cyrilzakka/clinical-trials huggingface dataset:
Capsulorhexis Size and Capsular Outcome

Different capsulorhexis size results in different capsular outcome when treating pediatric cataract, and there should be an appropriate capsulorhexis size for the best capsular outcome.

Numerous studies have reported that ideal anterior capsulorhexis size is 4.5-5.0 mm with the capsulorhexis edges covering IOL optic surface because it can inhibit the proliferation and migration of remnant lens epithelial cells (LEC). But there are no reports investigating the relationship between the capsulorhexis size and the capsular outcome after pediatric cataract surgery. Therefore, the aim of the current study is to prospective evaluate the capsular outcomes of three controlled groups receiving different anterior capsulorhexis sizes (3.0-3.9, 4.0-5.0, 5.1-6.0 mm in diameter).

Eligibility Criteria:
Inclusion Criteria:

* Age\< 2 years
* performed cataract surgery without IOL implantation
* without capsular fibrosis, glaucoma, ocular trauma, corneal disorders before surgery
* No other corneal and systemic abnormalities
* Written informed consents provided

Exclusion Criteria:

* Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis
* Cases with surgical complications
* those who can't dilute pupil normally postoperation or can't complete the follow-up
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment

The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).

This is a single-blind (physician does not know the name of the assigned drug) and randomized (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and EE/DSG in female participants using oral contraceptive and have mild to moderate acne vulgaris. Tablets of EE/NGM and EE/DSG will be administered orally once daily for 6 months and will be instructed to visit for evaluation at Month 1, 3 and 6 post-administration. The efficacy will be evaluated efficacy primarily through total acne lesions count, which will be recorded at these evaluation visits. Unused study medications will be collected and drug accountability will be documented. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria: - Needs contraception in the family planning - Mild to moderate acne vulgaris - Agrees to take only the supplied study drug as treatment for acne during the 6-month treatment phase of the study - Signs and dates an informed consent to participate in the study - female participants aged 18 to 45 years Exclusion Criteria: - Pregnant or nursing - Known hypersensitivity to any of the ingredients and currently having significant adverse experiences from ethinyl estradiol, norgestimate or desogestrel - Any coexisting medical condition or were taking any concomitant medication that is likely to interfere with safe administration of ethinyl estradiol/norgestimate and ethinyl estradiol/desogestrel, in the Investigator's opinion - Taking system retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively - Taking investigational medication or oral contraceptives within 30 days prior to Screening
Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer

The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis.

Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage I endometrial cancer
* Laparoscopic operation

Exclusion Criteria:

* post-operative oncologic follow-up \< 12 months
* extra-uterine evidence of disease
On-lay Versus Pre-peritoneal Hernioplasty in Incisional Lumbar Hernia

To compare between the outcome of on-lay and pre-peritoneal techniques of hernioplasty in incisional lumbar hernia repair.

Lumbar hernia is found as a challenge even in the era of advanced medicine, due to its rarity which complicate its diagnosis and treatment\[1\]. Lumbar hernia is the protrusion of an organ intra-peritoneal or extra-peritoneal tissue through a congenital or acquired defect in the posterolateral abdominal wall\[2\]. Incisional Lumbar hernia is among the types of lumbar hernia that accounts for 25% of cases\[3\]. Post abdominal surgeries, the tissue strength can only regain 80% of its maximum tensile power under perfect conditions. Thus, each abdominal surgery is a predisposing factor for lumbar incisional hernia \[4\] Primary closure of the defect with sutures, has proven to have a high failure rate so the integration of the mesh in hernia repair has significantly flattened the recurrence curve. Taking the advantage of Laplace's law, the mesh aims to reinforce or bridge the defect and distribute the intra-abdominal pressure across the entire synthetic sheet rather than just the defect. \[5\] The two most used mesh placing techniques are on-lay and pre-peritoneal. Each method has its benefits and drawbacks. \[6\] Some surgeons outweigh the on-lay technique to avoid extensive dissection. Thus, it is a faster and easier technique; nevertheless, there are several local wound issues. \[7\] The pre-peritoneal method allows the surgeon to apply the mesh posterior to the fascial plane in front of the peritoneum. The latter technique is gaining popularity with time \[8\]

Literature are deficient in comparing on-lay and pre-peritoneal technique in the repair of incisional lumbar hernia.

Eligibility Criteria:
Inclusion Criteria:

* Incisional lumbar hernia
* Recurrent lumbar hernia
* Age more than 16 years old

Exclusion Criteria:

* Complicated lumbar hernia (irreducible, obstructed, strangulated hernia)
* Denovo lumbar hernia
Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1

The purpose of this study is to investigate the effects of mexiletine treatment for 6 months on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning, cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).

This study will provide data on the long term (6 months) safety and efficacy of mexiletine in:

* improving the distance participants are able to walk in six minutes;
* reducing myotonia;
* improving muscle strength;
* increasing lean muscle mass;
* decreasing musculoskeletal pain;
* improving gastrointestinal function and swallowing);
* improving functional abilities;
* decreasing cardiac arrhythmias; and
* improving disease-specific health related quality-of-life.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of DM1, confirmed by DM1 genetic mutation
* Ability to walk 30 feet (assistance with cane and/or leg bracing permitted)
* Presence of grip myotonia

Exclusion Criteria:

* Congenital DM1
* Treatment with Mexiletine within past 8 weeks
* Second or third degree heart block, atrial flutter, atrial fibrillation, ventricular arrhythmias, or is receiving medication for treatment of a cardiac arrhythmia
* Receiving another antimyotonia drug
* Liver or kidney disease requiring ongoing treatment
* Has a seizure disorder
* Is pregnant or lactating
* Had severe depression within 3 months or a history of suicide ideation
* Has any one of the following medical conditions: uncontrolled diabetes mellitus, congestive heart failure, symptomatic cardiomyopathy, symptomatic coronary artery disease, cancer (other than skin cancer) less than five years previously, multiple sclerosis, or other serious medical illness.
* Drug or alcohol abuse within 3 months
* Coexistence of another neuromuscular disease
* Is unable to give informed consent
* Severe arthritis or other medical condition (besides DM1) that would significantly impact ambulation
Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. Therefore, in this study the investigators intend to compare the effect of ezetimibe monotherapy or ezetimibe plus statin combination therapy on the atherosclerosis regression using FDG-PET.


Eligibility Criteria:
Inclusion Criteria:

* hsCRP \> 2 mg/L and LDL cholesterol \> 130 mm/dL

Exclusion Criteria:

* history of cardiovascular disease
* diabetes
* uncontrolled hypertension
* active infection
* previous anti-hyperlipidemic agents within 6 months
* previous steroid or anti-inflammatory agents within 6 months
* liver disease
* renal disease
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.


Eligibility Criteria:
Inclusion Criteria:

1. 20-45 years old healthy males
2. Body mass index 19.0 \~ 28.0 kg/m2

Exclusion Criteria:

1. Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB
2. Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration
3. Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders
4. Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)
5. Fever greater than 38.3℃ within a week prior to administration of study drug
6. Previous or current drug abuse
Effect of Exogenous Ketosis During Ultra-endurance Exercise

The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the main focus. In this context, subjects (n=24) will perform a 100km ultrarunning trail, while receiving either ketone ester (KE, n =12) or placebo (CON, n=12). Experimental measurements will be performed immediately before and after the ultramarathon as well as 24h after the ultramarathon.


Eligibility Criteria:
Inclusion Criteria:

* Males between 18 and 55 years old
* Recreational or competitive runner having performed an ultramarathon (\>42km) during the last 2 years
* Good health status confirmed by a medical screening
* Body Mass Index (BMI) between 18 and 25

Exclusion Criteria:

* Any kind of injury/pathology that is a contra-indication to perform ultra-endurance exercise
* Intake of any medication or nutritional supplement that is known to affect exercise performance
* Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
* Blood donation within 3 months prior to the start of the study
* Smoking
* More than 3 alcoholic beverages per day
* Current participation in another research trial
* Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
* Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)
Decreasing ED Utilization by Nudging Patients to Call Their Providers

In the present study, patients will be sent a message shortly after completing a medical procedure that informs or reminds them that they can reach out to Geisinger, and how to do it, if they have any medical issues or concerns. Researchers will assess if such messages make patients more likely to contact Geisinger with post-procedure medical concerns and decrease emergency department utilization.

Decreasing emergency department (ED) over-utilization is a priority for healthcare systems across the country. Patients uncertain about a medical issue routinely end up in the ED when less costly and time-consuming alternatives could have addressed their concern. If patients reach out to healthcare facilities rather than heading directly to the ED, they can often be directed toward resources better suited to their concerns than the ED.

Geisinger is thus working to encourage patients to contact healthcare providers if any concerns arise and patients are uncertain about where to go for care. Patients who have recently had a medical procedure may be particularly valuable to encourage, as they routinely have concerns related to the procedure and discharge can serve as a useful touch-point to remind the patient where they can go for questions or concerns.

In the present study, patients will be sent a patient portal message shortly after completing any Women's Health medical procedure. The message will inform or remind patients how they can reach Geisinger if they have any medical issues or concerns. The purpose of this study is to assess if such messages make patients more likely to contact Geisinger with medical concerns and, in turn, decrease unnecessary ED utilization. This study will A/B test 2 messages, encouraging patients to either call their recent provider directly or to call a tele-nurse hotline, and will assess if these messages perform better than a control group that will not be sent any such message.

Generalized linear models will examine the primary study outcomes as a function of the study arms (between-subjects).

Eligibility Criteria:
Inclusion Criteria:

* Patient had a procedure in Women's Health within the study period (including both surgical and in-office procedures as well as baby delivery)
* Patient is enrolled in myGeisinger, Geisinger's patient portal

Exclusion Criteria:

* If procedure was labor that resulted in fetal demise or stillborn.
New Strategy to Predict Early Sepsis

This is an observational prospective multicentre study on patients attending the emergency department and suspected to have sepsis. Blood markers characteristic of a Cellular Reprogramming (CR) signature and predicting severe sepsis and organ failure will be measured and validated.

Sepsis is a life-threatening medical condition caused by an infection and the complex and dysfunctional way by which the human body attempts to deal with it. It can affect people of all ages, causing 18-30 million cases and 5-8 million deaths annually worldwide. However, early diagnosis of sepsis is challenging due to the diversity and overlap of symptoms with other disorders and the lack of an early and accurate diagnostic method. Hancock and colleagues defined a gene expression signature characteristic of biological changes occurring during sepsis, known as cellular reprogramming (CR) and reflecting a type of immune amnesia (inability to respond to bacterial signals). This signature was shown to predict the development of sepsis and organ failure at first clinical presentation in the emergency room, by examining patient blood samples taken during an initial pilot single-center study.

This project will validate and refine the CR signature and demonstrate reproducibility, specificity, and sensitivity in a larger multi-center study to enable a new strategy to predict Sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Presenting to the Emergency Department
* Attending physician suspects possible sepsis based on at least 2 sign of Systemic inflammatory response syndrome (SIRS) criteria and suspicion of infection

Exclusion Criteria:

* Patient is terminal (death anticipated in 12 hours)
* Informed consent unobtainable if the subject survives to hospital discharge.
* Subjects who are unable to provide blood as a standard of care.
* Blood sample could not be taken within 24 hours of a physician's first contact with the patient.
Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease

The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question\[s\] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical complaint related to Peyronie's disease;
* At any stage of the disease (acute or chronic).

Exclusion Criteria:

* Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant;
* Metallic implants over or under the area to be treated.
A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy
2. Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before inclusion
3. The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
4. Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC
5. Perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (AED) monotherapy or must be planned to substitute one of two AEDs of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. It will be specified which AED is planned to be substituted by perampanel upon inclusion. It is assumed that participants start treatment with perampanel closely after the baseline visit. Retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and inclusion does not exceed 7 calendar days. In this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated

Exclusion Criteria:

1. Participants with known psychogenic non-epileptic seizures
2. The participant had already received perampanel in the past
3. Simultaneous participation in an interventional clinical study and/or taking an investigational drug
Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation

This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75 years.
* Diagnosed with Type 2 diabetes (HbA1c between 7.0% and 10.0%).
* Stable anti-diabetic medication regimen for at least 3 months prior to the study.
* Willingness to provide genetic and metabolic data.

Exclusion Criteria:

* Type 1 diabetes or other specific types of diabetes.
* Significant renal, hepatic, or cardiovascular diseases.
* Use of dietary supplements that affect glucose metabolism within the last 3 months.
* Pregnancy or breastfeeding
carDIo-ttranSSfOrm nucLEar Imaging Study

The investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171).

This is a multicenter trial of 80 subjects enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) who will undergo baseline and follow up Tc-99m PYP to assess for the change in myocardial uptake of the tracer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform.
* Patients have to meet the inclusion and exclusion criteria of CARDIO-TTRansform trial to be enrolled.
* Patient willing to consent for the study and undergo the study procedures.

Exclusion Criteria:

* None