cyrilzakka/clinical-trials huggingface dataset:
Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins

GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder

ENDPOINTS

* Absorption kinetics of phenolic compounds in plasma
* Bioavailability of vitamins C, E, and carotenoids into plasma

Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).

Phytonutrients are regarded to play an important role in many health-related issues like:

* Improvement of redox balance
* Anti-inflammatory effects
* Prevention of chronic diseases like CVD, stroke, diabetes II, Alzheimer´s, AMD, and certain forms of cancer
* Beneficial effects on human´s microbiome Therefore it is of scientific interest whether this product provides absorbable phytonutrients/phenolics and vitamins to support mechanistic explanations for the beneficial outcomes observed in the past after intake of Juice Plus+®.

GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder

MERITS

* This study would reveal knowledge whether and to which extent specific vitamins and phenolic compounds are absorbed, including absorption kinetics/metabolism.
* Data of this study may provide support for mechanistic arguments on the beneficial clinical outcomes observed and published in the past.

ENDPOINTS

* Absorption kinetics of phenolic compounds in plasma
* Bioavailability of vitamins C, E, and carotenoids into plasma

Absorption kinetics of phytonutrients:

* Open-, one-arm study, absorption kinetics over 10 hours
* 5 blood sample collections: baseline (= 0); 1hr, 2hrs, 5hrs and 10 hours after intake of 3 capsules
* Wash-out of all food supplements and dietetic foodstuff: 2 weeks
* Wash-out of phytonutrients: 48 hours before baseline sampling, accomplished via a phytonutrient-poor diet.

Bioavailability of vitamins C, E, A and carotenoids:

* Open-, one-arm study over 8 weeks
* 2 blood sample collections: at baseline (2 weeks after the phenolics experiment) and after 8-weeks
* Wash-out of all food supplements and dietetic foodstuff: 4 weeks, 2 weeks before the phenolics experiment + another 2 weeks Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).

Eligibility Criteria:
Inclusion Criteria:

* 20 healthy men and women, 20-50 years old;
* non-smokers;
* BMI \>20 und \<30 kg/m2;
* no medication;
* premenopausal;
* normal dietary habits (no specific diets, meals, food components etc.);
* adherence to wash-out period.

Exclusion Criteria:

* all people not meeting the inclusion criterions;
* diet: subjects consuming \>4 servings of fruits and vegetables per day;
* subjects with any kind of food allergy or histamine intolerance;
* highly trained subjects (\> 5 training units/week);
* women with menstrual dysfunctions;
* pregnancy
* alcoholics.
Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects

The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of 2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).

Secondly, safety will be observed (tolerability) clinically after administration of a single dose in study subjects, by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Accepted Informed Consent
2. Study subjects male, aged 18 to 50 years;
3. Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;
4. Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.

Exclusion Criteria:

1. Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
2. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
3. Having made regular use of medication in the 4 weeks prior to the start of the study or have made use of medications that interfere with the pharmacokinetics / pharmacodynamics of drugs studied a week before the start of the study;
4. Have been hospitalized for any reason, up to 8 weeks before the start of the study;
5. Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;
6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
7. To present the pressure of any etiology requiring pharmacological treatment;
8. Display history of myocardial infarction, angina and / or heart failure.
ProvoxLife Adoption Trends for Heat-Moisture Exchanger

This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Information from this study may help doctors learn more about factors associated with patterns of use and how often patients use the ProvoxLife HME system.

PRIMARY OBJECTIVE:

I. To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.

SECONDARY OBJECTIVES:

I. To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes.

OUTLINE:

Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of tracheoesophageal puncture (TEP) and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>= 18 years of age planned for or status post total laryngectomy
* Using or ready for fit of HME system

Exclusion Criteria:

* Active malignancy if post-total laryngectomy (TL) at the time of enrollment
* Unable to complete questionnaires in English language

  * The primary endpoint derives from a study specific questionnaire, due to limited resources, is only available in English language
* Cognitive or other limitations that preclude independent self-care or completion of questionnaires

  * Cognitive or other limitations that preclude independent self-care or completion of questionnaires will be assessed in the screening interview by the clinical or research team
Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation.

The possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of pulmonary ultrasound to evaluate early pulmonary overload due to fluid administration at a subclinical stage. Indeed, fluid administration can generate a sub-clinical interstitial syndrome that can be detected by passing from a profile A to a profile B in lung ultrasound. The transition from a profile A to a profile B therefore corresponds to the transition from a state of preload dependent to a state of preload independence. However, this tool has not been studied in the operating room. The main objective of this study will be to study the correlation between pulmonary ultrasound and SV variation measured by esophageal Doppler during fluid administration in patients with haemodynamic optimisation in the operating room during digestive, urological, gynecological and orthopedic surgeries. The main expected result is the following: good correlation between the absence of increased SV in the esophageal Doppler and the appearance of a B-profile lung ultrasound fluid administration in the operating room.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans
* inclusion criteria:
* Patient having a digestive, urological, gynecological, vascular or orthopedic surgery
* Haemodynamic optimisation requiring titration of the fluid administration
* Informed consent signed

Exclusion Criteria:

* Non-consent
* Chronic pulmonary pathology: COPD with pulmonary emphysema, pulmonary fibrosis
F901318 Single Ascending Dose Study in Healthy Male Volunteers

F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.

Double blind, placebo controlled, ascending single intravenous dose, sequential group study. Forty subjects will be studied in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (active or placebo) on the second dosing day.

All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.

Cohorts will be dosed at 2 weekly intervals. There will be a review of safety and pharmacokinetic data prior to each dose escalation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-90 kg inclusive
2. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable)
3. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

1. Male subjects who are not, or whose partners are not willing to use appropriate contraception (such as a condom) with established use of oral, injected or implanted hormonal contraceptive, intrauterine device or diaphragm with spermicide for three months after the last dose
2. Subjects who have received any prescribed systemic or topical medication within 14 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of dosing with study drug (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
4. Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
5. Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months
Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry

This research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section.

Spinal anesthesia is the procedure of choice for elective cesarean section (CS) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus.

Accurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. More than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism.

The baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status II.
* Gestational age (GA) ≥ 36 weeks.
* Women planned elective cesarean section under spinal anesthesia.

Exclusion Criteria:

* Patient refusal to participate in the study.
* Gestational age of \< 36 or ≥40 weeks of pregnancy.
* Pregnancy-induced hypertension.
* Diabetes.
* Cardiovascular diseases, arrhythmia.
* Antepartum hemorrhage.
* Body Mass Index (BMI) above 36 kg/m2.
* Clinical fetal complications.
Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer

Open-label multicenter randomized Phase III trial.

Randomized trial of surgery with or without Paclitaxel (taxol) plus Carboplatin as neoadjuvant or adjuvant chemotherapy in patients with operable, non-small-cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* The patients eligible for the study are those with a diagnosis, histologically or cytologically proven, of NSCLC without metastases at stages IB, IIA, IIB and IIIA (not N2) of the disease. Patients with stage IA and tumor size \>2cm will be eligible as well.
* Patients aged \> 18 years.
* Tumor considered resectable by the attending surgeon.
* The patient must have an ECOG \*2 or Karnofsky \>60%.
* The patients need to have adequate hematological, renal and hepatic function defined as:

Absolute neutrophil counts (ANC\*) \*1.5 x 109/L Platelet counts \*100 x 109/L Total bilirubin \*1.25 x upper limit of normal distribution Serum creatinine \<120 umol/L (\<1.5 mg/dl) Creatinine clearance \>60 ml/min

* ANC = segmented neutrophils + banded neutrophils

  * The patients should have recovered from any serious surgical sequellae.
  * Informed consent must be obtained from the patient in accordance with the requirements of the IRB/EC.
  * If female, the patient must not be pregnant or breast-feeding. Women of child bearing potential need to have a pregnancy test performed and to take appropriate contraceptive action during the period of the study.
  * Operability criteria: Lung function test will be performed so as to confirm a predictive postoperative value of FEV-1 \>-800 ml, i.e. correct homeostasis. A carbon monoxide diffusion test is to be conducted and, when applicable, repeated following the induction treatment while taking into account the sensitivity of post-chemotherapy pulmonary toxicity detection.

Exclusion Criteria:

* Patients who have previously been treated with chemotherapy and/or radiotherapy.
* History of significant cardiovascular disease such as non-controlled hypertension, unstable angina or congestive heart failure even if these are controlled by medication. Documented history of acute myocardial infarction in the previous year, ventricular arrhythmias that required medication or 2nd or 3rd atrial-ventricular blocks.
* Pre-existing sensory or motor neurotoxicity grade \>2 based on the WHO criteria.
* Active infection or other clinical state that could seriously reduce the patient's capacity to tolerate the treatment protocol, including previous allergic reactions to products containing Cremophor (e.g. cyclosporin or vitamin K).
* Previous or concomitant malignant tumor (with the exception of in situ cervical carcinoma, baso-cellular carcinoma, squamous cell skin carcinoma or urothelial superficial carcinoma) which are considered potentially curable with oncological treatment and have a disease free survival (DFS) greater than 5 years EXCEPTING breast cancer, melanoma and hypernephroma
* Marked psychoses or senility
Microcurrent and Aerobic Exercise Effects on Abdominal Fat

The purpose of this study was to analyze microcurrent short and long term effects used with aerobic exercise on abdominal fat.

Nutritional patterns have been changed during XXI century with sugar and fat's high proportions that allied to sedentarism increased body fat. There is already a well establish relationship between total body fat excess, cardiometabolic diseases and increased mortality, knowing that abdominal fat (android pattern), different from body index, presents an additional influence to health risks. Women with their abdominal adipocytes (visceral fat) show an increased lipolitic activity that releases free fat acids to the systemic and portal circulation leading to a metabolic syndrome, increasing the risk of cardiovascular diseases Aerobic exercise is a way to decrease fat as it stimulates lipolysis through an increase in catecholamine's level resulting from a sympathetic system nervous activity raise. The most used exercise for lipid elimination is the prolonged aerobic moderate exercise with a minimum of 30 mn.

Nevertheless aerobic exercise practice reduce globally lipidic sources and not locally . Electrolipolysis using microcurrent has been used in clinical practice as a technique to reduce abdominal fat. This technique can be applied transcutaneously or percutaneously seeming that the former is not so effective as skin can be an obstacle to the current effect on visceral and subcutaneous fat .

Abdominal fat excess is associated with cardiometabolic diseases and can be prevented using microcurrent and aerobic exercise to stimulate lipolysis.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 30 years
* presenting a normal to pre-obese body mass index (18.5 - 29.9 Kg/m2)
* moderate physical activity level (between 600 and 3000 metabolic-minute/week (MET-min/week)) scored by International Physical Activity Questionnaire (IPAQ)

Exclusion Criteria:

* submitted to other fat reduce procedure
* to show cardiovascular risk factors or diseases and/or any physical condition limiting aerobic exercise
* to present any contra indications to microcurrent and/or aerobic exercise
* to take medication that influence lipid metabolism, and to be pregnant
A Pharmacokinetic Study of Melphalan in Children

The purpose of this study is to examine the pharmacokinetics (PK) of melphalan in children undergoing hematopoietic stem cell transplantation (HSCT). Melphalan is an important component of HSCT preparative regimens, but can be associated with significant toxicity. PK data is a powerful clinical tool that, when used to develop individualized treatment plans for a specific patient, may ultimately increase the likelihood of selecting the right dose for the right patient and/or of reducing the number of adverse drug events. The investigators' goal is to establish baseline pediatric melphalan PK data. These data may be used for patient specific dosing of melphalan in the future to minimize toxicity and improve transplant outcomes.

Hematopoietic stem cell transplantation (HSCT) continues to be the only curative therapy for patients with many hematological diseases. The adverse effects associated with chemotherapy agents used as part of HSCT preparative regimens are not insignificant and can be life threatening at times. The investigators' central hypothesis is that increased systemic exposure to melphalan due to variation in PK in younger children leads to increased toxicity seen in them. Although the PK of melphalan has been studied in animal models and in adult patients, limited data exists in pediatric patients especially those undergoing allogeneic HSCT. The objective of this study is to describe the pharmacokinetics of melphalan in children undergoing hematopoietic stem cell transplantation. Up to forty patients who are scheduled to receive melphalan as part of their preparative regimen will be enrolled. Prior to the start of the preparative regimen, study participants will receive a test dose of melphalan (10% of the standard dose). Blood samples will be collected at specific time points prior to and after the administration of the test dose and again around the full standard dose of melphalan. This study will establish that a novel method (dry blood spot assay) of determining PK of melphalan can be utilized in the clinical setting. Additionally, urine samples will be collected to measure markers of kidney injury, which will help correlate melphalan exposure with toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing either allogeneic RIC HSCT, or autologous transplant containing melphalan as part of the preparative regimen at CCHMC will be included.

Exclusion Criteria:

* Failure to sign informed consent, or inability to undergo informed consent process.
* It is not medically advisable to obtain the specimens necessary for this study.
Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis

It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.


Eligibility Criteria:
Patient Inclusion Criteria

* Major patient between 18 and 50 years
* Patient with relapsing or remitting multiple sclerosis defined according to revised Mc Donald criteria 2010
* Written, free and informed consent dated and signed
* Patient affiliated to a social security scheme

Control Inclusion Criteria:

* Person between the ages of 18 and 50
* Written, free and informed consent dated and signed
* Person affiliated to a social security scheme
* Person with multiple sclerosis

Exclusion Criteria:

* Contraindication to the use oxygen (O2): Acute or chronic respiratory insufficiency
* Pregnant or lactating woman
* Inability to see fundus (cataract), retinopathy, glaucoma
* Use of vasoactive substances (eg nasal decongestants, triptans, alkaloids) in the last 48 hours
* Use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, ..) and steroids (corticosteroids) in the last 48 hours
* Known Diabetes or taking antidiabetics in the last 48 hours
* Use of statins in the last 48 hours
* Known hypertension or antihypertensive treatment in the last 48 hours
* Any cardiac pathology (valvulopathy, angina, ventricular arrhythmia or atrial fibrillation), vascular (arteritis obliterating the lower limbs, stenosis of the arteries with encephalic destiny, coronary artery disease) or significant respiratory (asthma, Chronic obstructive pulmonary disease, interstitial pathology)
* Alcohol consumption within 8 hours
* Ophthalmoparesis or incapacitating nystagmus (impossibility of correctly evaluating the fundus)