cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity

Prospective single center study to evaluate the safety and effectiveness of Restylane Silk for treatment of tear trough correction.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 21 and 65 years old
2. Tear trough deformity, Hirmand Type-1 and Type-2
3. Is voluntarily willing to consent to participate in the study
4. Is willing to comply with all requirements of the study including being photographed, follow post treatment care instructions, to attend all treatment, and follow up visits
5. Willingness to waive rights to use of still photos of themselves for research, marketing, or promotional reasons, including on the internet and on social media outlets.
6. Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study.
7. Ability to provide informed consent.

Exclusion Criteria:

1. Marked delineation of the inferior orbital rim in the lateral aspect of the eyelid/orbit
2. Use of botulinum toxin in the periorbital region within the past 6 months.
3. Treatment with injectable fillers in the midface or periorbital region within the past 2 years or treatment at any time in the past with a permanent filler in the midface or periorbital region such as silicone, or PMMA (Artefill)
4. Laser skin resurfacing of the periorbital region within the past one year.
5. History of lower eyelid blepharoplasty or periorbital surgery in tear trough region.
6. The subject has a coagulation disorder or is currently using anti-coagulation medication
7. History of facial nerve palsy.
8. Inability to discontinue the use of nonsteroidal anti-inflammatory drugs or anticoagulants prior to treatment.
9. Current participation in another active clinical trial protocol
10. Presence of malar festoons
11. Active cutaneous infections
12. Allergy or sensitivity to benzocaine, lidocaine, prilocaine, or tetracaine.
13. Pregnant or nursing females
14. Other factors as deemed by the Principal Investigator that would make a subject unqualified for participation.
15. The subject has a history of keloids or compromised wound healing
16. The subject has a known adverse reaction to previous injection with hyaluronic acid or other subcutaneously injected device
Paternal Involvement in Psychiatric Care of Adolescents Managed for Depression or Suicide Attempt

Parental involvement, both quantitative and qualitative, is fundamental for a good psycho-emotional development of the child. The lack of parental involvement and especially paternal involvement significantly promotes the occurrence of behavioral disorders in children and later, in adolescence, the onset of depressive symptomatology. On the other hand, parental involvement has a protective role in the occurrence of behavioral disorders and decreases the risk of suicide attempts in adolescence. The authors of these cohort studies agree on the need for research on the identification of factors determining paternal involvement in order to organize specific prevention actions and targeted interventions to promote the involvement of fathers in psychiatric care of their adolescents.

The prevention of adolescent suicide attempts appears to be a real public health issue in Reunion Island with a suicide rate among under-35s twice as high as in Reunion than in metropolitan France.

This work is a continuation of the guidelines of good practice of the High Authority of Health (HAS) which insist on the importance of "supporting the parental function by health and public action".


Eligibility Criteria:
Inclusion Criteria:

Teenagers aged 13 to 17

* managed for a depressive episode (ADRS score\> 3) or for a suicide attempt
* speaking and understanding French and / or Creole language

Exclusion Criteria:

* fathers without legal responsibility for the child
* absence of consent of the adolescent or those responsible for parental authority
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)

The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal arteries (PPA).

A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.

Eligibility Criteria:
Inclusion Criteria:

* Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4
* Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet all of the following criteria:

  * Calcified lesions with degree of stenosis ≥70% or occlusions
  * Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course
  * Vessel diameter ≥3.0 mm and ≤6.0 mm
  * Total lesion length (or series of lesions) ≤150mm
  * Target lesion located at least 3 cm above the inferior edge of the femur by visual estimate
* Patent infrapopliteal and popliteal artery

Exclusion Criteria:

* Target lesion/vessel with in-stent restenosis
* Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to the procedure
* Target lesion/vessel previously treated with any stent placement, atherectomy, laser or other debulking devices prior to the procedure
* Subjects who have undergone surgery or endovascular of the SFA/PPA in the target vessel to treat atherosclerotic disease within 3 months prior to the index procedure
* Use of drug-coated devices, atherectomy, laser or other debulking devices other than the Jetstream System, chronic total occlusion (CTO) devices or cutting balloon, Angioscore or similar devices in the target limb SFA/PPA during the index procedure
* History of major amputation in the target limb
* Subject has a history of coagulopathy or hypercoagulable bleeding disorder
* Subject with untreatable hemorrhagic disease or platelet count \<80,000mm3 or \>600,000mm3 as baseline assessment.
* Concomitant renal failure with a serum creatinine \>2.0 mg/dL
* Receiving dialysis or immunosuppressant therapy
* History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment
* Unstable angina pectoris at the time of the enrollment
* Septicemia at the time of enrollment
* Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
* Presence of aneurysm in the target vessel
* Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure
* Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure
Daily Activity Study of Health: Increasing Physical Activity in Aging

In this six-week behavioral intervention, sedentary older adults will receive daily health messaging via their smart phone to better understand their daily activities and emotions. Participants undergo structural and functional brain imaging before and after the intervention along with measures of their behavioral, emotional and thinking functions.

This project will obtain data on the effects of a six week intervention designed to increase subjects' motivation to increase their physical activity. Subjects will be randomized into two different conditions to examine the efficacy of self-affirmation + positive messaging versus a control group that receives negative messaging only on changes in physical activity.

We will also examine whether any differential physical activity or structured exercise engendered in the two groups is maintained at 3 months post-intervention.

Secondary outcome measures will include a battery of cognitive, psychosocial, and neuroimaging measures that are designed to explicate the mechanisms that underlie motivation effects for physical activity in sedentary older adults.

Eligibility Criteria:
Inclusion Criteria:

* Age range 60-95
* Not exercising more than 150 minutes of moderate/vigorous intensity per week AND sitting more than 8 hours per day
* No contraindications to MRI (if opting for MRI)
* Being able to speak English fluently
* Body Mass Index (BMI) between 20 and 40
* Normal or corrected-normal vision based on the minimal 20/20 standard
* Ambulatory without severe pain or the assistance of walking devices
* No diagnosis of a neurological disease
* Regular access to a computer with internet or smartphone

Exclusion Criteria:

* Primary care physician does not approve additional physical activity
* Inability to ambulate without assistive device
* Any unstable medical condition
* Current diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Axis I or II disorder including Major Depression
* History of major psychiatric illness including schizophrenia (not including general anxiety disorder or depression)
* Current treatment for cancer - except non-melanoma skin
* Neurological condition (multiple sclerosis, Parkinson's disease, dementia, mild cognitive impairment) or brain injury (traumatic or stroke)
* Current alcohol or substance abuse
* Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis or other cardiovascular event
* Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year
* Not passing the Telephone Interview of Cognitive Status (TICS) as normal
* Use of any anti-psychotic, anti-depressant, anti-anxiety, and attention deficit disorder (ADD/ADHD) medications.
Cognitive Outcome After Gamma Knife Radiosurgery in Patients With Brain Metastases (CAR-Study A)

Stereotactic radiosurgery (SRS) is increasingly applied in patients with brain metastases (BM) and is expected to have less adverse effects on cognitive functioning than Whole Brain Radiation Therapy (WBRT). Because cognitive functions are essential for daily functioning, and may affect therapy compliance and quality of life in general, a full understanding of cognitive functioning in patients with BM after SRS is essential.

CAR-Study A is a prospective study to evaluate cognitive functioning in patients with 1-10 BM accepted for treatment with Gamma Knife radiosurgery (GKRS).

CAR-Study A is a prospective study to evaluate cognitive functioning after GKRS in patients with 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan. Neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12, 15, and 21 months after treatment. Follow-up assessments will be combined with 3-monthly MRI-scans.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven malignant cancer
* 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan
* Maximum total tumor volume 30 cm3
* Lesion ≥ 3 mm from the optic apparatus
* Age ≥ 18 years
* Karnofsky Performance Status (KPS) ≥ 70
* Anticipated survival \> 3 months

Exclusion Criteria:

* No prior histologic confirmation of malignancy
* Primary brain tumor
* A second active primary tumor
* Small cell lung cancer
* Lymphoma
* Leukemia
* Meningeal disease
* Progressive, symptomatic systemic disease without further treatment options
* Prior brain radiation
* Prior surgical resection of brain metastases
* Additional history of a significant neurological or psychiatric disorder
* Participation in a concurrent study in which neuropsychological testing and/or health-related QOL assessments are involved
* Contra indications to MRI or gadolinium contrast
* Underlying medical condition precluding adequate follow-up
* Lack of basic proficiency in Dutch
* IQ below 85
* Severe aphasia
* Paralysis grade 0-3 according to MRC scale (Medical Research Council)
Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

The investigators aim to compare the use of a suprainguinal fascia iliaca compartment block vs lumbar plexus block as an adjunct to general anesthesia in pediatric patients undergoing orthopedic procedures involving the hip or upper femur. This study will help determine the efficacy of the two techniques and their advantages when compared to each other including time to perform the block, opioid consumption reduction, effects on postoperative pain, and the length of stay.


Eligibility Criteria:
Inclusion Criteria:

* ASA grade I-III
* Undergoing elective orthopedic surgical procedures involving the hip and upper thigh

Exclusion Criteria:

* Local anesthetic allergy
* Skin or localized infection at the site of catheter insertion
* Patient or parent refusal
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD

The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.

Chronic obstructive pulmonary disease(COPD) is a preventable and treatable illness, which is clinically characterized by persistent airflow limitation that is usually progressive. It's well known that airflow limitation lead to air trapping particularly during exercise, resulting in increased dyspnea and limitation of exercise capacity. Thus, COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea. The sedentarism results in physical deconditioning and alterations of the peripheral muscles, and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more sedentarism. Thereby, measures should be taken to interrupt this vicious cycle. Some previous studies suggested that niv acting as an add-on therapy could help unloading the inspiratory muscle, reducing the dynamic compression of the airway, diminishing the dynamic hyperinflation,to some extent, relieved dyspnea during exercise in COPD patients. However,those measures were taken during exercise, acting as an add-on therapy. Whether NIV can play a role as a rescue therapy to relieve exertional dyspnea while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is still not quite clear. Therefore, we hypothesize that niv as a rescue-therapy has the same effect on relieving dyspnea in stable severe COPD patients just like the add-on therapy.

Eligibility Criteria:
Inclusion Criteria:

* severe COPD (post bronchodilator FEV1/FVC \< 70% and FEV1 \< 50% predicted)
* stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
* dyspnea as a main symptom that limited daily activities

Exclusion Criteria:

* obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination
* facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
* oxygen saturation(SpO2) \< 88% at rest with a fraction of inspired oxygen(FiO2) ≥ 0.5
* systolic blood pressure \> 160mmHg or diastolic blood pressure \> 100mmHg at rest
* unstable angina or a myocardial infarct in the previous four weeks
* resting sinus tachycardia ( \> 120 beats/min)
* patients with musculoskeletal or neurological disorders
* patients who are unable to give informed consent
Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution

The main aim of the study is to evaluate the effectiveness of Individualized Meta-Cognitive Training (EMC +), in people with psychosis of brief evolution on symptoms, especially on positive symptoms. Secondary aims would be to assess the effect of EMC+ in metacognition, psychosocial and neuropsychological functioning, and to assess the maintenance of program effects on 6 months.

This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.The evaluator will be blind to the group to which the patients belong. The sample for the overall project will be a total of 70 people with a diagnosis of psychotic spectrum, less than 5 years of experience and with a score =\> 3 positive PANSS (last month) and treated in one of the participating institutions. The evaluation was performed at baseline, at post-treatment and at 6 months follow up. Symptoms, metacognition, psychosocial and neuropsychological functioning were assessed.

The EMC consists of 10 therapeutic units with weekly sessions of 45-60 minutes. The material available for the Individualized Metacognitive Training (EMC) program is made up of power-point presentations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified.
* Less than 5 years of evolution.
* Score at or above 4 on the PANSS during the last year (delusions, grandiosity, suspiciousness).

Exclusion Criteria:

* Traumatic brain injury, dementia, or intellectual disability (premorbid IQ ≤70).
* Substance dependence.
* Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).
Vital Sign Monitor Device Validation - WARD

Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.

Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device.

Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.

Patients: up to 1000 medical and/or surgical patients will be included. Intervention: Studies with various wireless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device. Other statistical assessments of agreement may be chosen as secondary outcomes, dependent on the data-structure

Setting: the study will be carried out in up to 76 hours with collection of vital sign data pre-, intra or postoperatively.

Eligibility Criteria:
No inclusion or exclusion criteria
Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes-

The main objectives of the proposed project are:

1. To provide essential data on acute stroke management (quality indicators) incorporating hard clinical outcomes that will contribute to an ongoing process of quality improvement
2. To develop an interactive multichannel platform, for collecting, cleansing and curating high quality in-hospital and follow up data, applying multidimensional quality assessment analysis, providing statistical and analytic reports, monitoring behavioral changes and supporting overall project's management.
3. To evaluate patients' and physicians' experiences and their impact on stroke management.
4. To assess severe negative impact of stroke on the life of survivors including quality of life and disability
5. To measure health related and non- health (loss of productivity, informal care) related national expenditure for stroke care using a bottom up approach
6. To evaluate the value of care focusing on health outcomes compared with total costs of achieving them

A prospective cohort multicenter study of patients with first ever acute stroke, hemorrhagic and ischemic, (ICD-10 codes: I61, I63 and I64) admitted within 48 hours of symptoms onset to seven NHS and University hospitals will be conducted. About 1,000 patients (2% of all new cases/annually) will be recruited from six urban and semi-urban areas with 5.5 mil people (50% of Greek population), reporting 25,000 discharged stroke cases annually (53% of all stroke discharges), according to data derived from Hellenic Statistical Authority. All patients will be followed for three months. Moreover, a sub-group of the 300 firstly recruited patients will be followed for a year to obtain data on post hospital health and social needs, health services utilization (medication, rehabilitation, outpatient visits) and productivity loss . Patient enrolment and follow up is estimated to last 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64)
* Patients with First ever acute stroke
Research on the Improvement of Intestinal and Immune Functions by Probiotics

Evaluate the effectiveness and safety of Limosilactobacillus fermentum LF61 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to undergo 3 follow-up visits during the intervention period
2. Be willing to provide blood, urine and stool samples 2 times during the intervention period
3. Willing to self-administer one of the 7 probiotics (BI45, BBi32, LS97, LB42, LF61, LH76, LR08)/placebo once a day during the intervention period
4. Good eyesight, can read and write, can wear glasses
5. Have good hearing and be able to hear and understand all instructions during the intervention -

Exclusion Criteria:

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood
5. Internal organ failure (heart, liver or kidney failure, etc.)
6. Have received radiation or chemotherapy in the past
7. have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
8. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past -