cyrilzakka/clinical-trials huggingface dataset:
Ilizarov Frame or Uni Planar External Fixator in the Cost-conscious Era

Tibial shaft fracture is a common injury worldwide. Their treatment, prognosis, and outcome are determined by the mechanism of injury, presence of communition, soft tissue injury and displacement. In developing countries, lack of education,socioeconomic backgrounds, delay in presentation and appropriate planning for surgery add further to complicate the situation and may end in delayed union, non-union, multiple surgeries and ultimate results in increased morbidity. This study was conducted to determine the outcome of open tibia shaft fracture treated with Ilizarov or AO External Fixator.

Tibial shaft fracture is a common injury worldwide. Their treatment, prognosis, and outcome are determined by the mechanism of injury, presence of communition, soft tissue injury and displacement. In developing countries, lack of education,socioeconomic backgrounds, delay in presentation and appropriate planning for surgery add further to complicate the situation and may end in delayed union, non-union, multiple surgeries and ultimate results in increased morbidity. This study was conducted to determine the outcome of open tibia shaft fracture treated with Ilizarov or AO External Fixator. It was retrospective Cohort study. Two groups were compared in terms of fracture healing, mechanism of injury, fracture classification, Participant's ambulation at discharge, New Injury Severity Score (NISS), duration of hospital stay, duration of fracture union, need for secondary procedures and complications. Investigators concluded that circular fixator application has favorable outcomes for Gustilo grade III open tibial shaft fractures as compared to uniplanar external fixator.

Eligibility Criteria:
Inclusion Criteria:

Participants with open tibia shaft fracture type III (A, B, C) as per Gustillo classification of open fractures stabilized with external fixation either circular or uniplanar external fixator were included

Exclusion Criteria:

* All closed and type I and II open tibia shaft fractures according to Gustillo classification of open fracture, Intra-articular fracture extending to knee and ankle joints were excluded.
Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

Investigators will conduct this single-center, prospective cohort study to explore the prevalence and risk factors of renal function progression in post-liver transplantation patients with renal impairment after renal biospy and to understand the the pathology of kidney disease in post-liver transplantation patients with renal impairment.

This is a single-center, prospective, cohort study. This study will include approximate 369 post-liver transplantation patients with renal impairment and have received renal biopsy. Demographic characteristics, medical history, etiology of liver failure, concomitant medications, baseline laboratory parameters, etc., will be recorded. All participants will receive standard treatment by hepatologists and nephrologists based on the pathological results. All participants will be followed up for 96 weeks. Renal function, concomitant medications, and other laboratory parameters, etc., will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* patients received liver transplantation
* new onset of proteinuria(defined as 24-hour proteinuria\>1g/24h, or Urinary albumin creatinine ratio(UACR)\>300mg/g at least two occasions
* have received renal biopsy in the past 3 months
* Signed informed consent form(ICF)

Exclusion Criteria:

* patients received renal transplantation
* hepatic failure
* severe bleeding risk or platelet \<70\*109/L
* chronic kidney insufficiency with eGFR\<30ml/min·1.73m2,or kidney atrophy, or solitary kidney, or medullary sponge kidney, or polycystic kidney, or obstructive nephropathy
* uncontrolled mental disease or unable to cooperate during operation
* Pregnancy or lactation
* not suitable for this study judged by investigaters
Development of AI Model for Renal Tumor Diagnosis Using CT and Lab Tests

This multi-center retrospective study aims to develop a multimodal artificial intelligence diagnostic model using preoperative contrast-enhanced CT images and routine laboratory parameters from patients with renal tumors. The model is designed to assist clinicians in accurately predicting the pathological subtypes of renal tumors preoperatively, enabling detailed diagnoses and advancing precision medicine.


Eligibility Criteria:
Inclusion Criteria:

* Underwent renal tumor resection with a complete postoperative pathological report, and the pathological diagnosis is one of the following types: clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, renal angiomyolipoma, or renal oncocytoma.
* Complete and available four-phase contrast-enhanced CT scans prior to surgery.
* Complete and available routine laboratory test results prior to surgery.

Exclusion Criteria:

* Incomplete CT data or poor image quality that affects diagnostic analysis.
* A time interval of more than three months between imaging or laboratory testing and pathological diagnosis.
* Patients diagnosed with fat-rich renal angiomyolipoma (AML).
* Pathological diagnosis indicating the coexistence of two or more pathological types of renal tumors.
Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty

Several authors and large registries have suggested the potential for an increased risk of all-cause revision with the use of posterior cruciate-substitution (PS) total knee arthroplasty (TKA). The purpose of the current study was to compare posterior cruciate retaining (CR) and PS implants with respect to the functional and radiographic results, prevalence of osteolysis, revision rates and survivorship.

The supremacy debate between posterior cruciate-retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA) has now entered into the 4th decade. Multiple research studies have investigated CR and PS TKAs on the basis of kinematic, clinical, radiographic, and survivorship analysis. Despite arguments in favor of CR or PS TKA designs, several short or mid-term studies have shown no difference in functional outcomes between these two designs. Considering the fact that CR and PS TKA fare equally at short-term and mid-term, the decision to select either design should depend on their long-term survivorship. There have been few long-term survivorship analysis that have directly compared CR and PS TKAs with aseptic revision for any reason as the end point.

These long-term studies of CR and PS TKA have been done independently. A comparison of the results in the same patients eliminates the variability that is introduced by differences in gender, age, weight, comorbidity, bone quality, and activity level and allows for a meaningful comparison of the impact of fixation on the outcome of TKA. However, variability in terms of the preoperative severity of arthritis cannot be eliminated because of the design on both sides is rarely identical.

The purpose of this study was to identify differences in implant survivorship between CR and PS TKAs in patients with osteoarthritis who were younger than 65 years of age and CR implant in one knee and PS implant in the other.

Eligibility Criteria:
Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery
Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids

The hemorrhoidal disease affects approximately 4.4%-36% of the general population, and it has been estimated that \>50% of the population aged \>50 years experiences hemorrhoidal problems . Traditional hemorrhoidectomy, including Milligan-Morgan, Ferguson, and Whitehead procedures , are known to cause significant postoperative pain and discomfort and result in a poor quality of life after operation. Since the first introduction of the novel procedure hemorrhoidopexy by Longo in 1998, it has been considered as a safe procedure causing less postoperative pain and resulting in earlier recovery; furthermore, the patients are able to resume their normal daily life and work. The PPH stapler (Ethicon Endo-Surgery, Inc. Cincinnati, OH, USA) was also first introduced in 1998 as a device to perform this procedure. Subsequently, a new device, the DST stapler (Covidien, Mansfield, MA, USA), was introduced in 2008 with some structural differences, including a detachable anvil, three anchor points over different levels, a larger case, and different agraffe sizes.

However, the majority of current studies have been focusing on the use of PPH stapler for hemorrhoidopexy, and comparison with the DST stapler has been rarely discussed. One randomized controlled trial that compared between the PPH stapler and the DST stapler reported that the DST stapler demonstrated a better hemostatic ability and allowed the resection of a larger area of mucosal prolapse; however, that trial focused only on bleeding among the postoperative complications. Currently, only a limited number of studies have compared these two devices in terms of pain, complications, and anorectal stricture incidence rate. The present investigation is a matched cohort-control study aimed to compare the postoperative short-term outcomes among patients with grade III and IV hemorrhoids who were treated with either the PPH or the DST stapler. The specimen surface area and the relationships with complications were also analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Grade III and grade IV hemorrhoid

Exclusion Criteria:

* Anal fistula, rectal polyo\\p
Study of Sand Versus Wood Chip Surfaces on School Playgrounds to Minimize Injury in School Children

This study will compare children's injury rates (arm fracture, head injury and other injuries) when playing on playground equipment on granite sand versus wood fibre playing surfaces.

The hypothesis is that injury rates (arm fracture, head injury and other injuries) among school children are equal on granite sand and wood fibre playground surfaces.


Eligibility Criteria:
Inclusion Criteria:

* School children
* Ages 5-11
* Injured on falls from play equipment during supervised school hours

Exclusion Criteria:

* Children injured outside of supervised school hours
Hepatoprotective Effect of Remote vs Local Preconditioning of Liver

The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury of remote ischemic preconditioning of the liver against local ischemic preconditioning of the liver during human liver resections.

In this randomized control study, a total of 60 patients were randomized into 3 groups: remote ischemic precondition group - RIPC (3 intervals of 5 minute right upper limb ischemia with 3 intervals of 5 minute reperfusion), local ischemic precondition group - LIPC (15 minutes of inflow liver occlusion followed by 10 minutes of reperfusion before liver transection), control group - CG (group without ischemic preconditioning before liver transection). Patients were also stratified according to the extent of the hepatectomy. Hepatoprotective effect was evaluated by comparing serum transaminase levels, bilirubin levels, albumin, and protein levels, coagulograms and pathohistological exams. We also measured flow rate by Doppler ultrasound of hepatic artery and portal vein before and after preconditioning.

Eligibility Criteria:
Inclusion Criteria:

* patients with colorectal cancer liver metastasis all of which signed an informed consent

Exclusion Criteria:

* having any other underlying liver disease, or preoperative increased liver transaminase, bilirubin
* patients with chronic cardiac, pulmonary or renal disease
"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure

The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.

Stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. They are self sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop in many different cell types in the body. Premature ovarian failure (POF) is the loss of ovarian function in women less than 40 years. It is associated with sex steroid deficiency, amenorrhea, infertility, and elevated serum gonadotropins. This work aimed to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) transplantation in women suffering from POF. Out of 112 high risk patients for POF, 10 cases were diagnosed as POF. The ten POF patients were scheduled for MSC transplantation at Al- Azhar University Hospitals. MSC preparation from the bone marrow of the iliac crest was laparoscopically injected in the ovaries. Endometrial fractional biopsy is histopathologically (HP) and Immunohistochemically (IH) stained and evaluated according to Edessy stem cells score (ESS) (1).

Eligibility Criteria:
Inclusion Criteria:

* Post-menarche female less than 40 years old.
* Normal karyotyping female.
* Primary ovarian failure females
* Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
* Agree to sign the designed consent for the study.

Exclusion Criteria:

* Autoimmune diseases.
* Breast cancer, ovarian cancer.
* Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
* Those with major medical problems such as malignancy, hepatitis, etc.
The Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia

The purpose of this study is to explore the effects and safety of transcutaneous electrical nerve stimulation (TENS) at home for patients diagnosed with insomnia on the improvement of insomnia and nervous stability.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 19 and under 65
* Those who meet the criteria for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for Insomnia
* Those with a score of 8 or higher based on the Korean version Insomnia severity index (ISI-K)
* A person whose sleeping environment and habits are regular, usually between 9:00 p.m. and 1:00 a.m., go to bed, lie down for 7 to 10 hours, and wake up between 5 and 10 a.m.
* In the case of patients who regularly take drugs for improving insomnia at least once a week, those who agree to discontinue taking the prohibited drugs in this study for a total of 5 weeks, 1 week to remove the drug effect after screening and 4 weeks for the clinical study period
* Persons who do not have a reason to prohibit the use of electrotherapy that can significantly affect biomarkers in relation to this study
* A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and understanding a sufficient explanation about this clinical trial

Exclusion Criteria:

* Those who have been diagnosed with sleep arousal disorders other than insomnia (hypersomnia disorder, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep arousal disorder, parasomnia)
* Those who have insomnia due to physical illness or medications being taken
* Patients with major medical and neuropsychiatric diseases other than sleep disorders
* Persons who have had or are currently undergoing dental treatment with a history of implanting metallic materials into the upper body, such as the transcranial or face, neck, etc., where non-invasive electrical stimulation is difficult or impossible
* Compliance was evaluated by writing a sleep diary for 1 week from the start of treatment, and if a sleep diary of 3 days or less was kept for 1 week, it was excluded from the study.
* Those who have changed the type and dose of drugs used within the last 3 months, or the type and time of cognitive behavioral therapy
* If you are currently registered in another clinical trial or use another clinical trial drug or device within 60 days from the time of screening

Exclusion criteria prior to intervention (After the sleep diary for one week after the screening test, if the following criteria are met, the patient will be excluded from participation in the study before the intervention.)

* Those with less than 8 points based on the Korean version of Insomnia severity index (ISI-K)
* When writing a sleep diary for a week, if it is written for less than 3 days or has an irregular sleep schedule
First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic

This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.

The patients will be randomized into two arms, A and B, in function of the intervention dose. The quality of life of te parents as well as the daily median crying time and the number of daily crying will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Full term healthy infant (37-41 weeks amenorrhea)
* Birth weight \>2750 g
* Aged between 2 and 8 weeks
* Presenting symptoms of infant colic as defined by Rome IV criteria by Zeevenhoven et al. 2017
* Signed written informed consent of the parent/tutor

Exclusion Criteria:

* Premature birth
* Using probiotics as a treatment, different from the one that could contain the formula at the time of study recruitment
* Acute or chronic illness as judged by the investigator which avoids the participation to the study .
* Parents unable to understand the requirements of study participation as judged by the investigator
* Malnutrition as judged by a body weight/height ratio \<5 %
The FEEDBACK Trial, a Randomized Controlled Trial

With a worldwide proliferation of simulation centers, it is essential to explore the optimal setting for laparoscopic training and investigate different learning approaches, e.g. a self-directed approach. Therefore, the researchers investigated the following in a randomized controlled trial: the impact of instructor feedback vs. an independent, self-directed approach when training a complex operational task on a laparoscopic virtual reality simulator.

The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when training on a virtual reality simulator.

For virtual reality (VR) simulation the benefits are clear; the drawbacks are less clear. Throughout the last decade several studies have found a positive effect on the learning curve as well as improvement of basic psychomotor skills in the operating room after VR training. VR simulators offer standardized and reproducible laparoscopic tasks, ranging from simple basic skills training to full procedures such as a cholecystectomy or salpingectomy. Despite the now well-established advantages of VR simulators, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training in the surgical education. This is mainly due to lack of knowledge concerning the time and human resources/cost needed to train novice surgeons to an adequate level.

This randomized trial investigates whether instructor feedback is pivotal for the trainee when training operational tasks (a laparoscopic salpingectomy) on a VR simulator. The VR simulator used in this trial is the LapSim from Surgical Science, Sweden. Instructor feedback consists of standardized feedback for ten minutes and with a maximum of three optional feedback sessions; the trainees (in the intervention group) decides them selves when they want a feedback session. The trainees in both the control group and the intervention group have to reach a predefined proficiency level on the VR simulator within 8 weeks with 3-hour training sessions each time. Furthermore, the trial focuses on different learning approaches, e.g. a self-directed approach and an independent approach.

The randomization process will take place at a central unit; Copenhagen Trial Unit, Denmark. Stratification variables are: 1)Gender 2)Computer game experience (less that 20 hours annually)

Eligibility Criteria:
Inclusion Criteria:

* Medical student at Copenhagen University with passed bachelor degree
* Signed informed consent

Exclusion Criteria:

* Prior experience with surgical virtual reality simulators
* \> 3 independent laparoscopic procedures
* Not fluent in the Danish language
Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

Phase III clinical study for the evaluation of clinic and cardiologic effects of isosorbide mononitrate from the incidence of events (angina episodes).

This is an open, comparative, monocentric trial. The hypothesis, regarding the number of angina episodes, to be tested are:

* H0: μD = 0 ot H0: μAfter = μBefore
* HA: μD ≠ 0 ot HA: μBefore ≠ μAfter

Phase III study, monocentric, open, with a single treatment arm in patients with stable angina to evaluates efficacy and safety. The study will be sponsored by pelo Laboratórios Baldacci. All patients who participate in the study shall sign two copies of the informed consent form. The inclusion of patients is expected to last until 12 months from the approval of the Ethics Committee and ANVISA.

Follow up will last at least 2 weeks for each included patient. A total of 86 patients will be recruited for this study and all of them will initiate treatment with 20 mg monocordil tablets. After 2 consecutive weeks using the investigational product (+2 days), the patients will be evaluated again, particularly for the parameters under study, this is, quantity and severity of angina episodes and adverse events. The selected patients shall also be 18-80 years old of both genders, with proved diagnosis of stable angina through clinical exams such as ECG, physical effort tests or similar. Patients will receive 20mg monocordil tablets (Baldacci Laboratories).

The evaluations will take place in two opportunities: one at the visit of medical evaluation and recruitment in the study (along with the deliver of the study medication and a diary) and the second one after 2 weeks (+2 days) of use of 20mg monocordil tablets for medical evaluation and discharge of the study (return of the diary and medication accountability).

Eligibility Criteria:
Inclusion Criteria:

* Capacity for understanding and agreement in signing the informed consent form
* Age 18 between 18 and 80 years old
* Have a diagnosis of stable angina, proved by ECG, test of physical effort or similar
* Not being under treatment with other nitrate for stable angina
* Medical indication for the use of isosorbide mononitrate (Monocordil)

Exclusion Criteria:

* Presence or serious comorbidities (under judgement of the investigator)
* Allergy to any of the component of the investigational product
* Pregnant female patients, brest feeding and/or in fertile condition who wish to get pregnant during the study and deny the use of contraceptives