cyrilzakka/clinical-trials huggingface dataset:
Analysis of Endocavitary Electrical Signal and Surface Electrocardiogram to Predict Ablation Outcome in Persistent Atrial Fibrillation

Background :

Despite recent progress in the management of patients with Atrial Fibrillation (AF), AF remains one of the main risk factor of stroke, heart failure and cardiovascular mortality in the world. AF is the most common cardiac arrhythmia, and its prevalence is expected to grow in the coming years.

Catheter ablation (CA) of AF can be successful in restoring and maintaining Sinus rhythm (SR) in patients with paroxysmal, and persistent AF. Haissaguerre et al. have shown that AF ablation of the heart by isolating the Pulmonary Vein is usually sufficient. However, when ablating persistent AF patients ablating pathological regions in the atria is also required. CA is still a challenging procedure, and reported success rate for persistent AF patients remains relatively low (around 60%). This procedure is associated with risks inherent to any invasive cardiac procedures.

A better identification of good responders would reduce the risks associated with ablation, especially for patients with low odds of favorable outcome, while also increasing the success rate of the procedure. It has been shown in the literature the long-term CA outcome can be predicted non-invasively by atrial fibrillatory wave (f-wave) amplitudes.

Hypothesis :

We assume that a morphological analysis of the f-waves on standard twelve ECG will allow for a better CA outcome prediction.

Objectives :

The aim of this study is to automatically analyse the morphology of the ECG signal before a CA procedure, extract relevant features for an accurate prediction of long-term CA outcome for patients in persistent AF.


Eligibility Criteria:
Inclusion Criteria:

* Patients for which clinical data, along with the ECG signals before and during the CA procedure are available,
* Patients who underwent a first ablation procedure for persistent AF

Exclusion Criteria:

* ECG data is not interpretable
* Patients who underwent a second or umpteenth ablation procedure for persistent AF
Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial Disease

The purpose of the study is to use a new research imaging technique, a kind of magnetic resonance imaging (MRI), to measure important metabolic features of muscle, including mitochondrial function, in people with mitochondrial disease and in healthy individuals. (Mitochondria are tiny organelles that generate energy for the body.)

It is hoped that this new strategy will help physicians to understand better the health problems of people with mitochondrial disease. Eventually, this could lead to better diagnostic and treatment approaches.

There are two study-related visits.

The first visit is a "screening" visit to ensure eligibility. This includes fasting blood tests. The second visit is an MRI scanning session. This also takes around 2 - 3 hours, with no more than 1.5 hours spent in the actual MRI machine. It may be possible to complete these two visits on the same day. Otherwise, the MRI session should occur within 3 months of the screening visit. In addition, an optional physical capacity visit will occur on the same day as the MRI session.

Eligibility Criteria:
Group 1) Mitochondrial Disease:

Inclusion Criteria:

* Genetic diagnosis of mitochondrial disease
* Be able to perform sub-maximal leg exercise for several minutes
* Be able to provide written, informed consent
* Cognitively and medically stable and able to comply with study procedures
* Able to fast for 4 hours prior to blood draw and/or MRI scanning
* Be willing to stop taking any over-the-counter vitamins and supplements that are neither prescribed nor recommend by their physician for 2 weeks prior to MRI scanning

Exclusion Criteria:

* Diabetes
* Alcohol/substance abuse
* Smoking
* Use of any investigational agents within 4 weeks of enrollment
* Any contraindication to MRI scanning

Group 2) Healthy Individuals:

Inclusion Criteria:

* Be able to perform sub-maximal leg exercise for several minutes
* Be able to provide written, informed consent
* Cognitively and medically stable and able to comply with study procedures
* Able to fast for 4 hours prior to blood draw and/or MRI scanning
* Be willing to stop taking any over-the-counter vitamins and supplements that are neither prescribed nor recommend by their physician for 2 weeks prior to MRI scanning

Exclusion Criteria:

* Carry a diagnosis of mitochondrial disease
* Have a first-degree relative with a diagnosis of mitochondrial disease
* Diabetes
* Alcohol/substance abuse
* Smoking
* Use of any investigational agents within 4 weeks of enrollment
* Any contraindication to MRI scanning
Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes and at least one of the following:

  * Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2
  * Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and \<60 mL/min/1.73 m2)
  * A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and \<60 mL/min/1.73 m2)
* Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.

Exclusion Criteria:

* Type 1 diabetes mellitus
* Cardiovascular event or procedure ≤ 3 months prior to Visit 1
* Unstable serum creatinine
* Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and \< 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and \< 110 mmHg unless treated with at least 3 anti-hypertensive medications
* Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg
* Baseline Serum Potassium \> 5.0 mmol/L
* Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
* Patients with NYHA class III or IV heart failure
* Known renal artery stenosis
* Previous randomization into the AVOID trial (CSPP100C2201)

EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:

- Aliskiren or aliskiren containing fixed combination products must not be used

Other protocol-defined inclusion/exclusion criteria applied
Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation

The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.


Eligibility Criteria:
Inclusion Criteria:

1. Adult recipients older than 18 years;
2. Patients diagnosed with end-stage renal diseases and volunteered to register in the Transplant and Dialysis Registry of China awaiting for deceased donor kidney transplantation;
3. First single kidney transplantation;
4. The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent;
5. Ethics committee approved.

Exclusion Criteria:

1. Patients less than 18 years old, or more than 65 years old;
2. Patients who receive multiple organ transplants;
3. Diagnosed with malignancy or had a history of malignancy in the past 5 years;
4. non-kidney transplantation history.
Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers

The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer

Hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). These complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor.

Based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. Conformal RT to the tumor bed of T1 breast cancers satisfies both requirements.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (at least 2 years without menstrual period):

hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.

* Original tumor non-palpable (mammographically detected).
* Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
* N0 or sentinel node negative or N0 clinically if the tumor is \<1 cm in size.
* Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined.
* Prescribed antihormonal therapy as part of their management.

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast.
* Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
* Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
* Women with a diagnosis of multifocal breast cancer.
The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients

A double-blind and placebo-controlled study is conducted in the current human study.

The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.

Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
* BMI≥28 for obese groups;
* Aged between 40 and 75 years.

Exclusion Criteria:

* Type 1 diabetes;
* Cardiovascular disease;
* Cancer;
* Liver or kidney disease;
* Premenopausal women, pregnancy or lactation;
* Allergy to fish;
* Have participated in other clinical trials in the last three months.
Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures

This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial.

The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.

The main findings of the original trial had been published on Ophthalmology \[2007;114: 2244-2251\].


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included.

Two different groups of patients were potentially eligible:

1. Those patients who were controlled (IOP\< 21 mmHg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit.
2. Patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (IOP \< 21 mmHg, or, as judged by the physician, target IOP was not reached).

Pseudoexfoliation glaucomas and patients with diabetes were not excluded.

Exclusion Criteria:

All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition.

1. Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure. The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used, and grades II, III, and IV were included. Grades 0 and I were excluded.
2. Ocular surgery or argon laser trabeculoplasty within the last 3 months.
3. Ocular inflammation/infection occurring within 3 months before the pretrial visit.
4. Neovascular glaucomas.
5. Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
6. Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement.
7. Patients on either bimatoprost or the LTFC.
8. Patients who had undergone refractive surgery. General
9. Inability to adhere to treatment/visit plan.
10. Participation in any other clinical trial (i.e., requiring in- formed consent) within 1 month before the prestudy visit. 11. Pregnancy, nursing, or, if applicable, nonuse of adequate contraception.

12. Any drug known to affect IOP.
Neuropsychologic, Neuroradiologic, Endocrinologic, and Genetic Aspects of Klinefelter Syndrome

The purpose of this study is to investigate the following:

1. Whether Klinefelter Syndrome is associated with altered total and regional brain volumes and altered brain activity.
2. The influence of genetic factors and testosterone treatment on the neuropsychological phenotype, total and regional brain volumes and brain activity in men with Klinefelter syndrome.

Klinefelter syndrome (KS) is the most common sex-chromosome disorder in men with a prevalence of 1 in 660 men. Men with the syndrome have an additional X-chromosome. The syndrome is associated with cognitive and behavioral dysfunction and also with hypogonadism. Magnetic resonance imaging have pointed to different volumetric alterations in several brain structures. Several genetic factors involving the X-chromosome have been suggested to influence the neuropsychological phenotype in men with KS.

The aim of this study is to investigate the following: 1.Whether KS is associated with altered total and regional brain volumes and altered brain activity. 2.Whether genetic factors influence the neuropsychological phenotype, total and regional brain volumes, and brain activity in men with KS. 3.Whether testosterone treatment improves cognitive skills and change brain activity in men with KS.

Participants are divided in 5 groups: 1. 50 men with KS who receive testosterone treatment. 2. 50 men KS who do not receive testosterone treatment. 3. 100 age-matched control men.4. 50 age-matched control women are included as a control group for X-chromosome inactivation pattern. 5. Parents of KS subjects in group 1 and 2 are included to determine the parental origin of the supernumerary X-chromosome. Methods include a 3-hour battery of standardized neuropsychological tests to cover a broad range of cognitive domains and to assess major domains of personality. We use magnetic resonance imaging to measure total and regional brain volumes and functional magnetic resonance imaging to measure brain activity while subjects are performing a attention-demanding cognitive task. The genetic testing includes the parental origin of the supernumerary X-chromosome, the pattern of X-chromosome inactivation, androgen receptor (AR) CAGn repeat length, and gene expression profile of brain-expressed genes.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60 years
* verified KS karyotype (KS patients)

Exclusion Criteria:

* present or past neurological diseases
* present or past head trauma
* contraindication to perform MR scans(Claustrophobia,Magnetic or electric foreign bodies - including cardiac pacemakers, magnetic cerebrovascular clips and electric non-removable appliances dosing medicine)
* extreme adiposity (BMI \> 35 kg/m2)
Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes

SPECIFIC AIMS

1. To determine whether pioglitazone will reduce levels of asymmetric dimethylarginine(ADMA) in patients with diabetes.
2. To determine whether nitric oxide(NOx) products are increased with pioglitazone treatment.
3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).

The primary purpose of this study is to determine whether treatment with pioglitazone can reduce serum levels of asymmetric dimethylarginine (ADMA) in patients with adult diabetes. Recent research has found that elevated serum ADMA is associated with increased cardiovascular events and mortality, particularly in people with diabetes (Boger 2005, Zoccali 2006, Ueda 2007). ADMA, by mediating nitric oxide (NO) availability, may trigger pro-atherogenic effects. High plasma concentration of this substance has been associated with intima-media thickening, left ventricular hypertrophy and all-cause and cardiovascular mortality in patients with end-stage renal disease, and associated with increased cardiovascular events in patients with diabetes (Kryzazanowska 2007). The result of higher levels of ADMA and reduced output of NO increases vasoconstriction, increases inflammation, and interferes with endothelial function. Preliminary studies indicate that pioglitazone may reduce ADMA levels, and thus lower cardiovascular risk.Thus, this protocol will test whether pioglitazone can reduce ADMA levels in adult patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 40--75 years-of-age, non-pregnant
* Informed consent
* History of type 2 Diabetes Mellitus
* Stable weight for the last 3 months (no change greater than +5% of body weight)
* ADMA \> 0.50 µM/L (mean of non-diabetic reference group) (Devangelio 2007)
* On stable medical therapy for at least 3 months
* A working telephone

Exclusion Criteria:

* Any history of known coronary heart disease, including a history of congestive heart failure, myocardial infarction, coronary re-vascularization, or stroke
* Pregnancy
* Chronic kidney disease, serum creatinine \>2.0mg/dl, chronic liver disease, or uncontrolled hypertension (\>160/100).
* Current participation in a formal weight loss program or planning to start such a program during the next 3 months
* Collagen vascular disease, infection, or other inflammatory condition
* Electrocardiogram (EKG) evidence of ischemia or infarction
* Macular edema (swelling of the back of the eye), recent excessive weight gain (over 5% of weight in 30 days), elevated liver function tests \> 2.5 X the upper limit, or history of osteoporosis
Serum Carotenoids and Risk of Gastrointestinal Tract Cancer: Meta-analysis of Ten Studies

Previous studies have suggested that serum carotenoids may be associated with risk of gastrointestinal tract cancer (GIT cancer), but the results were inconsistent. Thus, the investigators conducted a meta-analysis to evaluate the associations between serum carotenoids and risk of GIT cancer.


Eligibility Criteria:
Inclusion Criteria:

* The study had both case and control groups
* Serum carotenoids levels, relative risk (RR) or OR and corresponding 95% CI were reported
* Patients in case group were diagnosed with GIT cancer

Exclusion Criteria:

·Animal studies
EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)

Cancer patients need central venous access according to the different types of chemotherapy and support drugs for their treatment path. The presence of a central vascular access brings mechanical issues, thrombotic and infectious complications that can undermine the patient's health and the life of the catheter, therefore the management of venous accesses is clinically relevant. The prevention of infections remains mainly based on correct hand washing and compliance with aseptic techniques. This is a multicenter intervention study is composed by a single experimental arm (home) and a calibration arm (outpatient). The study is designed to evaluate that the complication rate recorded in the two groups are similar.


Eligibility Criteria:
* Share patient choice
* availability at the patient's home at least once a week
* availability during on line appointment time with the tutor/video