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NCT ID: NCT05101824 Active, not recruiting - Bone Metastases Clinical Trials

Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease

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

This is a prospective, investigator-initiated, phase II, multicentre-study, investigating the efficacy and toxicity of definitive SABR of osseous oligometastases, when pragmatically introduced into a daily clinical setting.

NCT ID: NCT05099159 Completed - Hot Flashes Clinical Trials

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)

Start date: October 29, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: - record information about the participants' hot flashes in an electronic diary - answer questions about the participants' symptoms The doctors will: - check the participants' health - take blood samples - ask the participants questions about what medicines the participants are taking and if the participants are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.

NCT ID: NCT05096403 Suspended - Clinical trials for Cold Agglutinin Disease

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

Start date: October 20, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin disease (CAD).

NCT ID: NCT05095571 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study

Start date: October 7, 2021
Phase: N/A
Study type: Interventional

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The mean survival from the time of diagnosis is 2.5 years. Apart from Riluzole, there is no effective treatment. Care of advanced ALS will have a cost of 4-8 million NOK (Norwegian kroner) per year. Research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to Nicotinamide Adenine Dinucleotide (NAD) can delay disease progression. Nicotinamide riboside (NR) can increase cells' access to NAD and Pterostilbene will stimulate sirtuins. The investigators want to study whether combination therapy with NR and Pterostilbene can inhibit neurodegeneration in ALS and thereby delay disease development, increase survival and improve quality of life in ALS. In the NO-ALS extension study the investigators will follow the patients who completed the original NO-ALS study. Objectives are to evaluate adverse events and give patients possibility of compassionate use, and secondarily to see if the combination of NR and pterostilbene (EH301) will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.

NCT ID: NCT05093777 Recruiting - Cerebral Palsy Clinical Trials

Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage

PIHMulti
Start date: October 10, 2021
Phase: N/A
Study type: Interventional

By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.

NCT ID: NCT05092061 Completed - Clinical trials for Overweight and Obesity

Resistance Training in Adults With Obesity

Start date: October 14, 2021
Phase: N/A
Study type: Interventional

The purpose of this project is two-fold: (1) to assess if two different resistance training protocols elicit different responses in the acute phase and (2) to assess if the same two different protocols will elicit different long-term responses on muscular strength, body composition and cardiometabolic health. The project will include 30 adults with obesity (defined as BMI ≥ 30 or abdominal obesity according to the International Diabetes Federation). In the acute phase blood lactate, heart rate, enjoyment and perceived exertion will be assessed after the two resistance training protocols. In addition, the mean 24-h blood glucose concentration after exercise will be compared between the two protocols. For the long-term effects blood markers of cardiometabolic health, blood pressure, body composition, objectively measured physical activity and physical fitness will be assessed before and after the intervention. Also, perceived health-related quality of life will be assessed before and after the intervention.

NCT ID: NCT05091268 Active, not recruiting - Endometriosis Clinical Trials

Effect of Physical Activity and Pain Education on Endometriosis-associated Pain

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Endometriosis is a benign gynecological condition where the uterine endometrium is located outside the uterus. The condition affects up to 10% of women of fertile age and up to 70% of women with endometriosis have symptoms with severe pain during menstruation (dysmenorrhea), pain during intercourse (dyspareunia), and/or chronic pelvic pain. Current treatments are dictated by the primary symptom: pain and are limited to surgery and hormonal treatments with often short-lived effects. Advances in the understanding of the condition have expanded to focus on less invasive and non-pharmacological treatments. Systematic reviews and meta-analyses of observational studies have focused on the protective role of physical activity and exercise on the risk of developing endometriosis. The results from these studies have been inconclusive. However, the efficacy of physical activity and exercise on pain among women with endometriosis has not been tested in high-quality randomized controlled trials (RCT).

NCT ID: NCT05090527 Completed - Penicillin Allergy Clinical Trials

Penicillin Allergy Delabeling Project

PenProv
Start date: July 28, 2021
Phase: N/A
Study type: Interventional

A investigational study to establish: 1. A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments. 2. A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling. 3. A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians. 2. Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.

NCT ID: NCT05088434 Completed - Clinical trials for Irritable Bowel Syndrome

Fecal Microbiota Transplantation and ACHIM for Manipulating Gut Microbiota in IBS Patients

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The double-blinded placebo-controlled study compares the effect of fecal microbiota transplantation vs. Anaerobically Cultivated Human Intestinal Microbiota (ACHIM) or placebo (own feces) on manipulating the gut microbiota in patients with diarrhea-predominant irritable bowel syndrome (IBS).

NCT ID: NCT05087446 Recruiting - Mental Disorder Clinical Trials

Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care

Start date: October 26, 2021
Phase: N/A
Study type: Interventional

Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Many of the patients referred to outpatient mental health care have complex difficulties with both mental and somatic ailments, in addition to difficulties with social conditions related to, for example, education, work, finances and social support. Functional difficulties can come as a result of mental illness. However, it can also be the opposite way; not functioning at work, study or daily life in general can cause mental symptoms and ailments. Many of these people are referred to mental health care even if the basic problem cannot be solved by psychotherapy or medication. Some of the referred patients do not have a psychiatric illness, but a reaction to a stressful and demanding situation and strains over time. Compound health challenges require individualized assessments and clarifications in order to offer the right measures. Traditionally in mental health care, the patient is placed on a waiting list to receive assessment and therapy for a specific condition. With this background, the investigators believe it is important to early identify the referred patients who will benefit from measures other than traditional assessment and treatment in mental health care. Knowledge of other aid agencies is important to find the right measures at the right time. This is important for the individual patients, who are often young people going to "get started in life". It is also important for the health services because the capacity to provide a good health service is a limited resource. From a societal perspective it is important that the health care offered contributes to reducing social security dependence. The purpose of this randomized, controlled trial is to compare the effect of traditional management of newly referred patients in outpatient clinics with assessment through an Early Assessment Team. The investigators believe that early assessment may have a positive effect on mental health, quality of life and function. The outcome goals can be summarized as less use of resources in outpatient clinics and society and better function and life for patients.