cyrilzakka/clinical-trials huggingface dataset:
Acute Effects of Two Neoprene Knee Sleeves

This study aimed to evaluate the immediate effects of two different types of elastic neoprene knee sleeves on balance and pain in patients with knee osteoarthritis (KOA). One knee sleeve was a standard elastic neoprene sleeve, while the other had four metal supports for additional stability.

In this randomized controlled study, 60 patients (50 females, 10 males) diagnosed with KOA were divided into two groups:

Group 1: Wore a standard elastic neoprene knee sleeve Group 2: Wore a neoprene knee sleeve with four metal supports

Each participant underwent clinical assessments before and after wearing the knee sleeve. The following tests were used:

Balance Assessments:

Berg Balance Scale (BBS): Measures overall balance ability. Timed Up and Go (TUG) Test: Evaluates mobility and fall risk. Functional Reach Test (FRT): Assesses stability by measuring how far a person can reach forward.

Fall Index (Tetrax® posturography): Provides an objective measure of fall risk.

Pain Assessment:

Visual Analog Scale (VAS): Measures the intensity of pain.

Further long-term studies are necessary to determine whether these immediate benefits persist over time.

KOA is a common joint disorder that leads to pain, stiffness, and impaired balance, increasing the risk of falls. Knee sleeves are often used as supportive devices to provide stability and reduce pain. However, there is limited evidence on their effectiveness in improving balance and reducing pain in KOA patients.

Eligibility Criteria:
Inclusion Criteria:

* Radiographic knee osteoarthritis grade 2 (mild) or 3 (moderate) according to Kellgren-Lawrence scale,
* Knee muscle strength of 4 and above and those who voluntarily participated in the study
* Signed the informed consent form

Exclusion Criteria:

* Patients with arthroscopy of the knee joint within the last 1 year, knee and/or hip replacement,
* Limitation of joint range of motion,
* History of inflammatory rheumatic disease,
* History of vestibular and cerebellar disease,
* Visual loss of less than 2/10 in both eyes,
* History of diseases of the central and peripheral nervous system (Parkinson's disease, stroke, ataxia, dementia, multiple sclerosis, peripheral neuropath etc.)
Secondary Databased Post-marketing Surveillance Study of BNT162b2

This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.

This study is a retrospective, non-interventional, observational study using Korean Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-COV-N) database that includes COVID-19 vaccination/infection and claims data in Korean population. For the primary objective, cohort and self-controlled design will be used for measure of occurrence and measure of association, respectively. For the secondary objective, cohort design will be used for measure of occurrence.

Primary objective:

* To describe the frequency and estimate the incidence ratio of adverse events of special interest (AESIs) following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea
* To evaluate the relative risk of AESIs following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea, using a self-controlled case series (SCCS) design

Secondary objective:

- To describe the frequency and estimate the incidence ratio of severe COVID-19 outcomes (COVID-19 hospital admission, COVID-19 intensive care unit \[ICU\] admission, and COVID-19 death).

Eligibility Criteria:
1. Primary Objectives 1-1. Measure of Occurrence Inclusion Criteria For the measure of occurrence, analytical populations will include following individuals,

   * Who meet the predefined criteria for each study population.
   * With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period.

   Exclusion Criteria For the measure of occurrence, analytical populations will exclude following individuals,
   * With diagnosis of AESI during the AESI-specific clean window; or
   * With diagnosis of AESI between first dose and second/third dose of primary series when analyzing for the second/third dose.

   1-2. Measure of Association Inclusion Criteria For the measure of association, analytical populations will include following individuals,
   * Who meet the predefined criteria for each study population.
   * With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period; and
   * Who had incident AESI during the observation period. Exclusion Criteria For the measure of association, analytical populations will exclude following individuals,
   * Who do not have both risk and control window time. If an individual disenrolls, dies, or reaches the end of the study period during the risk window prior to accumulating any control window time, he/she will be excluded; or
   * With a diagnosis of AESI during the AESI-specific clean window.
2. Secondary Objective Inclusion Criteria For the secondary objective, the study populations will include following individuals,

   * Who meet the predefined criteria for each study population. Exclusion Criteria
   * None
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.

Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity.

The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and greater
2. Both male and female patients eligible
3. Diagnosis of chronic sinusitis that is not responsive to medical management
4. Planned endoscopic sinus surgery (recommended by PI, consented to by patient)

Exclusion Criteria:

1. Extensive sinonasal polyps
2. Extensive previous sinonasal surgery
3. Extensive sinonasal osteoneogenesis
4. Cystic fibrosis
5. Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
6. Sinonasal tumors or obstructive lesions
7. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
8. Ciliary dysfunction
9. Pregnant females
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate

It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile \[MDBGN\], parthenolide) for diagnosing allergic contact dermatitis.

The TRUE Test standard panel consists of two tape strips, panel 1 with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. TRUE test panel 1 and 2 contain 23 of the most frequent contact allergens.With these 23 allergens, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in TRUE Test in order to detect more contact allergic reactions. Therefore goldnatriumthiosulphate, methyldibromoglutharonitrile and parthenolide are developed for inclusion in a third TRUE Test panel. This study is a dose-response study using 3 dilution series to detect the optimum concentration of the 3 allergens. A phase-III study will be performed afterwards to establish the efficacy and safety of the three allergens.

Eligibility Criteria:
Inclusion Criteria:

* Positive MDBGN patch test within the latest 5 years or positive Parthenolide patch test within the latest 5 years or positive Goldnatriumthiosulphate patch test within the latest 5 years.
* Age more or equal to 18 years.
* Signed informed consent.

Exclusion Criteria:

* Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
* Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
* Treatment with UV-light during the latest 3 weeks.
* Widespread active dermatitis or dermatitis on test area.
* Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period.
* Subjects not able to cooperate.
* Participation in other clinical studies during the study period and 3 weeks prior to study start.
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot

20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

Data obtained from parents of preterm infants and parents of full-term infants on sleep, stress, and infant nutrition will be compared.

An evaluation of the usability of the mobile app hosting the chatbot, the study chatbot and its functionality in general among this population will also be conducted

Eligibility Criteria:
Inclusion Criteria:

Subjects (parent and infant) must meet the following criteria:

* Healthy infants (preterm and full-term) must be 0-6 months of age at time of enrollment
* Infants must be at home (discharged from the hospital) at time of enrollment
* Informed consent from parent whose age is ≥21 years
* Parent must be proficient in the English language
* Parent must be able to comply with the required study tasks, as per PI's judgment
* In-home access to reliable internet connections; a mobile device suitable for electronic communication

Exclusion Criteria:

Infant must not meet any of the following criteria:

* Known to have current or previous illnesses/conditions which could interfere with the study outcome (per PI's clinical judgment)
* Must not be currently participating in any other clinical study

Parent must not meet any of the following criteria:

* Must not be known to have a significant medical condition that might interfere with the study (per PI's clinical judgment) that meets one of the following criteria:
* Presence of current mental illness or history of mental illness
* Any acute or chronic illness that makes the parent unsuitable for the study based on the PI's judgment
* Must not be a single parent
* Inability of the parent to comply with the study protocol or PI's uncertainty about the willingness or ability of the parent to comply with the protocol requirements
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* are male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication, with a history of biopsy and endoscopy confirmed UC;
* have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in the opinion of the Investigator, the patient does not require steroids;
* have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with stool less than half of the time) and stool frequency (1-2 stools greater than normal per day) as defined by the TM-Mayo Score

Exclusion Criteria:

* have UC known to be confined to the rectum (isolated rectal proctitis);
* have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
* have a significant co-existing illness or other condition(s), including but not limited to cancer or significant organic or psychiatric disease on medical history or physical examination, that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedures
Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification

Cataract is a leading cause of blindness in the world. Cataract surgery is one of the most commonly performed ocular procedures. We aim to compare the newer generation biometry formula; the Kane formula with the commonly used SRK-T formula for intraocular power calculation in uneventful phacoemulsification surgery to assess the post-operative refractive outcomes at one month post-surgery.

Purpose: To compare post-operative refractive outcome with Sanders Retzlaff Kraff theoretical (SRK T) and Kane formulae for intraocular lens (IOL) power calculation in cataract patients Study Design: Prospective, interventional study Place and Duration of Study: Department of Ophthalmology, Fauji Foundation Hospital, Rawalpindi Material and Methods: A total of a 70 eyes, 35 in each group will be included in our study. The patients will be randomly divided into two groups. In cases of bilateral cataract, one eye will be included in each group for better control. IOL power calculation in Group A will be done with the SRK-T formula and in group 2 with the Kane Formula. Autokeratometry and A-scan ultrasound will be done for biometry. Inclusion criteria will be uncomplicated cataract in both genders. Exclusion criteria will be ocular trauma, uveitis, previous intraocular surgery, or any retinopathy. All patients will undergo phacoemulsification with foldable lens implantation by two experienced surgeons. Post-operative refractive outcome will be evaluated at one month after surgery. The two groups will be compared.

Results: The results will be calculated by SPSS. Conclusion: A conclusion will be drawn on the basis of our results.

Eligibility Criteria:
Inclusion Criteria:

* Senile cataract (nuclear, cortical, posterior subcapsular, mature, hypermature cataract)
* Absence of other ocular pathology causing diminished visual acuity
* patients above 40 years of age
* Astigmatism \> 2.5 diopters

Exclusion Criteria:

* Retinal diseases
* Maculopathy
* Uveitis
* Complications during phacoemulsification
* Combined procedures
* Previous ocular surgery
* Trauma
* Secondary cataract
Manuka Honey for Wound Care

Since antiquity, honey has been recognized for its healing properties. Literature about the use of medicinal honey for wound care dates back centuries with recent data suggesting its use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey (Leptospermum scoparium) to have significant immune benefits and the ability to influence all phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous clinical studies have identified positive benefits for wound healing. However, there is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent in local wound care and scar healing.

In order to better understand Manuka Honey's ability to aid in healing, the investigators are conducting a randomized, controlled, single-blinded study of patients undergoing reconstructive surgery. This project uses split thickness skin graft and free tissue transfer donor sites as standard wound models to compare the effects of Manuka Honey versus standard wound care therapies. Through the use of standard wound model and objective measurement tools, the investigators hope to better elucidate any benefits of this novel wound care 'technology.'

Free tissue transfer (FTT) and split-thickness skin grafting (STSG) are important aspects of head and neck reconstruction. The radial forearm skin flap and fibula osteocutaneous flap are commonly used in head and neck reconstruction. After harvest, closure of these donor sites often requires split thickness skin grafting. The grafting is usually done from the thigh. The grafted free flap donor site along with the STSG donor site is often the source of significant post-operative pain and complications including delayed wound healing, graft loss and infection. There is no consensus in the literature on the best care for these donor sites with surgeons employing a wide variety of surgical dressings for local wound care. There is literature dating back centuries on the use of medicinal honey for wound care, with recent data suggesting its use in patients suffering from burns or pressure ulcers. However, there is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent in local wound care.

Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 18 undergoing reconstructive surgery with FTT and/or STSG

Exclusion Criteria:

* All patients under the age of 18
* Any patients with documented honey allergy
* Patients with documented collagen vascular diseases
* Patients with documented coagulopathy
* Patients with history of prior skin grafting
BV-AVD-R Treatment Children Hodgkin's Lymphoma

The goal of this clinical trial is to use modified Brentuximab Vedotin+doxorubicin+vinblastine+dacarbazine+Rituximab(BV-AVD-R) regimen in Chinese Classical Hodgkin's Lymphoma(HL) children. The main questions it aims to answer are:

* \[Overall Response Rate(ORR) :Complete Response(CR)+Partial Response(PR)\]
* \[progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.\] Participants will be given modified BV-AVD-R regimen according to rapid early responders (RER) or slow early responders (SER) after 2 cycles.

This study is a prospective study with period from October 2022 to December 2024, and planned to enroll 44 children with newly diagnosed intermediate- and high-risk classical HL. All patients will undergo Positron Emission Tomography(PET)/Computed Tomography(CT) at the time of initial diagnosis and after 2 cycles of modified BV+R+AVD regimen to determine early response. Rapid early responders (RER) deﬁned as CR after 2 cycles of therapy. Slow early responders (SER) defined as no CR (partial response (PR) or stable disease) after 2 cycles of therapy. Intermediate-risk patients were stage IA bulk/E, IB, IIA bulk/E, IIB, and IIIA. High-risk patients were stage IIB bulk/E, IIIA bulk/E, IIIB, and IVA/B.

The primary endpoints include ORR (CR+PR) and adverse events. The secondary endpoints include progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≤ 18 years old, regardless of gender;
2. According to the WHO classification criteria in 2016, pathologically confirmed classic Hodgkin's lymphoma is immunohistochemical CD30 positive;
3. Newly diagnosed classic Hodgkin's lymphoma: all stages
4. The main organs function normally and meet the following definitions:

Blood routine examination: neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 75 x 109/L, hemoglobin count ≥ 80 g/dL; Liver and kidney function: AST and ALT ≤ 2.0 upper limit of normal values; Bilirubin ≤ 2.0 mg/dL; Creatinine clearance rate ≥ 60 mL/min; 5) Functional status

* For patients aged 1-16, the Lansky score is ≥ 60 points.
* For patients over 16 years old, the Karnofsky score is ≥ 60 points. 6) Previous treatment
* Except for emergency mediastinal irradiation (\<1000cGy) due to superior vena cava (SVC) syndrome, Hodgkin's lymphoma guidance treatment was not allowed before.

  8) Informed consent
* Patients or their legally authorized guardians must have a thorough understanding of their illness and the nature of the study (including foreseeable risks and possible adverse reactions), and must sign an informed consent form.

Exclusion Criteria:

1. Karnofsky\<60% or Lansky\<60% for individuals under 16 years old.
2. Children with Hodgkin's lymphoma who have received other chemical and radiation treatments.
3. Initially rated as low-risk pediatric classic Hodgkin's lymphoma (IA, IIA, without large masses)
Digital Versus Traditional Booking System for Clinical Appointments

In the Canadian Forces Health Services Ottawa clinical administrative resources are currently constrained, directly impacting workflow and patient care. Given the nature of the current EMR and digital health infrastructure, DBS is not currently being employed. Therefore, investigators sought to determine the relative benefit of using an online booking system when compared to TB. To the investigator's knowledge, validation of this type has not been conducted in this setting.

Introduction: The impact of digital booking systems (DBS) on clinical care, administrative efficiency and health care costs have not previously been explored in the Canadian Forces Health Services. No show rates were shown to be reduced by 6-42% percent compared to traditional booking (TB) depending on the system and the clinic. Therefore, investigators sought to determine the relative benefit of using an online booking system when compared to TB.

Methods: Main outcome variables included total time for booking all patients between groups including the start to end dates of each intervention, the number of hours spent on the phone / answering emails, and the number of phone calls and emails received, and the number of phone calls / emails regarding booking problems, cancellations, changes and no shows. Descriptive and mean comparative statistics will be used to determine any differences between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have never been seen for new consultations

Exclusion Criteria:

* none
Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery

In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.

After being informed about the study and potential risks, written consent was obtained from all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Classification (ASA) I-II patients
* 18-70 aged patients
* patients who scheuled elective breast cancer surgery

Exclusion Criteria:

* American Society of Anesthesiologists Classification (ASA) III-IV patients
* patients with coagulopathy
* patients with infection at the injection site
Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA

Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block


Eligibility Criteria:
Inclusion Criteria:

* Single elective total knee replacement in ASA 1-3 without significant cardiovascular limitation

Exclusion Criteria:

* patient at risk in usage COX-2 for post operative pain control