cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Pharmacokinetics Study of ATH-1020

This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy young and elderly subjects.

This is a Phase 1 first-in-human, 2-part adaptive study. Both Part A and Part B will be performed in a randomized, placebo-controlled, and double-blind manner.

Part A - Single Ascending Dose (SAD) Part A will be a SAD study investigating multiple dose levels of ATH 1020.

Part B - Multiple Ascending Dose (MAD) Part B will be a multiple ascending dose (MAD) study investigating multiple dose levels of ATH-1020.

Subjects in Cohort B5 (4 subjects) will additionally undergo CSF sampling pre-dose on Day 4 and up to 3 post dose timepoints to evaluate ATH-1020 blood-brain-barrier penetration

Eligibility Criteria:
Inclusion Criteria:

All Subjects

1. Body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m2 at Screening, with minimum weight of 60 kg.
2. Subjects in generally good health per the investigator's discretion.
3. Male subjects and their partners must be willing to comply with the contraceptive requirements of the study.
4. Subjects must have adequate venous access.

   Part A (SAD)
5. Male subjects aged 18 to 50 years at the time of signing the informed consent.

   Part B (MAD)
6. Male subjects aged 18 to 50 years (Cohorts B1, B2, B3, and B5); male and post-menopausal female subjects aged 65 to 85 years (Cohort B4) at the time of signing the informed consent.

Exclusion Criteria:

1. History of significant drug allergies (including to any excipients) or of anaphylactic reaction.
2. Any condition per the investigator's discretion, which while not requiring chronic medication use, is likely to require intermittent/acute therapeutic intervention.
3. Any history of seizures or loss of consciousness for an unknown reason.
4. History of or positive results of serology screening for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
5. Abnormal liver tests
6. Impaired renal function.
7. History of having taken another investigational drug within 30 days prior to Admission (Day -1).
8. Major surgery within 90 days prior to Admission (Day -1) or anticipated surgery during the study.

   Part A (SAD)
9. Female subjects are not permitted.
10. Any medical condition that requires chronic medication use.

    Part B (MAD)
11. A history of intermittent benzodiazepine (short-acting only) or other treatments for insomnia and anxiety are allowed, provided that the subject is able to abstain from their use during the Screening period, and from Admission until discharge from the study.
12. Reported changes in cognition and reported history of declines in everyday life in the last year.

    Part B (MAD) CSF Sampling (Cohort B5)
13. Subject history of or current contraindication to lumbar puncture/spinal catheterization.
14. Clinically significant abnormalities in coagulation parameters.
FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis

Giant cell arteritis (GCA) causes inflammation of the arteries and can lead to serious complications such as blindness, necessitating rapid diagnosis and treatment. Although older technology non-digital PET/CT scans are routinely used for the diagnosis of GCA in large arteries, they have not been able to reliably detect inflammation of the small arteries responsible for blindness. Recent technological advances have enabled PET/CT imaging of millimetric disease in the body, which are now able to resolve small arteries. In the proposed research study, patients who are suspected by their doctors to have GCA will undergo an ultrasound of the temporal arteries, and digital PET/CT scan after injection of radioactive glucose. Digital PET/CT scans will be interpreted for the presence of abnormal uptake in the large and small arteries, as well as for the presence of other causes of the patient's symptoms. The diagnostic accuracy of PET/CT and ultrasound will be evaluated with respect to an expert panel diagnosis of giant cell arteritis and compared. Results will be adjusted for lack of a perfect reference test using advanced statistics. The goal will be to see if digital PET/CT can become a single, integrated test to diagnose this disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years, capable and willing to provide informed consent and can tolerate PET/CT.
* ESR ≥ 50 mm/h and/or CRP ≥ 10mg/L within 1 week of PET/CT referral.
* New suspected giant cell arteritis according to at least one of the following criteria:

Cranial GCA symptoms (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, masseter pain on prolonged mastication) PMR symptoms: shoulder and/or hip girdle pain associated with inflammatory stiffness.

Suspected large-vessel vasculitis based on angiography, MRA, or CTA.

Exclusion Criteria:

* Initiation of corticosteroid or immunosuppressive therapy \>4 days before PET/CT.
* Prior TAB or treated GCA with suspected relapse.
* Non-fasting or hyperglycemia (\>11.1 mmol/L) resulting in altered FDG biodistribution.
Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback (NFB), may represent a new therapeutic opportunity for patients with Attentional Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and inhibitory control. In this context, the investigators have focused on an attention-enhancing form of NFB based on the EEG alpha rhythm, known to influence sensory detection and attention. In light of recent evidence showing that both attention and impulsivity can be modified with a single-session of alpha-NFB, the objective is to determine whether these effects stabilize in the long-term, after multiple, daily sessions of training at home.

A short- (single-session) and a long-term (multi-session) experimental design will be used to collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL groups. Each participant will undergo individual at home sessions of 45-minute video-replay of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5 sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm will be reflected in the dynamically varying opacity of the video-replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively. In the CONTROL group, the recording will be passive without real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home training, each participant will have two visits in the lab: (1) complete clinical and neuropsychological evaluation and (2) EEG session including resting state and task-related EEG before and after a short NFB intervention (30 minutes). For the CONTROL group participants, the latter will be replaced by a sham intervention utilizing non-contingent feedback.

Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power and (ii) the degree of normalization will be a dimensional predictor of individual improvement in behavioral and clinical measures of executive function, impulsivity and inattention. These results should lay the foundation for building neurocognitive treatments, by harnessing neuroplasticity mechanisms intrinsic to the brain.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ADHD
* Currently stabilized (euthymic)
* General good health
* Normal or corrected-to normal visual acuity

Exclusion Criteria:

* Mood Disorders
* PTSD
* Borderline Personality Disorder
* Substance Use Disorder
* Structural Brain Abnormalities
* Cerebrovascular Disease
* Epilepsy
* Stroke
* Head Trauma
* Cardiovascular Disease
* Renal Failure
* Hepatic Dysfunction
* Impaired visual acuity
Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

The purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age (no upper age limit)
2. AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
3. Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
4. Scheduled for definitive CRT as primary treatment of their oropharynx cancer

Exclusion Criteria:

1. Prior history of radiation therapy to the head and neck
2. Prior history of mucosal head and neck cancer.
3. Not willing or able to comply with study specific procedures
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

The exploratory objective of this pilot study is to evaluate the feasibility and safety of an enhanced recovery protocol that will allow adult patients to be discharged to home on an oral antibiotic regimen for three days following a laparoscopic appendectomy for complicated appendicitis. Feasibility will be determined by high compliance and adherence of patients to the postoperative instructions, while safety will be assessed by the incidence of postoperative infectious complications and requirement for re-admission.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18 and 65 years of age.
* Patients undergoing a laparoscopic appendectomy.
* Diagnosis of complicated appendicitis based on pre-operative imaging or intra-operative assessment. The definition of a complicated appendicitis will include: (a) perforated appendicitis, without generalized peritonitis; (b) gangrenous appendicitis, without generalized peritonitis; (c) suppurative appendicitis; (d) iatrogenic perforation of the appendix.
* Meet criteria for discharge from the post-anesthesia care unit (PACU).
* Ability to reliably follow up with the study procedures.

Exclusion Criteria:

* Age \< 18 years or \> 65 years.
* Pregnancy.
* Homelessness.
* Patients who present with generalized peritonitis.
* Patients with comorbid conditions, including diabetes mellitus, immunosuppressed state for any reason, patients on chronic anticoagulation (excluding Aspirin 81 mg).
* Patients who present with septic shock.
* Patients who require conversion to an open appendectomy.
* Patients who present with additional findings on imaging studies or intra-operatively, including ileus or small bowel obstruction.
* Based on surgeon's clinical judgment for reasons that may not be outlined above.
* Allergy or intolerance to study medication(s)
Olive Leaf Extracts in the Control of Cardiovascular Risk

This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

Patients over 18 years of age with:

1. Arterial hypertension (hypertension).
2. Or diabetes.
3. Or one or more other cardiovascular risk factors (AHA, ESC) or risk of cardiovascular disease\> 20% according to the Framingham scale (apart from hypertension and diabetes were included.

This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

All the population will benifit of a biological assessment which include:

* Complete lipid profile, blood sugar, creatinine
* HbA1c (if the patient is diabetic).
* Inflammatory assessment: reactive protein C

Three populations will be randomized:

1. The population of patients with hypertension.
2. The population with diabetes.
3. The population of patients with other risk factors with a Framingham\> 20% In each study population, the patient will be assigned to one of two treatments (atherolive or placebo). The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.

For patients in the hypertension group:

A blood pressure or glycemic holter will be carried out for 24 hours respectively and diabetics.

The raw data (hourly averages) are stored on a computer .

For diabetic patients:

Continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. These patients will be equipped with an iPro continuous glycemic monitoring

For other patients (Framingham\> 20%) For this group, the initial assessment will also include a specific assessment. Assessment of endothelial function by the digital plethysmography method to measure flow-mediated dilation (FMD or flow-mediated dilation expressed by the RHI) and specific biological assesement ( Willebrand factor, Homocystein )

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with:

  1. Arterial hypertension (hypertension).
  2. Or diabetes.
  3. Or one or more other cardiovascular risk factors (AHA, ESC) or risk of cardiovascular disease\> 20% according to the Framingham scale (apart from hypertension and diabetes.

Criteria exclusion:

-. Exclusion criteria: None.
Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

A study to assess multiple ascending doses of AR882 in healthy adult males.


Eligibility Criteria:
Inclusion Criteria:

* Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and \< 9 mg/dL (535 µmol/L)
* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
* Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History and/or presence of drug addiction or excessive use of alcohol
Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia

This cluster randomized controlled trial is to examine whether decision support for goals of care can improve quality of communication and decision-making and improve the quality of palliative care for nursing home residents with advanced dementia.


Eligibility Criteria:
Inclusion Criteria:

* Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia

Exclusion Criteria:

* Non-related legal surrogate without personal knowledge of resident
LC Bead LUMI for Prostatic Artery Embolization

Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.

Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.

Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.

This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size

Eligibility Criteria:
Inclusion Criteria

1. Male
2. Age \> 40
3. Prostate gland \>50 grams as measured by pre-procedural CT angiogram (CTA)
4. Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
5. Moderate to severe LUTS as defined by IPSS score \>18
6. Peak urine flow rate (Qmax) \<12 mL/sec
7. Capable of giving informed consent
8. Life expectancy greater than 1 year

Exclusion Criteria

1. Severe vascular disease
2. Uncontrolled diabetes mellitus
3. Immunosuppression
4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
5. Complete urinary retention
6. Impaired kidney function (serum creatinine level \> 1.8 mg/dL or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
7. Confirmed or suspected bladder cancer
8. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
9. Ongoing urogenital infection
10. Previous pelvic radiation or radical pelvic surgery
11. Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (\> 10 ng/mL or \> 4.0 ng/mL and \< 10 ng/mL with free PSA \< 25% of total PSA without a negative biopsy).
12. Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000
13. Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.

Psychological distress is common among adults newly diagnosed with cancer and those awaiting cancer treatment(s). Although preoperative psychological distress has been shown to be associated with poorer physical health and adverse treatments among colorectal cancer survivors, few psychological interventions have been developed to reduce distress, and improve physical health in the preoperative period. Moreover, whether a preoperative psychological intervention, delivered in addition to a multimodal Prehabilitation program can improve psychological and physical health remains unknown. Therefore, the purpose of this pilot cohort study was to examine the impact of a structured psychological intervention, given in addition to standard Prehabilitation, on preoperative psychological health and functional capacity in colorectal cancer patients awaiting surgery.

All participants will receive a multimodal prehabilitation program preoperatively for 4 weeks, composed of three elements: aerobic and strength training exercise program, nutritional counselling and psychological support. The exercise program will be three times per week and include a combination of home-based (twice per week) and supervised (once per week) sessions. Participants' nutritional status and dietary intake will be assessed by a registered dietician/nutritionist, and a whey protein supplement (Immunocal) will be prescribed to achieve a daily intake of 1.5 g protein/kg. Psychological support will consist of a 90-minute interview/session at baseline and weekly in-person follow-ups before surgery aimed at reducing psychological distress and improving adherence to the exercise program and nutritional recommendations. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

Eligibility Criteria:
Inclusion Criteria:

* Currently aged 18 years or older
* Diagnosed with non-metastatic, colorectal cancer
* Awaiting resection of malignant colorectal lesions
* Able to provide informed consent in English or in French

Exclusion Criteria:

- Have health condition(s) interfering with ability to safely perform exercise at home or to complete testing procedures (e.g., non-ambulatory, dementia, severe end-organ disease, morbid obesity, cardiac abnormalities)
Open Label, Dose Escalation Phase I Study of AZD2281

The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

* Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea.
Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression

The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 25 to 65 included
* Information and signed informed consent
* Patients with a diagnosis of major depressive episode in remission
* MADRS score between 14 and 22
* Patients with residual symptoms as assessed by MADRS items
* No cognitive impairment.
* Right-handed

Exclusion Criteria:

* Subjects with legal incapacity or limited legal capacity
* Subjects unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
* Pregnant women
* Subjects in the exclusion period of another study or is on the "national volunteer list".
* Subjects with another psychiatric pathology (bipolar mood disorder, psychosis, obsessive-compulsive disorder, addictive pathology, schizophrenia)
* Subjects under a protective measure such as guardianship or safeguard of justice.