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NCT ID: NCT04964934 Recruiting - Clinical trials for ER-Positive HER2-Negative Breast Cancer

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

SERENA-6
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

NCT ID: NCT04964336 Recruiting - Multiple Sclerosis Clinical Trials

An Observational Study to Investigate the Role of B Cells in Multiple Sclerosis

Start date: February 5, 2018
Phase:
Study type: Observational

Multiple sclerosis (MS) typically afflict young people in their twenties, when they start a career and establish a family. The disease thus imposes a severe impact on quality of life and heavy economic burdens on society. Critical barriers to progress in the field are the lack of knowledge of relevant immune cell subsets driving the pathology and the targets of the immune response within the central nervous system. In this project, we will test the hypothesis that a subgroup of MS patients is defined by a genetically determined B cell response against specific antigenic epitopes. The hypothesis is based on our recent, pioneering results showing that approximately half of MS patients have a restricted population of B cells in the cerebrospinal fluid defined by polymorphisms in the constant heavy-chain of the immunoglobulin B cell receptor, the G1m1 allotype. Here, we aim to characterize the G1m1 B cells, to disentangle the genetic basis of the B cell response, and to identify the molecular targets.

NCT ID: NCT04960800 Not yet recruiting - Pregnancy Related Clinical Trials

Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis

Start date: September 2021
Phase: N/A
Study type: Interventional

Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Treatment of this condition aim to reduce the inter-rectus distance, and conservative treatment including therapeutic exercise is the primary treatment of choice. To date, there is no generally accepted protocol of therapeutic exercises for this condition, and the evidence as to which exercise modality is the most effective and feasible in reducing the inter-rectus distance in women presenting with diastasis rectus abdominis is both sparse and weak. As this condition occur during the last two trimesters of pregnancy and as there is a paucity of high-quality studies on a pregnant population, investigators will conduct a randomized controlled trial on the effect of a specific exercise program during pregnancy on diastasis rectus abdominis. 100 pregnant women in gestation week 25 presenting with diastasis rectus abdominis of ≥ 28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomization. The intervention group will participate in a 12-week specific exercise program, consisting of two group sessions and two self-managed sessions weekly. The control group will not participate in any exercise intervention; however, participants will be recommended to follow national guidelines for general exercise during pregnancy. Participants will be assessed prior to intervention, post intervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-rectus distance in mm, measured by two-dimensional ultrasonography.

NCT ID: NCT04959565 Completed - Clinical trials for Relative Energy Deficiency in Sport

Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency

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

The aim of this study is to develop, implement and evaluate the effects of a 16 week practice orientated sports nutrition education and counselling program aiming to improve energy availability and to investigate the effects on physiological and psychological health, sports nutrition knowledge, and athletic performance in well-trained female endurance athletes with risk of RED-S. The FUEL (in Norwegian: Forstå Utholdenhetsidretts Ernæring - et Læringsprogram; in English: Food and nUtrition for Endurance athletes - a Learning program) recovery program consists of virtual lectures with central themes within sports nutrition in addition to individual consultations.

NCT ID: NCT04957719 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

SOS-AMI
Start date: August 14, 2021
Phase: Phase 3
Study type: Interventional

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

NCT ID: NCT04957628 Recruiting - Alcohol Consumption Clinical Trials

AlcoTail - Implementation of Tailored Interventions

Start date: September 13, 2021
Phase:
Study type: Observational

This study aims to investigate the implementation and real-world effects of an intervention for harmful use of alcohol and psychoactive medicinal drugs among hospital inpatients. Due to the negative impact of alcohol consumption on health outcomes, a call for action has been made by the Norwegian Ministry of Health, with focus on screening patients for alcohol consumption and evidence-based tailored interventions for those with medium or high consumption. In addition, non-prescribed use of psychoactive medicinal drugs, or concomitant use with alcohol, can also have negative health effects, therefore improved monitoring of the use of these are warranted. Interventions will be introduced as routine procedures at Norwegian hospitals in the upcoming year, and 2500 patients receiving acute medical care will be included in the control group before the intervention is implemented, and 2500 patients in the case group after the implementation is effectuated. This study will evaluate the implementation process using baseline data on self-reported alcohol- and psychoactive medicine use, motivation to reduce consumption and mental distress. In addition, left-over blood samples used for diagnostic purposes will be collected and analyzed for alcohol, psychoactive medicinal and illicit drugs. After 12 months baseline data will be coupled to patient journal data and relevant registry data in order to evaluate the effects of the intervention.

NCT ID: NCT04957394 Active, not recruiting - Parenting Clinical Trials

Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention

FAMPART
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Prior to this pilot study, it is unclear whether comparing a manualized version of the Family Partner Model to standard practice in the Child Welfare Services would be feasible. Results will inform whether and how to design a fully powered randomized controlled trial to test the effects of a manualized version of the Family Partner Model on child maltreatment. The specific results of the pilot study will inform 1) randomization procedures, 2) data sources to be used, 3) sample size calculations, and 4) adaptations to the design and measures for a fully powered randomized controlled trial.

NCT ID: NCT04945876 Recruiting - Parkinson Disease Clinical Trials

Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease

mHEXANUT
Start date: April 30, 2021
Phase: N/A
Study type: Interventional

A randomized, controlled trial to evaluate the effect of six months digital follow-up, after a stay at a rehabilitation center, on functional and nutritional status in people with Parkinson Disease.

NCT ID: NCT04943926 Recruiting - Hypertension Clinical Trials

Dietary Strategies for Remission of Type 2 Diabetes

CARBCOUNT
Start date: January 4, 2022
Phase: N/A
Study type: Interventional

In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs/capabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in/can be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal/hepatic fat accumulation, adipose tissue biopsies and/or measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.

NCT ID: NCT04943042 Active, not recruiting - Clinical trials for Immune Thrombocytopenia

An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP

ADOPT
Start date: February 22, 2022
Phase:
Study type: Observational

This is a multi-center, observational, Phase 4 study in patients with Immune Thrombocytopenia (ITP) designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge base regarding the use of Doptelet in routine medical practice. Patients eligible for participation will, as part of their routine medical care, be receiving Doptelet for the treatment of ITP.