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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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: Daivobet ointment, topical steroids measure: Clinical Improvement of Oral Lichen Planus Lesions measure: Objective Response Score measure: Subjective Response Score sex: ALL minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Mansoura University, Faculty of Dentistry status: RECRUITING city: Mansoura state: Dakahlia zip: 35516 country: Egypt name: Mona Montaser role: CONTACT email: mmontaser@mans.edu.eg lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06327607 id: IEO 1952 briefTitle: Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients overallStatus: RECRUITING date: 2023-06-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-25 name: European Institute of Oncology class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 82 type: ESTIMATED name: Control Group name: Psychosexological intervention measure: Evaluation of differences between two arms in female sexual satisfaction and functionality scores measure: Evaluation of differences between two arms in levels of quality of life measure: Evaluation of differences between two arms in levels of anxiety and depression measure: Evaluation of differences between two arms in levels of sleep quality sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06327594 id: XTang-0002 briefTitle: Assessment System of Sarcopenia in Lung Cancer Patients overallStatus: RECRUITING date: 2023-11-01 date: 2027-11 date: 2028-11 date: 2024-03-25 date: 2024-03-25 name: West China Hospital class: OTHER briefSummary: 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 conditions: Lung Cancer conditions: Ultrasound studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1500 type: ESTIMATED name: ultrasound scan name: CT/MRI scan measure: Death measure: Perioperative complications sex: ALL minimumAge: 40 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinyi Tang status: RECRUITING city: Chengdu state: Sichuan country: China name: Xinyi Tang, Dr. role: CONTACT phone: +8615680819215 lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06327581 id: 101005 briefTitle: Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata overallStatus: RECRUITING date: 2023-12-15 date: 2024-09-23 date: 2024-12-22 date: 2024-03-25 date: 2024-03-25 name: Zagazig University class: OTHER_GOV briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Lactic Acid name: vit D name: Triamcinolone Acetonide name: Saline measure: hair regrowth improvement assessed by 5-point semiquantitative regrowth score (RGS) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rana Ehab status: RECRUITING city: Zagazig zip: 44519 country: Egypt name: rana ehab, md role: CONTACT phone: 01000896453 email: ranaehab015@gmail.com lat: 30.58768 lon: 31.502 hasResults: False
<\|newrecord\|> nctId: NCT06327568 id: IEO 1663 briefTitle: Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens overallStatus: RECRUITING date: 2022-06-17 date: 2026-06-17 date: 2029-06-17 date: 2024-03-25 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: 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 conditions: Anal Intraepithelial Neoplasia 1 conditions: Anal Cancer conditions: High-Risk Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Fabio Bottari role: CONTACT name: Cristina Trovato, MD role: SUB_INVESTIGATOR name: Anna Daniela Iacobone, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06327555 id: M2023123 briefTitle: Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction overallStatus: RECRUITING date: 2023-09-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-25 date: 2024-03-25 name: Peking University Third Hospital class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 252 type: ESTIMATED name: the traditional rehabilitation group name: the remote rehabilitation group measure: the Lysholm Knee Scoring Scale measure: knee Isokinetic strength measure: Y-balance balance test measure: Tegner score measure: the 36-item Short Form Health Survey(SF-36) measure: Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale measure: VAS pain score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: quan Jian Wang status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: quan J Wang, M.D. role: CONTACT phone: 13801076267 email: wjqsportsmed@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06327542 id: 22-37078B id: 1R61MD018333 type: NIH link: https://reporter.nih.gov/quickSearch/1R61MD018333 briefTitle: Group-based Integrative Pain Management in Primary Care Safety Net Clinics acronym: IPMP+ overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-04-30 date: 2024-03-25 date: 2024-03-26 name: University of California, San Francisco class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 factorial trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 360 type: ESTIMATED name: Group Acupuncture name: Integrative Group Medical Visits measure: Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function. measure: Change in Social support and Pain Questionnaire (SPQ) measure: Change in average pain intensity on the 0-10 numeric rating scale measure: 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. measure: Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b measure: Change in Internalized Stigma of Chronic Pain (ISCP) survey measure: Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a measure: Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ) measure: Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form measure: Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9) measure: Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2) measure: Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC) measure: Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale measure: Change in experiences of discrimination in healthcare sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tom Waddell Urban Health Clinic city: San Francisco state: California zip: 94102 country: United States name: Jesse Wennik, NP role: CONTACT lat: 37.77493 lon: -122.41942 hasResults: False
<\|newrecord\|> nctId: NCT06327529 id: 2101814 briefTitle: Zinc and Iron Absorption From Common Beans in Young Adult Women overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-26 name: University of California, Davis class: OTHER briefSummary: 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 conditions: Iron Absorption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A four arm multi-tracer non-randomized crossover design primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Study participants will be masked to the type of bean that they will be receiving. whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: SER 118 name: LMP 1001 name: LPA 586 name: KAT B1 measure: Fractional Zinc absorption measure: Fractional Iron absorption measure: Total Zinc absorption measure: Total Iron absorption sex: FEMALE minimumAge: 19 Years maximumAge: 24 Years stdAges: ADULT facility: Department of Nutrition city: Davis state: California zip: 95616 country: United States lat: 38.54491 lon: -121.74052 hasResults: False
<\|newrecord\|> nctId: NCT06327516 id: M2020023 briefTitle: Lysophosphatidylglycerol in Asthma Pathogenesis overallStatus: RECRUITING date: 2015-01-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-25 date: 2024-03-26 name: Peking University Third Hospital class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: lipidomics sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking university third hospital status: RECRUITING city: Beijing state: None Selected zip: 100191 country: China name: Chun Chang role: CONTACT phone: 15810075362 email: doudou1977bysy@sina.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06327503 id: 36/7-2024 briefTitle: Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-06-30 date: 2024-03-25 date: 2024-03-27 name: University of Belgrade class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: saliva samples collecting measure: NGF levels in saliva measure: GDNF levels in saliva measure: BDNF levels in saliva measure: s-Klotho levels in saliva measure: VEGF levels in saliva measure: IL-6 levels in saliva measure: opiorphin levels in saliva measure: unstimulated saliva flow sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Belgrade School of Dental Medicine city: Belgrade zip: 11000 country: Serbia name: Marija S Milic, DDS Ph.D role: CONTACT phone: +381112646280 phoneExt: 122 email: marija.milic@stomf.bg.ac.rs lat: 44.80401 lon: 20.46513 hasResults: False
<\|newrecord\|> nctId: NCT06327490 id: UF-BRE-012 briefTitle: 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 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-06 date: 2024-03-25 date: 2024-04-22 name: University of Florida class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: ICG-guided manual lymphatic drainage name: Traditional manual lymphatic drainage measure: Subject compliance measure: Relative volume change measure: Bioimpedance measure: Breast cancer related lymphedema symptoms measure: Incidence of progression to late stage breast cancer related lymphedema measure: Health-related quality of life sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States name: Lisa Spiguel, MD role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 hasResults: False
<\|newrecord\|> nctId: NCT06327477 id: NU 23S01 id: NCI-2024-01927 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STU00220015 id: NU 23S01 type: OTHER domain: Northwestern University id: P30CA060553 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA060553 briefTitle: Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma overallStatus: RECRUITING date: 2024-04-02 date: 2027-07-01 date: 2028-07-01 date: 2024-03-25 date: 2024-04-26 name: Northwestern University class: OTHER name: National Cancer Institute (NCI) briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Intensity-Modulated Radiation Therapy name: Resection name: Spatially-fractionated Radiation Therapy measure: Recommended phase II dose (Phase I) measure: Pathological complete response (Phase II) measure: Incidence of adverse events (Phase I) measure: Overall response rate (ORR) (Phase II) measure: Progression-free survival (PFS) (Phase II) measure: Overall survival (OS) ( (Phase II) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Seth M. Pollack role: CONTACT phone: 312-695-6180 name: Seth M. Pollack, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06327464 id: 23-03228 briefTitle: Exogenous Ketones and Appetite overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-01 date: 2025-04-01 date: 2024-03-25 date: 2024-04-04 name: University of British Columbia class: OTHER briefSummary: 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 conditions: Obesity conditions: Ketones conditions: Appetitive Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 22 type: ESTIMATED name: Exogenous ketones measure: Acylated ghrelin area under the curve (AUC) measure: Peptide-YY(3-36) area under the curve (AUC) measure: Glucagon-like peptide 1 area under the curve (AUC) measure: Insulin area under the curve (AUC) measure: Glucose area under the curve (AUC) measure: Leptin area under the curve (AUC) measure: Hunger rating from visual analog scale measure: Satiety rating from visual analog scale measure: Prospective food consumption rating from visual analog scale measure: Desire to eat rating from visual analog scale measure: Dietary energy intake at a single meal measure: Free-living dietary energy intake measure: Postprandial energy expenditure sex: ALL minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: University of British Columbia - Okanagan city: Kelowna state: British Columbia zip: V1V1V7 country: Canada name: Sarah Purcell, PhD role: CONTACT phone: 2508079827 email: sarah.purcell@ubc.ca lat: 49.88307 lon: -119.48568 hasResults: False
<\|newrecord\|> nctId: NCT06327451 id: IRB2024-YX-037-01 briefTitle: Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma overallStatus: RECRUITING date: 2024-04-01 date: 2026-02-28 date: 2027-02-28 date: 2024-03-25 date: 2024-03-25 name: Tianjin Medical University General Hospital class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Atorvastatin 20mg measure: progression-free survival measure: Overall survival measure: Tumor control rate measure: Hepatic burden of GBM patients after receiving atorvastatin administration measure: Percentage of participants with treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin zip: 300052 country: China name: Chunsheng Kang role: CONTACT phone: +8602260817499 email: kang97061@tmu.edu.cn name: Xiaoteng Cui role: CONTACT phone: +8602260817481 email: xiaotengcui@tmu.edu.cn lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06327438 id: REC/211/MTI.PT/2401041 briefTitle: Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial overallStatus: RECRUITING date: 2024-03-16 date: 2024-06-16 date: 2024-07-16 date: 2024-03-25 date: 2024-03-25 name: South Valley University class: OTHER briefSummary: To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled study primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Complex decongestive therapy name: Cryotherapy name: Kinesio taping measure: Arm girth measurement is measured by Circumferential measurements measure: Pain severity is measured by VAS measure: The QOL is measured by SF-36 measure: Range of motion (ROM) is measured by UG sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Ragaee Saeed Mahmoud status: RECRUITING city: Giza state: Faisal country: Egypt name: Ragaee Mahmoud role: CONTACT phone: 00201223611112 email: ragaeesaeedpt10@gmail.com name: Reham Mahmoud role: CONTACT phone: 00201015447798 email: rsm_211pt@yahoo.com lat: 30.00808 lon: 31.21093 facility: Ragaee Saeed Mahmoud status: RECRUITING city: Faisal state: Giza zip: 002 country: Egypt name: Reham Saeed, Doctora role: CONTACT phone: 00201223611112 email: rsm_Pt211@yahoo.com name: Rabab Saeed, Doctora role: CONTACT phone: 00201017855222 email: rababSaeed10@yahoo.com lat: 30.01744 lon: 31.20376 hasResults: False
<\|newrecord\|> nctId: NCT06327425 id: MCG-Tachyarrhythmia briefTitle: MCG for Localization of Tachyarrhythmia's Origin overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2024-12 date: 2025-02 date: 2024-03-25 date: 2024-03-25 name: Qilu Hospital of Shandong University class: OTHER briefSummary: 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 conditions: Atrial Flutter conditions: Paroxysmal Supraventricular Tachycardia conditions: Atrial Tachycardia conditions: Atrial Fibrillation conditions: Premature Ventricular Contraction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: Magnetocardiography measure: Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard. sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06327412 id: KayseriCHLYMP01 briefTitle: The Effects of Aerobic Exercise in Patients With Primary Lower Extremity Lymphedema overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-25 date: 2024-03-27 name: Kayseri City Hospital class: OTHER_GOV briefSummary: 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 conditions: Aerobic Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 35 patients with primary stage 2 and 3 lower extremity lymphedema, aged 18-65, who apply to the lymphedema outpatient clinic and meet the criteria of the International Society of Lymphology, will be included. Patients participating in the study will be randomized into 2 groups: aerobic exercise group (Group 1) and home exercise group (Group 2). According to randomization, 18 patients will be included in one group and 17 patients in the other.
Cardiopulmonary exercise test (CPET), 30-second-stand-sit test (30s-CST), 6-minute walk test (6MWT), Lymphedema Circumference and Volume Measurement, Bioimpedance Measurement, Lower Extremity Functional Scale (LEFS), Lymphedema Life Impact Scale ( LLIC), Hospital Depression and Anxiety Scale (HADS), Numerical Rating Scale (NRS) forms will be filled in the cardiopulmonary rehabilitation unit of Kayseri City Hospital in the 0th, 4th and 16th weeks. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Aerobic exercise on the treadmill name: Walking between 12-13 RPE (The Borg Rating of Perceived Exertion) according to the Modified Borg Scale measure: 30-second sit-stand test (30-s chair-stand test, 30s-CST) measure: Cardiopulmonary exercise test (CPET) measure: 6-minute walk test (6MWT) measure: Circumference and volume measurement measure: Bioimpedance measurement measure: Lower Extremity Functional Scale (LEFS) measure: Lymphedema Life Impact Scale (LLIC) measure: Hospital Anxiety and Depression Scale (HADS) measure: Numerical Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital city: Kayseri zip: 38080 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
<\|newrecord\|> nctId: NCT06327399 id: MS-373-2023 briefTitle: Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation. overallStatus: RECRUITING date: 2024-01-21 date: 2024-04 date: 2024-05 date: 2024-03-25 date: 2024-03-25 name: Kasr El Aini Hospital class: OTHER briefSummary: 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 conditions: Intubation Complication studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Dexmedetomidine infusion name: Dexmedetomidine bolus name: Atropine Sulfate name: Ephedrine name: Propofol measure: Mean blood pressure upon laryngoscopy measure: Blood pressure & Heart rate measure: Propfol measure: Bradycardia sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Cairo University Hospitals status: RECRUITING city: Giza zip: 11562 country: Egypt name: Maher a Fawzy, MD role: CONTACT phone: 01201730249 email: kasralainirec@kasralainy.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False
<\|newrecord\|> nctId: NCT06327386 id: 202434 briefTitle: The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PET/MR in Neoadjuvant Therapy for Gastric Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-25 date: 2024-03-25 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: 18F-FAPI#18F-FDG measure: Evaluation efficacy of tumor regression level measure: expression of FAP measure: expression of GLUT1 measure: SUV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com lat: 29.56278 lon: 106.55278 hasResults: False
<\|newrecord\|> nctId: NCT06327373 id: Pro00114903 briefTitle: A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia acronym: SOPHIE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-06-30 date: 2024-03-25 date: 2024-03-25 name: Duke University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Oxygen name: Room air measure: Change daily hypoxemia burden measure: Change in six minute walk distance measure: Change in Montreal Cognitive Assessment (MoCA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Davita Durham East city: Durham state: North Carolina zip: 27701 country: United States lat: 35.99403 lon: -78.89862 facility: Davita Durham Downtown city: Durham state: North Carolina zip: 27703 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Research Triangle Park city: Durham state: North Carolina zip: 27703 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Durham Regional city: Durham state: North Carolina zip: 27704 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Durham West city: Durham state: North Carolina zip: 27705 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Bull City city: Durham state: North Carolina zip: 27707 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Durham Southpoint city: Durham state: North Carolina zip: 27713 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Hope Valley city: Durham state: North Carolina zip: 27713 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Vance County city: Henderson state: North Carolina zip: 27536 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 36.32959 lon: -78.39916 facility: Davita Kerr Lake city: Henderson state: North Carolina zip: 27537 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 36.32959 lon: -78.39916 facility: Davita Roxboro city: Roxboro state: North Carolina zip: 27573 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 36.39375 lon: -78.98279 hasResults: False
<\|newrecord\|> nctId: NCT06327360 id: FDG_ 88-16 briefTitle: Illness Expectations in Pulmonary Fibrosis acronym: CAMFP overallStatus: ENROLLING_BY_INVITATION date: 2023-10-10 date: 2023-10-10 date: 2025-10-01 date: 2024-03-25 date: 2024-04-05 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico name: FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: Psychological questionnaires measure: Adherence to Pharmacological Treatment measure: Adherence to Oxygen Therapy measure: Adherence to Non invasive ventilation measure: Illness beliefs measure: Pharmacological treatment Beliefs measure: Illness Expectations measure: Illness Cognitions measure: Socio-demographic variables measure: Clinical and medical data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano city: Milano zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 facility: Don Gnocchi Foundation city: Milano zip: 20148 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06327347 id: 2020-05_C2H briefTitle: Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg acronym: C2H overallStatus: RECRUITING date: 2022-07-17 date: 2026-03-31 date: 2026-07-31 date: 2024-03-25 date: 2024-03-25 name: Cristalens Industrie class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignement primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative is perforemd by a blinded evaluator. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: intraocular lens implantation in cataract surgery measure: Binocular Distance Corrected Intermediate Visual Acuity sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC) status: RECRUITING city: Heidelberg country: Germany name: Raquel Willrich Amroussi role: CONTACT phone: +49 6221 56-36849 email: raquel.willrichamroussi@med.uni-heidelberg.de lat: 49.40768 lon: 8.69079 hasResults: False
<\|newrecord\|> nctId: NCT06327334 id: 2023/03 briefTitle: Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial acronym: BHIANCA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-05-15 date: 2027-05-15 date: 2024-03-25 date: 2024-03-25 name: CMC Ambroise Paré class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Bilateral brain-heart interactions measure: Poor neurological outcome evaluated using the CPC score measure: Mortality measure: Post-anoxic encephalopathy severity evaluated by composite prognostic markers combining EEG patterns, somatosensory evoked potentials (SEP) and neuron specific enolase (NSE). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brest University Hospital city: Brest state: Bretagne zip: 29609 country: France name: Pierre BAILLY, MD role: CONTACT email: pierre.bailly@chu-brest.fr name: Pierre BAILLY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.3903 lon: -4.48628 facility: Ambroise Paré - Hartmann Private Hospital Group city: Neuilly-sur-Seine state: Ile-de-France zip: 92200 country: France name: Guillaume GERI, MD, PhD role: CONTACT email: guillaume.geri@clinique-a-pare.fr name: Guillaume GERI, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.8846 lon: 2.26965 facility: Cochin Hospital city: Paris state: Ile-de-France zip: 75014 country: France name: Alain CARIOU, MD, PhD role: CONTACT email: alain.cariou@aphp.fr name: Alain CARIOU, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Nantes University Hospital city: Nantes state: Pays De La Loire zip: 44093 country: France name: Jean-Baptiste LASCARROU, MD role: CONTACT email: jeanbaptiste.lascarrou@chu-nantes.fr name: Jean-Baptiste LASCARROU, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 facility: Marseille University Hospital city: Marseille state: Provence-Alpes-Côte d'Azur zip: 13005 country: France name: Jeremy BOURENNE, MD role: CONTACT email: jeremy.bourenne@ap-hm.fr name: Jeremy BOURENNE, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 hasResults: False
<\|newrecord\|> nctId: NCT06327321 id: 23-PP-08 briefTitle: Vitiligo Treatment by Targeting TYK2 Mediated Responses acronym: ViTYK overallStatus: RECRUITING date: 2024-05-05 date: 2026-05-05 date: 2026-11-05 date: 2024-03-25 date: 2024-04-12 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 128 type: ESTIMATED name: Deucravacitinib name: Volunteer without treatment measure: rate of depigmentation measure: number of patient with the T-VASI 50 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nice - Hôpital de l'Archet status: RECRUITING city: Nice state: Alpes-Maritimes zip: 06200 country: France name: Passeron Thierry, PhD role: CONTACT phone: +33492036488 email: passeron.t@chu-nice.fr name: pradelli Emmanuelle role: CONTACT phone: +33492036488 email: pradelli.e@chu-nice.fr name: Thierry Passeron, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: APHP, Henri Mondor status: NOT_YET_RECRUITING city: Paris state: Creteil country: France name: Khaled EZZEDINE, PhD role: CONTACT email: khaled.ezzedine@aphp.fr name: Khaled EZZEDINE, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CHU de Bordeaux status: NOT_YET_RECRUITING city: Bordeaux state: Talence zip: 33000 country: France name: Julien Seneschal, PhD role: CONTACT email: julien.seneschal@chu-bordeaux.fr name: Julien Seneschal, PhD role: SUB_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: CHU de Lille status: NOT_YET_RECRUITING city: Lille country: France name: Laurent MORTIER, PhD role: CONTACT email: Laurent.MORTIER@chu-lille.fr name: Laurent MORTIER, PhD role: SUB_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: HCL status: NOT_YET_RECRUITING city: Lyon country: France name: Cécile LESORT, PhD role: CONTACT email: cecile.lesort@chu-lyon.fr name: Cécile Lesort, PhD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False
<\|newrecord\|> nctId: NCT06327308 id: 2023/803 briefTitle: Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. acronym: CARDIOFIBROCIR overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-03-31 date: 2027-12-31 date: 2024-03-25 date: 2024-03-27 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: MRI name: Blood sampling measure: Primary outcome measure measure: 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 : measure: Analysis of the association between myocardial extracellular volume (MECV) (explained variable) and plasma 3-HM concentration (explanatory variable). measure: 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). measure: 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. measure: Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) according to cirrhotic cardiomyopathy status occurring between inclusion and LT. measure: Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) occurring between inclusion and LT, according to cirrhotic cardiomyopathy status. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Besancon - Hopital Minjoz city: Besançon zip: 25000 country: France name: Delphine WEIL, MD, PHD role: CONTACT lat: 47.24878 lon: 6.01815 facility: CHU Dijon - Hopital François Mitterrand city: Dijon zip: 21000 country: France name: Marianne LATOURNERIE, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: CHRU Nancy - Hôpital de Brabois city: Nancy zip: 54000 country: France name: Mouni BENSENANE -OUSSALAH, MD role: CONTACT lat: 48.68439 lon: 6.18496 facility: CHU Strasbourg - Hopital de HautePierre city: Strasbourg zip: 67000 country: France name: Camille BESCH, MD role: CONTACT lat: 48.58392 lon: 7.74553 hasResults: False
<\|newrecord\|> nctId: NCT06327295 id: ATB1651-102 briefTitle: A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-06-30 date: 2026-01-30 date: 2024-03-25 date: 2024-03-25 name: AmtixBio Co., Ltd. class: INDUSTRY briefSummary: The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis conditions: Onychomycosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: ATB1651-102- Cohort 1 name: ATB1651-102- Cohort 2 name: ATB1651-102- Cohort 3 name: ATB1651-102- Cohort 4 name: Placebo measure: To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis. measure: To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis. measure: To assess and collect the percentage and severity of adverse events (AEs). measure: Maximum plasma concentration (Cmax) measure: Time to maximum plasma concentration (Tmax) measure: Apparent terminal elimination rate constant (λz) measure: Area under curve (AUC) measure: Apparent terminal half-life (t 1/2) measure: Apparent clearance (CL) measure: Apparent terminal volume of distribution (VD) measure: Plasma ATB1651 trough concentrations (Ctrough) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New Zealand Clinical Research Christchurch city: Christchurch zip: 8011 country: New Zealand name: Corey Sellwood, Dr role: CONTACT phone: +64 800 862 278 name: Corey Sellwood, Dr role: PRINCIPAL_INVESTIGATOR lat: -43.53333 lon: 172.63333 hasResults: False
<\|newrecord\|> nctId: NCT06327282 id: ChinaPLAGHPAIN briefTitle: the Effect of Preoperative Pain Education by Anesthesia Nurses on Postoperative Pain Among Adult Patients Undergoing Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-01-01 date: 2025-04-04 date: 2024-03-25 date: 2024-04-16 name: Chinese PLA General Hospital class: OTHER briefSummary: To explore the effects of preoperative pain education on postoperative pain among patients undergoing abdominal surgery. conditions: Postoperative Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 116 type: ESTIMATED name: education on pain and related knowledge measure: Occurrence of pain measure: Mastery of the use of patient-controlled analgesia pump measure: Patient satisfaction with postoperative analgesia measure: Adverse events of patients using analgesic pump were recorded measure: The number of times that the analgesic pump was pressed during each 24h and the amount of analgesic pump remaining at this time were recorded measure: The use of rescue analgesics after surgery measure: The postoperative sleep status of patients was evaluated sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06327269 id: MOHW111-TDU-B-221-114009 briefTitle: Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma overallStatus: RECRUITING date: 2021-04-01 date: 2024-12 date: 2026-12 date: 2024-03-25 date: 2024-04-18 name: Chang Gung Memorial Hospital class: OTHER name: Ministry of Health and Welfare, Taiwan briefSummary: 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 studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Lenvatinib 10 mg measure: Recurrence-free survival with adjuvant therapy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery status: RECRUITING city: Kaohsiung zip: 833 country: Taiwan name: Chih-Che Lin, Ph.D role: CONTACT phone: +88677317123 phoneExt: 8880 email: chihchelin@cgmh.org.tw name: I-Hsuan Chen, Ph.D role: CONTACT phone: +88677317123 phoneExt: 8582 email: ann0401@cgmh.org.tw lat: 22.61626 lon: 120.31333 hasResults: False
<\|newrecord\|> nctId: NCT06327256 id: 1509-0002 id: 2023-509293-29-00 type: REGISTRY domain: CTIS id: U1111-1299-6907 type: REGISTRY domain: WHO International Clinical Trials Registry Platform (ICTRP) briefTitle: 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 overallStatus: RECRUITING date: 2024-03-28 date: 2024-09-27 date: 2024-09-27 date: 2024-03-25 date: 2024-04-12 name: Boehringer Ingelheim class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: BI 3000202 name: Placebo name: Midazolam measure: Percentage of subjects with drug-related adverse events measure: Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12) measure: Maximum measured concentration BI 3000202 in plasma (Cmax) measure: Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state measure: Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state measure: Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state measure: 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 measure: Maximum measured concentration of midazolam in plasma (Cmax) after a single dose sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: SGS Life Science Services - Clinical Research status: RECRUITING city: Edegem zip: 2650 country: Belgium name: Boehringer Ingelheim role: CONTACT phone: 080049616 email: belgique@bitrialsupport.com lat: 51.15662 lon: 4.44504 hasResults: False
<\|newrecord\|> nctId: NCT06327243 id: TUMRHS briefTitle: The Effects of Kinesio Taping on Pain, Range of Motion, and Functional Performance in People With Knee Osteoarthritis overallStatus: RECRUITING date: 2024-03-01 date: 2024-04-01 date: 2024-04-30 date: 2024-03-25 date: 2024-03-25 name: Taibah University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In a randomized and single-blinded approach, participants are divided into two groups. One group receives actual Kinesio taping, while the other undergoes a sham procedure, with neither group aware of their specific treatment type to ensure unbiased results. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will not know if they are receiving the actual Kinesio Taping (KT) treatment or a sham taping. The KT will be applied following the correct standards for the rectus femoris muscle, including appropriate stretching. Conversely, the placebo taping will be applied horizontally across the muscle fibers without any stretching. The therapists applying the tape will know which treatment each participant is allocated to ensure that the application of either the real KT or the placebo taping aligns with the study's protocol. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Elastic tape ( kinesio tape) name: Sham Taping measure: Pain (Visual analog scale) measure: Knee range of motion measure: Timed up and go test measure: The 50-foot Walk measure: Knee Osteoarthritis Outcome Score (KOOS) sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taibah University status: RECRUITING city: Medina zip: 42353 country: Saudi Arabia name: President of the university role: CONTACT email: tawasul@taibahu.edu.sa name: Marwan MA Aljohani, Phd role: CONTACT email: mmjohani@taibahu.edu.sa lat: 24.46861 lon: 39.61417 hasResults: False
<\|newrecord\|> nctId: NCT06327230 id: SRRSH2023-0627 briefTitle: The Application of Thoracic Epidural Analgesia in Patients With Acute Pancreatitis overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-04-30 date: 2024-03-25 date: 2024-03-25 name: Sir Run Run Shaw Hospital class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 88 type: ESTIMATED name: Thoracic Epidural Analgesia measure: The change in systemic inflammatory response syndrome (SIRS) and organ dysfunction after inclusion. measure: The change in intra-abdominal pressure (measured via bladder pressure) after treatment. measure: The change in resting pain and movement pain after inclusion. measure: Peripheral blood inflammation and immune markers. measure: intestinal microbiota measure: total ICU treatment time measure: adverse event occurrence rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06327217 id: OC-2023-009 briefTitle: Long Term Results After Hip Arthroscopy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-25 date: 2024-03-25 name: Reinier Haga Orthopedisch Centrum class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 451 type: ESTIMATED name: Bilateral hip x-ray name: Questionnaires measure: To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side. measure: To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative. measure: To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy. measure: To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy. measure: To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score. measure: To determine patient satisfaction 5-10 years after hip arthroscopy. sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Reinier Haga Orthopedic Center city: Zoetermeer zip: 2725 NA country: Netherlands lat: 52.0575 lon: 4.49306 hasResults: False
<\|newrecord\|> nctId: NCT06327204 id: Low Level laser 24 briefTitle: Efficacy of Different Low Level Laser Therapy Sessions overallStatus: COMPLETED date: 2023-03-01 date: 2023-10-01 date: 2023-12-01 date: 2024-03-25 date: 2024-03-25 name: October 6 University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: 940-nm diode laser / one session name: 940-nm diode laser / two session name: 940-nm diode laser/ three session measure: pain score measure: maximum mouth opening measure: quality of life questioner sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry, October 6 University city: Cairo zip: 21523 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06327191 id: 23-CRFG-21 id: 23-CRFG-21 type: OTHER domain: Clinical Research Facility Galway (CRFG) study number briefTitle: EMERGE Mothers and Kids overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-03-25 date: 2024-03-25 name: National University of Ireland, Galway, Ireland class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 321 type: ESTIMATED name: No intervention as the study is observational. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up.. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension. measure: 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. measure: 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. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06327178 id: NFEC-2023-520 briefTitle: Abscopal Effects of Stereotactic Body Radiotherapy in Metastatic Clear Renal Cell Carcinoma overallStatus: RECRUITING date: 2023-10-01 date: 2024-01-31 date: 2024-04-30 date: 2024-03-25 date: 2024-03-26 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED measure: Objective Response Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Guozhu Xie role: CONTACT email: xieguozhu@126.com lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06327165 id: 1-2023-0072 briefTitle: Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension overallStatus: RECRUITING date: 2024-03-18 date: 2024-12-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-27 name: Yonsei University class: OTHER briefSummary: 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 conditions: Spinal Anesthesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: observation measure: predictive value of ANI monitor for spinal hypotension during cesarean delivery measure: Optimal cutoff value of ANI level for predicting occurrence of hypotension sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Health system, Severance Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Seung Hyun Kim, Associate Professor role: CONTACT phone: 82-2-2224-1055 email: anesshkim@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06327152 id: 2659 briefTitle: Caffeine Use in the Management of Preterm Infants overallStatus: RECRUITING date: 2024-02-22 date: 2026-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-03-26 name: University of California, Irvine class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Families, nurses, therapists, and doctors will be blinded. Only pharmacy will be unblinded and know which subjects are in each treatment arm. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Caffeine name: Sterile Water Placebo measure: Time to full feeds measure: Time to discharge measure: Post menstrual age (PMA) at time of discharge measure: Number of significant cardiopulmonary events measure: Weight change sex: ALL minimumAge: 1 Day maximumAge: 40 Weeks stdAges: CHILD facility: UC Irvine Medical Center status: RECRUITING city: Orange state: California zip: 92868 country: United States name: Cherry Uy, MD role: CONTACT phone: 714-456-6933 email: ccuy@hs.uci.edu name: Cherry Uy, MD role: PRINCIPAL_INVESTIGATOR name: Ernest Lai, MD role: SUB_INVESTIGATOR name: Muhammad Aslam, MD role: SUB_INVESTIGATOR lat: 33.78779 lon: -117.85311 hasResults: False
<\|newrecord\|> nctId: NCT06327139 id: CTRIAL 23-24 briefTitle: Optimising Patient Experience in Head and Neck Radiotherapy acronym: OPEN overallStatus: RECRUITING date: 2024-01-02 date: 2025-05 date: 2025-07 date: 2024-03-25 date: 2024-03-25 name: Irish Research Radiation Oncology Group class: NETWORK briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. A faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring, a faceless five point mask in conjunction with intra fraction surface guided monitoring and a conventional closed face five point mask without the use of intra fraction surface guided monitoring are being investigated in this study. The set-up accuracy will be based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction. primaryPurpose: TREATMENT masking: NONE count: 201 type: ESTIMATED name: Conventional 5 point closed face immobilisation mask. name: 5 point open face immobilization mask name: 3 point open face immobilization mask measure: 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. measure: 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). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Luke's Radiation Oncology Network status: RECRUITING city: Dublin zip: D06 HH36 country: Ireland name: Roisin O Maolalai, BSc role: CONTACT phone: 0035314065458 email: Roisin.OMaolalai@slh.ie name: Emma Noone, BSc MA role: CONTACT phone: 003534065467 email: Emma.Noone@slh.ie name: Sinead Brennan, FFR RCSI role: PRINCIPAL_INVESTIGATOR lat: 53.33306 lon: -6.24889 hasResults: False
<\|newrecord\|> nctId: NCT06327126 id: BFHHZS20240001 briefTitle: Efficacy and Safety of Single-session Endoscopic Stone Extraction overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-25 date: 2024-04-18 name: Beijing Friendship Hospital class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED name: two-session ERCP name: single-session ERCP measure: Success rate of complete stone removal measure: ERCP-related complication rate measure: Length of stay measure: Hospital expenses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Wei Jiang role: CONTACT phone: 18663186116 email: jfw899w@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06327113 id: IRB#23-001248 briefTitle: Antibiotic Tumescent For Chronic Wounds acronym: TAI overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2027-03-25 date: 2028-03-25 date: 2024-03-25 date: 2024-03-25 name: University of California, Los Angeles class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single center, prospective, comparative interventional, two-arm parallel group, randomized, clinical safety and efficacy trial comparing a group receiving standard wound care with tumescent antibiotic injection (TAI) with a control group receiving standard wound care primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: CeFAZolin Injectable Solution measure: Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI measure: Secondary Objective - To evaluate wound size and closure. measure: Secondary Objective - Chronic-wound-related pain measure: Secondary Objective - Rating Quality of life measure: Exploratory Objectives - Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis). measure: Exploratory Objectives - Assess the number of clinical signs of infection in participants. measure: Exploratory Objectives - Determine the species of pathogenic bacteria present in wound. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06327100 id: 2023-0934 id: NCI-2024-02551 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: 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) overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2029-05-01 date: 2031-05-01 date: 2024-03-25 date: 2024-04-29 name: M.D. Anderson Cancer Center class: OTHER name: Active Biotech AB briefSummary: 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 conditions: Post-polycythemia Vera Myelofibrosis conditions: Post-Essential Thrombocytosis Myelofibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Ruxolitinib name: Tasquinimod measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Lucia Masarova, MD role: CONTACT phone: 832-750-4211 email: lmasarova@mdanderson.org name: Lucia Masarova, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06327087 id: 22-00874 briefTitle: Appetite and Dietary Intake Across the Menstrual Cycle overallStatus: RECRUITING date: 2022-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-25 date: 2024-04-04 name: University of British Columbia class: OTHER briefSummary: 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 conditions: Healthy conditions: Dietary Habits studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 23 type: ESTIMATED name: No intervention measure: Energy intake measure: Hunger area under the curve measure: Satiety area under the curve measure: Prospective food consumption area under the curve measure: Free-living ad libitum energy intake measure: Resting metabolic rate measure: Body composition measure: Estradiol measure: Progesterone measure: Physical activity patterns sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of British Columbia - Okanagan status: RECRUITING city: Kelowna state: British Columbia zip: V1V1V7 country: Canada name: Sarah Purcell, PhD role: CONTACT phone: 2508079827 email: sarah.purcell@ubc.ca lat: 49.88307 lon: -119.48568 hasResults: False
<\|newrecord\|> nctId: NCT06327074 id: 21-3063.cc briefTitle: Testing the Engaged Approach to Lung Cancer Screening overallStatus: RECRUITING date: 2024-03-11 date: 2025-12 date: 2026-12 date: 2024-03-25 date: 2024-03-25 name: University of Colorado, Denver class: OTHER name: Bristol-Myers Squibb briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 40 type: ESTIMATED name: Engaged Approach to Lung Cancer Screening measure: Percentage of the intervention group who would like to continue the EA-LCS framework measure: Percentage of the intervention group who would recommend the EA-LCS framework to other programs measure: Percentage of participants who would describe the framework as workable measure: Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM) measure: Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM) measure: Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Hospital status: RECRUITING city: Denver state: Colorado zip: 80045 country: United States name: Jamie Studts role: CONTACT email: Jamie.Studts@CUANSCHUTZ.EDU name: Jamie Studts, PhD role: PRINCIPAL_INVESTIGATOR name: Erin Hirsch role: SUB_INVESTIGATOR lat: 39.73915 lon: -104.9847 hasResults: False
<\|newrecord\|> nctId: NCT06327061 id: R01DA058659 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA058659 id: IRB00026607 type: OTHER domain: JHSPH IRB briefTitle: Social Network Overdose Prevention and Education Intervention overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-12-01 date: 2024-03-25 date: 2024-04-16 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a standard two-group clinical trial, one group is the experimental, the other the control primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Both groups receive overdose prevention training whoMasked: PARTICIPANT count: 600 type: ESTIMATED name: Network overdose prevention name: Standard of care health education measure: Number of drug overdoses measure: Participant drug use measure: Number of Network member contacts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Bloomberg School of Public Health city: Baltimore state: Maryland zip: 21205 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06327048 id: School of Nursing briefTitle: Application of Cognitive Training Based on Remind Strategy in Glioma Patients With Cognitive Impairment overallStatus: RECRUITING date: 2024-03-06 date: 2024-11-30 date: 2024-12-01 date: 2024-03-25 date: 2024-03-25 name: YuanYuan Ma class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-randomized intervention study primaryPurpose: OTHER masking: SINGLE maskingDescription: Blind the evaluator whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Individual cognitive rehabilitation training based on Remind strategy was given measure: Montreal Cognitive Assessment(MoCA) measure: The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30) measure: The EORTC QLQ-Brain Neoplasms 20(EORTC QLQ-BN20) measure: Self-Rating Anxiety Scale(SAS) measure: Self-Rating Depression Scale(SDS) measure: Modified Barthel Index(MBI) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yuanyuanma status: RECRUITING city: Lanzhou state: Gansu country: China name: yuanyuan ma, Bachelor role: CONTACT phone: 15294126094 email: 1657107645@qq.com lat: 36.05701 lon: 103.83987 hasResults: False
<\|newrecord\|> nctId: NCT06327035 id: 2023-A02660-45 briefTitle: Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center acronym: PROWALK overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2025-04-01 date: 2025-04-01 date: 2024-03-25 date: 2024-03-25 name: Clinique Les Trois Soleils class: OTHER name: Le Normandy briefSummary: 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 conditions: Gait, Hemiplegic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Gait rehabilitation measure: Functional Ambulation Classification measure: Postural Assesment Scale for Stroke Patient measure: Timed Up and Go measure: 10-Meter Walk Test measure: 6Minute-Walk Test measure: Motricity Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06327022 id: P0038444 briefTitle: Social Media-based Electronic Bibliotherapy for Dementia Caregivers overallStatus: COMPLETED date: 2022-07-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-25 date: 2024-03-25 name: The Hong Kong Polytechnic University class: OTHER briefSummary: 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 conditions: Quality of Life conditions: Dementia Caregivers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Social media-based electronic bibliotherapy name: Usual care measure: Changes in mental health measure: Changes in health related quality of life measure: Changes in caregiving appraisal measure: Changes in psychological wellbeing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Kowloon country: Hong Kong lat: 22.31667 lon: 114.18333 hasResults: False
<\|newrecord\|> nctId: NCT06327009 id: fasting ramadan in GN patients briefTitle: Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-04-22 date: 2024-05-22 date: 2024-03-25 date: 2024-03-25 name: Alexandria University class: OTHER briefSummary: This research aims to assess effects of ramadan fasting on kidney function and proteinuria in patients with glomerulonephritis. conditions: Fasting Ramadan studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: fasting month of ramadan measure: Change in kidney function measure: Change in proteinuria sex: ALL minimumAge: 18 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Aexandria University city: Alexandria zip: 21526 country: Egypt name: Mohamed Mamdouh Elsayed, MD role: CONTACT email: dr_mohamedmamdouh87@yahoo.com lat: 31.21564 lon: 29.95527 hasResults: False
<\|newrecord\|> nctId: NCT06326996 id: 23-001185 briefTitle: Thiamine Intervention and Coronary Artery Bypass Grafting acronym: B1&CABG overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-01 date: 2026-05 date: 2024-03-25 date: 2024-04-01 name: University of California, Los Angeles class: OTHER briefSummary: 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 conditions: Coronary Artery Bypass Grafting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Post-CABG patients with and without thiamine treatment. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be assigned a random number, double-blind randomized, \& longitudinal study design. whoMasked: PARTICIPANT count: 52 type: ESTIMATED name: Thiamine name: Placebo measure: Effects of thiamine treatment intervention on blood lactate levels. measure: Effects of thiamine treatment intervention on blood thiamine levels. measure: Effects of thiamine treatment intervention on blood inflammatory levels. measure: Evaluate cognitive function in CABG patients with thiamine treatment. measure: Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment. measure: Examine cognition in CABG patients with thiamine treatment. measure: Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment. measure: Cognition assessment in CABG patients after thiamine treatment. measure: Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment. measure: Long term effect of thiamine treatment intervention on quality of life. measure: Long term effect of thiamine treatment intervention on daily activities using PASE. measure: Long term effect of thiamine treatment intervention on daily activities using PPA. sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06326983 id: IRB-P00047028 briefTitle: Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-04-01 date: 2024-03-25 date: 2024-03-25 name: Boston Children's Hospital class: OTHER briefSummary: 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 conditions: Post-operative Nausea and Vomiting (PONV) conditions: Emergence Delirium conditions: Opioid Analgesic Adverse Reaction conditions: Anesthesia conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Dexmedetomidine name: Acetaminophen name: Ketorolac name: Morphine measure: Median Pain Scores in the Post-Anesthesia Care Unit measure: Post-operative pain at 12-24 hours measure: Post Operative Anesthesia Unit Length of Stay (hours) measure: Opioid rescue medication administration measure: Emergence Delirium measure: Post-operative nausea and vomiting measure: Procedure length (minutes) measure: Intraoperative Blood pressure (mmHg) measure: Intraoperative Heart rate (beats per second) measure: Vasopressor administration sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06326970 id: HenanICE202401 briefTitle: SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-22 date: 2024-03-22 name: Henan Institute of Cardiovascular Epidemiology class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: 99mTc-FAPI SPECT imaging measure: positive uptake sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326957 id: 334979 V1 15/01/2024 id: NIHR302904 type: OTHER_GRANT domain: National Institute for Health & Care Research (NIHR) id: 24/LO/0142 type: OTHER domain: Research Ethics Committee (REC) briefTitle: Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE) acronym: SELF-BREATHE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-02 date: 2028-07 date: 2024-03-22 date: 2024-03-25 name: King's College Hospital NHS Trust class: OTHER briefSummary: 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.

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