cyrilzakka/clinical-trials huggingface dataset:
Efficacy of an Innovative Kinesiotaping Bandage Compared to Traditional Tape in Stabilising Ankle Inversion and Plantar Flexion in Triathletes.

Efficacy of an Innovative Kinesiotaping Bandage Compared to Traditional Tape in Stabilising Ankle Inversion and Plantar Flexion in Triathletes: A Triple-Blind Experimental Study.

Background and Purpose:

Lateral ankle sprains are a common injury among triathletes, impacting their performance and recovery time. Although traditional functional tape is effective in stabilising the ankle joint, it has limitations in aquatic sports due to its lack of water resistance. This study will evaluate the efficacy of an innovative kinesiotaping (KT) bandage, designed to combine water resistance with the restrictive properties of traditional tape. The primary objective will be to determine which type of bandage is more effective in stabilising ankle inversion and plantar flexion in triathletes.

Study Design:

This will be a triple-blind experimental study involving 20 federated triathletes. Each participant will have three different bandages (traditional tape, innovative KT, and placebo) applied in a randomised order. Goniometric and functional tests will be used to measure the outcomes.

Interventions:

Traditional Tape: Standard restrictive bandage. Innovative KT Bandage: Elastic, water-resistant bandage with additional restrictive properties.

Placebo: Gauze bandage without stabilising properties.

Methods of Evaluation:

Goniometric measurements (flexion, inversion) and functional tests (Star Excursion Balance Test, Hopping Test, Vertical Jump Test) will be conducted. The bandages will be applied and evaluated in a controlled environment, with participants and investigators blinded to the type of bandage.

Expected Outcomes:

It is anticipated that the innovative KT bandage will provide stabilisation comparable to traditional tape for critical ankle movements while overcoming the limitations of tape in aquatic conditions. It is also expected to demonstrate significant advantages in functional tests.

Clinical Relevance:

This study aims to provide evidence for optimising the management of ankle injuries in triathletes, offering a practical and effective solution to maintain athletic performance under demanding conditions.


Eligibility Criteria:
Inclusion Criteria:

* Adult men (over 18 years old).
* Federated triathletes.
* No medical conditions or pathologies that could affect the measurements.
* Signed informed consent.

Exclusion Criteria:

* Recent surgeries that compromise ankle function.
* Severe prior ankle injuries (fractures, ligament tears).
* Presence of chronic musculoskeletal diseases.
* Use of ankle support devices during the tests.
* History of severe dermatological allergies or intolerance to the materials used in the bandages.
* Use of supplements or medications that could influence muscular or joint performance.
The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum

Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. However, as such scans inescapably imply exposure to ionizing radiation, novel imaging techniques have been investigated. Three-dimensional optical surface scanning is a promising new technique to acquire the trunks' three-dimensional (3D) surface topography. Based on this 3D scan, one is able to calculate the external Haller Index that is known to highly correlate with the conventional gold standard Haller Index that is based on internal measures. Both the conventional and external Haller Index are known to be affected by the respiratory phase in which the scan is acquired, however, what is the effect of patient position on the external Haller Index, and if affected, how should one correct for this phenomenon? To investigate this, a retrospective single-centre pilot study will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Patients that received a three-dimensional optical surface scan to quantify their pectus deformity

Exclusion Criteria:

* None
Tenelia Triple Combination Study

After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Subjects will visit the centers on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Type 2 Diabetes Mellitus
2. Adults aged ≥ 19 years old
3. Patients with HbA1c 7%\~11% at Screening and Run-in visit

Exclusion Criteria:

-
Accessible and Affordable Moisturizers for Atopic Eczema

Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's essential drug list (EDL) but are not available to most rural patients. To assess whether accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two separate sub-studies were conducted using a randomized controlled single (assessor) blind trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG, petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines were continued as prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Atopic dermatitis as defined by the united kingdom (UK) Working party Diagnostic Criteria
* Atopic Dermatitis patient with mild to moderate stable atopic eczema with parents/guardians willing and able to apply study moisturizers as directed and commit to attend all visits.

Exclusion Criteria:

* Less than 1 year of age
* Patients with atopic dermatitis treated with systemic preparations
Occupational Exposures Among Firefighters

This study aims to understand the effect of occupational exposures, including PFAS exposures, among firefighters.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older; any gender
* Currently (or previously) employed as a firefighter, full-time or part-time, participating in Vincere's First Responder Cancer Screening Program
* Willing to provide a blood, urine, and/or tissue sample
* Able to provide informed consent to participate in the study

(A small group of non-firefighters will be enrolled to act as a comparison group)
Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea

The primary objective of the proposed project is to estimate the economic impact of a national rotavirus immunization program in preventing rotavirus diarrhea among Korean children.

Rotavirus is the leading cause of severe acute diarrhea or gastroenteritis among young children worldwide. In the first 5 years of life, about 90% of children experience at least one episode of rotavirus infection.Each year, rotavirus diarrhea is responsible for 440,000 deaths, 2 million hospitalizations, and 25 million outpatient visits among children younger than 5 years worldwide. In South Korea, rotavirus diarrhea rarely causes mortality, but it cause significant morbidity. A recent population-based study in Korea has estimated that the annual incidence of rotavirus diarrhea accounts for 56.9 cases per 1,000 children less than 5 years old. Oral, live pentavalent human-bovine reassortant rotavirus vaccine has been developed and licensed for the use of preventing rotavirus disease in many countries. Yet, there has been no research done to assess the impact of national rotavirus immunization program in Korea. It is expected that systematic appraisal on the national burden of rotavirus infection and potential public health and economic benefits of rotavirus vaccination for children in Korea will assists health policy makers to set a priority for the prevention of this disease.

Eligibility Criteria:
Inclusion Criteria:

* children aged under 5 years and diagnosed as acute gastroenteritis

Exclusion Criteria:

* none
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)

Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to Screening and remain on their stable dose throughout the trial. Subjects will receive placebo or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid biomarkers and cognitive and psychological measures.


Eligibility Criteria:
Inclusion criteria:

* Meets the current cognitive classification of MCI or mild dementia due to AD pathology (all subjects having a "positive" biomarker for amyloid β) as defined by the National Institute on Aging - Alzheimer's Association (NIA-AA) research criteria
* Aged 50 to 85 years, inclusive at time of consent

Exclusion criteria:

* Currently has any neurological condition other than AD (Alzheimer's disease)-related that could be contributing to the subject's cognitive impairment
* Significant pathological findings on brain MRI at Screening, including but not limited to multiple microhemorrhages
* Any psychiatric diagnosis or symptoms, e.g., hallucinations, major depression,anxiety or delusions that in the Investigator's opinion could interfere with assessment of cognition or confound the diagnosis of MCI or mild dementia due to AD in the subject.
* A lifetime history of cerebrovascular events or non-vasovagal related loss of consciousness within the last 10 years
* Any other abnormality of the ECG at Screening and/or Baseline (including QRS \> 110 ms, abnormal electrical axis, PR interval \> 220 ms and conduction abnormalities) considered clinically significant by the investigator
* History of cardiac arrhythmias, ischemic heart disease or cerebrovascular disease
* Lower spinal malformation on physical or lumbar spine radiography, local spinal infection, or other abnormality, including but not limited to obesity, that would prevent LP or insertion of an indwelling catheter for CSF sampling
* Any history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse).
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry

The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.


Eligibility Criteria:
Inclusion Criteria:

* Children with acute otitis media

Exclusion Criteria:

* Amoxicillin allergy
* Tympanic membrane perforation
* Tympanostomy tubes (current)
* Complication of acute otitis media such as mastoiditis
Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local anesthetics from the epidural to the subarachnoid space. When compared with conventional epidural block, it provides improved sacral block and onset of analgesia.

Despite the benefits associated, the supportive literature remains scarce. No trial has determined if similar results could be obtained with a smaller needle.

In this trial, DPE using 25- and 27-gauge (G) spinal needles are compared. The main outcome will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (NRS). The hypothesis is that that both needle sizes will result in similar onset times and therefore designing the current study as an equivalence trial.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant woman
* singleton and vertex presentation
* 37-42 weeks of gestational age
* active labor with cervical dilation \< 5cm
* body mass index between 20 and 35 kg/m2
* desired labor epidural analgesia

Exclusion Criteria:

* adults who are unable to give their own consent
* presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes)
* known fetal anomalies
* increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* allergy to LA
* prior sacral or lumbar spine surgery
A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct )

This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).


Eligibility Criteria:
Inclusion Criteria:

* Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines.
* Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

* Contraindications according to the summary of product characteristics.
* Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).
Improving Brief Alcohol Interventions With a Behavioral Economic Supplement

The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing alcohol use and alcohol-related consequences in college students.

BMIs are associated with reductions in alcohol consumption and related problems, but effect sizes are generally small. One BMI trial indicated that behavioral economic variables such as low levels of proportionate substance-free reinforcement and inelastic demand for alcohol predicted poor intervention response, and that participants who successfully reduced their drinking increased their participation in academic and other substance-free activities. A subsequent NIAAA R21 developed a substance-free activity session (SFAS) supplement to traditional alcohol BMIs that attempted to increase engagement in constructive alternatives to drinking by enhancing the salience of delayed rewards (academic and career success) and the patterns of behavior (academic engagement) leading to these outcomes. This study indicated that a two session (alcohol BMI + SFAS) preventive intervention resulted in significantly greater reductions in alcohol problems relative to a two session (alcohol BMI + Relaxation) active control condition. The BMI+ SFAS was also associated with significantly greater reductions in heavy drinking for participants with lower levels of substance-free reinforcement at baseline. This was the first controlled study to demonstrate that a supplement to traditional BMIs can improve outcomes. The current study will extend these promising pilot results by (a) increasing the efficacy of the behavioral economic SFAS by including booster contact, (b) increasing power and generalizability by recruiting 425 students from two universities and including a no-treatment control group, (c) measuring drinking, as well as behavioral economic mechanisms as mediators and moderators of intervention outcomes (delay discounting, alcohol reinforcing efficacy, substance-free reinforcement) at 5 time points over a sixteen month period, and (d) evaluating the economic costs and benefits associated with the SFAS. The goals of the SFAS - increasing student engagement in academic, campus, and career-related activities- are consistent with the priorities of most colleges.

Eligibility Criteria:
Inclusion Criteria:

* Male and female University of Memphis and University of Missouri
* College freshman or sophomore
* Full time student status
* Report 2 or more heavy drinking episodes (5/4 drinks for men/women) in the past month

Exclusion Criteria:

* Employed more than 20 hours per week
Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery

This is a prospective cohort study designed to assess intra-abdominal blood volume and hemodynamic status by measuring the diameter of the inferior vena cava (IVC) using 3D and Doppler ultrasound within 24 hours after gynecological surgery. The study will examine the association between these ultrasound findings and postoperative outcomes, including hemoglobin drop, need for blood transfusion, pain, infection, and length of hospitalization. Approximately 250 women undergoing laparotomy, laparoscopy, or vaginal surgery at Holy Family Hospital will be enrolled. The study also aimed to define postoperative normograms for fluid volume and IVC parameters and to evaluate whether ultrasound-guided decision-making could improve postoperative care and reduce unnecessary interventions.

Postoperative intra-abdominal bleeding is a significant contributor to morbidity and, in some cases, mortality following gynecological surgery. Timely recognition of intra-abdominal blood loss is essential for appropriate clinical intervention. In cases where bleeding is into the abdominal cavity, diagnosis is more difficult and may be delayed.

Ultrasound is a non-invasive, rapid, and widely available tool for assessing free intra-abdominal and pelvic fluid. Modern machines allow for 3D volumetric assessment of fluid collections, as well as Doppler-based measurements of the inferior vena cava (IVC) diameter and its collapsibility index-both of which are known to correlate with intravascular volume status and blood loss. Currently, there are limited data establishing normal ranges of intra-abdominal fluid or IVC diameter postoperatively, and little is known about the magnitude of these measurements and clinical outcomes after gynecologic procedures.

This prospective cohort study aims to quantify intra-abdominal fluid and determine IVC diameter and its collapsibility index using advanced ultrasound imaging within 24 hours after surgery. Patients undergoing open, laparoscopic, or vaginal gynecological procedures will be included. The study will explore correlations between ultrasound findings and clinical outcomes such as hemoglobin drop, need for blood transfusion, infection, pain, and length of hospital stay. Additionally, we aim to develop reference normograms for postoperative normal ranges of intraabdominal fluid volume and IVC diameter.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years and older
* Undergoing gynecological surgery including laparotomy, laparoscopy, and vaginal pelvic surgery
* Able to provide informed consent

Exclusion Criteria:

* Undergoing minor procedures (e.g., dilation and curettage, hysteroscopy, or cervical conization)
* Known preoperative coagulation disorders
* Postoperative admission to the intensive care unit (ICU)
* Clinical indication requiring ultrasound as part of standard postoperative care
Effects of Vagus Nerve Pulmonary Branch Block on Postoperative Cough After VATS Lung Resection

Postoperative cough after pulmonary resection is a common issue seen after thoracic surgeries, hindering patients' recovery and affecting their postoperative quality of life. While vagus nerve pulmonary branch block has been known to reduce intraoperative coughing, its impact on postoperative cough post lung resection is uncertain. This study aims to assess the effects of vagus nerve pulmonary branch block on postoperative cough after VATS lung resection. A randomized controlled trial involving 104 thoracoscopic lung resection patients will assign them randomly to a vagus nerve pulmonary branch block group or a control group. The primary outcome measure is the postoperative cough incidence 3 weeks after lung resection. The secondary outcomes include assessing hoarseness in PACU, peak expiratory flow (PEF) on the first post-op day, NRS scores for cough, and LCQ-MC scores at 3 weeks post-surgery, as well as cough occurrence, NRS scores, and LCQ-MC scores at 8 weeks post-procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old.
* BMI between 18 and 30 kilograms per square meter (kg/m²).
* ASA Physical Status Classification of I, II, or III.
* Preoperative pulmonary imaging demonstrating peripheral lesions, with clinical staging T≤2, N≤1, M0.
* Undergone thoracoscopic lung resection surgery.
* Patients managed by the same lead surgeon's team.
* Obtained informed consent, with patients agreeing and signing the informed consent document.

Exclusion Criteria:

* Patients with a history of chemotherapy or previous pulmonary surgery.
* Presence of chronic cough due to respiratory infectious diseases, pharyngitis, rhinitis, COPD, asthma, post-nasal drip syndrome, etc.
* Individuals exhibiting ECG abnormalities such as atrial fibrillation, bundle branch block, frequent ventricular premature beats, pre-excitation syndrome, etc.
* Currently using ACE inhibitor medications.
* Presence of preoperative hoarseness.
Protein Ingestion and Skeletal Muscle Atrophy

The effect of different protein intakes on skeletal muscle atrophy during short term unilateral leg immobilisation.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>18 and \<28 no prescription medications or current illness.

Exclusion Criteria:

* BMI \<18 and \>28 current prescription medication no history of leg injury.
* Smoker
* Medical conditions including (cardiovascular disease ((e.g. hypertension)), metabolic disease ((e.g. type 2 diabetes)), any personal or family history of deep vein thrombosis.
Procurement of Human Specimens for the Evaluation of Early Markers of Sepsis

Procure blood specimens from individuals presenting to the emergency department (ED) with signs and /or symptoms of systemic infection or sepsis. The samples will be used for research and development activities related to sepsis, infections, etc.


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age or older
* For women of child bearing years: not known to be pregnant
* Blood culture ordered as part of the ED, ICU (or equivalent) or hospital floor stay.

Exclusion Criteria:

* Previously enrolled in this study
* Vulnerable individual
* Unable to speak and/or understand English