cyrilzakka/clinical-trials huggingface dataset:
A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD

This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection.


Eligibility Criteria:
Inclusion Criteria:

Subjects who only meet all of the following criteria are eligible for this study:

* nAMD subjects who have been enrolled in the SKG0106-related study and received SKG0106 injection;
* Subjects who voluntarily sign an informed consent form (ICF) and comply with the protocol to complete the study

Exclusion Criteria:

* Subjects who are judged by the investigator unsuitable for this study
Immediate Effects of Open and Closed Kinetic Chain Exercises on Upper Extremity in Stroke Patients.

Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters.


Eligibility Criteria:
Inclusion Criteria:

* Stroke diagnosis;
* Hemiplegia;
* Subacute\&chronic phase (more than 3 months);
* Brunnstrom 3-4-5;
* Unsupported sitting ability;
* Being volunteer.

Exclusion Criteria:

* Having Botox within the last 6 months;
* 4 according to Modified Ashworth Scale;
* Other neurological diagnosis other than stroke.
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

To evaluate the effects of Terlipressin infusion on blood loss \& transfusion requirements in cirrhotic patients undergoing major liver resections.


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension

Exclusion Criteria:

* Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets \< 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR \< 50ml/min), heart failure, Bradyarrhythmia (heart rate \< 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure \>160/100mmHg), and Pregnancy
Hearing and Vestibular Interactions in the Collection of Own Body and Sense of Self

The investigators objective is twofold. Investigators propose to study how the vestibular and auditory information interact in the construction of coherence between the staff and extrapersonal space.

Furthermore, investigators want to investigate whether, even in the absence of gravity, the auditory spatial information allocentric provide a framework for spatial reference.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged between 18-65 years
* Affiliates to a social security system or, for non-residents in France, holder of a European Health Insurance Card European (EHIC European Health Insurance Card)
* Who are willing to take part in the study,
* Who gave written informed consent,
* Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects.

Exclusion Criteria:

* People who took part in a biomedical research protocol for which the exclusion period is complete,
* People with psychotic disorders and / or depression,
* People receiving psychotropic medication,
* People with alcohol dependence or illicit substances,
* People with visual acuity less than 8 / 10ths corrected by lenses or glasses,
* People with a significant decrease in hearing,
* pregnant women.
Duodenal Exclusion for the Treatment of Type 2 Diabetes

The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.


Eligibility Criteria:
Inclusion criteria:

* Age between 20 and 50 years old;
* BMI between 27 and 34.9;
* Oral agents or insulin to control T2DM;
* Inadequate control of diabetes as defined as HbA1c\>8.0% but \<10%
* Understanding of the mechanisms of action of the treatment

Exclusion criteria:

* More than 5 years of T2DM diagnosis;
* C-peptide \<1pg/ml (off insulin)
* Previous abdominal operations;
* History of gastritis
* History of GERD
* History of peptic ulcer disease
* Inflammatory bowel disease
* Coagulopathy;
* Liver cirrhosis;
* Unable to comply with study requirements, follow-up schedule or give valid informed consent;
* Currently pregnant (pregnancy test required for confirmation for those of child bearing years)
* Patient is not available for programmed follow-up during the study period
* Patient is unwilling to forgo good samaritan blood donation during the study period
Early Renal Replacement Therapy in COVID 19 Patients With AKI Does it Improve the Outcome?

patients will be divided into two equal groups, each group including 50 adult patients with a confirmed diagnosis of covid, patients with acute kidney injury, the first group will be treated with early hemodialysis, second group will be conservative until there is an urgent need for dialysis


Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥18 years old) with confirmed severe acute respiratory syndrome coronavirus 2 infections admitted to the ICU.

Exclusion Criteria:

* •Malignancy.

  * Immuno-deficiency diseases.
  * Chronic diabetic, cardiac and hypertensive patients
  * autoimmune diseases.
Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children

a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children

Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap defects or following complications of primary esophageal anastomosis, as well as in patients with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted that the ideal esophageal replacement is one that resembles the function of the native esophagus with minimal deterioration over time. Several techniques of esophageal replacement have been developed. These have focused mainly on the use of native tissues (including the stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used. (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support the use of minimally invasive surgery (5) however, equivalent comparative studies in the pediatric population are lacking. As such, it is unclear whether minimally esophageal replacement is as safe as the open procedure in children. The present study aims to address this question by comparing the postoperative outcomes of children who underwent minimally invasive versus open esophageal replacement procedures at single-center and multicenter levels.

Eligibility Criteria:
Inclusion Criteria:

All children undergoing oesophageal replacement aged one to 18 years. Due to

1. long gap esophageal atresia
2. caustic ingestion
3. congenital esophageal stenosis or strictures

Exclusion Criteria:

* patient who underwent previous esophageal replacement operations.
Comparative Analysis of Ultrasound-Guided Versus Landmark-Based Techniques for Regional Anesthesia in Egyptian Patients

Regional anesthesia is a cornerstone in modern surgical practices due to its ability to provide effective pain management and reduce reliance on general anesthesia. Traditional landmark-based techniques, widely used due to their simplicity and cost-effectiveness, rely on surface anatomy and palpation to guide needle placement. However, these techniques are associated with a higher risk of complications, including failed blocks and nerve injuries.

Ultrasound-guided techniques have emerged as a safer, more precise alternative, offering real-time visualization of anatomical structures. Studies suggest that ultrasound guidance improves the success rate, reduces procedural time, and minimizes complications. Despite global advancements in ultrasound-guided regional anesthesia, limited research addresses its efficacy and safety specifically in Egyptian patients, whose unique anatomical and physiological characteristics may influence outcomes.

This study seeks to fill this knowledge gap and provide evidence-based guidance tailored to this population, focusing on brachial plexus blocks.

Regional anesthesia is a cornerstone in modern surgical practices due to its ability to provide effective pain management and reduce reliance on general anesthesia. Traditional landmark-based techniques, widely used due to their simplicity and cost-effectiveness, rely on surface anatomy and palpation to guide needle placement. However, these techniques are associated with a higher risk of complications, including failed blocks and nerve injuries.

Ultrasound-guided techniques have emerged as a safer, more precise alternative, offering real-time visualization of anatomical structures. Studies suggest that ultrasound guidance improves the success rate, reduces procedural time, and minimizes complications. Despite global advancements in ultrasound-guided regional anesthesia, limited research addresses its efficacy and safety specifically in Egyptian patients, whose unique anatomical and physiological characteristics may influence outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ● Adult patients aged 18-65 years undergoing upper limb surgery requiring brachial plexus block.

  * Patients capable of providing informed consent

Exclusion Criteria:

* ● Patients with contraindications to regional anesthesia (e.g., infection at the site, severe coagulopathy).

  * History of severe allergic reactions to local anesthetics.
  * Anatomical abnormalities affecting the brachial plexus block.
  * Obesity (BMI \> 35) or other conditions that might confound results.
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.

Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.

Eligibility Criteria:
Inclusion Criteria:

* Ages 19 to 50
* At least 2 year history of ragweed allergic rhinitis
* Positive skin prick tests to ragweed \>5 mm wheal diameter
* IgE \<700 iU/m

Exclusion Criteria:

* Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days.
* History of immunotherapy in the past 2 years
* Exposure to Omalizumab in the past 2 years
* Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
* Asthma other than mild intermittent
* Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
* Known sensitivity to study drug Xolair
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Patients with a previous history of cancer
* Use of any other investigational agent in the last 30 days
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effects of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.

Eligibility Criteria:
Inclusion criteria:

* Participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy

Exclusion criteria:

* Age \< 18 years or legal age of adulthood, whichever is greater
* LDL-C \< 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
* LDL-C \< 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
* Fasting serum triglycerides \> 400 mg/dL (4.52 mmol/L)
* Known history of homozygous familial hypercholesterolemia

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.

It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.


Eligibility Criteria:
Inclusion Criteria:

* Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for Aneuploidy).
* Males over 18 years of age whose semen sample meets the basic conditions predetermined by the ZyMōt Multi 850µL chip.
* Fresh semen samples.
* Embryos are to be deposited in a time-lapse incubator.
* Women over 37 years of age who have obtained in follicular puncture a number of MII oocytes greater than or equal to 4.

Exclusion Criteria:

* Males with severe asthenozoospermia (\<10% progressively motile spermatozoa), globozoospermia (spermatozoa with morphological alterations and lack of acrosome) and/or azoospermia (absence of spermatozoa in the ejaculate).
* Seminal samples obtained by testicular biopsy.
* Samples incubated with calcium ionophore.
* Males and females with previously known abnormal karyotype.
* Oocytes coming from the oocyte donation program.
Diabetic Foot Ulcer Prevention System

To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. Has no history of diabetes
3. Has no previous history of foot ulceration
4. Has no previous history of foot surgery
5. Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
6. Has no history of peripheral neuropathy
7. Has no history of peripheral arterial disease
8. Must be able to provide meaningful written informed consent for the study

Exclusion Criteria:

1. Has active foot ulceration and infection
2. Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
3. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
4. Has an implantable electronic device
5. Is aged \<18
Regeneration of Liver: Portal Vein Embolization Versus Radiofrequency Assisted Ligation for Liver Hypertrophy (REBIRTH)

The aim of this study is to compare two different techniques (portal vein embolization and radiofrequency assisted liver partition with portal vein ligation) for increasing liver volume prior to major liver resection.

Liver resection remains the gold standard treatment for patients with liver tumours providing them the only chance for long-term survival. In up to 45% of cases that are amenable to surgical resection, an extended hepatectomy (removal of part of the liver) is usually necessary to achieve a clear resection margin. However, there must be enough liver left behind to meet the demands of the body. Indeed, liver failure due to insufficient remnant liver volume is still the principal cause of postoperative death following a major liver resection.

The liver receives its main blood supply from two vessels (the portal vein and the hepatic artery). In order to decrease the complications and improve the safety of extensive liver surgery in patients with insufficient future liver remnant volume (FLRV), pre-operative embolization (i.e. blockage) of part of the portal vein can be undertaken.

This has the effect of inducing growth of the liver on the unaffected side. Thus, when the resection is carried out, an increased FLRV (of around 12%) reduces post-operative liver failure. An alternative technique is to perform surgical ligation of the portal vein along with splitting of the liver.

The diseased portion of liver is left in the body for 7-10 days while the healthy side is induced to grow. During this time, the diseased portion continues to support the body's requirement for liver function and reduces the risk of liver failure. FLRV has been shown to increase by around 74% with this technique.

However, there are more postoperative complications with the alternative technique such as bile leaks. The aim of this study is to test a new way of splitting the liver so that the increased FLRV can be achieved without the increased complication rate.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Any patient requiring right or extended right hepatectomy with FLRV less than 25% on preoperative volumetric study
* WHO performance status 0, 1 or 2
* Patient able to comply with protocol requirements and deemed fit for surgical resection
* Written informed consent

Exclusion Criteria:

* Inability to give informed consent
* Pregnancy
* WHO status 3 or 4
* New York Heart Association Classification Grade III or IV
Sample Size Definition in Cochrane Hepato-Biliary Trials

Sample size definition provides important information, allowing the groundwork for transparent reporting. The sample predefinition allows the trial to be large enough to be able to address the question that is being asked.

The aim of the present study is to assess, in all the randomized controlled trials (RCT) included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of reporting sample size the accuracy of the calculations, the accuracy of the a priori assumptions and the effect on the agreement with pooled results in meta-analyses.

The investigators aim to answers to these questions

Questions

* How large a proportion of recent hepato-biliary RCTs does report an adequate sample size estimation?
* Primary outcome is clearly defined ? and clinical meaningful ?
* Is the sample size calculation based on the primary outcome ?
* Does the predicted control event rate coincide with the actual one?
* What is the predicted intervention effect?
* Are confidence intervals of primary outcome results reported? Is there evidence of difference between the two arms?
* Is the effect size so large (\> 50%) to suggest post hoc definition ?
* What is the accepted error alpha and beta?
* How many study do not comply with the usual rule of alpha = 5% beta = 20%?
* Do trials with planned sample size do better than those without ? Is the overlap between CI results less frequent ? Are their results more frequently "statistical" significant ?
* Do trials with planned sample more frequently agree with pooled results in meta-analysis ?
* Has the protocol been published in a public register before inclusion of participant?
* How often is intention-to-treat analyses employed as primary analysis?
* How often is the trial results resting upon subgroup analysis?

Methods:

All the randomized clinical trials included in a systematic review of the Cochrane Hepato-biliary group (according to my search 272) were detected and retrieved. Only two arm, parallel group superiority randomised controlled trials with a single primary outcome.

The investigators excluded reports for which the study design was factorial, cluster, or crossover For all selected articles, the investigators systematically retrieved and assessed the full published report of the trial, any extra material or appendices available online, the study design article, if cited, and the details of online registration of the trial, if mentioned. A standardised data collection form was generated on the basis of a review of the literature and a priori discussion and tested by the research team.

Eligibility Criteria:
Inclusion Criteria:

* Two arms, parallel group superiority randomised controlled trials with a single primary outcome,

Exclusion Criteria:

* Reports for which the study design was factorial, cluster, or crossover