cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis

The perspective of the patient is defined by the patient reported outcomes (PROs). This is a main part of the care in psoriatic arthritis. However , PROs can be influenced by environmental parameters.

Ultrasound represents an objective instrument in the context of psoriatic rheumatism (RhPso) care because it measures inflammatory activity and structural damage at joint and periarticular level.

it is the first study to evaluate the role of inflammatory and structural ultrasound abnormalities as a cause of modification of the patient's perspective measured by PROs in patients with RhPso.

It is an interventional study. Patients will be enrolled in the rheumatology department Of Ambroise Paré Hospital in collaboration with the dermatology departments of the hospital.

All patients with psoriatic arthritis, beginner or established, or patients with psoriasis suspecting the beginning of rheumatism who will consult or are already followed in those departments and give their approval for the study will undergo

* a clinical rheumatologic assessment (number of painful or swollen joints, enthesitic pain, inflammatory spinal pain)
* an ultrasound assessment (peripheral joints, tendon and enthesitic structures and nails).

Those assessment will be made the same day of their consult in one those departments. They will be asked to complete questionnaires (PROs) on the overall assessment of the disease, pain, quality of life, tiredness, physical limitation / disability and the impact of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders above 18 years old
* Capable of adhering to the protocol
* Consent given
* Present one of those disease:
* RhPso (confirmed diagnosis) according to The Classification for Psoriatic arthritis criteria (CASPAR)
* Rheumatoid arthritis according to ACR/EULAR criteria (American College of Rheumatology/ European League Against Rheumatism)
* Digital osteoarthritis according to american college of rheumatology (ACR) criteria
* Cutaneous psoriasis
* Having signed a consent form
* Affiliated to a regimen of health insurance

Exclusion Criteria:

* Patient refusing the study
* The association of two rheumatic diseases (for example: psoriatic arthritis and gout, rheumatoid arthritis and arthritis etc)
* The association of another chronic pathology likely to lead to joint manifestations (systemic diseases, bowel chronic inflammatory diseases, overload diseases, ...)
* Patient under trusteeship or protection of vulnerable adults
* Pregnant or nursing women
Virtual Reality for Phantom Limb Pain

This study will develop a virtual reality-based treatment for phantom limb pain among Veterans and test it against the most established behavioral therapy for phantom limb pain, mirror therapy.

The VA system performs more than 10% of all amputations in the U.S., a percentage translating into more than 50,000 upper and lower extremity amputations in the past decade. Among Veterans with amputations, research suggests that upwards of 70% experience phantom limb pain (PLP), an often chronic and debilitating condition with adverse effects on quality of life and poor responsiveness to conventional pain treatments. The use of virtual reality technology for chronic pain management is a novel and rapidly advancing area of study, with existing research suggesting that virtual reality treatments are effective for acute pain management, promising for chronic pain management, and as yet untested for PLP. In the current study, the investigators will develop a virtual reality environment that simulates mirror therapy - the gold standard behavioral treatment for PLP - comparing the efficacy of this modality in a population of Veterans with PLP against a standard mirror therapy treatment validated by this research team in a previously supported clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21-75 Veteran receiving care at VA San Diego Healthcare System
* Upper or lower extremity amputation with reported PLP for at least six months
* PLP intensity \> 3/10
* English-speaking, literate, with stable residence
* Able to operate a VR headset as evidenced by direct observation

Exclusion Criteria:

* Major medical illness that might confound effects of pain on function, e.g.:

  * advanced cardiac
  * pulmonary disease
* current active alcohol or substance use disorder as evidenced from medical record
* currently active suicidality
* homicidality, or unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
* moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
* prior mirror therapy experience
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function

Primary objective:

To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.

Secondary objectives:

To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 - 79 years of age inclusive.
* BMI 19 - 40 kg/m2.
* Renally Impaired Subjects: In otherwise stable health except for Renal Disease.
* Healthy volunteers must have/be: eGFR as calculated by MDRD of ≥ 80 mL/min, and Matched to renally impaired subjects for age (± 15 years), weight (± 15 kg), and if possible BMI, race and gender.
* Subjects with renal impairment must have 2 separate eGFR that are within 20% of each other and clinically stable for a minimum of 6 months.
* No clinically relevant abnormalities in the results of the laboratory screening or admission evaluation other than those consistent with renal impairment or related disease/disorder in the appropriate subject group as determined by the Investigator.

Exclusion Criteria:

* Currently taking or have taken a GLP -1 agent (e.g., Byetta®, Victoza®) within the past year.
* Subjects who have previously received PB1023.
* Known allergy or serious adverse effect to an approved or investigational GLP-1 receptor analog/agonist.
* Serious Infection within 60 days of admission.
* Donation or loss of greater than 400 mL of blood 56 days prior to enrollment.
* Unstable cardiovascular disease defined as per protocol.
* Clinically significant hepatic dysfunction defined as per protocol.
* Female subjects who are pregnant, trying to become pregnant or lactating.
* Known history of or active alcohol or drug abuse within 12 months prior to Screening or positive alcohol and/or drug screen.
* Positive for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies.
* Participating in any other study at time of screening other than observational studies or have received any other investigational drug or device within 30 days or 5 half-lives prior to dosing or are taking part in a non-drug study which in the opinion of the Investigator would interfere with the outcome of the study.
Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA

The main objective of this study is to compare two post-stroke/TIA (transient ischemic attack) imaging strategies in terms of the number of clinically important (i.e. requiring specific treatment according to current recommendations) lesions detected. The first strategy is the current/usual strategy in each participating centre and the second strategy consists in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose angiography and subsequently resorting to elements of the usual strategy if required.

The secondary objectives are:

A. To compare the patient pathways between the two arms in terms of time to diagnosis, and duration of hospitalization.

B. To compare the consumption of imaging exams (number and type) and total body irradiation between the two arms.

C. To compare the diagnostic efficiency between the two arms in terms of detection of predefined lesions, and performance ratios.

D. To study the thickness of the left atrial wall as a risk factor for permanent atrial fibrillation.

E. To compare the distribution of suspected neoplasms between the two groups, as well as the number of detected incidentalomas.

F. To compare the survival and the incidence of new cardiovascular events between the two arms at 12 months and 36 months.

G. To compare the quality of life between the two arms at 12 months and 36 months.

Eligibility Criteria:
Inclusion Criteria:

* The patient was informed about the implementation of the study, its objectives, constraints and patient rights
* The patient has given free and informed consent and signed the consent
* Patient affiliated with or beneficiary of a health insurance plan
* Patient available for 36 months of follow-up
* The patient has had a stroke (within the past 10 days, diagnosis confirmed by MRI with a diffusion sequence) or transient ischemic attack (within the past 10 days, ABCD2 score greater than 3) without haemorrhage

Exclusion Criteria:

* The patient is currently participating in or has participated in another biomedical research study within the past three months or is currently in an exclusion period determined by a previous study.
* Patient under guardianship or judicial protection
* Refusal to sign the consent
* Inability to correctly inform the patient or his/her trusted person about the study
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contraindication for a treatment used in this study
* Known allergy to contrast medium or severe allergy to iodine
* Known active malignancy or history of cancer treatment
* The patient has already undergone a full body scanner in the previous three months
* Renal failure with creatinine clearance below 60 ml / min
* Monoclonal immunoglobulin
* History of severe symptomatic cardiovascular event (myocardial infarction, aortic dissection, mesenteric ischemia, renal ischemia)
* Emergency situations that hamper the planned course of the study
Effects of Alcohol on Simulated Driving

Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. The present study will investigate the effects of five different dosages of ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering performance and brain activity will be recorded in both single- and dual-task conditions.


Eligibility Criteria:
Inclusion Criteria:

* He/she is aged between 21-50
* Written informed consent
* Right-handed
* Normal static binocular acuity, corrected or uncorrected
* Normal hearing
* Social Drinker (average of 7 to 21 alcoholic drinks per week)
* Possession of a drivers license
* Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion Criteria:

* Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
* Positive urine pregnancy drug screen in women
* Use of psychoactive medication
* Positive alcohol breath test
* Prior enrolment in the same study
* Physical or mental illness
* Excessive alcohol use (\>21 alcoholic drinks per week)
* Excessive smoking (more than 10 cigarettes per day)
* Intake of caffeine-containing beverages over 5 glasses per day
Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)

This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes mellitus
* 21 to 72 years of age
* taking rosiglitazone and metformin (or Avandamet) for at least 3 months, and on a stable dose of rosiglitazone (or Avandamet) for at least 2 months
* glycosylated hemoglobin (HbA1c) level of \>/=7.5% but \</=10.0%
* fasting blood sugar level \>/= 125 mg/dL but \</= 279 mg/dL
* BMI 26-43 kg/m2
* direct bilirubin \< 1.5x the upper limit of normal (ULN)
* serum creatinine \< 1.5 mg/dL (males) or \< 1.4 mg/dL (females)
* blood urea nitrogen (BUN)\</=40 mg/dL
* all other clinical laboratory parameters (hematology, serum chemistry, and urinalysis) within normal limits or not clinically significant
* ECG normal, or abnormalities not clinically significant
* surgically sterile, postmenopausal, or using adequate contraception and have a negative pregnancy test at Screening
* willing and able to sign an informed consent form

Exclusion Criteria:

* diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis
* treatment with insulin, TZDs (excluding rosiglitazone) or any other oral or injected antidiabetic (excluding metformin or Avandamet) within 3 months prior to screening or during study treatment
* change in lipid-lowering medication within 2 months of screening
* taken systemic corticosteroids within 1 month prior to screening or during study treatment
* history of or current/active cardiovascular disease
* significant current pulmonary conditions
* significant thyroid disease
* CPK value \> 3x ULN
* a female who is pregnant or lactating
* systolic BP \> 160 mm Hg or a diastolic BP \> 90 mm Hg at screening
* previous or current history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to randomization
* liver function tests (ALT, AST, ALP) \> 2 times ULN, or active liver disease at screening
* history of positive HIV
* positive hepatitis B test at screening
* weight loss or gain \>/= 15 lbs within 3 months of screening
* history of substance abuse (including alcohol abuse) within 2 years prior to screening
* donated and/or received any blood or blood products within 3 months prior to randomization
* taken an investigational study medication within 30 days prior to screening or during the study
Gait and Alzheimer Interaction Tracking (GAIT) Study

The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

Although gait disorders are frequently associated with Alzheimer's disease (AD), few studies have focused on their characterization and mechanism. Exploring the associations of the gait characteristics - more particularly the gait variability - with the cognitive performance of AD patients on one hand, and with the morphological brain abnormalities on the other hand, could be useful to understanding the mechanisms of gait disorders in AD.

The main objective of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Able to walk without walking aid on 15 metres
* Score of Mini-Mental Examination (MMSE) \> 10
* Written informed consent to participate in the study (or trustworthy person)
* Being affiliated to a social security regime
* Near visual acuity ≥ 2/10
* Absence of severe depression (score in the 15-item Geriatric Depression Scale ≤ 10)

Exclusion Criteria:

* Score of Mini-Mental Examination (MMSE) ≤ 10
* Subject suffering from pre-existing impellent disturbances
* History of cerebrovascular accident or other cerebro-spinal pathology
* Poor workmanship of the written or oral French language
* Refusal of subject to be informed on possible hanging bare anomaly during study
* Use of walking aid
* Acute medical or surgical disease in the past 3 months
* Refusal to participate (or trustworthy person)
* Contra-indication to the achievement of a Magnetic Resonance Imaging
* Near visual acuity \< 2/10
* Presence of severe depression (score in the 15-item Geriatric Depression Scale \> 10)
A Website to Teach Children Safety With Dogs

Dog bites result in over 800,000 doctor/ER visits, 6000 hospitalizations, and a dozen deaths each year in the United States. By a large margin, children suffer the highest risk - and children typically are bitten by familiar dogs in familiar places. Several programs exist to reduce pediatric dog bite risk, but few are empirically-supported or theoretically-motivated. None are widely disseminated. This study builds from existing child dog bite prevention programs to develop and then evaluate a website to teach children safe interactions with dogs. The website will be interactive, entertaining, and engaging, allowing children (target ages 4-6) to learn in a technologically-sophisticated and interactive environment. It will be developed based in behavioral theory. Hearkening child development theory, it will teach and permit practice of cognitive skills that develop in early childhood and are critical to safety with dogs: impulse control, perspective taking, and attention to details. Hearkening health behavior change theory, the website will help children and their parents perceive personal vulnerability to bites, recognize normative behavior to protect themselves, and have personal motivation to change previous habits. Overarching the website design will be goals to create an engaging and entertaining environment, and to facilitate cognitive and behavioral change on the part of both child and parent via multiple mechanisms. Besides teaching children, the website will educate parents via an innovative messaging system triggered by child attainment of points and "skill levels".

Following website development, an evaluation study will investigate usability and efficacy of the website using a repeated measures pre-test, post-test experimental design. 68 children ages 4-6 will be recruited, complete a pre-intervention assessment evaluating knowledge and behavior relevant to dog safety via multiple methods, and then be randomly assigned to use either the newly-developed dog safety website or a control pedestrian safety website at home over the subsequent 2 weeks. Frequent reminders will encourage website use. Following the 2-week period, all children will return for a post-intervention assessment battery to evaluate knowledge and behavior change. Data will be analyzed using descriptive and inferential statistics, with primary hypotheses tested using linear mixed models.


Eligibility Criteria:
Inclusion Criteria:

* parent and child speak English,
* exposure to dogs with some frequency,
* internet access at home

Exclusion Criteria:

* physical or disability preventing valid participation in study
Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal abstinence syndrome (NAS)

Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.

A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with NAS

Eligibility Criteria:
Inclusion Criteria:

* Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
* Gestational age greater than or equal to 36 weeks
* Less than or equal to 48 hours of treatment with morphine for NAS

Exclusion Criteria:

* Presence of seizures
* Congenital malformations, genetic syndromes or the presence of TORCH infections
* Major medical problems
* Heart rate and/or blood pressure instability
Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease

This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects of repeated transcranial direct current stimulation for the treatment of apathy in moderate Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.

Forty patients were randomized to receive either active or sham-tDCS over the left dorsolateral prefrontal cortex (DLPFC). Patients received six sessions of intervention during two weeks and were evaluated at baseline, at week one and two, and after one week without intervention. Clinical raters, patients, and caregivers were blinded. The primary outcome was apathy. Global cognition and neuropsychiatric symptoms were examined as secondary outcomes.

Eligibility Criteria:
Inclusion criteria:

1. Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)
2. Possible Alzheimer's Disease defined by NINCDS-ADRDA (National Institute for Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
3. Mini Mental State Examination scores from 10 to 20
4. Apathy defined by a score equal or higher to 14 in Apathy Scale

Exclusion criteria:

1. Clinical instability
2. Epilepsy
3. Metallic clip in the head
4. Use of alcohol and psychotropic drugs
The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib

An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first Screening examination
* BMI: between 18 and 32 kg / m²

Exclusion Criteria:

* Regular use of medicines at the time of Screening, including prescription medications, herbal supplements and high dose vitamins
* Sitting systolic BP \> 140 mmHg or Diastolic BP \> 90 or \< 60 mmHg
* History of hypersensitivity or allergy
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study