cyrilzakka/clinical-trials huggingface dataset:
Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations

Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.

Eligible participants will undergo a full day screening visit, if still eligible they will come to Hartford Hospital in Hartford, Connecticut to take part in the full study. Participation requires overnight stays between each of the five study visits. On each of the study days participants are dosed with either a low dose of THC marijuana, a high dose of THC marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)

This responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. The project also will link an extensive literature on CNB's effects on laboratory cognitive tests to simulated driving performance for the first time, providing a crucial validation of CNB's neurofunctional effects identifying maximally relevant candidate measures for field sobriety tests. To this goal, the proposed study was based upon a careful and thorough review of the scientific literature describing CNB effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent CNB use. The study will carefully characterize the persistence of CNB's acute effects on cognitive test performance and driving over a several-hour time span. This will allow us to identify the point at which any effects of CNB intoxication on cognitive tests and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.

Participants

Eligibility Criteria:
Inclusion Criteria:

* Must have a current driver's license
* Have used marijuana before
* Right handed

Exclusion Criteria:

* Females who are pregnant or breast feeding
* Any serious medical, or neurological disorder
* Any psychiatric disorder
* No major head traumas
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years


Eligibility Criteria:
Inclusion Criteria:

* Group 1: Healthy children 2-10 years of age;
* Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.

Exclusion Criteria:

* Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
* Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
MG1-MAGEA3 With Ad-MAGEA3 and Pembrolizumab in Patients With Previously Treated Metastatic Melanoma or Cutaneous Squamous Cell Carcinoma

This is a Phase 1b open-label dose escalation trial of Ad/MG1-MAGEA3 and Pembrolizumab in patients with Metastatic Melanoma or Cutaneous Squamous Cell Skin Cancer that has failed prior standard of care treatments. Upon determination of a Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) the study will be expanded into up to 24 additional Metastatic Melanoma patients.

This is a Phase 1b open-label dose escalation trial of Ad/MG1-MAGEA3 and Pembrolizumab in patients with Metastatic Melanoma or Cutaneous Squamous Cell Skin Cancer that has failed prior standard of care treatments. This study will consist of two arms where the dose will be increased independently until the maximum tolerated dose (MTD) / maximum feasible dose (MFD) is reached.

Arm 1 - Low-dose cyclophosphamide, followed by an Ad-MAGEA3 intramuscular (IM) prime, followed by intravenous (IV) administration of MG1-MAGEA3 and IV pembrolizumab.

Arm 2 - Ad-MAGEA3 IM injection as a prime, followed by IV administration of MG1-MAGEA3, followed by intratumoral (IT) injection of MG1-MAGEA3 into tumors and IV pembrolizumab.

In the Phase 1b Expansion for each arm, additional patients will be enrolled at the MTD/MDF as determined in Phase 1 in order to more thoroughly explore immune response, pharmacokinetics/dynamics, and safety for Malignant Melanoma patients who have failed standard therapies.

Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed diagnosis of locally advanced metastatic melanoma or cutaneous squamous cell carcinoma that has failed standard therapies
* For patients treated intratumorally, must have a lesion suitable for direct injection of MG1-MAGEA3
* Have at least one tumor amenable to biopsy
* Have measurable disease via RECIST 1.1 criteria
* Adequate organ function and performance status
* Additional inclusion criteria present

Exclusion Criteria:

* Prior treatment with any MAGE-A3 vaccine immunotherapy
* Prior systemic therapy for cancer within 4 weeks (8 weeks for lung radiation), and has recovered from chemo-related toxicities to Grade 1 or less
* Intolerant to prior PD1/PD-L1 therapy
* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
* Known active CNS metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic therapy in the past 2 years.
* Conditions likely to have resulted in splenic dysfunction.
* Known HIV/AIDS, active HBV or HCV infection.
* Additional Exclusion criteria exist
Evaluation of Efficacy and Safety of Agalsidase Beta in Heterozygous Females for Fabry Disease

Fabry disease (OMIM 301500) is an X-linked inborn error of sphingolipid metabolism resulting from the deficiency of the lysosomal enzyme alpha-galactosidase A. Heterozygous females for Fabry disease may be symptomatic with cardiac, renal or cerebrovascular involvement. Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients treated with agalsidase beta (FABRAZYME). In contrast, no randomized, controlled study of the efficacy of recombinant alpha-galactosidase A has been reported in heterozygotes for Fabry disease.

The primary objective is to evaluate cardiac left ventricular mass (measured with echocardiography by unique investigator) in females over 15 years of age affected with Fabry disease receiving 70 mg of agalsidase beta every other week, as compared with an untreated controlled group matched for gender and age.

The secondary objectives include evaluation of :

* left ventricular posterior wall thickness (echocardiography)
* interventricular septum thickness (echocardiography)
* tissue doppler imaging (myocardial function)
* EKG
* creatinaemia
* serum cystatin C level
* urinary protein/creatinine ratio
* microalbuminuria
* Gb3 urinary levels

Evaluation of tolerance and safety with :

* Home therapy infusions follow up
* Vitals
* Physical examination
* Adverse events
* Antibodies levels

Eligibility Criteria:
Inclusion Criteria:

* Female patients over 15 years with clinical and biological evidence of Fabry disease (GLA gene mutation detected)

Exclusion Criteria:

* Pregnancy
* Allergy to agalsidase beta
* Congestive heart failure
* Creatinaemia \> 135 µmol/l
* Medical history of stroke during the last year
* Medical history of more than 2 transient ischemic attack
* Blood pressure \> 160/95
* Modification in medications treating for blood pressure during the last 3 months before enrollment
* Complete absence of clinical or biological symptoms
* Weight \> 87 kg or \< 35 kg
Trial for People With Established Type 2 Diabetes During Ramadan

Dual therapy with metformin and Liraglutide is more effective at helping people with established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no severe hypoglycaemic events.

Participants in the control arm will essentially continue with their standard routine care and those in the intervention groups will either receive Liraglutide in addition to metformin or those on dual therapy will switch from their sulphonylurea/pioglitazone to Liraglutide and continue with metformin. Informed consent and baseline data will be collected 4-8 weeks prior to the start of Ramadan. This will allow time for a run in period for the titration of Liraglutide prior to the fasting period. Ramadan is followed by Eid-al-Fitr a 3-day Islamic holiday that marks the end of this holy month. Tradition includes amongst early morning prayers/celebration through feasting. Therefore, participants will be invited to attend the first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post Ramadan. Randomisation will not be revealed until after the baseline data have been collected.

Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 18 years old with established T2DM on metformin only
* or dual therapy of metformin plus a sulphonylurea or pioglitazone
* with a HbA1c between 7 - 11 % if on monotherapy and between 6.5 - 12% if on dual therapy

Exclusion Criteria:

* Are pregnant or breast feeding
* Suffer from terminal illness
* Have significant renal or liver impairment
* Are unable to provide informed consent
* Have severe and enduring mental health problems
* Are not primarily responsible for their own care
* Are receiving insulin therapy
* Type 1 diabetes
Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy

To develop and endoscopic Raman spectroscopy probe for delivery down and channel in an endoscope to make near instant assessments of the condition of the oesophagus without the need for expensive and distressing tissue removal (biopsies).

The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when illuminated with a low power laser. The investigators intend to use this technique, known as "Raman Spectroscopy" to tell if tissue in the oesophagus is cancerous, healthy or at some stage before full blown cancer, which is termed pre-cancer. It has been shown in the laboratory that this method will be at least as accurate as the conventional methods used now, but will provide the surgeon with instant results without the delay and cost of a laboratory analysis by pathologists.

A miniature probe has been developed that slides through a channel in the endoscope (telescope) to the surface of the oesophagus to make near instant assessments of its condition without the need for expensive and distressing tissue removal (biopsies). This project plans to move this technique from the laboratory to the clinic by demonstrating that the method is safe and reliable for use in real patients.

Eligibility Criteria:
Inclusion Criteria:

* Barrett's oesophagus

Exclusion Criteria:

* Unfit for endoscopic and biopsy assessment
UMOX - New Device for Oropharyngeal Preoxygenation

The UMOX is a device that has been designed as an alternative to the conventional face mask for preoxygenation to be used when an optimal preoxygenation with a facemask is difficult to achieve(i.e: when a leak is present. A previous study in our hospital (unpublished data) has shown that the UMOX was only as effective as the conventional mask when a nose clip was used to prevent the patients from breathing in some air through the nose, thus preventing the dilution/contamination of the 100% oxygen delivered.In that study, the verbal indication giving to the subjects to breathe through the mouth was better than no indication at all but still yielded unsatisfactory results.

For this reason, the present study was designed to verify the hypothesis that while using the UMOX for preoxygenation, the verbal indication of breathing 8 vital capacity breaths added to the indication of breathing through the mouth would bring equivalent results -measured by the expired fraction of oxygen- as a preoxygenation of normal tidal breathing through a facemask during 3 to 5 minutes.

Preoxygenation was performed with the 60 volunteers placed in the supine position with 100% oxygen. All volunteers went though preoxygenation with two techniques: 1) breathing normal tidal volumes at a normal respiratory rate for a period of 5 minutes through a tight fitting conventional face mask, and 2) eight deep breaths (i.e. vital capacity breaths) through the UMOX device with verbal indication to use only the mouth to breathe.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II, smoker or non smoker

Exclusion Criteria:

* patients under 18 years old or over 65 years old; edentulous patients or those with craniofacial malformations, beards or mustaches; patients that have \>30 kg over their ideal weight; and patients with moderate to severe pulmonary pathology
BEnefit of HYpnosis on Pain During Stitches in Emergency Room

Suturing is a daily practice in the emergency department, but it can be painful and stressful for patients. Hypnosis is increasingly used as a complement to the usual painkillers. The aim of our study was to investigate the impact of hypnosis on stitch placement in emergency department patients presenting with lacerations assessed by heart rate variability.

The aim of this randomized, controlled, single-center, prospective study is to evaluate the impact of hypnosis during suturing in emergency department patients presenting with a laceration assessed by heart rate variability.

All patients with eligibility criteria will be included if the patient gave his written consent.

Patients will be randomized to one of two arms: (1) Hypnosis or (2) Standard Of Care (SOC) A heart rate monitoring belt will be fitted to the patient for both groups. The patient will be asked to complete a self-assessment questionnaire on pain and stress, as well as socio-demographic parameters.

A blood sample will be collected and the heart rate and blood pressure will be measured.

Stitches will be taken with or without hypnosis, and after 30 minutes, the pain and stress self-assessment questionnaire will again be completed by the patient, and a new blood test will be taken.

the heart rate monitoring belt will be removed, and the study will be completed for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years, admitted in Clermont-Ferrand University Hospital Emergency Department
* suturable wound
* patient's consent obtained

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patient under guardianship, curators or safeguard of justice
* Person unable to give consent
* History of cardiac rhythm disorders (fibrillation, pacemaker)
* Psychiatric pathology
* Age \< 18 years
* Surgical wound
* Eyelid, nose, ear or mouth wounds
* Patients who do not speak French
* Deaf patients
* Patients with no social security coverage
* Use of MEOPA
* Intake of toxic substances
* Head trauma with a Glasgow Score \< or = to 14
* Patient with endocrinal pathologies on cortisol axe
* Refusal to take part in the study
Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
2. Able to comply with all study procedures and requirements.

Exclusion Criteria:

1. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
2. Fatal prognosis of an underlying medical condition (\<12 months life expectancy);
3. History of Guillain-Barre syndrome;
4. Bleeding diathesis or receiving anticoagulants of the coumarin type;
5. Hospitalization or residence in a nursing care facility;
6. Planned to receive seasonal influenza vaccine outside of this study;
7. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
8. Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
9. Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the study;
10. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;
11. Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.
Acupuncture on Post-Stroke Overactive Bladder

This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms. Participants will be put into groups randomly and compared. There are two groups: traditional acupuncture and usual care. The ratio of group allocation is 1:1.

Current practice in management of OAB is quite limited. Acupuncture, which is a major treatment modality of traditional Chinese medicine, has also claimed to have favourable therapeutic effect on OAB. Previous study found that acupuncture at the BL-33 point was effective for controlling the overactive bladder. Although acupuncture has been shown to be effective in treating OAB, there has been no randomized controlled trial examining the efficacy of acupuncture on patients with post-stroke. Given the high incidence of OAB in post-stroke patients, potentially effective alternative treatments should be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese aged 18 or above
2. Patient suffering from first ever stroke or recurrent stroke with no urinary symptom in previous episode(s);
3. Patient with classic symptoms, i.e. urgency, urinary frequency or urge incontinence and Overactive Bladder Symptom Score (OABSS) score ≥3 and the urgency item rated as at least 2-point;
4. Not taking any medication for OAB
5. Able to communicate
6. No current acupuncture or transcutaneous electrical nerve stimulation treatment

Exclusion Criteria:

1. Urinary retention with post-void urinary volume \> 100ml;
2. Current urinary tract infection;
3. Preexisting history of OAB or bladder outlet obstruction or underactive bladder;
4. Significant cognitive impairment with MMSE \< or =19;
5. Coexisting Alzheimer's disease, Parkinson's disease, spinal cord disorder or progressive neurological disease such as multiple sclerosis;
6. Active skin lesion or open wound over the needle placement areas;
7. Having valvular heart defects, severe cardiac diseases, or bleeding disorders,
8. Being fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation;
9. Pregnant;
10. Malignancies at the sites of selected acupoints;
11. Receiving acupuncture treatment 1 month before baseline.
Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection

Acute aortic dissection (AD) is a deadly, difficult to diagnose disease presenting with an array of common and unspecific symptoms. Aortic dissection detection (ADD) risk score is a bedside clinical tool to estimate the risk of AD. D-dimer has been evaluated in several studies as a biomarker of AD and has showed a pooled diagnostic sensitivity of 97%. However, considering the severe morbidity and mortality of AD, a negative d-dimer per se is considered insufficient to rule-out AD in unselected patients.

The aim of the present study is to evaluate whether the diagnostic performance of d-dimer differs in patients at different clinical risk of AD, and in particular whether a negative d-dimer test may allow safe rule-out of AD in any patient subgroup without necessity to perform urgent aortic imaging.

Consecutive adult patients with suspected AD presenting to Emergency Department will be enrolled before the establishment of a final diagnosis; a standardized clinical form comprehensive of presence/absence of 12 risk markers allowing ADD risk score fulfilled and d-dimer levels measured at presentation.

The aortic imaging exam used to confirm or refuse of AD will be computed tomography angiography or transesophageal echocardiography and final diagnosis established after reviewing of all available data.

The accuracy, failure rate and efficiency of a diagnostic strategy combining standardized clinical stratification via the ADD risk score with d-dimer testing will therefore be assessed.

Acute AD will include the following etiological entities, also known as acute aortic syndromes: acute aortic dissection, intramural aortic hematoma, penetrating aortic ulcer and spontaneous aortic rupture.

A pre-specified secondary sub-analysis will evaluate the diagnostic accuracy of focus cardiac ultrasound (FoCUS) and chest x ray for suspected AD.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Presentation to the ED with any of the following symptoms: chest pain, back pain, abdominal pain, syncope or symptoms of perfusion deficit (central nervous system, mesenteric, myocardial, or limb ischemia)
* Aortic dissection considered among the differential diagnosis by the attending physician. Enrollment in the study will be decided by the attending physician during evaluation in the ED and before the establishment of a final diagnosis.

Exclusion Criteria:

* An alternative diagnosis to AD objectively established by the attending physician after the initial medical evaluation
* Clinical severity or other conditions not allowing complete evaluation/proper enrollment
* Lack of consent to participate to the study