cyrilzakka/clinical-trials huggingface dataset:
Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia

A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. The role of the right hemisphere in recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.

The investigators will evaluate, at inclusion and at 6 weeks, the reorganization of functional and structural brain connectivity maps before and after rehabilitation of aphasia with art therapy and standard orthophonic rehabilitation versus a control group that received only standard orthophonic rehabilitation.

The investigators will include all consecutive patients with recent ischemic or hemorrhagic stroke with unilateral lesion(s) of the parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute phase at 24-48h.

All patients will undergo 2 MRI with tensor diffusion sequences (structural connectivity) and fMRI (functional magnetic resonance imaging) resting state sequences (functional connectivity) at inclusion and 6 weeks after rehabilitation with or without art therapy.

The investigators aimed to demonstrate that early activation of the right hemisphere related to the practice of the visual arts could facilitate the recovery of language in later strokes completely disrupting the language areas of the left hemisphere.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recent ischemic or haemorrhagic stroke with unilateral lesion (s) of the parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute phase at 24-48h
* Post stroke delay of 15 days to 2 months
* Existence of moderate to severe phasic disorders on Aphasia Rapid Test score (ART, score\> 6, scale of 26 items)
* Patient able to read and understand French
* Rightful
* Normal and corrected vision and hearing
* Absence of pre-existing degenerative neurological disorder
* Patient having signed his consent
* Age ≥ 18 years

Exclusion Criteria:

* Patients with contraindications to MRI or claustrophobic
* Patients under legal protection
* Patients with behavioral disorders or disabling neurovisual disorders making participation in art therapy impossible
* Mute patients, illiterate patients
* Patients leaving the neurological SSR department prematurely
* Patients not affiliated to a social security scheme
* Pregnant or lactating women.
The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients

The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.

The study is a randomized controlled study with careful controls. Our study population is comprised of 240 BC patients in palliative and curative care (comprised of 50% Jewish and 50% Arab). This population will be randomized to receive a standard art therapy intervention or a comparison group. The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist The comparison group will engage in the coloring of prefabricated shapes (mandalas) and will receive Psychoeducation on topics related to coping with BC, identical to the topics of the AT group. This design will allow the study to test the mechanism of AT that is beyond the effects of time with a group, focus on a task and engagement with art materials.

Eligibility Criteria:
Inclusion Criteria:

* adult (\>18) females with initial or recurrent BC
* intervention can begin 3 months after finishing chemotherapy and radiotherapy (RT) and one month after surgery, up until 18 months after treatment completion.
* can complete assessments in Arabic or Hebrew
* provides informed consent.

Exclusion Criteria:

* male
* lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or with a pre- cancer diagnosis of fibromyalgia or chronic fatigue syndrome
* active suicidal plan (will ensure immediate intervention);
* dementia/other disorder that would preclude informed consent or comprehension of assessments
* Individuals taking anticholinergic medications, and post myocardial infarction (6 months before recruitment) or with a pacemaker, which would render the metric of HRV invalid.
* Flare-up in systemic autoimmune disease (such as arthritis, lupus or multiple sclerosis), thyroid dysfunction that requires increases in medication
Fluvastatin AmelIorates aTHerosclerosis Study

The study is designed to assess the effect of statin on atherosclesrosis progression as well as to explore its potential mechanism besides lipid modifying , such as effect on inflammation and vascular calcification.

Carotid IMT has been used in various studies (e.g. ASAP, ARBITER, METEOR) and is well accepted as a valid surrogate marker for atherosclerosis. The thickness of CIMT is significantly associated with the presence and the extent of coronary disease. Slower progression of atherosclerosis as measured by carotid ultrasound is also associated with a lower risk of nonfatal MI. In a meta analysis, for every 0.0 1-mm-per-year decrease in carotid IMT, there was a significant 18% reduction in the risk of nonfatal MI. Measurement of carotid IMT carries the advantage of being non-invasive and easy to use with a good degree of reproducibility.

Statins have been shown to slow the progression of atherosclerosis or even to induce regression of atherosclerosis. Change of carotid IMT by statins have been found to correlate with the extent of LDL-C reduction and HDL-C increase however non-lipid effects (e.g. effects on inflammation, calcification ) may also play a role in the beneficial effects of statins on atherosclerosis.Osteopontin (OPN), an acidic phosphoprotein, and osteoprotegerin (OPG), a member of the tumor necrosis factor-a receptor superfamily, have been recently demonstrated to modulate vascular calcification. Recent studies have shown an association of serum OPN and OPG levels with cardiovascular diseases and vulnerable carotid plaque .

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed coronary heart disease
2. One or more maximum IMT measurements of ≥1.1mm.
3. Age 45 to 70 years old
4. LDL-C≥130mg/dL
5. Not receiving regular lipid lowering treatment
6. Written Informed Consent

Exclusion Criteria:

1. Myocardial infarction as the first symptoms of coronary heart disease
2. Patients with known hypersensitivity to fluvastatin or any of the excipients
3. Pregnancy or lactation, or women of childbearing potential not using effective contraception
4. Known muscle disease or history of muscle disease (e.g. myopathy, myositis, rhabdomyolysis) and/or serum CK levels greater than 2 x upper limit of normal (ULN)
5. renal dysfunction
6. Active liver disease and/or serum transaminase levels (ALT, AST) greater than 2x ULN
7. Any conditions the investigator consider not suitable for long-term follow up
Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy

An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose.

An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose. Secondary objectives include to evaluate the anti-tumoral efficacy of AdVince infusions on metastatic neuroendocrine tumors, to determine the replication profile of AdVince and to determine the humoral (antibody) and cytokine-mediated immune response to AdVince. Minimum 12 and maximum 35 patients will be included, the number is based on the toxicity observed.

Eligibility Criteria:
Inclusion Criteria:

1. Subject´s written informed consent
2. Histologically and radiologically confirmed progressive neuroendocrine carcinoma of gastrointestinal, pancreatic or bronchial origin with multiple liver metastases. Progression in Clinical symptoms and tumor growth verified over the last 6 months on CT or MRI
3. Cancer that is not considered resectable for potential cure or tumor reduction
4. Patent portal vein and adequate liver perfusion
5. Liver dominant disease with involvement of \<60% of liver parenchyma
6. Karnofsky performance status of \>=70%
7. Life expectancy of \>=6 months
8. \>=18 years of age
9. Must use a reliable method of contraception if sexually active and of reproductive potential
10. Plasma creatinine \<105 ug/ml
11. Aspartate transaminase (AST), Alanine transaminase (ALT) and Alkaline Phosphatase (ALP) \<3.0-fold upper limit of normal
12. Total bilirubin \<2.0-fold upper limit of normal
13. Prothrombin time (PT)/International Normalized Ratio (INR) \<2.0 and Prothromboplastin time (PTT) within normal limits
14. Neutrophils \>1500/ml, hemoglobin \>100 g/L, platelets \>100 000/ml
15. Patients with functioning NET should have cover by somatostatin analog

Exclusion Criteria:

1. Known chronic liver dysfunction Before the development of metastatic cancer (e.g. cirrhosis, chronic hepatitis)
2. Active infection, including documented HIV and hepatitis C
3. Any viral syndrome diagnosed within the previous 2 weeks
4. Chemotherapy within the previous 4 weeks Before the first treatment
5. Radiotherapy to the target tumor site within the last 24 weeks from the baseline CT scan
6. Concomitant malignancy
7. Pregnant or lactating females
8. Prior participation in any research protocol that involved administration of adenovirus vectors
9. Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease
10. Continuing treatment with any other cancer therapy
The P4 Intervention Study to Improve Adolescent Health

The primary objective is to conduct a pilot study to determine the efficacy of evidence-based interventions delivered in primary care clinic settings on parent-teen health communication.

Primary care provides a means by which to connect evidence-based interventions with patients; however, many interventions have been evaluated using randomized controlled trials (RCTs) in non-healthcare settings.

The primary objective is to conduct a pilot study to determine the effect of evidence-based interventions delivered in primary care clinic settings on parent-teen communication about alcohol use, sexual health, and safe driving.

Eligible participants are healthy adolescent patients from the Children's Hospital of Philadelphia (CHOP) primary care network with a well-child visit scheduled between the ages of 14 to 17 years with one parent willing to participate. Adolescents that hold an intermediate driver's license, that are pregnant, or that have pervasive development disorder or a developmental delay are excluded from this study.

Parents will be given written psychoeducational intervention materials on communicating with their adolescents about alcohol use, sexual health, or safe driving (e.g.,booklets, tip sheet brochures, activity workbooks, web links), receive coaching about using the intervention materials, and provider endorsement of the materials during the well-child visit, as well as follow-up phone health coaching 2 weeks after the appointment.

The primary endpoints are evaluating the difference between the intervention and control groups on parent-teen communication on the targeted health topics.

Eligibility Criteria:
Inclusion Criteria:

1. CHOP Primary Care patient
2. Scheduled for a well-child visit that parent and teen both plan to attend within 3 weeks of enrollment
3. \[Teen Driving Arm Only\] Planning on having the medical certification for the permit application completed at their next well child visit and planning on taking their driving permit test in the next 8 weeks

Exclusion Criteria:

1. Not fluent in written or spoken English
2. Developmental Delay or Pervasive Developmental Disorder
3. Pregnant female
4. \[Teen Driving Arm Only\] Already has driving permit (has taken and passed the knowledge test) and/or the medical certification for the permit application was not completed at the well child visit
Local Vibration in Cervical Radiculopathy

The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy.

At least 34 patients diagnosed with cervical radiculopathy who meet the inclusion and exclusion criteria will be included in the study. Subsequently, the patients will be randomly divided into two groups. Patients in the first group will receive placebo local vibration application in addition to conventional treatment, while patients in the second group will receive local vibration application in addition to conventional treatment

Eligibility Criteria:
Inclusion Criteria:

* 1. Between the ages of 18 and 70,
* 2. Nerve root compression according to the magnetic resonance imaging,
* 3. Unilateral or bilateral neck pain rated 3 or higher on the Numeric Pain Rating Scale, or neck pain with paresthesia or upper extremity pain rated 3 or higher on the Numeric Pain Rating Scale.

Exclusion Criteria:

* 1. History of previous cervical or thoracic spinal surgery,
* 2. Symptoms or signs of upper motor neuron disorder,
* 3. Body mass index (BMI) higher than 35 kg/m2,
* 4. Having received spinal injection in the last two weeks,
* 5. Presence of local infection at the application site,
* 6. Upper extremity nerve entrapment syndrome (such as carpal tunnel or cubital tunnel syndrome),
* 7. Diagnosis of systemic inflammatory arthritis (such as rheumatoid arthritis, etc.),
* 8. Having engaged in strenuous exercise in the last 24 hours,
* 9. Poor or noncompliance to the treatment program
Comparison of the Effects of Vojta and Bobath Treatment on Gait and Balance in Diplegic Cerebral Palsy

This study aims compare the effects of Vojta verses Bobath therapy on gait in children with diplegic cerebral palsy and to compare the effects of Vojta versus Bobath therapy on balance in children with diplegic cerebral palsy. The study will also determine the combined effects of Vojta and Bobath on gait and balance in children with diplegic cerebral palsy.

The study may provide non-invasive and cost-effective treatment option in improving balance \& gait in children with cerebral palsy. This can increase the child independence, confidence and quality of life. Additionally, this study may contribute to the development of evidence-based rehabilitation protocols, which can help guide clinical decision-making and treatment options. The study may provide insight into the feasibility and safety of combining Vojta and Bobath treatments, which can guide future research and practice in this area. Moreover, combination of treatments may have better outcomes as compared to the two individual techniques. The study aims compare the effects of Vojta verses Bobath therapy on gait in children with diplegic cerebral palsy and to compare the effects of Vojta versus Bobath therapy on balance in children with diplegic cerebral palsy. The study will also determine the combined effects of Vojta and Bobath on gait and balance in children with diplegic cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of spastic diplegic cerebral palsy
* GMFCS level II \& III
* Modified Ashworth score greater than 1+
* Age 3-8 Years
* Either gender
* Children capable of understanding and executing commands;
* Children who can adopt the orthostatic position necessary to assess balance \& gait

Exclusion Criteria:

* Children with any other associated disease (DDH, any orthopedic complication)
* Children with mental retardation;
* Who cannot participate constantly in physical therapy sessions;
* Profound visual or hearing impairments;
The Effects of FES in a Variety of Walking Conditions in People With MS

The aim of this study is to measure the difference in the walking performance when functional electrical stimulation (FES) is on and off in people with MS that present foot drop under different 'real life' conditions, i.e. walking while doing another task that requires your attention and after been physically tired

People with Multiple Sclerosis (pwMS) often experience foot drop, which means that the foot is not adequately lifted from the ground when walking. Functional Electrical Stimulation (FES) is applied to the shin muscles to aid lifting the foot of the ground and reduces the risk of trips and falls. PwMS that are users of functional electrical stimulation (FES) report that one of the benefits is that it reduces the mental effort of walking and that as a result less concentration is needed when they walk. Motor fatigability, which is the reduced ability of the muscles to produce force or power, also negatively affects the walking performance of pwMS. There have been several studies showing the benefits of FES to the walking of pwMS, but not while performing two tasks at the same time and experiencing fatigability resembling more daily life conditions. The proposed study aims to investigate the direct orthotic effect of FES (FES on vs off) in three different conditions, which include just walking, walking while performing an attention-demanding task and walking with an attention-demanding task after having completed a fatiguing task. The study design of this research allows the quantification of benefits of the use of FES which have until now only be reported subjectively.

Eligibility Criteria:
Inclusion Criteria:

For people with MS:

* Clinically definite multiple sclerosis according to the revised McDonald criteria.
* People with EDSS ≤ 5.0.
* People with MS who experience foot drop.
* Able to walk at least 200 meters unassisted, i.e without walking aids.

For healthy participants:

* Not been diagnosed with any neurological disease or have any other condition or injury which will affect walking ability.

Exclusion Criteria:

For people with MS:

* Clinically diagnosed relapse within the last month.
* Any musculoskeletal impairment that can affect walking ability.
* Cognitive impairments; with a score in the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) ≤ 75.
* Depression and anxiety; with a score in Hospital Anxiety \& Depression Scale (HADS) \> 10.
Community-Based Physical Activity Intervention for Underserved Cancer Survivors

This clinical trial evaluates a community-based physical activity program for underserved cancer survivors. Cancer and its treatment significantly influence physical, psychosocial, and cognitive functioning. Historically, community sites (local and national) have not been staffed to offer support services such as physical, and occupational therapies (everyday life activities to promote health and well-being) or nutrition counselling, and do not offer a whole-person model of care. In this study, researchers have partnered with the YMCA to provide tailored home-based exercise programs for underserved cancer patients and survivors. Accessing exercise professionals may allow patients to prevent acute problems from becoming chronic, long-lasting physically weak impairments that directly influence patients' quality of life.

PRIMARY OBJECTIVE:

I. To assess the feasibility and acceptability of a community-based 12-week physical activity intervention.

SECONDARY OBJECTIVE:

I. To assess the effectiveness of a virtual physical activity intervention by evaluating pre-post changes in quality of life (QoL).

EXPLORATORY OBJECTIVE (OPTIONAL):

I. To virtually assess changes in functional performance in a small subgroup.

OUTLINE:

Participants participate in virtual exercise classes at least three times a week (TIW) over 20-60 minutes for 12 weeks. Participants are expected to work towards achieving the national physical activity exercise guidelines of 150 minutes of moderate intensity aerobic based physical activity and 2-3 strength training sessions each week.

After completion of study intervention, patients are followed up at 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Have had a previous cancer diagnosis OR are a caregiver for a patient who has had a previous cancer diagnosis
* Not in active treatment for cancer
* Over 18 years of age

Exclusion Criteria:

* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, atrial fibrillation (AFIB), multiple myeloma, or psychiatric illness/social situations that would limit compliance with study requirements
* Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
* Are pregnant or nursing
* Are unwilling or unable to follow protocol requirements
* Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System of Periodontitis

The goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using ELISA in obese individuals. Researchers will compare different stages of periodontitis to see if degrees of inflammation and periodontal therapy related obesity


Eligibility Criteria:
Inclusion Criteria:

* obese persons with Body Mass Index (BMI) more than 40 and suffering from periodontitis

Exclusion Criteria:

* Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
* Patients subjected to previous periodontal therapy 6 months before sampling. Patients with systemic or local inflammatory conditions other than periodontal disease.
* Neither lactating nor pregnant.