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## Maternal Adherence to MMS in Nepal - NCT ID: NCT06327646 - Study ID: 66677 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-07-20 - Lead Sponsor: Helen Keller International ### Study Description Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned. ### Conditions - Supplementation - Pregnancy Related - Postnatal Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Multiple Micronutrient Supplement Blister - Multiple Micronutrient Supplement Bottle - Iron Folic Acid Blister ### Outcomes Primary Outcomes - 180 days adherence: MMS (2 types) vs. IFA Secondary Outcomes - 30, 90, and 225 days adherence - 180 adherence: MMS blister vs MMS bottle - MMS acceptability - Antenatal Care Utilization at 180 days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment - NCT ID: NCT06327633 - Study ID: ZZ2024 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-08-01 - Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School ### Study Description This is a pilot, prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of olfactory training on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI). ### Conditions - Type 2 Diabetes Mellitus - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Olfactory Training ### Outcomes Primary Outcomes - Change of olfactory brain activation by fMRI Secondary Outcomes - Change of cognitive function - Olfactory threshold test - Change of metabolism ### Location - Facility: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China @@
## Treatment Of Oral Lichen Planus - NCT ID: NCT06327620 - Study ID: A002021015 - Status: RECRUITING - Start Date: 2022-01-15 - Completion Date: 2024-05-20 - Lead Sponsor: Mansoura University ### Study Description This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug.Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis.The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition. ### Conditions - Lichen Planus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Daivobet ointment, topical steroids ### Outcomes Primary Outcomes - Clinical Improvement of Oral Lichen Planus Lesions Secondary Outcomes - Objective Response Score - Subjective Response Score ### Location - Facility: Mansoura University, Faculty of Dentistry, Mansoura, Dakahlia, 35516, Egypt @@
## Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients - NCT ID: NCT06327607 - Study ID: IEO 1952 - Status: RECRUITING - Start Date: 2023-06-09 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months.The study is randomized in the two following arms:Control arm (standard care pathway) Psychosexual intervention arm ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Control Group - Psychosexological intervention ### Outcomes Primary Outcomes - Evaluation of differences between two arms in female sexual satisfaction and functionality scores Secondary Outcomes - Evaluation of differences between two arms in levels of quality of life - Evaluation of differences between two arms in levels of anxiety and depression - Evaluation of differences between two arms in levels of sleep quality ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Assessment System of Sarcopenia in Lung Cancer Patients - NCT ID: NCT06327594 - Study ID: XTang-0002 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2028-11 - Lead Sponsor: West China Hospital ### Study Description 1. To explore the diagnostic value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI for sarcopenia in patients with lung cancer.2. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the prognosis and the effect of nutritional support in patients with lung cancer during perioperative period.3. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the long-term prognosis of patients with lung cancer. ### Conditions - Sarcopenia - Lung Cancer - Ultrasound ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ultrasound scan - CT/MRI scan ### Outcomes Primary Outcomes - Death - Perioperative complications Secondary Outcomes ### Location - Facility: Xinyi Tang, Chengdu, Sichuan, N/A, China @@
## Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata - NCT ID: NCT06327581 - Study ID: 101005 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2024-12-22 - Lead Sponsor: Zagazig University ### Study Description Alopecia areata (AA) is an immunologically mediated disease characterized by non-scarring hair loss (Madni and Shapiro, 2000). AA is presented by rapid and complete hair loss in one or more round or oval patches, usually on the scalp, beard area, eyebrows, eyelashes, and less commonly, on other hairy areas of the body (Berker et al., 2010 and James et al., 2011) Alopecia areata is a T-cell-mediated autoimmune disease. There is a complicated interplay between loss of immune privilege in the hair follicle, autoimmune-mediated hair follicle damage, and activation of inflammatory pathways that have been argued to explain the development of this disorder, but the exact pathophysiology of AA remains unknown. Hair follicles are infiltrated by autoreactive CD8 and CD4 T lymphocytes, which attack hair follicle-derived autoantigens while sparing the stem compartment (Rajabi et al., 2018).Alopecia areata can be treated with topical and/or intralesional corticosteroids, which are the treatment of choice. Anthralin, minoxidil, coal tar, and topical immunotherapy are examples of other topical treatments. Systemic immunosuppressants such as cyclosporine, systemic steroids, Janus kinase inhibitors, and methotrexate may be considered in severe resistant cases (lee and lee, 2017).Intralesional triamcinolone acetonide is preferred in cases of AA , as it is well known as anti-inflammatory and interferes with local immunity of the skin, which helps in the recovery of the disease, but if used in wrong technique or given in a high dose, it might cause all the side effects of corticosteroid, especially skin atrophy (Berker et al., 2010).Lactic acid is a member of alpha-hydroxy acids. It has been used in the treatment of many skin diseases, like AA and vitiligo. Lactic acid stimulates spontaneous secretion of vascular endothelial growth factor (VEGF) by human reconstructed epidermis. VEGF is an angiogenic cytokine involved in angiogenesis and wound healing and stimulates the growth of hair follicles resulting in recovery of AA. Other studies suggest that lactic acid may act through its irritant effect (Al-Tammimy, 2005).Vitamin D interacts with the innate and adaptive immune systems in a variety of ways, the majority of which contribute to its downregulation (Nancy and Yehuda, 2009). It has a powerful effect on T and B lymphocytes, influencing their activation responses (Arnson et al., 2007).All cells of the immune system express 1,25-dihydroxyvitamin D3 receptors (VDRs) and are therefore vulnerable to calcitriol-mediated modulation. Vitamin D3 has the ability to influence the migration and maturation of different dendritic cell subtypes and their production of chemokines and cytokines, giving them an immunoregulatory and tolerogenic role (Illescas-Montes et al., 2019) It has been shown that VDRs are highly expressed in the keratinocytes of human hair follicles and the absence of their expression is associated with reduced hair follicle growth and epidermal differentiation. Reduced VDR expression in the hair follicles of affected areas has also been observed in studies of AA patients' scalp (Çerman et al., 2015).Microneedling (MN) is a technique that comprises puncturing the skin repeatedly with sterile microneedles (Iriarte et al., 2017). It promotes hair regeneration by triggering stem cells in the hair bulge, which results in the generation of growth factors. It also improves blood circulation to the hair follicles and influences the local immune cells (Chandrashekar et al., 2014). Moreover, combining MN with applied topical drugs facilitates their absorption through the microchannels created within the epidermis (Fertig et al., 2018). ### Conditions - Alopecia Areata ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lactic Acid - vit D - Triamcinolone Acetonide - Saline ### Outcomes Primary Outcomes - hair regrowth improvement assessed by 5-point semiquantitative regrowth score (RGS) Secondary Outcomes ### Location - Facility: Rana Ehab, Zagazig, N/A, 44519, Egypt @@
## Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens - NCT ID: NCT06327568 - Study ID: IEO 1663 - Status: RECRUITING - Start Date: 2022-06-17 - Completion Date: 2029-06-17 - Lead Sponsor: European Institute of Oncology ### Study Description Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors. Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors (AIN) (H-SIL) to invasive anal tumors.The diagnosis of AIN is made by cytology or biopsy during routine examinations. To date, no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose.The performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach. ### Conditions - Anal Intraepithelial Neoplasia 2 - Anal Intraepithelial Neoplasia 1 - Anal Cancer - High-Risk Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients. Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction - NCT ID: NCT06327555 - Study ID: M2023123 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-06-30 - Lead Sponsor: Peking University Third Hospital ### Study Description Trial purpose: To evaluate the safety and effectiveness of using a new remote rehabilitation platform for postoperative rehabilitation in patients with anterior cruciate ligament rupture compared to conventional rehabilitation care through a randomized controlled trial.Test subjects: This study is a multicenter study that recruited 252 participants from three centers (aged ≥ 18 years) for cruciate ligament rupture reconstruction; Exclude patients who have undergone revision and bilateral surgery, and exclude patients with collateral ligament and posterior cruciate ligament injuries in the knee joint.Trial plan: The subjects were randomly enrolled and randomly divided into two groups: the remote rehabilitation group and the traditional rehabilitation group, using a mixed block randomization method. The probability of being divided into both groups was 50%. All subjects received routine outpatient diagnosis and treatment, with the same content. The remote rehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance. The traditional rehabilitation group receives routine rehabilitation diagnosis and treatment, with face-to-face rehabilitation twice a week. All subjects are required to undergo regular follow-up (1 day before surgery, 3 months after surgery, 6 months).Outcome measures: The main outcome measures were knee isokinetic muscle strength and Lysholm knee joint score . the secondary outcome measures were Y-balance test, Tegner activity scale, health survey summary table (SF-36),The other outcome measures were Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale, vas pain score. ### Conditions - Anterior Cruciate Ligament Reconstruction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - the traditional rehabilitation group - the remote rehabilitation group ### Outcomes Primary Outcomes - the Lysholm Knee Scoring Scale - knee Isokinetic strength Secondary Outcomes - Y-balance balance test - Tegner score - the 36-item Short Form Health Survey(SF-36) ### Location - Facility: quan Jian Wang, Beijing, Beijing, 100191, China @@
## Group-based Integrative Pain Management in Primary Care Safety Net Clinics - NCT ID: NCT06327542 - Study ID: 22-37078B - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-30 - Lead Sponsor: University of California, San Francisco ### Study Description Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Group Acupuncture - Integrative Group Medical Visits ### Outcomes Primary Outcomes - Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function. - Change in Social support and Pain Questionnaire (SPQ) Secondary Outcomes - Change in average pain intensity on the 0-10 numeric rating scale - Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference. - Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b - Change in Internalized Stigma of Chronic Pain (ISCP) survey - Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a - Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ) - Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form - Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9) - Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2) - Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC) - Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale - Change in experiences of discrimination in healthcare ### Location - Facility: Tom Waddell Urban Health Clinic, San Francisco, California, 94102, United States @@
## Zinc and Iron Absorption From Common Beans in Young Adult Women - NCT ID: NCT06327529 - Study ID: 2101814 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of California, Davis ### Study Description Fifteen female study participants will be enrolled in a randomized crossover study to measure fractional and total zinc and iron absorption from four common bean (Phaseolus vulgaris) varieties with varying phytate and polyphenolic contents. Phytate, the storage form of phosphorus in plants, and polyphenols, which contribute to the varied colors of common beans, are natural components of the beans and can reduce zinc and iron bioavailability from these foods. ### Conditions - Zinc Absorption - Iron Absorption ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - SER 118 - LMP 1001 - LPA 586 - KAT B1 ### Outcomes Primary Outcomes - Fractional Zinc absorption - Fractional Iron absorption Secondary Outcomes - Total Zinc absorption - Total Iron absorption ### Location - Facility: Department of Nutrition, Davis, California, 95616, United States @@
## Lysophosphatidylglycerol in Asthma Pathogenesis - NCT ID: NCT06327516 - Study ID: M2020023 - Status: RECRUITING - Start Date: 2015-01-01 - Completion Date: 2025-06-30 - Lead Sponsor: Peking University Third Hospital ### Study Description The study aims to investigate the relationship between the small molecule metabolite lysophosphatidylglycerol and asthma clinical features and explore its involvement in asthma pathogenesis. ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - lipidomics Secondary Outcomes ### Location - Facility: Peking university third hospital, Beijing, None Selected, 100191, China @@
## Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM - NCT ID: NCT06327503 - Study ID: 36/7-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-30 - Lead Sponsor: University of Belgrade ### Study Description Various signal molecules are detected in blood and tissues of patients with T2DM, that are important for the function of neural tissue in diabetic setting. Among them, specifically important are neuroprotective and neurotrophic growth factors such as nerve growth factor (NGF), glial cells - derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF). Furthermore, several other signal molecules are discovered to affect vascular tissues homeostasis in T2DM, including soluble alpha-klotho (s-Klotho), vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6). Most of these molecules are also detected in saliva in various states and diseases of orofacial system, but data about their levels in saliva of T2DM patients are lacking, although neural and vascular diabetic complications are present in orofacial tissues and organs. Also, there is no data about presence and levels of s-Klotho in saliva of healthy or T2DM patients, although it was reported that this molecule exerts protective effect on the salivary glands tissue. Salivary opiorphin is recently discovered pentapeptide, primarily isolated from saliva. It acts as an inhibitor of the enzymes that perform degradation of endogenous antinociceptive molecules enkephalins, affecting nociceptive signal transduction. This may be of special importance since some intraoral complications of T2DM (e.g. burning mouth) may have underlying peripheral neural changes as a pathophysiological mechanism. Against this background, the aim of the study is to detect the presence and levels of mentioned signal molecules in saliva of patients with and without T2DM. ### Conditions - Type 2 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - saliva samples collecting ### Outcomes Primary Outcomes - NGF levels in saliva - GDNF levels in saliva - BDNF levels in saliva - s-Klotho levels in saliva - VEGF levels in saliva - IL-6 levels in saliva - opiorphin levels in saliva Secondary Outcomes - unstimulated saliva flow ### Location - Facility: University of Belgrade School of Dental Medicine, Belgrade, N/A, 11000, Serbia @@
## A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer - NCT ID: NCT06327490 - Study ID: UF-BRE-012 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-06 - Lead Sponsor: University of Florida ### Study Description Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ICG-guided manual lymphatic drainage - Traditional manual lymphatic drainage ### Outcomes Primary Outcomes - Subject compliance Secondary Outcomes - Relative volume change - Bioimpedance - Breast cancer related lymphedema symptoms - Incidence of progression to late stage breast cancer related lymphedema - Health-related quality of life ### Location - Facility: University of Florida, Gainesville, Florida, 32610, United States @@
## Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma - NCT ID: NCT06327477 - Study ID: NU 23S01 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2028-07-01 - Lead Sponsor: Northwestern University ### Study Description This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard spatially fractionated radiotherapy (SFRT) refers to how the radiation is delivered to the tumor. SFRT means that different parts of the tumor are receiving different doses of radiation (fractionation) through beams that allow areas of higher and lower (peaks and valleys) of doses of the radiation. This spatial fractionation allows an overall high-dose radiation to be given in the peaks and those areas of the tumor may release cells and substances that may help with killing tumor cells, reducing tumor symptoms and shrinking tumors. Proton therapy is a type of radiation therapy that can overcome some of the barriers of standard SFRT. Protons are tiny radioactive particles that can be controlled in a beam to travel up to the tumor and, compared to the particles used in standard radiotherapy, proton therapy can deliver higher doses to the tumor because smaller doses of radiation are delivered to tissues away from the tumor. This allows radiation therapy dose-escalated (continuously increasing the dose of radiation) treatment to tumors even though the tumor is near radiation sensitive organs like the colon. Giving P-SFRT with standard radiation therapy may work better in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. ### Conditions - Retroperitoneal Sarcoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Computed Tomography - Intensity-Modulated Radiation Therapy - Resection - Spatially-fractionated Radiation Therapy ### Outcomes Primary Outcomes - Recommended phase II dose (Phase I) - Pathological complete response (Phase II) Secondary Outcomes - Incidence of adverse events (Phase I) - Overall response rate (ORR) (Phase II) - Progression-free survival (PFS) (Phase II) - Overall survival (OS) ( (Phase II) ### Location - Facility: Northwestern University, Chicago, Illinois, 60611, United States @@
## Exogenous Ketones and Appetite - NCT ID: NCT06327464 - Study ID: 23-03228 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-01 - Lead Sponsor: University of British Columbia ### Study Description People with obesity have different appetitive responses to stimuli compared to people without obesity. For example, people with obesity have a blunted postprandial ghrelin ('hunger' hormone) response, lower glucagon-like peptide 1 (GLP-1) and peptide-YY (PYY; associated with satiety) compared to people without obesity. Given the favorable effects of exogenous ketones on appetite previously observed in healthy adults of normal body weight, it is possible that these supplements can alter appetite hormones in a manner that may closer match that observed in people without obesity. To explore this research question, investigators will conduct a randomized single-blind cross over study to characterize appetite and dietary intake after ingestion of an exogenous ketone supplement within adults with obesity (compared a control condition without exogenous ketones) and compared to adults without obesity. The research team will also explore differences in postprandial energy expenditure and fuel utilization. Twenty-two healthy young- and middle-aged adults will be included (up to n=26 enrolled). In addition to a baseline visit to measure body composition, participants will undergo two 4.5-hour study visits, one of which will include a ketone diol supplement and one will have a placebo. Participants will be given a 1-day run-in diet prior to each study day to support energy balance. On each study day visit, participants will undergo a resting metabolic rate test (indirect calorimetry) followed by a fasting appetite rating and blood sample collection. Participants will then be provided with a standard breakfast meal (one with the ketone supplement and one with placebo). Appetite ratings and blood sample collection will be repeated 60, 120, and 180 minutes after the meal. Indirect calorimetry will be completed after the 30, 90, and 150 minute assessments. After the 180-minute timepoint, participants will be provided with a buffet-like lunch meal with instructions to eat as much or as little as they would like to determine ad libitum dietary intake at a single meal. To assess free-living ad libitum dietary intake, participants will receive 1.5 days of food boxes tailored to their preferences, with uneaten food returned at the end of the 1.5-day period. This study will be the first to assess the impact of exogenous ketones on appetite in obesity and would help inform future weight loss intervention trials. ### Conditions - Appetite - Obesity - Ketones - Appetitive Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Exogenous ketones ### Outcomes Primary Outcomes - Acylated ghrelin area under the curve (AUC) Secondary Outcomes - Peptide-YY(3-36) area under the curve (AUC) - Glucagon-like peptide 1 area under the curve (AUC) - Insulin area under the curve (AUC) - Glucose area under the curve (AUC) - Leptin area under the curve (AUC) - Hunger rating from visual analog scale - Satiety rating from visual analog scale - Prospective food consumption rating from visual analog scale - Desire to eat rating from visual analog scale - Dietary energy intake at a single meal - Free-living dietary energy intake - Postprandial energy expenditure ### Location - Facility: University of British Columbia - Okanagan, Kelowna, British Columbia, V1V1V7, Canada @@
## Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma - NCT ID: NCT06327451 - Study ID: IRB2024-YX-037-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-02-28 - Lead Sponsor: Tianjin Medical University General Hospital ### Study Description Glioblastoma (GBM) is the primary intracranial malignant tumor with the highest morbidity and mortality, and the 5-year survival rate is less than 10%. The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year, which seriously threatens people's life and health. At present, the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory, and the median survival time of GBM patients is only 14.4 months. Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia. In recent years, statins have shown good anti-tumor effect. Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway. Therefore, the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin (ATO) combined with temozolomide (TMZ) in primary and recurrent glioblastomas with high EGFR expression.The investigators designed a multicenter, single-arm, double-blind, phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM. After informed consent was signed by the patient or authorized family members, the patients were treated with the current STUPP regimen and ATO (20mg, qn) orally. The patients were regularly followed up for 52 weeks after treatment. The primary endpoint was progression-free survival (PFS), which was defined as the time from the start of GBM surgery to tumor progression (recurrence) or death. The secondary end point was the rate of tumor control, which was defined as the proportion of patients with a complete response, a partial response, or a stable disease that had shrunk or remained stable for a given period of time. Safety will be assessed during the study by monitoring of regular MRI scans, laboratory tests (liver function, lipid profile, blood routine), electrocardiography, vital signs (blood pressure, pulse, temperature), and weight.The results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety. ### Conditions - Glioblastoma, IDH-wildtype ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Atorvastatin 20mg ### Outcomes Primary Outcomes - progression-free survival - Overall survival - Tumor control rate Secondary Outcomes - Hepatic burden of GBM patients after receiving atorvastatin administration - Percentage of participants with treatment-related adverse events ### Location - Facility: Tianjin Medical University General Hospital, Tianjin, N/A, 300052, China @@
## Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial - NCT ID: NCT06327438 - Study ID: REC/211/MTI.PT/2401041 - Status: RECRUITING - Start Date: 2024-03-16 - Completion Date: 2024-07-16 - Lead Sponsor: South Valley University ### Study Description To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema ### Conditions - Breast Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Complex decongestive therapy - Cryotherapy - Kinesio taping ### Outcomes Primary Outcomes - Arm girth measurement is measured by Circumferential measurements - Pain severity is measured by VAS Secondary Outcomes - The QOL is measured by SF-36 - Range of motion (ROM) is measured by UG ### Location - Facility: Ragaee Saeed Mahmoud, Giza, Faisal, N/A, Egypt @@
## MCG for Localization of Tachyarrhythmia's Origin - NCT ID: NCT06327425 - Study ID: MCG-Tachyarrhythmia - Status: NOT_YET_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2025-02 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation. ### Conditions - Tachyarrhythmia - Atrial Flutter - Paroxysmal Supraventricular Tachycardia - Atrial Tachycardia - Atrial Fibrillation - Premature Ventricular Contraction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Magnetocardiography ### Outcomes Primary Outcomes - Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of Aerobic Exercise in Patients With Primary Lower Extremity Lymphedema - NCT ID: NCT06327412 - Study ID: KayseriCHLYMP01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Kayseri City Hospital ### Study Description Our aim in this study is to evaluate the effects of lymphedema on exercise capacity, body composition, functional level and quality of life in lymphedema patients with primary lower extremity involvement. ### Conditions - Primary Lymphedema - Aerobic Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic exercise on the treadmill - Walking between 12-13 RPE (The Borg Rating of Perceived Exertion) according to the Modified Borg Scale ### Outcomes Primary Outcomes - 30-second sit-stand test (30-s chair-stand test, 30s-CST) Secondary Outcomes - Cardiopulmonary exercise test (CPET) - 6-minute walk test (6MWT) - Circumference and volume measurement - Bioimpedance measurement - Lower Extremity Functional Scale (LEFS) - Lymphedema Life Impact Scale (LLIC) - Hospital Anxiety and Depression Scale (HADS) - Numerical Rating Scale (NRS) ### Location - Facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital, Kayseri, N/A, 38080, Turkey @@
## Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation. - NCT ID: NCT06327399 - Study ID: MS-373-2023 - Status: RECRUITING - Start Date: 2024-01-21 - Completion Date: 2024-05 - Lead Sponsor: Kasr El Aini Hospital ### Study Description Dexmedetomidine bolus dose may provide similar or less hemodynamic changes (less bradycardia and less hypertension) than infusion dose during induction of anaesthesia and tracheal intubation. ### Conditions - Dexmedetomidine - Intubation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dexmedetomidine infusion - Dexmedetomidine bolus - Atropine Sulfate - Ephedrine - Propofol ### Outcomes Primary Outcomes - Mean blood pressure upon laryngoscopy Secondary Outcomes - Blood pressure & Heart rate - Propfol - Bradycardia ### Location - Facility: Cairo University Hospitals, Giza, N/A, 11562, Egypt @@
## The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PET/MR in Neoadjuvant Therapy for Gastric Cancer - NCT ID: NCT06327386 - Study ID: 202434 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University ### Study Description Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Although surgical treatment can benefit the survival of the vast majority of patients, currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone. Neoadjuvant therapy reduces tumor volume and improves tumor response rate through preoperative radiotherapy and chemotherapy, thereby increasing R0 resection rate and improving overall survival, without increasing postoperative complications and mortality. Timely imaging re staging during neoadjuvant therapy can allow patients to enter the surgical stage earlier, thereby reducing their preoperative burden. According to the different stages of neoadjuvant therapy, clinical staging can be divided into baseline stage (cBSstage) and clinical rest stage (cReStage) after neoadjuvant therapy.At present, the conventional imaging methods for diagnosing cBStage in gastric cancer include CT, endoscopic ultrasonography (EUS), and MRI. The NCCN guidelines recommend CT for cBStage, with a diagnostic accuracy of 77.1% to 88.9%. Similarly, EUS and MRI were also used for cBStage, with accuracy rates of 65.0% to 92.1% and 71.4% to 82.6%, respectively. The application of diffusion-weighted imaging (DWI) has improved the accuracy of MRI diagnosis of cBStage to 93%.However, due to the destruction of the gastric wall structure by neoadjuvant therapy, accurate imaging re staging is difficult. Currently, accurate tumor regression grading can only be obtained through surgical resection of pathological specimens. For cReT after neoadjuvant therapy, the diagnostic accuracy of EUS is only 63% (T2: 44%, T3: 68%, T4: 90%). Due to the presence of chronic inflammatory reactions, such as tumor cell apoptosis, necrosis, fibrosis, etc., in both the tumor and the critical normal gastric wall after neoadjuvant therapy, imaging cannot accurately identify the level of gastric wall, leading to the current low value of CT for cReT. Meanwhile, due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation, and not all lymph node volumes that experience these pathological reactions will rapidly decrease, the accuracy of CT diagnosis of cReN is only 44%, while the sensitivity and specificity of EUS diagnosis of cReN are 50% and 56%, respectively.In addition, positron emission tomography (PET) can reflect the abnormal metabolism, protein synthesis, DNA repair, and cell proliferation of tumors at the molecular level, providing important information in tumor grading diagnosis, prognosis evaluation, treatment decision-making, and efficacy monitoring. The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues, while most types of malignant tumors exhibit high metabolism. Therefore, 18F-FDG can be used for the diagnosis, staging, and treatment monitoring of cancer. However, in gastric cancer patients, 18F-FDG has certain limitations, including 1) interference with physiological or inflammatory uptake of the gastric wall; 2) Low uptake of 18F-FDG is present in signet ring cell carcinoma, mucinous adenocarcinoma, or other poorly differentiated cancers with high mucus content; 3) There are cases of false positive FDG after immunotherapy. In the study of SUV changes in the tumor area before and after treatment, it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70%.Tumor associated fibroblasts are closely related to tumor growth, invasion, and distant metastasis, and their activation requires the involvement of fibroblast activation protein (FAP). Therefore, radiolabeled fibroblast activation protein inhibitor (FAPI) can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP. Currently, a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer. Furthermore, prospective studies have shown a certain relationship between tumor regression grade (TRG) and 18F-FAPI rate of change parameters (SUVmax, SUVavg, SUVR).Therefore, in the early stage of this study, 18F-FAPI combined with 18F-FDG PET/MRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer, preoperative assessment of tumor regression grade after treatment, and re staging to guide the development of further clinical treatment plans. ### Conditions - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 18F-FAPI#18F-FDG ### Outcomes Primary Outcomes - Evaluation efficacy of tumor regression level Secondary Outcomes - expression of FAP - expression of GLUT1 - SUV ### Location - Facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, Chongqing, Chongqing, 400010, China @@
## A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia - NCT ID: NCT06327373 - Study ID: Pro00114903 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-06-30 - Lead Sponsor: Duke University ### Study Description The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia. ### Conditions - Pulmonary Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Oxygen - Room air ### Outcomes Primary Outcomes - Change daily hypoxemia burden Secondary Outcomes - Change in six minute walk distance - Change in Montreal Cognitive Assessment (MoCA) ### Location - Facility: Davita Durham East, Durham, North Carolina, 27701, United States @@
## Illness Expectations in Pulmonary Fibrosis - NCT ID: NCT06327360 - Study ID: FDG_ 88-16 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-10-10 - Completion Date: 2025-10-01 - Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus ### Study Description This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments. ### Conditions - Pulmonary Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Psychological questionnaires ### Outcomes Primary Outcomes - Adherence to Pharmacological Treatment - Adherence to Oxygen Therapy - Adherence to Non invasive ventilation - Illness beliefs - Pharmacological treatment Beliefs - Illness Expectations - Illness Cognitions Secondary Outcomes - Socio-demographic variables - Clinical and medical data ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milano, N/A, 20122, Italy @@
## Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg - NCT ID: NCT06327347 - Study ID: 2020-05_C2H - Status: RECRUITING - Start Date: 2022-07-17 - Completion Date: 2026-07-31 - Lead Sponsor: Cristalens Industrie ### Study Description The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator.This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint.The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - intraocular lens implantation in cataract surgery ### Outcomes Primary Outcomes - Binocular Distance Corrected Intermediate Visual Acuity Secondary Outcomes ### Location - Facility: Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC), Heidelberg, N/A, N/A, Germany @@
## Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial - NCT ID: NCT06327334 - Study ID: 2023/03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-05-15 - Lead Sponsor: CMC Ambroise Paré ### Study Description Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state. Current recommendations suggest using a multimodal approach to predict poor prognosis, meaning combining markers together. Yet, a substantial proportion of patients do not have a clear prognostic evaluation even when applying the latest ESICM recommendations algorithm published in 2021. It is therefore important to identify new prognostic markers to predict both unfavorable and favorable outcomes. Data regarding the pathophysiological mechanisms of post-anoxic encephalopathy suggest a diffuse anoxo-ischemic injury. However, post-mortem neuropathology data suggest that these lesions do not uniformly affect neuroanatomical structures, with some regions (especially hippocampal and insular) appearing more sensitive to anoxia. Conversely, the brainstem appears less affected by anoxic lesions. Under physiological conditions, there are interactions between the heart and the brain, and between the brain and the heart mainly related to the autonomic nervous system, through interactions between central cortical control structures (especially insular) and brainstem structures (at the level of the bulb) and peripheral structures of the heart. Exploring the pathophysiological mechanisms of heart-brain interactions post-CA could thus help better understand the pathophysiology of anoxo-ischemic encephalopathy, before considering potential therapeutic targets. Furthermore, this heart-brain dysfunction could have prognostic value. Indeed, recent studies in healthy subjects and patients with consciousness disorders suggest that autonomic nervous system activity measured by brain-heart interactions could be a reliable marker of consciousness and cognitive processing. These coupled heart-brain interactions can be evaluated through synchronous electroencephalogram (EEG) and electrocardiogram (ECG) recordings, as there are coupled interactions between the signals of these two organs. The existence of abnormal brain-heart coupling could be associated, on the one hand, with the severity of post-anoxic encephalopathy, and on the other hand, with neurological prognosis in patients with persistent coma post-CA.This ancillary study of a multicentre prospective cohort "HEAVENwARd study" (NCT06044922) will assess the prevalence and prognostic value of bilateral brain-heart interactions in comatose patients after CA. ### Conditions - Cardiac Arrest ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Bilateral brain-heart interactions Secondary Outcomes - Poor neurological outcome evaluated using the CPC score - Mortality - Post-anoxic encephalopathy severity evaluated by composite prognostic markers combining EEG patterns, somatosensory evoked potentials (SEP) and neuron specific enolase (NSE). ### Location - Facility: Brest University Hospital, Brest, Bretagne, 29609, France @@
## Vitiligo Treatment by Targeting TYK2 Mediated Responses - NCT ID: NCT06327321 - Study ID: 23-PP-08 - Status: RECRUITING - Start Date: 2024-05-05 - Completion Date: 2026-11-05 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. Achieving the best treatment outcomes for vitiligo involves addressing the autoimmune inflammatory response to stop the depigmentation process and promoting the differentiation of melanocyte stem cells to induce repigmentation. The loss of melanocytes in vitiligo is a result of an autoimmune process. While the IFN gamma pathway plays a crucial role in the adaptive immune response in vitiligo, there is increasing evidence highlighting the importance of the innate immune response. Deucravacitinib, an allosteric TYK2 inhibitor, has shown effectiveness and safety in treating psoriasis. It inhibits the responses of IFN alpha (IFNα), IFN beta (IFNβ), and IL12, and may also have an impact on the Th1 response. The hypothesis is that by targeting the IFN type I response and IL12, deucravacitinib could effectively halt the depigmentation process and facilitate repigmentation of vitiligo lesions. When combined with NB-UVB, the process of repigmentation should be significantly enhanced. The primary objective is to compare the proportion of patients treated with deucravacitinib versus placebo achieving VITIL-IA 50 at week 24.Interventions Following central randomization, patients will be assigned to receive either deucravacitinib 12mg daily (QD) or a placebo daily (QD) for a duration of 24 weeks. At the end of this period, patients will be re-randomized to receive either deucravacitinib 12mg QD alone or deucravacitinib 12mg QD + twice weekly narrowband UVB treatment twice weekly for an additional 24 weeks.Throughout the study, there will be a total of six visits conducted: selection, inclusion, Week 12, Week 24, Week 36, and Week 48. In patients who volunteer, a skin biopsy will be performed on both the lesional and peri-lesional areas at baseline, Week 12 and Week 36. Serum and plasma samples will be collected at the screening visit, Week 12, Week 24, Week 36, and Week 48. ### Conditions - Vitiligo, Generalized ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Deucravacitinib - Volunteer without treatment ### Outcomes Primary Outcomes - rate of depigmentation Secondary Outcomes - number of patient with the T-VASI 50 ### Location - Facility: CHU de Nice - Hôpital de l'Archet, Nice, Alpes-Maritimes, 06200, France @@
## Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. - NCT ID: NCT06327308 - Study ID: 2023/803 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2027-12-31 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description The aim of this multicenter prospective observational pilot study is to describe the evolution of myocardial fibrosis in cirrhotic patients before and after liver transplantation (LT). Through multimodal analysis of myocardial function and architecture, and analysis of specific markers of inflammation, we aim to explore the following hypotheses: 1) systemic inflammation promotes myocardial fibrosis in cirrhotic patients and could be an early marker of cirrhotic cardiomyopathy; 2) LT allows resolution of myocardial fibrosis by preventing the bacterial translocation that favors the development of deleterious systemic inflammation. ### Conditions - Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI - Blood sampling ### Outcomes Primary Outcomes - Primary outcome measure Secondary Outcomes - Prevalence of cirrhotic cardiomyopathy according to 2019 criteria [Izzy M, et al. Hepatology 2020;71:334-45], echocardiographic signs of left ventricular systolic and diastolic dysfunction : - Analysis of the association between myocardial extracellular volume (MECV) (explained variable) and plasma 3-HM concentration (explanatory variable). - Analysis of the association between myocardial extracellular volume (MECV) and the concentration of markers of inflammation (CRP, procalcitonin, copeptin, IL-6) and proteins modulating the degree of inflammation (LBP, PLTP, CETP). - Analysis of the association between the difference in MECV in transplant recipients between visit 2 and visit 3 according to the degree of immunosuppression, measured by mean residual tacrolemia in the 12 months post-LT. - Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) according to cirrhotic cardiomyopathy status occurring between inclusion and LT. - Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) occurring between inclusion and LT, according to cirrhotic cardiomyopathy status. ### Location - Facility: CHU Besancon - Hopital Minjoz, Besançon, N/A, 25000, France @@
## A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis - NCT ID: NCT06327295 - Study ID: ATB1651-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-01-30 - Lead Sponsor: AmtixBio Co., Ltd. ### Study Description The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis ### Conditions - Onychomycosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ATB1651-102- Cohort 1 - ATB1651-102- Cohort 2 - ATB1651-102- Cohort 3 - ATB1651-102- Cohort 4 - Placebo ### Outcomes Primary Outcomes - To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis. Secondary Outcomes - To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis. - To assess and collect the percentage and severity of adverse events (AEs). - Maximum plasma concentration (Cmax) - Time to maximum plasma concentration (Tmax) - Apparent terminal elimination rate constant (λz) - Area under curve (AUC) - Apparent terminal half-life (t 1/2) - Apparent clearance (CL) - Apparent terminal volume of distribution (VD) - Plasma ATB1651 trough concentrations (Ctrough) ### Location - Facility: New Zealand Clinical Research Christchurch, Christchurch, N/A, 8011, New Zealand @@
## the Effect of Preoperative Pain Education by Anesthesia Nurses on Postoperative Pain Among Adult Patients Undergoing Abdominal Surgery - NCT ID: NCT06327282 - Study ID: ChinaPLAGHPAIN - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-04-04 - Lead Sponsor: Chinese PLA General Hospital ### Study Description To explore the effects of preoperative pain education on postoperative pain among patients undergoing abdominal surgery. ### Conditions - Postoperative Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - education on pain and related knowledge ### Outcomes Primary Outcomes - Occurrence of pain Secondary Outcomes - Mastery of the use of patient-controlled analgesia pump ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma - NCT ID: NCT06327269 - Study ID: MOHW111-TDU-B-221-114009 - Status: RECRUITING - Start Date: 2021-04-01 - Completion Date: 2026-12 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT. ### Conditions - High Risk of Recurrence ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Lenvatinib 10 mg ### Outcomes Primary Outcomes - Recurrence-free survival with adjuvant therapy Secondary Outcomes ### Location - Facility: Department of Surgery, Kaohsiung, N/A, 833, Taiwan @@
## A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam - NCT ID: NCT06327256 - Study ID: 1509-0002 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-09-27 - Lead Sponsor: Boehringer Ingelheim ### Study Description The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BI 3000202 - Placebo - Midazolam ### Outcomes Primary Outcomes - Percentage of subjects with drug-related adverse events Secondary Outcomes - Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12) - Maximum measured concentration BI 3000202 in plasma (Cmax) - Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state - Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state - Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state - Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose - Maximum measured concentration of midazolam in plasma (Cmax) after a single dose ### Location - Facility: SGS Life Science Services - Clinical Research, Edegem, N/A, 2650, Belgium @@
## The Effects of Kinesio Taping on Pain, Range of Motion, and Functional Performance in People With Knee Osteoarthritis - NCT ID: NCT06327243 - Study ID: TUMRHS - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-04-30 - Lead Sponsor: Taibah University ### Study Description The goal of this clinical trial is to evaluate the effectiveness of Kinesio Taping in individuals with knee osteoarthritis (KOA). KOA is a common condition that can lead to pain, stiffness, and decreased mobility. The main questions it aims to answer are:* Does Kinesio Taping reduce pain in individuals with KOA?* Can Kinesio Taping improve the range of motion and functional performance in those suffering from KOA?Participants will be asked to:Attend assessment sessions at the outpatient Physical Therapy clinic at Taibah University.Undergo Kinesio Taping three times over 12 days. Complete specific physical tests and questionnaires before and after the intervention period to measure their pain and mobility.Researchers will compare the group that receives Kinesio Taping with the group that receives sham (placebo) taping to see if there are significant differences in pain reduction and improvements in movement and daily function. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Elastic tape ( kinesio tape) - Sham Taping ### Outcomes Primary Outcomes - Pain (Visual analog scale) - Knee range of motion - Timed up and go test - The 50-foot Walk - Knee Osteoarthritis Outcome Score (KOOS) Secondary Outcomes ### Location - Facility: Taibah University, Medina, N/A, 42353, Saudi Arabia @@
## The Application of Thoracic Epidural Analgesia in Patients With Acute Pancreatitis - NCT ID: NCT06327230 - Study ID: SRRSH2023-0627 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-04-30 - Lead Sponsor: Sir Run Run Shaw Hospital ### Study Description Acute pancreatitis (AP) is one of the most common diseases of the digestive system, with its incidence increasing year by year. 15%-25% of patients will develop severe acute pancreatitis (SAP), characterized by necrosis and infection of the pancreas and surrounding tissues, as the investigators as multiple organ dysfunction syndrome (MODS), with a mortality rate as high as 17%. Currently, there is a lack of effective measures in clinical practice to regulate the early inflammation and immune response in acute pancreatitis. Animal experimental studies have confirmed that TEA, by blocking the abdominal sympathetic nerves, increases arterial blood flow and venous capacity, improves pancreatic perfusion insufficiency caused by AP, and alleviates metabolic acidosis. Simultaneously, TEA can suppress the secretion of catecholamines during the stress state of acute pancreatitis, reducing the release of inflammatory mediators and thereby inhibiting the inflammatory response. Our team's earlier animal experiments have further confirmed that TEA improves intestinal inflammation in mice with pancreatitis. This improvement is marked by a significant reduction in the concentrations of inflammatory cytokines such as IL-1β and TNF-α. Additionally, there is an observed alteration in the intestinal microbiota, characterized by an increase in the proportion of beneficial bacteria. Based on these findings, it is speculated that TEA, by reducing catecholamine release and downregulating sympathetic activity, effectively mitigates inflammation and stress responses in patients with pancreatitis. Furthermore, TEA dilates small arteries in blocked segments, thereby improving blood flow and microcirculation within the affected area. Indirectly, TEA increases vagal nerve activity, which in turn slows down the progression of intestinal ischemia, consequently reducing the impact of the "second hit" caused by the translocation of intestinal bacteria and endotoxins into the bloodstream, which exacerbates acute pancreatitis. Despite these promising results, clinical data on the efficacy of TEA in acute pancreatitis remains insufficient. Moreover, the precise mechanisms by which TEA influences the progression and severity of acute pancreatitis are yet to be fully elucidated. In order to further validate the clinical therapeutic effects of TEA and gain a deeper understanding of its mechanisms, the investigators have conducted this clinical study. ### Conditions - Acute Pancreatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thoracic Epidural Analgesia ### Outcomes Primary Outcomes - The change in systemic inflammatory response syndrome (SIRS) and organ dysfunction after inclusion. - The change in intra-abdominal pressure (measured via bladder pressure) after treatment. - The change in resting pain and movement pain after inclusion. Secondary Outcomes - Peripheral blood inflammation and immune markers. - intestinal microbiota - total ICU treatment time - adverse event occurrence rate ### Location - Facility: Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, 310016, China @@
## Long Term Results After Hip Arthroscopy - NCT ID: NCT06327217 - Study ID: OC-2023-009 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Reinier Haga Orthopedisch Centrum ### Study Description A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown. ### Conditions - Femoro Acetabular Impingement ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bilateral hip x-ray - Questionnaires ### Outcomes Primary Outcomes - To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side. Secondary Outcomes - To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative. - To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy. - To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy. - To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score. - To determine patient satisfaction 5-10 years after hip arthroscopy. ### Location - Facility: Reinier Haga Orthopedic Center, Zoetermeer, N/A, 2725 NA, Netherlands @@
## Efficacy of Different Low Level Laser Therapy Sessions - NCT ID: NCT06327204 - Study ID: Low Level laser 24 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2023-12-01 - Lead Sponsor: October 6 University ### Study Description Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function. ### Conditions - Myofascial Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 940-nm diode laser / one session - 940-nm diode laser / two session - 940-nm diode laser/ three session ### Outcomes Primary Outcomes - pain score Secondary Outcomes - maximum mouth opening - quality of life questioner ### Location - Facility: Faculty of Dentistry, October 6 University, Cairo, N/A, 21523, Egypt @@
## EMERGE Mothers and Kids - NCT ID: NCT06327191 - Study ID: 23-CRFG-21 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: National University of Ireland, Galway, Ireland ### Study Description The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.The primary objectives of the EMERGE Mothers and Kids follow up study are:1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 6 years post the index pregnancy;2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds. ### Conditions - Gestational Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention as the study is observational. ### Outcomes Primary Outcomes - To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up.. - To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome. - To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up. - To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension. - To examine the associations of GDM diagnosis, sum of fasting, 1-hour, and 2-hour glucose z-scores after 75-g load, insulin sensitivity, and lipid levels at 24-32 weeks' gestation with lipid levels 3-6 years postpartum. - To determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Abscopal Effects of Stereotactic Body Radiotherapy in Metastatic Clear Renal Cell Carcinoma - NCT ID: NCT06327178 - Study ID: NFEC-2023-520 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-04-30 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description Prior research has indicated that stereotactic body radiotherapy (SBRT) can effectively trigger systemic anti-tumor immune response. The goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy in patients of metastatic clear renal cell carcinoma. The primary objective was to assess the objective response rate (ORR) and complete response (CR) in non-irradiated lesions, and incidence of adverse events (AEs). ### Conditions - Abscopal Effects of Stereotactic Body Radiotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Objective Response Rate Secondary Outcomes ### Location - Facility: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China @@
## Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension - NCT ID: NCT06327165 - Study ID: 1-2023-0072 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-12-31 - Lead Sponsor: Yonsei University ### Study Description Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol. ### Conditions - Cesarean Section - Spinal Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observation ### Outcomes Primary Outcomes - predictive value of ANI monitor for spinal hypotension during cesarean delivery Secondary Outcomes - Optimal cutoff value of ANI level for predicting occurrence of hypotension ### Location - Facility: Yonsei University Health system, Severance Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Caffeine Use in the Management of Preterm Infants - NCT ID: NCT06327152 - Study ID: 2659 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2026-12-31 - Lead Sponsor: University of California, Irvine ### Study Description This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster. ### Conditions - Apnea of Prematurity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Caffeine - Sterile Water Placebo ### Outcomes Primary Outcomes - Time to full feeds Secondary Outcomes - Time to discharge - Post menstrual age (PMA) at time of discharge - Number of significant cardiopulmonary events - Weight change ### Location - Facility: UC Irvine Medical Center, Orange, California, 92868, United States @@
## Optimising Patient Experience in Head and Neck Radiotherapy - NCT ID: NCT06327139 - Study ID: CTRIAL 23-24 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2025-07 - Lead Sponsor: Irish Research Radiation Oncology Group ### Study Description This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy.Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment. ### Conditions - Head and Neck Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional 5 point closed face immobilisation mask. - 5 point open face immobilization mask - 3 point open face immobilization mask ### Outcomes Primary Outcomes - The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction. Secondary Outcomes - Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12). ### Location - Facility: St. Luke's Radiation Oncology Network, Dublin, N/A, D06 HH36, Ireland @@
## Efficacy and Safety of Single-session Endoscopic Stone Extraction - NCT ID: NCT06327126 - Study ID: BFHHZS20240001 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-05-01 - Lead Sponsor: Beijing Friendship Hospital ### Study Description This is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction. ### Conditions - Choledocholithiasis With Acute Cholangitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - two-session ERCP - single-session ERCP ### Outcomes Primary Outcomes - Success rate of complete stone removal - ERCP-related complication rate Secondary Outcomes - Length of stay - Hospital expenses ### Location - Facility: Beijing Friendship Hospital, Beijing, Beijing, 100050, China @@
## Antibiotic Tumescent For Chronic Wounds - NCT ID: NCT06327113 - Study ID: IRB#23-001248 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2028-03-25 - Lead Sponsor: University of California, Los Angeles ### Study Description Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic leg wounds will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations. ### Conditions - Non-healing Wound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CeFAZolin Injectable Solution ### Outcomes Primary Outcomes - Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI Secondary Outcomes - Secondary Objective - To evaluate wound size and closure. - Secondary Objective - Chronic-wound-related pain - Secondary Objective - Rating Quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF) - NCT ID: NCT06327100 - Study ID: 2023-0934 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2031-05-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF. ### Conditions - Primary Myelofibrosis - Post-polycythemia Vera Myelofibrosis - Post-Essential Thrombocytosis Myelofibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ruxolitinib - Tasquinimod ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Appetite and Dietary Intake Across the Menstrual Cycle - NCT ID: NCT06327087 - Study ID: 22-00874 - Status: RECRUITING - Start Date: 2022-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: University of British Columbia ### Study Description Lay language summary: Women are younger and menstruating about monthly ("pre-menopausal") often have fluctuations in the food they eat ("dietary intake") across the menstrual cycle. However, relationships between food intake and appetite, metabolism, body composition (i.e., the proportion of muscle and fat), physical activity and premenstrual symptoms have not been reported. This study will measure appetite and food intake in laboratory and usual life settings in healthy pre-menopausal women in two hormonally different parts of the menstrual cycle. Data on ovarian hormones, metabolism, body composition, physical activity and premenstrual symptoms will also be collected to assess their potential relationship with food intake. ### Conditions - Appetitive Behavior - Healthy - Dietary Habits ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Energy intake - Hunger area under the curve - Satiety area under the curve - Prospective food consumption area under the curve Secondary Outcomes - Free-living ad libitum energy intake - Resting metabolic rate - Body composition - Estradiol - Progesterone - Physical activity patterns ### Location - Facility: University of British Columbia - Okanagan, Kelowna, British Columbia, V1V1V7, Canada @@
## Testing the Engaged Approach to Lung Cancer Screening - NCT ID: NCT06327074 - Study ID: 21-3063.cc - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2026-12 - Lead Sponsor: University of Colorado, Denver ### Study Description The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Engaged Approach to Lung Cancer Screening ### Outcomes Primary Outcomes - Percentage of the intervention group who would like to continue the EA-LCS framework - Percentage of the intervention group who would recommend the EA-LCS framework to other programs - Percentage of participants who would describe the framework as workable Secondary Outcomes - Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM) - Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM) - Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM) ### Location - Facility: University of Colorado Hospital, Denver, Colorado, 80045, United States @@
## Social Network Overdose Prevention and Education Intervention - NCT ID: NCT06327061 - Study ID: R01DA058659 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-12-01 - Lead Sponsor: Johns Hopkins Bloomberg School of Public Health ### Study Description The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs). ### Conditions - Drug Overdose ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Network overdose prevention - Standard of care health education ### Outcomes Primary Outcomes - Number of drug overdoses - Participant drug use Secondary Outcomes - Number of Network member contacts ### Location - Facility: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, 21205, United States @@
## Application of Cognitive Training Based on Remind Strategy in Glioma Patients With Cognitive Impairment - NCT ID: NCT06327048 - Study ID: School of Nursing - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2024-12-01 - Lead Sponsor: YuanYuan Ma ### Study Description The purpose of this study is to form an interdisciplinary team to dynamically evaluate patient cognitive outcomes and develop an individualized cognitive training program for Chinese brain tumor patients ### Conditions - Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Individual cognitive rehabilitation training based on Remind strategy was given ### Outcomes Primary Outcomes - Montreal Cognitive Assessment(MoCA) Secondary Outcomes - The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30) - The EORTC QLQ-Brain Neoplasms 20(EORTC QLQ-BN20) - Self-Rating Anxiety Scale(SAS) - Self-Rating Depression Scale(SDS) - Modified Barthel Index(MBI) ### Location - Facility: Yuanyuanma, Lanzhou, Gansu, N/A, China @@
## Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center - NCT ID: NCT06327035 - Study ID: 2023-A02660-45 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2025-04-01 - Lead Sponsor: Clinique Les Trois Soleils ### Study Description The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units. ### Conditions - Stroke - Gait, Hemiplegic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gait rehabilitation ### Outcomes Primary Outcomes - Functional Ambulation Classification Secondary Outcomes - Postural Assesment Scale for Stroke Patient - Timed Up and Go - 10-Meter Walk Test - 6Minute-Walk Test - Motricity Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Social Media-based Electronic Bibliotherapy for Dementia Caregivers - NCT ID: NCT06327022 - Study ID: P0038444 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2023-12-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description This study aims to assess the efficacy of social media-based electronic bibliotherapy in improving the well-being of informal caregivers of people with dementia compared to a control group. ### Conditions - Mental Health - Quality of Life - Dementia Caregivers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Social media-based electronic bibliotherapy - Usual care ### Outcomes Primary Outcomes - Changes in mental health Secondary Outcomes - Changes in health related quality of life - Changes in caregiving appraisal - Changes in psychological wellbeing ### Location - Facility: The Hong Kong Polytechnic University, Kowloon, N/A, N/A, Hong Kong @@
## Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis - NCT ID: NCT06327009 - Study ID: fasting ramadan in GN patients - Status: NOT_YET_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2024-05-22 - Lead Sponsor: Alexandria University ### Study Description This research aims to assess effects of ramadan fasting on kidney function and proteinuria in patients with glomerulonephritis. ### Conditions - Fasting Ramadan ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - fasting month of ramadan ### Outcomes Primary Outcomes - Change in kidney function - Change in proteinuria Secondary Outcomes ### Location - Facility: Faculty of Medicine, Aexandria University, Alexandria, N/A, 21526, Egypt @@
## Thiamine Intervention and Coronary Artery Bypass Grafting - NCT ID: NCT06326996 - Study ID: 23-001185 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: University of California, Los Angeles ### Study Description The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects. ### Conditions - Coronary Heart Disease - Coronary Artery Bypass Grafting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thiamine - Placebo ### Outcomes Primary Outcomes - Effects of thiamine treatment intervention on blood lactate levels. - Effects of thiamine treatment intervention on blood thiamine levels. - Effects of thiamine treatment intervention on blood inflammatory levels. - Evaluate cognitive function in CABG patients with thiamine treatment. - Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment. - Examine cognition in CABG patients with thiamine treatment. - Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment. - Cognition assessment in CABG patients after thiamine treatment. - Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment. - Long term effect of thiamine treatment intervention on quality of life. - Long term effect of thiamine treatment intervention on daily activities using PASE. - Long term effect of thiamine treatment intervention on daily activities using PPA. Secondary Outcomes ### Location - Facility: UCLA, Los Angeles, California, 90095, United States @@
## Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery - NCT ID: NCT06326983 - Study ID: IRB-P00047028 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Boston Children's Hospital ### Study Description This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure. ### Conditions - Tonsillitis - Post-operative Nausea and Vomiting (PONV) - Emergence Delirium - Opioid Analgesic Adverse Reaction - Anesthesia - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine - Acetaminophen - Ketorolac - Morphine ### Outcomes Primary Outcomes - Median Pain Scores in the Post-Anesthesia Care Unit - Post-operative pain at 12-24 hours - Post Operative Anesthesia Unit Length of Stay (hours) Secondary Outcomes - Opioid rescue medication administration - Emergence Delirium - Post-operative nausea and vomiting - Procedure length (minutes) - Intraoperative Blood pressure (mmHg) - Intraoperative Heart rate (beats per second) - Vasopressor administration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease - NCT ID: NCT06326970 - Study ID: HenanICE202401 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Henan Institute of Cardiovascular Epidemiology ### Study Description This observational study aims to learn about the preliminary exploration of 99mTc-FAPI imaging in heart diseases and its potential application.Participant involves patients with myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors, health conditions may also studied as control.The main questions it aims to answer are 1, radionuclide 99mTc labeled fibroblast-activated protein inhibitors (99mTc-FAPI) imaging in the use of cardiac diseases and its limitations. 2, the performance in subjects with different control of hypertension to evaluate myocardial injury and fibrosis for providing a molecular biological basis for the study of diseases and mechanisms.Participants will undergo 99mTc-FAPI imaging by Single-photon emission computed tomography (SPECT) and record their cardiac disease characterization and treatment. ### Conditions - Myocardial Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 99mTc-FAPI SPECT imaging ### Outcomes Primary Outcomes - positive uptake Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE) - NCT ID: NCT06326957 - Study ID: 334979 V1 15/01/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-07 - Lead Sponsor: King's College Hospital NHS Trust ### Study Description Background:Some health conditions make breathing difficult and uncomfortable. When this happens every day, it is called chronic breathlessness. Over 3 million people living with heart and lung disease have chronic breathlessness in the UK.Breathlessness is very difficult for patients themselves and their families, resulting in disability and feelings of fear, distress, and isolation. Due a to lack of supportive breathlessness services many patients frequently attend hospital Accident and Emergency (A\&E) departments seeking help.Given the on-going challenges faced by the National Health Service (NHS) in the United Kingdom, such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online, as it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users.With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves.SELF-BREATHE has been tested as part of its development. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients' breathlessness and their life? This is the question this research seeks to answer.Aims1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients.MethodsThe research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation.These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks.This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness. ### Conditions - Chronic Obstructive Pulmonary Disease - Bronchiectasis - Interstitial Lung Disease - Lung Cancer - Asthma - Dyspnea - Fibrotic Lung Disease - Chronic Lung Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SELF-BREATHE ### Outcomes Primary Outcomes - Numerical Rating Scale (NRS) Worst Breathlessness Secondary Outcomes ### Location - Facility: King's College Hospital NHS Foundation Trust, London, N/A, MK40 4DG, United Kingdom @@
## Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery - NCT ID: NCT06326944 - Study ID: MS-527-2023 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2024-05 - Lead Sponsor: Kasr El Aini Hospital ### Study Description Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block. ### Conditions - Fascia Transversalis Plane Block ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Ultrasound- guided Fascia Transversalis plane block - Ultrasound-guided Transversus abdominus plane block - Fentanyl - Pethidine - Acetaminophen ### Outcomes Primary Outcomes - Time to First need of analgesia Secondary Outcomes - Total Pethidine Consumption - Postoperative pain assessment FLACC ### Location - Facility: Cairo University Hospitals, Giza, N/A, 11562, Egypt @@
## Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction - NCT ID: NCT06326931 - Study ID: JE001 - Status: COMPLETED - Start Date: 2022-06-24 - Completion Date: 2023-06-22 - Lead Sponsor: Jacksoneye ### Study Description This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks. ### Conditions - Meibomian Gland Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - thermal pulsation - warm compress ### Outcomes Primary Outcomes - Change in MGS score for the worse eye Secondary Outcomes - Change in MGS score for the worse eye - Change in OSDI score - Change in OSDI score - Incidence of adverse events ### Location - Facility: Jacksoneye, Lake Villa, Illinois, 60046, United States @@
## Duodenal Microbiota in Functional Dyspepsia - NCT ID: NCT06326918 - Study ID: RP026 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2025-06-30 - Lead Sponsor: King Chulalongkorn Memorial Hospital ### Study Description The goal of this observational study is to assess the type of duodenal microbiota and duodenal microbiome in in FD patients compared to control group. The main questions it aims to answer are:* What are the differences in the type of duodenal microbiota and is there a difference in duodenal microbiome diversity between patients diagnosed with functional dyspepsia (FD) and the control group?* Are there any significant variations in the composition and diversity of gut microbiota between patients with FD and the control group, considering the method of sample collection (duodenal brushing vs. duodenal biopsy)? ### Conditions - Functional Dyspepsia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Duodenal mucosal brushing - Duodenal mucosal biopsy ### Outcomes Primary Outcomes - Specific microbial genus using mucosal brushing - Microbiome diversity using mucosal brushing Secondary Outcomes - Specific microbial genus using mucosal biopsy - Microbiome diversity using mucosal biopsy ### Location - Facility: King Chulalongkorn Memorial Hospital, Bangkok, N/A, 10330, Thailand @@
## CAPABLE Transplant - NCT ID: NCT06326905 - Study ID: IRB00437750 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Johns Hopkins University ### Study Description The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist and 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial. ### Conditions - Quality of Life - Depression - End Stage Renal Disease - Disability Physical ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - CAPABLE Transplant- Open Label Pilot - CAPABLE Transplant- Randomized Control Trial ### Outcomes Primary Outcomes - Waitlist-status as assessed by data obtained by the National Kidney Registry Secondary Outcomes - Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument - Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument - Change in Pain as assessed by the Brief Pain Inventory - Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) - Change in Social engagement as assessed by the Lubben Social Network Scale - Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale - Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale - Change in Frailty as assessed by the Fried Frailty Phenotype - Change in Health Team Communication as assessed by the CollaboRATE Scale Measure - Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale - Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living ### Location - Facility: Johns Hopkins School of Nursing, Baltimore, Maryland, 21205, United States @@
## Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery - NCT ID: NCT06326892 - Study ID: CHR1-101-2024 - Status: RECRUITING - Start Date: 2023-07-31 - Completion Date: 2024-10-15 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction. ### Conditions - Rectal Cancer - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Natural Orifice Specimen Extraction (NOSE) - Traditional specimen extraction ### Outcomes Primary Outcomes - Surgical Site Infections (SSI) Secondary Outcomes - Opioid rescue - Postoperative pain - Postoperative ileus - Incisional hernia - Overall postoperative complications ### Location - Facility: IRCCS Humanitas Research Hospital, Rozzano, MI, 20089, Italy @@
## A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients - NCT ID: NCT06326879 - Study ID: 3527 - Status: RECRUITING - Start Date: 2023-11-30 - Completion Date: 2027-10-30 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients ### Conditions - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Incidence rate ratio of colorectal cancer recurrence Secondary Outcomes - Correlation between lifestyle and incidence rate of colorectal cancer recurrence - Correlation between genetic profile and incidence rate of colorectal cancer recurrence - Correlation between molecular profile and incidence rate of colorectal cancer recurrence - Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence ### Location - Facility: IRCCS Humanitas Research Hospital, Rozzano, MI, 20089, Italy @@
## Otoacoustic Emissions in Different Blood Types - NCT ID: NCT06326866 - Study ID: E-74555795-050.04-941208 - Status: COMPLETED - Start Date: 2024-02-07 - Completion Date: 2024-03-18 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds. ### Conditions - Hearing Loss, Cochlear ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Otoacoustic emissions (non-invasive) ### Outcomes Primary Outcomes - Signal to noise ratios Secondary Outcomes ### Location - Facility: Eyyup KARA, İstanbul, N/A, 34107, Turkey @@
## Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models - NCT ID: NCT06326853 - Study ID: Adipofisi - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: IRCCS San Raffaele ### Study Description The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue ### Conditions - Endocrine Disorders - Adiposity - Pituitary Adenoma - Cushing Syndrome - Acromegaly - Hypopituitarism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment - NCT ID: NCT06326840 - Study ID: 98107 - Status: COMPLETED - Start Date: 2010-05-31 - Completion Date: 2011-06-10 - Lead Sponsor: Taipei Medical University Hospital ### Study Description The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:1. The effect of metformin on olanzapine-induced metabolic disturbance2. The effect of metformin on olanzapine-induced hyperprolactinemiaParticipants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks. ### Conditions - Metabolic Disturbance - Hyperprolactinemia - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Metformin ### Outcomes Primary Outcomes - Glucose level - prolactin level - Insulin level - low-density lipoprotein cholesterol (LDL-C) level - high-density lipoprotein cholesterol (HDL-C) level - cholesterol level - triglycerides level - leptin level Secondary Outcomes - Clinical Global Impression scale ### Location - Facility: Taipei Medical University-Wan Fang Hospital, Taipei, N/A, 116, Taiwan @@
## In'Oss™ (MBCP® Putty) Ortho - NCT ID: NCT06326827 - Study ID: P231127IBSORTHO - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-08 - Lead Sponsor: Advanced Medical Solutions Ltd. ### Study Description Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery ### Conditions - Orthopedic Disorder - Trauma Injury - Extremity Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - In'Oss™ (MBCP® Putty) ### Outcomes Primary Outcomes - Successful bone defect reconstruction in the extremities Secondary Outcomes - Evaluation of functional mobility restoration in the extremities with PRO measures - Evaluation of patient's pain intensity with VAS pain scale - Evaluation of safety of In'Oss - Evaluation of device usability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults - NCT ID: NCT06326814 - Study ID: TDU16837 - Status: COMPLETED - Start Date: 2021-10-11 - Completion Date: 2023-05-05 - Lead Sponsor: Sanofi ### Study Description Primary objective* The tolerability and safety of SAR443809 Secondary* The PK parameters of SAR443809* The PD activity of SAR443809* The immunogenicity of SAR443809 ### Conditions - Paroxysmal Nocturnal Hemoglobinuria ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Humanized anti-Factor Bb monoclonal antibody - Placebo ### Outcomes Primary Outcomes - Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs) - Incidence of potentially Clinical laboratory abnormalities Secondary Outcomes - PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax - PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax - PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast) - PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞) - PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z) - PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast) - PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL) - PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F) - PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss) - PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F) - PK parameters of SAR443809 for SC administrations: absolute bioavailability (F) - Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50]) - Complement classical pathway activity (Wieslab CP) - Incidence of treatment -emergent Anti-SAR443809 antibodies ### Location - Facility: Parexel International Site Number : 8400002, Glendale, California, 91206, United States @@
## Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients - NCT ID: NCT06326801 - Study ID: REC/014220 Muhammad Iqbal - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2024-01-18 - Lead Sponsor: Riphah International University ### Study Description To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke ### Conditions - Stroke, Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Resistive Diaphragmatic breathing exercise - Diaphragmatic breathing exercise - Conventional stroke physiotherapy ### Outcomes Primary Outcomes - pulmonary function - Trunk Control - Functional Capacity Secondary Outcomes ### Location - Facility: Northwest General Hospital, Peshawar;, Peshawar, Punjab, 44000, Pakistan @@
## Effects of Moderate Intensity Soleus Push-ups vs Sustained Soleus Push-ups on Lipid Profile Among Young Population - NCT ID: NCT06326788 - Study ID: 3912 Mehnoor Butt - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-07-30 - Lead Sponsor: Riphah International University ### Study Description To determine the effects of Short duration moderate intensity soleus push- ups VS Sustained Soleus Push-ups on lipid profile among Young Population. ### Conditions - Health Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Short Duration Moderate Intensity Soleus Push-ups - SUSTAINED SOLEUS PUSH-UPS ### Outcomes Primary Outcomes - Change in Lipid Profile Secondary Outcomes ### Location - Facility: Riphah Rehabilitation Center, Islamabad, N/A, 46600, Pakistan @@
## Research on Precision Pharmaceutical Care for Heart Transplant Recipients - NCT ID: NCT06326775 - Study ID: KY20240311-KS-02 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-12 - Completion Date: 2026-12 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description Establishing personalized dose prediction and related adverse drug reaction prediction models for immunosuppressive drugs after heart transplantation using multiple methods to construct a precise pharmaceutical service system for heart transplant patients has important research value and clinical significance in improving the safety and effectiveness of medication for patients. ### Conditions - Heart Transplant Patients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Steady state whole blood trough concentration of tacrolimus Secondary Outcomes ### Location - Facility: Pharmacy Department of Nanjing First Hospital, Nanjing, Jiangsu, 210006, China @@
## Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic - NCT ID: NCT06326762 - Study ID: younes - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-10-30 - Lead Sponsor: Mohammed VI University Hospital ### Study Description the investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. The most noted medical histories were diabetes (38.8%), hypertension (28.6%), and renal insufficiency (17.1%). Regarding laboratory findings: the mean white blood cell count was 15,985.16 cells/mm³, the mean C-reactive protein (CRP) level was 227.69 mg/L, and the mean procalcitonin level was 50.43 µg/L. In terms of blood gas analysis: the mean lactate level was 3.67 mmol/L, and the mean PCO2 gap (DELTAPCO2) was 4.85. All our patients were continuously monitored by pulse wave analysis: the mean cardiac output was 5.69 L/min, and the mean cardiac index was 4.14 L/s/m² All our patients underwent an echocardiogram, which is a routine examination in our department and is performed at the patient's bedside. The average left ventricular ejection fraction (LVEF) was 51.73%, and the average subaortic peak velocity (ITV) was 14.66 cm.Subsequently. the investigators examined the clinical and paraclinical profile of patients with septic cardiomyopathy. the investigators identified 19 patients with this condition, while 79 patients did not exhibit cardiac involvement. The percentage was significantly higher in the population with cardiac involvement, accounting for 28.3%. Among the patients with cardiac involvement, 76.5% had a PCO2 gap (DELTAPCO2) ≥ 6 mmHg, a significantly reduced cardiac output with an average of 3.3 L/min, and a predominantly low cardiac index, with 64.3% having an index \< 2.2 L/min/m². The mortality rate was significantly increased at 73.7%. ### Conditions - Gap co2 - Cardiac Output, Low - Cardiac Defect ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - comparaison ### Outcomes Primary Outcomes - gapCO2 Secondary Outcomes ### Location - Facility: younes Oujidi, Berkane, N/A, 9999, Morocco @@
## Effectiveness of Modified Graded Motor Imagery Training in Stroke Patients - NCT ID: NCT06326749 - Study ID: 2024/19 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-15 - Lead Sponsor: Inonu University ### Study Description In the study, movement observation training, Modified Graded Motor Imaging Training, which includes upper extremity functional exercises, and Graded Motor Imaging Training, where the standard protocol is applied, will be used in stroke patients to improve their upper extremity motor functions and daily lives. It is aimed to present it on an evidence-based basis by investigating its effects on Daily Living Activity, quality of life, upper extremity-specific right/left lateralization performance, mental stopwatch performance and motor imagery skills. ### Conditions - Graded Motor Imagery - Stroke - Action Observation Training - Motor Imagery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Modified Graded Motor Imagery and Conventional Treatment Group - Graded Motor Imagery and Conventional Treatment Group - Conventional Treatment Group ### Outcomes Primary Outcomes - Fugl-Meyer Upper Extremity Motor Rating Scale - Wolf Motor Function Test (WMFT) - Modified Barthel Index - Stroke-Specific Quality of Life Scale Secondary Outcomes - Lateralization Assessment - Mental Chronometry Time - Kinesthetic and Visual Imagery Questionnaire (KGIA) ### Location - Facility: Inonu University, Malatya, N/A, 44280, Turkey @@
## Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer - NCT ID: NCT06326736 - Study ID: 2024NZKY-014-02 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Jinling Hospital, China ### Study Description The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Surgery - Camrelizumab - SJ-Neo006 - Gemcitabine+Abraxane ### Outcomes Primary Outcomes - Incidence of Treatment Emergent Adverse Events (TEAEs) Secondary Outcomes - Disease control rate (DCR) ### Location - Facility: Wang Sizhen, Nanjing, Jiangsu, N/A, China @@
## Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects - NCT ID: NCT06326723 - Study ID: SIM0808-101 - Status: COMPLETED - Start Date: 2023-09-04 - Completion Date: 2024-02-05 - Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. ### Study Description This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult Chinese subjects. ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Daridorexant ### Outcomes Primary Outcomes - Pharmacokinetic Endpoints1 - Pharmacokinetic Endpoints2 - Pharmacokinetic Endpoints3 - Pharmacokinetic Endpoints4 - Pharmacokinetic Endpoints5 - Pharmacokinetic Endpoints6 - Pharmacokinetic Endpoints7 Secondary Outcomes - Safety Endpoints1 - Safety Endpoints2 - Safety Endpoints3 - Safety Endpoints4 - Safety Endpoints5 - Safety Endpoints6 - Safety Endpoints7 - Safety Endpoints8 ### Location - Facility: Nanjing Drum Tower hospital, Nanjing, Jiangsu, 210000, China @@
## The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong - NCT ID: NCT06326710 - Study ID: P0045122 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description In recent years, research teams around the world have developed interventions to educate older adults to use outdoor exercise facilities (OEFs) to improve health outcomes like strength, balance, mobility, PA level, and weight. These interventions employed trainers or therapists to instruct, and monitor exercise training for older adults using the public accessible OEFs. Apart from therapist or trainer-led intervention, an Australian research team developed a mobile application, and social support strategies to help participants to use OEFs to enhance their aerobic and resistance-based PA.A recent local in-depth qualitative study discovered that OEFs in Hong Kong attracted frailer older adults (i.e., those who recovered from a major illness or who has chronic diseases), and their caregivers to use OEFs to support and maintain their daily PA behavior. Some used OEFs to complement their formal rehabilitation sessions. It appears that OEFs in Hong Kong serves as an important health maintenance space for frailer older adults in the city to "age in place", yet educational training related to OEFs has been lacking over the years. Signage besides the exercise equipment has been the only education material for users over the years.A mobile app-based physical activity education intervention will be developed for frail old adults in Hong Kong. The intervention has two components: (1) mobile app; and (2) face-to-face group session that teaches the how to use correctly and safely use OEF in public parks to maintain PA habits.The main objective of this study is to evaluate the feasibility, acceptability, and pilot effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention. Primary outcomes include recruitment rate, retention rate, attrition rate, attendance, perceived usefulness of the app. Secondary outcomes include exercise self-efficacy, mental well-being, physical activity level.This study adopts a mixed-method design with quantitative and qualitative method. This study is a pilot randomized controlled trial, running for 4 months evaluating of the effectiveness of the mHealth intervention. 40 frail older adults will be randomized into (i) mHealth group or (ii) control group.Quantitative analysis will be adopted to investigate the effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention on the health outcomes of frail older adults. The qualitative component will consist of semi-structure interviews with the frail older adults to understand the acceptability of the intervention. ### Conditions - Physical Inactivity - Frailty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - mHealth - Health Talk ### Outcomes Primary Outcomes - Feasibility outcome: Recruitment rate - Feasibility outcome: Intervention completion rate - Feasibility outcome: Attrition rate - Feasibility outcome: Attendance - Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App - Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program Secondary Outcomes - Change in Physical activity level (Objective) at 1 month and 3 months - Change in Physical activity level (Subjective) at 1 month and 3 months - Change in Exercise self-efficacy at 1 month and 3 months - Change in Mental well-being at 1 month and 3 months - Change in usage of outdoor exercise facilities ### Location - Facility: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, N/A, N/A, Hong Kong @@
## Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML) - NCT ID: NCT06326697 - Study ID: HIK-AZA-2023-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Hikma Pharmaceuticals LLC ### Study Description A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions ### Conditions - Acute Myeloid Leukaemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Azacitidine - Onureg ### Outcomes Primary Outcomes - Cmax - AUC0-t Secondary Outcomes - AUC0-∞ - Kel - Tmax - T1/2el - Adverse Events (AEs) - Change in clinical safety labs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Suvorexant and Alcohol - NCT ID: NCT06326684 - Study ID: 88524 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2027-03-15 - Lead Sponsor: University of Kentucky ### Study Description This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Alcohol - Placebo - Suvorexant - Suvorexant ### Outcomes Primary Outcomes - Reinforcing Effects of Alcohol Secondary Outcomes - Craving - Mood - Alcohol Response - Heart rate - Blood pressure - Breath Alcohol Level - Temperature - Side Effects - Delay Discounting - n-back Task - Stop-Signal Task Inhibitory Failures - Sleep ### Location - Facility: Psychopharmacology of Addiction Laboratory, Lexington, Kentucky, 40507, United States @@
## A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot) - NCT ID: NCT06326671 - Study ID: STXA-BE-03 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-04 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co. Ltd) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®, Handihaler®, Strength: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Tiotropium Bromide Inhalation Powder - Spiriva HandiHaler ### Outcomes Primary Outcomes - Peak concentration (Cmax) - Area under the plasma concentration versus time curve (AUC) 0-t - Area under the plasma concentration versus time curve (AUC) 0-∞ Secondary Outcomes - The time to maximum plasma concentration (Tmax) - The elimination half-life (t1/2) - Terminal elimination rate constant (Kel) ### Location - Facility: Henan (Zhengzhou) Zhonghui Cardiovascular Hospital, Zhengzhou, Henan, 450003, China @@
## Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage - NCT ID: NCT06326658 - Study ID: TCM for Frequent AECOPD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-31 - Lead Sponsor: Henan University of Traditional Chinese Medicine ### Study Description To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bufei Yishen Prescription Granule ### Outcomes Primary Outcomes - The number of acute exacerbations Secondary Outcomes - The number of AECOPD leading to hospitalization and death - Time of onset of the first AECOPD - Severity of AECOPD - Duration of AECOPD - Case fatality rate - Lung function - Score for clinical signs and symptoms - 6-minute walking distance (6MWD) - The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT) - The MOS item short fromhealth survey（SF-36） ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome - NCT ID: NCT06326645 - Study ID: IRB23-891 - Status: NOT_YET_RECRUITING - Start Date: 2024-12-01 - Completion Date: 2025-12-01 - Lead Sponsor: Lindsey Russell, MD ### Study Description The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. . ### Conditions - Short Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Crofelemer Oral Product ### Outcomes Primary Outcomes - Ostomy output reduction Secondary Outcomes - Change in average weekly Parenteral Support (PS) volume - Change in SBS-QoL (Short bowel syndrome quality of life) - Change in GSRS (Gastrointestinal Symptom Rating Scale) - Change in intestinal absorption of fluids and macronutrients with consequent reduction of macronutrient requirements in patients with SBS - Change in weekly need for parenteral electrolytes ### Location - Facility: Cleveland Clinic Main Campus, Cleveland, Ohio, 44106, United States @@
## Comparative Effectiveness Study of Constant-Load Versus Graded Aerobic Exercise in Obese Children With Bronchial Asthma - NCT ID: NCT06326632 - Study ID: RHPT/0022/023 - Status: COMPLETED - Start Date: 2022-10-30 - Completion Date: 2023-12-07 - Lead Sponsor: Cairo University ### Study Description This study aimed to compare the effect of constant-load aerobic exercise (CL-AE) and graded aerobic exercise (G-AE) on cardiopulmonary fitness, and functional capacity in a cohort of obese children with bronchial asthma (BA).A total of 78 children with BA were randomly assigned to the CL-AE group (n = 26, who underwent moderate-intensity aerobic training with the training load maintained at the same level throughout the entire program, besides the respiratory re-training program), the G-AE group (n = 26, received an intensity- and duration-graded aerobic training in addition to the respiratory re-training program), or the control group (n = 29, who only engaged in a respiratory re-training program). Interventions were administered three times/week for 12 successive weeks.The cardiopulmonary fitness and functional capacity were evaluated in the three groups before and after the completion of the assigned interventions. ### Conditions - Bronchial Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Constant-load Aerobic Exercise - Graded Aerobic exercise - Respiratory Re-training ### Outcomes Primary Outcomes - Peak oxygen uptake Secondary Outcomes - Six-minute walk test - Dyspnea - Fatigue ### Location - Facility: Ragab K. Elnaggar, Al Kharj, Riyadh, N/A, Saudi Arabia @@
## Survival Benefit of Primary Tumour Resection Compared to Systemic Therapy Alone in Stage IV Colorectal Cancer Patients - NCT ID: NCT06326619 - Study ID: SurvSysT - Status: COMPLETED - Start Date: 2012-01-01 - Completion Date: 2020-12-31 - Lead Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane ### Study Description About 20-25 percent of all colorectal cancer patients are diagnosed with International Union Against Cancer (UICC) stage IV disease. The benefit of primary tumor resection in the palliative context is therefore of high concern. However, empirical evidence from randomized and observational studies is inconsistent.The objective of the present study is to compare the survival of palliative stage IV colorectal cancer patients selected for primary tumor resection and systemic treatment (PTR+SYST) to patients with systemic treatment only (SYST). ### Conditions - Colorectal Cancer - Neoadjuvant Systemic Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Primary tumor resection - Systemic Therapy ### Outcomes Primary Outcomes - Survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants - NCT ID: NCT06326606 - Study ID: 23-MLS101-101 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: MycoMedica Life Sciences PBC ### Study Description MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Psilocybin - Placebo ### Outcomes Primary Outcomes - Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) - Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS). Secondary Outcomes - Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax) - Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC) - Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax) - Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½) - Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F) - Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F) - Sensorial effects of MLS101 - Cognitive function ### Location - Facility: CMAX Clinical Research Pty Ltd, Adelaide, South Australia, 5000, Australia @@
## Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn - NCT ID: NCT06326593 - Study ID: P.T.REC/012/005049 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-06-01 - Lead Sponsor: MTI University ### Study Description Inhalation injury is a composite of multiple insults including: supra glottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.Wii fit aerobic training gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for adult and elderly people with low energy levels. A review showed that video games are safe and feasible in the children with lung complications. Children' balance, aerobic and cognitive functions, quality of life improved and depressive mood decreased. WII aerobic games also make children to communicate better with other family members. ### Conditions - Inhalation Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Wii aerobic training - conservative chest care ### Outcomes Primary Outcomes - Forced vital capacity (FVC) - forced expiratory volume in 1 second (FEV1) - peak expiratory flow (PEF) Secondary Outcomes - Upper and lower chest expansion (2nd intercostal space, xiphoid)]) - Functional capacity 6-Minute Walk Test (6-MWT) - Timed Up and Go test (TUG) ### Location - Facility: Heba Elfeky, Cairo, N/A, 6347113, Egypt @@
## Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals - NCT ID: NCT06326580 - Study ID: MS.22.09.2144 - Status: COMPLETED - Start Date: 2022-10-20 - Completion Date: 2024-02-20 - Lead Sponsor: Mansoura University ### Study Description Obstructive sleep apnea syndrome (OSAS)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (Kuczynski, W., 2019). These episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (Huon, L.-K.A., 2017). OSAS predominantly affects 26% of individuals between 30 and 70 years in the U.S (apnea hypopnea index ≥5 events per hour) (Schwartz, M., 2018).Obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. Yet this disorder remains undiagnosed in a substantial portion of our population. It is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with OSA (Park, J. G., 2011).The test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study ### Conditions - Osa Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected. Secondary Outcomes ### Location - Facility: Mansoura University, Mansoura, Dakhlia, 050, Egypt @@
## Comprehensive Connected Cancer Care (C4): Intervention Evaluation - NCT ID: NCT06326567 - Study ID: 84032 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-06 - Lead Sponsor: Timothy Mullett ### Study Description The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services. ### Conditions - Cancer - Health Care Utilization ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - C4 Program ### Outcomes Primary Outcomes - Change in Health Related Quality of Life (FACT-G7) Secondary Outcomes - Overall Survival ### Location - Facility: University of Kentucky, Lexington, Kentucky, 40506, United States @@
## Single Arm Pilot Trial of Virtual and In-person STEP2 - NCT ID: NCT06326554 - Study ID: 22-5933 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-01-01 - Lead Sponsor: University Health Network, Toronto ### Study Description The goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments, and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic.Participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months. ### Conditions - Oncology ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) ### Outcomes Primary Outcomes - FACIT-PAL 14 Secondary Outcomes - FACIT-PAL 14 - ESAS-r-CS - PHQ-9 - FAMCARE-P16 - Generalized Anxiety Disorder-7 - Patient Global Impression of Change ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Listening to the Holy Quran on Vital Signs in Coma Patients - NCT ID: NCT06326541 - Study ID: okutan - Status: COMPLETED - Start Date: 2023-01-05 - Completion Date: 2023-12-30 - Lead Sponsor: Bitlis Eren University ### Study Description The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs.Does listening to the Holy Quran have a positive effect on the life values of coma patients? ### Conditions - Sequelae of; Complications Surgical and Medical Care ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - music therapy ### Outcomes Primary Outcomes - systolic blood pressure- (mmHg) - diastolic blood pressure- (mmHg) - pulse (number of beats/min) - body temperature (degrees Celsius) - saturation (%-oxygen saturation) Secondary Outcomes ### Location - Facility: Bitlis Eren University, Bitlis, N/A, 13100, Turkey @@
## SGLT2 Inhibitors and Perioperative Period - NCT ID: NCT06326528 - Study ID: SGLT2 inhibitors - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-10-01 - Lead Sponsor: Assiut University ### Study Description The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University. ### Conditions - Perioperative Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SGLT2 inhibitor ### Outcomes Primary Outcomes - Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial. - NCT ID: NCT06326515 - Study ID: Government College University - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-09-10 - Lead Sponsor: Government College University Faisalabad ### Study Description to investigate the impact of cognitive behavior therapy for psychiatric problems among patients with opioid use disorder with relapse condition.In this randomize control trail (RCT), N=120 patients with relapse condition would be taken. After enrolment patients' eligibility assessment would be completed and then n=60 patients would be allocated to experimental (n=30) and waitlist control (n=30) through random assignment. Patient's age range would be between 20 to 30 years. ### Conditions - Psychoeducation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - psychoeducation - Stigma Reduction and Relapse Management ### Outcomes Primary Outcomes - The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022). - Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018): - Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018). - Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016): - Perceived Stigma of Addiction Scale - Brief Cope Inventory (BCI) Secondary Outcomes - World Health Organization Quality-of-Life Scale ### Location - Facility: Dr Khalid Mahmood, Faisalābad, Punjab, N/A, Pakistan @@
## A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma - NCT ID: NCT06326502 - Study ID: 22ETN101-2IND001 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2027-06-07 - Lead Sponsor: Etnova Therapeutics Corp. ### Study Description ETN101 is a multiple tyrosine kinase inhibitor (mTKI) targeting fms-like tyrosine kinase 3 (FLT3), receptor tyrosine kinase (KIT), vascular endothelial growth factor receptor 2 (VEGFR2), and platelet-derived growth factor receptor beta. Both in vitro and in vivo studies showed that ETN101 treatment/administration inhibited cancer cell survival and proliferation. In animal models, ETN101 had antitumor activity when administered to animals that did not respond to conventional targeted anticancer agents. ### Conditions - Hepatocellular Carcinoma - Advanced Hepatocellular Carcinoma - Liver Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ETN101 ### Outcomes Primary Outcomes - Dose-limiting Toxicity (DLT) Secondary Outcomes ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus - NCT ID: NCT06326489 - Study ID: 105122023-1/05.12.2023 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-11-30 - Lead Sponsor: ELIAS Emergency University Hospital ### Study Description The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores. ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Switching to the Medtronic 780G insulin pump ### Outcomes Primary Outcomes - Variations in HbA1c Secondary Outcomes - changes in insulin requirements - changes in time in range (TIR) levels - changes in time below range (TBR) - changes in coefficient of variation (CV) - changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization - changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores ### Location - Facility: Elias University Emergency Hospital, Bucharest, Sector 1, 011461, Romania @@
## A Study to Demonstrate the Safety and Efficacy of Siplizumab in the Treatment of Hidradenitis Suppurativa - NCT ID: NCT06326476 - Study ID: IRB-300012699 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa. ### Conditions - Hidradenitis Suppurativa ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Siplizumab ### Outcomes Primary Outcomes - Change in inflammatory lesion counts Secondary Outcomes - Change in Hidradenitis Suppurativa Clinical Response (HiSCR) - Change in Hurley Stage - Change in Dermatology Life Quality Index (DLQI) scores - Improvement in Visual Analogue Scale (VAS) pain scores - Change in Lesion Counts ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies - NCT ID: NCT06326463 - Study ID: DIRECT70 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2031-07-01 - Lead Sponsor: St. Jude Children's Research Hospital ### Study Description The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).Primary ObjectiveTo determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy.Secondary ObjectivesTo evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease. ### Conditions - Hematologic Malignancy - ALL, Childhood - AML, Childhood - Lymphoma - MDS ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fludarabine - Cyclophosphamide - CD70-CAR T cell infusion (Autologous) - Mesna ### Outcomes Primary Outcomes - Maximum tolerated dose of CD70-CAR T cells Secondary Outcomes ### Location - Facility: St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States @@
## Traditional In-Person Vs. Remote AR Clinical Simulation - NCT ID: NCT06326450 - Study ID: 74626 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: Stanford University ### Study Description This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario ### Conditions - Educational Problems ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Augmented Reality Headset ### Outcomes Primary Outcomes - Progression through the ACLS clinical simulation demonstrated by NTS and TS Secondary Outcomes - Demonstration of NTS during ACLS scenario - Evaluation of the AR system's usability - Exploration of perceptions, attitudes, and opinions of the AR simulation participants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses - NCT ID: NCT06326437 - Study ID: 1223 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Sun Yat-sen University ### Study Description The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 6-week dyadic intervention ### Outcomes Primary Outcomes - the Kessler psychological distress scale-10 Secondary Outcomes - The Illness Cognition Questionnaire - Dyadic Coping Inventory - European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 - Locke-Wallace Marital Adjustment Scale ### Location - Facility: The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510000, China @@
## Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department - NCT ID: NCT06326424 - Study ID: 2023H0085 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-03-01 - Lead Sponsor: Ohio State University ### Study Description Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools. ### Conditions - Delirium - Dementia - Hospital Acquired Condition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Empatica EmbracePlus ### Outcomes Primary Outcomes - Proportion of participants who develop delirium Secondary Outcomes - Intervention Acceptability - Biosensor data usability - Correlation of biosensor array data with clinical delirium ### Location - Facility: The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States @@
## A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors - NCT ID: NCT06326411 - Study ID: NST-628-001 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2029-11 - Lead Sponsor: Nested Therapeutics, Inc ### Study Description This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options. ### Conditions - Oncology - MEK Mutation - RAF Gene Mutation - Ras (KRAS or NRAS) Gene Mutation - Melanoma - NSCLC - Glioma - Solid Tumor, Adult - MAPK Pathway Gene Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - NST-628 ### Outcomes Primary Outcomes - Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors - Part A: Determine the recommended dose for expansion of NST-628 - Part B: Evaluate objective tumor response rate Secondary Outcomes - Part A: Evaluate objective tumor response rate - Part A and B: Evaluate progression free survival (PFS) - Part A and B: Evaluate overall survival (OS) - Part A and B: Characterize the pharmacokinetics of NST-628 ### Location - Facility: Scientia Clinical Research, Ltd, Rand, New South Wales, 2031, Australia @@
## The Effect of Using 3D Printers and Moulage on Improving Stoma Care - NCT ID: NCT06326398 - Study ID: 3D moulage - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Namik Kemal University ### Study Description When studies in the literature are examined, there are studies in which various methods are applied to students' stoma care knowledge and skills. Additionally, it is seen that there are studies using moulage or 3D printers as simulation applications in nursing education. However, there is no study on high-reality simulation application using 3D printer and moulage technique together.nIn this research, the effect of the stoma created with a 3D printer in a high-reality simulation on the stoma care knowledge and skills, satisfaction and self-confidence of nursing students will be examined by using the moulage technique. In addition, this application will be compared with nursing students' stoma care practices in the stoma model, which is classified as low-reality simulation. We think that our project will be unique in this field, as it uses current technological methods together in this planned research and is different from similar studies. ### Conditions - Stoma Colostomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Stoma Care ### Outcomes Primary Outcomes - Knowledge Level Evaluation Form Regarding Stoma Care - Stoma Care Skill Grading Key - Student Satisfaction and Self-Confidence Scale in Learning Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Machine Learning Predictive Models for Sepsis Risk in ICU Patients With Intracerebral Hemorrhage - NCT ID: NCT06326385 - Study ID: 53244021 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-05-30 - Lead Sponsor: Xiangya Hospital of Central South University ### Study Description Patients with intracerebral hemorrhage (ICH) in the intensive care unit (ICU) are at heightened risk of developing sepsis, significantly increasing mortality and healthcare burden. Currently, there is a lack of effective tools for the early prediction of sepsis in ICH patients within the ICU. This study aims to develop a reliable predictive model using machine learning techniques to assist clinicians in the early identification of patients at high risk and to facilitate timely intervention.The Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) is an international online repository for critical care expertise. This database contains patient-related information collected from the ICUs of Beth Israel Deaconess Medical Center between 2008 and 2019. It includes a vast dataset of 299,712 hospital admissions and 73,181 intensive care unit patients.The eICU Collaborative Research Database (eICU-CRD) comprises data from over 200,000 ICU admissions for 139,367 unique patients across 208 US hospitals between 2014 and 2015, providing a valuable resource for critical care research.This study aims to establish and validate multiple machine learning models to predict the onset of sepsis in ICU patients with ICH and to identify the model with the optimal predictive performance. ### Conditions - Intracerebral Hemorrhage - Sepsis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Occurrence of sepsis Secondary Outcomes ### Location - Facility: Le Zhang, Changsha, Hunan, 410008, China @@
## The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients - NCT ID: NCT06326372 - Study ID: Delirium - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-07-01 - Lead Sponsor: Tepecik Training and Research Hospital ### Study Description Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia. ### Conditions - Hyperoxia - Delirium in Old Age ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - control - ORi+SpO2 ### Outcomes Primary Outcomes - Correlation of FiO2 and ORi value - Correlation of ORi and Delirium Secondary Outcomes - Correlation of FiO2 and delirium ### Location - Facility: Aykut Saritaş, İ̇zmi̇r, N/A, 35640, Turkey @@
## Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia - NCT ID: NCT06326359 - Study ID: Soh-Med-24-02-03MD - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-10 - Lead Sponsor: Sohag University ### Study Description Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia ### Conditions - Androgenic Alopecia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - autologous stromal vascular fraction ### Outcomes Primary Outcomes - hair density - hair shaft thickness Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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