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NCT ID: NCT05924347 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

EARLYBIRD
Start date: June 16, 2023
Phase:
Study type: Observational

Rationale: Despite several decades of research, the exact etiology of adolescent idiopathic scoliosis (AIS) remains unclear. In AIS, spine curvature begins with and progresses during the adolescent growth spurt. Previous studies are only performed on populations with already established scoliosis and normal spinal growth (of bone and IVD tissue) during adolescence has also not been defined. Growth pattern differences may exist between scoliotic and nonscoliotic subjects. Previous studies support the hypothesis that AIS is a spinal deformity that starts with decompensation in the IVD and is linked to sagittal spinal alignment. However, to understand its cause and pathogenic mechanism, the changes to the adolescent spine must be assessed longitudinally during the growth period coinciding with the period prior to and during the onset of AIS. Ideally this should include a cohort who do and do not develop AIS and their assessment must be minimally harmful, without radiation exposure. Certain populations are at increased risk for scoliosis development (i.e. girls with family members with scoliosis and 22q11.2DS patients). New imaging modalities (boneMRI, 3D spinal ultrasound) allow for non-radiographic monitoring of spinal growth.

NCT ID: NCT05924243 Recruiting - Parkinson Disease Clinical Trials

A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease

Start date: September 22, 2022
Phase: Phase 1
Study type: Interventional

This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).

NCT ID: NCT05923697 Recruiting - Clinical trials for Substance Use Disorders

Addiction-focused EMDR in Inpatients Who Use Non-opioid Drugs: a Multiple Baseline Study

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

Rationale: It is well established that Substance Use Disorders (SUD) have severe health consequences. Despite behavioral and pharmacological treatment options, relapse rates remain high. In particular, for non-opioid drugs, such as amphetamines, cocaine, base-coke and cannabis, established, evidence-based pharmacological options to reduce craving, to substitute substance use or to enforce abstinence are lacking. Therefore, there is a need for effective interventions for patients who use non-opioid drugs to reach and maintain long-term abstinence. A potential interesting intervention is addiction-focused Eye Movement Desensitization and Reprocessing (AF-EMDR) therapy. However, the limited research on AF-EMDR therapy and mixed findings thus far prohibit clinical use. Recently, on the basis of diverse findings thus far, an adjusted AF-EMDR therapy protocol has been developed.

NCT ID: NCT05920356 Recruiting - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Start date: November 16, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

NCT ID: NCT05920148 Recruiting - Aging Clinical Trials

The Immu-KNEE-ty Study

Start date: March 12, 2024
Phase:
Study type: Observational

The goal of this observational study is to determine changes in immune functioning after total knee replacement surgery in elderly. The study population consists of 14 patients aged 65 years or over undergoing primary total knee replacement surgery. Immune functioning will be assessed at multiple timepoints before and after surgery (i.e., ± 6 weeks before, and 1 day, 1 week, ± 2 weeks, and ± 6 weeks after surgery). Each patient will serve as his/her own control. Immune functioning will primarily be assessed by determining the change from baseline in monocyte-derived TNFα production at 1 week after surgery. Changes in monocyte responsiveness are considered indicative for changes in immune functioning. As secondary objective, additional parameters of immune functioning will be assessed. In addition, the course of immune functioning following total knee replacement surgery will be investigated. Burden and potential risks for the patient are estimated to be minor. During the study, 5 blood samples of 20 mL will be collected over a period of ± 12 weeks, resulting in a total blood draw of 100 mL. During surgery a sample of synovial fluid (± 2 mL) will be taken from surgical waste. Before and after surgery patients will report their pain medication intake and the presence of cold and flu-like symptoms in a diary. Patients do not directly benefit from the study.

NCT ID: NCT05919758 Recruiting - Neoplasms Clinical Trials

Value of Right-sided Hemicolectomy for Chldren With High-risk Neuroendocrine Tumors of the Appendix

NETkids
Start date: May 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to investigate the beneficial value of complementary surgery for appendiceal neuro-endocrine tumours in children. .

NCT ID: NCT05919407 Recruiting - Myasthenia Gravis Clinical Trials

Pyridostigmine and Amifampridine for Myasthenia Gravis

IMPACT-MG
Start date: March 22, 2023
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, crossover intervention study evaluating the effect of pyridostigmine (part 1) and amifampridine (part 2) in Myasthenia Gravis (MG).

NCT ID: NCT05917275 Recruiting - Clinical trials for Primary Hypertension

Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

HT-PREDICT
Start date: April 4, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to develop biomarkers composed of multiple OMICs (MOMICs) for prediction of blood pressure response to antihypertensive drugs in the treatment of primary hypertension. The main objectives are: - Primary objective: - To identify MOMICs biomarkers that predict the response in 24-hour blood pressure to antihypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine) - Secondary objectives: - To identify a MOMICs biomarker that predict the response in night-time blood pressure to anti-hypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine) - To identify MOMICs biomarkers that predict side effects, including changes in QoLof olmesartan, amlodipine and hydrochlorothiazide. - Exploratory objective: - To assess changes in MOMICs biomarkers induced by each drug Participants will undergo three 4-week treatment periods: - Each subject receives 3 out of 4 possible treatments (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine). - Before and after each treatment period OMICS measurements and an ABPM are performed. - At the end of each treatment period blood is sampled for drug level testing to assess adherence. - Electrolytes and kidney function are checked 5-7 days after start of each treatment period.

NCT ID: NCT05917067 Recruiting - Thyroid Diseases Clinical Trials

Fluorescence Imaging of the Parathyroid Glands of Children

FLUOPATCH
Start date: September 1, 2023
Phase:
Study type: Observational

The aim of this study is to develop a standardized and user-independent imaging workflow model for autofluorescence and quantified fluorescence angiography with Indocyanine Green (ICG) of the parathyroid glands of children. For this purpose, all pediatric patients will undergo thyroid surgery with the use of autofluorescence and quantified ICG-fluorescence. This study could be the first step in reducing the rate of postoperative hypocalcemia in children, by using fluorescence angiography during pediatric thyroid surgery.

NCT ID: NCT05916651 Recruiting - Clinical trials for Internalizing Problems

Promoting Resilience in Youth Through Mindfulness mEditation

PRYME
Start date: July 7, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial (RCT) is to assess whether mindfulness training reduces early stage internalizing problems such as anxiety, worrying, and low mood in help-seeking youth. Participants will be randomly assigned to one of two groups: 1) mindfulness + care-as-usual (CAU) or 2) CAU-only. The mindfulness program was developed specifically for youth with internalizing problems. The 8-week training program consists of weekly 2-hour sessions, with mindfulness, yoga, and mindful active movement in each session. In addition, participants are invited to practice at home in between sessions for around 20 minutes per day. Data will be collected at baseline (T0), end-of-treatment (T1) (or 2-3 months after baseline for the CAU-only group), and at 2 months follow-up (T2) and 6 months follow-up (T3). Measurements will include: - Self-report questionnaires (T0, T1, T2, T3) - Psychiatric diagnostic interview (T0, T3) - MRI scans (T0, T1) - Cognitive tasks (T0, T1) The primary outcome parameter is the total number of internalizing problems measured with the Adult Self Report (ASR) at end-of-treatment. The effect of mindfulness training (mindfulness + CAU vs. CAU-only) on internalizing problems at T1 will be assessed using a linear-mixed effects model.