cyrilzakka/clinical-trials huggingface dataset:
The Effect of Varenicline on D2/D3 Receptor Binding in Smokers

This study will evaluate effects of treatment with varenicline, a smoking cessation drug, on the dopaminergic system by using Positron Emission Tomography (PET) imaging with new radioligand, \[11C\]-(+)-PHNO. The investigators primary hypothesis is that chronic varenicline administration will increase dopamine (DA) receptors levels (\[11C\](+)PHNO) within the human brain.

Subjects will undergo a pre-treatment PET and MRI scans for baseline \[11C\](+)PHNO measures on Day 1. Subjects will subsequently be provided an initial 2-week supply of study medications (varenicline) and directions for use. Any adverse events, compliance to medication and smoking patterns will be noted during these two weeks. Varenicline will be used at the same dosage regimen as used for smoking cessation. After subjects go through a post-treatment PET and MRI scans on Day 10, they will be instructed to set up a quit date. There will then be follow-up visits every 2 weeks for the duration of the medication phase (3 months total) and a visit at 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be nicotine dependent, males and females of any ethnic origin between 21 and 45 years old.
* Meet DSM-IV criteria for nicotine dependence,
* Smoke ≥10 cigarettes/day, Baseline FTND score ≥4, CO level ≥10 and are motivated to quit within 30 days of initial intake.
* Treatment seeking smokers that are willing to use varenicline as a treatment approach for their smoking cessation attempt
* No previous use of medication for smoking cessation in previous month prior inclusion.

Exclusion Criteria:

* Pregnancy (a urine pregnancy test will be performed before each PET in women)
* Trying to become pregnant or breastfeeding;
* Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization.
* Presence of metal objects in the body (e.g. some artificial joints, bone pins, surgical clips, skull plate, certain part of dental braces) or implanted electronic devices (e.g. cardiac pacemaker, neurostimulator), that preclude safe MR scanning.
* Claustrophobia.
* Cardiovascular or cerebrovascular diseases.
* Major psychiatric disorders including mood, anxiety or psychotic disorders with historical evidence of suicidal or homicidal behaviour.
* History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor. Gross structural brain abnormalities as revealed by T1 weighted images.
* Current use or use during the previous month of medication that may affect the CNS at the time of scanning (including illicit and non-illicit psychoactive drugs).
* Learning disability, amnesia or other conditions that impede memory and attention.
* Allergy to varenicline.
* Renal insufficiency.
* Use of other smoking cessation aids
Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to be a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV measurement has not been yet validated in thoracic surgery during one-lung ventilation. The modifications of intrathoracic pressure induced by one-lung ventilation may altered the capabilities of PPV to predict fluid responsiveness.This study was designed to assess the ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery.

Methods: a prospective observational study. Thirty five patients undergoing a pulmonary resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid challenges with a 250 milliliters colloid solution in response to hemodynamic instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined as an increase in stroke volume index (SVI)\>10% (measured with oesophageal doppler). PPV will be calculated from recorded artery pressure curve (PPVref) before and after each fluid challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will be recorded simultaneously before and after each fluid challenge.

Statistical analysis: receiver operating characteristic curve will be used to assess the PPV capability to predict fluid responsiveness. Correlation analysis will be achieved using a Pearson test or Spearman's rho test when necessary. Continuous data will compared using a Student t test or a Mann-Whitney test when necessary.

* pulse pressure variation
* preload dependency
* one-lung ventilation
* thoracic surgery

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a thoracic surgery (lobectomy, bilobectomy or pneumonectomy).
* All patients requiring a hemodynamic monitoring (artery catheter, oesophageal doppler).

Exclusion Criteria:

* Arrythmia.
* Pregnant patient.
* Patients less than 18 years old.
* oesophageal or gastric pathologies precluding the use of oesophageal doppler.
* pathologies precluding the use of artery catheter.
Vital Signs Patch Early Feasibility and Usability Study

To assess the feasibility and usability of the VSP System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.

The primary objective of this clinical feasibility study is to evaluate the feasibility of the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for the duration of their hospital stay up to 7 days.

The VSP will take and monitor vital signs in addition to the normal equipment the facility uses to monitor and take vital signs. This study will not be assessing safety and no comparator groups will be used. As this study will not be treating any particular disease or condition, no randomization or blinding is required. Subjects will be chosen as they are admitted in accordance with the general population characteristics, inclusion and exclusion criteria and willingness to sign the Informed Consent.

This clinical study involves a device with no additional drugs administered.

During this study, a single VSP System patch will be worn for up to 48 hours. The first patch will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second patch can remain on the subject for the duration of the subject's hospital stay, or up to seven (7) consecutive days. Individual patient use will determine the duration of time that the second patch can be worn.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female in-patients with vital signs considered 'stable' by clinical caregivers.

Exclusion Criteria:

* Pediatric patients
* Female patients who are pregnant
* Patients with internal or external defibrillators
* Patients who have undergone surgery and still have a fresh incision on the chest.
* Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
* Patients in the Critical Care Unit (CCU)
* Patients who otherwise satisfy any of the contraindications associated with the VSP system.
Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients

Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a major modifiable risk factors and one of the most important public health problems. Mortality from cardiovascular disease increases progressively with increasing blood pressure (BP) in a linear, continuous and independent. The pathophysiological mechanisms involved in the pathogenesis of hypertension exhibit metabolic abnormalities, which are related to endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of plants, but in our food, mainly present in red wine and grapes, has shown protective effects in cardiovascular diseases, such as preventing the damage caused by oxidative stress, decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective effect of vascular endothelium, with increased release of nitric oxide and decreased production of free radicals in animal models, but human studies are limited and insufficient to clarify the possible effects of trans-resveratrol (biologically active form) on endothelial function, blood pressure and central aortic pressure in treated hypertensive individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol supplementation on endothelial function in treated hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged between 45 and 65 years, of both genders.
* Patients with a previous diagnosis of hypertension.
* Patients with endothelial disfunction.
* Stable use of antihypertensive treatment for at least 2 months.
* Patients with food consumption maintained for at least 4 weeks, oriented to limit the intake of foods rich in polyphenols, such as peanut butter, cranberry, blackberry, red grapes, red wine, green tea and chocolate.
* Signing the consent form.

Exclusion Criteria:

* Smoking.
* Diabetes Mellitus and / or use of insulin or oral hypoglycemic agents.
* Hormone replacement therapy.
* Use of ß-blockers and statins.
* Sleep apnea.
* Changes in thyroid function, chronic renal and liver diseases.
* Clinically evident coronary heart disease with previous myocardial infarction and / or revascularization, with clinical signs of heart failure, cardiac arrhythmia, symptomatic or clinically significant valvular disease, prior stroke.
* History of drug or alcohol abuse. Presence of some kind of eating disorder;
* Diets restricted by choice (vegetarianism, carbohydrate restriction);
* Use of nutritional supplements (vitamins, minerals), to at least seven (7) days prior to the study;
* Patients who have any severe illness and life-threatening any condition, disease or therapy that, in the opinion of the investigator, may adversely affect the results, interfere with the study objectives or jeopardize the safety of patients.
Travelling in Patients With Sleep Related Breathing Disorders

One questionnaire has been configured to ask therapy naive and treated patients about their travel activities. Travel activities include private and professional traveling. Another questionnaire collects medical information.

Including a German sleep committee a new questionnaire has been created to ask patients about their travel Habits. Only travels over a onenightstay were of interest. All detailed Information about the Destination has been asked. A Special Point of interest were the Impacts of traveling. For each Patient a doctor completed the medical history including sleep related breathing disorder and relevant medical conditions e.g. orthopedic Impacts.

Eligibility Criteria:
Inclusion Criteria:

* patients with sleep related breathing disorder
* informed consent provided

Exclusion Criteria:

* patients with no sleep related breathing disorder
* no informed consent provided
Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females

The purpose of this study is to determine whether the Hair Loss Prevention Lotion named MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Androgenetic Alopecia.

This study verifies whether the tested product has any efficacy in the treatment of Androgenetic Alopecia.

* The evaluated product (Hair Loss prevention Lotion) is called:MEXIS, MPAF, M6S PATENT.
* 20 volunteers both men and women suffering from hair loss both in parties and over the entire scalp with age between 18 and 70 years have been selected for this test .
* Samples of the product have been applied following their usual use: as they are.
* On the selecting volunteers have been used:

  1. The pull test by pulling with fingers of some hair and counting them to estimate the evolution of the pathology.
  2. A sebum-meter to check the presence of scales on the scalp.
  3. A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.
* Volunteers were also asked about:
* Fluffiness
* Sheen
* Itching
* Presence of scales on scalp
* Oily hair
* Product's acceptability
* The readings are taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45 days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the medical studio. Then they analyzed and reported in a graph.
* Summarizing tables and graphs of the data were taken during experimentation.

Eligibility Criteria:
Inclusion Criteria:

* Good state of general health
* Suffering from hair loss
* No pharmacological treatment in progress
* Promise not to change the usual daily routine
* No atopy in the anamnesis

Exclusion Criteria:

* Illness
* Good state of hair
* Pharmacological treatment in progress
* Denial of the continuance of the usual daily routine
* Atopy in the anamnesis
A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers

The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.

This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* No previous/current history of infection, cerebrovascular, neurological, cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant systemic disease, glucose intolerance, gout or hematological disorder
* Normal 12-lead Electrocardiogram (ECG)
* Systolic blood pressure \<140 mm Hg and diastolic blood pressure \<90 mm Hg
* Non-smoker within 3 months prior to screening
* Willing to abstain from alcohol during the study

Exclusion Criteria:

* Positive screen for illicit drug or alcohol consumption
* Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of cancer (excluding completely excised squamous or basal cell carcinoma)
* Positive tuberculin skin test or known history of tuberculosis infection
* Known history of serious head injuries, seizures or eating disorders
* Body Mass Index \<18.0 or \>30.0
* History of renal dysfunction, clinically significant creatinine or clinically significant abnormal liver function tests, hemoglobin \<130 g/L
* Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first dose of study drug.
* Drug or alcohol abuse within 1 year prior to study entry
* Steroid injections within 12 weeks prior to first dose of study drug
* Live vaccine within 7 days prior to first dose of study drug
Cardiovascular and Renal Risk in Spain

IBERICAN is a multicenter, longitudinal and observational population-based study of patients daily attended in Primary Care setting in Spain.

This study is aimed to determine the prevalence and incidence of cardiovascular risk factors in adult population in Spain.

Patients will be followed-up for a minimum period of 5 years, every 6 months or a lesser period when clinically required.

It has been estimated that a total of 15,000 individuals will be included.

IBERICAN (Identificación de la poBlación Española de RIesgo CArdio Vascular y reNal) is a multicenter, longitudinal and observational population-based study of patients daily attended in Primary Care setting in Spain.

The aims of IBERICAN are to determine the prevalence and incidence of cardiovascular risk factors in adult population in Spain. Moreover, the development of cardiovascular outcomes, and risk factors control rates will be also analyzed.

In IBERICAN, subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain will be included.

No specific recommendations will be provide to physicians about treatments. As a result, treatments of patients will be prescribed, modified or withdrawn according only to physicians´ judgment. The study has been approved by the ethic committee of Hospital Carlos III, Madrid on February 2013. Before inclusion, every patient will provide a written informed consent.

Patients will be followed-up for a minimum period of 5 years, every 6 months or a lesser period when clinically required. Excepting a blood analysis in the previous 6 months before the inclusion, no other specific diagnostic tool or technique will be required for being included in the study. All blood and urine analysis or other techniques will be performed according to clinical practice during the follow-up.

It has been estimated that a total of 15,000 individuals will be included.

Eligibility Criteria:
Inclusion Criteria:

* National Health Care System user.
* Resident at Spain in the last 5 years.
* Attended by investigator in Primary Care setting.

Exclusion Criteria:

* Change of regular residence to other city or country in the following 6 months.
* Life expectancy less than 5 years.
* Difficult to follow-up.
Baseline and First Trimester Uterine Artery Doppler Velocimetry to Predict Poor Obstetric Outcomes in IVF

The researchers aim to determine how baseline (preconceptional) and first-trimester uterine artery Doppler measurements affect obstetric complications in women undergoing high-quality blastocyst transfer and to determine the correlation between the two Doppler measurements.

Only patients with high-quality blastocyst-stage embryos will be included in the study. In frozen embryo transfer cycles prepared hormonally, basal bilateral uterine artery Doppler velocimetry will be performed before treatment (preconception) in each patient.

Bilateral uterine artery Doppler velocimetry will be performed during the basal ultrasonography (2-5 days of menstruation). The absence of any uterine artery notches, diastolic or reverse flow will also be noted. In addition, sub-endometrial (arcuate artery) blood flows will be evaluated by Doppler ultrasonography.

For endometrial preparation, estrogen replacement will be given for approximately 12-14 days as a routine In cases with endometrial thickness ≥7mm, progesterone treatment will be started and embryo transfer will be planned on the 6th day of the treatment.

In the pregnant group, measurements will be repeated at the end of the first trimester (11-14 weeks) and uterine artery Doppler velocimetry will be reevaluated. In addition, patients will be followed up until delivery and possible obstetric complications will be recorded.

Baseline and first-trimester uterine artery Doppler ultrasonography findings will be compared with obstetric results. Obstetric outcomes such as birth weight at the end of pregnancy, small-large for gestational age, presence of hypertension, and preterm delivery will be correlated with preconceptional and first-trimester uterine artery Doppler parameters.

Eligibility Criteria:
Inclusion Criteria:

* Exogenous hormone preparation of the endometrial lining
* High embryo quality ((≥2BB) according to Alpha criteria
* Embryo transfer at the blastocyst stage

Exclusion Criteria:

* Patients whose treatments were canceled for any reason before the embryo transfer procedure
* Patients who underwent embryo transfer in the cleavage stage
* Presence of low-quality (\<2BB) blastocysts
* \>15% loss of viability of the embryo during embryo thawing,
* Patients with congenital uterine malformations,
* Patients in whom Doppler velocimetry cannot be performed optimally
Immunotherapy for Peanut Allergy

Currently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects with accidental peanut ingestion over the course of the two years of SLIT. The primary endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams) at the completion of the two years of the study.

Peanut allergy is one of the most serious of the immediate hypersensitivity reactions to foods in terms of persistence and severity of the reaction and appears to be a growing problem. Allergen-specific immunotherapy (IT) is currently being examined as a treatment option because of the persistence of this hypersensitivity reaction and the lack of effective treatment. An understanding of the molecular mechanisms of peanut-specific IT is vital to ensure the eventual, successful treatment of peanut-allergic patients.

The goal of this proposal is to develop peanut immunotherapy (IT) for patients with peanut allergic reactions. This innovative application is designed to utilize the extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy have been unsuccessful primarily because of the severe side effects of therapy.

The specific aim of the study is to desensitize/tolerize peanut-allergic subjects with peanut allergen-specific, sublingual immunotherapy (SLIT) and begin to determine the molecular mechanism of the peanut-specific T-cell response during SLIT.

The hypothesis is that peanut SLIT will desensitize patients with peanut allergic reactions by the induction of peanut specific regulatory T cells resulting in immune modulation of the peanut allergic reaction.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 6 and 35 years of age
* Diagnosed with peanut allergy by positive prick skin test, CAP FEIA of 15 Ku/L or greater
* History of significant clinical symptoms within one hour after ingestion of peanuts
* Family's compliance with all study visits

Exclusion Criteria:

* Subjects with medical history preventing a BDPCFC to peanut
* Subjects unable to cooperate with challenge procedure
* Subjects unable to be reached by telephone for follow-up
* Subjects with a history of severe anaphylaxis to peanut