cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis

Echo intensity (EI) assessment using ultrasonography helps monitoring disease-induced muscle quality changes. However, there are no study investigating the reliability of EI in patients with knee osteoarthritis (OA). The primary aim of the present study was to investigate the inter and intra-rater reliability of EI evaluation by grayscale histogram analysis of quadriceps femoris muscle in patients with knee OA. The second aim was to compare the mean grayscale values obtained using both the Free Hand Tool (FHT) and Rectangular Marquee Tool (RMT) methods in ImageJ. Thirty patients with knee OA were included in this cross-sectional study. The echogenicity measurements of the Rectus Femoris, Vastus Inter-medius, Vastus Lateralis and Vastus Medialis were performed by two different researchers. Reliability analysis of EI measurements were calculated with using intraclass correlation coefficient (ICC), standard error of measurement (SEM) and coefficient of variation (CV) and Bland and Altman plot analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients had tibiofemoral joint OA in at least one knee according to the American College of Rheumatology classification criteria with knee pain most days of the past month and osteophytes apparent on knee radiograph were included to the study

Exclusion Criteria:

* Patients were excluded if they had a history of lower limb joint replacement and fracture, rheumatoid arthritis, diabetic neuropathy or polyneuropathy, and cardiovascular and neuromuscular problems.
Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty

Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans will be affected by the disease. Despite the relative good track record of total knee replacement, it remains a biomedical device that can fail over time. A recent study looking at the current mechanisms of total knee replacement failures, listed polyethylene wear and osteolysis around implants. The material used for polyethylene insert as well as the conformity of articular surface of implants has been modified to decrease wear. While introducing modularity, the usage of metal backing in tibial base plates became obvious as it offered better stress distribution to the proximal tibial bone. However, it introduced other modes of failures. Micromotion has been demonstrated between the metal backing and the tibial liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision. Factor influencing the surgeon's choice of implant include: reproductibility and longevity of results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of elasticity of the tibial base plate has a direct effect on periprosthetic bone biology. Studies have described a significant decrease in postoperative Bone mineral density (BMD), adjacent to the implants, after total knee replacement. No study, to our knowledge, has looked at BMD in vivo after total knee replacement comparing different tibial base plate designs. Direct effect of changes in design on overall implant survival can be studied with randomized clinical trials isolating specific variables. No randomized clinical trial has looked at tibial insert stiffness and modularity, and it effect on bone density changes, synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study variables, one would aim at randomizing an homogenous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial insert modularity and stiffness.

Number of patients: 80 Ages: 55 - 75 years old Sex: male and female Race: all

Eligibility Criteria:
Inclusion Criteria:

* Tri-compartmental knee arthrosis
* 55 to 75 years of age
* Stable health condition

Exclusion Criteria:

* Inflammatory arthritis
* Osteonecrosis
* Infection
* Amputation (AK or BK)
* Biphosphonates
* Metal in the proximal tibia (25cm)
* History of fracture or osteotomy
* Ligament instability
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer

Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathological proven prostate adenocarcinoma.
2. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

   a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. \> 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
3. Karnofsky performance status of 50 (or ECOG/WHO equivalent).
4. CT or as part of the PET study or performed within one month of PSMA PET.
5. Age \> 18.
6. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Undergoing investigational therapy for prostate cancer.
2. Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
3. Unable to lie flat, still or tolerate a PET scan.
4. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
5. Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
6. Absence of PSA and total testosterone tests within 4 weeks.
Personalizing Preprocedural Sedation for Regional Anesthesia

This is a prospective, randomized study in patients who receive a nerve block prior to surgery. The aim is to investigate whether individual differences in psychosocial and pain profiles may play a role in how patients experience sedation for regional anesthesia. The study will utilize a mixed-methods approach, including a randomized controlled intervention and semi-structured interviews, in order to systematically investigate the relationship between an individual patient's level of catastrophizing and efficacy of procedural sedation, while exploring patient satisfaction with the preoperative nerve block experience.

The primary quantitative outcome will be pain severity during nerve block placement. Secondary quantitative outcome is patient satisfaction. Validated psychometric assessment tools (pain catastrophizing scale) will be used to stratify patients according to baseline degree of pain catastrophizing (high versus low baseline pain catastrophizing). These groups will then be randomized to receive either titrated pharmacologic sedation (i.e., additional midazolam and fentanyl beyond a standard low midazolam dose) or intraprocedural educational reassurance. Semi-structured interviews and qualitative analysis will be used to explore patient's experiences with nerve block placement and identify themes regarding what makes this experience more positive or negative for individuals with different characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18
* English speaking
* Willingness to undergo psychophysical testing
* Willingness to have nerve block performed
* Surgical or procedural patient
* Single shot nerve block

Exclusion Criteria:

* Cognitive dysfunction that precludes communication
* Declines or is not eligible clinically to receive sedation with midazolam and/or fentanyl at discretion of the non-study clinical team (Examples: frailty, cognitive dysfunction)
* Allergy or hypersensitivity to midazolam or fentanyl
* Declines nerve block
* Does not complete survey needed for randomization
* Current pregnancy and/or breastfeeding
Collection of Head Images During Radiotherapy

The primary objective of this observational study is to quantify the translation, rotation, and deformation of patient head positions of head and neck cancer patients over the course of a radiation therapy treatment for head and neck cancer. This objective will be achieved by comparing X-ray images collected during each treatment session with those obtained from the planning CT scan. Secondary objectives include (1) the use of the collected X-ray images to develop realistic artificial X-ray images where patient movement can be simulated and (2) to determine whether motion can be detected from individual X-ray images acquired during radiation therapy treatment.

Participants will undergo their radiation therapy treatment for HNC as planned and per the routine clinical management protocol. As part of this routine treatment, multiple x-ray images will be acquired to assist in accurate positioning of the patient for their planned radiation therapy. Normally these images are stored for a few days and then discarded. This study will be collating, storing and analysing these images. These X-ray images will be paired with the corresponding pre-treatment CT scan that is routinely acquired for each patient, as well as the locations of organs of interest, such as the tumour and surrounding structures. The patient treatment plan will also be collated, as it will allow for analysis of how any motion affects the accuracy of dose delivery. The patient radiation treatment delivery record will be collected to help sort and categorise the acquired images. Information on potential confounding or interacting factors will be collected: demographic information will be collected including sex, age, tumour stage and histology.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of head and neck cancer (any stage)
* Age 18 years or greater
* Receiving radiation therapy to the head and neck with a thermoplastic immobilisation mask
* An ECOG score in the range of 0 to 2
* Any other prior or concurrent therapy allowed

Exclusion Criteria:

* People with cognitive impairment which would preclude them from providing informed consent
* People who are unable to speak and read English and for whom obtaining consent would be difficult.
The Impact of Practicing Active Breathing Exercises on Elderly Individuals Living in the Community

The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

The investigators have designed a simple and user-friendly training method called "Active Breathing Exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.
A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.

This study compares standard open rotator cuff repair versus arthroscopic mini-open rotator cuff repair by measuring the disease-specific quality of life at 2 years in patients with full thickness rotator cuff tears.

Hypothesis: There is no difference in disease-specific quality of life outcome at two years between open versus arthroscopic mini-open repair for patients with full-thickness rotator cuff tears.

Rotator cuff injury affects a diverse group of patients and leads to significant disability with respect to lost time from work and the inability to play sports, thereby affecting the individual's quality of life.

The standard treatment for full-thickness rotator cuff repair is with an open acromioplasty procedure. An alternative procedure for a full-thickness rotator cuff tear is with a combined procedure of arthroscopic acromioplasty and mini-open repair, which has the potential advantages of a preserved deltoid origin, lower perioperative morbidity, shorter hospital stays and less soft tissue dissection. The progression towards arthroscopic repair requires a comparison to the standard, open procedure for full-thickness rotator cuff tears, using validated outcomes in a randomized fashion.

This study is designed as a multi-centre randomized controlled trial with a priori sample size calculation of 28 patients per group. Patients presenting with unremitting pain, failed conservative treatment of at least 3 months, weakness of the rotator cuff and positive imaging indicating a full-thickness rotator cuff tear are eligible for the study. Previous surgery on the affected shoulder and massive rotator cuff tears are excluded. Patients are randomized using computer-generated block randomization, stratified by surgeon, to either open or mini-open rotator cuff repair.

Disease-specific quality of life is assessed using the validated Rotator Cuff Quality of Life Questionnaire, a self-administered, 34-item questionnaire designed specifically to assess patients before and after surgery. It utilizes a visual analog scale scored out of 100, with a higher score reflecting a better quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unremitting pain in the affected shoulder who have failed conservative treatment for at least 3 months
* Weakness of rotator cuff (MRC grades 4-, 4 or 4+)
* Positive diagnostic imaging on the affected shoulder indicating a full-thickness rotator cuff tear which may include arthrogram, ultrasound or MRI
* Age \> 18 years
* English speaking

Exclusion Criteria:

* A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
* Previous surgery to the affected shoulder
Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence

The purpose of this study is to develop an innovative wearable tracking protocol that will use Artificial Intelligence (AI) technology to monitor sleep and behavior of 3-7 year old children.


Eligibility Criteria:
Inclusion Criteria - Children:

* Ages 3-7.
* Outpatients or Inpatients.
* Any gender, race or ethnicity.
* Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent .
* EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg \& Pincus, 1999).
* Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
* Families approached for participation will be asked to commit to complete the treatment.
* At least one primary caregiver and the identified child will have to be able to speak and understand English.

Exclusion Criteria - Children:

* Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
* Parents not consenting to the study.
* Parents or child is not able to adhere to the study protocol.
* A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator's discretion.
* Unable to speak and understand English.
* Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
* Children in foster care.

Inclusion Criteria - Adults:

* Agree to wear Garmin watch.
* Ages 18-99.
* Any gender, race, ethnicity.
* Able to provide informed consent.

Exclusion Criteria - Adults:

* Unable to speak and understand English.
* Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
Pseudoaneurysm of the Greater Palatine Artery Following Autogenous Connective Tissue Gingival Graft : A Case Series

Gingival recession is defined as the apical migration of the gingival margin from the amelocemental junction. This condition may be associated with symptoms such as tooth hypersensitivity, root decay, and cosmetic complaints from patients. Many treatments have been used to treat gingival recession and the gold standard is the autogenous connective tissue gingival graft because of its predictability. This type of gingival graft is performed by harvesting connective tissue from patients' hard palate. Periodontists and general dentists frequently perform these gingival grafts. Occasionally, some patients develop postoperative complications that need to be addressed in an hospital setting. An uncommon but concerning complication of an autogenous connective tissue gingival graft is a donor site pseudoaneurysm of the greater palatine artery. No description of this complication following a gingival graft has been identified in the current literature. One case report mentioned that pseudoaneurysm of the greater palatine artery looks like a pulsatile nodule associated or not with pain on palpation. From the experience of the investigators, patients may consult an hospital setting having a complaint of major oral bleeding. Local hemostatic agents can palliate this type of bleeding, but angiographic embolization is often required. Several cases were treated in the investigators' hospital. Thus, the investigators believe it is relevant to share this experience with the scientific community. The primary objective of this case series is to inform dental professionals of the existence and the management of postoperative pseudoaneurysm of the greater palatine artery following autogenous gingival graft. The secondary objective is to find potential solutions to minimize the incidence of this morbid complication.


Eligibility Criteria:
Inclusion Criteria:

* Population : Patients having a diagnostic of pseudoaneurysm of the greater palatine artery who had an autogenous connective tissue gingival graft
* Intervention : Patients treated with local hemostatic agents or by angiographic embolization
* Comparison : None

Exclusion Criteria:

* Missing data in patients' chart precluding complete data extraction
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection

The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ICA)
* Subject is either (A) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (B) asymptomatic with carotid stenosis ≥ 70% by angiography
* Target lesion can be covered by a single stent of no more than 40 mm in length
* Target lesion reference vessel diameter (RVD) is 4.0 mm - 7.0mm
* Sufficient landing zone required for successful deployment of integrated embolic protection filter
* Willing to comply with all follow-up required study visits
* Provision of written informed consent before index procedure

Exclusion Criteria:

* Life expectancy of less than one year
* An evolving, acute or recent stroke within 14 days of study evaluation
* Acute myocardial infarction within 72 hours before procedure
* Known sensitivity to contrast media that cannot be adequately controlled with pre-medication
* Subject has a total occlusion of target carotid artery
* Subject has a previously place stent in ipsilateral carotid artery
* Severe circumferential lesion calcification that may restrict full deployment of carotid stent
* Presence of filling defect or thrombus in target vessel
* Presence of "string sign" of target vessel
* Carotid (intracranial) stenosis located distal to target lesion
* Greater than 50% stenosis of common carotid artery proximal to target lesion.
* Known mobile plaque in aortic arch
Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

More than ninety percent of adults in Taiwan are suspected to carry periodontal disease, which causes bad breath, swollen and bleeding gums, plaque and even tooth loss. Half of the patients, however, are ignorance these clinical syndromes because of no obvious pain. In this study, the investigators selected six periodontal disease-associated bacteria strains, including Porphyromonas gingivalis (Pg), Fusobacterium nucleatum (Fn), Actinobacillus actinomycetemcomitans (Aa), Tannerella forsythia (Tf), Treponema denticola (Td) and Prevotella intermedia (Pi) as diagnostic markers. Using real-time PCR and MALDI Biotyper, the investigators will establish the database of oral microorganisms in Taiwanese people, providing periodontal disease clinical markers of high-risk groups and the basis for personal medicine of therapy in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Age≧25
2. 3≦periodontal screening and recording≦4
3. 16 natural teeths and 6 front teeth at lesat
4. GI≧1.25
5. PI≧2

Exclusion Criteria:

1. People who have oral lesion, dental braces, denture, mouthwash allergy, or serious systemic disease
2. People who have ever eaten antibiotics and Anti-inflammatory drugs over the last 6 months
3. People who have ever eaten Immunosuppressive drugs, antiepileptic drugs, antihypertensive drugs, or anticoagulant
4. Pregnant women or the woman who eat birth control pills