cyrilzakka/clinical-trials huggingface dataset:
Modified Aortic Root Enlargement Procedure

This study is a prospective observational clinical trial, in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and efficacy of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.

Small aortic annulus (SAA), which is prevalently observed in patients with severe aortic stenosis (AS), constitutes a significant challenge in treatment and may give rise to post-operative prosthetic valve mismatch (PPM) and an elevated late mortality rate. The optimal approach for treating SAA remains controversial. Transcatheter aortic valve replacement (TAVR) has yielded superior valvular hemodynamic outcomes in patients with SAA; however, the incidence of PPM subsequent to surgery remains considerable. Aortic root enlargement (ARE) represents an effective solution for SAA, but the conventional method of aortic ring enlargement for ARE has restricted efficacy. In 2021, Yang Bo proposed an enhanced ARE approach, where the mitral curtain of the aortic valve was incised in an inverted Y-shape along the left non-coronary junction, enabling the enlargement of the number 3-5 of the aortic ring

Eligibility Criteria:
Inclusion Criteria:

* 1) Symptomatic severe AS patients aged 50-70 years who are planning to undergo biological valve replacement (diagnostic criteria for echocardiography are: mean transvalvular pressure gradient ≥ 40mmHg or flow velocity ≥ 4.0 m/s, aortic valve area (AVA) ≤ 0.8 cm2 or iEOA\<0.5 cm2/m2) 2) Merge SAA (defined as mean aortic annulus diameter ≤ 23 mm measured by CT)

Exclusion Criteria:

* 1) High surgical risk, STS score\>8% 2) Severe lesions in multiple coronary arteries requiring PCI or CABG 3) Simultaneous surgical intervention is required for severe mitral and tricuspid valve disease 4) Combining other complex cardiovascular diseases requires simultaneous surgical treatment 6) Combined severe pulmonary arterial hypertension or left ventricular dysfunction (LVEF\<40%) 7) Severe respiratory, liver and kidney dysfunction, or other important organ dysfunction combined 8) Concurrent infective endocarditis in active phase 9) Previous history of cardiac surgery
Comparison of Two Treatments for Post-Traumatic Stress Disorder

This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.

Exposure to traumatic events, such as automobile accidents and assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. PTSD is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. Both CBT and antidepressant therapy have been shown to effectively treat PTSD symptoms; however, comparisons of the treatments are limited. This study will compare the short- and long-term effectiveness of CBT and the antidepressant sertraline.

Participants will either be randomly assigned to CBT or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. Participants in the CBT group will have 10 weekly sessions of therapy. During the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. Participants will also be encouraged to practice the techniques learned in therapy in everyday life. Participants in the antidepressant group will take sertraline daily for 10 weeks. These participants will be seen weekly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. The medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. At the end of 10 weeks, participants in the antidepressant group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 24 months. Participants who do not respond to their assigned or chosen treatment will be offered the other treatment for 10 weeks. Self-report scales and questionnaires will be used to assess participants' PTSD symptoms, depression, anxiety, and social functioning. These assessments will occur at 3, 6, 12, and 24 months after the study treatment period.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of PTSD
* Experienced traumatic event at least 12 weeks prior to study entry
* Willingness to discontinue current CBT or antidepressant treatment

Exclusion Criteria:

* Current diagnosis of schizophrenia or delusional disorder
* Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
* Current diagnosis of alcohol or substance dependence within 3 months prior to study entry
* Ongoing intimate relationship with the perpetrator of the traumatic event
* History of nonresponse to either CBT or sertraline
* Medical contraindication for sertraline
To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients

To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients

A prospective, single center study to evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients.

The objective of this study to investigate the refractive and visual performance of PanOptix and explore their correlation with ELP change, capsular bending formation, IOL tilt/decentration in high myopic cataract patients.

PanOptix IOL provides good refractive outcomes and visual quality because of few ELP change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* 26 ≤Axial length\<30mm, IOL power ≥6D (PanOptix IOL power is available +6D-+30D )
* Eyes with corneal astigmatism less than 1.0D (IOLMaster 700, Carl Zeiss Meditec AG)
* Eyes with pupil diameter between 3 and 5.5 mm (iTrace, Tracey Technology, Houston, Texas, USA)
* Eyes with angle kappa and angle Alpha ≤0.50 mm (iTrace);
* Eyes with corneal spherical aberration ≤ 0.50 (Pentacam).

Exclusion Criteria:

* Irregular corneal astigmatism
* Serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment
* Moderate-severe dry eye, corneal scarring, amblyopia
* Patients who can't cooperate with post-op 3 months follow-up.
Pulse Oximeter Test

Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia


Eligibility Criteria:
Inclusion Criteria:

* Good general health with no evidence of medical problems

Exclusion Criteria:

* Smoking
* Anemia
Early Palliative Care in Patient With Acute Leukaemia

Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion.
* Patients in whom a curative strategy (transplant) is not considered.
* patients older that 75 years at the diagnosis
* informed signed consent

Exclusion Criteria:

* unable to answer the questionnaire
* psychiatric disorders other than depression
* persons under guardianship
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo.


Eligibility Criteria:
Inclusion Criteria:

Patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (CPB) and who meet all following criteria:

1. Age greater than 18 years old
2. Preoperative iron-deficiency anemia, defined as Hb \<130 g/L with any one of:

   1. ferritin \< 30 μg/L; or
   2. ferritin 30-100 μg/L and transferrin saturation \<20%; or
   3. reticulocyte Hb content \< 29 pg, where available

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

1. specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
2. established contraindications to IV iron:

   1. hypersensitivity to the iron product
   2. history of \>2 food and/or drug allergic reactions (excluding drug intolerance)
   3. non-iron deficiency anemias such as myelodysplastic syndrome
   4. history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
   5. decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
   6. active infection
3. preoperative unstable hemodynamics defined as the requirement for vasopressors or inotropes, or active bleeding (as noted in the clinical record and/or defined as a requirement for red blood cell transfusion for ongoing clinical bleeding)
4. refusal of blood products for religious or other reasons
5. known pregnancy
6. already enrolled in this trial
7. enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
8. receipt of intravenous iron at any point in the 6 weeks prior to randomization
Head Position After Endovascular Therapy

The aim of this trial is to investigate whether head elevation position after endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.

The optimal head position for patients with acute ischemic stroke (AIS) remains uncertain. The HeadPoS study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. However, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median National Institutes of Health Stroke Scale score of 4). It is unclear how to arrange the patient's head position after endovascular treatment.

The hypothesis of this trial: Compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs consistent with acute ischemic stroke;
2. Age ≥ 18 years old;
3. Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);
4. NIHSS score ≥ 8 points before endovascular treatment;
5. ASPECTS score ≤ 7 points before endovascular treatment;
6. Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ；
7. The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time);
8. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. Pre-stroke mRS score\>1 point;
2. Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
3. Currently in pregnant or lactating or serum beta HCG test is positive on admission;
4. Contraindications to a flat head position;
5. Any terminal illness with life expectancy less than 6 months;
6. Participating in other clinical trials;
7. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
8. Unlikely to be available for 90-day follow-up.
"Prospective Evaluation of Immediate & Early Loading of Zimmer Hydroxyapatite Coated Dental Implants"

The purpose of this study is to compare the success rates of two surgical protocols. One protocol will have the implants placed at the time of tooth extraction and placed into function. The other protocol will have the implants placed into healed extraction sites and placed into function.

Forty-eight patients (22 men, 26 women) were enrolled in the study and received 48 implants. The population was divided into 2 groups: Group A implants (n=23) were loaded immediately on the day of surgery and Group B implants (n=19) were loaded 3 weeks after surgery. Cone Beam Computed Tomography (CBCT) scans were taken preoperatively to aid in treatment planning. Bone density was evaluated on CBCT scans in Hounsfield units (HU) and by tactile feedback during surgery. Insertion torque was recorded at time of implant placement. Resonance frequency analysis, performed on the day of surgery, at the time of loading, and at 6, 12 and 24 months, was used to record implant stability according to the unit's Implant Stability Quotient (Osstell ISQ). Standardized radiographs were taken at time of implant placement and at 6, 12 and 24 months to measure crestal bone stability. Bone level changes were measured by software (Image J, available online at: http://rsbweb.nih.gov/ij/download.html; last accessed 28 August 2014).

Eligibility Criteria:
Inclusion Criteria:

1. May be either male or female
2. Must be at least 18 years of age
3. Must be of sufficiently good health to undergo routine dental treatment. including the surgical procedures associated with placement of dental implants.
4. Must be partially edentulous requiring single dental implants in their maxilla or mandible
5. Must have sufficient amount of native bone or healed bone grafted sites (by socket grafting, maxillary sinus augmentation and ridge augmentation).
6. Must not have any active infection
7. Must have adequate bone height for at least a 10mm long dental implant
8. Must be physically, emotionally and financially able to undergo the surgical procedure planned
9. Must be adequately compliant

   -

Exclusion Criteria:

1. Have any requirements for antibiotic premedication for infective endocarditis, artificial joints or any other condition
2. Have uncontrolled hypertension
3. Have uncontrolled diabetes
4. Are serological HIV positive
5. Have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed treatment
6. Smoke cigarettes or use other tobacco products
7. Have taken any investigational drugs anytime in the previous month
8. Have dental conditions likely to require treatment, necessitating exit from the study such as deep cavities, abscesses, or moderate-severe gum disease
9. Have had radiation therapy to the head and neck
10. Are unwilling or unable to sign the informed consent
11. Don't demonstrate willingness to return for a required number of visits
12. Need an immediate dental implant placement following tooth extraction

    -
PLIN1 Variants in Precocious ACS (SCAPLIN)

This study aims to identify a genetic predisposition factor of precocious acute coronary syndrome occurrence (ACS). ACS is a major public health problem and the first cause of mortality in the world. It can be due to several risk factor such as heredity. the investigators make the hypothesis that occurrence of early ACS (defined as \<50yo for men and \<55yo for women) could be the initiatory event of a mild form of genetic lipodystrophy . Our previous study shown an occurrence risk of ACS about 8.3 in patients carrying a mutation in the PLIN1 gene versus patients without a mutation. The PLIN1 gene encode for perilipin 1 protein localized on the lipid droplet surface. This protein phosphorylation activates the triglycerides lipolysis. Our goals in this study are multiple: to validate the high frequency of mutations in this gene in patients with early ACS, to determine differences in triglycerides metabolism and also relapse rate between carrier and non-carrier patients of mutation in PLIN1. Our first aim will be to carry out the inclusion of 200 patients with precocious ACS. This will allow us to obtain around 15 patients carrying a mutation in the PLIN1 gene based on our previous study. the investigators will reprogramme patients' cells (carrying or not a PLIN1 mutation) in human Induce Pluripotent Stem cells (hIPSc). These hIPSc will be differentiated in cell types of interest as adipocytes or macrophages. the investigators will then study triglycerides metabolism (lipid droplet formation, localization and phosphorylation of perlipin 1) in these cells and atheroma plaque formation. Finally, the investigators will study clinical data such as relapse rate and searching for correlation with PLIN1 mutation.


Eligibility Criteria:
Inclusion Criteria:

* Age of the patient when ACS occurs (between 18 and 50yo for men, between 18 and 55yo for women)
* Written informed consent

Exclusion Criteria:

* Men \<18yo or \>50yo
* Women \<18yo or \>55yo
* ACS causes (toxic, coronary dissection)
* Congenital cardiac malformations
* Familial hypercholesterolaemia
* Pregnancy, breast-feeding women or vulnerable profile.
* Patient refusal to participate or previously included in a clinical research trial.
Lifestyle Intervention in Overweight Women

The Exercise and Obesity Health Promotion (PESO) program is a randomized controlled trial designed to analyze the effects of a lifestyle intervention in weight management and health-related parameters of overweight and obese premenopausal women

The PESO (Exercise and Obesity Health Promotion Program) is a program of weight control and exercise promotion for overweight and obese premenopausal women, developed by specialists in exercise, nutrition, and psychology, under medical supervision. It is a program that promotes the autonomy of the participants and the permanent modification of their habits and lifestyles, without the use of drugs or any other products, devices, or techniques of "slimming".

Participants in the PESO Program were able to enjoy a regular and multifaceted group program, aiming to increase knowledge about permanent body weight control, increased motivation and practice of physical activity and exercise, and improved habits food and nutrition. Increases in functional mobility, metabolic health, quality of life and the physical and mental well-being of the participants are central priorities of this Program.

The PESO Program was conducted in a university context and was led by teachers and researchers from the Faculty of Human Motors and other national and foreign institutions. The program is not for commercial purposes, it does not entail financial costs for the participants and it is involved in a wide range of scientific research projects, which have been recognized by individuals and external entities as relevant and of interest to the general population and the community in particular.

Eligibility Criteria:
Inclusion Criteria:

* older than 24 years,
* be premenopausal and not currently pregnant,
* BMI higher than 24.9 kg/m2,
* free from major disease

Exclusion Criteria:

* Not meeting the inclusion criteria
A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer

The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery)

To explore whether peptidoglycan fragments can be used as screening or diagnostic indicators for colorectal cancer

Eligibility Criteria:
Inclusion Criteria:

* People who underwent total colonoscopy in gastroenteroscopy room.
* People who agree to participate in this study and are willing to sign informed consent.

Exclusion Criteria:

* Previous diagnosis of malignant tumors other than colorectal cancer.
* Received any of the following drug treatments within 1 month before sample collection: ① Drugs used for the treatment of colorectal diseases; ② Antibiotics; ③probiotics; ④ Laxatives.
* Patients with a family history of colorectal cancer.
Evaluation of the Value of Cerebral Perfusion Scintigraphy in the Study of Post-stroke Fatigability

At present there is no consensus for post-stroke imaging except for the realization of early cerebral CT at 24 hours post-thrombolysis. The use of cerebral perfusion scintigraphy would predict the course of a stroke. Indeed, it has been shown that a good perfusion is linked to a good evolution of the neurological deficit. This test is used routinely to evaluate cerebral perfusion in patients with stroke. This technique was also used to study the mechanisms of post-stroke aphasia and to highlight neuronal disconnections after stroke, a reflection of the functioning of neural networks.

Neuropsychological tests are almost always done at 3 months. Fatigue is studied: PSF scale at 3 months, 6 months and 2 years. Research needs to be continued in this area because the pathophysiology remains unknown and the symptoms are disabling for patients. Using cerebral perfusion imaging would bring elements of understanding of this mechanism and ultimately improve the management of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients: 18 to 60 years old at the initial diagnosis
* Admission for transient ischemic attack, stroke, dissection, TVC
* RANKIN less than or equal to 2
* Neuropsychological tests at +3 months: MoCA\> 26 (to eliminate cognitive deteriorations too important for the good realization of the battery)
* Absence of psychiatric history
* Absence of psychotropic medication
* No history of stroke
* No complaint of pre-stroke fatigue
* Having signed the consent form

Exclusion Criteria:

* Impossibility of giving the subject or his family enlightened information (subject in emergency situation, difficulties in understanding the subject, etc.)
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Refusal of the patient to participate in the study