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NCT ID: NCT04702516 Recruiting - Osteopenia Clinical Trials

The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture

Start date: March 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The hypothesis for this study is that the GLP-1Ra Semaglutide has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 40-85 years at increased risk of bone fractures. Treatment involves injection of Semaglutide 1.34 mg/ml once a week or corresponding volume of placebo once a week for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue tests (bone biopsy), and direct bone strength measured by microindentation at the start and end of the study.

NCT ID: NCT04701151 Recruiting - Side Effect of Drug Clinical Trials

NORTH-REG Dwell-Time Study

Start date: February 3, 2021
Phase: Phase 4
Study type: Interventional

Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations. The study will include patients from Denmark, Iceland, Norway and Sweden.

NCT ID: NCT04701034 Recruiting - Fertility Disorders Clinical Trials

Intravenous Immunoglobulin and Prednisolone for RPL After ART.

RPL
Start date: February 6, 2021
Phase: Phase 2
Study type: Interventional

Recurrent pregnancy loss (RPL) affects around 5 % of women in reproductive age. The underlying cause of RPL is most often unknown, probably multifactorial, and no treatment with documented effect on chance of live birth exists. In unexplained cases of RPL, primarily the immune system is hypothesized to play a pivotal, causative role, since autoantibodies and specific human leukocyte antigen (HLA) alleles as well as unbalanced distribution of leucocyte subsets, especially natural killer (NK) cells and T-helper (Th) cells, occurs more frequently in patients with unexplained RPL. For that reason, many treatment regimens used in autoimmune diseases have been tested on RPL patients, as for example prednisolone and intravenous immunoglobulin (IVIg). IVIg (Privigen) consist of a broad spectrum of structurally and functionally intact IgG antibodies. The mechanism of action is not fully elucidated, but certainly IVIg do help opsonise and neutralize foreign cells and pathogens. Prednisolone support this anti-inflammatory action by suppressing migration of polymorphonuclear leukocytes, and reducing the volume and activity of the immune system and the capillary permeability. A retrospective, observational pilot study suggested that a combination of prednisone and IVIg in first trimester improves the chance of a live birth in women with RPL after assisted reproductive technologies (ART) (Nyborg et al., 2014). A randomized controlled study is necessary for determining if this immunomodulatory treatment definitely is effective in patients with unexplained RPL after ART (defined as IVF or ICSI ad FER). Potentially, this study will be able to establish evidence for an effective treatment to women with unexplained RPL after ART, who otherwise have a poor prognosis.

NCT ID: NCT04700774 Recruiting - Depression Clinical Trials

Behavioral Activation for Depression: A Randomized Controlled Trial

Start date: January 20, 2021
Phase: N/A
Study type: Interventional

The present study is a randomized controlled trial that will evaluate two versions of behavioral activation (BA); one version which is a standard BA program and one which is a motor enhanced BA program (mBA). In both programs, the patient will receive all standard BA interventions, whereas these - in the mBA program - will be supplemented with interventions focused on noticing and manipulating posture and movement associated with action initiation. The mBA program builds upon recent evidence pointing to motor manipulations of posture and movement as having the potential to assist in action initiation and thus following through with the planned activity schedule. Previous research has shown that patient compliance with the activity schedule is causally associated with depression reduction, which will be explored as a mediator of treatment gains.

NCT ID: NCT04700605 Recruiting - Balance; Distorted Clinical Trials

Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.

Start date: October 27, 2020
Phase:
Study type: Observational [Patient Registry]

Agreement and intra-rater reliability between static balance test using Nintendo Wii Balance Board and gait test under dual-task conditions in community-dwelling older adults.

NCT ID: NCT04699734 Recruiting - Neuropathic Pain Clinical Trials

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Start date: September 8, 2020
Phase: N/A
Study type: Interventional

The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy

NCT ID: NCT04699188 Recruiting - Lung Cancer Clinical Trials

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

KontRASt-01
Start date: February 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

NCT ID: NCT04698616 Recruiting - Malignant Lymphoma Clinical Trials

Lean Body Mass and Side Effects in Patients With Lymphoma

Start date: February 9, 2020
Phase:
Study type: Observational

The primary purpose is to investigate the relationship between the dose of chemotherapeutic agents per kilogram of lean body mass (LBM) and the development of side effects induced by chemotherapy in patients with lymphoma. Secondarily, the maximum tolerable dose of chemotherapeutics (MTD), patients' quality of life (QOL), nutritional status and physical activity during the course of treatment are estimated.

NCT ID: NCT04695782 Recruiting - Clinical trials for Rectal Cancer Recurrent

Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

ReRad II
Start date: October 10, 2020
Phase: Phase 2
Study type: Interventional

Study design: A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer. Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.

NCT ID: NCT04694807 Recruiting - Depression Clinical Trials

Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age

Start date: April 23, 2021
Phase: N/A
Study type: Interventional

While most bereaved individuals cope adaptively with the loss of a loved one, a significant minority experiences more severe and complicated grief reactions. Complicated grief reactions is an umbrella term for different types of post-loss complications, including symptoms of Prolonged Grief Disorder (PGD), depression, anxiety, and posttraumatic stress. These post-loss complications may all cause persistent suffering and functional impairment, thus pointing to a need for efficacious treatment. While Cognitive Behavioural Therapy (CBT) is a relatively well-documented efficacious treatment for symptoms of PGD, depression, anxiety, and posttraumatic stress in the period after a loss, the relative efficacy of a transdiagnostic individually delivered versus group-based CBT for these types of complicated grief reactions (CBTgrief) remain unknown. Furthermore, little evidence exists about the relative cost-effectiveness of individually delivered versus group-based CBTgrief and why and how it works. The theory of CBTgrief proposes that it works by targeting three maintaining mechanisms in PGD: 1) Insufficient integration of the loss, 2) negative loss-related cognitions, and 3) depressive and anxious avoidance. These maintaining mechanisms have also shown to be statistically associated with depression, anxiety, and posttraumatic stress in the period after a loss, suggesting that different types of complicated grief reactions might share some of the same maintaining mechanisms. However, this proposed theory of change has yet to be empirically tested as a whole. These knowledge gaps are crucial for the understanding of efficacious and cost-effective treatment formats as well as central treatment mechanisms in the psychological treatment of complicated grief reactions. The present study thus aims to examine the relative efficacy of an individually delivered versus group-based CBTgrief by means of a randomized non-inferiority trial. Secondary aims include an investigation of the relative cost-effectiveness of individually delivered versus group-based CBTgrief as well as treatment mediators. Finally, explorative analyses of potential moderators of intervention effects of CBTgrief will be conducted.