cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects

Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.

Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress.

The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged from 18 to 50 years
* Men and women
* With national health insurance cover
* With a Body Mass Index between 18.5 and 27.9
* Who have given their written informed consent to take part in the study.

Exclusion Criteria:

* Subjects unable to understand the nature and aims of the study and/or those who have difficulty communicating with the investigator.
* Adults under ward of court.
* Those in custody following a decision of the court or the administration.
* Subjects with a risk of a major change in their diet during the trial.
* Those who drink more than 5 cups of tea or coffee a day.
* Those who consumed more than 25 grammes of alcohol a day, every day of the year preceding the inclusion visit.
* Those who present a history of or current use of psycho-active substances (drugs such as cocain, morphine, heroin...).
* Subjects currently in a period of exclusion relative to another research protocol or for whom the annual cummulation of payments for participation in biomedical research has reached the annual ceiling.
* Presence of any treated chronic disease, and any acute disease within the 4 weeks preceding the inclusion and randomisation visit.
* Persons with diabetes treated with insulin or oral antidiabetics.
* Subjects on lipid-lowering therapy and/or on antioxidants (such as vitamin E, vitamin C, selenium, ß-carotene, Zinc) in the month preceding inclusion.
* Subjects taking multivitamin supplements in the month preceding inclusion.
* Pregnant or breast-feeding women
Effect of Hydroxycitrate on Urine Chemistry

Hydroxycitrate (HCA) is a compound extracted from the fruit, Garcinia Cambogia. Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. There has been recent evidence that hydroxycitrate is a potent inhibitor of calcium oxalate crystal growth and can lead to the dissolution of the crystals. The purpose of this research study is to study the effect of Hydroxycitrate (HCA) supplements on HCA urinary excretion and on urine chemistries in kidney stone formers and normal subjects.


Eligibility Criteria:
Inclusion Criteria:

Stone formers group:

* Established diagnosis of recurrent calcium stone formers
* Ages between 18 and 80
* Subjects must be able to read and follow instructions clearly and able to do 24 hour urine collections.
* Subjects must be voluntarily willing and able to sign an informed consent form.

Control Group:

* In addition to b, c and d above, subjects must not have any known kidney disease or family history of renal stones. Inclusion would be based on information provided by participants.

Exclusion Criteria:

-
Evaluating an Online Wellness Intervention for Greek Adolescents

The investigators are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, the investigators are conducting a randomized controlled trial with Greek adolescents attending high school in the Attica region in Greece. Students will be randomized to the COMET condition or to an active control condition.

Primary outcome measures (depressive symptoms, anxiety symptoms, subjective well-being) will be measured at two weeks post-intervention and four weeks post-intervention.

The investigators will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).


Eligibility Criteria:
Inclusion Criteria:

* Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.
Acute Withdrawal From Smoked Cocaine - 9

The purpose of this study is to develop an experimental paradigm to examine acute withdrawal symptoms from cocaine.

Although there are clearly identifiable withdrawal syndromes following cessation of a number of abused drugs such as alcohol and heroin, it is unclear whether a withdrawal syndrome follows the cessation of crack cocaine. A laboratory model of withdrawal from smoked (crack) cocaine would provide a safe and systematic method of testing the efficacy of behavioral or pharmacological treatments for withdrawal symptoms following cocaine smoking cessation. Therefore, this study investigated acute behavioral, subjective, and physiological withdrawal symptomatology for 6 hrs following 7 deliveries of 2 dose sized (0.07 vs. 0.4 mg/kg) of smoked cocaine. The behavioral measure was performance on a computerized reaction time task, subjective measures included participant and observer ratings of mood and withdrawal symptomatology, and physiological measures comprised heart rate and blood pressure. It was hypothesized that signs and symptoms of withdrawal from smoked cocaine would be greater following the 0.4 mg/kg dose size, compared to the 0.07 mg/kg dose size.

Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-45 with a history of smoked cocaine use at least twice a week for the past six months, including 0.5 g of cocaine in a 24hr period on at least one occasion. In good health as evidenced by physical exam and complete blood count, chest X-ray and electrolyte and liver function tests, with a normal resting 12-lead electrocardiograph (ECG) and blood pressure of less than 140/90 mmHg. Using an acceptable method of birth control. Having a urine toxicology screen positive for cocaine metabolites.

Exclusion Criteria:

Any DSM-IV Axis I disorder other than cocaine abuse or dependence, or dependence or daily use of psychoactive drugs other than nicotine or caffeine. A history of violence and/or currently on probation, parole or awaiting trial. Pregnant as determined by serum pregnancy screen, lactating or having delivered a child in the past 12 months. Seropositive tests for the human immunodeficiency virus (HIV) or hepatitis B. History of seizure disorder.
Functional Assessment Screening Tablets - Patient Reported Measures

The team's ultimate goal is to improve health care quality and effectiveness and support patient-centered care. In this project, we, the investigators, will test whether providing patients with guideline based-recommendations regarding tobacco use, physical activity and mental and physical health-related quality of life (patient reported measures: PRMs) using health information technology increases doctor-patient discussions regarding these topics and results in improvements in PRMs. We will randomize physicians in a single general internal medicine practice. Patients seeing intervention physicians will receive guideline-based recommendations regarding PRMs, those seeing control physicians will not. We will compare differences in doctor-patient discussions regarding PRMs between the intervention and control groups. The successful completion of this project will provide evidence the effectiveness of involving patients in their care through the use guideline-based feedback.


Eligibility Criteria:
Inclusion Criteria:

* physicians who see patients in the University of Pittsburgh General Internal Medicine Practice.
* patients of physician's who have consented to participate.

Exclusion Criteria:

* age less than 18.
Use of Continence Care Protocol in UK Nursing Homes.

This is a retrospective cohort study. In the investigation the clinical use of the Skin and leakage protocol (SLEP) is to be investigated. The SLEP is a generic digital diary form filled out to give information about the current status of continence care among care home residents. The SLEP tracks the number of leakage occurrences and daily skin health over a period of time with the purpose of assisting care staff in making decisions regarding continence care. The SLEP has been introduced at several United kingdom National Health Service care homes and with this investigation the investigators want to retrospectively analyse the data to determine the clinical usefulness of the form.

The primary objective of the study is to describe any changes in product leakage rate at the baseline and follow up time period.


Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with urinary incontinence managed with an absorbing incontinence product.
* The skin and leakage protocol have been used in the care of the subject and there is data from at least two measurements.
* Subject is cared for in a Residential care home using the skin and leakage protocol.
* Subject is over 18 years of age.

Exclusion Criteria:

* Subject is not using an absorbing incontinence product to manage incontinence.
The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.

This study is a placebo-controlled, randomized, double blind, clinical trial to investigate the safety, tolerability and efficacy of the psychedelic dimethyltryptamine (DMT), in addition to a short course of psychotherapy, on Alcohol Use Disorder (AUD). The investigators hypothesize that relative to control (0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion plus psychotherapy), a single psychedelic dose of DMT (plus psychotherapy) in individuals with AUD will 1) be safe and 2) well-tolerated, and 3) reduce alcohol consumption measured in the laboratory the day after, and over the following 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
* Medically healthy
* Ability to provide consent

Exclusion Criteria:

* Unstable medical conditions
Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score

PROBIC

Rationale: Procalcitonin measurements can reduce the number of blood cultures in the ICU.

Objective: The investigators suggest that PCT is a marker for blood stream infection in all patients in the ICU in whom attending physicians/ intensivists order blood culturing in the suspicion of microbial infection. The investigators want to demonstrate that its use for guiding blood culturing is cost-effective and safe compared with blood cultures alone.

Study design: Prospective, non- inferiority, multicenter, single-blinded, cluster- randomised cross-over clinical trial.

Intervention (if applicable): The intensive care units will be allocated into two groups: a control group (blood culture) and the intervention group (procalcitonin).

Main study parameters/endpoints: Safety, expressed as mortality at day 28 and 90, with a mortality difference not exceeding a between groups difference of 10% by non-inferiority analysis.

Cost-effectiveness, expressed in euro, calculated by deducting costs of procalcitonin testing from saved blood cultures compared with standard treatment spending on blood cultures in the control group.

ICIS

Rationale: The aim was to evaluate the Intensive Care Infection Score (ICIS) in predicting microbial infection and its sequelae in critically ill patients in whom attending physicians/ intensivists order blood culturing in the suspicion of microbial infection.

Objective: Because of the complexity of the pathophysiology of systemic inflammation it is unlikely that a single parameter will have sufficient diagnostic accuracy for infection. Therefore we will study combining parameters producing a diagnostic score.

Study design: Prospective, multicenter, cohort trial. Supplement for the control arm of the ProBIC study.

Intervention (if applicable): Blood is drawn for daily routine laboratory measurements and collected in K3EDTA aliqnots. The ICIS score is composed of five blood-cell derived parameters which can be extracted using the same aliqnots.

Main study parameters/endpoints: To develop and evaluate a blood- cell derived score to enable the diagnosis of microbial infection, its likelihood, its invasiveness and severity.


Eligibility Criteria:
Inclusion Criteria:

* Patients will need to be over the age of 18 and suffering from an assumed infection deemed clinically worthy for blood culturing.

Exclusion Criteria:

* Uncontrolled malignancy
* Immunosuppressive or immunostimulatory therapy
* Neutropenia, defined as leukocyte count less then 0.5x109/L
* Moribund patients
* Predetermined illness with an expected death within 24 hours
A Study of ALKS 3831 in Adults With Schizophrenia

This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years, inclusive
* Body mass index (BMI) of 17-30 kg/m2, inclusive
* Diagnosis of schizophrenia that is clinically stable

Exclusion Criteria:

* Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting \<2 years
* Current diagnosis of alcohol or drug use disorder, moderate or severe
* Clinically significant or unstable medical illness, condition, or disorder
* Pregnant or breastfeeding
* Significant changes in diet or exercise regimen or plans to join a weight management program during the study
* Opioid medications taken within 14 days and/or need to take opioid medication during the study period
* History of hypersensitivity to or intolerance of olanzapine
* Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year
Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.

The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. A secondary aim is the assessment of the influences of vasopressors and inotropic drugs on Eadyn, as a parameter of ventriculo-arterial coupling.

Assessment of the cardiovascular status and haemodynamics comprise directly or indirectly cardiac output, which is determined by left ventricular preload, contractility, afterload and heart rate. Various haemodynamic monitors have been introduced in anaesthesia and ICU practice, providing cardiac output either non-invasively or invasively. The combined use of arterial pressure monitoring with these devices provides insight not only in cardiac output but offers bedside assessment of most determinants of cardiovascular function. Both pulse pressure variation (PPV) and stroke volume variation (SVV) have been described as dynamic descriptors of fluid responsiveness, a measure allowing optimization of preloading conditions if haemodynamics show signals of insufficient perfusion.

Arterial load can be assessed based on a two-element Windkessel model with a static and dynamic component. The static part consists of a resistive element (systemic vascular resistance: SVR = (MAP/C0)\*80, with MAP, mean arterial pressure; CO, cardiac output) and a pulsatile component (net arterial compliance C = SV/arterial pulse pressure with SV, stroke volume). Arterial elastance is considered being an integrative variable, associating both steady elements and heart rate (Ea = .9\*SAP/SV with EA, arterial elastance; SAP, systolic arterial pressure). The dynamic component Eadyn is the ratio of PPV and SVV during a mechanical ventilator cycle, providing a functional assessment of ventriculo-arterial coupling.

Combined use of arterial pressure tracing (or its non-invasive surrogate) and (non-) invasive stroke volume actually may provide an interesting framework for haemodynamic monitoring and subsequent optimization in many surgical, postoperative or ICU patients. This study aims to copy as good as possible the handling and the way of management as in a clinical setting.

Eligibility Criteria:
Inclusion Criteria:

- ICU patients, treated/supported with noradrenalin or dobutamine.

Exclusion Criteria:

* Septic shock
* Aortic valve regurgitation and defect of septum
* Severe aortic sclerosis, aortic prosthesis
* Severe hypertension (MAP \> 130 mmHg)
* Cardiac arrhythmia
* Tachycardia with a heart rate higher than 150 bpm
* Age below 18 or above 75 y
* Patient height below 120 cm (48") or above 230 cm (90")
* Patient weight less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
* Intra-aortic balloon pump
Paracervical Versus Intracervical Lidocaine

The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.


Eligibility Criteria:
Inclusion Criteria:

* Women presenting for elective first trimester abortion

Exclusion Criteria:

* Gestation over 12 weeks by ultrasound
* Weight less than 98 pounds
* Known allergy to lidocaine
* Known nonviable pregnancy
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
* Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
* Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED

Exclusion Criteria:

* Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
* Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
* Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
* Subject has any medical or psychiatric condition
* Subject has any history of alcohol or drug abuse
* Subject is currently taking felbamate
* Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
* Subject is on a ketogenic diet
* Subject has a known sodium channelopathy
MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study

To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.

This is a randomized, prospective, single-blind study that evaluates the effect of removal of scar tissue during pacemaker/ICD pocket revision on infection and complications. Subjects will be randomly assigned to either removal of the scar tissue surrounding the implanted device during device replacement or to device replacement without removal of this tissue. Subjects will be followed for one year post-procedure for the occurrence of infection, bleeding/hematoma, or other complications.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or greater
2. Willingness to provide written informed consent
3. Subjects presenting for any of the following:

   1. pacemaker/ICD generator change
   2. pacemaker/ICD lead replacement
   3. pacemaker/ICD lead revision
   4. pacemaker/ICD upgrades

Exclusion Criteria:

1. Age less than 18 years
2. Unwillingness to provide written informed consent
3. Subjects unable to give consent
4. Pregnant or nursing women
5. Patients who have undergone pocket revision or manipulation less than 365 days prior
6. Patients who have undergone pacemaker or ICD implantation less than 365 days prior
Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients

Early detection of esophageal intubation, one of the most common complications while performing endotracheal intubation (ETI), is crucial to adequate airway management, especially among patients suspected of difficult intubation (DI). Detective approaches with ventilation require time, increase the risk of emesis and aspiration to patients, and increase the risk of particle aerosolization to health providers under the epidemic of aerosol-borne diseases. Our study will determine the effectiveness of real-time sonography assisted to direct visualization to detect esophageal intubation before ventilation among DI patients.

A single-blind, superiority, randomized controlled study. 224 eligible participants requiring elective orotracheal intubation under general anesthesia with suspected DI will be randomized 1:1 to sonography and direct visualization versus direct visualization alone. The primary objective will be to investigate, in suspected DI patients, if the real-time sonography-assisted with direct visualization results in improved specificity in the detection of inadvertent esophageal intubation before ventilation compared with direct visualization while performing intubation. The secondary objectives will be to compare the sensitivity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), diagnostic odds ratio (DOR), positive predictive value (PPV), negative predictive value (NPV), and detective self-confidence grade using sonography-assisted direct visualization vs direct visualization. Test characteristics will be calculated using standard formulas for a binomial proportion, and the corresponding 95% confidence intervals (CIs), by the Wilson interval method.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 18 years old.
* Requiring elective orotracheal intubation under general anesthesia in the OR.
* Suspected DI according to airway assessments ，and with low risk of difficult ventilation.
* Planning to use a Macintosh laryngoscope blade on the first attempt, whether direct or video laryngoscopy.
* Signed written informed consent.
* Willingness for the primary anesthesia team to participate.

Exclusion Criteria:

* Anterior neck lesions, masses, lacerations, or subcutaneous emphysema.
* A history of neck operation or tracheotomy.
* Allergies to ultrasound coupling gel.