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NCT ID: NCT06240533 Not yet recruiting - Low Back Pain Clinical Trials

Implementation of P3C-LBP in Swedish Primary Care

P3C-LBP
Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate the implementation of a patient centered coordination care (P3C) pathway for the management of patients with low back pain (LBP) in primary care, in Östergötland health care region, Sweden. The main questions the study aims to answer are: - Do health care quality indicators improve over time after repeated implementation interventions of a P3C pathway for patients with LBP. - What are the health care practitioner perspectives regarding barriers and facilitators determining implementation success of a P3C pathway for patients with LBP.

NCT ID: NCT06232707 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

ALUMMINATE
Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT06230068 Not yet recruiting - Breast Cancer Clinical Trials

ExBRAC - Expressive Writing in Breast Cancer

ExBRAC
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The EXBRAC pilot study will investigate the quality of life of patients with breast cancer, and the effect of an intervention with expressive writing. This is a pilot study with two purposes, the first is to create a questionnaire specifically developed for the ExBRAC study, and the second to evaluate the feasibility of the expressive writing.

NCT ID: NCT06223698 Not yet recruiting - Breast Cancer Clinical Trials

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

SWE-Switch
Start date: May 2, 2024
Phase: Phase 3
Study type: Interventional

Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice. The primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios: - In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen. - In postmenopausal women at diagnosis.

NCT ID: NCT06219395 Not yet recruiting - Clinical trials for Iron Deficiency Anemia

Capsule Endoscopy in Iron Deficiency Anaemia

WCE-IDA
Start date: March 1, 2024
Phase:
Study type: Observational

This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)

NCT ID: NCT06212362 Not yet recruiting - Anxiety Clinical Trials

Stepped Care Versus Group Cognitive Behaviour Therapy for Paediatric Anxiety in Primary Care

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Objectives: Over the past decade in Sweden, a novel approach to primary healthcare units, known as first-line mental health (FLMH), has been introduced to enhance mental health services for children and adolescents. Through a structured and collaborative method involving experts, clinicians, and patients, a trans-diagnostic psychological intervention for anxiety was formulated based on cognitive behavioural therapy (CBT), designed to align with the FLMH care framework. This study seeks to assess the efficacy of the CBT intervention "Step-by-Step" in a randomised, single-blind, parallel-group, multisite non-inferiority trial. The objective is to investigate whether this treatment is not less effective than the evidence-based Cool Kids program. Rationale for the Study: Childhood anxiety is prevalent and linked to suffering and impairment across various life domains. While cognitive behavioural therapy (CBT) is a proven treatment for anxiety disorders in children, there is a pressing need to enhance access to such interventions. Introducing CBT for childhood anxiety within primary care settings offers an avenue for early and readily available treatment. However, a gap exists in the availability of CBT interventions specifically designed for and assessed within primary care contexts.

NCT ID: NCT06163339 Not yet recruiting - Mental Health Issue Clinical Trials

Evaluation of the Cultural Formulation Interview (CFI)

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Studies show that the mental health of children may have deteriorated in recent decades. In Sweden, several national initiatives have been implemented to develop and strengthen interventions for children's mental health. One of these initiatives involves enhancing the first line of primary care for children with mental health issues, whose mission is to provide early intervention, i.e., support for mild to moderate mental health problems. The responsibility for children with moderate to severe mental health issues lies with child and adolescent psychiatry. Research indicates that children with a migration background, to a lesser extent than native-born children, have contact with both the first line of mental health care and child and adolescent psychiatry. There is also research showing that when newly arrived individuals do seek care, they may receive poorer quality care than others and, for example, may be misunderstood. From the perspective of equal healthcare, this is a significant shortcoming. In our study, the investigators address differences between healthcare providers and families based on cultural factors as a possible reason for the lack of equality in healthcare. In the study, the investigators aim to evaluate whether the Cultural Formulation Interview (CFI) improves the connection between healthcare providers and families and increases the family's involvement in treatment, ultimately leading to better mental health for the child. The method can be said to aim at enhancing the assessment, compliance, and treatment that are currently available within healthcare.

NCT ID: NCT06145490 Not yet recruiting - Healthy Clinical Trials

Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance and Interoception in Healthy Individuals and Panic Disorder.

BINCAP
Start date: August 2024
Phase: N/A
Study type: Interventional

The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including Healthy Controls (HC) and participants with Panic Disorder (PD). The primary aim of the study is to investigate the neural correlates and behavioral effects of caffeine (versus placebo), and its impact on emotional reactivity, decision-making, and interoception, and compare the effects in individuals with PD vs HCs. Subjective anxiety and the occurrence of panic attacks will also be measured. Multimodal neuroimaging methods, such as structural and functional MRI, will be used to address the aims of the study. Emotional reactivity, emotional decision-making and interoception will be measured with experimental tasks in a 7 Tesla (7T) magnetic resonance (MR) scanner, jointly with measures of skin conductance, heart rate, respiratory rate, and self-reported ratings of anxiety and interoception. Emotional reactivity will be assessed using emotional and neutral faces. Emotional decision-making will be assessed with an approach-avoidance conflict task. Changes in interoception (bodily sensation, such as pulse and respiration) will be explored using a task in which participants are asked to focus on their breathing or an external stimulus. Caffeine effects on brain resting-state activity will also be assessed. All tasks will be conducted while in the 7T MR scanner. A secondary aim of the study is to examine the impact of genetic variability in the adenosine A2A receptor (ADORA2A) genotype (e.g., rs5751876 T/T) on the effects of caffeine (vs placebo), as ADORA2A genotype has previously been associated with elevated caffeine-induced anxiety.

NCT ID: NCT06141070 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease

ANDROMEDA
Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.

NCT ID: NCT06115629 Not yet recruiting - Gastric Cancer Clinical Trials

Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial

SARONG-II
Start date: November 2023
Phase: Phase 3
Study type: Interventional

Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most patients with cancer of the oesophagus and stomach are treated with surgery with or without additional chemotherapy or radiotherapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection. Despite these improvements, in around half of patients treated with surgery, the cancer will return, usually within the first three years. At present there is very little evidence as to how patients who have been treated for cancer of the oesophagus or stomach should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery. The SARONG-II study will investigate if regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive imaging surveillance (including regular radiological scans and a camera test (endoscopy)) or clinical follow-up. The study aims to recruit at least 952 participants in Europe over a 32-month period. Patients undergoing surgery for oesophageal or stomach cancer will be invited to participate in the study at around 4 to 8 weeks after their surgery. (i) The imaging surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months after randomisation. They will also receive endoscopy at 12 months after randomisation (ii) The clinical surveillance group will receive a review in clinic or by telephone at 6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year according to local practice The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with oesophagus or stomach cancer. The investigators anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for oesophagus and stomach cancer.