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NCT ID: NCT04082429 Active, not recruiting - Clinical trials for Haemophilia B Without Inhibitors

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

explorer8
Start date: November 13, 2019
Phase: Phase 3
Study type: Interventional

This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with the study medicine 1 time every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for up to 6.5 years. The length of time the participant will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (21 April 2026 at the latest). Participants will have to come to the clinic for up to 40 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in, and approximately 8 weeks for the rest of the study. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in an electronic diary during the study and may also be asked to wear an activity tracker.

NCT ID: NCT04081038 Completed - Oral Cancer Clinical Trials

Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies

mouthcancer
Start date: August 31, 2019
Phase:
Study type: Observational [Patient Registry]

In 2007, The World Health Assembly (WHA) adopted a resolution to prevent oral cancer. The resolution urged the member states to ensure that measures against oral cancer was integrated into a national cancer control program by engaging and train dental personnel in screening, early diagnosis and treatment. Oral cancer is a severe oral health issue as it is potentially fatal and is the 5-6 most common tumor with approximately 275,000 cases for oral and 130,300 cases for pharyngeal cancers, excluding nasopharynx, globally. In Sweden,1000 new cases yearly is discovered and it is increasing. The explanation is an aging population and an increase in tonsil and tongue cancers caused by HPV, especially in younger subjects. This is due to changing sexual habits. Tumors caused by tobacco and alcohol are constant. Despite the decreasing prevalence of smoking and certain smoking-associated cancers, an increased incidence of tonsillar cancer has been seen in both Finland and Sweden. High risk HPV (hrHPV) oral cancer is also increasing.

NCT ID: NCT04081025 Completed - Quality of Life Clinical Trials

Oral Health and Risk Factors for Oral Disease

Start date: January 1, 2018
Phase:
Study type: Observational

Oral health has improved considerably in recent decades in Sweden, as well as in other countries. However, despite great improvements with regard to periodontal disease and dental caries in recent decades, global problems still persist, and as a consequence of retaining natural teeth high up in age, the risk for oral disease increases.

NCT ID: NCT04080024 Completed - Breast Cancer Clinical Trials

A First-in-human Clinical Evaluation of SN132D in Patients With Breast and Pancreatic Cancer

SPAGOPIX-01
Start date: August 23, 2019
Phase: Phase 1
Study type: Interventional

This phase I, first-in-human (FIH) study is open-label, non-randomised and non-placebo-controlled. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single intravenous dose of SN132D in approximately 24 patients with breast and pancreatic cancer. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.

NCT ID: NCT04079491 Terminated - Oral Lichen Planus Clinical Trials

Intra and Extra Oral Inspection of Oral Mucosa

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

Dental health professionals have a responsibility to perform routine intra- and extraoral inspection on their patients for detecting abnormalities. As dental hygienists (DH) and dentist (D) often see their patients on a regular basis, they have the opportunity to provide this screening, and at an early stage detect abnormalities.

NCT ID: NCT04079049 Recruiting - Breast Cancer Clinical Trials

BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases

BreCLIM-2
Start date: January 1, 2020
Phase: Phase 3
Study type: Interventional

Breast cancer is the second most common cancer in Sweden with an incidence of 8000 per year. The role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver. The purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. The primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. The secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. The aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. The overall purpose is to ameliorate treatment for advanced breast cancer.

NCT ID: NCT04078321 Completed - Clinical trials for Spastic Cerebral Palsy

Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The main purpose with this study is to investigate the effectiveness of a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for treatment of spasticity in children with cerebral palsy.

NCT ID: NCT04077580 Enrolling by invitation - Clinical trials for Recurrent Urinary Tract Infection

The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI

ImpresUWP3
Start date: November 1, 2019
Phase: Phase 4
Study type: Interventional

Recurrent urinary tract infection (UTI) in elderly women is a major driver of antibiotic prescription. Hence, the question of feasible and appropriate preventive measures are important issues in this field. Methenamine hippurate is frequently prescribed in Norway and Sweden as prophylaxis for recurrent UTI. Methenamine hippurate acts via the production of formaldehyde from hexamine, which in turn acts as a bacteriostatic agent, therefore methenamine hippurate is not defined as an antibiotic. According to a Cochrane review 2012 the rates of adverse events for preventing UTI was low. Although this review showed methenamine hippurate might be effective in preventing UTI in the short term, there is a need for large well-conducted randomised controlled trial (RCT) to clarify both the safety and effectivity of preventive methenamine hippurate for longer term use. This is particularly important for longer term use for people without neuropathic bladder disorders. A Norwegian longitudinal observational study including women aged 50-80 years with recurrent UTI indicated a significant and large reduction of more than 50% in antibiotic prescriptions for UTI after start of prophylactic methenamine hippurate. This further strengthens the need for an RCT of methenamine hippurate as prophylaxis for recurrent UTI.

NCT ID: NCT04077307 Recruiting - Leukemia Clinical Trials

A Study in Leukemia Patients With Karonudib

MAATEO
Start date: December 3, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies. Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.

NCT ID: NCT04076878 Completed - Stroke Clinical Trials

Effects of Using the Electrodress Mollii on Spasticity

Start date: August 15, 2017
Phase: N/A
Study type: Interventional

Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii suit provides electric stimulation through multiple electrodes places in a tight fitting suit. This study relates to the clinical trials performed at the University department of rehabilitation medicine at Danderyd Hospital in Stockholm and comprises an initial study of effects on spasticity ("Mechanical substudy") and a following, exploratory treatment trial ("Clinical substudy") in patients with spasticity after stroke.