cyrilzakka/clinical-trials huggingface dataset:
Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214

This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to placebo, ketamine, and phentermine in healthy recreational polydrug users.

A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users.

Eligibility Criteria:
Inclusion Criteria:

* Current recreational polydrug users with experience with at least 2 drug classes of abuse.
* At least 10 lifetime uses of stimulants drugs (eg, amphetamine, cocaine, methamphetamine) and 10 lifetime occasions of recreational use of psychedelic drugs (eg, cannabis, ketamine, dextromethorphan, PCP, MDMA \[ecstasy\], LSD, mesacline, or psilocybin).
* Recreational use of other classes of drugs is permitted, including opioids (eg, codeine, morphine, or heroin), minor tranquilizers, or sedatives (eg, benzodiazepines or barbiturates).
* Male or female volunteers aged 18 to 55, inclusive with a body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening.
* Must pass qualification phase eligibility criteria.

Exclusion Criteria:

* Self-reported history of drug or alcohol dependence (except caffeine) in the past 12 months, including subjects who have ever been in a drug rehabilitation program (other than treatment for smoking cessation).
* Unwillingness or inability to abstain from recreational drug use for the duration of the study from screening until follow-up.
* Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
* Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the volunteer at greater risk during study participation.
* Currently smoking more than 20 cigarettes (or 2 cigars) per day, and/or unwillingness to abstain from smoking for durations of at least 12 hours.
* Use of tobacco cessation product within 1 month (eg, nicotine substitution products, bupropion, etc).
Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber

The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC)

A monocentric, double-blind, placebo-controlled, cross-over study conducted outside of the pollen season. The study lasts 3 months for each patient, which includes a screening period, two exposure visits in the Alyatec Environmental Exposure Chamber (EEC) with active or placebo air cleaners, and a follow-up visit.

Patients with early asthmatic reaction during baseline exposure are randomly allocated to one of two sequences: active air cleaners /placebo or placebo/active air cleaners. Randomization is balanced (1:1) between the two sequences. There is a 3-week wash-out period between the two exposures.

Eligibility Criteria:
Inclusion Criteria:

* Controlled intermittent asthma (step 1 treatment, according to GINA Guideline 2016) with or without association with cat allergy related rhino-conjunctivitis;
* Sensitization to cat allergen extract as defined by skin prick test for cat extract with a wheal diameter of ≥3 mm greater than negative control (ALK, HØrsholm, Denmark) and specific IgE anti Fel d 1 ≥ 0.7 kU/L ( ImmunoCAP, Thermofisher, Uppsala, Sweden);
* FEV1 ≥ 70% of the predicted value;
* No cat exposure at home or outside of the home during the study;
* Positive methacholine challenge test performed using an AeroDoseur DTF-Atomisor ATO-AD 12 (Saint-Etienne, France);
* Early asthmatic response during baseline cat allergen exposure.

Exclusion Criteria:

* Uncontrolled asthma, asthma control test inferior to 20 within the 4 weeks preceding the study.
* Uncontrolled asthma 2 weeks after stopping LABA treatment.
* LABA treatment within the 2 weeks preceding the study.
* Severe asthma (\> GINA 2)
* Subject lives with a cat
* Cat desensibilisation within the 6 previous months.
* Active smoker
Introduction of Sophrology and Art Therapy in Hand and Upper Limb Surgery at Lyon University Hospital

The human and economic impact of hand and upper limb pathologies, whether acute or chronic, surgical or medical, is considerable on a national level. Hand wounds and traumas account for 1/3 of work-related accidents and their consequences. The surgical procedure and its technical quality are essential, but so is the re-education and rehabilitation phase. It is in this post-operative context that sophrology and art therapy could have their place. Literature in this precise field is non-existent. A study is therefore needed to determine the quality of life, feasibility and acceptability of these new techniques in the rehabilitation department of the Édouard Herriot Hospital's Hand and Upper Limb Surgery Unit.

Sophrology and art therapy could help to limit upper-limb sequelae by promoting confidence-building and functional participation, thus helping patients to return more quickly to an active life. Given the current state of knowledge, the hypothesis being tested is that, within the framework of an existing multi-disciplinary team, art therapy and sophrology could improve quality of life and find favorable adherence on the part of patients usually cared for in the upper limb surgery department.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged ≥ 18 years)
* Men and women
* Cared for in the hand and upper limb surgery department as part of emergency or scheduled activity or rehabilitation.
* Wishing to benefit from sophrology and/or art therapy in their care pathway.
* Having expressed his non-opposition

Exclusion Criteria:

* Patients under legal protection
* Any patient who does not have a sufficient command of the language to enable comprehension and expression.
Diaphragm Function and Diver Endurance

This project will test the following hypotheses:

1. Training of the inspiratory muscles increases underwater endurance and reduces hypercapnia in divers.
2. Inspiratory muscle training while breathing low concentration carbon monoxide (200 ppm) for 30 minutes daily improves diaphragm performance to a greater degree than the same training breathing air.
3. Inspiratory muscle training increases hypercapnia ventilatory response (gain) in those individuals with a low gain.
4. Variability in oxygen (O2) and carbon dioxide (CO2) permeability of erythrocyte membranes is a determining factor in underwater exercise performance.

The aims of this project are to: (1) test a method that could increase personal endurance and reduce excessive rise in blood carbon dioxide during underwater exercise in divers; and (2) understand the mechanisms by which red blood cells transport oxygen and carbon dioxide and their possible effects on exercise capacity. During underwater exercise, personal endurance capacity and elevated blood PCO2 are key parameters that affect a diver's safety and performance. Unlike exercise on dry land, hypercapnia often occurs during dives and can impair cognitive function and predispose the diver to central nervous system (CNS) oxygen toxicity and convulsions underwater. Some people intrinsically have low ventilatory chemosensitivity, and are more likely to develop hypercapnia during a dive. Lack of stamina may also be a mission-critical variable, and both endurance and the ability to control blood carbon dioxide depend on the respiratory muscle (mainly diaphragm) function, for which endurance capacity is related to mitochondrial number. Previous studies from our lab have demonstrated increased mitochondrial biogenesis with training while breathing a low, sub-toxic (200 ppm) level of carbon monoxide. In this study we will test the effect of daily respiratory muscle training with and without added carbon monoxide on respiratory muscle power, diaphragm thickness, respiratory muscle endurance and exercise endurance during a subsequent dive to 50 feet of sea water. Arterial PCO2 and lactic acid levels will be measured during exercise tests before and after training. Transport of O2 and CO2 through erythrocyte cell membranes occurs mostly through channels. Erythrocytes from volunteers in this study will be tested for O2 and CO2 permeability, and to correlate gas transport efficiency with exercise performance and blood PCO2.

Eligibility Criteria:
Inclusion Criteria:

* Normal volunteers
* Non-smokers
* Range of hypercapnic ventilatory responses
* VO2peak ≥35 mL.kg-1.min-1 (males)
* ≥30 mL.kg-1.min-1 (females)

Exclusion Criteria:

* Pregnancy
* Cardiorespiratory disease, including hypertension
* Neuromuscular disease
* Anemia
* Hemoglobinopathy, including sickle cell disease and trait
Diagnosis Assessment With Diaana #3

Single-center, unblinded, 2:1 parallel pseudo-randomized efficacy trial.

In the intervention group only, resident physicians will be assisted by the automated medical history-taking device "Diaana" during their consultations in outpatient ambulatory unit of the Geneva University Hospital.

In both groups, the differential diagnosis of the resident physician will be compared to the gold-standard diagnosis of the senior physician.

Automated medical history-taking devices (AMHTD) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. In this study, the investigators aimed to establish whether an AMHTD of interest, "Diaana", allowed the physician to establish a more precise differential diagnosis.

A single-center, unblinded, 2:1 parallel pseudo-randomized efficacy trial will be performed. A consultation follow-up is organized at 4-6 weeks, were the gold-standard diagnosis is established by the senior physician. The study will take place in the emergency outpatient unit of La Colline Hospital (Geneva, Switzerland) and include patients suffering from symptoms covered by Diaana.

Patients in the intervention group will fulfill Dianna. Then, the resident physician will read Diaana summary, perform his consultation, and fulfill case report form, including his differential diagnosis. Then, the senior physician will see the patient and establish the gold-standard diagnosis. In the control group, the residents will directly establish a differential diagnosis, without the help of Diaana.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the emergency outpatient unit of La Colline hospital (Geneva, Switzerland)
* Patients suffering from symptoms localized to the superior or inferior member, the back, hand the chest wall.

Exclusion Criteria:

* Strictly dermatologic concerns
* Toes trauma (because the diagnosis of those conditions is generally obvious)
* Medical condition considered as urgent
* Inability to complete de digilatized Diaana form (sight problems, language, inability to use a tablet computer)
Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion
* Anatomical evidence of significant single-vessel coronary stenosis defined by either:

  * ≥70% stenosis on invasive coronary angiography (ICA)
  * Severe stenosis on CT coronary angiography (CTCA)
* Physiological evidence of ischaemia with a positive test on at least one of the following:

  * Stress echocardiography
  * Cardiac magnetic resonance perfusion
  * Myocardial perfusion scintigraphy
  * Invasive metrics of coronary physiology

Exclusion Criteria:

* Age \<18 years
* Recent acute coronary syndrome
* Previous coronary artery by-pass graft
* Significant left main stem disease
* Multivessel disease (defined as \>50% angiographic stenosis in other vessels)
* Chronic total occlusion in the target artery
* Moderate to severe valvular disease
* Moderate to severe left ventricular impairment
* Chronotropic incompetence with a pacemaker
* Contraindication to PCI or a drug-eluting stents
* Contraindication to antiplatelet therapy
* Contraindication to adenosine
* Moderate to severe respiratory disease
* Physical inability to exercise
* Pregnant
* Inability to consent
Effects of Dapagliflozin on Progression of Alport Syndrome

Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or genetic confirmation of Alport syndrome;
* eGFR ≥ 30 ml/min/1.72m2;
* Proteinuria \> 0.5 g/24 h;
* Use of an ACE inhibitor or ARB, dose stable for more than 4 weeks;

Exclusion Criteria:

* Concurrence of other types of kidney disease;
* type 1 or type 2 diabetes;
* use of other types of sodium-glucose cotransporter 2 inhibitors within the month prior to enrollment, or prior allergy to such drugs;
* ACEI combined with ARB, or direct renin inhibitors, aldosterone receptor antagonists;
* Uncontrolled hypertension (blood pressure greater than 160/90 mmHg during screening);
* Patients undergoing renal transplantation or maintenance dialysis treatment;
* Coexist with other serious and/or unstable diseases, such as serious cardiovascular diseases, respiratory diseases, liver diseases or neuropsychiatric diseases;
* Patients who are participating in clinical trials of other drugs;
* Pregnant or lactating women, or patients who do not want to receive contraception.
Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 years old
* Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)
* Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging
* Karnofsky Performance Status scale \>/=50 (due to brain pathology)
* Adequate hematological, renal and hepatic function
* Patients willing to participate in the study and signing the informed consent

Exclusion Criteria:

* Karnofsky Performance Status scale \<50
* Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study
* Patients not suitable for follow-up
Impulsivity, Neural Deficits and Cocaine Addiction

The purpose of this study is to assess neurocognitive and associated neural regions/circuitry disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.

This study is designed to explore putative differences in impulsive behaviors and decision making in cocaine-addicted and healthy control subjects using functional magnetic resonance imaging (fMRI), single photon emission tomography (SPECT), and neurocognitive tasks. We predict that cocaine-addicted subjects will demonstrate neurocognitive and neural alterations in measures of impulsivity and decision-making when compared to healthy controls. That is, cocaine-addicted subjects will show both decreased activation and decreased resting measures of regional cerebral blood flow (rCBF) of the brain structures associated with impulsivity and decision-making. Furthermore, neurocognitive and neural deficits associated with impulsivity and decision-making will be associated with each other and with measures indicative of an impulsive relapse and altered decision making.

Eligibility Criteria:
Inclusion Criteria:

* Cocaine-dependence (patient population) or no cocaine-dependence (control population).

Exclusion Criteria:

* Other medical or psychiatric disorders that may effect neural functioning.
* Medications that may effect neural functioning.
GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients

The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing. The control group will receive standard prenatal care.

The secondary aims include assessing the impact of the video educational tool versus standard care on pregnant participants': perception of likelihood of having a baby affected by a genetic problem, intended plan for genetic testing, patient-provider communication, retention of prenatal genetics knowledge, and perception of genetic data privacy.

Participants will be asked to:

1. Watch video education (if randomized to this group) and complete a baseline survey at their dating ultrasound regarding knowledge of prenatal genetics, prior experiences, and demographics
2. Complete a follow up survey after seeing their prenatal care provider regarding: decisional conflict scale with respect to prenatal genetic testing decision (primary outcome), perception of likelihood of having a baby affected by a genetic problem (secondary outcome) and the type of genetic testing chosen (secondary outcome).
3. Complete a second follow up survey six to ten weeks from the second survey to assess: Provider patient communication, retention of genetics knowledge, patient recollection of testing performed, and self-reported out of pocket cost related to genetic testing.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age
* Preferred language English or Spanish
* Singleton pregnancy
* No documentation of genetic screening results or counseling during this pregnancy
* Gestational age \<24 weeks

Exclusion Criteria:

* Diagnosed with a fetal anomaly
* Diagnosed with known abnormal nuchal translucency test
* Diagnosed with fetal loss
* Use of a donor oocyte (egg) this pregnancy
* Prior involvement in other research study regarding prenatal genetic testing in the past two years
Probiotics Supplementation in Premature Infants

The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.


Eligibility Criteria:
Inclusion criteria

* Gestational age between 26 weeks and 31 weeks
* Birth weight between 700 to 1600 g
* Eutrophic infants (weight between -2 to 2 DS, Usher curves)
* Admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life.
* Still on parenteral feeding or infusion on the 5th day of birth

Non inclusion criteria

* Digestive disorders \> or equal to 1b on Bell stage
* Severe intra-ventricular haemorrhage (stage 3-4) before 5th day of life.
* Severe malformations or digestive malformations
* No antenatal corticosteroid therapy
* Severe medical or surgical disorder affecting the absorption, digesting and as a result the growth (Hirschsprung disease, lactose intolerance, cow milk protein allergy, mucoviscidosis).
* Parents geographical distance preventing the hospitalization follow-up in the hospital participating unit (geographical distance planned before the infant reaches 1500 g or 32 weeks of gestational age)

Exclusion criteria

* Enteral/Oral feeding termination during more than 72 hours due to severe digestive disorders (\> or equal to 2a on Bell stage )
* Serious digestive surgery
Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth

Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the reference treatment based on calcium hydroxide repeated stimulations.

36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study (inclusion period: 12 months). These patients will be randomly divided into two groups: one treated with MTA®, and the other one with calcium hydroxide. For each patient, the total duration of the study will be 12 months. Recalls will be performed at 15 and 21 days and then at 3, 6 and 12 months to assess by clinical and X-ray exams the main success criterion: presence of a calcified apical barrier or not. Additional criterions such as presence of clinical symptoms or not, apical morphology and depth of this apical barrier will be observed. This randomised prospective therapeutic study will allow to assess the ability of MTA® inducing apexification of a non vital immature tooth. Furthermore, it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices.

Eligibility Criteria:
Inclusion Criteria:

* Indication of apexification treatment of an anterior immature tooth
* Patients aged 6 to 18
* Enlightened agreement of the patient and his/her legal representatives
* Prerequisite medical examination

Exclusion Criteria:

General disease

* diabetes
* immunosuppression of whatever origin (AIDS, drugs, ...)
* severe asthma
* chronical disease requiring treatment
* eating disorders (anorexia, bulimia, malnutrition, ...) Oral disease
* periodontal disease
* Administration of corticoids in a period of 3 months preceding the inclusion
* Patient with no social security cover
Home-based tDCS for Apathy in Alzheimer's Disease

The purpose of this study is to assess feasibility, acceptability, and safety of providing tDCS to Alzheimer's disease and related dementias (ADRD) patients with apathy and to assess the efficacy of tDCS for ADRD-related symptoms, with a primary focus on apathy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of possible or probable ADRD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria
* Mild or moderate dementia, as defined by a MMSE score between 14 and 26
* Clinically meaningful apathy for at least four weeks, clinically diagnosed according to 2018 Apathy Diagnostic Criteria or defined as Neuropsychiatric Inventory (NPI-Q) apathy score equal or above 4 (i.e., severity of 'moderate' or greater and caregiver distress 'mild' or greater).
* Stable doses of cholinesterase inhibitors, memantine and other psychotropic medications for at least three months.

Exclusion Criteria:

* Unstable medical conditions
* History of epilepsy
* Metallic objects in the brain
* Diagnosis of major depression and/or a score higher than 18 on the Cornell Scale for Depression in Dementia