck pain/symptoms; neck pain symptoms within the last 6 months; confirmation or possibility of pregnancy; dizziness; vertigo, or nausea; history of cervical spine surgery; rheumatoid arthritis; osteoporosis; osteopenia; ankylosing spondylitis; cancer; or vertebral artery insufficiency.
Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

Estimating the risk of future cardiovascular events such as death, stroke and myocardial infarction using traditional risk factors (such as age, gender, smoking, diabetes, hyperlipidaemia and hypertension) is well accepted in patients with and without existing cardiovascular disease. These estimates are based on a number of robust observational studies, including the original Framingham study. While these methods apply reasonably well on a population level their application to the individual patients is not always straightforward. In addition, risk charts, such as those published by the Joint British Societies and American Heart Association, may underestimate risk in certain groups, notably diabetics and patients of Indo-Asian background, whilst overestimating risk in others (by as much as 50% in some studies).

A number of variables including clinical, biochemical, and enzymatic have been evaluated to see if they add to conventional "risk-reduction" models such as Framingham and if so, to understand if they may be used in routine clinical practice.

The aim of this study is to assess several known and a few novel risk-factors (heart rate variability, pulse wave analysis, high-sensitivity CRP and BNP) prior to planned elective coronary angiography (cross-sectional analysis) and in a prospective cohort of high and low-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Male or Female

Exclusion Criteria:

* Acute coronary syndrome
* Urgent angiography
* Assessment would constitute harm to patient
* Informed consent not obtained