cyrilzakka/clinical-trials huggingface dataset:
Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

The overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive control among dependent smokers.

In a double-blind, randomized controlled trial, dependent smokers will be randomized to a 6-week very low nicotine content (VLNC) cigarette condition (N=50) or a 6-week normal nicotine content cigarette control condition (NNC; N=25). Participants will undergo functional magnetic resonance imaging (fMRI) scans at baseline and 6-weeks to investigate the nicotine-related modulation of brain circuitry involved in incentive salience valuation and executive control. Imaging tasks will engage the incentive salience of smoking cues and non-smoking rewards and executive control functions to identify changes in functional activity within, and effective connectivity between, known salience and executive control brain circuitry. A novel fMRI task using specialized odor presentation equipment and fMRI sequences will assess neural cue reactivity to smoke odors.

Eligibility Criteria:
Inclusion Criteria:

* 21-60 years old
* Smoke \>5 cigarettes per day
* \>1 year of daily smoking
* No quit attempt in prior month and not planning to quit smoking within next 3 months
* Able to understand and consent to study procedures
* High school or lower educational attainment or annual household income \< $50,000
* Plan to live in local area next 3 months
* Women not pregnant or nursing and taking steps to avoid pregnancy
* Able to read and write in English
* Access to computer with internet service that allows for Zoom

Exclusion Criteria:

* Use of non-cigarette tobacco products in the past 7 days
* Use of illicit substances more than once a week in the past 3 months (excluding marijuana)
* Current alcohol abuse impairing participation
* MRI safety contraindications (e.g., metal implants, claustrophobia)
* Unstable or significant medical conditions (e.g., chronic obstructive pulmonary disorder, coronary heart disease)
* Major neurological conditions or brain trauma
* Major surgeries planned in next 3 months
* Use of smoking cessation medication in prior month (e.g., varenicline, patch)
* Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
* Unwillingness to provide urine samples
* Unwilling to smoke study assigned cigarettes for the remainder of the trial
* Plans to move or take extended travel out of the area in the next 3 months
* Any other condition or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
* Self-reported color blindness
* Left-handedness
* Smell dysfunction as determined via standardized assessment
Glasgow Coma Scales and General Anesthesia

The study evaluates the general anesthesia management with BIS monitorization in terms of hemodynamic stability, drug concentrations and drug consumption in patients who underwent surgery due to intracranial pathology and who were divided in three different GCS groups.

BIS monitoring is mostly used for anesthesia depth and sedation level follow-up, however it can also be used for monitoring consciousness after resuscitation of cases with acute brain injury and cardiac arrest. It is not always possible to monitor and objectively measure the changes in the level of consciousness in clinical practice. Therefore, device-based methods have been introduced in monitoring the state of consciousness. Bispectral index (BIS) monitoring may be preferred in follow up of the state of consciousness in critical patients such as those with acute brain injury, in terms of ease of use, ability to obtain numerical results and continuous monitoring. BIS monitoring is mostly used for follow up of anesthesia depth and sedation level, while it can also be applied for monitoring state of consciousness following resuscitation in cases with acute brain injury and cardiac arrest.In this study, we aimed to investigate general anesthesia management performed by bispectral index monitoring in patients who underwent surgery due to intracranial pathology and with different Glasgow Coma Scales.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 65 years
* ASA II-III
* intracranial surgery

Exclusion Criteria:

* Patients with additional disease (electrolyte impairment, uremia, etc.),
* liver and renal failure affecting consciousness level other than intracranial pathology
Gastric Emptying After Tea With Milk in Pregnancy.

The aim of the study is to assess the difference in gastric emptying using ultrasound of pregnant patients following a cup of tea with milk or a similar volume of water.

The study involves the allocation of either 250ml of water or 200ml of tea and 50ml of milk to fasted parturients, and assessment of gastric antrum CSA at intervals up to 2 hours. The study will be performed in patients with \>34 weeks gestation at the antenatal clinic. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope. The ultrasound assessor will be blinded to the group allocation.

Participants will be asked to come to clinic in the morning fasting from solids for \>6 hours and for 2 hours for clear fluids. Gastric ultrasound will be performed on the fasted pregnant patients in the right lateral decubitus position to establish a baseline and ensure that the gastric antrum is empty. Gastric antrum CSA will be measured.

Intervention group:

The intervention group will be given 200ml of black breakfast tea with 50ml of full fat milk. This should be consumed within 5 minutes. Gastric ultrasound will be performed at intervals up to 2 hours after the intervention in the right lateral decubitus position. Gastric antrum CSA will be measured. Three measurements of CSA will be taken and averaged.

Placebo group:

The placebo group will be given 250ml of water. This should be consumed within 5 minutes. Gastric ultrasound will be performed at intervals up to 2 hours after the intervention in the right lateral decubitus position. Gastric antrum CSA will be measured. Three measurements of CSA will be taken and averaged.

Eligibility Criteria:
Inclusion Criteria:

* Women with a singleton pregnancy \>36 weeks.
* Subjects must be female, aged 18 years or above at baseline.
* Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

* Allergy/sensitivity to milk/tea.
* A medical or surgical condition leading to delayed gastric emptying (e.g. Diabetes Mellitus).
* Not fasting for 6 hours for food or 2 hours for clear fluids.
* No baseline ultrasound assessment.
* Inability to visualize the gastric antrum.
* Vomiting or inability to finish drink.
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252

The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2 diabetes mellitus subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy Subject Cohorts:

* Healthy male or female subjects
* Age 18 to 50 Years (inclusive)
* Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive)

Type 2 Diabetic Subject Cohorts:

* Male or female Type 2 diabetic subjects who are currently being treated with a stable dose of metformin
* Age 18 to 65 Years (inclusive)
* BMI between 25.0 and 40.0 kg/m2 (inclusive)
* Have a glycosylated hemoglobin (HbA1c) of \>7.0% to ≤9.5%
* Have a fasting plasma glucose (FPG) \<240 mg/dL

Exclusion Criteria:

Healthy Subject Cohorts:

* Known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic and dermatological or connective tissue disease
* Subjects with a systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg

Type 2 Diabetic Subject Cohorts:

* Subjects with a known medical history or presence of type 1 diabetes mellitus
* Subjects with known medical history of acute metabolic diabetic complications
* Subjects with uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>95 mmHg
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery

The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing general surgery of the lower limb at high risk of developing venous thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism

Exclusion Criteria:

* Patients with a history of hypersensitivity to the ingredients of fondaparinux
* Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
* Patients with acute bacterial endocarditis
* Patients with severe renal impairment
SEarchiNg BiomarkErs Cerebral Amyloid Angiopathy (SENECA)

Cerebral amyloid angiopathy (CAA) is one of the major types of cerebral small vessel disease, and a leading cause of spontaneous intracerebral hemorrhage and cognitive decline in elderly patients. Although increasingly detected, a number of aspects including the pathophysiology, the clinical and neuroradiological phenotype and the disease course are still under investigation. The incomplete knowledge of the disease limits the implementation of evidence based guidelines on patient's clinical management and the development of treatments able to prevent or reduce disease progression.

The SENECA (SEarchiNg biomarkErs of Cerebral Angiopathy) project is the first Italian multicentre cohort study aimed at better defining the disease natural history and identifying clinical and neuroradiological markers of disease progression. By a multidisciplinary approach and the collection of a large and well phenotyped series and biorepository of CAA patients, the study is ultimately expected to improve the diagnosis and the knowledge of CAA pathophysiological mechanisms.

The SENECA is an Italian multicenter network integrating the experience of neurologists, neuroradiologists, neuro-ophthalmologists and biologists and allowing the standardized collection of a well-characterized wide series of sporadic and familial CAA patients.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients ≥55 years (with the exception of genetic cases), referred to the participating centres, with a diagnosis of possible probable and definite symptomatic or asymptomatic CAA, defined according to the modified Boston neuroradiological criteria, who had undergone at least one brain MRI (mandatory requirement for inclusion of the patient in the study) will be recruited.

Exclusion Criteria:

* evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain MRI, pregnancy and breastfeeding
Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit

The purpose of this study is to assess the effect of sound insulation and music therapy on the comfort of mechanically ventilated patients admitted to intensive care unit measured by the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Patients over 18 years old
* Patients with a level of consciousness BIS ≥ 50

Exclusion Criteria:

* Patients with withholding treatment
* Patients with partial or complete reduction of hearing in one or both ears
* Patients with altered mental states: psychosis, schizophrenia, paranoia, neurosis, etc.
* Patients with acute disease of the central nervous system: stroke, coma, encephalopathic process, etc.
* Patients with an axillary temperature \> 37.5º
The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.

The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include electrocardiography (ECG), noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). Two peripheral intravenous catheters wil be placed for fluid replacement and administration of drugs.

Participants will be randomly assigned to one of the following groups:

Group A: Women will receive 4 milligrams (mg) of ondansetron diluted in 100 milliliters (ml) of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Group B:Women will receive 8 mg of ondansetron diluted in 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Group C:Women will receive 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Subsequently, after receiving 500ml of colloid solution, spinal anesthesia will be performed at level L3-L4 or L4-L5 in the vertebral space with 1.6ml of 0.75 percent ropivacaine and 15mcg of fentanyl, using a 27-gauge pencil point spinal needle with patients in a left lateral position. After subarachnoid infusion, participants will be placed supine with left uterine displacement and anesthetic and motor blockage will be evaluated every one minute until anesthetic blockage reaches the level of T4 neurotome and the motor block becomes complete (Bromage grade 3). This time will be called Time to max effect (Tmax).

Hypotension, defined as systolic blood pressure below 100 millimeters of Mercury (mmHg), will be treated using 5mg ephedrine if the heart rate is less than 100 beats per minute or with 20mcg of phenylephrine if the heart rate is greater than 100 beats per minute. Bradycardia, defined as a fall in heart rate below 60 beats per minute will be treated with atropine (0.6mg).

Immediately after the delivery of the neonate, all women will receive a solution of oxytocin (20 units) intravenously. Half an hour before the end of the procedure they will receive an additional 1g of paracetamol and 75mg of diclofenac.

Eligibility Criteria:
Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-II
* Singleton pregnant women in full term pregnancy
* Patients scheduled for cesarean section
* Height 158cm-170cm

Exclusion Criteria:

* patient's own refusal
* contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics)
* ondansetron allergy
* body mass index\> 33kg / m\^2
* height \<158cm, or\> 170cm
* hypertensive disorders of pregnancy
* cardiovascular disease
* receiving selective serotonin reuptake inhibitors (SSRI's) or treatment for migraine
* placenta previa.
A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts will evaluate the effects of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of RO5285119 on Day 6.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 18 to 55 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination
* Body mass index (BMI) between 18 to 30 kg/m2 inclusive
* Women must be postmenopausal (for at least 12 months of amenorrhea confirmed by FSH, or for at least 24 months if on hormone replacement therapy) or surgically sterile (absence of ovaries and/or uterus)
* For men with a female partner of child-bearing potential: agreement to use a barrier method of contraception during the treatment period and for at least 3 months after the last dose of study drug

Exclusion Criteria:

* Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
* Positive for hepatitis B, hepatitis C , or HIV infection
* Participation in an investigational drug or device study within 90 days prior to first dosing
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Hypersensitivity to itraconazole, to any of the other ingredients, or to any other triazole antifungal, or any other known contraindications to itraconazole as stated in the SmPC
* Hypersensitivity to fluoxetine or to any of the other ingredients, or any other known contraindications to fluoxetine as stated in the SmPC
Epidemiology of Gunshot Wounds Injuries Admitted in ICU in France

In civilian practice, the incidence of firearm violence depends on the country. In high income countries, most cases are reported in the USA or South Africa. In these countries, gunshot wounds (GSW) represent 20% of death cases in trauma centers, more than motor vehicle collisions.

The mortality in civilian practice occurs during the first 24 hours following GSW, mainly due to hemorrhage and traumatic brain injury, though long term effects on physical and psychological outcomes have also been shown.

Some factors of mortality specific to GSW have been established: multiples wounds, homicide vs suicide attempt, impact zone, or firearm caliber.

Few specific guidelines have been published concerning civilian GSW management. These cases are mostly treated in standard guidelines, such as hemorrhagic shock or traumatic brain injury guidelines. As in other trauma mechanisms, the "platinum ten minutes and golden hour" concept is applicable.

In Europe, the incidence of civilian GSW is much lower and few European studies have been published recently. Penetrating injuries in Europe are less likely to be GSW, and are more often self-inflicted than in the USA. In addition, European studies are heterogeneous, due to the difference in populations, healthcare systems and GSW being grouped with stabbing wounds under the label "penetrating trauma".

However, there is a global concern in Europe regarding a potential rise of GSW, with higher severity score than conventional trauma patients and often necessitate ICU admission. Studies analyzing data from different European countries show significantly different ICU admission rates for overall GSW, ranging from 17% up to 30%.

Therefore, the investigators conducted a multicenter, retrospective study on four French University Hospitals aiming to describe the epidemiology (mortality and type of organ damage) and identify prognosis factors of civilian GSW admitted in ICU.


Eligibility Criteria:
Inclusion Criteria:

* Admission for gunshot wound care in ICU between 1st of January 2015 and June 30th 2021 at Nimes University Hospital, Marseille North University Hospital, Montpellier University Hospital, Toulon Military Teaching Hospital.
* Patient ≥ 15 years old

Exclusion Criteria:

* Patient \< 15 years old
* Patient who objected to the use of their data.
Psychometric Testing: Cued vs. Learned Suppression

In this line of research, the researchers are examining whether performance on a cued attentional suppression (ignoring) task is related to performance on a learned attentional suppression task. In addition, these measures are related to the capacity of working memory and every day inattentive traits.

This is a behavioral study. The researchers will measures performance on multiple tasks. 1) a cued attentional suppression task, where participants are told the color of the item they are supposed to ignore on each trial. 2) a learned attentional suppression task, where participants learn over experience that a particular color is not the target. 3) a visual working memory capacity measurement 4) an inattentive trait report task, where participants report their experiences of inattention during their daily lives.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected-to-normal visual acuity, normal color vision

Exclusion Criteria:

* age
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices

The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)


Eligibility Criteria:
Inclusion Criteria:

* Subject has been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device according to current guidelines and/or center's current practice
* Subject is willing and capable (or appropriate legal representative is willing and capable) of authorizing access to and use of health information as required by an Institution's Institutional Review Board (IRB), Research Ethics Board (REB) or Ethics Committee (EC)
* Is willing and capable (or appropriate legal representative is willing and capable) of providing authorization/consent for participation in the study.

Exclusion Criteria:

* Subject is unable or unwilling to comply with the study protocol requirements
* Subject is under the legal age for signing study consent in accordance with state or national law
* Subject has a life expectancy of less than twelve months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician's discretion)
* Subject on active heart transplant list
* Subject with any prior pulse generator infection or lead infection which is either systemic or localized
* Subject received a commercially available Boston Scientific ICD or CRT-D device with a battery capacity of 1.5 amp/hour or less
* Subject implanted with Boston Scientific's subcutaneous implantable defibrillator system (s-ICD) or has a lead that is under recall/advisory at the time of enrollment