cyrilzakka/clinical-trials huggingface dataset:
Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained

Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained

Wavefront analysis and other objective methods are the mainstream approaches for assessing visual quality after refractive surgery, with high-order aberrations being the main observation indicators. Some studies have explored the correlation between various complications after SMILE surgery and high-order aberrations. However, research on lenticule retained after surgery has mainly focused on clinical management and case reports of overt lenticule retained, while there is a lack of high-quality observational studies on the population with covert lenticule retained (periphery residual lenticule) to serve as evidence. This often puts clinicians in a dilemma of whether to perform another surgery to remove the remnants. In summary, although research on lenticule retained after SMILE surgery is gradually increasing, systematic studies on their relationship with higher-order aberrations are still insufficient. This study aims to fill the gap in existing research by comparing and analyzing high-order aberrations between patients with and without periphery residual lenticule, providing a more comprehensive assessment of postoperative visual quality. This will offer important theoretical basis and practical guidance for improving SMILE surgical techniques and optimizing postoperative management.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, gender unrestricted;
2. Equivalent spherical refraction ≤ -10.0D, corrected distance visual acuity ≥ 1.0, myopia stable for ≥ 2 years, and no contact lens wear for at least 2 weeks;
3. The patient voluntarily participates in this study, signs the informed consent form, and agrees to follow up according to the study plan;
4. Predicted postoperative residual corneal stromal thickness ≥ 280 micrometers.

Exclusion Criteria:

1. Subclinical keratoconus, keratoconus, moderate to severe corneal opacities or scars, and other ocular conditions;
2. Diabetes, keloid-prone constitution, autoimmune and connective tissue diseases, etc.;
3. Severe mental disorders such as generalized anxiety disorder, panic disorder, depression, schizophrenia, and bipolar disorder; inability to cooperate with physicians;
4. Refusal to participate in the study.
A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.
2. No prior systemic treatment for metastatic NSCLC.
3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
4. Tumors with PD-L1 expressed in ≥ 50% tumor cells.
5. At least 1 measurable lesion as defined per RECIST v1.1.
6. ECOG Performance Status ≤ 1.

Key Exclusion Criteria:

1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Active autoimmune diseases or history of autoimmune diseases that may relapse.

Note: Other protocol defined Inclusion/Exclusion criteria may apply
X-ray Dose Reduction Study for Endovascular Interventional Radiology

ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes, shorter pulses and the introduction of automatic real-time motion compensation in subtraction imaging are used, which are known to positively influence image quality . The final effect on the clinical image quality in peripheral angiography is investigated in this study.

X-ray dose and image quality are related by laws of physics. Low dose and high image quality cannot be achieved at the same time. However, image processing algorithms can help an x-ray system to acquire images with lower dose without influencing image quality or achieving higher image quality with equal dose. The primary aim of this study is to verify if the diagnostic image quality is equal or better when using a significant reduction in X-ray dose for endovascular digital subtraction angiography in combination with a novel imaging technology compared to using normal dose with conventional image technology.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age undergoing digital subtraction angiography for diagnosis or treatment of iliac artery disease.

Exclusion Criteria:

* Patients not willing or unable to give consent to participate
* Patients already involved in a clinical trial
* Patients under the age of 18
* Pregnant or breastfeeding women
* Patients with kidney disease (eGFR \< 60)
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation

Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring implementation.

500 patients with an indication for ICD (primary and secondary prevention) will be included in the registry during a period of 12 months. For the survey, patients must answer two questionnaires.

The first one will assess the knowledges regarding Home-Monitoring which certainly depend on the time devoted to patient information during the implantation. This period of training is important and has a direct impact on the CardioMessenger use by the patient. Although the study is multicenter, the aim is not to evaluate or compare practices of each center for the information provided to patients. The objective is to find ways to improve this phase.

A second questionnaire was designed to observe the perception of Home-monitoring by the patient and thus to understand how this new technology is apprehended. This part is important because we must take in consideration patient point of view and expectations to improve care and offer new products or services.

A focus on patients' perception and appreciation may give a support to the elaboration of training and prevention strategies, the anticipation of the needs, and the improvement of the technology. All these improvements may eventually take part in the success of ICD treatment.

Eligibility Criteria:
Inclusion Criteria:

* Primo ICD implantation with Home-Monitoring system

Exclusion Criteria:

* NYHA Class IV
* Pregnant women or women who plan to become pregnant during the trial
* Patient whose medical situation is not stable
* Presence of psychiatric illness, depression, anxiety disorders
* Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \> 70mg/dl or creatinine \>3mg/dl, liver failure, etc.
* Age \< 18 years
* Patient unable to handle the CardioMessenger correctly
* The patient is not willing and able to comply with the protocol (i.e. unable to answer to the questionnaires)
* Change of residence expected during the study
* Participation in another clinical study
* Patient unwilling to sign patient informed consent
Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

the presence of cesarean section niche has adverse effects on success of ART outcome

A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.

It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

Eligibility Criteria:
Inclusion Criteria:

* All women should have the following:

  * Aged from 18 - 37 years old.
  * Undergoing fresh ICSI cycles.
  * A normal uterus with no anomalies or pathologies.
  * At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).
  * Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).

Exclusion Criteria:

* Younger than 18 or older than 37 years old.
* Congenital uterine abnormality or pathology.
* Presence of a hydrosalpinx.
* Chronic diseases which are not suitable for pregnancy.
* ICSI cycles with fresh or frozen TESE samples.
Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.

The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥ 21 years.
* Subject is Caucasian.
* Subject is healthy, as judged by the Investigator.
* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
* Subject has smoked at least for the last 3 years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.
Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS)

Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed.

In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment.

The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.

Even if two small case control studies underlined the positive effect of high dose methylprednisolone on the relapse risk in the PP period in MS, these data have to be confirmed by a larger study. The impact of such a strategy remains also uncertain concerning the risk of long term disability. In this project, the investigators will also analyze the influence of the delay of DMD reintroduction after delivery on the relapse risk but also on the risk of disability. The results will have an important role in the therapeutic management of the post-partum period in MS patients.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing MS patients according to MacDonald criteria 2010
* Age between 15 and 49 years old at the pregnancy
* Age between 18 and 51 years old when filling the questionnaire of the study
* At least one full pregnancy with live birth after the beginning of the MS diagnosis
* At least one neurological visit during the 12 months period after the delivery
* At least one neurological visit per year in the 12 months preceding the pregnancy
* Pregnancy must occur between 01/2007 and 01/2017 In case of several pregnancies per woman, only the first one occurring in the period will be analyzed
* Having received information on the protocol and not having expressed opposition to participating in the study.

Exclusion Criteria:

* Patients who have received Immunoglobulines or plasma exchanges after the delivery in prevention of a relapse
* Patients presenting a SPMS or PPMS form at the beginning of pregnancy
* Protected persons referred to in Articles L. 1121-6 to L. 1121-9 of the code of public health (eg minors, persons deprived of liberty, ..) except nursing mothers postpartum.
Washing Pipe with a Spray Nozzle for Topical Anesthesia During Bronchoscopy

The goal of this randomized control trial is to evaluate the effectiveness and safety of using a spray nozzle, compared to the conventional method, for topical anesthesia by the spray-as-you-go technique in reducing cough frequency, improving cough, discomfort, tolerance, satisfaction, reducing the dosage of lidocaine consumption of patients during flexible bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. A planned flexible bronchoscopy
3. Being able to communicate with Mandarin Chinese or Taiwanese Hokkien

Exclusion Criteria:

1. are unwilling to join the study
2. have tracheostomy or are intubated
3. will receive intravenous anesthesia during flexible bronchoscopy
4. known to be pregnant
Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis

The purpose of this study is to assess the effects of dexmedetomidine while patients undergo treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a supplemental anesthetic agent will result in better postoperative pain management.

Inclusion Criteria: Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.

Data collected will include:

I. Postoperative Outcomes i. Pain Reported (Visual Analogue Scale) ii. Post-operative opiate use iii. Time in PACU iv. Time until discharge v. Adverse Events (i.e. nausea/vomiting, nursing intervention) II. Intermediate-term Outcomes (4-6 weeks) i. Interstitial Cystitis Symptom \& Problem Index ii. Revised McGill Pain Score

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
* 2. Gender of Patients: Male \& female,Age of Patients: 18 and older

Exclusion Criteria:

* Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.
Catheter Over Needle (CON) vs Catheter Through Needle (CTN).

This is a randomized clinical trial with the objective of comparing the time of insertion of two types of perineural catheters in shoulder surgery. These devices are thin lines that have to be inserted over a needle or throw a needle, depending of the type of catheter that is used. The hypothesis is: the installation of Contiplex C or catheter over needle (CON) is faster than a normal contiplex catheter or Catheter throw needle (CTN) at same rate of effectivity.

In the market, there is currently two types of catheter to perform a continuous nerve block. One is called Contiplex throw needle catheter that is the most used device and other needle available for performing this block called the Contiplex® C Set, which uses a different method called Catheter over Needle (CON). This method involves advancing the catheter immediately along with the needle upon puncture, and once it reaches the target site, the needle inside the catheter is removed, leaving the catheter in its final working position. This eliminates the step of threading the catheter through the needle. Additionally, this technique allows for the visualization of the final catheter site in vivo with a single operator.

Considering the differences between both techniques, the hypothesis proposed in this study is that in adult patients undergoing shoulder and proximal humerus surgery requiring anesthetic/analgesic management with inter-scalene catheters, the use of the Catheter over Needle (CON) technique results in shorter installation time and similar effectiveness compared to the conventional technique of catheter insertion through the needle (CTN) with tunnel fixation.

The primary objectives will be to compare the block execution times between the CTN and CON techniques, as well as the effectiveness rate of both catheters

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Rotator cuff or proximal humerus surgery
* ASA I-III
* BMI 18-39 kg/m2
* Acceptance of receiving a peripheric nerve block

Exclusion Criteria:

* Inability to provide consent for the study
* Coagulopathy
* Sepsis
* Severe Renal or hepatic disease (Creatinin \> 2.0 or Child C)
* Allergy to local anesthetics
* Previous peripheral nerve damage
* Refusal of postoperative continuous block technique
CIED Implantation in Low BMI Patients

The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).

A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.

Eligibility Criteria:
Inclusion Criteria:

* BMI of less than 23.
* Already scheduled for or a clinical decision made to have one of the following qualifying CIED implant procedures using a device cleared by the U.S. FDA:

  * De novo pacemaker, ICD, or S-ICD;
  * Upgrade or change out of existing CIED to a pacemaker, ICD, or S-ICD
* Clinically stable and able to tolerate procedure.
* Be able and willing to return for follow-up care through the 3-month visit.
* Must possess the ability to provide informed consent.

Exclusion Criteria:

* Patients with a known sensitivity to porcine material.
* Participation in another clinical study.
* Active infection. Clinical diagnosis of an active infection at the time of CIED implant (CIED infection, pneumonia, UTI, endovascular, cellulitis, bacteremia, or other major systemic infection).
* Female patient who is pregnant, or planning to become pregnant during the length of the study.
* Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis in the past 12 months.
* Life expectancy of less than 3 months.
Secondary Prophylaxis of Gastric Variceal Bleed

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis
2. Patients who had bled from GOV2 or IGV1（≥5 days and ≤ 28days）
3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery
2. Non-cirrhotic portal hypertension
3. Contraindications to cyanoacrylate injection or BRTO
4. Portal cavernoma
5. Hepatorenal syndrome
6. Proven malignancy including hepatocellular carcinoma
7. End-stage renal disease under renal replacement therapy;
8. Cardiorespiratory failure
9. Pregnancy or patients not giving informed consent for endoscopic procedures
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction.

Study design:

Multicenter, prospective, opened, randomized.

Primary endpoints:

ST resolution \>70% 60 minutes after PCI

Secondary endpoints:

Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI \<3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score \>1


Eligibility Criteria:
Inclusion Criteria:

* ST elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm ST segment elevation in two lead
* Minimum 3 mm ST segment elevation in one leads
* Vessel reference diameter \> 2.5 mm
* When vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation

Exclusion Criteria:

* Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
* Active bleeding or coagutopathy
* Prior CABG or PCI
* Known ejection fraction EF \<35%
* Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/
* LBBB, pacemaker rhythm
* Severe calcifications
* Previous Myocardial infarction
* Stroke history
* Patient directly after reanimation
* Known thrombocytopenia- platelets \< 100 000
* Pregnancy
* Cancer disease
* No future patient cooperation expected
* Patient's taking part in the other clinical trials
* Fibrynolisis directly administered before PCI
* Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis
* Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
* Active bleeding or coagutopathy
* Prior CABG or PCI
* Known ejection fraction EF \<35%
* Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/
* LBBB, pacemaker rhythm
* Severe calcifications
* Previous Myocardial infarction
* Stroke history
* Patient directly after reanimation
* Known thrombocytopenia- platelets \< 100 000
* Pregnancy
* Cancer disease
* No future patient cooperation expected
* Patient's taking part in the other clinical trials
* Fibrynolisis directly administered before PCI
* Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis
* Liver insufficiency