cyrilzakka/clinical-trials huggingface dataset:
Psychological Effects of a Set of Essential Oils

The goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. The main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being.

Participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart.

The potential beneficial effects of a set of Essential Oils (EO) are being tested in the form of a Randomized Clinical Trial (RCT). There are five conditions: a control (receiving a neutral/no-odor stimulus) and four active groups (receiving one of the four EO).

The study is a within-subjects/between-subjects design with five arms and involves comparisons between pre-intervention and post-intervention between: (a) Initial psychological states of the participants, and (b) After inhalation of the stimuli. Participants will be randomly allocated to one of the five experimental arms.

For medium effect sizes assumed (f = 0.25), 5 groups and two measurements in time (pre and post stimulus administration) a minimum of 80 subjects total sample size is needed.

Affective states (relaxation, contentment, happiness, motivation, tension), as well as data on mood; depression, anxiety, and stress will be assessed.

Data about familiarity, pleasantness and intensity of the stimuli will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Adults (at least 18 years old)

Exclusion Criteria:

* Allergies to Essential Oils
* Medical conditions that could have an effect on sense of smell
Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.

This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its variations after painful stimulations in children with cerebral palsy : acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy).

Cerebral Palsy (CP) is the most common cause of motor handicap in childhood. CP is caused by damage to the developing brain, resulting in limits in movement, posture, or communication ability. CP affects about one newborn on 450. Pain management is one of the major expectations of CP patients (La Foundation Motrice, 2009) but in this population, pain is not recognized and inadequately treated.

Autonomic nervous system (ANS) is the automatic part of our nervous system regulating vital functions like cardiac beats or respiration. It is divided in sympathetic and parasympathetic. Analysis of heart rate variability (HRV) allows isolation of variations due to parasympathetic and their study. Works from the CIC-IT 807 lead to creation of an index called ANI (Analgesia Nociception Index), which is very sensitive to pain. It is validated on adults (Jeanne, 2012). It could be helpful to assess pain in CP, particularly in patients with communication disabilities. It is important to study this new tool in CP children before developing clinical applications.

Main objective of this study is to demonstrate that ANI is relevant in CP children and that it is sensitive to pain like in adults. Population will be 40 CP children (6-18y) receiving rehabilitation therapy in specialized centres. Duration of the study is 2 years. Parent's consent should be obtained. Investigators will record heart rate of children in 3 conditions in their rehabilitation centres: usual position, acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy). Parameters will be calculated in CIC-IT 807 lab (heart rate, ANI). Values of ANI and heart rate before and after painful stimulations will be compared. Correlation between ANI and results of usual pain assessment tools (rFLACC scale, visual analog scale) or characteristics of the population will be analyzed.

Lille University Hospital and CIC-IT 807 lab will collaborate with 2 pediatric rehabilitation centers: Centre Marc Sautelet and Zuydcoote Hospital.

Expected result is that ANI is relevant to CP children. Clinical applications are multiple: pain assessment, adaptation of medical equipment.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy
* Rehabilitation care with physiotherapy and/or toxinum botulinum injections
* Absence of identified autonomic nervous system disease
* Parental and children (if applicable) consent obtained
* French National Health System cover

Exclusion Criteria:

* baseline Respiratory Frequency \> 30/min
* beta-blockers or atropinic treatment
* Pacemaker, cardiac rhythm disease
* Diabetes mellitus
A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo

RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-85 years who have given written informed consent
* Subjects with a body mass index within range 18-35 kg/m2
* Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol
* Female subjects using a highly effective method (S) of contraception

Exclusion Criteria:

* Subjects who have a history of keloid scarring, surgery within one year of the first dosing area
* Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised
* Subjects with any clinically significant medical condition or history of any condition which may impair wound healing
Rifaximin for Prevention of Travellers' Diarrhea

The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. travelling to Mexico within 72 hours of enrollment
2. read and understand English
3. in good health

Exclusion Criteria:

1. acute diarrhea within previous 7 days
2. taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
Genes of Hypertension in African Americans

To identify genes contributing to hypertension in African Americans by focusing on the physiological pathways that determine arterial pressure.

BACKGROUND:

Since the mid 1990s, the investigators have extensively characterized African Americans for phenotypes related to cardiovascular and renal function. Based on recently completed genome scans, they have identified several chromosomal regions likely to contain genes influencing hypertension-related phenotypes in hypertensive, African American sib pairs. For several phenotypes, overlapping QTLs have also been identified in related studies in a genetically isolated French Canadian population and/or in homologous chromosomal regions in the F2 cross of Dahl-salt sensitive x normotensive Brown Norway rats.

DESIGN NARRATIVE:

The investigators will extensively phenotype 500 hypertensive and 500 normotensive African American subjects to conduct a genetic association study, using a single nucleotide polymorphism (SNP) genomic scan approach. To achieve a clear separation of blood pressures from hypertensive subjects, normotensive subjects will be selected from the lower third of the population-based blood pressure distribution. Hypertensive (BMI), and age. Inclusion of phenotypes is based on their relevance to the pathophysiology of hypertension and prior evidence of "heritability." Candidate genes for SNP analysis will be selected within chromosomal regions of two quantitative trait loci (QTLs) that they have previously demonstrated to be linked to hypertension-related phenotypes--a QTL for body mass index on chromosome 1 and a QTL for microalbuminuria on chromosome 18. SNP analyses will be carried out in 15 percent of the genes within each of these QTLs, and genes will be selected on the basis of their relevance to hypertension, including documented sequence conservation for blood pressure related QTLs with rat or mouse. The final goal of the project is to determine if distinct clusters of blood pressure related phenotypes can be identified that will permit stratification of hypertensive individuals into distinct subgroups to facilitate the analysis of the genetic determinants of hypertension and/or provide mechanistic leads to genes contributing to these traits.

Eligibility Criteria:
African Americans, age 18-75 years
New Technologies in the Management of Lumbopelvic Pain

Lumbopelvic pain represents one of the leading causes of disability and pain in the world population. It is estimated that 84% of the world's population will suffer from lumbar pelvic pain in their lifetime. This high prevalence causes it to be classified as a public health problem.

Traditional primary care measures have failed to reduce the prevalence, recurrences and costs of this pathology. In the search for treatments focused on reducing public spending, the concept of tele-rehabilitation appears. It is a tool, via telematics, that provides knowledge on rehabilitation and education in neurobiology of pain, demonstrated in cardiovascular and respiratory diseases. It has been suggested that the use of this instrument could help improve the patient's quality of life at the biopsychosocial level.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years.
* Non-specific low back pain less than 12 weeks of evolution.
* Knowledge of new information and communication technologies.
* Internet access.

Exclusion Criteria:

* Inflammatory pathologies of the locomotor system.
* Infectious processes.
* Oncological processes.
* Neurodegenerative diseases.
* Pain with neuropathic characteristics.
* Fractures.
* Lack of fluency in Spanish.
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes

The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.

This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus.

Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Treated with multiple daily insulin injections of insulin pump for at least 12 months
* Body Mass Index (BMI): 18.5-28.0 Kg.m²

Exclusion Criteria:

* Type 2 diabetes mellitus
* Receipt of any investigational product within 3 months prior first dosing
* Clinically significant abnormalities as judged by the investigator
* Any systemic treatment with drugs known to interfere with glucose metabolism
* History of alcoholism or drug/chemical abuse as per investigator's judgement
* Use of tobacco or nicotine-contained product within 1 year prior to screening
* Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF

This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 40 years and ≤ 85 years of age at screening.
* Diagnosed with HF with NYHA functional class II or III.
* Screening echocardiography with LVEF ≥ 60%.
* Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with comorbid atrial fibrillation or flutter.
* Body mass index \< 40 kg/m2.
* Participants on beta-blockers, angiotensin-converting enzyme (ACE)/angiotensin II receptor blocker (ARB) or angiotensin receptor/neprilysin inhibitor (ARNI), or sodium-glucose contransporter-2 (SGLT2)-inhibitors must be on stable doses for more than 4 weeks prior to screening.
* Participants on a glucagon-like peptide-1 (GLP-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study.

Exclusion Criteria:

* History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Impact of Flumazenil on the Emergence Delirium

Flumazenil rapidly antagonizes benzodiazepines (BZDs); it may induce agitation, seizure, or delirium, especially when applied to patients who have taken BZDs for a long time. On the contrary, it may help patients regain consciousness in a stable and calm state by appropriately reversing the central nervous system depressant effects of BZDs. In this study, we aim to investigate the impact of flumazenil on the emergence delirium in patients anesthetized with remimazolam, the short-acting BZD drug.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 19 years or older undergoing surgery under general anesthesia

Exclusion Criteria:

* Peripheral nerve block or Neuraxial block
* Uncontrolled hypertension (HTN) (systolic blood pressure (SBP) ≥180 mmHg)
* Uncontrolled diabetes mellitus (DM) (HbA1c ≥9.0%)
* Hepatic dysfunction (Total bilirubin ≥3.0 mg/mL or Liver enzyme ≥Upper normal limit x 2.5)
* Renal dysfunction (Estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2 or Dialysis)
* Moderate or severe chronic obstructive pulmonary disease or Respiratory failure
* Emergency
* Hepatectomy or Liver transplantation
* Intraoperative cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) use
* Head trauma, Increased intracranial pressure, Craniotomy
* Chronic use of benzodiazepines (BZDs)
* Anxiety, Alcohol/Drug dependence, Addiction to tricyclic antidepressants (TCAs)
* Allergic reaction to BZDs, flumazenil, or other drugs used in general anesthesia
* Severe allergy or Anaphylaxis history
* Lactose-related genetic disorders
* Myasthenia gravis or Myasthenia gravis syndrome
* Myocardial infarction or Cerebrovascular events within 6 months
* Symptomatic coronary artery disease
* Organic brain disease
* Cognitive impairment (Inability to understand informed consent)
Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude

Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function during exercise in lowlanders older than 40 years travelling from 760 m to 3'100 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis on right heart function during exercise in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

An interim analysis will be carried out when 200 participants will have completed the study and/or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, age 40-75 yrs, without any disease and need of medication.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.
* Kyrgyz ethnicity

Exclusion Criteria:

* Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
* Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
* Allergy to acetazolamide and other sulfonamides.
Key Nutrients and Mental Health

The purpose of the project is to investigate whether an intervention program with vitamin D supplementation is able to improve the biology of stress resilience as well as subjective well-being in individuals with antisocial behavior problems (forensic inpatients).

This is a randomized control trial looking at the effects of vitamin D supplements on mental health in a group of forensic inpatients. More specific the effects of vitamin D will be investigated in relation to underlying biological mechanisms associated with resilience (e.g., serotonin, cortisol, heart rate variability and executive functioning), but also subjective well-being such as sleep quality, anxiety, depression, self-reported resilience and physical activity. About 100 participants will be randomized to an intervention group (vitamin D) or a control group (placebo). The intervention will last for 3-4 months. Pre-test will start in October/November 2017 and post-test in April/May 2018.

Eligibility Criteria:
Inclusion Criteria:

* Patients with intelligence quotient \> 70 will be invited.

Exclusion Criteria:

* Patients with intelligence quotient \<70 will be excluded.
* Patients already taking vitamin D.
* Patients with psychotic disorders.
Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease

The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for LTBI

Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Although the tuberculin skin test (TST) is recommended for screening of latent tuberculosis infection (LTBI) in all candidates for liver transplantation, the performance of the TST in this setting is less than optimal, due to a lack of specificity and a lack of sensitivity in a population that is relatively immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved for the diagnosis of LTBI. QFT-G is expected to be more specific than TST. However, there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation. We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease. We hypothesize that the QFT-G test will correlate better with the risk of LTBI.

Eligibility Criteria:
Inclusion Criteria:

* Chronic liver disease on the waiting list or being wait listed for liver transplantation

Exclusion Criteria:

* Unable to provide informed consent

  * Previous history of immediate hypersensitivity to TST
  * Previous severe local ulceration with TST
  * Suspected active TB
Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia

A comparison of reproductive and obstetrical outcomes is retrospectively performed among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia between January 2001 and December 2019.

Azoospermia affects almost 20% of all infertile males and It can be divided into obstructive azoospermia (OA) and nonobstructive azoospermia (NOA). Assisted fertilization with testicular sperm extraction (TESE) and intracytoplasmatic sperm injection (ICSI) has been successfully applied for its treatment.

Review of the literature shows that there is a lack of consensus about reproductive outcomes between men with OA and NOA. No study has ever investigated differences in obstetrical outcomes between these two groups before.

The objective of this study is to retrospectively determine differences in reproductive and obstetrical outcomes among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia.

The primary outcomes that will be investigated include:

* Reproductive outcomes: pregnancy rate, live birth rate (LBR) and abortion rate.
* Obstetrical outcomes: twinning rate, gestational age, prematurity rate, birth weight, cesarean section rate and the rate of the main obstetrical complication, such as pre-eclampsia, gestational hypertension, intrauterine growth restriction (IUGR).

Eligibility Criteria:
Inclusion Criteria for obstructive azoospermia group:

* infertility
* diagnosis of obstructive azoospermia
* ICSI-TESE cycles

Inclusion Criteria for non-obstructive azoospermia group:

* infertility
* diagnosis of non-obstructive azoospermia
* ICSI-TESE cycles

Exclusion Criteria:

* Sperm donation
* Use of ejaculated sperm
* Couples who underwent pre-implantation genetic testing
Prevalence of Cardiovascular Risk Factors in Upper Vestibular Neuritis

Vestibular neuritis is the second cause of vertigo, it constitutes 5 to 6% of the aetiologies of vertigo in an otoneurological consultation.

Infection or reactivation of a neurotropic virus of the herpes group (HSV-1) in the vestibular lymph node is thought to be the cause of the unilateral vestibular deficit.

Upper vestibular neuritis is more common than lower, or total involvement. Goebel (2) explains this by an anatomical predisposition of the vestibular nerve canal to inflammation, unlike the singular nerve canal which is shorter and wider giving way to a certain degree of edema without consequence on its contents.

However, the innervation territory of the superior vestibular nerve is superimposable on the territory supplied by the anterior vestibular artery. The anterior, lateral semicircular canals and the utricle are affected. Current complementary vestibular and imaging examinations cannot differentiate between inflammatory or vascular involvement in upper vestibular neuritis.

The increased presence of cardiovascular risk factors in patients with upper vestibular neuritis would be an argument in favor of ischemic involvement of the anterior vestibular artery.


Eligibility Criteria:
nclusion criteria:

* Major subject (≥18 years old),
* Subject having presented an episode of upper vestibular neuritis recorded on the Video Head Impulse Test Ulmer device at the HUS between 01/01/2016 and 01/31/2020,
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Patient who expressed his opposition to participating in the study,
* Total vestibular neuritis,
* impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
* Subject under safeguard of justice,
* Subject under guardianship or guardianship,
* Lack of video head impulse test data.