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NCT ID: NCT06245434 Not yet recruiting - Clinical trials for Acute Brain Injury Coma

Circadian Rhythmicity During Coma Awakening

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

Acute brain injury is a major cause of admission to intensive care units, as well as of mortality and morbidity, worldwide and for all age groups. With most patients surviving these injuries thanks to recent medical advances, society is facing not only the growing burden of disability, but above all the ethical issues involved in withdrawal of life-sustaining therapies (WSLT). To resolve this dilemma, effective treatment would be necessary, but this is hampered by our limited knowledge of the pathophysiological mechanisms of the natural history of coma, from onset to recovery. A more systematic description of coma awakening using a multimodal battery in intensive care unit patients would enable us to refine the awakening and re-emergence of consciousness and define appropriate biomarkers for selecting candidates in interventional studies. The investigators hypothesize that the current postulate of successive stages (i.e. from one clinical class to the next) of coma recovery is incomplete, as it does not take into account the rhythmic nature of wakefulness. The investigators propose that the best correlate of the natural history of coma recovery is a gradual shift from the loss of physiological cycles to a circadian rhythmicity of arousal indices (behavioural and neurophysiological) and a wide amplitude of metric fluctuations in assessing content richness.

NCT ID: NCT06280196 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC

Start date: August 15, 2024
Phase: Phase 3
Study type: Interventional

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.

NCT ID: NCT06360159 Not yet recruiting - Stress Clinical Trials

Massage for Newborns Receiving Nasal CPAP

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

One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications. Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP.

NCT ID: NCT06384495 Not yet recruiting - Stroke Clinical Trials

How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?

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

Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population. Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity. The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point. Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface.

NCT ID: NCT06405230 Not yet recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Patient-derived Organoids and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

Start date: August 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate the utility of two biomarker tools: Patient-derived organoid (PDOs) and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.

NCT ID: NCT06425835 Not yet recruiting - Dislocation Clinical Trials

Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments

VR
Start date: August 15, 2024
Phase:
Study type: Observational [Patient Registry]

Study and evaluate the effectiveness of virtual reality in pain management.

NCT ID: NCT06430580 Not yet recruiting - Clinical trials for Cannabis Use Disorder

Cannabinoids and Biological Reactivity to Stress

COBRAS
Start date: August 15, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to test the impact of two drugs that produce temporary stress-like symptoms, both in isolation and together, on cannabis use motivation in individuals with Cannabis Use Disorder. The main questions it will answer are: 1. How do different forms of stress affect cannabis use motivation? 2. How do different forms of stress affect the body's natural cannabinoids? Researchers will compare a placebo to both drugs in isolation, as well as together, across four separate lab visits. Participants will: 1) Complete a clinical screening interview (by phone or in-person) and visit the lab for a medical screening, and if eligible: a) Visit the lab four times where they will: i). Take one of four drug combinations ii). Complete an interview, questionnaires, and computerized tasks iii). Have their brain activity recorded with an EEG cap iv). Provide three blood samples

NCT ID: NCT06438640 Not yet recruiting - Hip Fractures Clinical Trials

Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)

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

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months.

NCT ID: NCT06439030 Not yet recruiting - Stress Clinical Trials

Mobile and Web-Based Healing Program on University Students Affected by Earthquakes

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

This research is a randomized controlled study that will be conducted in an online environment. The study comprises five stages. The first stage, PREPARATION, involves obtaining ethical approval and permissions from universities, preparing data collection tools, and identifying scholarship recipients. The second stage is the development of the MOBILE AND WEB-BASED application. The third stage is the SITUATION ASSESSMENT stage. In this stage, the post-earthquake trauma level, coping skill level, emotional eating levels, and the status of healthy lifestyle behavior of students enrolled in the Nursing Departments of firat University, Osmaniye Korkut Ata University, and Ankara University will be determined using one of the quantitative data collection tools, PETLDS (Objectives 1, 2, 3, and 4). The fourth stage is the INTERVENTION stage, where the prepared training and applications will be implemented within the program (Objectives 5, 6, 7, and 8). The fifth stage is the EVALUATION stage, involving the collection of final test data and analysis.

NCT ID: NCT06440551 Not yet recruiting - Obesity Clinical Trials

Puerto Rican Obesity Intervention for Men

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

The goal of this clinical trial is to address the high rates of overweight/obesity in Puerto Rican (PR) men. The main question it aims to answer is whether virtual culturally relevant classes supporting physical activity and healthy eating for Puerto Rican men at different levels of acculturation to the US culture, will help these men achieve clinically meaningful weight loss. The purpose of this project is to assess whether a virtual intervention tailored for Puerto Rican men that includes information about healthy eating, physical activity, sedentary behavior is feasible and acceptable compared to a general health (GH) intervention. It is also to determine whether this intervention leads to healthier eating, increased physical activity, less sedentary behavior (low activity), and clinically meaningful weight loss. Hypothesis 1: Test the feasibility (recruitment, retention, adherence, fidelity) and acceptability (treatment components, intervention leaders, telehealth modality, technology and equipment, intervention satisfaction, satisfaction with randomized study, and measures) of a randomized 4-month synchronous telehealth lifestyle intervention led by a community health promoter and behavioral health specialist, who will receive either: TeleSalud HE-PA/SB" or TeleSalud GH in 48 PR men. Hypothesis 2: Demonstrate proof -of-concept by achieving a clinically significant weight reduction of ≥ 5% of baseline weight in the TeleSalud HE-PA/SB intervention after 4 months and at the end of the 4-month maintenance compared to the TeleSalud General Health intervention. Researchers will compare this to a group that will receive information about general health topics - not healthy eating or physical activity. - Participants in both groups will meet via virtually for 4 months (twice per week for 3 months and once per week for 1 month). - Participants will then meet one per month for a maintenance session for the next 4 months.