There are about 8563 clinical studies being (or have been) conducted in Sweden. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
RESEARCH PLAN I-TITLE Role of Doppler endoscopic probe in the diagnosis of subepithelial gastrointestinal lesions. II-BACKGROUND Subepithelial lesions (SEL) are commonly encountered during routine endoscopies with an estimated prevalence of 3.5%. Most of the SELs are detected during upper gastrointestinal endoscopy. Subsequently, endoscopic ultrasound (EUS) is performed to better characterize the lesion and to rule out the presence of a vascular lesion before tissue sampling due to the high risk of severe bleeding with tissue acquisition in vascular injury. However, EUS can rarely establish a definitive diagnosis per se with limited accuracy. In large lesions, it is possible to use cytology or histology needles via the EUS instrument to collect cells/tissue within the lesion. It can lead to accurate diagnosis and consistent management. However, EUS-guided tissue sampling can be technically challenging, with poor yield for small or mobile SELs. In addition, EUS is an expensive technique, high operator dependency and performed only in tertiary centers. It creates a time gap between endoscopic detection and the EUS examination and increases costs. That delay in diagnosis is a source of anxiety for the patient and for the caregivers. Several methods were proposed to increase the diagnostic yield of tissue acquisition techniques, such as "bite-on-bite" biopsies which showed a limited diagnostic yield. Alternatively, the "unroofing" technique has also been advocated for histological diagnosis. In unroofing, a loop is used to remove the normal epithelium covering the subepithelial lesions and after epithelial removal, a biopsy forceps or loop is used to sample subepithelial lesions. Other techniques include endoscopic resection by snare or submucosal dissection. These enable a surgical specimen but are technically demanding and have been complicated by perforation and bleeding in most series. There is a need for a method that enables rapid diagnosis in the same session as endoscopic detection of SEL regardless of their size. That method should ideally enable histological diagnosis with low risks of complications and should not require high technical expertise and should not be highly dependent on the operator. The ideal solution to address the diagnosis of gastrointestinal (GI) SEL would be one that would provide a tissue sampling after exclusion of a highly vascular lesion, in the same session as endoscopic detection. Doppler endoscopic probe (DEP) is a Doppler endoscopic probe specially developed for the GI system, which enables blood flow detection during endoscopy. DEP is CE and FDA approved and can be used through the working channel of the endoscope. Unlike standard EUS, which requires advanced endoscopic training, DEP is much easier to use. It allows the characterization of lesions as non-vascular, venous or arterial. Recent studies have demonstrated the safety and efficacy of DEP in vascular characterization in the gastrointestinal tract. III PURPOSE Primary objective: - Proof of concept evaluation of the role of DEP in the characterization of GI SEL as non-vascular or vascular (arterial or venous) - Relationship between findings on DEP versus findings on EUS (considered the gold standard) regarding SEL characterization as non-vascular or vascular (arterial or venous). Secondary purposes: - Accuracy in removing the histological characterization of subepithelial GI lesions. - Complications in connection with tissue acquisition - Inter-observer agreement of DEP and EUS results. IV METHODS This is a pilot projective feasibility study that will be run by Karolinska University Hospital in Stockholm Patients with subepithelial GI lesions were referred for EUS evaluation. The study will include 30 patients. A conventional gastroscopy will be performed. After identification of the lesion, DEP is performed. The DEP probe is lubricated and deployed through the working channel of the endoscope. The probe will contact the mucosa slightly, covering the SEL. Then evaluate the lesion in 2 different angels. The results will be characterized and recorded qualitatively: no flow / arterial flow / venous flow and in terms of intensity: soft, medium or high. After DEP, evaluation EUS will be performed by another endoscopist who will be tied to the DEP results. EUS will be considered the gold standard. After both assessments, the lesion is characterized as no vessel / arterial / venous and as soft / medium / high flow intensity. EUS will be followed by removal of SEL in patients where EUS excludes the presence of high vessel disease. "Unroofing" will be performed using a conventional endoscopic loop, through the working channel of the endoscope. After the surface of the lesion is disturbed, a biopsy forceps will be used for tissue acquisition. Tissue will be stored in formalin and processed and evaluated by the pathologist.
The goal of this clinical trial is to compare the effects of a surgical and a non-surgical treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint. The main questions it aims to answer are: - Are the treatments effective? - Is the surgical treatment more effective than the non-surgical treatment? Participants will receive surgical treatment (PIP joint denervation) or non surgical treatment (patient education plus exercise). Researchers will compare the non-surgical and surgical groups to see if pain, patient-reported function, quality of life, movement and grip strength differs between the groups.
The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.
A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease
The purpose of the D4325C00007 study is to identify and characterise patients with known or newly diagnosed CKD for possible participation in future renal clinical studies and to obtain an overview on current treatment choices for this patient group in different regions.
to study the videonystagmography response to a bone conducted vibration on the mastoid by B250 bone transducer in patients affected by vestibular loss, Menieres disease and Superior Semicircular Canal Dehiscence Syndrome vs healthy control subjects
Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed. The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department. The main research question is: - Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes? Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group. The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records >1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (>6 months).
The goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. The main questions aims to answer: - Primary: determine the progression-free survival rate (PFSR) at 3 months Secondary: determine the objective response rate (ORR), duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS). Ensure the safety and tolerability, Determine Quality of Life (QoL) • Exploratory: Characterize the TME Participants will be asked to ensure - Baseline biopsy and further optional biopsies - Treatment propranolol 40 mg BID and pembrolizumab 2 mg/kg Q3 weeks - Evaluation, blood counts, QoL and blood samples for biomarkers according to schedule
This study consists of Part A and Part B. Part A is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with NAs in CHB participants. Part B is a multi-center, open clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with PegIFN-α and NAs in CHB participants.
Optimal diagnostic management and underlying pathophysiological mechanisms of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies have not been fully clarified. The current diagnostic classification system based on three different umbilical artery flow patterns has no increasing scale of severity and the predictive value is limited. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double fetal demise. Outcome prediction is furthermore important in the selection of cases that will be offered selective reduction (to provide the larger twin with better prospects), as well as determining monitor frequency and possible hospital admission. As outcome prediction is clinically challenging, patient counselling is too, and parents often encounter a great deal of uncertainty during the pregnancy. Furthermore, little is known about the brain development of sFGR children (both during pregnancy and after birth). Moreover, the psychological impact of an sFGR pregnancy of the future parent)s) has not been studied before. The impact of these factors should be taken into account during patient counseling, which is currently not the case. By our knowledge, this is the first international, multicenter, prospective cohort study on that will address the abovementioned questions and knowledge gaps in MCDA pregnancies complicated by selective fetal growth restriction.