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NCT ID: NCT04210999 Recruiting - Clinical trials for Achilles Tendinopathy

Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy

Start date: April 5, 2022
Phase: N/A
Study type: Interventional

Achilles tendinopathy is a common and often long-lasting injury among exercising individuals. The primary purpose of the study is to compare treatment with supervised or homebased resistance training. The secondary purpose is to compare treatment with either corticosteroid or High Volume Injection (HVI) for those patients not responding to the primary treatment. The tertiary purpose is to evaluate the effect of surgery in those patients not responding to the primary and the secondary treatment. It is hypothesized that: 1. Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy 2. HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1 3. Surgery improves symptoms in patients not responding to treatment 1 and treatment 2 Study 1: 90 patients between 18 and 65 years of age with achilles tendinopathy for at least 3 months are randomly assigned to either A. Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months B. Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months Outcomes are change in patient reported outcome (VISA-A) from baseline to 3 and 6 months, ultrasound measured thickness and dopler activity of the achilles tendon, self reported activity level in percentage of the pre injury activity level. After the 3-month training intervention, and for the following 9 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the second part of the study. Study 2: Patients from study 1 which not are satisfied with the outcome are randomly assigned to either A. Same training intervention continued + High Volume Injection (HVI) B. Same training intervention continued + corticosteroid injection After the 4-month and for the following 8 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the third part of the study. Study 3: Patients from study 2 which not are satisfied with the outcome are operated

NCT ID: NCT04209244 Recruiting - Clinical trials for Leukemia, Acute Lymphoblastic

Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia

Start date: December 16, 2019
Phase: N/A
Study type: Interventional

Acute lymphoblastic leukemia (ALL) is the most common malignant disease among children. Treatment results have improved over time due to intensive risk-adapted therapy and the 5-year survival rate is now above 90%. However, the burden of therapy has increased proportionally. Many children develop serious acute and chronic side effects, which impact on the patients expected lifespan and impair their quality of life as a result of therapy. Treatment with PEG-asparaginase and dexamethasone increases the levels of triglycerides and total cholesterol. Consequently, the incidence of hyperlipidemia is high during initial ALL therapy. Studies have suggested that hyperlipidemia is a risk factor for development of osteonecrosis, thrombosis and possibly acute pancreatitis. Long-chained marine omega-3 fatty acids, found in fish oil, decrease levels of triglycerides and total cholesterol in hyperlipidemic patients. Due to the high survival rate, it is of great interest to develop methods to reduce treatment related toxicities. The investigators hypothesise that daily intake of fish oil will prevent development of hyperlipidemia during ALL treatment phases with dexamethasone and PEG-asparaginase compared to placebo and that fish oil intake may reduce the incidence of severe adverse events related to ALL treatment.

NCT ID: NCT04196127 Recruiting - Clinical trials for Tension-Type Headache

Jaw Muscle Function in Patients With Tension-type Headache

Start date: December 6, 2019
Phase:
Study type: Observational

Patients with tension-type headache (TTH) and migraine often experience musculoskeletal complaints, like neck pain and/or jaw pain. Earlier studies have revealed an association between different headache types and neck pain and discussed the possible role of the cervical muscles. Furthermore, patients with neck pain show a decrease in motor control of the jaw, without having any other signs of TMD. Similarly, studies in patients with TMD have only found an indication for poorer neck muscle function. Patients with TMD also show a decrease in bite force and force steadiness compared to healthy controls. It is however, unknown if bite force and force steadiness are similarly impaired in patients with headache and/or neck pain. The current study will take a closer look at the jaw muscle function of in patients with TTH, with and without neck pain.

NCT ID: NCT04195360 Recruiting - Clinical trials for Postoperative Complications

Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)

Start date: December 2, 2019
Phase:
Study type: Observational

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA

NCT ID: NCT04193332 Recruiting - Clinical trials for Surgery--Complications

Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

NCT ID: NCT04191304 Recruiting - Clinical trials for Hypereosinophilic Syndrome

A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

NATRON
Start date: July 20, 2020
Phase: Phase 3
Study type: Interventional

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. Patients will continue to be recruited until approximately 38 patients have had their first HES worsening/flare during the DB treatment period at which point the data cut-off for the primary database lock (DBL) will occur. Treatment allocation will remain blinded until the primary DBL. After the study is unblinded for the primary analysis, patients and investigators will remain blinded to patients' individual treatment allocations until after the final patient completes the DB treatment period. The primary analysis will only include data from the DB treatment period of the study. A follow-up analysis will be performed once all patients have the opportunity to complete the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.

NCT ID: NCT04190589 Recruiting - Colorectal Cancer Clinical Trials

Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer

Start date: May 18, 2020
Phase: N/A
Study type: Interventional

A single-center prospective study to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.

NCT ID: NCT04189835 Recruiting - Clinical trials for Post-transplant Lymphoproliferative Disorder

EVITA Study - Epstein-Barr Virus Infection moniToring in renAl Transplant Recipients

EVITA
Start date: January 3, 2020
Phase:
Study type: Observational

Transplant recipients are treated with immunosuppressive drugs to avoid rejection of the transplanted organ. As the medication impairs the immune response, it also increases the risk of serious infections and cancer in transplant recipients compared with the general population. Previous studies have shown a close association between Epstein-Barr virus (EBV) and post transplant lymphoproliferative disorder (PTLD), with frequent demonstration of the virus in lesional tissues. Transplant recipients without evidence of EBV infection prior to transplantation (EBV seronegative) are at particularly high risk of developing PTLD. Other risk factors include a high viral load. As part of a preventive approach against PTLD, several transplantation units now monitor the occurrence of EBV DNAemia after transplantation. However, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for EBV analysis (whole blood or plasma) or the appropriate clinical action to take if EBV DNAemia is detected. Our aim is to estimate the incidence and clinical consequences of Epstein-Barr virus (EBV) DNAemia in whole blood and plasma in renal transplant recipients, and to determine if persistence of EBV DNAemia can predict excessive immunosuppression as indicated by the incidence of infections requiring hospitalisation, EBV driven PTLD and mortality.

NCT ID: NCT04189406 Recruiting - Infertility, Female Clinical Trials

Turner Syndrome Minipuberty Study

Minipuberty
Start date: February 1, 2020
Phase:
Study type: Observational

Rationale: Due to accelerated germ cell loss, infertility is a major problem in girls with Turner syndrome (TS). Therefore, cryopreservation of ovarian tissue or oocytes before exhaustion of the ovarian reserve may preserve fertility in patients with TS. However, in the majority of females with TS , the ovarian reserve is exhausted before the age of menarche. Early markers indicating and predicting the ovarian reserve are necessary. During mid-childhood the hypothalamic-pituitary-gonadal (HPG) axis is quiescent and gonadotropins are usually unmeasurable. Nonetheless, this axis is active during infancy. Therefore, gonadotropins are measurable with peak values at 3 months of age and with lower (but still measurable) values at 9 months of age, in a period called the minipuberty. The aim of this study is to find markers of ovarian capacity, during the minipuberty, in order to predict ovarian reserve in the future. Objective: The hormonal range of LH, FSH, AMH, inhibin B, testosterone and estradiol in girls with TS during the minipuberty and the relation of the hormone serum levels with the karyotype. Study design: A prospective, cohort study with a duration of 3 years. Study population: Girls with a pre- or perinatal diagnosis TS who are born in a medical centre in the Netherlands during the duration of the study Main study parameters/endpoints: Serum levels of FSH, LH, AMH, inhibin B, testosterone and estradiol at the age of 3 and 9 months.

NCT ID: NCT04189185 Recruiting - Olecranon Fracture Clinical Trials

Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Start date: December 5, 2019
Phase: N/A
Study type: Interventional

Simple displaced olecranon fractures are most often treated with tension band wiring. This is an effective treatment, but the risk of subsequent re-operation is high. The investigators propose open reduction and internal fixation with a strong suture, thus reducing the risk of re-operation significantly.