cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans

For this project, 4 groups of 38 infants have been created so as to evaluate the impact of Assisted-Reproduction Technology (ART) and more particularly the two procedures classically used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of culture in appropriate in vitro conditions to allow development of the embryo) in contrast with shorter culture of only two days.

Participation consists in accepting samples to be taken at the birth of the infant:

1. from the umbilical cord.
2. from the placenta.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written informed consent,
* Patients with national health insurance cover,
* Maternal age at conception between 20 and 43 years,
* Paternal age at conception between 18 and 50 years,
* Singleton pregnancy

Exclusion Criteria:

---Maternal disease:

* pulmonary, cardiac
* renal and metabolic diseases (including type 1 and 2 diabetes prior to the pregnancy)
* systemic inflammatory diseases
* hypertension
* neurological diseases
* chronic hepatitis B or C
* HIV infection
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation


Eligibility Criteria:
Inclusion Criteria:

* stable dose of opioids for at least 12 weeks before screening visit
* less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
* willing to stop laxatives and other bowel treatments; rescue laxative allowed

Exclusion Criteria:

* Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
* Have participated in another clinical trial of an investigational drug 30 days prior to screening
* History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
* History of chronic constipation prior to opioid therapy
* Females who are pregnant or breast feeding
* Have any condition that may affect drug absorption (e.g. previous GI surgery)
Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal

The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization
* ≥18 years of age
* Ability and willingness to provide written informed consent and HIPAA authorization

Exclusion Criteria:

* Chronic Atrial Fibrillation
* Heart Failure decompensation event within two weeks of enrollment
* Hypertrophic Obstructive Cardiomyopathy
* Patient currently enrolled in another ongoing clinical trial
* Pregnancy
* Less than 18 years of age
* Inability or unwillingness to provide written informed consent and HIPAA authorization
Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI \<30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. Previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of Functional Supplement.


Eligibility Criteria:
Inclusion Criteria:

* Men and women from 45 to 75 years old;
* Signed informed consent

Exclusion Criteria:

* Individuals with cardiovascular risk factors on drug treatment (dyslipidemia, hypertension, Diabetes Mellitus);
* Individuals with Metabolic Syndrome;
* Individuals with familiar background of premature cardiovascular disease;
* Individuals with BMI ≥ 30 kg/m2;
* Women that still maintain your menstrual cycle;
* Individuals with increased alcohol consumption 30g/day;
* Individuals that stop smoking in the next 20 weeks (during the study);
* Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics;
* Women that consume oral contraceptive;
* Individuals with mental disease or low cognitive function;
* Individuals with severe diseases (hepatic, kidney, cancer...);
* Individuals with drugs or supplements consumption to weight lost;
* Pregnant women or lactating;
* Individuals with intensive physical activity;
* Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.
Cconsumer Perspective and Understanding of the Term "Milk"

The objectives of this study are:

1. To determine the consumption behaviors of dairy and non-dairy milks across a diverse demographic.
2. To determine the purchasing behaviors of dairy and non-dairy milks across a diverse demographic.
3. To determine the variation in medical history and health conditions amongst consumers of dairy milk and non-dairy milk alternatives.
4. To assess the general knowledge and awareness of health associated with dairy milk and non-dairy milk alternatives.

This study is an observational, cross-sectional trial design focused on obtaining information about consumer understanding and perception of the term "milk" and how they affect consumer choice.

A planned sample size of 50 will be enrolled into the study. This study will require one initial screening visit and 1 Study Day. This study will take approximately 2 to 2 ½ hours per subject to complete.

The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, and completion of an eating habits questionnaire.

If willing and eligible to participate, subjects will be invited to participate in the study for 1 Study Day that participants can choose to continue on to after the Screening visit.

Subject will arrive at the center in fasted for at least 2 hours or longer. During the Study Day, each participant will be asked to participate in two activities. In the first activity, participants will be presented with eight differently-labeled milk cartons, each accompanied by a fixed price label, and asked to answer questions regarding consumption. In the second activity, participants will be presented with the same setup from the first activity, however, the price labels for each product is varied according to real market prices for each product. In this activity, participants will be asked to answer questions regarding purchasing. Following these two activities, participants will then be asked to answer a questionnaire on consumer choice for dairy and non-dairy milk.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent and comply with procedures

Exclusion Criteria:

* Under 18 years old
Clinical Comparison of Bulk-fill and Incremental Composite

The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin \[Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)\] and an incremental posterior composite resin \[Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility Criteria:
Inclusion Criteria:

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria:

* poor gingival health
* adverse medical history
* potential behavioral problems
A-line/CareTaker Comparison Study in ICU Patients

Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and Intra-Arterial Catheters in ICU Patients

The object of the work presented here was to validate a new approach to tracking blood pressure that is based on the pulse analysis of the peripheral arterial pressure pulse. The approach, referred to as the Pulse Decomposition Analysis (PDA) model, goes beyond traditional pulse analysis by invoking a physical model that comprehensively links the components of the peripheral pressure pulse envelope with two reflection sites in the central arteries.

In these experiments, approved by the University of Virginia Institutional Review Board, the arterial blood pressures of patients (23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height: 173.3 cm, SD: 9.4 cm, mean weight: 95.3 kg, SD: 27.4 kg) hospitalized in University of Virginia Medical Intensive Care Units (MICUs) were monitored using radial intra-arterial catheters, while the CareTaker system collected pulse line shapes at the lower phalange of the thumb of the ipsilateral hand.

Systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements and a Bland-Altman analysis was created. Results were within the limits established for the validation of automatic arterial pressure monitoring (AAMI/ANSI/ISO 81060-1:2013).

Eligibility Criteria:
Inclusion Criteria:

* male or female age 18 to 45
* presence of a radial arterial catheter
* informed consent by subject or surrogate
* available digital pulse

Exclusion Criteria:

* failure to meet all of the inclusion criteria
Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons. It is often associated with resistance to the actions of insulin hormone. Fat cells secrete a hormone called leptin. Recently, we have learned that obese or overweight persons make too much leptin, which may contribute to insulin resistance. Paradoxically, patients who do not have any fat cells, also have insulin resistance. In these patients, insulin resistance is caused by the absence of leptin and leptin replacement significantly improves insulin resistance and fat deposition in the liver. In an earlier study, we determined the leptin levels in patients with NASH and how these levels are related to body fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH have relatively low levels of leptin in contrast to the amount of body fat they had. We now would like to see if restoring leptin levels to normal will improve the disease process in these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive), who do not have any other cause for their liver disease. We have put some restrictions in body size such that a spectrum of patients from normal weight to obese range would be included. They will also demonstrate low leptin levels (levels similar to only 25% of normal population). We will use a genetically engineered form of leptin manufactured by Amylin Inc. given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters and body composition characteristics that we examined in our earlier study. We expect that patients with low blood leptin levels will show improvement in their liver disease and insulin resistance when their blood leptin levels are restored to normal.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven NASH
* Circulating fasting leptin \<9 ng/mL (staggered criteria for different BMI levels)

Exclusion Criteria:

* Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal prothrombin time or albumin)
* Presence of clinical lipodystrophy
* Presence of other liver disease
* Presence of clinical diabetes (fasting \>126 mg/dL or 2 hour post 75 g-glucose \>200 mg/dL or random glucose \>200 mg/dL with presence of diabetes symptoms or known history of diabetes)
* Any medication for treatment of NASH or obesity
* Presence of HIV
* Inability to give informed consent
* Presence of end-stage renal disease, any type of active cancer, or \>class 2 congestive heart failure ((New York Heart Association Functional Classification System), based on medical history and physical examination
* Presence of any other condition that limits life expectancy to \<2 years
* Active infection (may be transient)
* Any other condition in the opinion of the investigators that may impede successful data collection
Development and Prevention of Severe Heart Disease in Systemic Sclerosis

Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac blocks and ventricular arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based level. Short-term trials and retrospective studies have suggested a favourable and protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients with myocardial involvement. However, no data are presently available on the prevention and treatment of severe heart disease.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to assess the efficacy and safety of calcium channel blockers and angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac involvement.


Eligibility Criteria:
Inclusion Criteria:

* Juvenile and adult systemic sclerosis patients, with diagnosis according to the SSc ACR/EULAR criteria or the PRES/ACR/EULAR juvenile SSc criteria respectively
* Asymptomatic (for cardiac disease) systemic sclerosis patients at risk for severe heart disease with at least one of the following risk factors: male sex and/or DLCO lower than 80% and/or sPAP \> 30 mmHg and/or synovitis and/or joint contractures and/or digital ulcers and/or proteinuria.

Asymptomatic for cardiac disease is defined by patients without dyspnea NYHA \>/= II, without palpitations and without bilateral leg edema.

Exclusion Criteria:

* Any significant pulmonary parenchymal (FVC \< 70% and/or DLCO \< 70%), pulmonary vascular (estimated systolic PAP \> 40 mmHg), gastrointestinal (malabsorption syndrome or paralytic ileus) or renal (serum creatinine level \>1.2 mg/dl, dialysis or previous scleroderma renal crisis) involvement
* Patients with dyspnea class NYHA \>/= II
* Patients with palpitations
* Patients with bilateral leg edema.
Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery

At Zealand University Hospital, Denmark, the investigators will examine the immune function of patients with colorectal cancer before and after tumor resection.

The immune function will be assessed with functional profiling of the immune function (TruCulture®)

The study aims to describe alterations in the perioperative immune response to surgery. The generatied knowledge will lead to better under standing of perioperative pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laparoscopic resection of colorectal cancer with curative intent

Exclusion Criteria:

* Age under 18
* Neoadjuvant chemo or radiation therapy
Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among rheumatic and/or ischemic mitral lesions?.

Mitral valve replacement with preservation of leaflets, and added coronary artery-bypass surgery, when indicated, is it a feasible and reproducible procedure?.

The study was designed to compare outcome after prosthetic mitral replacement with preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical assessment. and echo-cardiograph.

Objectives: The aim is to compare outcome of modified preservation of mitral valve apparatus during prosthetic mitral replacement for rheumatic versus myocardial ischemia \&mitral valve disease.

Methods ;This prospective cross-sectional comparative study will include 50 patients with isolated rheumatic mitral valve disease (group A) and 50 patients with mitral disease and myocardial ischemia (group B), surgery is expected to be performed between 2017 and 2020 at one center. All patients will have modified preservation of mitral apparatus during prosthetic mitral replacement. Additionally, group B patients will have bypass grafts to left anterior descending and/or posterior descending / right coronary artery. Data will be collected and analyzed.

The Institutional Review Board (IRB), Ethics Committee (EC)-approval and consent of each patient were obtained.

Criteria for inclusion of patients and exclusion of others were determined according to the guide lines.

Statistical analysis::

Qualitative variables and their association among both groups were studied by applying Chi-square test and Fisher Exact test. Quantitative variables among both groups were compared by applying independent samples t-test. P \< 0.05 values mean statistically-significant results.

Eligibility Criteria:
Inclusion Criteria::

Mitral stenosis (MS)

* symptoms are severely limiting and cannot be managed with diuresis and heart rate control.

Mitral regurgitation(MR):

\* acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .

Chronic primary mitral regurgitation:

\* rheumatic heart disease: replacement before irreversible changes occur can be curative.

Mixed Mitral Stenosis and Mitral Regurgitation:

* If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.
* Myocardial ischemia associating or complicated with miral valve disease.

Exclusion criteria

* Patients showing good response to medical therapy, and Cases complicated by:
* ineffective endocarditis,
* previous myocardial re-vascularization
* ischemic ventricular septal defect,
* left ventricular aneurysm,
* Ruptured papillary muscles of mitral apparatus.
A Comprehensive Look at Vascular Access

The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.


Eligibility Criteria:
Inclusion Criteria:

* Requires peripheral venous access
* Intact skin on areas of assessment
* Patient and/or parent or legal guardian is able to understand consent

Exclusion Criteria:

* No Intact skin
* Patient is under anesthesia during peripheral venous access
* Patient is not a suitable candidate, as determined by the discretion of the investigator
Pain Neurophysiology Education for Sport Therapy Students

The effect of a 70 minute Pain Neurophysiology Education session on Sport Therapy Students Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain

This single-blind, randomised control trial aims to investigate the effect of a brief 70 minute Pain Neurophysiology Education session on sport therapy students knowledge, attitudes and clinical behaviour towards athletes with chronic pain. Participants will be selected from first year undergraduate and postgraduate sport therapy cohorts. Random number generator will assign participants into two subgroups. Group 1 will receive a control education on clinical 'red flags'. Red flags are questions that are routinely asked by therapists in clinical practice to screen for sinister pathology. Group 2 will receive education called 'Pain Neurophysiology Education' (taken from the Explain Pain publication). This mode of education uses the neurophysiology of pain to explain the experience, and has been used as an educational tool for patient, healthcare practitioners and students alike. Data collection (completion of three questionnaires) will take place immediately prior, and immediately after each education session.

The change in these outcomes pre and post intervention will subsequently be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* 1st year undergraduate sport therapy students
* 1st year postgraduate, pre-registration sport therapy students
* Enrolled at Teesside University, UK.

Exclusion Criteria:

* Previous detailed pain education on either PNE or Red Flags.
Surgeon-Anesthesiologist Collaboration

Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent surgical procedure for pheochromocytoma in 8 French university hospitals from January 2000 to December 2016

Exclusion Criteria:

* Age \< 18 years old
* Patients operated for incidentaloma or with paraganglioma diagnosis
Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa.

Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker


Eligibility Criteria:
Inclusion Criteria:

* patients who will have biopsy or surgery for PEComa or vascular pediatric tumor (RICH, NICH, hemangioma or pyogenic granuloma)
* A free, informed and written consent will be established

Exclusion Criteria:

* none