Split (1)

train · 22k rows

Record stringlengths 1 197k
<\|newrecord\|> nctId: NCT06332781 id: 2126175 briefTitle: Intravesical Gentamicin to Prevent Recurrent UTI overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-06-01 date: 2025-07-31 date: 2024-03-27 date: 2024-03-28 name: Women and Infants Hospital of Rhode Island class: OTHER briefSummary: Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI) conditions: Recurrent Uti studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Gentamicin name: Nitrofurantoin measure: UTIs measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: urobiome analysis measure: urobiome analysis sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332768 id: WEAN_2021 briefTitle: NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients overallStatus: COMPLETED date: 2017-09-01 date: 2022-01-01 date: 2022-03-01 date: 2024-03-27 date: 2024-03-27 name: Northern State Medical University class: OTHER briefSummary: The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support. conditions: Mechanical Ventilation Complication conditions: Weaning Failure conditions: Acute Respiratory Distress Syndrome conditions: High-flow Oxygenation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized assignment primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ACTUAL name: Respiratory support measure: Weaning failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City hospital # 1 city: Arkhangelsk state: Arkhangelsk Region zip: 163000 country: Russian Federation lat: 64.5401 lon: 40.5433 hasResults: False
<\|newrecord\|> nctId: NCT06332755 id: LG-LRCL001 briefTitle: Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors acronym: LB-LR1109 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2027-02 date: 2024-03-27 date: 2024-03-27 name: LG Chem class: INDUSTRY briefSummary: This is a Phase 1, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose(RP2D) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall cell lung cancer(NSCLC), head and neck squamous cell carcinoma(HNSCC), renal cell carcinoma(RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options. conditions: Non-small Cell Lung Cancer(NSCLC) conditions: Head and Neck Squamous Cell Carcinoma(HNSCC) conditions: Renal Cell Carcinoma(RCC) conditions: Urothelial Carcinoma conditions: Malignant Melanoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: LB-LR1109 measure: MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors measure: Incidence of Treatment-Emergent Adverse Events of LB-LR1109 measure: Preliminary efficacy of LB-LR1109 measure: Anti-tumor efficacy of LB-LR1109 measure: Pharmacokinetic profile of LB-LR1109 measure: Characterize PK of LB-LR1109 measure: Immunogenicity of LB-LR1109 measure: Quality of life of participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332742 id: QXZS for DOR briefTitle: Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased overallStatus: RECRUITING date: 2023-11-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-27 date: 2024-04-04 name: Yun Chen class: OTHER briefSummary: A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction conditions: Decreased Ovarian Reserve studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 178 type: ESTIMATED measure: Traditional Chinese medicine syndrome score measure: serum sex hormone levels measure: serum AMH levels measure: transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC) measure: Seven items of thyroid function measure: natural pregnancy rate sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine status: RECRUITING city: Nanjing state: Jiangsu zip: 210023 country: China name: Chen Yun role: CONTACT phone: 8613675167221 email: 66teoyq@gmail.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06332729 id: EG,KFS,lab reserach 6 briefTitle: Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-15 date: 2024-06-15 date: 2024-03-27 date: 2024-03-27 name: Mahmoud Reda Elsharkawy class: OTHER briefSummary: Summary:
Inclusion Criteria:
* Children aged four to eight years.
* Grade of spasticity ranging from 1 to 1+ on the Modified Ashworth scale.
* Classified as Level I or II on the Gross Motor Functional Classification System (GMFCS).
* Ability to follow verbal commands and instructions.
Exclusion Criteria:
* Previous neurological or orthopedic surgery in the lower extremities.
* Botox injection in the lower extremities within the past six months.
* Fixed deformity in the joints of the lower limb.
* Genu recarvatum secondary to surgery.
* Severe hearing and visual defects.
Materials for Subject Selection and Evaluation:
* Modified Ashworth Scale for muscle tone assessment.
* Gross Motor Functional Classification System (GMFCS) for functional activity classification.
* Digital goniometer for measuring the angle of knee hyperextension.
* Lafayette Manual Muscle Tester for quantifying muscle strength.
Methods:
* Assessment of muscle tone using the Modified Ashworth Scale, evaluating spasticity in calf muscles and hip/knee extensors.
* Evaluation of gross motor function using the GMFCS.
* Assessment of genu recarvatum using a digital goniometer.
* Assessment of muscle strength using the Lafayette Manual Muscle Tester, focusing on hamstrings and tibialis anterior muscles.
* Assessment of range of motion in the knee joint using Kinovea software.
* Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group (Group A and Group B).
Group A Treatment:
- Designed physical therapy program combined with pulley therapy for muscle strengthening.
Group B Treatment:
- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation.
The interventions in both groups aim to improve muscle strength, range of motion, and functional abilities in children with cerebral palsy. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: universal exercis unit name: functional electrical stimulation measure: muscle strength using muscle tester device measure: Range of motion using kinoviea software and digital goniometer measure: range of motion for the joint using digital geniometer sex: ALL minimumAge: 4 Years maximumAge: 8 Years stdAges: CHILD facility: Physical Therapy status: RECRUITING city: Kafr Ash Shaykh country: Egypt name: Mahmoud R Elsharkawy, bachelor role: CONTACT phone: 01021417889 email: mahmoud.elsharakawy1994@gmail.com lat: 31.11174 lon: 30.93991 hasResults: False
<\|newrecord\|> nctId: NCT06332716 id: KY20222234 briefTitle: Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors overallStatus: RECRUITING date: 2022-08-26 date: 2025-12 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: Jianjun Yang,MD class: OTHER briefSummary: Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors. conditions: Gastrointestinal Tumors，3D Organoids，Drug Sensitivity studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time. measure: Progression-free survival（PFS） measure: Overall survival（OS） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: XijingH status: RECRUITING city: Xi'an state: Shaanxi country: China name: Jianjun Yang role: CONTACT phone: 13756154175 email: yangjj@fmmu.edu.cn lat: 34.25833 lon: 108.92861 hasResults: False
<\|newrecord\|> nctId: NCT06332703 id: IACA briefTitle: Acanthamoeba and Artificial Intelligence overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-04 date: 2024-03-27 date: 2024-03-27 name: IRCCS Ospedale San Raffaele class: OTHER briefSummary: Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.
This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.
The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.
The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.
Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.
The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.
The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model. conditions: Acanthamoeba Keratitis conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 151 type: ESTIMATED measure: Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images. measure: Correlation assessment between IVCM images and laboratory results. sex: ALL minimumAge: 1 Year maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332690 id: 514.2021 briefTitle: OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO overallStatus: RECRUITING date: 2023-10-17 date: 2025-06 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: IRCCS Multimedica class: OTHER name: AbbVie briefSummary: The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome. conditions: Diabetic Macular Edema conditions: Macular Edema Due to Diabetes Mellitus conditions: Retinal Vein Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: dexamethasone implant measure: Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure) measure: Initial clinical characteristics in patients with a gain in BCVA (Best Corrected Visual Acuity) of ≥ 5, ≥ 10, and ≥ 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MultiMedica IRCCS Multimedica status: RECRUITING city: Milan zip: 20123 country: Italy name: Stela Vujosevic, MD role: CONTACT phone: +39 02 85 99 4601 email: stela.vujosevic@multimedica.it name: GAbriele Piccoli role: CONTACT phone: +39 02 85 99 4601 email: gabriele.piccoli@multimedica.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06332677 id: TERS briefTitle: Target of Suv420h1/2 in Hepatocytes overallStatus: RECRUITING date: 2023-03-01 date: 2025-02 date: 2026-02 date: 2024-03-27 date: 2024-03-27 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1/2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1/2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1/2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1/2 in human liver organoids/assembloids. conditions: NAFLD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: study the cellular and molecular mechanisms of correlation between the SUV420H1/H2 methyltransferase and the progression of liver damage in mice (San Raffaele Institute) and to confirm these findings in human samples and in vitro 3D liver models. primaryPurpose: PREVENTION masking: NONE count: 260 type: ESTIMATED name: the main genes and expression by comparing the transcriptomic lipidomic profile measure: the main genes and expression by comparing the transcriptomic lipidomic profile measure: the main genes and expression by comparing the transcriptomic lipidomic profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica status: RECRUITING city: Milano zip: 20122 country: Italy name: Luca Vittorio Carlo Valenti role: CONTACT phone: 02 5503 6595 email: luca.valenti@policlinico.mi.it lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-01-26 uploadDate: 2024-03-14T09:56 filename: Prot_SAP_000.pdf size: 703523 hasResults: False
<\|newrecord\|> nctId: NCT06332664 id: 2023-2330 briefTitle: Early Nutrition Intervention for M1 Stage Cancer Patients overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-07-01 date: 2024-03-27 date: 2024-03-27 name: Xingchen Peng class: OTHER briefSummary: In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.
However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.
Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting M1 advanced-stage cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice. conditions: Nutrition conditions: Cancer Metastatic studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 194 type: ESTIMATED name: Early Nutrition Intervention measure: the incidence of cachexia measure: overall survival ；progression-free survival measure: Physical Fitness Status measure: BMI measure: Nutritional risk and malnutrition status measure: Patient's emotional changes measure: Caregiver psychological burden measure: Patient's physical, social, and cognitive functioning measure: incidence of Sarcopenia measure: Nutritional risk and malnutrition status measure: Patient's emotional changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan Universit status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: XingChen Peng, Ph.D role: CONTACT phone: +8618980606753 email: pxx2014@163.com lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06332651 id: NL84684.091.23 briefTitle: Metabolic Availability in Older and Younger Men acronym: YOMA overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2025-04-01 date: 2024-03-27 date: 2024-03-27 name: Wageningen University class: OTHER briefSummary: The main goal of this study is to determine the metabolic availability of methionine in black beans, lysine in sorghum and lysine in milk using the indicator amino acid oxidation method both in older and in younger men. conditions: Ageing studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is a parallel intervention study. The intervention does not involve a drug or biologic product, however does involve an adaptation diet and a diet with measured amino acids dissolved in water, during the test day. We investigate the amino acid metabolic availability using the IAAO method. primaryPurpose: PREVENTION masking: NONE count: 28 type: ESTIMATED name: Black beans name: Milk name: Sorghum measure: Metabolic availability of methionine in black beans and lysine in milk and sorghum measured with the indicator amino acid oxidation method. sex: MALE minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wageningen University & Research status: RECRUITING city: Wageningen state: Gelderland zip: 6708PB country: Netherlands name: Fenna Hinssen, MSc role: CONTACT phone: +031648043165 email: yoma@wur.nl name: Karen Fransen, MSc role: CONTACT phone: +031648043165 email: yoma@wur.nl lat: 51.97 lon: 5.66667 hasResults: False
<\|newrecord\|> nctId: NCT06332638 id: IN_APA_124 briefTitle: PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects overallStatus: ENROLLING_BY_INVITATION date: 2024-03-19 date: 2024-07-31 date: 2024-07-31 date: 2024-03-27 date: 2024-03-27 name: HK inno.N Corporation class: INDUSTRY briefSummary: The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Tegoprazan 12.5mg name: Tegoprazan 25mg name: Famotidine 20mg measure: Cmax of tegoprazan and tegoprazan's metabolite M1 measure: AUC0-t of tegoprazan and tegoprazan's metabolite M1 measure: AUC0-∞ of tegoprazan and tegoprazan's metabolite M1 measure: Tmax of tegoprazan and tegoprazan's metabolite M1 measure: t1/2β of tegoprazan and tegoprazan's metabolite M1 measure: CL/F of tegoprazan measure: Vd/F of tegoprazan measure: Css,max of tegoprazan and tegoprazan's metabolite M1 measure: Css,min of tegoprazan and tegoprazan's metabolite M1 measure: Css,avg of tegoprazan and tegoprazan's metabolite M1 measure: AUCtau,ss of tegoprazan and tegoprazan's metabolite M1 measure: Tmax,ss of tegoprazan and tegoprazan's metabolite M1 measure: t1/2β,ss of tegoprazan and tegoprazan's metabolite M1 measure: CLss/F of tegoprazan measure: Vdss/F of tegoprazan measure: Accumulation index of tegoprazan measure: Fluctuation of tegoprazan measure: 24-hour, daytime and nighttime mean pH measure: 24-hour, daytime and nighttime median pH measure: 24-hour, daytime and nighttime TpH>3(%) measure: 24-hour, daytime and nighttime TpH>4(%) measure: 24-hour, daytime and nighttime Δ TpH>3(%) measure: 24-hour, daytime and nighttime Δ TpH>4(%) measure: 24-hour, daytime and nighttime Δ mean pH measure: 24-hour, daytime and nighttime Δ median pH sex: ALL minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: Inje University Busan Paik Hospital city: Busan zip: 47392 country: Korea, Republic of lat: 35.10278 lon: 129.04028 hasResults: False
<\|newrecord\|> nctId: NCT06332625 id: PNRR-MR1-2022-12375648 briefTitle: The Fingerprinting of Inherited Leukoencephalopathies: A New Brain Imaging, Genetic and Clinical Assessment acronym: FIABA overallStatus: RECRUITING date: 2023-05-22 date: 2024-02-05 date: 2025-11-22 date: 2024-03-27 date: 2024-03-27 name: IRCCS Fondazione Stella Maris class: OTHER name: Oasi Research Institute-IRCCS name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta name: IRCCS Ospedale San Raffaele briefSummary: Inherited leukoencephalopathies are a broad spectrum of genetically determined disorders, characterized by specific involvement of the white matter of the central nervous system. These pathologies are almost as common as other acquired white matter disorders, such as acute disseminated encephalomyelitis and multiple sclerosis. The onset can occur at any age, from prenatal life to adulthood, and the clinical picture is mostly progressive, but can also be non-evolving or, rarely, improve over time. Thanks to new diagnostic approaches, including next-generation genetic sequencing and recognition of magnetic resonance imaging patterns, in recent years the investigators have witnessed a significant increase in the number of genetically defined leukoencephalopathies. However, despite advances in genetic studies, inherited leukoencephalopathies include a large number of inherited white matter diseases in children and adults and remain of unknown cause in many patients (about 40%). This significant percentage of cases of unknown etiology represents a major challenge for public health, both in prognostic terms and, consequently, economically. However, even in leukoencephalopathies of genetically determined cause, the absence of specific biomarkers can be a limiting factor in the design and execution of clinical studies in search of promising therapies. As in other fields of neurology, the integration of clinical and genetic data with brain MRI data plays a fundamental role in the diagnostics of subjects affected by these pathologies. Currently, the methodologies commonly used in magnetic resonance imaging are qualitative, and evaluate brain lesions through the contrast between white and gray matter. The lack of specific biomarkers is therefore a limiting factor in the design of therapeutic challenges. In this regard, the development of new multiparametric quantitative magnetic resonance imaging (qMRI) methods could allow the investigators to identify new biomarkers to assess the etiology behind leukodystrophies, increasing diagnostic power and understanding the progression or improvement of leukoencephalopathy for both future trials and existing therapies. In this perspective, recent rapid "transient-state" magnetic resonance imaging methods, such as MR Fingerprinting (MRF), have proven effective in efficiently separating different components of brain tissue. These techniques consist of rapid and highly undersampled acquisitions performed by continuously changing the MR sequence parameters, thus obtaining a signal evolution that is unique for each combination of underlying tissue properties. Furthermore, if these techniques have already shown their validity at 3 Tesla, they could be even more informative in 7T MRI where the use of qMRI could provide more details thanks to the high image resolution.
The project's objective is to evaluate and validate new and innovative quantitative magnetic resonance imaging (qMRI) methodologies at both clinical and ultra-high fields in inherited leukodystrophies and those of unknown etiology.
This is a national, multi-institutional, multicenter exploratory study on the potential identification and predictability of early structural and metabolic markers in quantitative MRI at 3T and 7T in the diagnosis and follow-up of leukodystrophy and leukoencephalopathy in adults and during development.
The study will include multiple sub-studies:
1. A cross-sectional study in leukoencephalopathies at clinical fields.
2. A longitudinal study in leukoencephalopathies at 3T: natural history and therapy outcomes.
3. A cross-sectional and longitudinal study at 7T: The added value of ultra-high-field Magnetic Resonance Imaging in leukoencephalopathies. conditions: Leukoencephalopathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Brain quantitative magnetic resonance imaging measure: Quantitative Susceptibilty Mapping, QSM measure: Fractional Anisotropy, FA measure: Mean Diffusivity, MD measure: Relaxation times measure: Myelin water fraction, MWF measure: Neuromotor skills measure: Neuromotor skills measure: Epilepsy symptoms measure: Electroencephalography features measure: Neuro-psychological profile sex: ALL minimumAge: 0 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Associazione Oasi Maria SS Troina status: RECRUITING city: Troina state: Enna zip: 94018 country: Italy name: Maurizio Elia role: CONTACT lat: 37.78437 lon: 14.59605 facility: Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Cristina Baldoli role: CONTACT lat: 45.46427 lon: 9.18951 facility: Fondazione Istituto Neurologico Carlo Besta status: RECRUITING city: Milano zip: 20133 country: Italy name: Stefania Magri role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06332612 id: 8420224AROM briefTitle: Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial acronym: MROSF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-12 date: 2024-03-27 date: 2024-03-27 name: Ziauddin University class: OTHER briefSummary: OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition conditions: Oral Submucous Fibrosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. In Vitro (Cell Line) Study Design: Experimental in vitro study using OSF cell lines.
Groups:
* Metformin-treated
* Control (untreated)
* Vehicle control Clinical Trial Study Design: A pilot Randomized Controlled Trial (RCT) translating the in vitro findings into a clinical setting. It would be a single-blind, placebo-controlled designAll groups will undergo a 24-week intervention phase. Group 1 will receive standard treatment including topical cream betamethasone thrice daily and Pentoxifylline tablet 400 mg twice daily. Group 2 will receive Metformin 500 mg thrice daily. Group 3 will receive topical cream metformin thrice daily. All groups will be instructed to perform a stick mouth opening exercise twice daily, alternating sides, holding the stick for 10 minutes on each side, with a 10-minute rest in between. All groups will be single blinded to the intervention. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: It would be a single-blind, placebo-controlled design whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Metformin Hydrochloride name: betamethasone dipropionate name: Pentoxifylline measure: Cell Viability measure: Cytotoxicity measure: Morphological Changes Cell Shape measure: Morphological Change Cell Density measure: Morphological Change Extracellular Matrix (ECM) Structure measure: Cell Migration Assays measure: Cell Invasion Assays measure: Apoptosis Analysis measure: Assess Signaling pathway with optimal metformin concentration measure: Clinical Oral Mucosal Characteristics measure: Patient Burning sensation pain measure: Patient Mouth Opening sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ziauddin University city: Karachi state: Sindh zip: 74700 country: Pakistan name: Afifa Razi, FCPS OMFS role: CONTACT phone: +92 300 2247389 email: afifa.razi@zu.edu.pk name: Shumaila Usman, PhD role: CONTACT phone: +92 336 1882779 email: shumaila.usman@zu.edu.pk name: Afifa Razi, FCPS role: PRINCIPAL_INVESTIGATOR name: Shumaila Usman, PhD role: SUB_INVESTIGATOR name: Yamna Khurshid, PhD role: SUB_INVESTIGATOR lat: 24.8608 lon: 67.0104 hasResults: False
<\|newrecord\|> nctId: NCT06332599 id: rjhy20240001 briefTitle: Minocycline for Helicobacter Pylori Rescue Treatment overallStatus: RECRUITING date: 2021-10-01 date: 2024-04-30 date: 2034-06-30 date: 2024-03-27 date: 2024-03-27 name: Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting. conditions: Helicobacter Pylori Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED name: BQT name: EBM4M4 name: EBM3M3 name: EBM2M4 name: EBM2M3 measure: Helicobacter pylori eradication rate measure: Rate of adverse effects measure: Compliance rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: None Selected zip: 200127 country: China name: Yu Huang role: CONTACT phone: 0198621791879 email: 15626211482@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06332586 id: 202311087RINA briefTitle: The Learning Effect of Applying Diversified Teaching in Emergency Injury Classification -Taking the Emergency Nurse of a Regional Hospital in Yunlin County as an Example overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2024-04-04 date: 2024-05-05 date: 2024-03-27 date: 2024-03-27 name: National Taiwan University Hospital class: OTHER briefSummary: "Triage" is the first process of emergency treatment. It is mainly based on the severity of the disease and the appropriate allocation of limited people, time, place, and medical resources. It is very important and related to the quality of medical care. In order to accurately judge the severity of patients, reduce the individual errors of artificial memory and increase the consistency of the judgment of triage levels, the new emergency five-level triage classification standard (Taiwan Triage and Acuity Scale) was implemented in 2010. , TTAS), the purpose is to allocate medical resources in the most appropriate manner at the appropriate time. It has been revised many times so far, so correct injury classification can maximize the safety of people's lives. This article reviews the relevant literature and finds that to have an efficient injury classification so that each patient receives appropriate medical allocation, an organized, effective and systematic injury inspection process structure is needed to enable the injury nurse to perform correct inspections. Injury skills and cognition should be actively promoted, and this policy must require traumatization nurses to continuously update their traumatization cognition and skills, and must also continue to conduct regular assessments and reviews to continuously improve the quality of traumatization grading by traumatization nurses. It can be seen that triage nurses must have skills, knowledge, attitudes and systems to improve the accuracy of triage levels and ensure the treatment of patients who need priority treatment . Therefore, this study can be used to understand the learning effectiveness of trauma care before and after diversified teaching, which can be used as a basis for teaching new trauma care nurses. conditions: Triage studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 22 type: ESTIMATED name: Diversified teaching measure: Improving the injury diagnosis ability of triage diagnosis nurses through diversified teaching sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Taiwan city: Taipei zip: Taiwan country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06332573 id: 24-06 briefTitle: Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer acronym: SEXOCARE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Hôpital Européen Marseille class: OTHER briefSummary: Onco-sexology as a supportive care for patients treated for cancer is still rarely discussed or even non-existent in 2022. However, it's recommended to integrate the preservation of sexual health throughout the treatment and post-cancer process, given the impact of cancer, treatments and the importance of intimate life for a majority of patients.
Onco-sexology is one of the supportive care services validated by The French National Cancer Institute (INCa). It is also an objective of the 2014-2019 cancer plan and the 2017-2030 national sexual health strategy plan.
Although sexuality is one of the fundamental needs of the human being, including in the case of a chronic disease or cancer diagnosis, the lack of training of health professionals to deal with intimate life, the difficulty to exchange on this subject between caregivers and patients, the lack of financial support for onco-sexology consultations, are all obstacles to the global management of oncology patients. However, it's a request from patients to be able to discuss the subject in an intimate way with a professional.
While onco-sexology is already recommended as supportive care, a study on the impact of the delay in the management of sexual difficulties on quality of life could provide a sufficient level of evidence to change the practices and the care pathway of the oncology patient. Our objective is to study whether early management in onco-sexology has an impact on quality of life compared to late management (ie onco-sexology consultation before vs. after introduction of systemic oncological treatment). conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 168 type: ESTIMATED name: Onco-sexology support name: Onco-sexology support measure: Rate of patients with improved quality of life as measured by the 36-Item Short Form Survey (SF-36) at the end of onco-sexology support measure: Evaluation of the quality of life of patients at 6 and 12 months after the end of onco-sexology support through the 36-Item Short Form Survey (SF-36) questionnaire measure: Evaluation of the quality of sexual life at the end of the onco-sexology support in both groups through specific questionnaires (The sexual quality of life-female and men) measure: Evaluation of the quality of sexual life at 6 and 12 months after the end of the onco-sexology support through specific questionnaires (The sexual quality of life-female and men) measure: Evaluation of the body image, at the end of the onco-sexology support through the "Body Image Scale ". measure: Evaluation of the body image, of the patient at 6 and 12 months after the last consultation with the onco-sexologist through the "Body Image Scale". measure: Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care measure: Rate of patients expressing sexual difficulties during the consultation of announcement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Européen Marseille city: Marseille country: France name: Myriam BENNANI role: CONTACT phone: 0413428351 email: m.bennani@hopital-europeen.fr lat: 43.29551 lon: 5.38958 hasResults: False
<\|newrecord\|> nctId: NCT06332560 id: NL86247.091.24 briefTitle: Pain in Endometriosis And the Relation to Lifestyle acronym: PEARL overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-05 date: 2024-03-27 date: 2024-03-27 name: Radboud University Medical Center class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet intervention on health related quality of life and pain symptoms in women with endometriosis. And whether the addition of CBT enhancing this effect. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome.
Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy.
Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Anti-inflammatory diet (DI) name: Cognitive behavioral therapy (CBT) measure: Change in Pain intensity assessed by the Numerical Rating Scale measure: Change in inflammatory characteristics in menstruum measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30 measure: Change in general Quality of Life assessed by the Short Form 36 measure: Change in the composition of vaginal and intestinal microbiome measure: Change in Objective stress assessed by measuring scalp hair cortisol levels measure: Adherence and anti-inflammatory status of the diet measure: Change in sleep quality assessed by the PSQI measure: Change in physical activity level assessed by the IPAQ-SF measure: Change in Subjective stress assessed by the Perceived Stress Scale measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale measure: Changes in pain cognitions assessed by the pain catastrophizing Scale measure: Changes in Fatigue assessed by the checklist individual strength measure: Anti-inflammatory diet rating sex: FEMALE minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud University Medical Center city: Nijmegen country: Netherlands name: E Huijs, B role: CONTACT name: A.W. Nap, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 hasResults: False
<\|newrecord\|> nctId: NCT06332547 id: TICVS briefTitle: Transfusion in Cardiac Valve Surgery acronym: TICVS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-30 date: 2027-12-30 date: 2024-03-27 date: 2024-03-27 name: Guangdong Provincial People's Hospital class: OTHER briefSummary: This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups. conditions: Cardiac Surgery With Cardiopulmonary Bypass conditions: Valve Heart Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 1600 type: ESTIMATED name: Restrictive Transfusion Strategy name: Liberal Transfusion Strategy measure: A composite of postoperative morbidity and mortality measure: Rate of reoperation measure: Length of ICU Stays measure: Length of Postoperative Hospital Stay measure: Number of Blood Transfusion measure: Duration of mechanical ventilation measure: Postoperative thoracic fluid volume in the first 24 hours measure: Number of participants with postoperative atrial fibrillation measure: Number of participants with new-onset renal failure with dialysis measure: Number of participants with acute kidney injury measure: Number of participants with delirium measure: Hospitalization expense sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People's Hospital city: Guangzhou state: Guangdong zip: 510145 country: China name: Huang Huanlei, Phd role: CONTACT phone: 765 714 9765 email: hhuanlei@hotmail.com name: Huang huanlei, Phd role: PRINCIPAL_INVESTIGATOR name: Zhao Junfei, Phd role: PRINCIPAL_INVESTIGATOR name: He Biaochuan, Phd role: PRINCIPAL_INVESTIGATOR name: Zhang Zhaolong, BD role: PRINCIPAL_INVESTIGATOR name: Wang Zhenzhong, MD role: PRINCIPAL_INVESTIGATOR name: Wang Qiuji, MD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06332534 id: M14-671 briefTitle: Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-07-26 date: 2032-03-22 date: 2034-12-20 date: 2024-03-27 date: 2024-03-27 name: AbbVie class: INDUSTRY briefSummary: Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.
Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. conditions: Crohn's Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Upadacitinib measure: Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64 measure: Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12. measure: Number of Participants with Adverse Events measure: Achievement of clinical remission per PCDAI measure: Achievement of endoscopic response measure: Achievement of endoscopic remission measure: Achievement of clinical response per PCDAI measure: Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 measure: Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12 measure: Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06332521 id: 23CH296 id: ANSM type: OTHER domain: 2024-A00286-41 briefTitle: Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment acronym: BABYCRY_1000 overallStatus: RECRUITING date: 2024-03-20 date: 2029-04-01 date: 2029-04-01 date: 2024-03-27 date: 2024-04-26 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.
Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry. conditions: Newborn; Vitality conditions: Premature Infants conditions: Infant Development studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1100 type: ESTIMATED name: Acoustic signal analysis method measure: Fundamental frequency f0 (Hz) measure: Bailey-4 quantitative scale measure: Percentage voiced frames measure: Harmonics of f0 (Hz) measure: Median pitch f0 (Hz) measure: Harmonicity (dB) measure: Jitter (Percentage), measure: Q25 (Percentage) measure: Median Cepstral Peak Prominence (CPP) (dB) sex: ALL maximumAge: 4 Days stdAges: CHILD facility: Chu de Saint-Etienne status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: Hugues PATURAL, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
<\|newrecord\|> nctId: NCT06332508 id: 2022/00406 briefTitle: Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL) overallStatus: RECRUITING date: 2022-12-30 date: 2025-12 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: National University Hospital, Singapore class: OTHER name: National University of Singapore briefSummary: To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Pulsed electromagnetic fields (PEMFs) name: Anthracycline-based chemotherapy measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 measure: Treatment response as assessed by clinical measurement of tumor size using calipers sex: FEMALE minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University Hospital status: RECRUITING city: Singapore zip: 119074 country: Singapore name: Joline Si Jing Lim role: CONTACT phone: 69082222 email: joline_sj_lim@nuhs.edu.sg name: Joline Si Jing Lim role: PRINCIPAL_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False
<\|newrecord\|> nctId: NCT06332495 id: RC23_0573 id: 2024-A00025-42 type: OTHER domain: ANSM (IDRCB) briefTitle: Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers acronym: RIDAECUBA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-03 date: 2024-03-27 date: 2024-04-22 name: Nantes University Hospital class: OTHER briefSummary: the hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.
The objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study. conditions: Nurse-Patient Relations studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Questioning the patient during hygiene care measure: Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan. measure: Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3 measure: Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan. measure: Assess patient discomfort on the bedpan measure: Assess alteration of skin condition at the seat of the patient using the bedpan measure: Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan. measure: Assess the risk factors associated with the onset of pain when placing a bedpan. measure: Assess the difficulty of positioning and removing the bedpan. measure: Assess bedpan stability during use measure: Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital city: Nantes state: Loire Atlantique zip: 44093 country: France name: Pia SECHER-CAILLETEAU role: CONTACT email: pia.secher@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Cholet city: Cholet country: France name: Nelly DIXNEUF role: CONTACT phone: (+33) 2 41 49 69 85 email: nelly.dixneuf@ch-cholet.fr lat: 47.06667 lon: -0.88333 facility: CHU Laval city: Laval country: France name: ROMAIN CHAMPAGNE role: CONTACT phone: (+33) 672091548 email: Romain.CHAMPAGNE@chlaval.fr lat: 48.06667 lon: -0.76667 facility: CH Le Mans city: Le Mans country: France name: Emmanuelle Lecompte role: CONTACT phone: (+33) 681220543 email: gsicot@ch-lemans.fr lat: 48.0 lon: 0.2 facility: CHU Orleans city: Orléans country: France name: Guillaume FOSSAT role: CONTACT phone: (+33) 2 38.65.13.18 email: guillaume.fossat@chu-orleans.fr lat: 47.90289 lon: 1.90389 hasResults: False
<\|newrecord\|> nctId: NCT06332482 id: M0303023RP briefTitle: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-30 date: 2024-05-20 date: 2024-09-15 date: 2024-03-27 date: 2024-03-27 name: Mansoura University class: OTHER briefSummary: This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration. conditions: Prosthesis Durability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ACTUAL name: Implant supported screw retained prosthesis measure: measurement of occlusal prematurity measure: prosthestic complications sex: ALL minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University ,Faculty of dentistry city: Mansoura zip: P.O.Box:35516 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06332469 id: INSERT feasibility briefTitle: Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation acronym: INSERT overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2025-10-31 date: 2025-10-31 date: 2024-03-27 date: 2024-03-27 name: Linkoeping University class: OTHER_GOV briefSummary: The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group gets immediate access to the 9 week program, and the waitlist control group gets access after a 9 week waiting period. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Internet based education and support program for patients awaiting kidney transplantation measure: Kidney transplant understanding tool (K-TUT) measure: Self-care in chronic illness inventory v.4c measure: The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G measure: Pearlin Mastery Scale measure: The Depression Anxiety Stress Scales 21 (DASS-21) measure: Acceptance of chronic health conditions scale (ACHC) measure: EQ-5D-5L sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332456 id: ICM 2023-3169 briefTitle: Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography acronym: RESIST overallStatus: RECRUITING date: 2023-07-04 date: 2024-12 date: 2024-12 date: 2024-03-27 date: 2024-03-27 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases. conditions: Renal Microcirculation With Rubidium Positron Emission Tomography studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Renal blood flow in units of mL/min/100g measure: Renal vascular resistance in units of mmHg/mL/min/100g measure: Correlation between renal vascular resistance measured with PET and measured with echography measure: Coefficient of repeatability of renal blood flow sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montreal Heart Institute status: RECRUITING city: Montréal state: Quebec zip: H1T 1C8 country: Canada name: Matthieu Pelletier-Galarneau role: CONTACT phone: 5143763330 phoneExt: 4418 email: matthieu.pelletier-galarneau@icm-mhi.org lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06332443 id: CER-CEMTL-2023-3086 briefTitle: Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty. acronym: RCT SEA vs SA overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2026-03-15 date: 2024-03-27 date: 2024-03-27 name: Maisonneuve-Rosemont Hospital class: OTHER name: Mina Wahba Morcos name: Issam Tanoubi name: Pierre Drolet name: Ariane Clairoux name: Veronique Brulotte name: Marie-Eve Bélanger name: Philippe Richebé name: Karina Pellei briefSummary: To our knowledge, no study has compared the difference between these two NA techniques. Early postoperative adverse events like uncontrolled pain, orthostatic hypotension, urinary retention, and prolonged motor block are linked to late patient mobilization, prolong hospitalization and failure to discharge in outpatient setting. The type of anesthesia used may have an important impact. Therefore, this study has the potential to improve the already established ERAS program and improve patients care perioperative and postoperative. Showing that SED-EA and SA are equivalent will allow for a more efficient and reliable technique for THA/TKA ERAS program that can be further translated into other lower limb surgeries. conditions: Knee Injuries and Disorders conditions: Hip Injuries conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The group assignment will be given to the intraoperative anesthesia team by writing, by a research team member who will not participate in postoperative assessments. The intraoperative anesthesia team will not be blinded to the group assignment, but surgeons, patients, and assessors will be blinded. For the SA group, a sham epidural catheter will be placed on the patient's back by the anesthesia team in order to keep the surgeons, patients and assessors blind to the randomization group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Spinal anesthesia name: Sedation epidural anesthesia measure: Adverse Events measure: Time needed by the anesthesiologist to perform the technique measure: Time needed for the SA or SED-EA to achieve adequate sensory block measure: Intraoperative blood loss measure: intraoperative muscle tension measure: Extra Lidocaine needed measure: Conversion to GA measure: Total dose of the sedation measure: Hemodynamic stability measured measure: Time to return of motor and sensory function measure: Post-operative nausea measure: PONV and anti-emetics measure: Urinary retention measure: Opioid consumption measure: Length of stay measure: Failed discharded measure: Complications related to the technique performed. measure: Adverse event sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Maisonneuve Rosemont status: RECRUITING city: Montreal state: Quebec zip: H1T 2M4 country: Canada name: Serge Marquis, RN role: CONTACT phone: 5142523400 phoneExt: 5701 email: smarquis.hmr@ssss.gouv.qc.ca name: Janie Barry, MSc role: CONTACT phone: 5142523400 phoneExt: 4567 email: jbarry.hmr@ssss.gouv.qc.ca lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06332430 id: CW-202 briefTitle: Intratumoral CAN2109 in Subjects With Solid Tumors or Lymphomas overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2026-05-30 date: 2024-03-27 date: 2024-03-27 name: Canwell Biotech Limited class: INDUSTRY briefSummary: A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas. conditions: Solid Tumor conditions: Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: CAN2109 measure: Safety and tolerability measure: Recommended Phase 2 Dose (RP2D) measure: To determine the efficacy of CAN2109 measure: To evaluate the pharmacodynamics of CAN2109 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Sun Yat-Sen Memorial Hospital city: Guangzhou state: Guangdong zip: 510535 country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06332417 id: REC/RCR&AHS/23/0364 briefTitle: Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique overallStatus: RECRUITING date: 2024-02-29 date: 2024-06-05 date: 2024-06-15 date: 2024-03-27 date: 2024-03-27 name: Riphah International University class: OTHER briefSummary: This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Ba-Duan-Jin Based Deep Breathing Exercises name: FET (Forced Expiratory Technique) measure: 36-Item Short Form Survey (SF-36) measure: FEV1/FVC ratio measure: Exercise Tolerance : 6 minute walk test measure: Forced vital capacity (FVC) measure: Forced expiratory volume (FEV1) sex: ALL minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT facility: Social Security Teaching Hospital status: RECRUITING city: Lahore state: Punhab zip: 42000 country: Pakistan name: Faisal Rehman, MBBS role: CONTACT phone: +924299230227 email: info@pessi.punjab.gov.pk lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06332404 id: B3002024000047 briefTitle: Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry acronym: B-HNS overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2034-04 date: 2034-04 date: 2024-03-27 date: 2024-03-27 name: University Hospital, Antwerp class: OTHER briefSummary: Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.
The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital. conditions: Obstructive Sleep Apnea conditions: Sleep Apnea conditions: Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA) measure: Delta apnea-hypopnea index (AHI) as measured by a polysomnography measure: % of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h measure: Therapy adherence defined by the amount of hours therapy usage per night. measure: Delta oxygen desaturation index (ODI) as measured by a polysomnography measure: Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire measure: Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire measure: Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital city: Edegem state: Antwerp zip: 2650 country: Belgium name: Dorine Van Loo, Msc role: CONTACT phone: +3238215780 email: dorine.vanloo@uza.be name: Olivier Vanderveken, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 hasResults: False
<\|newrecord\|> nctId: NCT06332391 id: 202308349 id: R01HL168752 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL168752 briefTitle: Paced Heart Rate Acceleration for Cardiac Conditioning acronym: HeartExcel overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-06-30 date: 2028-11-30 date: 2024-03-27 date: 2024-03-27 name: Denice Hodgson-Zingman, MD class: OTHER name: The Cleveland Clinic name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed severe left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed. conditions: Heart Failure, Systolic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single blinded, randomized, controlled trial. Randomization to intervention versus sham groups in a 1:1 ratio. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Subjects and outcomes assessors are blinded to study group (intervention vs. sham) but investigator is not. During intervention vs. sham, subjects do not have access to vital sign data and sham procedures follow intervention procedures exactly with the exception that no change in pacing rate is delivered. A blinding questionnaire is given to subjects to assess adequacy of blinding. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Exercise-similar cardiac pacing name: Sham cardiac pacing measure: Change in left ventricular ejection fraction by echocardiogram measure: Quality of Life score on the Minnesota Living with Heart Failure questionnaire measure: Quality of Life score on the Kansas City Cardiomyopathy Questionnaire measure: 6-minute walk distance measure: Cardiopulmonary exercise test maximum oxygen consumption measure: Cardiopulmonary exercise test metabolic equivalents achieved measure: Cardiopulmonary exercise test peak power output achieved measure: Cardiopulmonary exercise test total exercise time measure: daily minutes of sedentary activity measure: daily minutes of low activity measure: daily minutes of moderate activity measure: daily minutes of vigorous activity measure: major adverse cardiac events measure: symptom score during the intervention/sham procedure measure: maximum achieved pacing rate during the intervention/sham procedure measure: presence of significant arrhythmia during the intervention/sham procedure measure: vital signs - systolic blood pressure during the intervention/sham procedure measure: vital signs - oxygen saturation in the blood during the intervention/sham procedure measure: tolerability - vital signs - cardiac output measure: vital signs - cardiac output during the intervention/sham procedure sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332378 id: sHasan briefTitle: Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-08-15 date: 2024-08-15 date: 2024-03-27 date: 2024-03-27 name: Dr. Sobia Hasan class: OTHER briefSummary: The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.
Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..
The main question it aims to answer are:
1. To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.
2. Effectiveness of exercises using Swiss ball in lowering waist circumference, and BMI.
3. Effectiveness of exercises on fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and glycosylated Hemoglobin (HbA1c) among Type II diabetic patients.
4. Effectiveness of exercises on autonomic nervous system activity on type II diabetic peripheral neuropathy patients.
By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).
Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity. conditions: Diabetic Neuropathies studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Experimental group 1 :Ball training name: Experimental group 2 :Frenkel Exercises name: Control Group measure: One Leg Stance measure: Berg Balance Scale measure: Timed Up and Go Test: measure: Diabetic Neuropathy Symptom Score measure: Hemoglobin A1C sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332365 id: ID: 3938/2022 briefTitle: Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers acronym: salivaLichen overallStatus: COMPLETED date: 2022-01-03 date: 2023-12-15 date: 2024-02-19 date: 2024-03-27 date: 2024-03-27 name: Pia Lopez Jornet class: OTHER briefSummary: Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus conditions: Oral Lichen Planus conditions: Oral Lichen Planus Related Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient.
Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Acetonide triamcinolone 0.2% +hyaluronicacid 1% name: Corticoid Acetonide triamcinolone 0.2% name: Hyaluronic acid 1% measure: Pain assessment scale measure: OHIP-14 questionnaire measure: reduction of clinical signs measure measure: Salivary level of oxidative stress biomarker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pia Lopez Jornet city: Murcia zip: 30004 country: Spain lat: 37.98704 lon: -1.13004 hasResults: False
<\|newrecord\|> nctId: NCT06332352 id: 00173470 briefTitle: Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears acronym: PRP for ALT overallStatus: RECRUITING date: 2024-01-25 date: 2025-01-25 date: 2026-01-25 date: 2024-03-27 date: 2024-03-27 name: University of Utah class: OTHER briefSummary: Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function.

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.