cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy

The purpose of this study is to evaluate the efficacy and safety of RT001 in patients with Infantile Neuroaxonal Dystrophy (INAD).

This is a single arm open-label study with a structured observation of INAD patients treated with RT001. Enrolled subjects will undergo observation and testing to determine the effect of RT001 treatment. Fifteen to twenty eligible subjects will be treated with RT001 for long-term evaluation of efficacy, safety, tolerability, and pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 months to 10 years of age
2. Medical history consistent with the symptoms of classic INAD (onset of symptoms between the ages of 6 months and 3 years)
3. Homozygous for PLA2G6 deficiency (variant alleles may be mixed heterozygotes)
4. Must have impairment in at least 2 of the assessed categories at baseline
5. Signed informed consent form (ICF) prior to entry into the study
6. Able to provide the necessary blood samples

Exclusion Criteria:

1. Received treatment with other experimental therapies within the last 30 days prior to the first dose
2. Requiring mechanical ventilation, other than positive air pressure support primarily for mitigation of sleep apnea.
3. Have a life expectancy of less than one year
4. Diagnosis of atypical NAD (ANAD)
5. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled
PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

The purpose of this study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures).

The purpose of this study is to determine if inflammation around the spinal nerves can be identified using a radioactive tracer \[11C\] PBR28 and integrated PET/MRI scan for the purpose of better treating patients who have radicular lumbar pain with epidural steroid injections.

Eligibility Criteria:
Inclusion criteria for pain subjects:

1. Subject is 18-75 years old.
2. Subject is able to give written informed consent.
3. Subject is currently diagnosed with lower extremity radicular pain regardless of specific or suspected etiologies.
4. Subject has a clear dermatomal distribution of the painful area extending to the distal lower extremities.
5. Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale (VAS) during the week prior to enrollment.

Inclusion criteria for healthy subjects:

1. Subject is 18-75 years old.
2. Subject is able to give written informed consent.
3. Subject has no history of chronic back/spine pain.

Exclusion criteria for all groups:

1. Subject recently received a lumbar ESI (within 8 weeks).
2. Subject starts new NSAID medication for pain during the study.
3. Subject has predominantly axial low back pain.
4. Subject has known pain condition secondary to hip joint arthritis.
5. Subject is pregnant or breastfeeding.
6. Subject has allergy to lidocaine.
7. Subject is treated with chronic corticosteroid therapy.
8. Subject is on anticoagulation therapy (i.e. Coumadin, Plavix, or Lovenox).
9. Subject has a known bleeding disorder (i.e. hemophilia).
10. Subject has uncontrolled high blood pressure \[\>170/100\].
11. Subject has a known heart condition.
12. Subject has known inflammatory disease (i.e. inflammatory bowel disease; ankylosing spondylitis; etc.).
13. Subject has known liver dysfunction or renal insufficiency or impaired elimination (Renal dysfunction is defined as eGFR \< 60. Hepatic dysfunction is defined as LFTs ≥ 3x ULN).
14. Subject has been hospitalized recently (within one month) for a major psychiatric disorder (i.e. major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychosis).
15. Subject has contraindications to MRI and PET scanning (i.e. presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, or claustrophobia).
16. Subject had research-related radiation exposure in the last 12 months.
17. Subject tests positive for use of illicit drugs, marijuana, or non-prescribed drugs.
Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.

The images from MRI will be analyzed to obtain information of fat content in all eight segments of the liver. Demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to orthoptic liver transplant

Exclusion Criteria:

* Patient's who do not agree to sign consent
The Relationship Between Pes Planus, Diaphragm, Postural Control, and Plantar Pressure

Our primary aim is to compare diaphragm function (resting thickness, activity/resting thickness ratio indicating contractility), postural control, and plantar pressure between individuals with pes planus and healthy controls without pes planus.

Pes planus deformity, by causing pronation during standing, affects the biomechanics of the lower extremities. Improper foot positioning can lead to changes in load distribution under the sole, and consequently, abnormal tensions in the soft tissues of the feet can spread to the upper body parts through the myofascial system. In light of all this information, our primary aim is to examine the diaphragm function and thickness in individuals with pes planus deformity and healthy individuals, and to investigate the relationship between diaphragm thickness and balance. Additionally, our secondary aim is to evaluate the relationship between pes planus, diaphragm thickness, and balance.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for individuals with Pes Planus Deformity

* Willing to participate in the study voluntarily
* Having a Navicular drop test value of 10mm or above
* Being between the ages of 18-30
* Having the physical capacity to perform assessments and tests
* Having a body mass index of 18-25 kg/m²

Exclusion Criteria:

* Exclusion criteria for individuals with Pes Planus Deformity:
* Termination of voluntariness
* Those with rigid flatfoot, pes cavus, hallux valgus, hallux rigidus, or calcaneal spur deformity
* Those with chronic systematic and metabolic diseases (e.g., diabetes mellitus, rheumatoid arthritis, etc.) and musculoskeletal problems (e.g., pes planus) that may affect foot functions and gait
* Those with any surgical history likely to affect balance, lower extremity strength, and postural control
* Those with any visual/vestibular, musculoskeletal, or neurological problems"

Inclusion criteria for healthy participants:

* Willing to participate in the study voluntarily
* Being between the ages of 18-30
* Having the physical capacity to perform assessments and tests
* Having a body mass index of 18-25 kg/m²
* Having the ideal height of the medial longitudinal arch of the foot (not having pes planus)

Exclusion criteria for healthy participants:

* Termination of voluntariness
* Those with chronic systematic and metabolic diseases (e.g., diabetes mellitus, rheumatoid arthritis, etc.) and musculoskeletal problems (e.g., pes planus) that may affect foot functions and gait
* Those with any surgical history likely to affect balance, lower extremity strength, and postural control
* Those with any visual/vestibular, musculoskeletal, or neurological problems"
Effect of Alpha-lipoic Acid on Biochemical Markers and Important Outcomes in Patients Admitted to Intensive Care Units

Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, the investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that the investigators expect to stay for more than 7 days in this ward and who have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization the investigators will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18;
* expected length of stay more than 7 days;
* using enteral feeding method during admitted to ICU

Exclusion Criteria:

* having the history of autoimmune disease
* severe renal or liver failure
* AIDS,
* hepatitis;
* having severe malnutrition at the admission time;
* having TPN at the admission time in ICU;
* extreme intolerance to enteral feeding.
Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)

The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.

As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with PCOS. These adverse effects may ultimately increase the risk for serious long-term complications in PCOS, including type 2 diabetes and cardiovascular disease. The key objectives of this research study are to determine the effects of vitamin D supplementation on insulin resistance, inflammation, mood and overall well-being in women with PCOS.

The protocol has been modified by adding the following specific aim: To compare vascular function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. We are currently recruiting healthy women who are age and BMI similar to the PCOS women and measure their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular reactivity. These healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. They will not be enrolled in the placebo or Vitamin D randomization process as described above.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS based on:

  * Eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and
  * Elevated testosterone levels

Exclusion Criteria:

* Current Pregnancy or Nursing
* Elevated calcium
* Kidney Stones or kidney disease
* Current use of vitamin D (other than a multivitamin)
* Use of metformin or other insulin sensitizing drugs in the last 3 months
* Elevated prolactin or untreated thyroid disease
* Diabetes, Liver disease, Heart disease, or other serious medical condition
Vascular Closure Device in Transcatheter Aortic Valve Replacement

Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing transfemoral TAVI at the Karolinska University Hospital

Exclusion Criteria:

* Patients undergoing TAVI with access other than transfemoral
* Use of closure device other than MANTA
The Effect of Frailty to Perioperative Complications in the Elderly

With the progression of population aging, the number of elderly patients undergoing surgery is increasing as well. However, as the condition of health differs greatly between individual elderly patients even of the same age, it is a necessity to evaluate elderly patients thoroughly and individually for better management of perioperative care.

Frailty is a condition in which patients are impaired at physical reserve and homeostatic control. Frail elderly people are at higher risk of morbidity and mortality after exposure to a stressor. Frail patients are at higher risk of perioperative complications and longer hospital stay. However, there has been no standard criteria or tool to evaluate frailty in the elderly. Neither has there been enough evidence explaining the mechanism between frailty and increased perioperative complications. Therefore, in this study we aim to discover the relationship between frailty and intraoperative hemodynamic instability, as well as perioperative complications in the elderly patients, hoping to find an adequate and practical model for preoperative assessment in the elderly hopefully for better perioperative outcome.


Eligibility Criteria:
Inclusion Criteria:

* age≥65 years
* elective major non-cardiac surgery
* general anesthesia
* American Society of Anesthesiologists(ASA) grade I,II,III
* study protocol fully understood by the patients, written consent obtained

Exclusion Criteria:

* emergency surgery
* in active state of infection or inflammation
* chronic kidney disease(CKD) stage 5
* having conditions that would interfere accurate measurement of upper extremity blood pressure (e.g. subclavian artery stenosis)
* having conditions that would interfere assessment of frailty assessment (e.g. mental disorder, hearing disorder)
* study protocol not fully understood, no written consent obtained
Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels

The goal of this clinical trial is to determine if Qualia NAD+ effectively increases NAD+ levels in the blood and to evaluate its safety.

Researchers will compare Qualia NAD+ to a placebo (a look-alike substance that contains no active drug) to assess its efficacy in increasing NAD+ levels in the blood.

Participants will:

Take Qualia NAD+ or a placebo every day for 4 weeks. Undergo blood tests before and after the trial.


Eligibility Criteria:
Inclusion criteria:

Provide voluntary, written, informed consent to participate in the study Agree to provide a valid cell phone number and are willing to receive communications through text.

Healthy male and female participants between the ages of 40-65 years of age. Willingness to complete questionnaires, records, and diaries associated with the study.

Willing to not consume any supplements, energy drinks/shots, or other products containing any form of supplemental vitamin B3 (e.g., niacin, niacinamide, nicotinamide ribosome, NMN) starting about 2 weeks prior to the baseline NAD fingerstick test and continuing through the intervention period.

Willing to not begin taking any new supplements during the study period, and to continue taking any supplements they are currently using regularly (with the exception of vitamin B3 containing supplements).

Willingness to self-administer the intracellular NAD fingerstick test kit at home for both a baseline and post-intervention blood sample, and to complete a release form that gives researchers access to the results of these tests.

Exclusion criteria:

Women who are pregnant, breastfeeding, or planning to become pregnant during the trial Known food intolerances/allergy to any ingredients in the product Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer Having had a significant cardiovascular event in the past 6 months Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent
Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia

Aphasia is a language disorder that affects oral and written expression and/or comprehension. It's one of the most disabling consequence of stroke. Nowadays, aphasia rehabilitation is supported by speech therapists and is based on oral and written language, comprehension and expression. However recent studies have shown links between language and motor function (especially tool use). Two domains that share neural substrates (Broca's area, basal ganglia) and that can influence each other.

The aim of this study is to show that a motor training with a tool (pliers) can improve short-term and long-term language abilities of aphasic patients who had a stroke at least 3 months ago.

The investigators hypothesis is that there is a learning transfer between tool use and language abilities in aphasic patients with an inferior frontal gyrus (IFG) lesion caused by a stroke, thanks to their shared neural resources.

Investigators aim to study long and short-time effects of this tool motor training with three experiments:

* E1 will study short-term effects by estimating pre-post effect of a motor training on language abilities. Investigators will experiment different effectors: tool, hand, none (control group); on patients and healthy volunteers.
* E2 will study long-term effects with multiple single-case experimental designs (SCED). Patients will undergo four weeks of on-off design.
* E3 will study long-term effects by estimating the efficiency of an experimental sensorimotor protocol of four weeks, comparing a group of patients with the experimental sensorimotor protocol to a control group of patients


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Adult male or female aged 18 years and over
* Right-handed
* Having signed an informed and written consent
* Affiliated to a social security scheme
* Have French as their first language

For patients :

* Left inferior frontal gyrus lesion following a stroke
* Stroke more than 3 months old
* Aphasia proven by a pathological score on the A-2 test of the Syntax Comprehension Battery (BCS)

Exclusion Criteria:

For all participants:

* Cognitive abilities that prevent completion of the study tasks (assessed with the MOntreal Cognitive Assesment (MOCA))
* Language skills impaired by other disorders (for example neurodegenerative disease)
* Cognitive impairing treatments (for example psychotropic drugs)
* Neurovisual disorder (hemineglect, unilateral spatial neglect)
* Impairment of both upper limb abilities that prevent motor training (pathological score in the Purdue Pegboard Test and/or Box and Block Test).
* Recurrence of a stroke impacting the reorganisation of neural networks
* Persons deprived of their liberty by a judicial or administrative decision Persons of legal age under a legal protection measure (guardianship, curatorship)
* Pregnant women, women in labour or nursing mothers, confirmed by questioning the participant
* Participation in another study at the same time as this one
TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration

VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.

The VERTACL study is a multi-center, randomized, Phase II trial to investigate whether a triple therapy, Avastin®, half fluence verteporfin PDT, and TAC- PF, results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.

Participants will be randomized (similar to the flip of a coin) in a 1:1 ratio to one of the two study groups: single therapy (Avastin®), or triple therapy (Avastin®, half fluence verteporfin PDT, and TAC- PF). Participants in the Avastin® alone arm will receive 1.25 mg intravitreal Avastin®, at every study visit. Participants in the triple-therapy arm will receive all treatments (Avastin®, half fluence verteporfin PDT, and TAC- PF) at baseline.

Following baseline, participants in the triple therapy study arm will receive study treatment on an as-needed (PRN) basis if protocol-specific re-treatment criteria are met. After randomization, participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment.

Participants will return to the clinic at month 24 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography, and fundus photography.

Eligibility Criteria:
Inclusion Criteria Includes:

* Drusen \> 63 mm
* Choroidal neovascularization under the fovea (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
* Greatest linear dimension (GLD) of entire lesion \< 5400 µm (no reading center confirmation required)
* ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
* Total area of lesion must \< 9 MPS DA
* 0-3 intravitreal injections of anti-VEGF monotherapy within 6 months of randomization with continuing evidence of exudative activity confirmed by FA or OCT within 4-8 weeks after the last injection

Exclusion Criteria Includes:

* Oral steroid use within 6 months
* Prior complications from steroid therapy
* Prior stroke, myocardial infarction, or end-stage malignancy

Study Eye Exclusion Criteria

* Geographic atrophy or fibrosis under the fovea
* Fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring more than 50% of total lesion
* Prior treatment with verteporfin within 12 months
* IOP is \>25 mmHg and the participant is on Cosopt
* Intraocular surgery within 6 weeks
* Prior vitrectomy
* Peribulbar steroid injection within 6 months
* Poor reactions to topical or periocular steroid treatment including elevated IOP
Understanding the Impact of School-Based Physical Activity Programs

The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two innovative school-based physical activity programs (a walking/running program and a classroom activity break program) will increase school-time and total daily minutes children engage in moderate-to-vigorous physical activity, relative to controls, and that children who attend schools with these PA programs will demonstrate improved cognitive functioning, academic achievement, and attendance, relative to controls.

The FLEX Study is a three-year, randomized control trial that seeks to understand how two different innovative school-based physical activity (PA) programs influence not only children's time spent in MVPA but also their cognitive and academic outcomes. The FLEX Study will be implemented and evaluated by researchers from Tufts University. The project is funded by the National Institutes of Health.

Schools participating in the study will be randomly assigned to receive a walking/running program, a classroom physical activity program, or no program (control) during first year and a half of the study. Third and fourth grade children will be enrolled in the study.

Physical activity will be assessed objectively using accelerometry. Additional measurements will include: BMI/BMI-z (measured height and weight), diet and physical activity questionnaires, cognitive functioning (tests of working memory and inhibitory control).

Eligibility Criteria:
Inclusion Criteria:

Children participants 3rd or 4th grade student in participating school (during first school year of study)

Exclusion Criteria:

Not a 3rd or 4th grade student