text
stringlengths 0
197k
|
|---|
Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Allopregnanolone measure: Study completion measure: Adverse Events measure: Infusion Reactions measure: Pharmacokinetics: Peak Plasma Concentration (Cmax) measure: Pharmacokinetics: Time of peak concentration (tmax) measure: Pharmacokinetics: Half-life (t1/2) measure: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) measure: Dopamine transporter (DaT) SPECT imaging measure: MRI: Regional brain volumes measure: MRI: Fractional Anisotropy measure: MRI: Quantitative anisotropy measure: MRI: Functional connectivity measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part I (non-motor EDL) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part II (motor EDL) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part III (motor examination) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part IV (motor complications) measure: Mean rate of change in the Unified Dyskinesia Rating Scale (UDysRS) total score measure: Change from baseline in Montreal Cognitive Assessment (MoCA) score measure: Change from baseline in Parkinson's disease Questionnaire (PDQ-39). measure: Change from baseline in Hamilton Depression Rating Scale (HAM-D) measure: Cambridge Cognition's Paired Associates Learning (PAL) Test measure: Cambridge Cognition's Motor Screening Task (MOT) measure: Cambridge Cognition's One Touch Stockings of Cambridge (OTS) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Arizona Clinical & Translational Science Research Center status: RECRUITING city: Tucson state: Arizona zip: 85721 country: United States name: Dakota Darby role: CONTACT email: dakotadarby@arizona.edu lat: 32.22174 lon: -110.92648 hasResults: False
|
<|newrecord|> nctId: NCT06262997 id: TU-FTR-AMUTLU-2 briefTitle: Effectiveness of Pilates and Taping in Office Workers With Neck Pain overallStatus: RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-02-15 date: 2024-02-16 date: 2024-02-23 name: Tarsus University class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of pilates and kinesiotape applications in office workers with neck pain. In this direction, neck pain and disability, pain threshold, muscle strength, range of motion, core endurance, postural awareness and quality of life will be evaluated. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group will receive only pilates training. Other group participants will receive kinesiobant application in addition to pilates training. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The researcher who will do the pilates training and taping and the other researcher who will do the pre-test and post-test are blinded. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Pilates name: Pilates and Kinesiotape measure: Neck Disability Index measure: Pain PressureThreshold measure: Muscle Strength measure: Range of Motion measure: Prone Bridge Test measure: Sits Up Test: measure: Postural Habits and Awareness Scale measure: Short Form 36 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tarsus University status: RECRUITING city: Mersin country: Turkey name: Ali Mutlu role: CONTACT name: Ali MUTLU role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False
|
<|newrecord|> nctId: NCT06262984 id: 2023/21-754 briefTitle: Therapeutic Play Before Nasopharyngeal Swabbing in Children overallStatus: COMPLETED date: 2024-02-19 date: 2024-03-13 date: 2024-03-13 date: 2024-02-16 date: 2024-03-15 name: Maltepe University class: OTHER briefSummary: The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure. conditions: Behavior, Coping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ACTUAL name: Therapeutic Play measure: Children's emotional manifestation sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Maltepe University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06262971 id: PCI-LM-Registry-2018 briefTitle: Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital overallStatus: COMPLETED date: 2018-06-01 date: 2022-12-31 date: 2023-12-31 date: 2024-02-16 date: 2024-02-16 name: Medipol University class: OTHER briefSummary: This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease. conditions: Coronary Artery Disease conditions: Left Main Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3620 type: ACTUAL name: Percutaneous coronary intervention measure: Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI measure: Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR) measure: Procedure-Related Complications Within 30 Days of PCI measure: Health-Related Quality of Life (HRQoL) Scores One Year After PCI measure: Rate of stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06262958 id: KUH5703459 briefTitle: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent acronym: REAL-SMART overallStatus: RECRUITING date: 2017-08-07 date: 2030-06-01 date: 2030-06-01 date: 2024-02-16 date: 2024-02-16 name: Kuopio University Hospital class: OTHER briefSummary: ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it conditions: Alcoholism conditions: Substance Abuse conditions: Alcohol Dependence conditions: Alcohol-Related Disorders conditions: Substance Use Disorders conditions: Adolescent Behavior conditions: Adolescent Problem Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment. primaryPurpose: TREATMENT masking: NONE count: 800 type: ESTIMATED name: ASSIST name: Treatment as usual measure: Decreased consumption of alcohol, tobacco or substances measure: BDI scores measure: GAD scores sex: ALL minimumAge: 14 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Kuopio University Hospital status: RECRUITING city: Kuopio zip: 70110 country: Finland name: Sanna Voutilainen, Res. nurse role: CONTACT phone: +358447175351 email: sanna.voutilainen@kuh.fi lat: 62.89238 lon: 27.67703 hasResults: False
|
<|newrecord|> nctId: NCT06262945 id: YDU/2024/120-1808 briefTitle: Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery. overallStatus: COMPLETED date: 2024-01-02 date: 2024-02-06 date: 2024-02-07 date: 2024-02-16 date: 2024-02-16 name: Beste Erismen class: OTHER briefSummary: The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days. conditions: Impacted Third Molar Tooth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 60 type: ACTUAL name: Diagnoses name: traditional osteotomies name: platelet rich fibrin name: Antibiotics, Penicillin name: low laser therapy, bicure laser name: Analgesic measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Trismus measure: Trismus measure: Trismus measure: Trismus measure: Swelling measure: Swelling measure: Swelling measure: Swelling measure: the number of analgesic tablets measure: the number of analgesic tablets measure: the number of analgesic tablets measure: the number of analgesic tablets sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Near East University city: Nicosia state: Lefkosa zip: 99138 country: Cyprus lat: 35.17531 lon: 33.3642 hasResults: False
|
<|newrecord|> nctId: NCT06262932 id: RADS regimen briefTitle: Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-08 name: Police General Hospital, Thailand class: OTHER briefSummary: The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen
|
* Repeated dosing regimen
|
* Standard dosing regimen conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Amiodarone measure: Heart rate measure: Normal sinus rhythm at 24 hours measure: Heart rate measure: Major adverse cardiovascular events measure: Phlebitis measure: Changed in heart rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06262919 id: CDRB436I1401 briefTitle: Special Drug Use-results Surveillance of Tafinlar/Mekinist overallStatus: RECRUITING date: 2024-02-09 date: 2031-12-31 date: 2031-12-31 date: 2024-02-16 date: 2024-03-22 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture. conditions: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Tafinlar/Mekinist measure: [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation measure: [Adult patients] overall response rate (ORR) measure: [Pediatric patients] Incidence proportion of ORR measure: [Pediatric and adult patients] Incidence proportion of PFS measure: [Pediatric patients] Number of patients with changes in height and body weight and sexual maturation sex: ALL minimumAge: 6 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Kobe state: Hyogo zip: 650-0011 country: Japan lat: 34.6913 lon: 135.183 facility: Novartis Investigative Site status: RECRUITING city: Akita zip: 010-8543 country: Japan lat: 39.71667 lon: 140.10826 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 534-0021 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 550-0015 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False
|
<|newrecord|> nctId: NCT06262906 id: BA-VCAP-01 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-16 date: 2024-04-25 name: [Redacted] hasResults: False
|
<|newrecord|> nctId: NCT06262893 id: Shoulder nerve blocks briefTitle: Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2025-12 date: 2026-01 date: 2024-02-16 date: 2024-02-16 name: Assiut University class: OTHER briefSummary: In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment. conditions: Shoulder Arthroscopy Blocks conditions: Dexamethasone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Shoulder arthroscopy blocks measure: Postoperative analgesia by visual analog scale (VAS). measure: Diaphragmatic excursion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University city: Assiut country: Egypt name: Assiut University role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False
|
<|newrecord|> nctId: NCT06262880 id: BIO-2305 briefTitle: Dietary Supplementation on Gastrointestinal Barrier Function overallStatus: RECRUITING date: 2024-02-06 date: 2024-12-20 date: 2025-02-06 date: 2024-02-16 date: 2024-03-08 name: Brightseed class: INDUSTRY briefSummary: The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo. conditions: Intestinal Permeability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 126 type: ESTIMATED name: plant derived phenolics name: Microcrystaline cellulose (MCC) measure: 0-2 h urine 13C Mannitol excretion measure: 2 to 8 h urine 13C Mannitol measure: 0 to 2 h urine LMR measure: 2 to 8 h urine LMR measure: Blood Biomarkers measure: Blood Biomarkers measure: Blood Biomarkers measure: Fecal Biomarkers measure: Fecal Biomarkers measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: 7-day recall of gastrointestinal symptoms measure: 7-day recall of gastrointestinal symptoms measure: Stool frequency measure: Stool consistency measure: Body Weight sex: ALL minimumAge: 30 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biofortis status: RECRUITING city: Addison state: Illinois zip: 60101 country: United States name: Chad Cook role: CONTACT lat: 41.9317 lon: -87.98896 hasResults: False
|
<|newrecord|> nctId: NCT06262867 id: ReadySetFood briefTitle: Early Allergen System Experience acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2026-09-01 date: 2026-09-01 date: 2024-02-16 date: 2024-02-20 name: Prollergy dba Ready Set Food class: OTHER name: ObvioHealth briefSummary: Multiple clinical trials have demonstrated that early allergen introduction, feeding babies common food allergens before six months, decreases children's risk of developing a food allergy. Despite successful food allergy introduction trials showing that food allergies can be prevented, early introduction in the required amount can be challenging for parents. In some studies, less than 20% of parents introduce peanuts before their child is six months old, and few feed them regularly after introduction. Ready. Set. Food! is a direct-to-consumer product that offers a convenient supplement with a daily dose regimen that can be added to breastmilk, formula, or food to make early allergen introduction easy. The formulation includes cow's milk, egg, and peanut, representing the majority of childhood food allergies, and the protein levels are based on doses found to be effective in clinical trials. Over 200,000 infants have used Ready. Set. Food!.
|
This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies. The study will enroll 1,100 infants stratified by their risk of developing a food allergy who are assigned to either receive Ready. Set. Food! supplements or follow standard allergen introduction practices recommended by their pediatrician.
|
The goal of this study is to assess how Ready. Set. Food! allergen introduction supplements improve the experience of parents introducing allergens, decrease healthcare costs related to food allergies, and decrease food allergy prevalence. conditions: Food Allergy in Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1110 type: ESTIMATED name: Ready. Set. Food! Stage 1 Mix ins measure: The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period measure: Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut measure: Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut measure: Frequency of caregiver-reported special interest adverse events (FPIES and anaphylaxis) after introduction to cow's milk, egg, and peanut by 12 months of age measure: The proportion of caregivers who are satisfied with introduction of egg, cow's milk, and peanut measure: The total allergy-related healthcare costs measure: The proportion of participants with food allergy to cow's milk, egg, or peanut measure: The proportion of participants with a suspected food allergy sex: ALL minimumAge: 2 Months maximumAge: 5 Months stdAges: CHILD hasResults: False
|
<|newrecord|> nctId: NCT06262854 id: AOU Careggi Firenze briefTitle: Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study acronym: BIG D-FOOT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-31 date: 2024-02-16 date: 2024-02-16 name: Azienda Ospedaliero-Universitaria Careggi class: OTHER briefSummary: This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures. conditions: Diabete Mellitus conditions: Foot Ulcer conditions: Osteomyelitis - Foot conditions: Surgical Procedure, Unspecified studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Granules of calcium sulphate with and without antibiotics are identical and undistinguishable. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Calcium-sulphate granules with tobramicina+vancomicina measure: The composite primary endpoint of this study will be the incidence osteomyelitis recurrence or new osteomyelitis in adjacent sites or tissue infection at the site of osteomyelitis. measure: Proportion of healed patients measure: Proportion of osteomyelitis recurrence measure: Proportion of post-surgical tissue infection measure: Proportion of wound recurrence measure: Proportion of patients undergoing major amputation measure: Proportion of patients undergoing new surgical intervention measure: Ulcer time-to-healing measure: Osteomyelitis time-to-recurrence measure: Any serious adverse events measure: Any non serious adverse events measure: Proportion of post-surgical dehiscence measure: Direct medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06262841 id: Murat Kaan Erdem briefTitle: Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments overallStatus: COMPLETED date: 2022-11-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-16 date: 2024-02-16 name: Ankara University class: OTHER briefSummary: The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life. conditions: Impacted Third Molar Tooth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 21 type: ACTUAL name: Piezosurgery name: Conventional burs measure: Change in Oral Health-related Quality of Life measure: Change in pain measure: Change in Mouth opening measure: Operation time measure: Change in facial swelling sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ankara University Faculty of Dentistry city: Ankara state: Çankaya zip: 06510 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
|
<|newrecord|> nctId: NCT06262828 id: UW 24-064 briefTitle: HEARTWISE - P-CARDIAC for Chinese: Population-based Study acronym: HEARTWISE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-01-31 date: 2027-04-30 date: 2024-02-16 date: 2024-02-16 name: The University of Hong Kong class: OTHER briefSummary: Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC. conditions: Cardiovascular Diseases conditions: CVD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: The relationship between P-CARDIAC risk score and heart disease related symptoms measure: P-CARDIAC risk thresholds determination sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Nursing, The University of Hong Kong city: Hong Kong country: Hong Kong name: Sze Ling Celine Chui, PhD role: CONTACT phone: (852) 3917 6629 email: cslchui@hku.hk lat: 22.27832 lon: 114.17469 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-31 uploadDate: 2024-01-31T01:00 filename: Prot_SAP_000.pdf size: 294821 hasResults: False
|
<|newrecord|> nctId: NCT06262815 id: 2023-06806-01 briefTitle: The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction acronym: NGTUBE-OBS overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: Daniel Wilhelms class: OTHER name: Linkoeping University briefSummary: Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.
|
Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.
|
To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed. conditions: Small Bowel Obstruction conditions: Frailty conditions: Nasogastric Tube studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Nasogastric tube placement name: Clinical Frailty Scale measure: Pain at Emergency Department discharge measure: Nausea at Emergency Department discharge measure: Hospital Length of Stay measure: Mortality measure: Admission for Small bowel obstruction measure: Emergency Surgery measure: Emergency Department Length of Stay sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sahlgrenska Universitetssjukhuset status: RECRUITING city: Göteborg country: Sweden name: Nina Bardhi, MD role: CONTACT lat: 57.70716 lon: 11.96679 facility: Östra sjukhuset status: RECRUITING city: Göteborg country: Sweden name: Mathias Jerkfelt, MD role: CONTACT lat: 57.70716 lon: 11.96679 facility: Skånes Universitetssjukhus status: ACTIVE_NOT_RECRUITING city: Lund country: Sweden lat: 55.70584 lon: 13.19321 facility: Skånes Universitetssjukhus status: ACTIVE_NOT_RECRUITING city: Malmö country: Sweden lat: 55.60587 lon: 13.00073 facility: Lasarett i Motala status: RECRUITING city: Motala country: Sweden name: Jens Wretborn, PhD role: CONTACT phone: +46101033000 email: jens.wretborn@regionostergotland.se lat: 58.53706 lon: 15.03649 facility: Vrinnevisjukhuset status: RECRUITING city: Norrköping country: Sweden name: Sigrid Wallden, MD role: CONTACT lat: 58.59419 lon: 16.1826 facility: Sundsvalls sjukhus status: RECRUITING city: Sundsvall country: Sweden name: Robert Schytzer, MD role: CONTACT lat: 62.39129 lon: 17.3063 facility: Akutmottagningen US Östergötland status: RECRUITING city: Linköping state: Östergötland zip: 58185 country: Sweden name: Jens Wretborn, PhD role: CONTACT phone: +46101033000 email: jens.wretborn@regionostergotland.se name: Alaa Hussein, MD role: CONTACT phone: +46101033000 email: alaa.hussein@regionostergotland.se lat: 58.41086 lon: 15.62157 hasResults: False
|
<|newrecord|> nctId: NCT06262802 id: 123123 briefTitle: Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2025-03-01 date: 2024-02-16 date: 2024-02-16 name: Radwa Hydar Ragab class: OTHER briefSummary: Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions conditions: Odontogenic Cysts studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DEVICE_FEASIBILITY masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Active decompression measure: Volume change sex: ALL minimumAge: 12 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06262789 id: 49RC23_0011 briefTitle: RAT-HEMATO : Return to Work After Malignant Hemopathy acronym: RAT-HEMATO overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-01 date: 2027-04-01 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Angers class: OTHER_GOV briefSummary: Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality. conditions: Leukemia conditions: Lymphoma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 264 type: ESTIMATED name: "Return-to-work after cancer" consultation measure: Return-to-work rate at 1 year (percentage) measure: Cumulative incidence of return-to-work at 1 year measure: Change or not of the professional situation in the 2 arms measure: Factors influencing return to work measure: Quality of life (SF-12 score) evolution measure: Anxiety and depression (HAD scale) evolution measure: Return-to-work self-efficacy (RTW-SE-11 scale) evolution measure: Self-assessment of the benefit of the "return-to-work after cancer" consultation sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Angers University hospital city: Angers country: France name: PAILLASSA Jérome, MD role: CONTACT phone: 02.41.35.45.24 phoneExt: +33 email: jerome.paillassa@chu-angers.fr lat: 47.46667 lon: -0.55 facility: Brest University Hospital, Morvan Site city: Brest country: France name: Marie-Anne Couturier, MD role: CONTACT phone: 02.98.22.30.37 email: marie-anne.couturier@chu-brest.fr lat: 48.3903 lon: -4.48628 facility: Caen University hospital city: Caen country: France name: Ghandi Laurent DAMAJ, MD role: CONTACT phone: 02.31.27.21.40 phoneExt: +33 email: damaj-gl@chu-caen.fr lat: 49.18585 lon: -0.35912 facility: Rennes University Hospital, Pontchaillou site city: Rennes country: France name: Roch HOUOT, MD role: CONTACT phone: 02.99.28.42.91 phoneExt: +33 email: roch.houot@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: Centre Henri Becquerel city: Rouen country: France name: Stéphane LEPRETRE, MD role: CONTACT phone: 02.32.08.22.23 phoneExt: +33 email: stephane.lepretre@chb.unicancer.fr lat: 49.44313 lon: 1.09932 facility: Rouen University Hospital city: Rouen country: France name: Laetitia ROLLIN, MD role: CONTACT phone: 02.32.88.82.69 email: laetitia.rollin@chu-rouen.fr lat: 49.44313 lon: 1.09932 facility: Tours University Hospital, Bretonneau Site city: Tours country: France name: Emmanuel GYAN role: CONTACT phone: 02.47.47.38.11 email: e.gyan@chu-tours.fr lat: 47.38333 lon: 0.68333 hasResults: False
|
<|newrecord|> nctId: NCT06262776 id: SIRZOSTER1.01 briefTitle: Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients acronym: SIR ZOSTER overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-06 date: 2026-11 date: 2024-02-16 date: 2024-02-16 name: Central Adelaide Local Health Network Incorporated class: OTHER_GOV name: National Health and Medical Research Council, Australia name: University of Adelaide name: Royal Prince Alfred Hospital, Sydney, Australia briefSummary: The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:
|
1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?
|
2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination. conditions: Immunosuppression conditions: Vaccine Response Impaired studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Recombinant zoster vaccine adjuvanted (SHINGRIX) measure: Functional T cell memory measure: Frequency of virus specific T cells measure: Magnitude of antibody response measure: Concentration of post-vaccination circulating cytokines measure: Frequency of polyfunctional T cells measure: Magnitude of vaccine-induced cross-protective antiviral responses measure: Frequency of virus-specific T stem cell memory compared to baseline measure: Incidence of shingles measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Tolerability of vaccination regimen as assessed by EQ-5D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06262763 id: HILT for SIJP briefTitle: High-intensity Laser Therapy for Sacroiliac Joint Pain acronym: Girls overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-03 date: 2023-04-28 date: 2024-03-28 date: 2024-02-16 date: 2024-02-16 name: Kafrelsheikh University class: OTHER briefSummary: Effect of high intensity laser on sacroiliac joint pain conditions: Sacroiliac Joint Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Laser Therapy name: Traditional exercises name: Placebo laser measure: Pain intensity measure: Pressure pain threshold measure: Functional disability sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Kafr Al-Sheikh University city: Kafr Ash Shaykh country: Egypt lat: 31.11174 lon: 30.93991 hasResults: False
|
<|newrecord|> nctId: NCT06262750 id: 00375/23 briefTitle: Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study acronym: SAPIENT overallStatus: RECRUITING date: 2023-12-01 date: 2023-12-01 date: 2025-11-01 date: 2024-02-16 date: 2024-02-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients conditions: Splanchnic Vein Thrombosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 170 type: ESTIMATED measure: Incidenze of bleedings events measure: Incidence of venous and arterial thromboembolic events measure: Rate of progress /stable /regressive measure: incidence of liver related events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC Servizio e DH Ematologia status: RECRUITING city: Rome zip: 00168 country: Italy name: Valerio De Stefano role: CONTACT name: Rossella Talerico role: SUB_INVESTIGATOR name: Silvia Betti role: SUB_INVESTIGATOR name: Francesco Santopaolo role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
|
<|newrecord|> nctId: NCT06262737 id: RBHP 2023 CHIAMBARETTA id: 2023-A01121-44 type: REGISTRY domain: ANSM briefTitle: Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol acronym: PISO overallStatus: RECRUITING date: 2023-09-30 date: 2024-10-01 date: 2025-10-01 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF. conditions: Macular Degeneration conditions: Diabetic Macular Edema conditions: Retinal Vein Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: OSDI measure: OSDI measure: HM measure: AM measure: NIBUT 1 measure: NIBUT 2 measure: Interferometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France lat: 45.77966 lon: 3.08628 hasResults: False
|
<|newrecord|> nctId: NCT06262724 id: Perforator Flaps briefTitle: Breast Reshaping Following Massive Weight Loss overallStatus: COMPLETED date: 2021-08-01 date: 2023-08-01 date: 2024-01-01 date: 2024-02-16 date: 2024-02-26 name: Ain Shams University class: OTHER briefSummary: Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss conditions: Breast Ptosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients were subjected to the same intervention. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Breast auto-augmentation measure: Measurement of breast volume by sono-mammography measure: Sternal notch to nipple distance measure: Nipple to inframammary fold distance measure: Measure of nipple-to-nipple distance sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medicine, Ain Shams University city: Cairo state: Abbasia zip: 11591 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
|
<|newrecord|> nctId: NCT06262711 id: 321917 briefTitle: Effects of Vitamin C on Skeletal Muscle acronym: VICS overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-03 date: 2024-02-16 date: 2024-02-16 name: University of East Anglia class: OTHER name: The Norfolk and Norwich University Hospitals NHS Foundation Trust name: The Quadram Institute Clinical Research Facility briefSummary: As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Crossover Assignment primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Double blind masking whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Vitamin C name: Placebo measure: Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups. measure: Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups. measure: Difference in knee extension strength between vitamin C and placebo groups. measure: Difference in hand grip strength between vitamin C and placebo groups. measure: Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups. measure: Difference in plasma vitamin C between vitamin C and placebo groups. measure: Difference in serum hs-CRP between vitamin C and placebo groups. measure: Difference in serum IL-6 between vitamin C and placebo groups. measure: Difference in serum TNF-α between vitamin C and placebo groups. measure: Difference in plasma P1NP between vitamin C and placebo groups. measure: Difference in plasma CTX between vitamin C and placebo groups. sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of East Anglia city: Norwich state: Norfolk zip: NR4 7TJ country: United Kingdom lat: 52.62783 lon: 1.29834 hasResults: False
|
<|newrecord|> nctId: NCT06262698 id: 81825902.903/148 briefTitle: The Effect of HBM-Based Education on Nursing Students acronym: HBM overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-16 date: 2024-02-16 name: Kafkas University class: OTHER briefSummary: The purpose of the study is to investigate the effect of HBM-based education on CAM knowledge, attitudes, and health beliefs related to medication use among nursing students through a randomized controlled trial.
|
Research hypotheses:
|
Hypothesis 01: There is no effect of HBM-based education on CAM knowledge level among nursing students.
|
Hypothesis 1: There is an effect of HBM-based education on CAM knowledge level among nursing students.
|
Hypothesis 02: There is no effect of HBM-based education on CAM attitude level among nursing students.
|
Hypothesis 2: There is an effect of HBM-based education on CAM attitude level among nursing students.
|
Hypothesis 03: There is no effect of HBM-based education on health beliefs related to medication use among nursing students.
|
Hypothesis 3: There is an effect of HBM-based education on health beliefs related to medication use among nursing students. conditions: Nursing conditions: Evidence-Based Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive six weeks of HBM-based training. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Participants were assigned to groups using the "simple randomization method". Participants were not informed of which group they were in. Automated computer-based randomization resulted in the implementation of the experiment with the scheduling scenario and confidential allocation of participants to one of the four intervention branches. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or a control condition. In addition, researchers coding and analyzing data will be blind to randomization and interventions. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Experiment group name: Pre-post test measure: The TCM Attitude Scale (CACMAS) The GETAT Attitude Scale (CACMAS): The scale, developed by McFadden et al. (2010), consists of 27 items rated on a 7-point Likert scale. Its Turkish validity and reliability were established by Köse et al. (2018). measure: The Medication Health Belief Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kafkas University Faculty of Health Sciences city: Kars zip: 36500 country: Turkey name: Gönül GÖKÇAY, Asist. Prof. role: CONTACT phone: 05447915549 email: gonul.gokcay@ogr.sakarya.edu.tr lat: 40.59825 lon: 43.08548 hasResults: False
|
<|newrecord|> nctId: NCT06262685 id: 2023-509418-12-00 briefTitle: Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins acronym: PREVESTATGx overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2025-02-10 date: 2025-03-04 date: 2024-02-16 date: 2024-02-16 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER name: Instituto de Salud Carlos III briefSummary: This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol conditions: Cardiovascular Diseases conditions: Dyslipidemias conditions: Statin Adverse Reaction conditions: Pharmacogenic Myopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will remain blinded to arm assigned because pharmacogenetic phenotype and statin/dose-guidance will only be exclusively accesible to the attending physician whoMasked: PARTICIPANT count: 216 type: ESTIMATED name: Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines name: Standard of Care (SoC) dosing of atorvastatin name: Standard of Care (SoC) dosing of simvastatin name: Standard of Care (SoC) dosing of pitavastatin name: Standard of Care (SoC) dosing of rosuvastatin name: Standard of Care (SoC) dosing of prasavastatin name: Standard of Care (SoC) dosing of lovastatin name: Standard of Care (SoC) dosing of fluvastatin measure: Incidence of clinically relevant statin-associated musculoskeletal events measure: Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate measure: Baseline change in statin therapy prescription measure: Cost of a statin preemptive pharmacogenetic prescription scheme measure: Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification measure: Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest measure: Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm measure: SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital La Paz city: Madrid state: Comunidad De Madrid zip: 28046 country: Spain name: Stefan Mark Stewart Balbás, MD role: CONTACT lat: 40.4165 lon: -3.70256 hasResults: False
|
<|newrecord|> nctId: NCT06262672 id: PR0319R01 briefTitle: Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process overallStatus: COMPLETED date: 2021-05-20 date: 2021-11-20 date: 2021-11-20 date: 2024-02-16 date: 2024-02-28 name: Kırklareli University class: OTHER briefSummary: The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail. conditions: Health Behavior conditions: Sleep conditions: Body Weight studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 236 type: ACTUAL name: Evaluation form measure: Health Promotion Life-Style Profile (HPLP-II) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Anthropometric Measurements sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirklareli University city: Kirklareli state: Kayalı zip: 39000 country: Turkey lat: 41.73508 lon: 27.22521 hasResults: False
|
<|newrecord|> nctId: NCT06262659 id: 2023-142 briefTitle: The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula overallStatus: RECRUITING date: 2024-03-08 date: 2024-06-10 date: 2024-09-10 date: 2024-02-16 date: 2024-03-12 name: Kudret Atakan Tekin class: OTHER briefSummary: Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives. conditions: Arteriovenous Fistula studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 66 type: ESTIMATED name: Doppler Ultrasonography Assessment measure: intraoperative Arteriovenous Fistula Flow Measurement sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kudret Atakan Tekin status: RECRUITING city: Merkez state: Çorum country: Turkey name: Kudret Atakan Tekin role: CONTACT phone: 05424912184 email: dr.kudretatakantekin@gmail.com hasResults: False
|
<|newrecord|> nctId: NCT06262646 id: NTEC-2023-677 briefTitle: Video-conferencing FACT for Young Children With Special Needs overallStatus: RECRUITING date: 2024-02-01 date: 2025-01-31 date: 2026-01-31 date: 2024-02-16 date: 2024-02-16 name: Chinese University of Hong Kong class: OTHER name: Hong Kong Christian Service name: Hong Kong Federation of Youth Groups name: Hong Kong Young Women's Christian Association name: Yang Memorial Methodist Social Service name: Hong Kong Sheng Kung Hui Welfare Council briefSummary: Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.
|
Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.
|
Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.
|
Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.
|
Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population. conditions: Autism Spectrum Disorder conditions: Attention Deficit Hyperactivity Disorder conditions: Specific Learning Disorder conditions: Communication Disorders conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 253 type: ESTIMATED name: Focused Acceptance and Commitment Therapy name: Control Group measure: Parenting stress measure: Parental depressive symptoms measure: Parental anxiety symptoms measure: Parental Psychological Flexibility measure: ACT Core Process Utilization sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Pui Tik YAU role: CONTACT phone: (852) 3943-9915 email: jamyau@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
|
<|newrecord|> nctId: NCT06262633 id: CRE-2023.079 briefTitle: A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer overallStatus: RECRUITING date: 2024-03-15 date: 2026-04-30 date: 2026-06-30 date: 2024-02-16 date: 2024-03-19 name: Chinese University of Hong Kong class: OTHER briefSummary: This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 103 type: ESTIMATED name: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation measure: The oncological control of prostate cancer measure: Cancer detection on biopsy of each ablated MRI visible lesion measure: Cancer detection on biopsy of each ablated MRI invisible lesion measure: Gleason 4 or 5 cancer detected on biopsy of ablated area measure: Out-of-field recurrence: Any cancer outside treated area on systematic biopsy measure: Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measure: PSA change measure: Urinary Symptoms after treatment measure: Sexual side effects after treatment measure: Continence side effects after treatment measure: Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity measure: Quality of life measured by ED-5Q-5Lquestionnaire measure: Quality of life in patients with prostate cancer measured by EPIC-26 measure: Quality of life measured by QLQ-C30, sex: MALE minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peter Ka-Fung CHIU status: RECRUITING city: Sha Tin country: Hong Kong name: Peter Ka-Fung CHIU, PhD,MBChB role: CONTACT phone: 35052625 email: peterchiu@surgery.cuhk.edu.hk lat: 22.38333 lon: 114.18333 hasResults: False
|
<|newrecord|> nctId: NCT06262620 id: 2022-NHLHCRF-LX-01-0201-06 briefTitle: The Comparisonof Mediastinal/Hilar Lymph Node Biopsies by EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2026-02-18 date: 2026-02-18 date: 2024-02-16 date: 2024-02-16 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic efficacy and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB) in mediastinal/hilar lymph node biopsies.
|
Participants will divided into EBUS-TBNA group, EBUS-TBCB group, and EBUS-TBFB group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBCB, or EBUS-TBFB according to the group.
|
Researchers will compare the adequacy of sampling by the three biopsy techniques, their sample quality, diagnostic rate, and incidence of each adverse events. conditions: Lymphadenopathy Hilar conditions: Lymphadenopathy Mediastinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 723 type: ESTIMATED name: EBUS-TBNA name: EBUS-TBCB name: EBUS-TBFB measure: Dignostic rate of EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB measure: Incidence rate of adverse events measure: the adequacy of sample acquisition measure: the quality of sample acquisition sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06262607 id: CLE400-NP-201 briefTitle: A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica overallStatus: RECRUITING date: 2024-01-29 date: 2024-12-31 date: 2025-01-15 date: 2024-02-16 date: 2024-04-17 name: Clexio Biosciences Ltd. class: INDUSTRY briefSummary: This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP). conditions: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 40 subjects, 2 arms, parallel primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: CLE-400 name: Vehicle measure: Percent change from baseline in weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 4. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical site 11 status: RECRUITING city: Bryant state: Arkansas zip: 72022 country: United States lat: 34.59593 lon: -92.48905 facility: Clinical site 01 status: RECRUITING city: Coral Gables state: Florida zip: 33134 country: United States lat: 25.72149 lon: -80.26838 facility: Clinical Site 10 status: RECRUITING city: North Miami Beach state: Florida zip: 33116 country: United States lat: 25.93315 lon: -80.16255 facility: Clinical Site 02 status: RECRUITING city: Indianapolis state: Indiana zip: 46250 country: United States lat: 39.76838 lon: -86.15804 facility: Clinical Site 23 status: RECRUITING city: Methuen state: Massachusetts zip: 01844 country: United States lat: 42.7262 lon: -71.19089 facility: Clinical Site 09 status: RECRUITING city: Dublin state: Ohio zip: 43016 country: United States lat: 40.09923 lon: -83.11408 facility: Clinical site 16 status: RECRUITING city: Houston state: Texas zip: 77004 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site 06 status: RECRUITING city: San Antonio state: Texas zip: 78213 country: United States lat: 29.42412 lon: -98.49363 hasResults: False
|
<|newrecord|> nctId: NCT06262594 id: L'ÉTOILE briefTitle: Lemborexant Treatment of Insomnia Linked to Epilepsy acronym: L'ÉTOILE overallStatus: NOT_YET_RECRUITING date: 2024-02-08 date: 2025-02-08 date: 2026-02-08 date: 2024-02-16 date: 2024-02-16 name: University of Manitoba class: OTHER name: Duke University briefSummary: The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy. conditions: Epilepsy conditions: Sleep studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: Lemborexant measure: WASO sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06262581 id: 2021-FXY-471 briefTitle: Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery overallStatus: RECRUITING date: 2023-09-23 date: 2024-11-30 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Sun Yat-sen University class: OTHER briefSummary: According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients. conditions: DMMR Colorectal Cancer conditions: Anti PD-1 conditions: Immunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Tisleizumab(BGB-A317) measure: pathological complete regression rate measure: CR rate measure: Major Pathological Response rate measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Gong C Chen, Prof role: CONTACT phone: +862087343584 email: chengong@sysucc.org.cn name: Zhi-zhong Pan, Prof role: SUB_INVESTIGATOR name: Xiao-jun Wu, Prof role: SUB_INVESTIGATOR name: Zhen-hai Lu, Prof role: SUB_INVESTIGATOR name: Pei-rong Ding, Prof role: SUB_INVESTIGATOR name: Li-ren Li, Prof role: SUB_INVESTIGATOR name: Fu-long Wang, M.D. role: SUB_INVESTIGATOR name: Rong-xin Zhang, M.D. role: SUB_INVESTIGATOR name: Jian-hong Peng, M.D. role: SUB_INVESTIGATOR name: Jun-zhong Lin, M.D. role: SUB_INVESTIGATOR name: Ling-heng Kong, M.D. role: SUB_INVESTIGATOR name: Cong Li, M.D. role: SUB_INVESTIGATOR name: Wu Jiang, M.D. role: SUB_INVESTIGATOR name: Wen-hua Fan, M.D. role: SUB_INVESTIGATOR name: Wen-hao Zhou, M.D. role: SUB_INVESTIGATOR name: Jing-hua Tang, M.D. role: SUB_INVESTIGATOR name: Yuan Li, M.D. role: SUB_INVESTIGATOR name: Miaoqing Wu role: SUB_INVESTIGATOR name: Di Cao role: SUB_INVESTIGATOR name: Yi-fan Liu role: SUB_INVESTIGATOR name: Da Kang role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
|
<|newrecord|> nctId: NCT06262568 id: Soh-Med-23-03-18MS briefTitle: Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases overallStatus: RECRUITING date: 2023-04-01 date: 2024-03-01 date: 2024-06-01 date: 2024-02-16 date: 2024-02-16 name: Sohag University class: OTHER briefSummary: The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education. conditions: High Risk Pregnancy and Maternal Near Miss Cases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 71 type: ESTIMATED name: assess the nurse knowledge and practices. measure: Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag University hospitals status: RECRUITING city: Sohag country: Egypt name: ghona Abd EL-Nasser, Professor role: CONTACT phone: 01123067894 email: mahmoud.hazem@nursing.sohag.edu.eg lat: 26.55695 lon: 31.69478 hasResults: False
|
<|newrecord|> nctId: NCT06262555 id: TYGH111061 briefTitle: Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy for Peripheral Lung Cancer overallStatus: RECRUITING date: 2024-03 date: 2024-06-30 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: Taoyuan General Hospital class: OTHER_GOV briefSummary: This research aims to develop an innovative photodynamic therapy (PDT) for peripheral lung tumors. Current treatments involve surgery, chemotherapy, and radiation. Photodynamic therapy, using light and photosensitizing drugs, is promising but has limitations. Our team proposes using Lipiodol, a contrast agent, instilled into the trachea via bronchoscopy, surrounding the tumor. Preliminary pig model trials showed safety. Clinical trials, building on a U.S. study (NCT02916745), commenced in October 2021, treating three cases. Initial results suggest safety, but efficacy requires further investigation. Based on ongoing trials, we propose a phase I trial with multiple light treatments from different directions and an additional dose after 48 hours to assess safety and efficacy. This study will guide future clinical trials for optimal PDT dosage. conditions: Lung Cancer conditions: Lung Cancer Metastatic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: Transbronchial PDT peripheral lung tumor ablation measure: Technical Feasibility measure: Technical Safety measure: Tumor remission rate sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taoyuan General Hospital, Ministry of Health and Welfare status: RECRUITING city: Taoyuan City zip: 320 country: Taiwan name: Yei-San Hsieh, MD role: CONTACT phone: +886-975061108 email: yeisanh@gmail.com name: Yei-San Hsieh, Dr. role: PRINCIPAL_INVESTIGATOR name: Hwi-Lu Chang, Dr. role: SUB_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False
|
<|newrecord|> nctId: NCT06262542 id: 111016 briefTitle: Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia overallStatus: RECRUITING date: 2024-03-13 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-12 name: Taichung Armed Forces General Hospital class: OTHER_GOV briefSummary: Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.
|
Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.
|
Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia. conditions: Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: moxibustion and Chinese herbal medicine group measure: Track the number of white blood cells sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Armed Force General Hospital status: RECRUITING city: Taichung state: Taiping zip: 411228 country: Taiwan name: ming huei cheng role: CONTACT phone: 0921059072 email: u9630091@cmu.edu.tw lat: 24.1469 lon: 120.6839 hasResults: False
|
<|newrecord|> nctId: NCT06262529 id: 22-AOI-06 briefTitle: Neurocognitive Impairment After Ischemic Stroke acronym: COG-TRA-Y MRI overallStatus: RECRUITING date: 2024-02-09 date: 2025-02-09 date: 2027-02-09 date: 2024-02-16 date: 2024-02-16 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.
|
Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.
|
Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).
|
Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.
|
The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: Cerebral MRI measure: evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: cannes Hospital status: NOT_YET_RECRUITING city: Cannes zip: 06600 country: France name: sylvain LACHAUD role: CONTACT email: s.lachaud@ch-cannes.fr name: Sylvain Lachaud role: PRINCIPAL_INVESTIGATOR lat: 43.55135 lon: 7.01275 facility: Nice University Hospital status: RECRUITING city: Nice zip: 06000 country: France name: Marina Passalboni role: CONTACT phone: 04 92 03 27 90 email: passalboni.m@chu-nice.fr name: barbara CASOLLA role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False
|
<|newrecord|> nctId: NCT06262516 id: CASE2824 briefTitle: Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-01-01 date: 2029-01-01 date: 2024-02-16 date: 2024-02-16 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:
|
* To determine oncologic outcomes, specifically 2-year recurrence-free survival
|
* To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
|
* To determine time to recurrence and recurrence patterns
|
* To determine use of adjuvant therapies
|
* To determine perioperative complications
|
Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection. conditions: Urothelial Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a 1:1 two armed randomized-controlled trial. primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: Nephroureterectomy name: Lymph Node Dissection measure: Recurrence-free survival measure: Treatment-free survival measure: Cancer-specific survival measure: Overall Survival measure: Time to recurrence measure: Use of adjuvant therapies measure: Perioperative complications sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Glickman Urological and Kidney Institute city: Cleveland state: Ohio zip: 44195 country: United States name: Mohamed Eltemamy, MD role: CONTACT phone: 216-444-5888 email: Eltemam@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.