cyrilzakka/clinical-trials huggingface dataset:
EDOF and Multifocal IOL Study

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 50-90
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
* Uncontrolled systemic or ocular disease
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.


Eligibility Criteria:
Inclusion Criteria:

* Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC
* Participants must have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment
* At least 1 measurable lesion according to RECIST 1.1
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing
* Life expectancy of \>= 12 weeks, as judged by the Investigator
* Adequate hematological function, hepatic function, renal function, coagulation function as defined in the protocol
* Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Previous and/or intercurrent cancers
* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
* Participants with symptomatic central nervous system (CNS) metastases
* Significant acute or chronic infection including known history of positive test for human immunodeficiency virus (HIV), active tuberculosis, uncontrolled biliary infection and active bacterial or fungal infection requiring systemic therapy (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 Day 1 prior to dosing.
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* History of or concurrent interstitial lung disease
* History of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
* Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints)
* Other protocol defined exclusion criteria could apply
Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study

This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.

Group 1 used metformin (1000 mg bid) and gliclazide (60 mg qd); Group 2 used the same amounts of metformin and gliclazide, with the addition of vildagliptin (50 mg bid). The patients were prospectively assigned to each of these two groups for the purpose of this study. Using Doppler ultrasound, all cases were measured for portal vein flow velocity, portal vein flow and portal vein diameter. Degree of hepatosteatosis was also recorded.

Eligibility Criteria:
Inclusion Criteria:

-type 2 DM cases and at least 3 months used the same drugs (metformin and gliclazide or metformin and gliclazide and vildagliptin)

Exclusion Criteria:

* used alcohol and cigarettes
* chronic liver disease,
* chronic renal failure,
* active infection
* patients using certain drugs which may affect portal pressure such as propronalol,
* calcium channel blockers,
* angiotensin-converting enzyme inhibitors,
* angiotensin receptor blockers and isosorbit monohydrate
ACOART AVF RENEW: A Post Market Clinical Study

The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥18 and ≤85 years of age
* The target AV fistula has undergone successful dialysis for at least 1 time
* Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）
* Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：

  * The physical examination was abnormal
  * Significant increase in dynamic venous pressure
  * Blood flow decreased significantly
* Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length
* Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as:

  * Residual stenosis of ≤ 30% AND
  * Absence of a flow limiting dissection (Grade ≥C) or perforation
* Patient provides written informed consent prior to enrollment in the study

Exclusion Criteria:

* Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
* Dialysis access is located in the lower extremity
* More than one lesion
* Patient with hemodynamically significant central venous stenoses
* Patient has presence of a stent located in the target AV access circuit
* Patient has undergone prior intervention of access site within 30 days of index procedure
* Patient with target AVF or access circuit which previously had or currently has a plan to surgery
* Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
* Patients undergoing immunotherapy or suspected/confirmed vasculitis
* Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type
* Patient has an infected AV access or systemic infection
* Patient has a life expectancy of \<24 months
* Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis
* Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
* Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study
The Study of Recommendation System DiaCompanion for Women With Gestational Diabetes Mellitus

This is a randomized controlled trial of a recommendation system implementation in the treatment of women with gestational diabetes mellitus (GDM). The trial assesses the aspects of system effects on maternal glucose control, the fetus and pregnancy outcomes. This study is an interventional, randomized controlled trial, open-labeled.

The study aims to clarify the effect of using DiaCompanion I (a mobile-based personalized recommendations system) on glycemic levels and pregnancy outcomes in women with GDM. Women with GDM are randomized to 2 treatment groups (utilizing and not utilizing the developed mobile-based system with data-driven personal recommendations focused primarily on postprandial glycemic response prediction). Data on glycemic levels during the study and consumption of major macro- and micronutrients will be collected using the mobile app with electronic report forms. The app provides women in the intervention group with the resulting data-driven prognosis of a 1-hour postprandial glucose level every time they input their meal data. The app also provides participants of the intervention group with a set of reminders and recommendations on the diet and lifestyle.

Apart from the assessment of the outcomes described below, biobanking of serum, plasma; cord fluid, HUVECs, faeces, and meconium will be performed. The samples may be used for further analyses in ancillary studies, which could be beneficial for GDM care based on evolution in scientific knowledge.

This biological collection is optional \[Time Frame: within 15 years after the end of the study\]:

* The blood samples will be collected at the same time as the sample routinely collected
* Maternal faeces will be collected within 5 days after inclusion and at gestational weeks 35-36
* Cord fluid will be collected
* HUVECs will be isolated from the cord after delivery
* Meconium will be collected within 24 hours after birth.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with GDM according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e. fasting plasma glucose between 5.1 mmol/L and 6.9 mmol/L after the 6th week of gestation and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 10.0 mmol/L and/or 2-hour plasma glucose value between 8.5 mmol/L and 11.0 mmol/L at the 24-31st week of gestation
* Age \>18 years
* Gestational age \>= 12 and \< 32 weeks
* No more than 4 weeks after confirmation of GDM diagnosis
* Singleton pregnancy
* The ability to navigate an app
* Provided informed consent

Exclusion Criteria:

* Preexisting diabetes of any type before the current pregnancy
* Need for insulin therapy at the time of screening
* Heart failure
* Chronic kidney disease
* History of bariatric surgery
* Use of long-term systemic corticosteroids
* Impaired mobility
* Known fetal malformations
* Concomitant participation in other clinical trials
Validation of Two New Questionnaires for Dupuytren's Disease

A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are standard and validated questionnaire instruments used to measure health related quality of life and function, they do not address patient specific issues. The investigators will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of Dupuytren's Disease in at least one finger
* Patients will be 35 years of age or older
* Patients will be able to read, speak, and understand English
* Patients will be able to provide voluntary written consent to participate

Exclusion Criteria:

* Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
* Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
* Patient has a known allergy to collagenase or any other excipient of XIAFLEX.
* Patient has received any collagenase treatments before the first dose of XIAFLEX.
* Any history of or current medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study
Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps

The investigators' study is a prospective study to evaluate the enhancement pattern of contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential diagnosis between gallbladder polyps by using software program of quantitative analysis.


Eligibility Criteria:
Inclusion Criteria:

* patient who will be received the exams to evaluate the polyps for treatment plan of surgical treatment
* have a plan to evaluate by EUS
* 19 years of age or older

Exclusion Criteria:

* difficult undergo EUS,
* allergy for contrast agent,
* renal failure,
* acute coronary syndrome
* pulmonary hypertension, 6) pregnancy
Role of Corneal Nerves in Dry Eye Disease

This study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. Additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Group with DED: Diagnosis of DED based on the TFOS DEWS II report
* Group without DED: No diagnosis of DED

Exclusion Criteria:

* Exclusion criteria:
* Systemic disease that may affect ocular health and innervation
* injury or history of operations on the anterior or posterior segment of the eye, which can affect the corneal structure and physiology
* regular application of systemic or ocular medication known to affect the tear film except from DED medications
* eye drops or makeup on the day of measurement.

Remarks:

Contact lens wearers are asked not to wear contact lenses for 1 week before the first appointment.

Participant with DED medications will be asked to use only conservative-free eye drops on the days of examination
Paediatric Spinal Cord Injury and Long-term Social Outcomes.

To provide the overall quality of life (QOL), activity and participation values for adults with paediatric onset spinal cord injury (SCI), stratified by injury level, neurological status and compare it with matched controls with adults with adult-onset SCI.

Evidence obtained from adult studies demonstrate that SCI can be a devastating experience that may result in reduced independence and change one's ability to participate in meaningful roles and activities.

Sadly, there is a paucity of similar studies into paediatric onset SCI. The profile of paediatric patients with SCI is different from adults and their long-term wellbeing outcomes are not well researched. Maximizing activity and participation following SCI is an important aspect of rehabilitation. Community integration is a long process that might take months to years after discharge from hospital after the initial injury. After discharge from hospital the subsequent management is done by community team comprising of physio and occupational therapists who are pivotal in supporting re-engagement in social activities.

There is a need for thorough analysis regarding the social outcomes of adults living with paediatric onset SCI. Quality of life, or life satisfaction, is arguably the most important outcome for children and adolescents with SCIs. This outcome may be the key to assessing the success of our treatment pathways and will allow us to target the resources available for rehabilitation to maximize the effects of rehabilitation programs.

There are large gaps in the literature regarding paediatric SCIs. Clinicians often struggle to give informed answers to questions such as:

* Will a child with SCI experience good quality of life in adulthood?
* Is there a difference in social activity and participation between adult onset and paediatric onset injuries?
* What helps social activity and participation of SCI patients?
* Is tetraplegia worse than paraplegia for social participation?
* Does social participation affect quality of life?
* Where can we target resources in rehabilitation program?

This study aspires to address these questions by conducting this questionnaire study to understand the factors that affect social participation. This will enable to highlight areas to target future resources for rehabilitation programmes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 60 years
* SCI for over 5 years duration

Exclusion Criteria:

* Patients unable to speak and understand English
* Patients not able to speak on phone
* Patients with intellectual disability affecting their ability to speak without aids.
* Cauda equina syndrome
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, the perioperative management of these patients undergo non-cardiac surgery has not yet been clear. This single- arm study was to evaluate the safety of continuous use of ASA in the perioperative period in routine minimally thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

1. patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need Minimally Invasive Thoracic Surgery;
2. VATS and robotic surgery are both permitted;
3. cardio-pulmonary function can tolerate surgery.

Exclusion Criteria:

1. cardio-pulmonary function couldn't tolerate surgery;
2. high bleeding risk after the pre- operative evaluation.
Clinical Benefits in Optimized Remote HF Patient Management

The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT-D) device reprogramming.

The outcome measure of the study is a combined endpoint of:

* Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
* Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
* 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months
* Left Bundle Branch Block (LBBB)
* Patients must be able to provide written informed consent
* Patients are mentally capable to participate in the Investigation (based on physician's discretion)

Exclusion Criteria:

* Patients already implanted with CRT or CRT-D device to be replaced
* Patients in long-standing persistent or permanent AT/AF
* Patients in dialysis treatment at the time of enrollment
* Patients in parenteral inotropic therapy at the time of enrollment
* Patients with epicardial Left Ventricular (LV) lead
* Patients with mechanical valvular prosthesis
* Patients with life expectancy \< 12 months
* Patients actively considered for cardiac transplant
* Patients \< 18 years old
* Pregnant women
Estimating Prevalence of Inherited Disorders of Sulfur Amino Acids Metabolism in Patients With Psychotic Disorders.

Screening for sulfur amino acid metabolism pathologies using a sulfitest in adult patients with psychotic disorder.

Psychotic disorder is a public health problem, with a cumulative incidence in the general population estimated at 3%. Although in most cases the origin is purely psychiatric, psychotic disorder can also represent a mode of entry into many organic pathologies. Among these, hereditary metabolic diseases, although rare in the general population, hold a special place, especially in view of their potentially treatable character. However, the identification of this type of disease within the mass of patients with psychotic disorders can be an extremely complex task, and has been the subject of scientific interest for many years.

Recently, at the Grenoble Alpes University Hospital, a new hereditary metabolic disease that causes psychotic disorders has been discovered. This disease was identified in a family of patients, most of whom had psychotic disorders, and all of whom had deep cystic leukoencephalopathy on MRI and a positive sulfitest. The discovery of this new hereditary metabolic disease raises the question of its prevalence in patients with psychotic disorders, and more generally of the prevalence of diseases of sulfur amino acid metabolism.

PsyNIT study therefore aims, using the sulfitest, to detect hereditary diseases of sulfur amino acid metabolism in a sample of patients with psychotic disorders without known organic etiology. The discovery of other patients would raise the question of screening more widely for this type of pathology, and would modify the management of the patients thus screened in terms of follow-up and possibly treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age and older,
* Followed for a psychotic disorder,
* With no known organic etiology for the psychotic disorder,
* Not having formulated its opposition to participation in the study (or his/her tutor/curator),
* Affiliated with the social security system.

Exclusion Criteria:

* Patients protected by law (minors, pregnant or breastfeeding women, deprived of liberty or hospitalized under constraint, under administrative or judicial supervision) except patients under tutorship or curatorship.
National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team

Patient who suffering of parietal endometriosis treat by cryoablation or chirurgical will be recorded in national registry. the patient will be follow during 3 years after treatement.

Eligibility Criteria:
Inclusion Criteria:

* Presence of parietal endometriosis: with suggestive clinical and imaging criteria (MRI and ultrasound)
* Symptomatic parietal endometriosis (VAS \> 3 OR bothersome bleeding OR reported impact on quality of life)

Exclusion Criteria:

* Endometriosis not affecting the anterior wall of the abdomen (as deep pelvic muscle: ilio-psoas, obturators, perineal, ischio-anal fossa)
* Minor patient (\< 18 years)
* Pregnant patient at any trimester
* Patient with hemostasis disorders (constitutional or acquired)
* Patient with systemic infection or localized scar infection upon inclusion.
* Patient with contraindications to MRI
* Female patient with a planned medical or surgical procedure for the duration of the study that may interfere with the proper conduct of the study.
* Patient unable to understand the information provided
* Patient who is not affiliated to the social security system
* Patient under curatorship or tutorship
* Patient with a nodule of primary or secondary malignant tumor origin