cyrilzakka/clinical-trials huggingface dataset:
Cohort Study of Heart Failure With Preserved Ejection Fraction in Chinese Han

To analyze factors contributing to the development and prognosis of heart failure with preserved ejection fraction.

Based on previous studies on development of heart failure with preserved ejection fraction (HFpEF), racial/ethnical background should be underscored when evaluating risk f actors for HFpEF incidence. As the ageing population increases sharply in China, HFpEF represents the dominant phenotype of all patients diagnosed with heart failure. In this cohort study, the investigators evaluated exposures or risk factors for HFpEF in Chinese Han patients with cardiovascular diseases (CVD). Our study may provide preventive and therapeutic targets for HFpEF in Chinese CVD patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CVD, defined as at least one diagnosis of coronary heart disease, hypertension, type 2 diabetes or cardiomyopathy. The definition of coronary heart disease was stenosis of the main coronary arteries ≥ 50% using percutaneous coronary angiography or coronary computed tomography angiography findings. The definition of hypertension was systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg or pharmacological treatment. The definition of type 2 diabetes was fasting blood glucose ≥ 7.0 mmol/L, random blood glucose ≥ 11.1 mmol/L and HbA1c \> 6.5% or the or the use of hypoglycaemic medications. Cardiomyopathy was defined as the presence of cardiac insufficiency in patients with dilated cardiomyopathy suggested by percutaneous coronary angiography or coronary CT angiography use of hypoglycaemic medications.

Exclusion Criteria:

* primary diagnoses of atherosclerosis (stenosis of the main coronary arteries \< 50%), congenital heart diseases, arrhythmia, lung diseases, aortic dissection, peripheral vascular diseases, pericardial diseases, myocarditis, hypertrophic cardiomyopathy, heart valvular diseases, cardiophobia, costal chondritis, shock, thyroid diseases, infection or concomitant liver or renal dysfunction.
Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects

The disposition of NRL972 after a 15-second intravenous injection of 2 mg NRL972 is distinctly slower in patients with hepatic cirrhosis and acute hepatitis than in healthy control subjects. NRL972 appears to be a suitable investigational marker of hepatic transporter clearance dysfunction.

Although the pharmacokinetics of NRL972 provide a reliable differentiation between subject groups, this approach relies on precisely timed sampling of venous blood, cautious preparation, handling and on-site storage of plasma samples, the transfer of samples to a central laboratory for analysis, and the availability of a validated assay procedure.

For these reasons, there is interest in developing and validating alternative methods for determining the concentration of NRL972 in venous blood. Two such methods have been developed to date, but their utility in determining NRL972 pharmacokinetics has yet to be established.


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting the following conditions will be eligible for enrolment:

* Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
* Caucasian
* Age: 20 to 45 years
* BMI 20 - 26 kg.m-2
* Healthy based on the pre-study examination
* Suitable veins for easy cannulation
* Willing and able to provide informed consent

Exclusion Criteria:

Subjects of any of the following categories will be excluded from enrolment:

General - all subjects

* Previous participation in the trial
* Participant in any other trial during the last 90 days
* Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
* History of any clinically relevant allergy
* Presence of any acute or chronic infection
* Presence or history of any relevant co-morbidity
* Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
* Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
* Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
* Positive serology for HBsAg, anti HBc and anti HCV
* Positive HIV test
* Positive alcohol or urine drug test on recruitment
* History of alcohol and/or drug abuse and/or daily use of \> 30 g alcohol
* Smoking more than 10 cigarettes/day or equivalent of other tobacco products
* Use of prohibited medication
* Suspicion or evidence that the subject is not trustworthy and reliable
* Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard

General - all females

* Positive pregnancy test
* Lactating
* Not using appropriate contraception in premenopausal women
Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis

clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated with a coronary bare metal stent. Recent research has identified endothelial progenitor cells as well as dendritic cells as components of neointima. Numerical and functional evaluation of endothelial progenitor and dendritic cells at the time of coronary stent implantation is assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent implantation is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old
* Scheduled for PCI
* Candidate for CABG if necessary
* Clinical evidence of ischemic heart disease and/or abnormal functional study
* New native coronary artery lesion \>50%-\<100% stenosis
* Lesion length\<30 mm, treatment with a single bare metal stent planned
* Reference diameter 2.5-3.5 mm
* Informed consent explained, red, understood and signed by the patient

Exclusion Criteria:

* Pregnancy, birth or lactation period \<6 months ago
* Women of childbearing age who do not intend to use accepted anticonceptive measures or who wish to get pregnant
* Left ventricular ejection fraction \<30%
* Acute myocardial infarction (ST-elevation, Q-wave evolution or CK-MB \>2x upper limit of normal)in the past month
* Contra-indication to PCI
* Diabetes mellitus
* Planned drug eluting stent implantation
* Total occlusion (TIMI 0 or 1)
* Ostial localisation (\<3.0 mm of the coronary ostium) of the lesion
* Bifurcational lesion with side branch \>2.0 mm or side branch which will be recanalised at occlusion due to PCI
* Lesion in arterial or venous bypass or anastomosis with coronary
* Angiographic contra-indication to IVUS
* Severe renal insufficiency (creatinine clearance \<30 mL/')
* Severe hepatic insufficiency
* Systemic inflammatory pathology of any kind
* Uncorrected hyperthyreosis
* Hematologic or other malignancy, prior radio- or chemotherapy
* Severe peripheral artery disease (accesproblem via groin)
* Use of corticosteroïds or immune suppression therapy
* Contrastallergy
* Life expectancy \<1 year
* Participation in other clinical study which has not ended yet
Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A

Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.

In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.

Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of unilateral cerebral palsy
* able to activate wrist and finger extensors
* being scheduled for BoNT-A treatment for upper limb

Exclusion Criteria:

* significant loss of wrist and or fingers
* history of orthopedic surgery to plegic upper limb
Preoperative Identification of the Histologically "Vulnerable" Plaque Using Non-invasive Imaging, Biomechanical Assessment and Baroreflex Evaluation in Patients With Severe Carotid Stenosis

Carotid artery stenosis due to atherosclerotic plaques accounts for an important cause of ischemic stroke. Current research seeks to risk stratify asymptomatic patients by characterizing rupture-prone plaques. Currently no single imaging modality can reliably identify those plaques before surgery. Recently, the 3D ultrasound (US) and the assessment of the mechanical stress on the vessel wall have been proposed as non-invasive tools that could play a role in the diagnostic work-up. Data of histological validation, however, are still needed. In this research, 3D US, non-invasive elastography, Finite Element Analysis of computed tomography angiography images and the study of the autonomic cardiovascular control will be used to identify preoperatively the vulnerable plaque in patients undergoing carotid endarterectomy. The results will be compared to that of histology of the removed plaque, aiming to provide a validation to each method for a possible application in the daily practice.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years;
* signed informed consent.

Exclusion Criteria:

* medical conditions limiting expected survival to \<1 year;
* patients with significant uncontrolled or unstable medical condition (heart failure or angina pectoris class NYHA III-IV, cardiac surgery in the previous 30 days, left ventricular ejection fraction \<30%, severe chronic obstructive pulmonary disease, myocardial infarction in the previous 30 days, coronary heart disease with revascularization indication, that is, the common trunk or more than two coronary vessels);
* tracheostomy;
* paralysis of the laryngeal nerve contralateral to the carotid stenosis;
* women of childbearing potential;
* inability to give informed consent;
* patients presenting contraindications to perform a CTA examination of neck vessels with contrast medium;
* patients with medical history of stroke/TIA within the previous 6 months.
A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults

The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. The objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient participants with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The participant enrolled meet the criteria of growth hormone deficiency in adults as per the Humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. The decision to receive somatropin or remain untreated is made by the participant in consultation with their attending physician.

While treatment of adult growth hormone deficient participants with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of participants in the context of the overall disease environment.


Eligibility Criteria:
Inclusion Criteria:

- Adult growth hormone deficiency as per the local Humatrope label and as judged by the attending physician

Exclusion Criteria:

- As per the local Humatrope label and as judged by the attending physician
Intraperitoneal Analgesia in Pediatric Laparoscopy

It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.

Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy is not pain free and control of post-laparoscopy pain remains a major concern. The exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain.

additionally poor pain control could limit the activity of children following laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

1. age (1 to 6 years)
2. ASA physical status I or II.
3. scheduled for laparoscopic hernia repair under general anesthesia.

Exclusion Criteria:

1. Allergy to study drugs,
2. Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
3. sever hepatic or renal impairment,
Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction

The present randomized control trial sought to establish glucose fluctuation as an important target for management on metabolic index, neurologic function, and quality of life in Type 2 diabetes mellitus (T2DM) patients and cerebral infarction (CI).

There is a significant association between glycemic ﬂuctuation and the incidence of diabetes macrovascular complications. Therefore, understanding the impact of glycemic fluctuations on diabetic macroangiopathy could be helpful for discovering a strategy of prevention and treatment of macroangiopathy in diabetes. However, previous studies on the glycemic fluctuation in T2DM patients with CI were cross-sectional studies, there has been no prospective intervention study confirming the effects of glucose fluctuation targeted management on the prognosis of T2DM patients following CI. Based on previous fingdings, investigators will assess the effects of glucose fluctuation targeted intervention on metabolic index, neurologic function, and quality of life in T2DM patients and CI.

Eligibility Criteria:
Inclusion Criteria:

* 1. cerebral infarction within one month, diagnosed by magnetic resonance imaging (MRI) or computed tomography (CT) according to 1995 acute cerebral infarction diagnosis standards promulgated by the Fourth National Cerebrovascular Disease Conference \[1\];
* 2. having type 2 diabetes mellitus (as defined by the WHO diagnostic criteria in 1999) \[2\];

Exclusion Criteria:

* 1. coexisting acute complications of diabetes including diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), metabolic acidosis;
* 2. severe comorbid chronic complications of diabetes;
* 3. active malignancy;
* 4. subjects with mental illness and communication disorders; 5) those actively participating in other research studies.
Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

Data from 2007 regarding iodine status among Portuguese pregnant women indicate this is an iodine deficient population group, with only 16.8% presenting adequate urinary iodine values. This may have serious implications for normal cognitive development of the offspring and a concerning socioeconomic impact. In 2013, concerns by the Portuguese Directorate-General of Health lead to the implementation of a public health policy (nº 011/2013) recommending iodine supplementation during pregnancy. IoMum emerges from this context to monitor and update iodine status in Portuguese pregnant women and to evaluate the effectiveness of the above policy by assessing clinical compliance to iodine supplementation and the impact of iodine supplementation in this vulnerable group. IoMum will update data on iodine nutrition in Portuguese pregnant women, promoting political actions towards the elimination of iodine deficiency and thus to the reduction of nutritional, social and economic inequalities.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending the 1st trimester fetal ultrasound scan, from the 10th to the 13th gestational week.

Exclusion Criteria:

* Use of Levothyroxine.
Clinical Outcomes After EMR or ESD of Colorectal Neoplasms - A Multicenter Registry

This study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

Colorectal cancer (CRC) is one of the most common causes of cancer-related death, however its morbidity and mortality can be reduced by colonoscopy screening and endoscopic removal of adenomas or early cancers.\[1\] Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms. Despite being a safe and convenient procedure, insufficient resection by EMR can result in a high risk of local recurrence, particularly in lesions ≥ 20 mm. Compared with EMR, ESD facilitates a higher rate of en bloc resection and a lower rate of local recurrence. A recent meta-analysis revealed that the local recurrence rate after colorectal ESD was 1% during a 2-year follow-up period. In addition, ESD can facilitate precise pathological diagnosis to assess the risk of lymph node metastasis of early CRC to judge whether salvage surgery is needed. Although the efficacy of colorectal ESD has been demonstrated, its usage is largely limited by its technical difficulty and risk of complications.

Both short- and long-term data on clinical outcomes and safety profiles for colorectal EMR and ESD are needed. Therefore, this study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who undergo EMR or ESD for colorectal lesions.

Exclusion Criteria:

* Not applicable.
Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

Retrospective observational review of severe envenomation treatment with CroFab

The objective of this study is to use previously collected retrospective observational data to compare treatment and outcome in patients treated with CroFab who have a severe envenomation to those with a mild/moderate envenomation.

Eligibility Criteria:
Inclusion Criteria:

* Must involve treatment of a human patient with CroFab between January 1, 2002 and December 31, 2004
* The record must contain all of the following:

  1. Clinical signs/symptoms prior to the first dose of antivenom,
  2. Documentation of all doses of antivenom used to treat the patient,
  3. Indication of whether or not initial control was achieved with antivenom.

To be included in the Efficacy Evaluable Population (EEP) in the current analysis, each record must meet the following criteria:

* Must contain enough information to calculate a severity score based on the 7-point severity scale.
* All records were included in the Safety Population in the current analysis.

Exclusion Criteria:

* Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.
Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T MRI Study

The present study is an opportunity to assess grey matter damage at the earliest phase of Multiple Sclerosis (MS) allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. Thirty MS patients without time and spatial dissemination criteria (only one symptomatic MRI lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal MRI study at 7T to assess grey matter injury. Clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. A longitudinal clinical and MRI follow up will be performed during 2 years.

The present study is an opportunity to assess grey matter damage at the earliest phase of MS allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. Thirty MS patients without time and spatial dissemination criteria (only one symptomatic MRI lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal MRI study at 7T to assess grey matter injury. Clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. A longitudinal clinical and MRI follow up will be performed during 2 years.

Eligibility Criteria:
Inclusion Criteria:

* First presumed inflammatory demyelinating event in the central nervous system involving either the optic nerve, the spinal cord, a brain hemisphere, or the brainstem without spatial and time dissemination criteria
* Oligoclonal bands on CSF analysis
* Age between 18 and 45
* No previous history of neurological symptoms suggestive of demyelination
* No steroids in the month before MRI
* First MRI within six months after the first clinical episode

Exclusion Criteria:

* Possible alternative diagnoses
* Previous history of neurological or psychiatric disease
* Previous administration of immunosuppressive drugs
* Pregnancy
* Patient unable to give his consent for the study or patient under tutorship
Time-based Register and Analysis of COPD Endpoints

The Time-based Register and Analysis of COPD Endpoints (TRACE) study is prospective cohort study aiming at evaluating COPD patients using simple basic tools normally used in the clinic at hand of any physician. The objective of the study is to accomplish specific aims. 1) describing the disease variation over time. 2) defining different disease behaviours; and 3) evaluating the impact of different therapeutic approaches on this behaviour in the different patient types. TRACE is a single center non-interventional prospective observational cohort study of COPD patients. Upon identification of cases, patients are followed-up in yearly visits sine die until death or lost to follow-up. Starting in 2012, during the yearly visits clinical, functional, radiological and analytical information is recorded via a standardized questionnaire. Variables recorded were: socio-demographics, tobacco history, comorbidities, clinical presentation during the previous year, exacerbations and hospitalization in the previous year, current pharmacological and non-pharmacological treatments, and complementary tests, including at least chest radiology, pre- and post-bronchodilator spirometry, and analytical results. Endpoints include a variety of clinically relevant variables including disease phenotypic expression, diagnostic measures and therapeutic responses.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Diagnosed of COPD, according to the current recommendations
* Evaluated in our COPD outpatient clinic in 2012 or the following years
* With three years of follow-up at least

Exclusion Criteria:

* Do not sign informed consent.
* With other relevant comorbidity that conditions their respiratory care