cyrilzakka/clinical-trials huggingface dataset:
Effects of Transcranial Temporal Interference Stimulation on Risky Decision-making and Impulse Control in Gambling Disorder

The purpose of this research is to investigate the effect of transcranial temporal interference stimulation (tTIS) targeting the dorsal anterior cingulate cortex in patients with gambling disorder.

This study will apply the emerging non-invasive deep brain stimulation of tTIS to the dorsal anterior cingulate cortex in a randomized, double-blind design to demonstrate the possibility of non-invasively targeting the anterior cingulate cortex to modulate impulse control and risky decision-making without activating other regions below the electrodes. Additionally, this study will combine the fMRI recordings to describe local and network effects on brain activity. Specifically, each participant will be assessed at baseline with a scale and T1WI sequence and diffusion tensor imaging, and will randomly receive a combination of stimulation sequentially during the intervention phase, with more than a one-week interval ensuring that there is no interference between each of the two stimulation sequences.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60, male or female, right handed;
* With 9 or more years of education, and able to cooperate in completing the questionnaire assessment and behavioural tests.
* Meets the DSM-5 diagnostic criteria for gambling addiction;
* Previous gambling behaviour of not less than 1 year's duration (at least one gambling session per week or more);
* Normal or corrected normal vision and hearing;
* Agrees to cooperate in completing the follow-up assessment;
* No history of neurological problems or head injury; and no skin sensitivity.
* Agree to cooperate in completing the follow-up assessment;
* No metal implantation in the head, no history of neurological problems or head injury, and no skin sensitivity.

Exclusion Criteria:

* Suffering from severe cognitive dysfunction, such as a history of head trauma, cerebrovascular disease, epilepsy, etc., use of cognitive-promoting medications in the last 6 months;
* Other psychoactive substance abuse or dependence in the last 5 years (except nicotine).
ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects

Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who participated in the ADAGIO study, and who entered the active phase of the study and
2. Subjects who are currently on rasagiline treatment (or subjects who have stopped rasagiline treatment, are willing to restart treatment, and in the opinion of the investigator will gain clinical benefit from restarting treatment) and
3. Subjects with a diagnosis of Parkinson's disease and
4. Subjects willing and able to give written informed consent

Exclusion Criteria:

1. Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently.
2. Subjects who cannot be given rasagiline due to any exclusion based on the local label (including pregnancy or nursing women) or due to the use of medications contraindicated for concomitant use with rasagiline according to local label
3. Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration

The aim of the present study is to find out whether fusion of multilevel SPECT/CT positive lumbar degeneration leads to a significant improvement of pain and disability.

Chronic back pain (CBP) is a very common clinical problem. It is dominantly caused by degenerative changes, while specific causes such as tumor, trauma or inflammatory conditions are relatively rare. Back pain may be a concomitant symptom of lumbar disc herniation or spinal canal stenosis and is a typical symptom of spondylolisthesis. Magnetic resonance imaging (MRI) plays a key role in the diagnosis, showing in detail the soft structures, vertebral bodies (Modic changes, MC) or signs of facet arthropathy. On the other hand, it also proves a number of clinically silent findings. Degenerative disc disease (DDD) or facet osteoarthritis are most often considered to be a pain generator. The problem, however, is that both entities are very common in the general population without a painful correlate, and there is still controversy in the literature about their role in the genesis of CBP.

Radionuclide bone scintigraphy with single photon emission computed tomography (SPECT) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. In the absence of other pathology the foci of increased osteoblastic activity reflex areas of mechanical stress and degenerative change in the skeleton. There is growing evidence about the relationship between DDD, facet arthropathy, and SPECT positivity. Although these findings have been recently confirmed by surgical studies, the evidence about the effect of surgical treatment of SPECT positive lumbar degeneration is still weak due to the small number of operated patients.

The aim of the present study is to define a possible correlation between degenerative changes of the lumbar spine and positivity on SPECT/CT imaging. Patients with multilevel SPECT+ DDD or facet arthropathy will undergo spinal fusion of the involved segments. Postoperative improvement will be measured by ODI (Oswestry Disability Index) and pain VAS (Visual Analogue Scale) in 6 and 24 months follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Lower back pain (in extension +/- pain in buttocks, groin, thigh) without radicular pain
* Symptoms \> 6 months after the failure of conservative management in the primary care setting
* MRI signs of degenerative disc disease or facet arthropathy
* Two- or more levels of positivity on lumbar SPECT/CT

Exclusion Criteria:

* Other spinal pathology (tumors, congenital defects, spondylolysis, or spondylolisthesis)
* Intolerance of SPECT examination
* Pregnancy
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults

This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27 subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated through 1 year post vaccination.

The study will enroll 54 subjects in four cohorts. All subjects will receive a single administration of VXA-BYW.10 at a low dose, a high dose or placebo.

Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-BYW.10 prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.

Cohort 1: 3 subjects at low dose; Cohort 2: 16 subjects at low dose and 8 placebo; Cohort 3: 3 subjects at high dose; Cohort 4: 16 subjects at low dose and 8 placebo

Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.

Eligibility Criteria:
Inclusion Criteria:

* In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.

Exclusion Criteria:

* Positive for B influenza by HAI.
* Has had an influenza vaccine in the past 2 years.
* Current history of chronic alcohol use and/or illicit and/or recreational drug use.
* History of any confirmed or suspected immunodeficient or immunosuppressive condition
* Positive serology for HIV, HCV, or HBV
* Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
* History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine
* Use of proton pump inhibitors(Nexium, Prilosec).
* Stool sample with occult blood at baseline exam
* Pregnancy
A Feasibility Study of Intensive Treatment With Prolonged Exposure

The primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (I-PE) in regular Swedish psychiatric care. The secondary objective is to investigate preliminary effects of i-PE in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.

The investigators will investigate I-PE delivered as a one-week intensive treatment consisting of nine individual sessions and five group sessions followed by three individual session two, four and eight weeks afterwards in a pilot trial. The feasibility and acceptability and preliminary effects of treatment- and assessment procedures will be evaluated using a within-group design with repeated measurements and qualitative interviews. The individual sessions will consist of imaginal exposure and processing and the group sessions of psychoeducation, rationale for treatment and in vivo exposure work. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialised in PTSD in Stockholm, Sweden.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for PTSD
* If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry
* ≥ 18 years
* Fluent in Swedish
* Signed informed consent

Exclusion Criteria:

* Other serious comorbidity as primary concern (for example ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, high suicidal risk)
* Other ongoing trauma-focused psychological treatment
* Ongoing trauma-related threat (e.g. living with a violent spouse)
Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera

Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the presence and severity of abnormalities of myocardial perfusion, as well as the extension of infarction residua. However, actual imagery devices (gamma cameras) have low resolution and detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection sensitivity and could allow proportionally diminishing injected activities or recording times. Only one pilot study has been recently published on this type of camera, the D.SPECT camera.

This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2 to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The purpose is to demonstrate the equivalence of images recorded by two camera types for diagnostic information and the secondary purpose is to demonstrate the superiority of the D.SPECT camera in terms of image quality.

This study will be conducted in Nuclear Medicine departments (Nancy Hospital, Bichat Hospital in Paris, Pasteur private hospital in Toulouse), with D.SPECT camera (Cyclopharma). The D.SPECT camera recording will be realized following the conventional camera recording and will not modify the routine programmed examination. Recording times of D.SPECT camera will be maximum 2 minutes for imaging with a strong activity of technetium-99m labeled dye and maximum 4 minutes for imaging with thallium-201 or with a low activity of technetium-99m labeled dye.6 study groups will be analyzed: 4 groups of patients initially doing stress tomoscintigraphy with thallium-201 (group 1) or with technetium-99m labeled dye and then testing 3 principal injection sequences (group 2, 3, 4), and 2 groups of patients initially doing "myocardial viability" assessment with rest tomoscintigraphy with thallium-201 (group 5) or technetium-99m labeled dye.

Recording comparison obtained with 2 cameras will be done according to qualitative and quantitative criteria on image quality and analyzing diagnosis concordance (presence, type and severity of observed abnormalities).

Eligibility Criteria:
Inclusion Criteria:

* Understanding and signature of informed consent
* Without any contraindication for tomoscintigraphy and stress techniques according to French Society of Cardiology and Nuclear Medicine criteria, as established for all patients doing this routine examination
* Not in emergency situation and with a stable clinical status (without any sign of heart or coronary failure, without uncontrolled high blood pressure under treatment)
* Having an effective contraception for women of childbearing potential

Exclusion Criteria:

* Patient under guardianship
Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer

The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.

Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy.
* Received no previous chemotherapy for metastatic breast cancer.
* Prior hormonal therapy is acceptable.
* Measurable or evaluable disease.
* Able to perform activities of daily living without considerable assistance
* Adequate bone marrow, liver and kidney function
* Must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years.
* Cardiac ejection fraction \< 45%.
* Women who are pregnant or lactating.
* Patients with meningeal metastases are ineligible.
* Moderate peripheral neuropathy
* History of hypersensitivity reaction to Taxotere
* Males with metastatic breast cancer

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Volume Kinetics for 20% Albumin in Different Clinical Situations

The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the patient is in a post surgical inflammatory state. The study also examines the increase in the plasma colloid osmotic pressure as a result of this infusion and its possible influence on markers of kidney damage.

15 volunteers, 15 patients undergoing surgery and 15 patients in the post-surgical phase will be recruited for this study because they have different degrees of vasodilatation and inflammation, which are factors of potential importance to the effectiveness of plasma volume expansion with albumin 20%. Hyperoncotic albumin should logically recruit fluid from the interstitial fluid space, but this possibility has recently been questioned in the "revised Starling equation".

The degree of plasma volume expansion and also the half-life will be estimated by population volume kinetics which uses serial analyses of the blood hemoglobin concentration and a summary measure of the excreted urine during the 5-hour experiment to calculate these outcome measures.

There is a risk that hyperoncotic solutions cause pre-renal anuria due to the rise in plasma oncotic pressure. As a safety measure we will assess the plasma oncotic pressure and relevant biomarkers of renal function during the experiments. The experiments will be ended with a slow infusion of 1 L of Ringer´s acetate to dilute any raised oncotic pressure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.
* Patients in ASA classes I-II scheduled for surgery.

Exclusion Criteria:

* Expected major hemorrhage during surgery.
* Blood hemoglobin concentration of \< 10 g/dL.
Ghrelin Changes After Roux-en-Y Gastric Bypass

The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Serum creatinine and liver function tests \< upper limits of normal
* Stable body weights for the past three months
* Women will have a negative pregnancy test
* patients who are already scheduled for RYGB with gastrostomy tube placement

Exclusion Criteria:

* Significant hepatic enzyme elevations (more than 100% of upper limits of normal)
* Serum creatinine \> 1.5 mg/dl
* history of ketoacidosis or current metabolic acidosis
* current use of oral anticoagulants
* Positive pregnancy test (beta-human chorionic gonadotrophin) for females
* intercurrent infections
* patients with prior gastric operations
Internal Discourses and Perception of Trail-running Effort

Determination of the effect of an intervention to develop the use of internal discourses on the perception of exercise during a sub-maximum effort following a trail running

The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sport practice is associated with various constraints specific to the activity.

These constraints imposed on the body during the preparation, participation and recovery of this type of effort have an impact on multiple aspects of the individual (physiological, psychological, neurological...). Some studies have made it possible in each of the fields to advance the current knowledge about the trail-running environment. However, there are very few links between variables from different fields of research, even though these links are at the origin of the complex individual responses observed in the field.

Therefore it seems important to study the practice of trail running and its consequences on the individual, relying on a systemic approach of the individual who studies how psychological phenomena, physiological and cerebral interactions to predict behaviour and its health consequences.

The biopsychosocial models are based on this systemic approach and postulate that the perception of the individual's effort would be the main limit to the continuity of effort, performance because it causes the intensity to decrease - or even stop the effort - if this sensation becomes too strong.

Consequently, the study of certain interventions aimed at reducing this perception of effort, such as the one proposed in this project, seems to be an essential step to propose to the practitioners of this type of sport strategies allowing to practice in a healthy and efficient way.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-55 years
* Subjects available in Grenoble before and during the 15 days after the race
* Subjects subject to a social security scheme
* Subjects able to sign informed consent.
* Fluent in French

Exclusion Criteria:

* Cardiorespiratory, metabolic and neurological conditions
* People treated with anxiolytics and/or neuroleptics or ATCD for behavioural disorders
* Persons refusing to sign the participation consent
* Persons under guardianship
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

Our study is planned as a prospective observational study. Patients undergoing therapeutic hypothermia in our intensive care unit after cardiac arrest will be enrolled. Each patient's cerebral oxygenation will be monitored with near-infrared spectroscopy (NIRS) in every 6 hours during our 24 hour lasting hypothermia period. Afterwards, patients will be monitorised in every 6 hours during the first day of hypothermia and than the mean values of daily cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia. Regional oxygen saturation (rSO2) will be noted from left and right probes. Full Outline of Unresponsiveness (FOUR) Score, Glasgow Coma Score (GCS) and cerebral performance category scale (CPC) will be noted at the beginning of therapeutic hypothermia and each day during normothermia, day 21 and the day of discharge from ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old
* Patients undergoing therapeutic hypothermia

Exclusion Criteria:

* Patients under 18 years
* Patients unsuitable for therapeutic hypothermia