cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients

The goal of this randomized controlled clinical trial was to determine the efficacy of play therapy in reducing perioperative anxiety in pediatric patients aged 3 to 6 years undergoing inguinal hernia surgery.

The main research question was:

Was play therapy effective in reducing perioperative anxiety levels in pediatric patients undergoing inguinal hernia repair?

Primary outcome measure: Anxiety level.

Patients were randomized into two groups:

1. an intervention group, which received play therapy involving a transport cart and toys; and
2. a control group, which received anxiolytic medication and standard care.

Researchers compared the control group and the play therapy group to evaluate differences in anxiety levels using the Visual Analog Scale for Parents (VAS-P) and the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).

Design and Study Population:

A randomized controlled clinical trial with parallel groups was conducted involving pediatric patients aged 3 to 6 years who were scheduled for inguinal hernia repair at Dr. Juan I. Menchaca Civil Hospital in Guadalajara, Mexico. Participants were randomly assigned to one of two groups: the play therapy group or the control group.

The play therapy group received a play-based intervention using toys. After five minutes of playing with a transport cart, the children were transported to the operating room in the same cart.

The control group received oral midazolam (0.1 mg/kg). After five minutes, they were transferred to the operating room either in a caregiver's arms or on a standard stretcher.

The study was approved by the Ethics and Research Committees (60/HCJIM-JAL/2023).

Assessment and Management of Anxiety:

Perioperative anxiety was assessed using two instruments:

The Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF), completed by the anesthesiologist.

The Visual Analog Scale for Parents (VAS-P), which measured anxiety as perceived by the child's parent or guardian.Both instruments were applied at three time points:

1. Upon initial contact with the anesthesiologist
2. After the intervention (play-based or pharmacological)
3. Upon arrival in the operating room Additionally, midazolam was administered as rescue therapy for any patient exhibiting significant anxiety (mYPAS-SF score \> 30 following the intervention).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 3 to 6 years.
* Patients of any sex.
* Patients scheduled for elective inguinal hernioplasty.
* Patients undergoing their first anesthetic-surgical procedure.
* Patients whose legal guardian provided informed consent.

Exclusion Criteria:

* Patients with known allergy to midazolam.
* Patients with abnormal perinatal history (e.g., neonatal hypoxia or chromosomal abnormalities).
* Patients undergoing emergency inguinal hernioplasty due to complications such as strangulation or incarceration.
Intracapsular Tonsillectomy in Adults

Comparing the classical extracapsular tonsillectomy (TE) performed with electrosurgery to intracapsular approaches (SIPT) by coblation or microdebrider. The patient group is adults with recurrent or chronic tonsillitis

Extracapsular tonsillectomy (TE) with monopolar electrosurgery is the most commonly used approach in adult tonsil surgery in Turku University Central Hospital, Finland.

In our study setting we are comparing intracapsular tonsillectomy (subtotal/intracapsular/partial tonsillectomy (SIPT) ) as the intervention group with extracapsular tonsillectomy as the control group.

SIPT is done with either coblation or microdebrider and TE with monopolar electrosurgery.

Indications for surgery are recurrent tonsillitis or chronic tonsillitis. The patient group is adults (16-65 years)

Safety, efficiency and cost-effectiveness are monitored in a prospective, patient-blinded and randomised study setting.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-65 years
* Planned tonsil surgery with informed consent
* Recurrent or chronic tonsillitis

Exclusion Criteria:

* Less than 1 month old, drained quinsy
* Acute "hot phase" tonsillitis
* Previous palatine tonsil surgery
* Suspicion or confirmation of malignancy
* High dose analgesics consumption
* Current CPAP-device usage for treatment of OSAS
* Untreated gastro-esophageal reflux disease
* Anticoagulative medication
* Any condition of hemophilia
* Pregnancy, lactation
* Current or positive history of malignant disease (if still active follow-up)
Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery

Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications.

This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Pectus excavatum repair with MIRPE
* Written consent for corrective surgery with intraoperative cryoanalgesia
* Written consent to participate in the study
* Age \>12 and \< 18 years

Exclusion Criteria:

* History of previous thoracic surgeries
* Reoperation for chest deformity
* Contraindication for cryoanalgesia
* Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety
Fib to Alb Ratio in Type 2 Dkd

Aimed to investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2 and to prove its possible role as a novel biomarker to predict and prevent DKD progression.

Diabetic kidney disease (DKD) is the most prevalent chronic kidney disease. Around 3540% of patients with type 2 diabetes mellitus (T2DM) will go on to develop DKD. DKD is characterized by albuminuria and reduced estimated glomerular filtration rate (eGFR), both of which are independent risk factors for end-stage kidney disease (ESKD), cardiovascular events, and death. DKD accounts for a significant increase in mortality among diabetic patients and is a grave threat to their clinical outcome.

Inflammation plays a major role in the development of DKD. Serum fibrinogen (FIB) is a biomarker of coagulation and inflammation. Elevated serum FIB is an independent risk factor of DKD progression to ESKD in patients with T2DM. Albumin (ALB) has anti-inflammatory functions and antioxidant properties. Hypoalbuminemia is associated with a poorer renal prognosis in patients with T2DM and DKD. Fibrinogen to albumin ratio (FAR) is a more significant prognostic marker than each single marker itself in cancer study.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 yrs.
* 50 Pts with type 2 DM that have DKD (presence of albuminuria in association with diabetic retinopathy) and 50 pts with type 2 DM but have no DKD.

Exclusion Criteria:

* Age below 18 yrs.
* Pts with ESKD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DKA and Cancer.
* Pt who refused to contribute in this study
Ocular Microbiome and Immune System in Dry Eyes

The primary objectives of this study are the characterization of the ocular microbiome as well as of the local immune system in participants with and without dry eye disease. Secondary objectives are the identification of differences in the ocular microbiome as well as in the immune system between participants with and without dry eye disease to ultimately find associations between the ocular microbiome and the immune system in dry eye disease.

Although dry eye disease is considered to be one of the most common ocular surface diseases worldwide, treatment options are only very limited and severe side effects are common. However, recent studies showed that the ocular microbiome may be crucial for maintaining ocular surface homeostasis. Disruption of this homeostasis, called dysbiosis, may lead to inflammation that is a key component in the pathogenesis of dry eye disease. It has been suggested that bacteria are invasive in ocular mucosal tissue, thereby effectively hidden from clearance by the local immune system and rendering the inflammation chronic. Therefore, the investigators hypothesize that the ocular microbiome may induce changes in the mucosal immune system of the eye, which in turn may accelerate the development of dry eyes. Since there is a crucial role of both, the ocular microbiome and the local mucosal immune system, on several diseases, the overall aim of this project is to assess the associations of the mucosal immune system and the ocular microbiome in dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign informed consent
* 18 years of age or older

Exclusion Criteria:

* Not willing or able to sign informed consent
* Younger than 18 years
* Recent (3 month) history of use of systemic and/or topical antibiotics
* Usage of medical eye drops (Lacrycon and other moisturizing eye drops are allowed)
* Recent (3 month) history of ocular surgery
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD).

CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure.

CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.

Chronic kidney disease (CKD) affects over 800 million people globally and is projected to be the 5th most common cause of death by 2040. CKD progresses to kidney failure, increases the risk of early death, heart disease, and leads to a poorer quality of life.

Current treatments do not entirely remove the risk of kidney failure in people with CKD. To improve the outcomes of people with CKD, it is crucial to find the best treatment or combination of treatments that can slow CKD progression. CAPTIVATE aims to address this need.

CAPTIVATE has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working.

Participants can participate in more than one treatment at the same time or at different times. Participants receive each study treatment for 2 years. For each treatment, participants are followed up at study visits that occur at approximately one month, 3 months, 6 months, 12 months, 18 months and 2 years after starting treatment. A final study visit occurs one month after the end of the 2-year treatment phase. Information collected at study visits include blood and urine test results, safety assessments and treatment adherence. Information about the overall health status of each participant is collected every 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2)
3. Currently receiving standard of care treatment according to treating physician
4. Eligible for randomisation in at least one recruiting domain-specific appendix
5. Participant and treating physician are willing and able to perform trial procedures

Exclusion Criteria:

1. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
2. Life expectancy less than 6 months
Development of Personalized Health Care Service in Patients With Breast Cancer

In order to develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching).


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user

Exclusion Criteria:

* Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who can not participate rehabilitation exercise program
Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa

The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.

Retinitis pigmentosa is a group of progressive hereditary diseases that diffusely affects the functioning of photoreceptors and the pigment epithelium. It may be speculated that a protective effect on the pigment epithelium, as it is supposed for L-Dopa, can slow the progression of the disease or even lead to an, at least transient, improvement of visual functions. To evaluate the effect of L-Dopa on retinitis pigmentosa progression, visual acuity, electroretinogram and visual field will be preformed regularly.

Eligibility Criteria:
Inclusion Criteria:

* All confirmed cases of retinitis pigmentosa
* VA of 20/400 or better

Exclusion Criteria:

* Advanced stages of retinitis pigmentosa with poor best corrected visual acuity (less than 20/400)
* co-existing eye morbidities interfering with retinitis pigmentosa (glaucoma, retinal detachment...)
* Flat electroretinogram
* Intolerance or counterindication to drug
* Unability for long-term follow-up
PS128 May Improve Off Duration on Parkinson's Disease

The purpose of this study is to investigate the short term effects (12 Weeks) of Lactobacillus plantarum PS128 (PS128) on Parkinson's disease (PD) symptoms.

This study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 treatment for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic Parkinson's Disease
* According to the record of ON / OFF diary for 3 consecutive days, the patient's daily off periods must be more than 3 hours a day.
* Between ages of 40-80 years old.

Exclusion Criteria:

* Patients on antibiotics within the preceding one month
* Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
* Have undergone surgery of liver, bladder, or gastrointestinal tract
* Have current or history of inflammatory bowel disease
* Have history of cancer
* Known allergy to probiotics
* Patients with comorbid dementia (Mini-Mental State Examination score ≤ 26) or major depression (The Beck Depression Inventory-II score ≥ 29)
* Have received deep brain stimulation
* Patients receiving artificial enteral or intravenous nutrition
Glucose Trnsporter and PEDF in Psoriasis

Psoriasis is a chronic relapsing cutaneous immune mediated inflammatory disease(IMID). In which there are skin lesions characterized by erythema, thickness and scale formation with different size from a pinhead to 20 cm in diameter. Prevalence of psoriasis is 2% to 4% worldwide. Psoriasis occurs at any age with two peaks: between 15-20 years and between 55-60 years. Women are presented with psoriasis at younger age than men ,but with less severity. lesions usually present on knee, elbow, scalp and sacral region this may be attributed to higher traumatic incident .

Psoriasis vulgaris is the most common type, and accounts 90% of cases. Patients with psoriasis vulgaris present with pain, itching and bleeding from skin lesions.

There are many theories for psoriasis pathogenesis: angiogenesis, decrease in apoptosis of keratinocyte, hyperproliferation , alteration of cell to cell adhesion and immune-mediated inflammation.

Patients with immune mediated inflammatory disease (IMID) are susceptible to develop diabetes mellitus, metabolic syndrome, hyperlipidemia, and hypertension.A previous study found that psoriatic patients are more susceptible to type 2 diabetes compared to control.

Glucose transporter type 1(GLUT1) is upregulated in psoriatic patient attributed to angiogenesis and execessive cell proliferation in those patients .Also expression of GLUT 1 is found high with hyperglycemia . A study reported that GLUT 1 density in placenta of women with gestational diabetes was found to be two folds higher than control.

Pigment epithelium derived factor (PEDF) has antiangiogenic effect. Topical application of PEDF on mouse model of psoriatic disease helps in reduction of skin proliferation and angiogenesis.

GLUT 1 overexpression was found to be associated with decrease in PEDF expression in diabetic retinopathy.

In view of that we will compare the level of GLUT 1 gene in psoriatic patients and psoriatic patients with diabetes, as well as healthy control, and detect the effect of PEDF on GLUT 1 expression in vitro using human keratinocytes cell line .


Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis vulgaris Patients with psoriasis vulgaris and type 2 diabetes

Exclusion Criteria:

* Factors affect GLUT 1 expression As: tumors either benign or malignant cause increase GLUT 1 expression
Analysis of Clinical Effect of Subanesthetic Dose of Esketamine Combined With Hip Capsule Peripheral Nerve Block in Elderly Patients Undergoing Total Hip Arthroplasty

To observe the clinical effect of esketamine combined with hip capsule peripheral nerve block in elderly patients undergoing total hip arthroplasty. A total of 120 elderly patients who underwent total hip arthroplasty in our hospital from January 2020 to May 2021 were randomly divided into three groups, 40 cases in each group. The observation group A was treated with esketamine subanesthetic dose combined with hip capsule peripheral nerve block, the control group B was treated with esketamine subanesthetic dose combined with lumbar plexus block, and the control group C was treated with esketamine subanesthetic dose for general anesthesia. The onset time of anesthesia, duration of block, postoperative recovery time, postoperative extubation time, MAP and HR indexes before anesthesia (T0), during skin incision (T1), 30 minutes after the start of surgery (T2), and at the end of surgery (T3) were recorded in the three groups, and the VAS score and Ramsay score at 0.5 h, 2 h, 6 h, 12 h, and 24 h after surgery, as well as the incidence of postoperative adverse reactions were recorded in the three groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 60 years
* American Society of Anesthesiology (ASA) II or III
* No serious coronary heart disease, hypertension, diabetes and related complications, no serious liver and kidney function damage, no mental illness

Exclusion Criteria:

* Allergic to ketamine
* Abnormal coagulation function
* Mental system diseases or cognitive dysfunction
* Severe liver and kidney dysfunction
Time Study for Biometry Measurements With the Lenstar and IntraOcularLens (IOL) Master 500

The objectives of this study are to determine the time needed to complete a full set of measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement) by each test device, the Lenstar 900 Version i4 and IOL Master 500.

This is an open-label study randomized by sequence. Each eligible subject who signs a consent form and fulfills all Inclusion/Exclusion criteria will undergo ophthalmic measurements by the two test products:

A. Haag-Streit Lenstar Version i4

B. Zeiss IOL Master 500

The order of measurements for the IOL Master 500 and the Haag-Streit Lenstar Version i4 will he randomized. The two possible sequences will be balanced (approximately 22 eyes each: AB,BA). One eye of each subject will be measured. Time needed to complete testing will be measured utilizing a stop-watch. Total time needed to complete all measurements of the study eye using each of the test products to capture a complete ophthalmic exam with the devices standard operating settings set to automatic measurement and analysis will be calculated by the following start and stop points:

First Timed Measurement: Measurement Acquisition Start: When the technician starts to acquire tbe first measurement Stop: When the technician has completed all measurements

Second Timed Measurement: Subject Data Entry Start: When the technician starts to enter the subject data. Stop: When the technician has completed subject data entry.

Third Timed Measurement: Complete Ophthalmic Exam with each test product Start: When tbe subject is seated at the instrument, just prior to the technician entering any subject data into the test product.

Stop: Upon completion of all measurements using one of the test products, just prior to printing results.

Three trained technicians will operate tbe same study devices (Haag-Streit Lenstar Version i4 and IOL Master 500). Approximately equal number of subjects will be assigned to each technician.

Eligibility Criteria:
Inclusion Criteria:

Subjects wbo meet all of the following criteria are eligible to participate in tbe study:

1. Male or female l8 years of age or older on the date of Informed Consent.
2. At least one eye of each subject must be a phakic eye.
3. Subject must be able to fixate on a target.
4. Able to understand and willing to sign tbe informed consent.

Exclusion Criteria:

Subjects will be excluded from the study if the following applies:

1. History of corneal surgery.
2. Use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam.
3. Any ophthalmic condition preventing use of either of the instruments used in the study.
4. Any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study.
5. Any medical condition, which, in tbe Investigator's judgment, interferes with the subjects ability to comply with tbe protocol, compromises subject safety, or interferes with tbe interpretation of the study results.