cyrilzakka/clinical-trials huggingface dataset:
AURAIA Study : Impact Evaluation at 3 Months Follow-up of a Brief Motivational Intervention in Reducing Alcohol Consumption Among Adolescents Aged 16-24 in Pontchaillou Hospital Emergency Department in Rennes, France

The purpose of this study is to evaluate the effectiveness of a Brief Motivational Intervention (BMI), in reducing alcohol consumption among patients with hazardous or harmful drinking admitted in emergency department (ED). Patients aged 16 to 24 and who tested positive for blood alcohol content (BAC) of 0.5g/l. or above are enrolled.

Patients receive either an information leaflet or an information leaflet plus a referral to a psychologist. BMI is provided by the psychologist. BMI consists in a first face-to-face interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are also invited to attend the BMI session. If necessary, patients can be referred to relevant care and treatment services for alcohol misuse.

In a simple blind, randomised controlled clinical trial of 280 patients, 140 patients are allocated to the treatment group and 140 to the control group. Randomisation is stratified according to patient's age (16-17 or 18-24). Opaque and sealed randomized envelops are used for randomisation.

Alcohol consumption is measured by self-report at 3 months. The principal criteria used to assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks in the last week. Other events such as ED readmission, quarrels related to alcohol, drinking and driving, sexual intercourse without protection will also be assessed. It is the first clinical trial in France comparing these two interventions among young patients in ED with this design.

Eligible patients are recruited by ED physicians. Staff in ED involved in the study is provided with a teaching session on the importance of alcohol misuse and inclusion procedures. Prior to enrolment, a written informed consent is requested from every patient. For patients under 18, a consent form is also requested from parent(s) or the legal tutor.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 16-24 attending ED services between Thursday 10 pm and Sunday 8 am
* Breathalyzer test with a blood alcohol content (BAC) of 0.5g/l or above
* Ability to give consent
* Parental or legal tutor's consent is requested for patients under 18

Exclusion Criteria:

* Already enrolled in the study
* Current ED visit for attempted suicide patients
* Current ED visit for injured trauma patients
* Alcohol dependence requiring hospitalisation or referral to local treatment
* Current enrolment or request to enrol in substance abuse treatment program
The Perceptual Experience of Argus II Users

This Basic Experimental Studies Involving Humans (BESH) study investigates phosphene perception and performance factors in blind participants implanted with the Argus II retinal prosthesis system. Using paired-electrode stimulation, we analyze how phosphene shape and number are influenced by neuroanatomical factors, stimulus parameters, and spatial offsets. Additionally, we examine the causes of high current thresholds and limited spatial resolution, which impede pattern vision in Argus II devices. This research aims to provide insights for optimizing stimulation strategies and improving retinal prosthesis design.

This study focuses on two experiments involving blind participants implanted with the Argus II retinal prosthesis:

Experiment 1: Paired-Electrode Phosphene Perception The study retrospectively analyzes 3548 phosphene drawings made by three participants. We investigate the impact of single- and paired-electrode stimulation on phosphene shape (area, perimeter, major/minor axis length) and the number of perceived phosphenes. Neuroanatomical parameters, including electrode-retina distance, electrode-fovea distance, and electrode-electrode distance (both along-axon and between-axon), are correlated with these outcomes. Statistical analyses include linear regression and partial correlation to examine the relationship between stimulation parameters and phosphene perception.

Experiment 2: Performance Factors in Argus II Prostheses This study explores the factors contributing to high current amplitude thresholds and poor spatial resolution in three participants. We measure current amplitude thresholds and two-point discrimination (the ability to distinguish stimulation on one versus two electrodes). Data from psychophysical experiments and simulations are analyzed to identify the roles of axonal stimulation, electrode lift, and retinal damage in limiting device performance.

These experiments aim to advance the understanding of epiretinal stimulation and inform the development of future retinal prostheses with improved spatial resolution and sensitivity.

Eligibility Criteria:
Inclusion criteria:

* Subject must be at least 25 years of age;
* Subject has been implanted with the Argus II system;
* Subject's eye has healed from surgery and the surgeon has cleared the subject for programming;
* Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback);
* Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days;
* Subject is capable of understanding patient information materials and giving written informed consent;
* Subject is able to walk unassisted.

Exclusion criteria:

* Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe;
* Sighted controls: Subject has a history of motion sickness or flicker vertigo
* Subject does not speak English;
* Subject has language or hearing impairment
Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study)

The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications.


Eligibility Criteria:
Inclusion Criteria:

Observation Criteria:

Male or female outpatients, aged 30 to 75 years of age, with idiopathic PD. Patients must be selected on the basis of a prospective recruitment plan documented at the site, with the objective of obtaining an unbiased representative sample.

Patients must have been treated with anti-parkinson medication for a period of one year or greater and demonstrated a treatment response, in the opinion of the Investigator.

Patients must be willing and able to comply with study procedures. Patients must be willing and able to give meaningful, written informed consent. This must be completed prior to beginning any study procedures, in accordance with GCP and local legislation.

Exclusion Criteria:
Testing a Behavioural Approach to Improving Cancer Screening Rates

Family doctors can play a critical role in successfully arranging cancer screening tests to occur, especially if they know which patients are due for these tests. However, they don't always interact with or take advantage of registry data to this end. For example, in Ontario, the Screening Activity Report provides exactly this information to family doctors, helping them identify their patients who are overdue for screening. Unfortunately, less than half of family doctors regularly use the Screening Activity Report even though they get monthly email reminders. One possible reason is that the reminders they receive are not designed to compel action. They are easy for family doctors to miss or dismiss. This study will compare multiple different ways of designing the reminders. The different versions of the email are tested in a 2\^3 factorial trial testing three behaviour change techniques to see which ones will lead to more family physicians interacting with the Screening Activity Report and at increasing the number of patients that get all the appropriate screening tests for cervical, breast, and/or colon cancer.

Screening is an important way to prevent cancer-related death, but many Ontarians do not receive guideline-recommended screening for cervical, breast, and colon cancer. Family physicians can play a critical role in successfully increasing screening rates. A recent evaluation by members of our team suggests that Screening Activity Report (SAR) use is associated with improved cancer screening, but there remains substantial room for improvement. For the SAR to reach its full potential to decrease cancer-related death by improving screening rates, family physicians must regularly access it and take the appropriate actions. Currently, family physicians receive monthly email reminders, which state that new data are available, but do not describe the benefits of the SAR for physicians or their patients. It is easy to imagine how a busy doctor would fail to act upon such emails, resulting in suboptimal use of the SAR and leading to avoidable delays in cancer screening, and management. Indeed, CCO data show that less than half of recipients attend to this email and \<7% click through to the SAR. The objectives for this trial are to compare different versions of the reminders in a randomized trial to identify the features that most increase use of the SAR. This is a pragmatic, 2\^3 factorial trial, comparing behaviour change techniques incorporated within email reminders to doctors increase their use of the SAR. Participants are those who are already sent monthly emails by CCO regarding the SAR. The trial will randomly assign participants to one of eight modified emails to determine which content is most effective at driving SAR-use over 4 months. With an expected sample size of over 5700 family physicians, we anticipate power to see differences of 3% across experimental conditions.

Eligibility Criteria:
Family physicians are eligible if they have signed up for the SAR and already receive reminder emails as part of their registration process for the SAR with CCO.
Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers

This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey

This study is to document the efficacy of Artacent™ Human Amniotic Membrane (Artacent) in the treatment of diabetic and vascular lower extremity ulcers. The study will add to the currently available literature by also assessing the impact of treatment on quality of life and on heal economic outcomes. Finally the study will follow patients for longer than previous studies and will obtain data on healing and recurrence at 6 months.

The objectives of this study are 1) to compare Artacent to standard of care (SOC) in the treatment of non-healing lower extremity ulcers and 2) to evaluate the impact of treatment on patient quality of life. Health economic outcomes will also be collected. The proportion of patients receiving Artacent who have wound closure with 12 weeks will be compared to those patients receiving SOC only will be compared. A comparison of time to wound closure will also be compared between the two populations.

Patients who are randomized to the SOC group (control) and require further treatment at 12 weeks due to incomplete wound healing, may receive treatment with Artacent if the investigator determines that to be a potentially beneficial option.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able and willing to give consent and to comply with study
* Lower extremity ulcer between 1 and 25 cm2 point after the 4 week run-in period
* Has received documented SOC treatment for 4 weeks or greater duration resulting in \<50% reduction in the ulcer size
* No clinical signs of infection at the ulcer site
* Serum Creatinine below 3.0 mg/dl
* Serum HgA1c below 12%
* Adequate circulation to the affected limb with ABI between 0.7 and 1.2 or tri-/bi-phasic arterial waveforms at the ankle of the affected leg.

Exclusion Criteria:

* Is participating in another wound study
* Has a Charcot foot
* Has previously received a different biological graft on the target foot
* Has more than one lower extremity ulcer
* Has an ulcer that probes to bone or involves tendon, muscle, joint capsule or has sinus tracts
* Is currently receiving radiation or chemotherapy
* Has an autoimmune connective tissue disorder
* Is taking any medication known to be an immune system modulator
* Is pregnant or is considering becoming pregnant within the next 6 months
3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)

The aim of this study is to compare the 3D OPTIMIZED MPRAGE WMN sequence to "conventional sequences" used in spinal cord analysis.

The patients will be explored at the cervical level with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 2D sagittal PSIR, 3D T1 MPRAGE sequences, and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE and 3D axial OPTIMIZED WMN MPRAGE. At the thoracic level, with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 3D T1 MPRAGE sequences and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE.

Multiple sclerosis is a common inflammatory disease of the central nervous system and the leading cause of non-traumatic physical disability in young adults.

Spinal cord involvement is common, affecting approximately 90% of patients, and can be revealed by sensory loss, neuropathic pain, spasticity, motor weakness, and bladder and bowel dysfunction. Spinal cord imaging plays an important role in the diagnosis of the disease, but also in the prognosis, particularly with regard to the location and severity of the damage.

Due to the location, small size and mobility of the spinal cord, its imaging raises technical problems and fewer studies have focused on spinal cord involvement in MS than on brain involvement.

Currently, the 2D sagittal T2 FSE sequence is the imaging of choice for spinal cord analysis. Numerous sequences have been developed recently, some of which show an increase in sensitivity at the cervical level, such as short tau inversion recovery (STIR) and phase sensitive inversion recovery (PSIR). The lesion load assessed on these conventional sequences lacks correlation with clinical status, probably due to a multifactorial mechanism of disability in MS, but also probably due to the limitations of the resolution of current sequences.

WHINUME study will investigate at the spinal cord level the interest of an optimised MP-RAGE sequence cancelling the spinal cord white matter signal. The hypothesis is that this sequence could have a good sensitivity, specificity and reproducibility between readers for the detection of spinal cord lesions compared to other sequences at the cervical level but also at the thoracic level. Therefore, it could replace the conventional sequences currently available.

This study will prospectively include 60 patients with multiple sclerosis confirmed by the McDonald 2017 criteria. All patients will sign a consent form. The 3D OPTIMIZED MPRAGE WMN will be compared to conventional sequences.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* CIS or RRMS
* Medullary symptomatology less than 6 months
* With or without an objective lesion on a subsequent MRI scan
* Signed the Informed Consent

Exclusion Criteria:

* Pregnant or potentially pregnant women
* Breastfeeding woman
* Contraindications to MRI
* Other diagnosis (Neuro-myelitis spectrum disease or Progressive Multiple Sclerosis)
* Surgical history on the spinal cord or lumbar spine
* Patient under legal protection
A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa.

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Eligibility Criteria:
Inclusion Criteria:

1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
3. On levodopa/dopa-decarboxylase inhibitor for at least one year.
4. Taking at least three doses and \>=300mg of levodopa per day for at least four weeks before randomization.
5. Predictable end of dose wearing off.
6. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.
7. Have an average of two hours of OFF time on 24-hour diaries.
8. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization.
9. Be at least 20 years of age.
10. Be willing and able to give written informed consent.

Exclusion Criteria:

1. Taking any excluded medications.
2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD.
3. Diagnosis of cancer within 5 years.
4. Diagnosis of clinically significant illness of any organ system.
5. Diagnosis of dementia or mini-mental status examination score of 25 or less.
6. History of drug or alcohol abuse or dependence within the past two years.
7. History of psychosis.
8. Significant drug allergies.
9. Taking anticonvulsants for seizures.
10. History of neurological malignant syndrome.
11. Pregnant or lactating females.
Effect of Physical Activity in Women With Manifest Osteporosis

Objectives: To investigate if a physical activity intervention (one year) can reduce the risk of falls (primary endpoint), improve physical function (balance and muscle strength) and cortical bone geometry as well as trabecular microarchitecture (secondary endpoints) in women, 70-80 years old, with manifest osteoporosis, treated with zoledronic acid, calcium and vitamin D.

Strategic goal: To include 200 patients (100 intervention and 100 controls) during 2010 and 2011 and randomize 100 patients to a one year physical activity intervention (3 hours weekly). The results will be published in an international scientific peer-review journal. All patients will receive standard medical treatment with calcium, vitamin D and yearly zoledronic acid.

Study rationale: The role of physical activity intervention has not previously been evaluated in patients with manifest osteoporosis and zoledronic acid treatment.

Methodology: Randomized controlled trial. All included patients (women 70-80 years of age) will have manifest osteoporosis, be treatment naïve, and will be treated on clinical indication with yearly infusions of zoledronic acid (approved treatment, for this patient category, by the Swedish Medical Products Agency). Patients with secondary osteoporosis, with disabilities, and with high levels of exercise at the baseline visit will be excluded. Intention to treat analysis will be used. Physical activity intervention includes 3 hours of weight bearing aerobic exercise per week, using a standardized program. Patients in both groups will be contacted monthly and asked about their exercise habits. Frequency of falls, physical activity level will be ascertained using questionnaires. Balance and muscle strength will be assessed using standardized tests. Bone geometry at the tibia diaphysis will be determined using an XCT2000 pQCT device (Stratec, Germany) and trabecular microarchitecture at the tibia metaphysis will be determined using an XtremeCT device (Scanco Medical AG, Switzerland). These examinations will be performed on all patients prior to the intervention and after the completion of the study.


Eligibility Criteria:
Inclusion Criteria:

* 70-80 years of age
* manifest osteoporosis, BMD T-score ≤2.5 SD at the lumbar spine and/or hip
* female
* walk without walking aid

Exclusion Criteria:

* male
* high level of exercise, ≥2 times/week, at baseline
* secondary osteoporosis
* previous treatment with bisphosphonate or other osteoporosis induced medicine
The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension

In this research study, the investigators are interested in learning how extracts from grape seeds can help those individuals with high blood pressure. The investigators also hope to learn how grape seed extract effects your blood and cell functions.

The grape seed extract the investigators will use in the study will be provided either in a beverage or a capsule form and is currently available on the market. This study is also using a placebo; therefore the treatment subjects receive may or may not contain the grape seed extract.

The purpose of this study is to determine if the grape seed extract (GSE) will lower blood pressure in people with slightly high blood pressure (Pre-Hypertension).

Elevated blood pressure, or hypertension, is a major risk factor for heart disease and stroke. Systolic and diastolic blood pressures meeting criteria for "pre-hypertension" double the absolute risk of stroke and ischemic heart disease over an extended age range from the 4th to the 8th decade of life. Lifestyle, particularly the diet, is critical in the prevention and management of hypertension. Polyphenolic compounds from various plant foods can promote blood pressure regulation and vascular health through protection of the endothelium from oxidant and or inflammatory stress and or stimulation of smooth muscle relaxation.

We will use a purified grape seed extract (GSE) in the proposed trial. This extract has been granted Generally Recognized as Safe (GRAS) status by Food and drug administration (GRAS Notice # GRN 000125, dated 08/18/2003, FDA, USA). Furthermore, GSE for use in the present trial has been used in previous human clinical trails and shown potent vasodilator properties in vitro and blood pressure lowering in metabolic syndrome patients. The proposed trial aims to verify the blood pressure lowering effect of GSE in an 'at risk' population for hypertension and to explore the extent to which other pathways of chronic disease may be modulated by GSE consumption.

Given this, the objectives of this study are as follows:

1. The primary objective of the proposed study is to demonstrate the effectiveness of GSE to lower blood pressure in pre-hypertensive individuals.
2. Secondary objectives will investigate the role of GSE to improve inflammatory- and oxidative stress- status, as well as its effect on endothelium function.

Eligibility Criteria:
Inclusion Criteria:

* male and female
* pre-hypertensive

  * systolic blood pressure (mmHg) 120 - 139 or
  * diastolic blood pressure (mmHg) 80 -89
* no clinical evidence of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease

Exclusion Criteria:

* pregnant and or lactating
* taking over the counter antioxidant supplements
* taking prescription medications that may interfere with study procedures or endpoints
* unusual dietary habits
* actively trying to lose or gain weight
* addicted to drugs and/or alcohol
* medically documented psychiatric or neurological disturbances
* smoker (past smoker may be allowed if cessation is \> 2 years)