Kolárovo, Slovenia
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Kaohsiung, Kaohsiung
Recruiting
The Clinical and Biological Effect of ESWT With Combined PRP Therapy on Rotator Cuff Lesions
Overall Design [Prospective randomized double-blind study for the clinical effect of combined ESWT and platelet-rich plasma (PRP) or PRP or ESWT alone or sham treatment on patients with shoulder rotator cuff lesions and without complete tear.] The participants will be separated into 4 groups according to computer statistical randomization. The investigators shall use STORZ MEDICAL Extracorporeal Shock Wave Therapy 3000 impulse 24KV (0.32mJ/mm2) Focus at two points (3000 impulse each point) near the insertion of supraspinatus and rotation interval of the involved shoulder. PRP: The PRP form Regen Kit BCT 1 Platelet Rich Plasma PRP will be used and will be injected into the Subacromial bursa (Hyajoint injection as a control) HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe The randomized, double-blind, placebo-controlled clinical study will involve 30-50 patients who have rotator cuff lesions without complete tear. The inclusion criteria are (1) patients who have pain around the shoulder, a positive impingement sign, and a positive imaging diagnosis of rotator cuff pathology without complete tear; (2) patients who do not respond to conservative therapy or rehabilitation for at least 3 months; and (3) patients age between 35 and 80 years, who sign the informed consent form. The investigators will exclude patients who have rheumatic diseases, glenohumeral osteoarthritis, full-thickness cuff tears, fractures, infections, or tumors; those who have received a subacromial injection within 3 weeks; and those who are pregnant or want to become pregnant; and those who have arrhythmia, pacemaker, coagulopathy, or malignancy. The intent-to-treat population is a fully randomized group of patients who have a baseline value (Constant score and VAS before treatment). The imaging diagnosis of a rotator cuff lesion is made by a musculoskeletal radiologist who has considerable experience in interpreting magnetic resonance imaging (MRI) results for shoulders. On MRI, rotator cuff tendinosis is characterized by increased in tratendinous signal intensity onT2-weighted images without tendon disruption. The tendinosis of the MRI imaging was further diverted into three grades. Grade 1 indicates less than 1/3 of the supraspinatus tendon is involved, Grade 2 indicates 1/3 to 2/3 and Grade 3 indicates more than 2/3 of the supraspinatus tendon is involved. Partial-thickness tearing is characterized by the presence of focal hyperintense fluid or a fluid-like signal intensity that extended into the tendon on the T2-weighted images. A full thickness tear is diagnosed by the extension of hyperintense fluid or fluid-like signal intensity through the entire thickness of the interrupted rotator cuff tendon on T2-weighted images. Every participant will have Subacromial injection of 2.5 ml PRP or HA (control) one week before ESWT or sham therapy. In Group I, patients receive 3000 impulses of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder as a 1-time treatment. Treatments are performed on an outpatient basis. The area of treatment (2 points near the supraspinatus insertion and rotator interval) is focused with a control guide on the machine, and surgical lubricant is placed on the skin in contact with the shockwave tube with the patient in a supine position. The sham treatment entail use of the device in which the silicone pad was removed from the stand-off device, but the participants can still hear the sound of the shock wave and have tingling sensation over the skin but without energy transduced. The participants' vital signs and local discomfort are monitored throughout the course of treatment. The treated area is inspected for local swelling, ecchymosis, or hematoma immediately after the treatment. The participants will have a pain medication-free interval 3 days prior to each evaluation. After treatment and during follow-up, participants will be restricted to the use of a 750mg of acetaminophen per day for pain, in order to facilitate usage and comparison of the medications among the patients. Follow-up examinations are performed independently by one of the coauthors, who is blinded to patient treatment status at 1week, 2week, 1month, 3 months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected one week and 1 month after treatment and shoulder MRI will be checked 12 months after treatment. The participants who have persistent shoulder discomfort may be advised to undergo surgical intervention.
Phase
N/ASpan
157 weeksSponsor
Chang Gung Memorial HospitalKaohsiung
Recruiting
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Phase
3Span
276 weeksSponsor
Jazz PharmaceuticalsKaohsiung
Recruiting
Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
Phase
N/ASpan
277 weeksSponsor
Arbutus Biopharma CorporationKaohsiung
Recruiting
Kaohsiung
Recruiting
The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia
After acute stroke, 25∼45% of patients show difficulties in swallowing, which is associated with a high risk of pneumonia, malnutrition, and mortality. In addition to traditional swallowing therapies for post-stroke dysphagia (PSD), the Iowa Oral Performance Instrument (IOPI) is used to provide tongue exercise program which improving swallowing function. In rehabilitation unit, ultrasound is a convenient tool and is more widely used in investigating oropharyngeal muscles mass and quality in PSD. Therefore, the investigators hope to assess the effects on swallowing function and oropharyngeal muscle mass on sonography after IOPI swallowing training in PSD. In this study, 60 stroke patients with or without dysphagia will be enrolled. Each patient will receive clinical assessments of swallowing and tongue functions, general and oropharyngeal muscles mass and quality by sonography, and life quality. Furthermore, the investigators'll enrolled 50 stroke patients with dysphagia and they will be randomly allocated in two groups. the investigators will provide two interventions including general swallowing therapy, and combined simple and IOPI therapies. First, the investigators will investigate the differences of swallowing and tongue functions, oropharyngeal muscles on sonography in patients with or without PSD. The effects of the swallowing therapies in masticatory and swallowing function, tongue pressure, oropharyngeal muscle mass, and life quality will be explored in PSD by using different swallowing therapies. The investigators will find out the most effective swallowing therapy from these 2 interventions for PSD. Furthermore, the investigators could explore that sonography is a clinically practical tool for assessing oropharyngeal muscles mass and quality in PSD.
Phase
N/ASpan
35 weeksSponsor
Chang Gung Memorial HospitalKaohsiung
Recruiting
Healthy Volunteers
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Phase
3Span
278 weeksSponsor
GlaxoSmithKlineKaohsiung
Recruiting
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period. An approximate total of eligible 207 participants will be randomized to one of the three treatment groups - 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. Placebo The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.
Phase
2Span
175 weeksSponsor
TakedaKaohsiung
Recruiting
Kaohsiung
Recruiting