cyrilzakka/clinical-trials huggingface dataset:
Outcome of Laparoscopic Inguinal Herniorraphy in Children

The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will be based on a review of hospital records and a questionnaire answered by families. Patient demographics (age, gender), affected side, type and duration of laparoscopic intervention, and outcome parameters (hernia recurrence, post-operative complications, eg. infections, length and type of postoperative pain medication, and length of the postoperative hospital stay) will be analysed.

Hernias of the abdominal wall occur if intra-abdominal tissue or peritoneum bulges through the abdominal wall. The most frequent locations of abdominal wall hernia are the inguinal region close to the groin, the umbilicus, and scars. Congenital inguinal hernias occur more frequently in the inguinal region if the vaginal process is not closed adequately at birth. Surgical procedures for correction of inguinal hernias are frequently carried out in children. Laparoscopic procedures to correct inguinal hernias in children are gaining more acceptance. The laparoscopic closure of hernias in children is considered effective and safe and represents an accepted alternative to the open surgical hernia repair. When compared to open surgical hernia repair in children, laparoscopic hernia repair causes smaller scars, allows for a faster postoperative recovery of children, requires less pain medication, and allows for an inspection of the contralateral side, thus facilitating simultaneous hernia repair in the same operation.

We aim to investigate the short-term results of laparoscopic inguinal hernia repair in children. The main outcome parameter of this single-center study is hernia recurrence or the occurrence of contralateral metachronous hernia. Secondary outcome measures are postoperative complications such as infections of the wound regions, the time between operation and discharge from hospital, and postoperative pain medication requirements. We chose a 4-year time interval for inclusion of patients. Data are retrieved from hospital records in a retrospective evaluation. In addition, a structured questionnaire sent to the families of children will document postoperative complaints and complications from 3 months after the operation onwards. Families not responding to the questionnaire will be offered a structured telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 1 day and 16 years who underwent a laparoscopic surgical procedure for correction of unilateral or bilateral inguinal hernia or recurrent inguinal hernia at a single institution

Exclusion Criteria:

* age of patient more than 16 years
* patients suffering from neuromuscular, chronic abdominal, chronic pulmonary, or malignant disorders
* patients suffering from degenerative soft tissue disorders
* patients receiving immunosuppressive drugs for more than 3 weeks or during a - 3-week perioperative time interval
Effect of Estradiol Pretreatment on Antagonist ICSI Cycles

Depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual follicle stimulating hormone (FSH) elevation that occurs during the late luteal phase, the aim of this work is to study the effect of estradiol pretreatment on follicular synchronization and intracytoplasmic sperm injection (ICSI) outcome in antagonist cycles

Gonadotropin-releasing hormone antagonist (GnRH-ant) cycles are characterized by higher patient acceptability with more attention being directed to the potential effect of steroid pretreatment to program antagonist protocol cycles, as marked size discrepancies of growing follicles reflect incoordinated maturation of follicular-oocyte complexes and complicates clinical criteria for human chorionic gonadotropin (hCG) administration. This phenomenon is associated with fewer mature oocytes and resulting embryos, which limits sufficient embryo selection for embryo transfer. Indeed, the large number of available embryos represented an important prognostic factor of invitro-fertilization (IVF) outcome, particularly in poor prognosis patients, possibly by increasing the probability that at least one good-quality embryo will be selected for embryo transfer. During COH, a better understanding of follicular development has resulted in the improvement of strategies for ovarian stimulation. This approach represents a potential and more physiological alternative to GnRH agonist or oral contraceptive pills pre-treatment in a trial to synchronize multi-follicular development and improve controlled ovarian hyperstimulation (COH) results. The present study is a randomized controlled trial that investigated whether E2 pre-treatment during the luteal phase affects developmental characteristics of growing follicles during COH. It depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual FSH elevation that occurs during the late luteal phase, thus testing for detection of the effect of luteal estradiol on follicular synchronization and its effect on ICSI outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Women age 20-37 years.
2. Anti-mullerian (AMH) level greater than 1.2 ng/ml.
3. Body mass index between 18 and 29 kg/m2.
4. Undergoing a first or second ICSI cycles.

Exclusion Criteria:

1. Endometriosis.
2. Uterine disorders such as fibroids and uterine anomalies.
3. Antral follicular counts (AFC) less than 10.
4. Azoospermic males.
The Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction

This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.

Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge. This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
* Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
* Age \>18 years.
* First-time stroke.
* Steady vital signs,
* Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Exclusion Criteria:

* The bulbar palsy caused by other diseases, such as neurodegenerative diseases.
* Pseudobulbar palsy.
* Complicated with other neurological diseases.
* Tracheostomy tube inserted.
* Simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
* Dysphagia caused by other possible diseases.
* Pregnant females.
Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient

The aim of this study is the comparison between the effects of supplementation with vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient.

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS).The most important reason for the limited success obtained in the treatment and prevention so far is most likely related to the limited knowledge about its cause and pathogenesis of MS.One of the recent proposed mechanism for autoimmunity base of MS is Th1/Th2 implance of as well as other inflammatory and anti-inflammatory T cell such as Th17 and Treg and their releasing cytokines. Therefore the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.

Eligibility Criteria:
Inclusion Criteria:

Patients who have used interferon beta in last 3 months. Patients with 1-5 EDSS

Exclusion Criteria:

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* Patients who have allergy to vitamin A compounds, OR
* Patients who have used vitamin supplements in last 3 months. -
Medium-term Results of the LPS™ System for Segmental Resection of the Distal Femur, a Multicenter Retrospective Study (RESIF)

The reconstruction of the distal femur using modular systems has become increasingly popular over the years, surpassing primary arthrodesis or amputation. Despite the significant advantages of using megaprostheses, complications are not uncommon. Although the Limb Preservation System™ (LPS™, DePuy Synthes; Warsaw, USA) is one of the most widely used megaprostheses in the French market, there is currently no national evaluation of this system, and only two studies have been conducted worldwide.

The aim of our study is to present the mid-term survival rates of the LPS™ implant in order to answer three main questions:

1. What are the overall outcomes of the LPS™ system in distal femur replacement?
2. What factors are associated with a reduced survival rate of the implant?
3. What is the cumulative risk of complications according to Henderson's classification?

The secondary objective is to analyze the occurrence of specific failures, providing insights for potential improvements in the design and use of the LPS™ implant.


Eligibility Criteria:
Inclusion Criteria:

- Patients who underwent distal femoral reconstruction using the LPS system.

Exclusion Criteria:

* Lost to follow-up before 3 months.
* Associated tibial reconstruction using the LPS system.
* Total femoral reconstruction using the LPS system.
Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)

The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (HSIL) \[vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)\] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection. For more information visit our study website at: www.VINresearchstudy.com


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 and above;
* Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit;

Exclusion Criteria:

* Biopsy-proven differentiated VIN;
* Any previous treatment for vulvar HSIL within 4 weeks prior to screening;
* Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;
* Pregnant, breastfeeding or considering becoming pregnant within 6 months following the last dose of investigational product;
* Immunosuppression as a result of underlying illness or treatment;
* Significant acute or chronic medical illness.
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric AKI

This study follows a group of patients admitted to the PICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict patients who will become fluid overloaded and develop acute kidney injury.

In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have developed, tested, and integrated an AKI risk-stratification/clinical recognition tool (RAI) and a urine biomarker (NGAL) to try to identify patients at risk vs. not at-risk for developing AKI. However, these factors alone have yet to be integrated into clinical decision support to optimize AKI therapies and patient outcomes. The furosemide stress test (FST), previously described in adults, may be a good predictor for the patients who need acute dialysis for AKI versus those that can be managed medically.

Through this study, the investigators will be following a cohort of patients admitted to the PICU who are identified as being at risk for developing AKI through RAI and NGAL results. The aim is to standardize the FST in this population, as well as determine the accuracy of the RAI-NGAL-FST clinical decision tool in predicting patients who become fluid overloaded and develop AKI.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Pediatric Intensive Care Unit (PICU)
* Renal Angina Index (RAI) greater than or equal to 8
* Urine NGAL greater than or equal to 150 ng/mL
* Indwelling urinary catheter

Exclusion Criteria:

* Evidence of volume depletion
* Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR \<60 mL/min/1.73m2)
* History of kidney transplantation
* Active DNR order or clinical team is not committed to escalating medical care
* Known history of allergic reaction to furosemide (only for FST)
Internet-delivered Group Counseling for Chronic Tinnitus

In the treatment of chronic tinnitus, psycho-education plays an import role to provide more insights into the symptoms of tinnitus. However, the need for e-health is increasing. As such, it is important to investigate if these psycho-education sessions can be delivered online, with the same efficacy compared to the traditional face-to-face delivery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with subjective, chronic tinnitus

Exclusion Criteria:

* Enrollment in other tinnitus treatments simultaneously at the time of the intervention
Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART

This post-registration observational study is designed to monitor the safety parameters and efficacy of Elpida® in actual practice in the first-line treatment of HIV-1 infected patients on the background of the standard baseline ART.

This study is a multicenter, open-label, post-registration observational non-interventional study of the use of Elpida® in the first line of therapy for HIV-1 infected patients against a background of standard baseline ART (NNRTIs + 2 NRTIs). The study is scheduled to be conducted approximately in 20 centers for the prevention and control of AIDS in Russia.

In total, 2000 HIV-1-infected patients who are prescribed therapy with Elpida® (20 mg capsules) against the background of standard baseline ART are planned to be included in the study.

The observational study will collect data from patients who signed informed consent and meet all inclusion/non-inclusion criteria from the time that precedes the therapy by Elpida® up to 96 weeks of treatment or until early elimination. The data will be obtained through routine visits and procedures, including demographics and history, height, body weight, body mass index (BMI), laboratory data (viral load of HIV-1, CD4+-T-lymphocytes, resistance mutations in HIV-1, screening for hepatitis B and C, syphilis, general and biochemical blood analysis, general urine analysis) and instrumental examinations (electrocardiography (ECG), chest X-ray/fluorography). Throughout the study, patients will keep observation diaries for recording AEs and concomitant therapy. Data on the intake of ART drugs and AE related to their use will also be collected.

Eligibility Criteria:
Inclusion Criteria:

1. A signed patient information sheet and a form of informed consent to participate in the study.
2. Men and women aged 18 and over.
3. Document supported HIV-1 infection.
4. Patients whom during the previous 24 weeks first line ART was prescried comprising the drug Elpida®, including patients who are ART-naive or were transferred to Elpida® from other first line ART regimens due to intolerance (transfer from other NNRTIs - within the class; transfer from protease inhibitors, including boosted ones, due to lipid metabolism disorders or other adverse reactions (AR) if the virological effectiveness of the previous ART regimen - was effective - reaching undetectable levels of viral load).

Exclusion Criteria:

1. Current participation in the clinical trial.
2. Significant alcohol and/(or) drug dependence, which, according to the researcher, can prevent collection of data.
3. Increase of AST/ALT levels by more than 2.5 times higher than the upper limit of the reference range at Week 0 visit.
4. Replication stage of chronic hepatitis C (presence of HCV RNA), requiring therapy.
5. Use of Elpida® in violation of indications officially approved by the Ministry of Health of the Russian Federation on the package leaflet.
6. Significant secondary diseases requiring treatment.
'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation

This study is designed as a randomized controlled trial to gain further insights into possible effects of a standardized 6-week Mindful Self-Compassion (MSC) training on psychiatric rehabilitation inpatients and aims

* to generate insights into which parameters of mental health, and especially emotion regulation, can be improved by MSC in this setting,
* to compare effects of MSC training with an established relaxation training (i.e., progressive muscle relaxation; PMR) and
* to determine the general conditions and patient characteristics influencing the effectiveness of MSC training.


Eligibility Criteria:
Inclusion Criteria:

1. Psychiatric diagnosis
2. Signed informed consent form
3. Full command of the German language

Exclusion Criteria:

1. Age \<18 years
2. Acute psychotic episode, acute suicidal tendencies, and acute addiction disorders
Exploration of Cerebral Pathophysiology During and After CABG Using CPB

Purpose:

The purpose of this study is to examine cerebral oxidative and inflammatory stress and cerebral hemodynamics during and after coronary artery bypass grafting and correlate with postoperative cognitive function.

Postoperative cognitive decline is a well-known and well-described complication following coronary artery bypass grafting. Severity ranges from postoperative delirium to stroke, but the majority of patients with postoperative cognitive decline following coronary artery bypass grafting have decline in recent and remote memory in particular.

The reason for the cognitive decline is still not fully understood though many reasons have been proposed.

Inflammation and oxidative stress may contribute to the postoperative cognitive dysfunction which may also be in combination with a reduced cerebral autoregulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass

Exclusion Criteria:

* Cerebrovascular disease
The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)

Chronic stress refers to a special emotional state caused by unexpected stress for a long time, with an increasing incidence in the population. It can cause the body to release hormones such as cortisol and adrenaline. Tumor patients often experience changes such as psychological and emotional abnormalities, decreased quality of life, and impaired social relationships. Under stimulation, patients often experience negative reactions such as anxiety or depression. Epidemiological studies have shown that stress can affect the prognosis of malignant tumors, but the effect of stress on the efficacy and prognosis of esophageal cancer is still unclear.

In animal models, chronic stress leads to an increase in tissue catecholamine levels, increased tumor burden, and increased invasiveness of ovarian cancer cells in mouse models. At the same time, stress can promote tumor neovascularization in mice. However, the mechanism by which chronic stress affects the occurrence and development of esophageal cancer is currently unclear. In addition to neurohumoral factors, chronic stress can cause changes in the gut microbiota, which in turn affects the body's digestion, metabolism, and immune function. It is a key gatekeeper of the immune response to tumors. Therefore, gut microbiota as an intermediate factor may also affect the occurrence and prognosis of various types of esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤ 75 years old
2. Pathologically diagnosed as esophageal cancer
3. Patient tumor tissue samples can be obtained
4. At least one measurable lesion can be evaluated according to the RECIST 1.1 standard
5. As a newly treated patient, they have not received systematic anti-tumor treatment for locally advanced or metastatic chest tumors
6. There is no obvious abnormality in the electrocardiogram and no obvious cardiac dysfunction
7. Hematology and liver and kidney function indicators meet the requirements

Exclusion Criteria:

1. Merge with other malignant tumors
2. Long term use of hormones or immunosuppressants
3. Concomitant acute or chronic mental illness
4. Patients who have been taking drugs that can alter the activity of the sympathetic nervous system for a long time or are currently taking them
5. Other malignant diseases that require systematic treatment
6. Patients who have undergone other clinical drug experiments before
7. Patients with symptomatic brain metastases