cyrilzakka/clinical-trials huggingface dataset:
Neuroform Atlas Stent for Intracranial Aneurysm Treatment

The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

The study is a prospective, multicenter, open-label, single arm post market follow-up registry designed to demonstrate the potential treatment of intracranial, saccular aneurysms with the Next Generation Neuroform Stent System. The study will evaluate the permanent morbidity and mortality rate within the 12 to 16 months following the procedure. The study will evaluate as well the percent occlusion of the treated target lesion on angiography in the absence of retreatment, or parent artery stenosis at the target location at 12 to 16 months. Subjects with documented saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has an intracranial aneurysm for which an endovascular treatment requiring stent assisted intracranial aneurysm coiling has been decided by the site investigator
2. Patient or legal representative is willing and able to provide written informed consent
3. Patient is willing able to comply with scheduled visits and examinations per protocol requirements

Exclusion Criteria:

1. Patient that is younger than 18 years old at the time of entry into the study
2. Patient with mRS \> 3
3. Patient has a saccular ruptured aneurysm \< 3 months
4. Patient has a fusiform aneurysm
5. Treatment of several aneurysms during the same procedure, except adjacent aneurysms treated with the same stent
6. Planned treatment of other aneurysm in the same vascular territory within the study time period
7. Patient with severe vasospasm that does not respond to pharmacological therapy
8. Aneurysm associated with an arteriovenous malformation, or any other lesion that could lead to hemorrhagic complications
9. Pregnant woman or child feeding
10. Any condition which will not allow the patient to comply with the necessary follow-up for this study (medical condition, patient leaving abroad)
11. Patient with confirmed allergy to nickel titanium (Nitinol)
12. Patient in whom antiplatelet and/or anticoagulation therapy is contraindicate
13. Patient for whom angiography and other examinations show that access to the target cerebral aneurysm by the stent may be impossible because of anatomical features
14. Patient for whom angiography and MRA/MRI is contraindicated
15. Patient with target aneurysm previously treated with a stent -
A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits

The overarching purpose of this project is to provide diabetes education to the diverse patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at California Pacific Medical Center. Because of high clinic volume in a teaching environment, our patients often experience long wait times. The goal of this program is to utilize this wait time for diabetes education, a much-needed corollary to the eye care that patients receive at our clinic.

This pilot project will investigate the impact of a program like this in our patient population. Specifically, the investigators are investigating whether diabetes education delivered in an ophthalmology setting enhances patient understanding of diabetes (via knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This is a 6-month study that runs through April 2015, and looks at the impact of an interactive diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of patients who meet with a diabetes educator will also be shown their own retinal images (compared to a normal retina).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes (as defined by evident systemic findings OR recent hemoglobin A1c OR patient report, as specific blood sugar data and knowledge of particular medications are often limited in this population)
* Age 18-75
* Able and willing to provide informed consent
* Speak English, Spanish, or any other language for which a translator is present

Exclusion Criteria:

* Advanced visual acuity loss in both eyes which prevents adequate use of educational tools
* Pregnant women, elderly patients (\>75 years old), children and adolescents (17 or younger)
* Non-English/Spanish speakers for whom a translator is not present
Improving Activity Engagement Among Persons With SCI During COVID-19

During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. Unfortunately, this can lead to negative effects including increase in emotional distress, feelings of isolation, and decreased activity engagement. Due to their limited mobility and greater likelihood of respiratory illness it is imperative to provide alternative forms of activity engagement to reduce their risk for secondary complications. Physical activity has been demonstrate to have numerous benefits for individuals with SCI ranging from enhanced health through prevention of secondary complications to improved subjective well-being. The current study proposes to provide an online physical activity program through web-based videoconferencing to person with SCI to improve overall wellbeing and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived experience and a Kinesiology graduate student will lead online sessions. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and guided meditation. In all cases, remote (i.e., in-home) participant monitoring of physiological signals will be conducted by the instructor to ensure safety of participants. Once the program has been completed, participants will be asked to complete self-report questionnaires related to acceptability, feasibility, and limited effectiveness. Participants will also be asked to complete a brief semi-structured interview examining barriers and facilitators of the program. Participant feedback from the interviews will be used to further develop of the program to meet the needs of the population and develop sustainable approaches for access to care in the community setting through collaborations with community partners (SCI Ontario, National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those with SCI during the COVID-19 quarantine.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years or older; living with a spinal cord injury; living in the community in Ontario; access to a computer and internet

Exclusion Criteria:

* Not cleared by a physician to participate
Holistic Approaches to Depression

The purpose of the study is to investigate whether yoga or a health education group alleviate depressive symptoms for an individual with a partial response to antidepressant medication.


Eligibility Criteria:
Inclusion Criteria:

1. Meets criteria for major depressive disorder (MDD) within the past two years; no history of bipolar disorder, schizophrenia, or psychotic symptoms in one's lifetime.
2. No current hazardous drug/ alcohol use.
3. Depression symptom severity. Participants must have a Quick Inventory of Depressive Symptoms (QIDS) score greater than or equal to 8 and less than or equal to 17.
4. Benefit from current treatment. Participants must report at least some benefit from their current antidepressant.
5. No significant suicidality, defined by a QIDS item #12 score \< 2 or PI judgement.
6. Currently taking an antidepressant for depression, at a minimally therapeutic dose. Participant has been taking an antidepressant for at least 8 weeks.
7. Antidepressant dose has not changed in the 4 weeks prior to study entry; Not planning to change antidepressant dosage in next 10 weeks.
8. (If in psychotherapy). Therapist and therapy frequency has not changed in the past 6 weeks AND not planning to change it in the next 3 months.
9. Medically cleared for moderate exercise, documented by a note from their primary care provider.
10. Not pregnant or planning on becoming pregnant in the next year.
11. Naïve to study interventions. Participants cannot have had \> 4 single sessions (or \> 8 total hours class time) of yoga, other classes in "mindful exercise," (e.g., qigong, tai chi), mindfulness based stress reduction, or health education in the past year or \>8 single classes of yoga within the past 2 years of the same. Participants can not have practiced yoga at least once per week for 8 weeks in a row in the past 5 years.
12. Does not practice meditation at home weekly or more often.
13. Understands English sufficiently well to complete study assessment.
14. Biomarker exclusions. Participants who are taking oral steroids, insulin or oral hypoglycemic agents, or oral antibiotics, or who refuse blood draws, will not participate in the biomarker component of the study; however, they may participate in the rest of the study.
Intraoperative VR for Older Patients Undergoing TKA

The objective of this study is to investigate whether the use of virtual reality (VR) during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative requirements while maintaining high levels of patient satisfaction as compared to both a music and sham VR + usual care control.

The investigators will conduct a three-armed randomized controlled trial with the following aims:

Specific Aim 1: Evaluate whether the use of VR during TKA can facilitate a reduction in intraoperative propofol dose required for patient comfort as compared to music and sham VR + usual care controls.

Hypotheses: Patients in both the VR and music groups will demonstrate reductions in propofol dose compared to sham VR + usual care controls. A reduction in propofol dose between the VR and music group will be smaller in magnitude.

Specific Aim 2: Assess the effect of VR during TKA on patient reported outcomes including overall satisfaction, pain, and anxiety as compared to music and sham VR + usual care controls.

Hypotheses: Patients in the VR group will report significantly higher satisfaction and better control of pain and anxiety than those in the music group and usual care group.

Specific Aim 3: Explore the potential effects of VR during TKA on other key secondary outcomes of perioperative efficiency, postoperative cognition, and functional recovery.

Hypotheses: Patients in the VR group will have shorter post-anaesthesia care unit (PACU) length of stay as compared to sham VR + usual care controls. The effect of VR on postoperative delirium, postoperative cognitive decline, postoperative opioid use and functional recovery will be exploratory endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia

Exclusion Criteria:

* Complex or revision surgeries
* Patients scheduled for "same day" TKA
* Open wounds or active infection of the face or eye area
* History of seizures or other symptom linked to an epileptic condition
* Patients who plan to wear hearing aids during the procedure
* Patients with a pacemaker or other implanted medical device
* Droplet or airborne precautions (as determined by local infection control policy)
* Non-English speaking or Non-Spanish speaking
* Patients booked to receive general anesthesia
* Moderate to severe dementia

Drop-Out Criteria:

* MoCA \<10 (this test will be administered on Day of Enrollment)
Study Watch Atrial Fibrillation (AF) Detection Investigation

This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Able to read and speak English
* Able and willing to sign written Informed Consent
* Interest in participating in the study
* Subjects with a known history of AF (including persistent or paroxysmal AF)
* Without significant limitation in ability to participate in the study, in the opinion of the investigator.

Exclusion Criteria:

* Currently in a paced rhythm
* Known severe allergy to nickel or metal jewelry
* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
Mechanism of Serum PRL in the Development of MAFLD

Metabolic associated fatty liver disease (MAFLD) has currently reached a worldwide epidemic. Serum PRL levels within or outside physiological range have been found to affect metabolic homeostasis differently. However, the relationship between serum PRL and MAFLD among diabetic patients is unclear. The investigators aimed to explore the association between serum PRL and the risk of MAFLD in patients with type 2 diabetes (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* aged 18\~65 years old,
* underwent the laboratory tests, hepatic ultrasonography, and valid transient elastography (FibroScan) examination

Exclusion Criteria:

* other known chronic liver diseases, such as chronic hepatitis B or C, autoimmune hepatitis, and haemochromatosis
* pre-existing active cancer, renal dysfunction, severe liver dysfunction, congestive heart failure or free abdominal fluid
* history of hyperthyroidism or hypothyroidism, pituitary diseases, and other types of diabetes
* significant alcohol consumption
* pregnancy
* receiving any therapeutic methods that could lead to liver steatosis or fibrosis, influence the glucolipid metabolism, or PRL levels, such as lipid-lowering, and PRL-lowering agents (bromocriptine) within 6 months prior to this study.
Sirolimus for Massive Polycystic Liver

The purpose of this study is to evaluate the effectiveness and safety of Sirolimus in reducing liver volume in autosomal dominant polycystic kidney disease.

Autosomal dominant polycystic kidney disease (ADPKD) is one of the most common causes of end stage renal disease (ESRD), affecting an estimated 0.2% of population. Of ADPKD patients, 58% in 15-24 year, 85% in 25-34 year, and 94% in 35-46 year olds suffer from polycystic liver in addition to polycystic kidneys. Several anti-proliferative drugs have been used in clinical trials to stop cyst growth both in liver and kidneys. Among them, octreotide and sirolimus have been shown to be one of the most promising drugs to reduce cyst volume. Sirolimus already has been used as one of the most potential oral immunosuppressants. Moreover, the serum trough level is quite easy to measure. Sirolimus is the mTOR inhibitor that has been proven to be effective in reducing cyst growth both in animal models. However, its efficacy and safety is not well proven in previous studies. This is a open-label, prospective study to evaluate the effectiveness and safety of Sirolimus to reduce cyst growth in ADPKD patients with massive polycystic liver.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65
* Patients diagnosed as ADPKD based upon the unified criteria for ultrasonographic diagnosis of ADPKD
* Polycystic liver with total liver volume \> 2500 mL or symptomatic polycystic liver
* Estimated glomerular filtration rate (IDMS-traceable MDRD equation) \>= 30 mL/min/1.73m2

Exclusion Criteria:

* Concomitant systemic renal parenchymal or urinary tract disease (random urine albumin-to-creatinine ratio \> 500 mg/g)
* WBC \< 4,000/uL, platelet \< 100,000/uL, or hemoglobin \< 10.0 g/dL
* Diabetes mellitus, cancer, or psychiatric disorder
* Increased liver enzymes (2-fold above normal value)
* Hypercholesterolemia (fasting cholesterol \> 200mg/dL) or hypertriglyceridemia (\>150 mg/dL) not controlled by lipid lowering therapy
* Infection with hepatitis B, C, HIV
* Any condition that could prevent full comprehension of the purpose and risks of the study
* Pregnant or lactating women or fertile women without effective contraception
* History of intervention, such as cyst aspiration or embolization in past 1 year
Neurocognitive Enhancement in Major Depressive Disorder

The purpose of this study is to examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. Subjects in this study will be randomized to receive Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises. Additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female.
2. Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.

Exclusion Criteria:

1. Presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury.
2. Subjects with a reading level below grade 6, as assessed with the Wide Range Achievement Test - Reading Recognition Subtest, will be excluded because of the likelihood of not understanding task instructions.
3. Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.
Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care

this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact of these pharmacodynamic parameters on the clinical and microbiological VAP will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Use of mechanical ventilation for more than 48 hours
2. Clinical suspicion of ventilation-acquired pneumonia (VAP) defined by new radiological persisting infiltrate (or ARDS) AND one of the following features:

   purulent tracheal aspirates OR temperature ≥ 38.3°C OR leukocytosis\> 10 giga/L
3. High risk of multidrug-resistant bacteria, defined as either at least 6 days of mechanical ventilation OR antibiotic treatment in the previous 15 days
4. Implementation of a prior distal respiratory sample for microbiological diagnosis by bronchoalveolar lavage (BAL) OR distal sampling by protected catheter (PDP)
5. Age ≥ 18 years
6. Implementing a medical examination
7. Obtain the written consent of the patient, one of its relatives or trusted person previously designated or emergency clause.

Exclusion Criteria:

1. Pregnant woman
2. Expected death within 72 hours of diagnosis of VAP patient
3. Dialysis
4. No affiliation to a social security scheme (beneficiary or legal)
5. Contraindication to one of classes of molecules used antibiotics (β-lactam / Fluoroquinolones / Aminoglycosides), contained in the Summary of Product Characteristics for authorization on the market.
An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of common wart(s)
* Ages between 3 to 11

Exclusion Criteria:

* Other types of wart(s), ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C
A Qualitative Investigation of CLEAT Participants

As the United Kingdom's National Health Service (NHS) waiting list soars above seven million people, with treatment wait times over two years, older people with chronic conditions face worsening symptoms, increased use of medications, more complicated surgeries with slower recovery, reduced quality of life, and loss of independence. As part of its plans to tackle this crisis, the NHS promotes exercise as a "miracle cure" for arresting the progress of disease and helping disease management and recovery. However, current plans promoting individual, home-based exercise, as well as on-site hospital-based programs of delivery, have met with only limited success, and face problems of decreased space, capacity, clinician time, as well as lack of knowledge and expertise with regard to effective behavior change. We have developed a community-based group exercise programme for older people with hip osteoarthritis. This community-based group exercise programme has successfully helped those with hip osteoarthritis (3.5 million over 45s in the UK) reduce pain and need for medication, as well as avoiding surgery, and has formed part of an NIHR trial examining the use of exercise and education versus standard physiotherapy care for the treatment of hip osteoarthritis. In order to better understand the mechanisms of action of this programme, the present study will examine, via focus groups interviews, the experiences of participants who have undertaken the exercise and education programme. The data generated from the focus groups will help to elucidate what "works" within the programme and will help inform future development of resources to support health professionals in providing exercise rehabilitation for older people with chronic conditions.


Eligibility Criteria:
Inclusion Criteria:

Participants who had previously been part of the NIHR-funded CLEAT trial. Those participants were defined as follows:

* Diagnosed with osteoarthritis of the hip as per NICE criteria.
* Male and female, aged 45 years and over
* Meeting the GP criteria for exercise referral
* Capable of giving informed consent
* Be able to understand English as necessary to benefit from the intervention, in the investigators' opinion.

Exclusion Criteria:

• Anyone not previously part of the NIHR-funded CLEAT trial. -
EMG Finding According to the Type of Lumbar Disc Herniation

Disc herniation is a common cause of low back pain and leg pain. Electromyography is the only test that can objectively examine nerve damage caused by a lumbar disc herniation. This study aimed to compare the MRI findings of disc herniation and the aspects of electromyography.


Eligibility Criteria:
Inclusion Criteria:

* Radicular pain within 6 months
* Disc herniation confirmed by lumbar MRI
* undergoing electromyography

Exclusion Criteria:

* Patients who refused electromyography
* Patients taking warfarin
* Lower limb amputation patient
* Pregnant women
* Patients who have undergone surgical treatment for disc herniation
* Patients with peripheral neuropathy ( AIDP, CIDP, diabetic amyotrophy, peroneal pals et al.)
Slow Coronary Artery Flow: Influence on Morbidity and Mortality

To compare patients with Slow Coronary Artery Flow to patients with normal flow and to determine whether there is a difference in their future incidence of heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent coronary angiography

Exclusion Criteria:

* Patients with coronary occulsion above 50%
* Patients with severe valve disorder