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Found 12 Actively Recruiting clinical trials

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Actively Recruiting

Amyotrophic lateral sclerosis ALS is a severe and fast-progressing nervous system disease with a typical survival time of about 2.5 years after diagnosis. Currently, Riluzole is the only treatment available, and the care for advanced ALS is very costly. Research suggests that increasing access to Nicotinamide Adenine Dinucleotide NAD and activating enzymes called sirtuins might slow disease progression. Nicotinamide riboside NR increases NAD, and Pterostilbene stimulates sirtuins. The study aims to evaluate whether a combination of NR and Pterostilbene can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. This extension study follows patients who completed the initial NO-ALS trial, where all participants receive the combination supplement EH301 Nicotinamide Riboside and Pterostilbene. It is an open-label study offering compassionate use and monitoring adverse events. The study will assess if this combination can reduce motor symptom progression, preserve lung function, and increase survival over a one-year follow-up. Participants who completed the original NO-ALS trial will be followed for one year with regular assessments. Researchers will monitor adverse events throughout this period and measure disease progression using the ALS Functional Rating Scale Revised and changes in vital lung capacity. The study aims to provide long-term safety and efficacy data while allowing continued access to the supplement. Total participation duration is one year from enrollment in the extension study.

Age: 35Years +All GendersPhase Not Applicable
17 locations
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Actively Recruiting

Researchers are evaluating a complex intervention to improve advance care planning ACP for severely ill elderly people living at home who are acutely admitted to hospital. This cluster randomized study involves twelve Norwegian geriatric hospital units and aims to enhance patient and family involvement in treatment decisions, improve quality of life, and support ethical and legal care planning. The project also explores barriers and facilitators to implementing ACP at clinical, health service, and governmental levels, including economic analyses. The intervention group receives a comprehensive support program that includes leadership commitment, training for staff, implementation teams, ACP coordinators, and practical tools such as guidelines and documentation templates. The control group receives no implementation support during the trial but will be offered the program afterward. The study period includes baseline, 9-month, and 18-month assessments for the intervention group and baseline and 18-month assessments for the control group. Participants will undergo questionnaires and interviews with patients, relatives, clinicians, and staff at multiple time points before, during, and after the implementation. Data from patient records and national health registers will be collected to assess the fidelity of ACP implementation, clinical outcomes, communication quality, and cost-effectiveness. The trial runs until December 2026 and includes various measures to evaluate the impact of the support program on ACP delivery and related outcomes.

Age: 70Years +All GendersPhase Not Applicable
12 locations
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Actively Recruiting

Researchers are evaluating the effectiveness of a brief behavioral intervention delivered by trained general practitioners GPs to reduce the prolonged use of Z-hypnotic sleep medications among elderly patients in primary care. This randomized controlled trial compares this intervention to usual care provided by GPs without the specific training. The study focuses on elderly patients with harmful use of hypnotics, aiming to improve medication use and related outcomes. Participants are randomly assigned to one of two groups an active group where GPs provide a short, structured behavioral intervention aimed at reducing inappropriate Z-hypnotics use, and a control group receiving usual care from GPs without this training. The controlled masked phase lasts 6 months, followed by an open single crossover where the control groups GPs receive the intervention training. Treatment effects are evaluated primarily 6 weeks after the intervention, with additional follow-ups at 6 and 12 months. During the study, assessments include self-reported medication use, automatic sleep monitoring using actigraphy, cognitive function tests, pain scales, and sleep experience questionnaires. Baseline assessments focus on self-reports and actigraphy to minimize assessment effects. Follow-ups occur in person and by telephone, with blinded evaluators. The main outcome measured is inappropriate Z-hypnotics use 6 weeks after the intervention, with longer-term monitoring up to 12 months to assess lasting impacts.

Age: 60Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Amyotrophic lateral sclerosis ALS is a severe and rapidly progressing nervous system disease with an average survival of two to three years after diagnosis. Patients experience significant physical and psychological challenges, and apart from the drug Riluzole, effective treatments are lacking. This study aims to understand how life-sustaining ventilation support, either non-invasive or with tracheostomy, impacts the quality of life of ALS patients, their partners, and children, addressing a difficult ethical issue in ALS care. Participants are divided into two groups those who choose life-prolonging treatment with long-term mechanical ventilation support and those who decline such treatment. The study involves a longitudinal questionnaire approach conducted in Norway, measuring overall, health-related, and disease-specific quality of life over time. Assessments occur at inclusion and then every three months up to 21 months. Throughout the study, ALS patients, their partners, and children complete various quality of life questionnaires, including the Quality of Life Scale, EQ-5D-5L, ALS-specific scales, and caregiver burden surveys. Researchers monitor changes in these assessments to understand the effects of ventilation support. The study is sponsored by Haukeland University Hospital and includes participants aged 8 years and older, with data collection planned until 2032.

Age: 8Years +All GendersPhase Not Applicable
9 locations
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Actively Recruiting

Researchers are investigating whether bipolar enucleation of the prostate BEEP leads to better urinary voiding outcomes than transurethral resection of the prostate TURP in men with enlarged prostates experiencing voiding problems. This multi-center randomized controlled trial focuses on men with prostate sizes between 30mL and 80mL who have lower urinary tract symptoms caused by benign prostate obstruction. The study also explores how symptom relief relates to the amount of tissue removed, differences in patient experiences between the two procedures, and the cost-effectiveness of BEEP compared to TURP. Participants will be randomly assigned to receive either TURP or BEEP, both transurethral surgical procedures performed to relieve urinary symptoms by removing prostate tissue. TURP involves removing central prostatic tissue starting from the bladder neck downwards, while BEEP removes tissue starting in the peripheral zone towards the bladder. Outcomes will be assessed at baseline and 12 months after surgery, with additional patient experience questionnaires at 3 and 12 months. Both procedures are performed under standard surgical care by experienced urologists. During the study, participants will complete the International Prostate Symptom Score IPSS to measure urinary symptoms and the Nordic Patients Experience Questionnaire NORPEQ to evaluate patient experience. Additional assessments include urinary flow measurements, residual urine volume, complications, catheter use, quality of life questionnaires, sexual function, and health care resource use. Cost-effectiveness will be analyzed using quality-adjusted life years QALYs over the 12-month follow-up. The study aims to enroll 120 men, with follow-up visits and data collection managed through electronic systems over one year.

Age: 0 - 80YearsMALEPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are investigating whether precision therapy guided by a Clinical Tumour Board is more cost-effective and beneficial compared to standard treatment for elderly patients with acute myeloid leukemia AML and high-risk myelodysplastic syndrome MDS. This phase II, randomized clinical trial focuses on patients aged 60 and older who are not eligible for intensive chemotherapy or stem cell transplant. Precision therapy is tailored based on genetic changes found in the tumor using next generation sequencing NGS. Participants first receive two 28-day cycles of standard treatment, which for AML includes azacitidine plus venetoclax if available, or azacitidine alone for MDS patients. During this initial treatment, bone marrow samples are analyzed by the Tumour Board to determine suitable targeted therapies for the precision therapy group. After initial treatment, patients without disease progression are randomized in a 21 ratio to either continue standard therapy or receive precision therapy combined with standard treatment. Throughout the 4 to 5 years of follow-up, patients undergo regular assessments including bone marrow evaluations, genomic profiling, and monitoring of treatment response, adverse events, quality of life, and healthcare costs. The study measures cost-effectiveness as the primary outcome, alongside survival, toxicity, transfusion dependence, and progression. Safety and efficacy are carefully tracked to understand the impact of personalized precision therapy in this elderly population.

Age: 60Years +All GendersPhase 2
1 location
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Actively Recruiting

Researchers are evaluating treatments for patients with metastatic prostate cancer, including both hormone-sensitive and castration-resistant forms. This international trial uses biomarker signatures identified from tumor or liquid biopsies to guide treatment assignments. The study compares standard care based on national guidelines with experimental treatments tailored to genetic changes related to prostate cancer. It uses an adaptive design to assign treatments based on ongoing results to improve patient outcomes. Participants are randomized to either a control group receiving standard care or an experimental group receiving treatments matched to their biomarker profile. Experimental treatments include androgen receptor signaling inhibitors, taxane-based chemotherapy combined with AR inhibitors, PARP inhibitors, AKT inhibitors, and carboplatin, depending on the biomarker signature and disease stage. Patients progressing during the trial may be re-assigned up to three times to different treatments based on updated biomarker profiles. Throughout the study, patients undergo regular assessments including progression-free survival monitoring up to 60 months. Researchers also track treatment response rates, overall survival, patient-reported outcomes, cost-effectiveness, and safety through adverse event reports. An independent board regularly reviews data to evaluate treatment effectiveness and may modify treatment assignments accordingly. The trial aims to personalize therapy for metastatic prostate cancer based on genetic markers.

Age: 18Years +MALEPhase 3
32 locations
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Actively Recruiting

Healthy Volunteer

Labor induction rates have been increasing steadily, with over one in four births in Norway currently occurring after induced labor. While certain groups of women benefit from labor induction, such as those with preeclampsia or gestational diabetes, induction can also increase the risk of complications like cesarean section and operative deliveries. This research aims to evaluate the effects of oral bicarbonate and intravenous butylscopolamine bromide in helping pregnant women with labor induction have spontaneous, non-operative births. The trial is a double-blind, randomized, placebo-controlled study with four groups. Participants receive combinations of oral bicarbonate or placebo and intravenous butylscopolamine bromide or placebo. The butylscopolamine bromide is given as a 1 mL intravenous injection, while bicarbonate or placebo is taken orally at a 4 g dose. This study assesses the impact of these medications on labor outcomes among pregnant women undergoing labor induction. Participants will be monitored throughout their labor, with researchers observing whether births are spontaneous or operative. The main outcome measured is the type of delivery, observed during the study period which lasts about one week through to birth. Safety and effectiveness are evaluated by comparing delivery outcomes across the different treatment groups. The study includes assessments related to labor progress and maternal and fetal conditions during delivery.

Age: 18Years - 50YearsFEMALEPhase 3
5 locations
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Actively Recruiting

Some patients experience cognitive decline after a stroke, but the reasons are not always clear. Researchers are studying whether an autoimmune response could explain this cognitive decline in a subgroup of stroke patients. This observational study aims to better understand immune system changes following a stroke. Participants in this study will have their immune responses analyzed through blood samples taken shortly after a stroke. The focus is on B cell and T cell activity in peripheral blood collected within one day of enrollment. The study does not involve treatment but observes natural immune responses after stroke. During the study, participants will provide blood samples to assess their immune response. Researchers will measure specific immune cells and monitor changes to understand the connection between stroke and cognitive decline. The study is led by the University of Oslo and will continue until June 2029.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Researchers are comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation to find out which is better at relieving persistent low back pain lasting at least one year in adults aged 20 to 65 years. Chronic low back pain is a leading cause of disability worldwide, with complex causes and limited effective treatments. This study aims to provide clearer evidence on treatment effects and explore new ways to diagnose and tailor treatments using advanced imaging and biomarkers. Participants will be randomly assigned to either lumbar interbody fusion surgery or a multidisciplinary rehabilitation program. The surgery involves fusion of one or two lumbar spine levels through either a transforaminal lumbar interbody fusion TLIF or anterior lumbar interbody fusion ALIF procedure, including stabilization with screws. The rehabilitation consists of 2.5 to 5-hour sessions, 2 to 4 days per week, for 3 to 5 weeks, focusing on cognitive and physical therapy guided by specialists. Both groups will undergo detailed imaging, blood tests, and activity monitoring throughout the study. Participants will provide information about their pain, disability, physical activity, and sleep patterns at several points during the study using questionnaires and accelerometers. Blood samples and imaging will be collected at baseline and follow-ups to assess biomarkers. Safety and adverse events will be closely monitored, especially for surgery participants, with clinical exams, blood tests, and scans. The main measure is the change in disability at one year, with additional evaluations up to two years. The study also assesses cost-effectiveness and quality of life impact over the follow-up period.

Age: 20Years - 65YearsAll GendersPhase Not Applicable
5 locations

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