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The hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants.
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The aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days. conditions: Preterm Birth Complication conditions: Digestive System Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Abdominal massage measure: Clinical Abdominal assessment scale for Preterm infants score (ECAP score) measure: Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes measure: Weight gain of preterm infants with feeding intolerance measure: Duration to reach the full ration measure: Duration of hospitalization in level 3 measure: 6-hour fasting windows measure: Incidence of occurrence of necrotizing enterocolitis measure: Evolution of digestive tolerance over time sex: ALL minimumAge: 3 Days maximumAge: 60 Days stdAges: CHILD facility: CHU clermont-ferrand city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 hasResults: False
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<|newrecord|> nctId: NCT06351189 id: CIVI/2022/AD-01 briefTitle: NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ? acronym: DYNAMIC SYSTEM overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-01 date: 2026-08-01 date: 2024-04-08 date: 2024-04-08 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: This study compares two modes of the NETTI wheelchair (dynamic or sitting) for patients with hyperkinetic syndromes, to discover which mode is the most comfortable and best suited to these patients.
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It is a prospective, single-center pilot study comparing two medical devices evaluated using SCED (Single Case Experimental Design) ABAB methodology: NETTI DYNAMIC chair in dynamic mode (intervention group; phase B) versus the same chair in static mode (control group; phase A). The subject will be his/her own control conditions: Hyperextension Spasms conditions: Involuntary Movements studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 5 type: ESTIMATED name: Observation measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in static mode (PHASE A) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Sex measure: Age measure: Height measure: Weight measure: Body mass index sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351176 id: 2024-6819 briefTitle: Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes acronym: DenSiFy cohort overallStatus: ENROLLING_BY_INVITATION date: 2023-07-04 date: 2024-12-22 date: 2025-08-29 date: 2024-04-08 date: 2024-04-08 name: CHU de Quebec-Universite Laval class: OTHER name: Diabetes Canada briefSummary: Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.
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This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D. conditions: Diabetes Mellitus, Type 1 conditions: Bone Health conditions: Bone Loss conditions: Bone Diseases, Metabolic conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 163 type: ESTIMATED name: Clinical tests name: Biochemical tests name: DXA scan with TBS and VFA name: AGEReader measure: Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2 measure: Change in areal bone mineral density (aBMD) at the spine in g/cm2 measure: Change in areal bone mineral density (aBMD) at the total hip in g/cm2 measure: Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2 measure: Change in Trabecular bone score (TBS) (unitless) measure: Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years measure: Glycemic control, assessed with skin advanced glycation end products (AGEs) measure: Presence of a microvascular complication (neuropathy, nephropathy, retinopathy) measure: Areal bone mineral density at the femoral neck, g/cm2 measure: Areal bone mineral density at the femoral neck, T-Score measure: Areal bone mineral density at the femoral neck, Z-Score measure: Areal bone mineral density at the total hip, g/cm2 measure: Areal bone mineral density at the total hip, T-score measure: Areal bone mineral density at the total hip, Z-score measure: Areal bone mineral density at the spine, g/cm2 measure: Areal bone mineral density at the spine, T-Score measure: Areal bone mineral density at the spine, Z-score measure: Areal bone mineral density at the distal third of radius, g/cm2 measure: Areal bone mineral density at the distal third of radius, T-score measure: Areal bone mineral density at the distal third of radius, Z-score measure: Trabecular bone score (TBS) at the lumbar spine (L1-L4) (unitless) measure: Vertebral Fracture Assessment (VFA) from the T4 to L5 vertebrae to detect the presence of vertebral fracture measure: Lean mass (arm, leg, trunk, android, gynoid and total) (g) measure: Fat mass (arm, leg, trunk, android, gynoid and total) (g) measure: C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) measure: Procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) measure: Osteocalcin (ng/mL) measure: Sclerostin (pmol/mL) measure: Change in C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) measure: Change in osteocalcin (ng/mL) measure: Change in procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) measure: Change in sclerostin (pmol/mL) measure: Skin advanced glycation end-products (AGEs) (arbitrary units) measure: Glycated hemoglobin (HbA1c, %) measure: Fasting glucose (mmol/L) measure: Complete blood count measure: Thyroid-stimulating hormone (TSH) (mU/L) measure: Lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol/HDL-cholesterol ratio, triglycerides, in mmol/L) measure: Creatinine (umol/L) measure: Microalbuminuria (mg/mmol) measure: Liver enzymes (AST, ALT) (U/L) measure: Calcium (mmol/L) measure: Albumine (g/L) measure: Phosphate (mmol/L) measure: 25-hydroxyvitamin D3 (nmol/L) measure: Parathormone (PTH) (ng/L) measure: Antitransglutaminase antibodies (U/mL) measure: Immunoglobulin A (IgA) (g/L) measure: Insulin like growth factor-1 (IGF-1) (ng/mL) measure: Follicle stimulating hormone (FSH, women) (U/L) measure: Total testosterone (men) (nmol/L) measure: Sex hormone-binding globulin (SHBG, men) (nmol/L) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut de recherches cliniques de Montréal (IRCM) city: Montréal state: Quebec zip: H2W 1R7 country: Canada lat: 45.50884 lon: -73.58781 facility: Centre de recherche du CHU de Québec-Université Laval city: Quebec City state: Quebec zip: G1V 4G2 country: Canada lat: 46.81228 lon: -71.21454 hasResults: False
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<|newrecord|> nctId: NCT06351163 id: 1451_03/BVNTW-VNCSKTE briefTitle: Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study overallStatus: COMPLETED date: 2016-01 date: 2020-12 date: 2024-03 date: 2024-04-08 date: 2024-04-08 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients. conditions: Intussusception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 181 type: ACTUAL name: Laparoscopic reduction name: Transumbilical mini-open reduction measure: Operating time measure: Intraoperative complications measure: Immediate postoperative complications measure: Time to feed measure: Hospital stays measure: Recurrence rate measure: Long-term complication rate sex: ALL minimumAge: 2 Months maximumAge: 12 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 facility: Vinmec Research Institute of Stem Cell and Gene Technology city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False
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<|newrecord|> nctId: NCT06351150 id: TQG3902-III-01 briefTitle: Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group. conditions: Vasodilatory Shock studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 214 type: ESTIMATED name: Angiotensin II Injection name: 0.9% sodium chloride injection measure: Proportion of subjects with blood pressure response at 3 hours after administration of study drug measure: Sequential Organ Failure Assessment (SOFA) total score measure: Cardiovascular SOFA subscore measure: Mortality at Day 7 measure: Mortality at Day 28 measure: Proportion of subjects with blood pressure response at 1 hour after administration measure: Proportion of subjects with blood pressure response at 2 hours after administration measure: Change in background vasoactive agent dose from 0 to 48 hours measure: Absolute change in blood lactate from 0 to 3 hours measure: Absolute change in blood lactate from 3 to 48 hours measure: Absolute change in heart rate from 0 to 3 hours measure: Absolute change in heart rate from 3 to 48 hours measure: Adverse events (AE) measure: Serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Yun Long, M.D. role: CONTACT phone: 13911608699 email: [email protected] lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Sun Yat sen University city: Guangzhou state: Guangdong zip: 510062 country: China name: Xiangdong Guan, M.D. role: CONTACT phone: 13802925067 email: [email protected] lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong zip: 510260 country: China name: Zhanguo Liu, M.D. role: CONTACT phone: 18520711669 email: [email protected] lat: 23.11667 lon: 113.25 facility: Qingyuan Hospital Affiliated to Guangzhou Medical University city: Qingyuan state: Guangdong zip: 511518 country: China name: Jingwen Yang, M.D. role: CONTACT phone: 13542498765 email: [email protected] lat: 23.7 lon: 113.03333 facility: The First Affiliated Hospital of Shantou University Medical College city: Shantou state: Guangdong zip: 515041 country: China name: Yongru Chen, M.D. role: CONTACT phone: 13411969797 email: [email protected] lat: 23.36814 lon: 116.71479 facility: Liuzhou General Hospital city: Liuzhou state: Guangxi zip: 545026 country: China name: Guangyu Lv, M.D. role: CONTACT phone: 13977210130 email: [email protected] facility: The Affiliated Hospital of Hebei University city: Baoding state: Hebei zip: 050031 country: China name: Zhanbiao Yu, M.D. role: CONTACT phone: 15188655821 email: [email protected] lat: 38.85111 lon: 115.49028 facility: The First Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150007 country: China lat: 45.75 lon: 126.65 facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu state: Henan zip: 233099 country: China name: Yongsheng Zheng, M.D. role: CONTACT phone: 13955252796 email: [email protected] lat: 32.94083 lon: 117.36083 facility: The First Affiliated Hospital of Henan University of Science and Technology city: Luoyang state: Henan zip: 450052 country: China name: Qizhi Fu, M.D. role: CONTACT phone: 13837944687 email: [email protected] lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450052 country: China name: Tongwen Sun, M.D. role: CONTACT phone: 13838516916 email: [email protected] lat: 34.75778 lon: 113.64861 facility: Union Hospital, Tongji Medical College of huazhong university of science and technology city: Wuhan state: Hubei zip: 430022 country: China name: You Shang, M.D. role: CONTACT phone: 15972127819 email: [email protected] lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 140008 country: China name: Lina Zhang, M.D. role: CONTACT phone: 15874875763 email: [email protected] lat: 28.19874 lon: 112.97087 facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China name: Quan Cao, M.D. role: CONTACT phone: 13851992695 email: [email protected] lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shaanxi zip: 710004 country: China name: Xiaochuang Wang, M.D. role: CONTACT phone: 13772152935 email: [email protected] lat: 34.25833 lon: 108.92861 facility: The First Hospital of Shanxi Medical University city: Taiyuan state: Shanxi zip: 030001 country: China name: Jing Cao, M.D. role: CONTACT phone: 13834691242 email: [email protected] lat: 37.86944 lon: 112.56028 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610044 country: China name: Yan Kang, M.D. role: CONTACT phone: 13808041931 email: [email protected] lat: 30.66667 lon: 104.06667 facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China name: Xiaobo Huang, M.D. role: CONTACT phone: 18140049936 email: [email protected] lat: 30.66667 lon: 104.06667 facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 830054 country: China name: Xiangyou Yu, M.D. role: CONTACT phone: 13009681003 email: [email protected] lat: 43.80096 lon: 87.60046 hasResults: False
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<|newrecord|> nctId: NCT06351137 id: INIV2023 briefTitle: Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain overallStatus: RECRUITING date: 2024-03-13 date: 2024-06-01 date: 2024-06-01 date: 2024-04-08 date: 2024-04-08 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Prehospital treatment of acute traumatic pain is common in military practice. Analgesics are usually administered intravenously (IV). Research from the civil prehospital environment shows that obtaining IV access can be difficult and time consuming, delaying onset of treatment. The challenges for obtaining IV access in the military prehospital setting are even bigger, for example in combat environments. However, this has not been assessed.
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Current guidelines also offer alternative routes of administration for analgesics, for example intranasal (IN) administration. IN administration is a fast, easy and effective route of administration. This study determines whether IN administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to IV administration in patients with acute traumatic pain in a simulated military prehospital environment. conditions: Acute Pain Due to Trauma conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Intravenous administration name: Intranasal administration measure: Time required for administration of analgesic (minutes) measure: Total time spent on scene (minutes) measure: Time required for obtaining IV access measure: Time required preparing IN administration measure: Satisfaction of the navy nurse regarding the used route of administration. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: Midas N de Grunt, MD role: CONTACT phone: +31205669111 email: [email protected] name: Markus W Hollmann, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06351124 id: 00005294 briefTitle: Beta-Hydroxybutyrate Feasibility Treating IBS acronym: BHB overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: University of Texas at Austin class: OTHER briefSummary: This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.
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The main questions it aims to answer are:
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* BHB supplementation will be feasible and acceptable to patients.
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* BHB supplementation will be associated with a reduction in systemic inflammation.
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* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.
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Participants will:
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* Take 3 capsules x 3 times per day for 4 weeks.
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* Document food consumption using a 24-hour food recall questionnaire.
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* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.
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Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease. conditions: Crohn's Disease conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a prospective, open-label, randomized, two-arm pilot trial of adults primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm. count: 12 type: ESTIMATED name: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease measure: Ability to enroll patients who meet the inclusion criteria within the target time frame measure: Adherence to proposed study timelines and anticipated study costs measure: Patient adherence to the intervention measure: Microbial Diversity measure: BHB Blood Levels measure: Gastrointestinal Symptoms measure: Quality of Life measure: Clinical Response measure: Systemic Inflammation measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin city: Austin state: Texas zip: 78712 country: United States name: Michelle Stickler, Associate Vice President, DEd role: CONTACT phone: 512-475-6323 email: [email protected] name: Thomas Street, Executive Director role: CONTACT phone: 512 495 5142 email: [email protected] lat: 30.26715 lon: -97.74306 hasResults: False
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<|newrecord|> nctId: NCT06351111 id: IRB-24-240 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-08 date: 2024-04-08 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06351098 id: 2024579 briefTitle: Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition acronym: HSR overallStatus: RECRUITING date: 2023-11-05 date: 2028-06 date: 2028-06 date: 2024-04-08 date: 2024-04-08 name: University of Maryland, College Park class: OTHER name: University of Massachusetts, Amherst briefSummary: To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims:
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* Examine neural markers that predict the sleep transition (Aim 1);
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* Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2);
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* Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3)
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* Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4) conditions: Memory studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: nap measure: Memory sex: ALL minimumAge: 36 Months maximumAge: 60 Months stdAges: CHILD facility: University of Maryland status: RECRUITING city: College Park state: Maryland zip: 20742 country: United States name: Tracy Riggins, Ph.D. role: CONTACT phone: 301-405-5905 email: [email protected] name: Postdoctoral Fellow role: CONTACT phone: 301-405-5922 email: [email protected] lat: 38.98067 lon: -76.93692 facility: University of Massachusetts status: RECRUITING city: Amherst state: Massachusetts zip: 01003 country: United States name: Rebecca MC Spencer, PhD role: CONTACT phone: 413-577-6128 email: [email protected] name: Postdoctoral Fellow role: CONTACT phone: 413-545-4831 email: [email protected] lat: 42.36723 lon: -72.51852 hasResults: False
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<|newrecord|> nctId: NCT06351085 id: 1937769-1 briefTitle: Enhancing Lung Cancer Screening Through Human-Centered Intervention acronym: ELFE overallStatus: RECRUITING date: 2022-11-10 date: 2025-04-14 date: 2025-04-14 date: 2024-04-08 date: 2024-04-08 name: University of California, Davis class: OTHER briefSummary: The purpose of this study is to further understand the factors involved in increasing lung cancer screening. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal. primaryPurpose: SCREENING masking: SINGLE maskingDescription: Biostatistician created a randomized table to allocate patient in either intervention 1 or 2. whoMasked: PARTICIPANT count: 2869 type: ESTIMATED name: Pre-Visit Planner name: Pre-Visit Planner + MyChart measure: Lung Cancer Screening measure: Completion of Interviews with Staff and Patients sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Davis status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Moon Chen, M.P.H, Ph.D role: CONTACT phone: 916-548-3928 email: [email protected] name: Moon Chen, M.P.H, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False
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<|newrecord|> nctId: NCT06351072 id: NOXANI briefTitle: Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia acronym: ANI overallStatus: RECRUITING date: 2024-04-02 date: 2024-09-01 date: 2024-10-01 date: 2024-04-08 date: 2024-04-26 name: University of Padova class: OTHER briefSummary: qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.
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No trials have compared them, so with this trial authors want to explore the correlations between them. conditions: Analgesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Correlation between qNOX and ANI values measure: Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain measure: Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Treviso Regional Hospital status: RECRUITING city: Treviso state: TV zip: 31100 country: Italy name: Federico Linassi role: CONTACT email: [email protected] lat: 45.66673 lon: 12.2416 hasResults: False
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<|newrecord|> nctId: NCT06351059 id: UE-0083 briefTitle: Acoustic Emission Biomarkers for the Detection and Monitoring of Early Knee Osteoarthritis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-07-31 date: 2024-12-31 date: 2024-04-08 date: 2024-04-19 name: Schulthess Klinik class: OTHER name: Ecole Polytechnique Fédérale de Lausanne briefSummary: The aim of this exploratory study is to further investigate the potential of acoustic emission biomarkers, assessed by the inmodi knee brace, to diagnose osteoarthritis (OA) at earlier stages. Therefore, 20 healthy participants and 100 patients with increased risk of knee OA will be recruited from the Schulthess Klinik in Zurich and examined twice with 9 ± 3 months' time interval. Anthropometric data, EOS radiographs and MR images of both knees, PROMs and acoustic emission data will be collected and evaluated. Artificial Intelligence algorithm will then be used to identify and validate the most promising acoustic emission biomarkers with a prognosis value in the prediction of knee osteoarthritis progress. conditions: Osteoarthritis, Knee conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ACTUAL name: InModi acoustic emission analysis measure: acoustic emissions measure: kinematic data measure: MRI / MOAKS measure: EOS / leg alignment measure: PROMS sex: ALL minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schulthess Klinik city: Zürich state: ZH zip: 8008 country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06351046 id: NCT05178082_WP3 briefTitle: Preventive Interventions for Chronic Pain Worsening overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-07-30 date: 2027-01-30 date: 2024-04-08 date: 2024-04-08 name: Rigshospitalet, Denmark class: OTHER name: The Novo Nordic Foundation briefSummary: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck. conditions: Chronic Non-Cancer Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): MBSR group, VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention. primaryPurpose: PREVENTION masking: NONE maskingDescription: The statistical analysis of the data will be blinded count: 78 type: ESTIMATED name: Online Mindfullness Based Stress Reduction Program name: Virtual Reality-based Pain Self-management program measure: Pain intensity measure: Pain intensity and interference in daily activities measure: Pain catastrophizing measure: Pain acceptance measure: Health status measure: Health related quality of life measure: Anxiety measure: Depression measure: Use of medication measure: Use of healthcare system measure: Number of absent days at work measure: Satisfaction with the intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351033 id: ADP_012023 briefTitle: Ozonized Oil as Dietary Supplement in Macular Degeneration overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-31 date: 2024-12 date: 2024-12 date: 2024-04-08 date: 2024-04-08 name: Alba Di Pardo class: OTHER briefSummary: Macular degeneration, also called age-related macular degeneration (AMD), is a leading cause of visual impairment and severe vision loss.
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AMD is a disease with a multifactorial etiology. The main factors which, associated with the genetic ones, increase the risk of WMD onset are represented by smoking, obesity, hypertension, cardio-vascular diseases, a diet rich in dietary fat and alcohol intake. From an organic point of view, AMD is a disease that affects the macular region of the retina, causing progressive loss of central vision.
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Retinal cells are characterized by high oxygen consumption. Reactive oxygen species (ROS), such as superoxide anion, hydrogen peroxide and hydroxyl radical are the standard product of cellular metabolism within the mitochondria. Under physiological conditions, ROS are neutralized by a system of antioxidants. In case of cellular metabolism disturbances or insufficiency of the antioxidant system, an excess of ROS can be produced which contributes to oxidative stress, widely described as exerting deleterious effects on cells. The high oxygen requirement and low levels of antioxidant enzymes make the retina extremely sensitive to oxidative stress and more susceptible to cell death. Prevention of neuronal death in the retina becomes a crucial aspect for the management of WMD.
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The treatment of choice for AMD today is the use of anti-VEGF (Vascular Endothelial Growth Factor) drugs, they are effective for neo-vascular AMD, acting on the inhibition of the angiogenic protein VEGF, which is produced in the retina and induced by hypoxia and other conditions. It is practice, however, to support the integration of nutritional supplements such as zinc, resveratrol, carotenoids such as lutein and zeaxanthin, vitamin E and Omega-3 fatty acids.
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The aim of this study is to evaluate the efficacy of ozonated oil with high ozonides (HOO) administered orally as gastro-resistant capsules (O3Zone, GS Pharma, Malta), as an integrative and complementary treatment in patients affected by macular degeneration in the possible slowing of disease progression. conditions: Maculopathy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: High ozonide (HOO) ozonated oil measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy and closure of the study sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Neuromed city: Pozzilli country: Italy lat: 41.51142 lon: 14.06252 hasResults: False
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<|newrecord|> nctId: NCT06351020 id: LM302-03-101 briefTitle: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-08-10 date: 2026-12-15 date: 2024-04-08 date: 2024-04-08 name: LaNova Medicines Zhejiang Co., Ltd. class: INDUSTRY briefSummary: This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: experimental arm:LM-302 control arm:Apatinib or Irinotecan primaryPurpose: TREATMENT masking: NONE count: 375 type: ESTIMATED name: LM-302 name: Apatinib name: Irinotecan measure: Overall Survival (OS) measure: Progression Free Survival (PFS) measure: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease control rate (DCR) measure: AE and SAE measure: Evaluate the immunogenicity of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of MMAE measure: Evaluation of pharmacokinetic characteristics of MMAE measure: Evaluation of pharmacokinetic characteristics of MMAE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06351007 id: NMM-4650-23-24-1 briefTitle: Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) acronym: EPAK overallStatus: RECRUITING date: 2023-09-19 date: 2024-07 date: 2024-07 date: 2024-04-08 date: 2024-04-08 name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran class: OTHER briefSummary: A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis.
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A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups. conditions: Chronic Kidney Disease conditions: Predialysis conditions: Peritoneal Dialysis conditions: Hemodialysis conditions: Educational Activities conditions: Adherence conditions: Nutritional Status studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: Nutritional education and psychological intervention name: Standard care measure: Patients´ dietary attitude measure: Dietary adherence measure: Nutritional knowledge measure: Muscle status measure: Muscle functionality measure: Nutritional status of predialysis patients measure: Nutritional status of dialysis patients measure: Patients´ quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán status: RECRUITING city: Mexico City zip: 14080 country: Mexico name: Ximena Atilano Carsi, PhD role: CONTACT phone: 00 52 55 56 17 65 42 email: [email protected] lat: 19.42847 lon: -99.12766 hasResults: False
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<|newrecord|> nctId: NCT06350994 id: APHP230625 id: IDRCB 2023-A01957-38 type: OTHER domain: ANSM briefTitle: Early Assessment of Cardiac Function After Treatment With CAR-T Cells acronym: Cardio CAR-T overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-10 date: 2027-01 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.
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Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.
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This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.
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The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5). conditions: Car T- Cell conditions: Hematologic Malignancy conditions: Acute Lymphoblastic Leukemia conditions: Lymphoma, B-Cell conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity measure: Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations measure: Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Critical care medicine department city: Paris zip: 75012 country: France name: Jérémie JOFFRE, MD, PhD role: CONTACT phone: +33 1 49 28 21 45 email: [email protected] name: Hafid AIT-OUFELLA, Professor role: CONTACT phone: +33 1 49 28 21 45 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06350981 id: FORE813 briefTitle: Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-03-01 date: 2024-04-08 date: 2024-04-08 name: Foundation for Orthopaedic Research and Education class: OTHER name: Pacira Pharmaceuticals, Inc briefSummary: The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores. conditions: Back Pain conditions: Surgery-Complications conditions: Narcotic Use conditions: Physical Stress conditions: Post Operative Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 76 type: ESTIMATED name: Exparel name: Bupivacain measure: Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion. measure: Total Postsurgical opioid consumption measure: Time to discharge measure: Time to ambulation measure: Maximum ambulated distance measure: Numeric Rating Pain Scale (Physical Therapy) measure: Numeric Rating Pain Scale measure: Oswestry Disability Index (ODI) measure: Pain Catastrophizing Scale (PCS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation for Orthopaedic Research and Education city: Tampa state: Florida zip: 33607 country: United States name: Deborah H Warren role: CONTACT phone: 813-910-3688 email: [email protected] lat: 27.94752 lon: -82.45843 hasResults: False
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<|newrecord|> nctId: NCT06350968 id: MEC-2023-0151 id: 10200012110003 type: OTHER_GRANT domain: ZonMw briefTitle: Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord acronym: INDEED overallStatus: RECRUITING date: 2023-10-01 date: 2026-06-30 date: 2026-12-31 date: 2024-04-08 date: 2024-04-08 name: Erasmus Medical Center class: OTHER name: Maasstad Hospital name: Spijkenisse Medical Center name: Franciscus &Vlietland name: IJsselland name: Ikazia Hospital, Rotterdam name: Van Weel-Bethesda hospital name: Albert Schweitzer Hospital name: Beatrix hospital briefSummary: The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD.
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The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed?
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Healthcare providers and patients are asked to use the module and share their experiences with it. conditions: Oncology conditions: Advance Care Planning conditions: Implementation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Implementation outcome measure: Intervention outcome measure: Implementation outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Joica Benschop status: RECRUITING city: Rotterdam zip: 3023TB country: Netherlands name: Joica Benschop, MSc role: CONTACT phone: +31622586583 email: [email protected] name: Wendy Oldenmenger, PhD role: CONTACT phone: +31651072608 email: [email protected] lat: 51.9225 lon: 4.47917 hasResults: False
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<|newrecord|> nctId: NCT06350955 id: 2022-01389 briefTitle: IV Iron-induced Hypophosphatemia After RYGB acronym: IVORY overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Lucie Favre class: OTHER briefSummary: The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®). conditions: Hypophosphatemia conditions: Roux-en-Y Gastric Bypass studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 94 type: ESTIMATED name: Iron isomaltoside name: Iron Carboxymaltose measure: incidence of hypophosphatemia in RYGB patients treated with intravenous iron sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350942 id: 1451_01/BVNTW-VNCSKTE briefTitle: One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication overallStatus: COMPLETED date: 2016-09 date: 2020-12 date: 2024-02 date: 2024-04-08 date: 2024-04-08 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children. conditions: Ureteral Duplication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU) measure: Mean operating time measure: Intraoperative complications measure: Conversion to open measure: Early postoperative complications measure: Median length of hospital stays measure: Mean UPM renal pelvis' APD measure: Mean SFU of UPM renal pelvis measure: Mean UPM ureter's diameter measure: Mean UPM DRF measure: Mean DRF of operated side sex: ALL minimumAge: 1 Month maximumAge: 10 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 facility: Vinmec Research Institute of Stem Cell and Gene Technology city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False
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<|newrecord|> nctId: NCT06350929 id: RC31/24/0017 briefTitle: Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients acronym: NORAFLOW overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-04-08 date: 2024-04-08 name: University Hospital, Toulouse class: OTHER briefSummary: Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.
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The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction. conditions: Hypotension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Cardiac output monitoring by the Starling™ SV Sebac® measure: Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction. measure: Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus. measure: Evaluation of the impact of the norepinephrine bolus on blood pressure correction. measure: Evaluation of the impact of the norepinephrine bolus on heart rate. measure: Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Toulouse Rangueil city: Toulouse zip: 31400 country: France name: François LABASTE, Dr role: CONTACT phone: 0561322822 phoneExt: +33 email: [email protected] lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06350916 id: IRB00082594 id: LCI-GI-CRC-SEAMLESS-2020 type: OTHER domain: Atrium Health briefTitle: Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery overallStatus: COMPLETED date: 2021-01-28 date: 2021-07-30 date: 2021-10-01 date: 2024-04-08 date: 2024-04-08 name: Wake Forest University Health Sciences class: OTHER name: Atrium Health Levine Cancer Institute briefSummary: The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery. conditions: Colorectal Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 75 type: ACTUAL name: SeamlessMD® Mobile Application measure: Perioperative ERAS metric completion rate measure: Postoperative hospital length of stay measure: Postoperative complications measure: 30-day readmission measure: Postoperative Opioid Consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States lat: 35.22709 lon: -80.84313 hasResults: False
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<|newrecord|> nctId: NCT06350903 id: ICM 2024-3356 briefTitle: Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging acronym: SWEET-HEART overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-08 date: 2024-04-09 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. conditions: Myocardial Suppression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Fast + High-fat low-carbohydrate diet name: Fast + Empagliflozin measure: Levels of serum Beta-hydroxybutyrate (BHB) mmol/L measure: Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L measure: Proportions of glycemia levels (mmol/L) <3.5 mmol/L measure: Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350890 id: HTD1801.PCT105 briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-11-05 date: 2025-03 date: 2025-09 date: 2024-04-08 date: 2024-04-18 name: HighTide Biopharma Pty Ltd class: INDUSTRY briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone. conditions: T2DM (Type 2 Diabetes Mellitus) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 405 type: ESTIMATED name: HTD1801 name: Placebo measure: Primary Endpoint: Mean Change in HbA1c measure: Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose measure: DB Phase: Mean Change in 2-Hour Postprandial Glucose measure: DB Phase: Proportion of patients achieving HbA1c <7.0% measure: DB Phase: Proportion of patients achieving HbA1c <6.5% measure: DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) measure: Open Label Extension (OLE) Phase: Mean Change in HbA1c measure: OLE Phase: Mean change in 2-Hour Postprandial Glucose measure: OLE Phase: Proportion of patients achieving HbA1c <7.0% measure: OLE Phase: Proportion of patients achieving HbA1c <6.5% measure: OLE Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: OLE Phase: Mean Change in LDL-C sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuancheng People's Hospital status: RECRUITING city: Xuancheng state: Anhui country: China lat: 25.40949 lon: 116.3841 facility: Beijing Pinggu Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Fuwai Hospital, CAMS & PUMC status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Huizhou Municipal Central Hospital status: RECRUITING city: Huizhou state: Guangdong country: China lat: 23.11147 lon: 114.41523 facility: Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: Cangzhou Central Hospital status: RECRUITING city: Cangzhou state: Hebei country: China lat: 38.31667 lon: 116.86667 facility: Handan First Hospital status: RECRUITING city: Handan state: Hebei country: China lat: 36.60056 lon: 114.46778 facility: Hengshui People's Hospital (Harrison International Peace Hospital) status: RECRUITING city: Hengshui state: Hebei country: China lat: 37.73222 lon: 115.70111 facility: Hebei Petro China Center Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: The First Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: The Fourth Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The Third Affiliated Hospital of Qiqihar Medical College status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Nanyang Medical College status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: Zhumadian Central Hospital status: RECRUITING city: Zhumadian state: Henan country: China lat: 32.97944 lon: 114.02944 facility: Huangshi Central Hospital status: RECRUITING city: Huangshi state: Hubei country: China lat: 30.24706 lon: 115.04814 facility: Jingzhou Central Hospital status: RECRUITING city: Jingzhou state: Hubei country: China lat: 30.35028 lon: 112.19028 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: The First People's Hospital of Changde City status: RECRUITING city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 facility: Hunan Provincial People's Hospital status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: Yueyang People's Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: Baotou City Central Hospital status: RECRUITING city: Baotou state: Inner Mongolia country: China lat: 40.65222 lon: 109.82222 facility: Inner Mongolia Autonomous Region People's Hospital status: RECRUITING city: Hohhot state: Inner Mongolia country: China lat: 40.81056 lon: 111.65222 facility: The First People's Hospital of Changzhou status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: Huai'an First People's Hospital status: RECRUITING city: Huai'an state: Jiangsu country: China lat: 33.50389 lon: 119.14417 facility: The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing Jiangning Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Sir Run Run Hospital Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: The Second Norman Bethune Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: Tonghua Central Hospital status: RECRUITING city: Tonghua state: Jilin country: China lat: 41.71972 lon: 125.92639 facility: Panjin Liaohe Oilfield Gem Flower Hospital status: RECRUITING city: Panjin state: Liaoning country: China lat: 41.121 lon: 122.0739 facility: The Sixth People's Hospital of Shenyang status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Qinghai Provincial People's Hospital status: RECRUITING city: Xining state: Qinghai country: China lat: 36.62554 lon: 101.75739 facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine status: RECRUITING city: Xianyang state: Shaanxi country: China lat: 34.33778 lon: 108.70261 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Liaocheng People's Hospital status: RECRUITING city: Liaocheng state: Shandong country: China lat: 36.45596 lon: 115.97766 facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: The Third People's Hospital of Datong status: RECRUITING city: Datong state: Shanxi country: China lat: 40.09361 lon: 113.29139 facility: Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: People's Hospital of Tianjin status: RECRUITING city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: The First People's Hospital of Kashgar status: RECRUITING city: Kashgar state: Xinjiang country: China lat: 39.47066 lon: 75.98951 facility: The Second Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 hasResults: False
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<|newrecord|> nctId: NCT06350877 id: PA RCT briefTitle: 1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being overallStatus: RECRUITING date: 2024-01-08 date: 2025-01 date: 2025-01 date: 2024-04-08 date: 2024-04-08 name: University of Toronto class: OTHER briefSummary: Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses.
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Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include:
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* Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes?
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* Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination?
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Trial participants will be randomly assigned to one of the following groups:
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1. 1:1 physical activity training;
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2. Group-based physical activity training consisting of small 5-8 person groups; or
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3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated.
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The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes. conditions: Physical Activity conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A 3-arm parallel Randomized Controlled Trial (RCT) assessing the immediate (post-intervention) and short-term (1-month) impact of the experimental arms (1:1 physical activity delivery and group-based physical activity delivery) compared to a 10-week control arm (wait-list control) will be conducted. A parallel arm design will be implemented, whereby participants will be randomized to a study arm and each study arm will be allocated a different intervention. The protocol adheres to CONSORT guidelines and SPIRIT recommendations for reporting of clinical trial protocols. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Following completion of the baseline assessment (T1), students will be randomly assigned to an experimental arm or the control arm by a program coordinator for the study. To prevent care provider bias, the physical activity coaches will remain blind to the purpose of group allocation and hypotheses of the study. Research Randomizer (www.randomizer.org) will be used to allocate participants into three equal groups using a blocked design (with an allocation ratio of 1:1:1). whoMasked: CARE_PROVIDER count: 93 type: ESTIMATED name: Physical Activity Intervention measure: Depression measure: Anxiety measure: Psychological distress measure: Social Support measure: Social Connectedness measure: Physical Activity Behaviour measure: Intervention Reach measure: Therapeutic Alliance measure: Intervention Satisfaction measure: Coach Perceptions sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Toronto, Mental Health and Physical Activity Research Centre status: RECRUITING city: Toronto state: Ontario zip: M5S 2W6 country: Canada name: Melissa L deJonge, Msc role: CONTACT phone: 9059739414 email: [email protected] name: Catherine M Sabiston, PhD role: CONTACT phone: 416-978-5837 email: [email protected] name: Melissa L deJonge, Msc role: SUB_INVESTIGATOR name: Delaney E Thibodeau, Msc role: SUB_INVESTIGATOR name: Sandra Yeun, PhD role: SUB_INVESTIGATOR name: Luc Simard role: SUB_INVESTIGATOR name: Catherine M Sabiston, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06350864 id: FMASU R11/2024 briefTitle: HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU overallStatus: RECRUITING date: 2024-01-20 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Ain Shams University class: OTHER briefSummary: Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) . conditions: Upper Gastrointestinal Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, randomized, comparative, controlled clinical trial study primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The patients and anesthesiologists in charge of the case will be unmasked as High-flow nasal cannula HFNC) shape,setting and preparation are completely different from the Conventional nasal oxygen therapy (COT), so masking both of them is impossible. whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: High-flow nasal cannula (HFNC) name: Conventional nasal oxygen therapy (COT) name: Upper gastrointestinal endoscopy (UGE) including gastroscopy name: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA) measure: Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure. measure: The median lowest SpO2 -Any episode of hypoxia -Clinically significant hypoxia -Sedation and procedure related adverse effects -Endoscopy procedure time -Anesthetic time -Propofol total used doses measure: Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes measure: Clinically significant hypoxia measure: Sedation related adverse effects (SRAEs) measure: Procedure-related adverse events (PRAEs) measure: Endoscopy procedure time measure: Anesthetic time sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University-Faculty of Medicine status: RECRUITING city: Cairo country: Egypt name: Ahmed M Mohamed, MD role: CONTACT phone: 002 01121318459 email: [email protected] name: Wessam Z Selima, MD role: CONTACT phone: 002 01001958858 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06350851 id: BA161WP1 briefTitle: Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination acronym: Obi1 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-04 date: 2024-04-05 date: 2024-04-05 name: Bioaster class: OTHER briefSummary: Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.
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To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.
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At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs. conditions: Onchocerciasis conditions: Loiasis conditions: Mansonelliasis conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 400 type: ESTIMATED name: Biological samples collection (blood drawing + feces) measure: Evaluation of the performance of the prototype diagnostic test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Higher Institute for Scientific and Medical Research city: Yaounde zip: 5797 country: Cameroon name: Joseph KAMGNO role: CONTACT phone: +237 6 75 06 91 58 email: [email protected] name: Joseph KAMGNO role: PRINCIPAL_INVESTIGATOR lat: 3.86667 lon: 11.51667 hasResults: False
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<|newrecord|> nctId: NCT06350838 id: KN-BCG-I briefTitle: Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC) overallStatus: COMPLETED date: 2022-11-11 date: 2023-02-13 date: 2023-02-13 date: 2024-04-05 date: 2024-04-05 name: Chengdu CoenBiotech Co., Ltd class: INDUSTRY name: Hunan Cancer Hospital briefSummary: Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC) conditions: Non-muscular Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: BCG for Therapeutic Use measure: Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events; measure: Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT). measure: Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count. measure: Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT). measure: Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count. measure: Effects on vital signs,such as temperature. measure: Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram. measure: Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure. measure: Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function. measure: Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG). measure: Shedding condition of the test drug in urine. measure: To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 415000 country: China lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06350825 id: 2023-SR-543 briefTitle: Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients overallStatus: RECRUITING date: 2016-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-04-05 date: 2024-04-05 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP) conditions: Metastatic Prostate Cancer conditions: Therapy, Directly Observed studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Cytoreductive prostatectomy or brachytherapy name: ADT+second-generation antiandrogens ± chemotherapy measure: rPFS measure: Safety of CRP in mHSPC patients sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Shangqian Wang, M.D. role: CONTACT phone: 13770561625 email: [email protected] name: Lixin Hua, M.D. role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2024-03-20 uploadDate: 2024-03-20T11:18 filename: Prot_ICF_000.pdf size: 125657 hasResults: False
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<|newrecord|> nctId: NCT06350812 id: PB119110 briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-04-29 date: 2025-04-29 date: 2024-04-05 date: 2024-04-05 name: PegBio Co., Ltd. class: OTHER briefSummary: The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: PB-119 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Effectiveness index measure: Effectiveness index sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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