cyrilzakka/clinical-trials huggingface dataset:
Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients

Heart transplantation is a life-sustaining therapy that allows patients with either congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time, however, the transplanted heart can develop problems. One of the more common and troubling problems is the development of stenoses, or narrowings, within the coronary arteries. These narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account for the single most common cause of death or need for repeat heart transplant in persons more than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac catheterization using coronary angiography (where dye is directly injected into the coronary blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good treatment for CAV aside from treatment of symptoms and listing for repeat heart transplantation. The goal of this study is to test several newer methods of diagnosing CAV. The first is called coronary flow reserve (catheterization test). The second is called Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI test, only for patients 12 and older). The older method (coronary angiography) will still be used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose patients with CAV earlier in the course, prior to a patient's development of abnormal angiograms. If this can be done, it is possible that better therapies will be able to be used to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the need for repeat heart transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 1 - 25 years who are status-post OHT (≤18 years at the time of transplantation) and undergoing routine post-transplant surveillance catheterization for endomyocardial biopsy and coronary angiography

Exclusion Criteria:

* The presence of sick sinus syndrome or 2nd or 3rd degree atrioventricular block (without a functioning implanted pacemaker)
* Hemodynamically significant valvular disease
* Severe asthma or bronchospasm, known severe CAV
* Pulmonary hypertension.
* Patients taking digoxin
* Verapamil and dipyridamole are also excluded given known interactions with adenosine.
Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.

If participants agree to be in this study, the investigators will ask the participants to do the following things:

At Initial enrollment for both longterm ketogenic diet and new modified Atkins diet participants

* Review of calendars (showing seizures) and 3-day food record
* Check height and weight, blood pressure, skin-fold thickness and waist circumference
* Standard modified Atkins diet clinic labs will be drawn as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
* Participant will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of enrollment or within 1 month of enrollment

At follow-up clinic visits (month 3 and month 6) for new modified Atkins diet participants

* Review of calendars and food records
* Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
* Check height and weight, blood pressure, skin-fold thickness and waist circumference

At follow-up clinic visits (month 12 and month 24) for new modified Atkins diet participants

* Review of calendars and food records
* Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
* Check height and weight, blood pressure, skin-fold thickness and waist circumference
* Participants will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of follow-up or within 1 month of follow-up

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Body mass index (BMI) \> 18.5
* Stable antiepileptic drug regimen for \> 1 month.

Exclusion Criteria:

* \< 18 years of age
* Body mass index (BMI) \< 18.5
* Changes in antiepileptic drug regimen \< 1 month prior to participation
* Previous cardiovascular event or treatment ((including myocardial infarction, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI))
* Acute pancreatitis
* Unwilling to restrict carbohydrates
* Kidney disease
* Contraindicated metabolic or mitochondrial disorder
Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo each year for three consecutive years. They will be followed over six months for a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. Rigorous demonstration of influenza vaccine leading to a reduction in major adverse vascular events in patients with heart failure would lead to a major change in how these patients are managed. Given the large burden of disease both in Canada and globally, the possibility to reduce cardiovascular and stroke related death is a compelling reason to conduct this trial.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and NYHA (New York Heart Association) functional class II, III and IV

Exclusion Criteria:

* Anaphylactic reaction to a previous dose of TIV(trivalent influenza vaccine)
* Known IgE( Immunoglobulin E)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
* Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
* Anaphylactic reaction to neomycin
* Patients who have had influenza vaccine in two of the three previous years
Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract

In this study, the investigators are studying new ways to look for abnormal tissues of the gastrointestinal tract during an endoscopy. We are using a VEGF-A targeting fluorescent probe and a NIR-II fluorescent endoscope to help detect abnormal tissues that are hard to see by the naked eye.

The main purposes of this study include:

1. To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal.
2. To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope.
3. To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected gastrointestinal lesions.
* Scheduled for a clinically-indicated endoscopy.
* Mentally competent person, 18 years or older.
* Approved to sign the informed consent.
* Adequate potential for follow-up.

Exclusion Criteria:

* Subjects with known allergy or negative reaction to ICG or derivatives.
* Undesirable function of heart, lung, kidney, or any other organs.
* Enrolled in other trials in the past 3 months.
* Pregnant or trying to conceive.
* Unable to tolerate an endoscopy.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* The researchers considered inappropriate to be included.
Stella Supera Siberia

Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criterias, the possible influence of calcifications and the quality of life of patients

Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.

Patient can be included up to the next day of the intervention.

Endovascular treatment of femoropopliteal lesion with SuperA stents :

Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.

The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.

A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure.

If needed, endovascular treatment could be realized on the inflow or outflow in the same time.

Patient follow-up :

Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).

The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.

All clinical surveillance events, complications and re-hospitalizations will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic PAD, Rutherford 2 to 6
* Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
* De novo femoropopliteal lesion
* Patient informed of the study and oral authorization collected

Exclusion Criteria:

* Under-age patient
* Patient of age, but under legal guardianship or care
* Potentially pregnant women
* Patients do not understand the French language
* Asymptomatic lesion
* Acute ischemia or acute thrombosis
* Lesion already treated
* No-atherosclerotic disease
* hemostasis disorder
* severe comorbidity with life expectancy less than 2 years
* contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
* patient participating in a clinical trial likely to interfer
* Comorbidity or other, according investigator, that may interfere with the conduct of the study
* lesion near to an aneurysm
* Patient follow-up impossible
* Patient refuse to participate
Pilot Study: VR Mind and VR Mind+ Intervention

The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be:

* the length of the laboratory session utilizing virtual reality exposure (feasibility),
* the ergonomics and ease of use for both patients and system operators (usability),
* the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety).

The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.

In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The pilot investigators will be tested for the feasibility, usability and safety of the system in order to obtain information useful in further designs for the clinical trial. The research consists of four laboratory sessions. The first and the last session will be dedicated to participant assessment. During the second and third session the virtual reality scenarios (2 x 10 minutes for each session) will be presented to participants. The participants will be playing a role of someone who is giving a speech (Public speaking scenario) and someone who is speaking on a phone in public (Telephoning in public scenario).

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-50 y.o.
2. Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
3. Signing informed consent

Exclusion Criteria:

1. Occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
2. Occurrence and/or recognition:

   1. psychosis,
   2. bipolar disorder,
   3. mental retardation
3. Exclusion based on interview:

   1. pregnancy,
   2. drug addiction,
   3. alcohol addiction,
   4. participating in the experimental session while intoxicated
   5. (current) neurological treatment of chronic disease of central nervous system,
   6. epilepsy,
   7. paroxysmal vertigo,
   8. presence of suicidal thoughts , tendencies or attempts,
   9. participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery

The collection of data regarding patient outcomes after surgical intervention creates imperative knowledge to include surgeon performance, cost analysis, base for surgical research and publication, which in turn assist surgeons to improve the standard of care utilizing evidence-based practice.

The concept of disease management stems from a logical evolution in the field of outcomes applications by healthcare provides is the concept of disease management. The basic premise of disease management is that there is a more optimal way to manage patients in order to reduce costs and improve health outcomes. The data collected from patient-reported outcomes allows the physician and staff to screen for specific health conditions, monitor patients individually, evaluate outcomes for specific groups, assess quality of care, determine impact of intervention and predict outcomes. Most of the follow-up results from this study will be obtained directly from the patient during follow-up visits, but other information may be obtained from medical records.

Evaluation of the surgical database Application will identify both patient and procedural variables that can predict adverse outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are Hepatopancreatico Biliary surgical patients.

Exclusion Criteria:

* Patients that are not Hepatopancreatico Biliary surgical patients.
Drug Cocktail Interaction Study of St. John's Wort Dry Extract Ze 117

This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.

Current data indicate that St. John's wort preparations may induce hepatic cytochrome P450 enzymes and transport proteins. This can result in drug interactions.

The study design is standard for DDI studies and is based on the regulatory guidance of the Food and Drug Administration (FDA) and of the European Medicines Agency (EMA).

A cocktail approach involving the administration of multiple cytochrome P450 (CYP)- or P-glycoprotein (P-gp)-specific probe drugs is used to simultaneously assess the activities of these enzymes and the transporter P-gp.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* Caucasian male or female subjects aged between ≥18 and ≤55years
* Physically and mentally healthy
* BMI between ≥19 and ≤29 kg/m2, and body weight ≤90 kg
* Non-smoker
* If female, the pregnancy test at screening and at admission must be negative

Exclusion Criteria:

* Known or suspected hypersensitivity to study drugs
* history of, any clinically significant diseases
* Positive test of hepatitis B, hepatitis C or HIV Screening
* Known photohypersensitivity
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age more than 18 years old (age of legal consent).
* Gestational age between 12-26 weeks.
* Hb level \> 10 g/dL.
* BMI between 25 kg/m2 and 35 kg/m2.
* Missed abortion.
* Living fetus with multiple congenital malformations incompatible with life.
* PPROMS with drained liquor and parents are consenting for termination of pregnancy.

Exclusion Criteria:

* Maternal age less than 18 years old.
* Gestational age less than 12 weeks or more than 26 weeks.
* Hb level \< 10 g/dL.
* Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus).
* Polyhydramnios.
* Anencephaly.
* Fibroid uterus.
* BMI less than 25 kg/m2 and more than 35 kg/m2.
* Coagulopathy.
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or estradiol.
* Placenta previa.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Development of a Constipation Risk Assessment Scale for Hospitalized Patients.

Develop a risk assessment scale for constipation of hospitalized patients to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.

Constipation remains a prominent problem in the hospital care setting given the accumulation of contributing factors. Indeed, one of the most common causes of constipation is the existence of irregular habits in stool schedules, including the fact of delaying the time to go to the toilet, which causes the subject for a prolonged period of time to inhibit symptoms. defecation reflexes.

These disorders are often increased by the lack of exercise and prolonged bed rest, which cause a lack of muscle of the abdominal strap, the abdominals not being able to play their role of compression.

Some drugs are also a major cause of the difficulty of intestinal elimination, including opiates, anticholinergics, anti-depressants, etc.

Finally, an unbalanced diet, a water deficiency are aggravating factors, as is anxiety. In the medical and para-medical literature, there is no complete and validated tool for assessing the risk of constipation at the admission of a hospital stay. This project is to develop a constipation risk assessment scale, which can be used autonomously by nurses, based on the risk factors identified in the literature, scales published in English, and 2007 recommendations from the French National Society of Gastroenterology, recommendations of the High Authority of Health and a consensus of experts. The use of such a tool would make it possible to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older
* Swallowing, drinking and eating
* Hospitalized in one of the participating services
* Hospitalized for a period of at least 4 days
* Able to give informed consent and answer questions about his or her lifestyle

Exclusion Criteria:

* Patient with major constipation at baseline (no stool for at least 6 days)
* History of intestinal surgery during the 10 days preceding the study,
* Hospitalized in palliative care or bed identified palliative care.
A Study of the Interruption on the Mother-to-child Transmission of Hepatitis B Virus （HBV MTCT）in Newborns at High Risk

Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine immediately after birth is the most important method of blocking mother-to-child transmission of HBV. However, regular doses of HBIG combined with hepatitis b vaccine blocking measures still have a failure rate as high as 5% \~ 15%.There are numerous studies to explore pregnancy women with HBV positive, especially high viral load of those women during pregnancy being treated with nucleoside analogs to increase the blocking rate of HBV MTCT, but there is still a failure rate of 2.2% to 18%. In this study, we will explore the efficiency of personalized blocking method of HBV maternal-neonatal transmission in high-risk newborns,according to the venous blood HBsAg state of neonatus at birth.

In this trial, the study population were consisted of patients suffering from chronic hepatitis B who had achieved HBeAg positive and HBV DNA \> 106 copies/ml and their newborns who were born with HBsAg positive. Before injecting hepatitis b vaccine and HBIG for newborns, we tested their vein blood HBsAg levels, and the venous blood HBsAg positive newborns were randomly divided into the control group and the interventional group in which group we injected the additional 200 IU HBIG within 24 hours after birth, in addition to routine injection. We gathered the neonatal venous blood of 0, 7 and 30 days to test the level of anti HBs, HBsAg and HBV DNA., then detected the level of anti HBs, HBsAg and HBV DNA when these children were seven months.According to the venous blood HBsAg state of neonatus at birth, exploring the efficiency of personalized blocking method of HBV MTCT in high-risk newborns.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml
* At birth the neonatal venous blood HBsAg positive

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
* without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.