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NCT ID: NCT06451952 Not yet recruiting - Clinical trials for Agitation in Dementia, Including Alzheimer's Disease

Virtual Darkness Theraphy for Agitation in Dementia

DARKDEM
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Behavioral and psychological symptoms of dementia (BPSD) such as anxiety, depression, psychosis and agitation, are prevalent, often treatment resistant, resource demanding and significantly deteriorates cognition, independency, quality of life and mortality in people with dementia. The DARK.DEM trial aims at developing new diagnostics and treatment for BPSD in both specialized and municipal dementia care. The investigators will develop digital phenotyping by determining the convergent validity of data from a smartwatch against established psychometric scales for BPSD for patients admitted to NKS Olaviken gerontopsychiatric hospital. The investigators will conduct an open label single blinded randomized controlled trial to determine the effectiveness, feasibility and safety of virtual darkness as adjunctive treatment of agitation in patients with dementia admitted to the hospital. The investigators will randomize minimum 72 patients to treatment as usual (psychotropic drugs, psychological and environmental interventions) or 14 days of virtual darkness therapy, that is, exposure to light deprived of blue wavelengths from 19.00-08.00, provided in a secluded patient unit with circadian lightening. Primary outcome is 14 days change in agitation assessed with Cohen-Mansfield Agitation Inventory. Secondary outcomes are change in diurnal variation of motor activity assessed with a smartwatch, other BPSD, activities of daily living, quality of life, use of psychotropic drugs, use of restraints and coercion, length of hospital stay and resource utilization. The investigators will conduct focus group interviews with managers and staff in nursing homes to explore barriers, enablers and adaptions to support implementation of the new methods in municipal dementia care

NCT ID: NCT06451757 Not yet recruiting - Clinical trials for Mitochondrial Diseases

KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases

KH176-301
Start date: January 2, 2025
Phase: Phase 3
Study type: Interventional

The KHENERFIN study is investigating whether the study medicine, sonlicromanol, is able to improve symptoms of fatigue and the impact of fatigue on daily life, and whether sonlicromanol is able improve physical abilities of people living with mitochondrial disease, such as balance control and lower limb skeletal muscle strength. For this study, the effects of sonlicromanol are compared with those from a placebo (study medication that looks like the actual study medicine but contains no active medicine). The study medicine (or placebo) is a powder that is dissolved in water and must be taken twice daily during the treatment period of 52 weeks. Additionally, the study evaluates the efficacy of sonlicromanol on selected secondary and exploratory outcome measures, as well as the safety and tolerability of sonlicromanol after 52 weeks of treatment with sonlicromanol.

NCT ID: NCT06451640 Not yet recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the efficacy and safety of TQC2731 injection in the treatment of chronic sinusitis with nasal polyps.

NCT ID: NCT06451055 Not yet recruiting - Clinical trials for Isolated Impaired Fasting Glucose

Low-calorie Diet in Isolated Impaired Fasting Glucose

Start date: July 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with i-IFG. Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.

NCT ID: NCT06450769 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Aronia and Non-alcoholic Fatty Liver Disease

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Adults newly diagnosed with NAFLD will be included in the study. At the beginning of the research, the socio-demographic characteristics and nutritional habits of the individuals will be questioned with a face-to-face questionnaire. In addition, at the beginning of the study, blood samples, 3-day food consumption record, physical activity record, anthropometric measurements (height, body weight, waist, hip and neck circumference and body composition analysis) and stool samples will be taken from the patients. Oxidative stress (TAS, TOS, SOD, Malondialdehyde, Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage) and inflammation (CRP, TNF-alpha, IL-17, IL-23, IL-10, IL-13, TGF-beta) parameters in blood samples will be analyzed. Patients will then be randomized into four groups to follow a Mediterranean diet supplemented with aronia, a Mediterranean diet, a low-fat diet supplemented with aronia, or a low-fat diet. Necessary training will be given to the participants so that they can apply the individually planned diet. Dietary adherence and anthropometric measurements will be evaluated every 2 weeks. At the end of the twelve-week follow-up, all parameters evaluated at the beginning of the study will be repeated and compared with previous values.

NCT ID: NCT06450197 Not yet recruiting - Clinical trials for Moderate to Severe Crohn's Disease

Phase IIa Study Evaluating AZD7798 in Crohn's Disease

AMALTHEA
Start date: June 17, 2024
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

NCT ID: NCT06450067 Not yet recruiting - Clinical trials for B-cell Acute Lymphoblastic Leukemia

Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia

Start date: June 5, 2024
Phase:
Study type: Observational

This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

NCT ID: NCT06449846 Not yet recruiting - Surgery Clinical Trials

Compare the Accuracy of ctDNA-MRD and MVI Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma

Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this study was to compare the accuracy of ctDNA-MRD longitudinal surveillance model and internationally accepted pathological MVI results in predicting recurrence after radical hepatectomy. At the same time, to explore the relationship among the two methods of predicting recurrence of hepatocellular carcinoma, postoperative adjuvant therapy and postoperative recurrence, this study further confirmed the effectiveness of ctDNA-MRD longitudinal monitoring model in monitoring postoperative recurrence of hepatocellular carcinoma and guiding treatment.

NCT ID: NCT06449534 Not yet recruiting - Shoulder Pain Clinical Trials

The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in RCRSP

Start date: June 3, 2024
Phase: N/A
Study type: Interventional

Brief Summary The aim of this randomized controlled study is to reveal the short-term effects of physical and social factors in different therapeutic environments on patients with rotator cuff related shoulder pain following the same exercise program. The main questions it aims answer are: - Is there any difference in terms of pain levels among groups with rotator cuff related shoulder pain who treated in different therapeutic settings. - Is there any difference in terms of functionality and self-efficacy among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.

NCT ID: NCT06449313 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer Stage III

Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advance Non-Small Cell Lung Cancer

NEO-SURG
Start date: September 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial] is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage III non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.