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Participants will be admitted to a monitored research unit for the trial. They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation (ROLDI). |
For standard initiation, participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use. Once they have at least moderately severe opioid withdrawal (Clinical Opiate Withdrawal Scale \[COWS\] 11 or higher), participants will receive 2 mg, 2 mg, 4 mg, and then 8 mg sublingual buprenorphine, with doses every 2 hours. They will then continue 8-12 mg twice daily. This is the current standard of care. |
For ROLDI, participants will not be required to have a period abstinence, they will have no or minimal withdrawal (COWS 4 or less) when starting buprenorphine, and participants will take 0.5 mg, 0.5 mg, 1 mg, 1 mg, 1 mg, and then 4 mg sublingual buprenorphine with dosing every two hours. They will then continue 8-12 mg twice daily. |
The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Buprenorphine measure: Successful initiation of buprenorphine maintenance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379971 id: 23-2327 briefTitle: Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-04 date: 2029-04 date: 2024-04-23 date: 2024-04-23 name: University of Colorado, Denver class: OTHER briefSummary: The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring's brain-related development during the first 18 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child's brain responses to sound at 4 weeks corrected age, and infant behaviors at 3 months and 18 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development. conditions: Child Development conditions: Cannabis Use studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phosphatidylcholine or placebo primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Placebo name: Choline measure: Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index measure: Auditory Sensory Gating (P50) measure: Child Behavior Checklist (CBCL) 1 1/2-5 measure: Maternal Plasma Choline Levels measure: Bayley Scales of Infant and Toddler Development sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: UC Health city: Aurora state: Colorado zip: 80045 country: United States name: Sharon Hunter, PhD role: CONTACT phone: 303-724-6246 email: [email protected] lat: 39.72943 lon: -104.83192 hasResults: False |
<|newrecord|> nctId: NCT06379958 id: IST-05 briefTitle: Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2024-05-31 date: 2024-09-30 date: 2024-04-23 date: 2024-04-23 name: Modern Biosciences Ltd class: INDUSTRY briefSummary: A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects. conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: leramistat 40mg name: Itraconazole 200 mg name: Phenytoin 100 Mg Oral Capsule name: Simvastatin 40mg measure: leramistat: Area under the curve - AUC0 t measure: leramistat: Area under the curve - AUC0 24 measure: leramistat: Area under the curve - AUC0 inf measure: leramistat: Maximum observed concentration - Cmax measure: leramistat: Time of the maximum observed concentration - Tmax measure: leramistat:Elimination rate constant -Kel measure: leramistat: Half life - t½ measure: leramistat: Plasma Clearance -CL/F measure: leramistat: Volume of distribution - Vz/F measure: Incidence of adverse event. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion city: Belfast country: United Kingdom name: Phase 1 Unit role: CONTACT name: Nadine Abdullah role: PRINCIPAL_INVESTIGATOR lat: 54.59682 lon: -5.92541 hasResults: False |
<|newrecord|> nctId: NCT06379945 id: PI23/01103 id: PI2024 01 1484 type: REGISTRY domain: Ethics Committee for Drug Research of the Salamanca Health Area briefTitle: Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA) acronym: UMBRELLA-SUMMA overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-12-31 date: 2024-04-23 date: 2024-04-23 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Carlos III Health Institute briefSummary: Myelodysplastic Syndromes (MDS) are heterogeneous clonal diseases characterized by difficult diagnosis, complex prognostic stratification and unsatisfactory treatment. Based on that, UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis (1), prognosis (2 and 3), and treatment (2), and facilitating future investigations (4) of the disease. |
More concretely, we propose: 1. The application of new technologies such as Optical Genome Mapping (OGM) in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods, as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients. 2. To provide all Spanish Group of MDS (GESMD) members who require it with the newly prognostic stratification of their patients (IPSS-M) by making Next Generation Sequencing (NGS) accessible for all of them. 3. Validate and improve a new prognostic system (AIPSS-MDS) previously developed within the GESMD, thanks to artificial intelligence, one of the tools with the most projection in the field of medicine currently. 4. To build and register ISCIII collections of cells, genetic material and/or plasma from all prospective MDS patients. |
On the other hand, the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient. Based on that, the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups: normal karyotype, trisomy 8 and 5q deletion. The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches. conditions: Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Structural variants and complex rearrangements in MDS measure: Mutations in MDS measure: Overall survival and leukemia-free survival in patients with MDS measure: ISCIII collections of viable samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Instituto de Investigación Germans Trias i Puyol status: RECRUITING city: Badalona state: Barcelona zip: 08916 country: Spain name: Francesc Solé, PhD role: CONTACT phone: 935 57 28 06 phoneExt: 4040 email: [email protected] lat: 41.45004 lon: 2.24741 facility: Hospital Universitario Vall d´Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: David Valcárcel Ferreiras, PhD role: CONTACT phone: 934 89 30 00 email: [email protected] lat: 41.38879 lon: 2.15899 facility: Clínica Universitaria de Navarra status: RECRUITING city: Pamplona zip: 31008 country: Spain name: Felipe López Cardoso, PhD role: CONTACT phone: 848 42 87 00 email: [email protected] lat: 42.81687 lon: -1.64323 facility: Complejo Asistencial Universitario de Salamanca status: RECRUITING city: Salamanca zip: 37007 country: Spain name: María Díez Campelo, PhD role: CONTACT phone: +34 923 29 11 00 phoneExt: 55418 email: [email protected] name: Sandra Muntión Olave, PhD role: CONTACT phone: +34 923 29 11 00 phoneExt: 55015 email: [email protected] lat: 40.96882 lon: -5.66388 hasResults: False |
<|newrecord|> nctId: NCT06379932 id: APHP240433 briefTitle: Pain and Muscle Biopsy acronym: BIODOMU overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-23 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Few studies have been conducted on pain assessment during and after open muscle biopsy. Furthermore, no clinical factors likely to influence pain perception during and after open muscle biopsy have been evaluated in previous studies.The proposed observational study aims to study pain perception in subjects over the aged of 18 years old who underwent an open muscle biopsy for a suspected myopathic disorder. Describing the main characteristics of pain during and after open muscle biopsy using a questionnaire will not only clarify this aspect, which is little studied in the literature, but will also provide information for improving analgesic management of the procedure.Studying the prognostic aspects of pain perception will give healthcare professionals an idea of which patients are at risk of suffering greater adverse effects from the procedure, so that they can be offered a personalised service in the future. conditions: Neuromuscular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Surveys completion measure: To describe the characteristics and intensity of pain during and after open muscle biopsy on the basis of a questionnaire including NRS scale. measure: To identify prognostic factors that may influence pain perception and to gather opinions to improve quality service measure: Gather patient feedback on procedures, facilities and reception to improve our service to patients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379919 id: C Acnes in TSA briefTitle: Wound Irrigation Comparative Effectiveness Study overallStatus: RECRUITING date: 2024-03-20 date: 2025-05-31 date: 2027-05-31 date: 2024-04-23 date: 2024-04-26 name: Orthopaedic Education and Research Institute (dba Hoag Orthopedics) class: OTHER name: Irrimax Corporation briefSummary: The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups. conditions: Cutibacterium Acnes Contamination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and Microbiology lab assessing cultures are blinded to the assigned irrigation treatment arm throughout the length of the study. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Irrisept Irrigation name: Saline Irrigation Solution Delivery measure: C Acnes Presence measure: American Shoulder and Elbow Surgeons Patient Reported Outcome Measure measure: Shoulder Range of Motion (ROM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Orthopedics status: RECRUITING city: Orange state: California zip: 92868 country: United States name: Edward Quilligan, BS role: CONTACT phone: 949-526-1570 email: [email protected] name: Kalyn Smith, BS role: CONTACT phone: (949) 526-1570 email: [email protected] lat: 33.78779 lon: -117.85311 hasResults: False |
<|newrecord|> nctId: NCT06379906 id: DMD, UE and Balance briefTitle: Upper Extremity Muscle Strength, Balance and Functional Skills in DMD overallStatus: COMPLETED date: 2023-11-10 date: 2023-12-10 date: 2024-03-10 date: 2024-04-23 date: 2024-04-25 name: Halic University class: OTHER name: Biruni University name: Istanbul University briefSummary: This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 32 type: ACTUAL name: Assessment measure: Upper Extremity Muscle Strength Measurements measure: Trunk Control Measurement Scale measure: Functional Reach Test measure: Timed Up & Go Test measure: Pediatric Evaluation of Disability Inventory sex: MALE minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06379893 id: 300128 id: 2024-510839-22-00 type: CTIS briefTitle: A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2024-11-15 date: 2024-11-15 date: 2024-04-23 date: 2024-04-23 name: HALEON class: INDUSTRY briefSummary: The purpose of this study is to investigate how topical diclofenac use can improve functional mobility and physical activity primarily, as well as other quality-of-life (QoL) parameters such as sleep, mood, and engagement in daily activities in participants with knee OA. conditions: Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 195 type: ESTIMATED name: Voltaren Gel 1% (diclofenac sodium) (US only) name: Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only) name: Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only) measure: Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 measure: Change from Baseline in the Average Minutes of MVPA at Week 2 measure: Change from Baseline in the Average Minutes of MVPA at Week 3 measure: Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21 measure: Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21 measure: Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21 measure: Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21 measure: Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21 measure: Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21 measure: MVPA on Each Day of the Study measure: WOMAC Physical Function Subscale Score on Days 7,14, and 21 measure: Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness measure: Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21 measure: Change from Baseline in Health-related Quality of Life Assessed Using European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire on Days 7, 14, and 21 sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379880 id: 2023-031 id: 2024-A00120-47 type: OTHER domain: ID-RCB Number briefTitle: Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution acronym: FEGALA overallStatus: RECRUITING date: 2024-04-25 date: 2024-11-25 date: 2025-02-25 date: 2024-04-23 date: 2024-04-29 name: Institut de cancérologie Strasbourg Europe class: OTHER name: Continuum Plus Santé name: Plateforme nationale qualité de vie et cancer name: WeShare briefSummary: FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring. conditions: Prostatic Neoplasms conditions: Lung Neoplasms conditions: Breast Neoplasms conditions: Colorectal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 506 type: ESTIMATED name: CONTINUUM+ CONNECT remote monitoring measure: Effect of the CONTINUUM+ CONNECT solution on the results in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings who did not require assistance in self-assessment measure: Effect of CONTINUUM+ CONNECT solution on the results at 3 months (± 15 days) post-inclusion in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months) measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months) measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group measure: Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion measure: Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion measure: Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning measure: Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sainte-Catherine, Institut du Cancer Avignon-Provence status: NOT_YET_RECRUITING city: Avignon zip: 84918 country: France name: Julien GRENIER, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: Polyclinique de Blois status: NOT_YET_RECRUITING city: Blois zip: 41260 country: France name: Yann MOTTAZ, MD role: CONTACT name: Yann MOTTAZ, Md role: PRINCIPAL_INVESTIGATOR lat: 47.58333 lon: 1.33333 facility: Pôle Santé République status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Pierre DALLOZ, MD role: CONTACT name: Pierre DALLOZ, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: centre Georges François Leclerc status: NOT_YET_RECRUITING city: Dijon zip: 21079 country: France name: Leila BENGRINE, MD role: CONTACT name: Leila BENGRINE, MD role: PRINCIPAL_INVESTIGATOR lat: 47.31667 lon: 5.01667 facility: Chu Dupuytren status: NOT_YET_RECRUITING city: Limoges zip: 87042 country: France name: Tiffany DARBAS, MD role: CONTACT name: Tiffany DARBAS, MD role: PRINCIPAL_INVESTIGATOR lat: 45.83153 lon: 1.25781 facility: Centre d'oncologie de Gentilly status: RECRUITING city: Nancy zip: 54100 country: France name: Laurene GAVOILLE, MD role: CONTACT name: Laurene GAVOILLE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA status: NOT_YET_RECRUITING city: Plérin zip: 22190 country: France name: Jérôme MARTIN-BABAU, MD role: CONTACT name: Jérôme MARTIN-BABAU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.54249 lon: -2.77983 facility: Institut Jean Godinot status: RECRUITING city: Reims zip: 51100 country: France name: Christelle JOUANNAUD, MD role: CONTACT name: Christelle JOUANNAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 49.25 lon: 4.03333 facility: CHU de Saint-Etienne status: NOT_YET_RECRUITING city: Saint-Priest-en-Jarez zip: 42270 country: France name: Pierre CORNILLON, MD role: CONTACT name: Pierre CORNILLON, MD role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 facility: Institut de cancérologie Strasbourg Europe status: RECRUITING city: Strasbourg zip: 67033 country: France name: Manon VOEGELIN role: CONTACT name: Philippe BARTHELEMY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Hôpitaux Universitaires de Strasbourg status: NOT_YET_RECRUITING city: Strasbourg zip: 67091 country: France name: Bertrand MENNECIER, MD role: CONTACT name: Bertrand MENNECIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False |
<|newrecord|> nctId: NCT06379867 id: HSK3486-112 briefTitle: A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects overallStatus: RECRUITING date: 2024-04-07 date: 2024-05-30 date: 2024-08-30 date: 2024-04-23 date: 2024-04-26 name: Haisco Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects. conditions: Anesthesia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: HSK3486 name: Placebo name: Moxifloxacin measure: ΔQTcI measure: ΔHR, ΔQTcF, ΔPR, and ΔQRS measure: Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals measure: AE and SAE measure: Cmax measure: AUClast measure: t1/2 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Beijing GoBroad Boren Hospital status: RECRUITING city: Beijing country: China name: Jie Hou role: CONTACT phone: 18611422958 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06379854 id: RCRAHS-ISB/REC/MS-PT/01814 briefTitle: Trunk Rotation And Lateral Flexion Exercises In Stroke Patients overallStatus: RECRUITING date: 2024-04-01 date: 2024-06 date: 2024-06 date: 2024-04-23 date: 2024-04-23 name: Riphah International University class: OTHER briefSummary: In this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: chest physiotherapy name: trunk rotation exercises,deep diaphragmatic also chest physiotherapy measure: Trunk Impairment Scale: measure: Peak Flow Meter measure: Chest Expansion: sex: ALL maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Shahida Khaliq Health Centre status: RECRUITING city: Islamabad zip: 44080 country: Pakistan name: Sara Jahan, MSPT role: CONTACT phone: +923415182331 email: [email protected] lat: 33.72148 lon: 73.04329 hasResults: False |
<|newrecord|> nctId: NCT06379841 id: STUDY00007357 briefTitle: Green Hysteroscopy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-23 date: 2024-04-23 name: Emory University class: OTHER briefSummary: The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time. |
Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time conditions: Hysteroscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 100 type: ESTIMATED name: Green Draping Procedure name: Full Draping Procedure measure: Difference in operative times measure: Infection Rate measure: Post Operative complication Rate measure: Peri operative Complication Rate measure: Number of cases of Fluid deficits measure: Operative room turnover time in Full Draping sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory Hospital city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Emory Dunwoody Clinic city: Atlanta state: Georgia zip: 30338 country: United States lat: 33.749 lon: -84.38798 facility: Emory Saint Joseph's Hospital city: Atlanta state: Georgia zip: 30342 country: United States lat: 33.749 lon: -84.38798 hasResults: False |
<|newrecord|> nctId: NCT06379828 id: 2024-0140 briefTitle: Self-assessment Tool for Implementing the ESCNH overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-10-01 date: 2026-09-01 date: 2024-04-23 date: 2024-04-25 name: European Foundation for the Care of Newborn Infants class: OTHER briefSummary: This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability. conditions: Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health conditions: Testing of the Developed Self-assessment Tool in European Hospitals conditions: Self-Assessment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Please note that this is an observational study; not applicable measure: Online self-assessment tool (including statements and questions) measure: Response rates measure: Demographics and characteristics measure: User-friendliness score of the self-assessment tool measure: Applicability score of the formulation of the questions measure: Qualitative feedback on illustration of output measure: Appraisal on the utilisation of the self-assessment tool measure: Scalability of the self-assessment tool and dissemination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Foundation for the Care of Newborn Infants (EFCNI) city: Munich state: Bavaria zip: 81379 country: Germany name: Isabel Geiger, Dr. role: CONTACT phone: 0049 89 89 0 83 26-0 email: [email protected] name: Julia Hoffmann, Dr. role: CONTACT email: [email protected] name: Luc Zimmermann, Prof. role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-17 uploadDate: 2024-04-17T07:49 filename: Prot_SAP_000.pdf size: 200372 hasResults: False |
<|newrecord|> nctId: NCT06379815 id: EMRL-23-03 briefTitle: Effect of Oral Lactate Ingestion on Appetite Regulation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08 date: 2024-08 date: 2024-04-23 date: 2024-04-23 name: Wilfrid Laurier University class: OTHER name: Natural Sciences and Engineering Research Council, Canada briefSummary: The goal if this study is to determine how oral lactate ingestion affects markers of appetite regulation. Researchers will compare oral lactate ingestion to a sodium chloride placebo. Participants will consume the lactate or placebo solution and then have blood samples and assessments of appetite over the course of 90 min. Free-living energy intake will be measured for 3 days surrounding each experimental session. conditions: Appetitive Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: The allocation of lactate and placebo will be completed by a researcher not involved in data collection. Both the participant and the researchers collecting and analyzing the data will be blinded to the treatment allocation. This will be completed in a counter-balanced order. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Sodium Lactate name: Sodium Chloride measure: Blood Lactate measure: Acylated ghrelin measure: Total ghrelin measure: Subjective appetite perception measure: Free-living energy intake sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06379802 id: 2023-00546-01 briefTitle: Lifestyle Intervention With Physical Activity and Diet acronym: LI-PAD overallStatus: RECRUITING date: 2024-02-12 date: 2025-12-31 date: 2027-12-31 date: 2024-04-23 date: 2024-04-23 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: The aim of this pilot randomized controlled trial LI-PAD is to identify whether a 6-month intervention approach to individually optimize lifestyle behavior, physical activity, and diet, is feasible and leads to larger improvements in body weight, cardiovascular disease risk factors, and health-related quality of life compared to simple written lifestyle advice, in individuals with overweight or obesity. |
The intervention group will be offered individual support for lifestyle behavioral change (precision health) and the control group will be offered written lifestyle advice, following national recommendations. In total, 60 population-based participants and 60 controls from the Gothenburg area, aged 45-65 years, will be recruited. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Individualized physical activity and diet measure: Change in body weight 1 measure: Change in body weight 2 measure: Change in body weight 3 measure: Change in body weight 4 measure: Length in cm measure: Weight in kilograms measure: Cardiovascular disease risk factor change - Body Mass Index (BMI) measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 1 measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 2 measure: Cardiovascular disease risk factor change - Waist-to-hip-ratio 3 measure: Cardiovascular disease risk factor change - Waist-hip-ratio 4 measure: Cardiovascular disease risk factor change - Blood pressure 1 measure: Cardiovascular disease risk factor change - Blood pressure 2 measure: Cardiovascular disease risk factor change - Blood pressure 3 measure: Cardiovascular disease risk factor change - Blood pressure 4 measure: Cardiovascular disease risk factor change - Long-term blood glucose control using glycated haemoglobin (HbA1c) measure: Cardiovascular disease risk factor change - Serum (total) Cholesterol (S-Cholesterol) measure: Cardiovascular disease risk factor change - High density lipoprotein (HDL) measure: Cardiovascular disease risk factor change - Low densitiy lipoprotein (LDL) measure: Cardiovascular disease risk factor change - Triglycerides measure: Cardiovascular disease risk factor change - Aerobic fitness (predicted V02 max) measure: Cardiovascular disease risk factor change - Physical activity level measure: Change in functional lower extremity muscle strength measure: Change in upper extremity muscle strength - Hand grip strength measure: Change in muscle strength - Shoulder flexion measure: Change in muscle strength - Ankle Plantar measure: Cardiovascular disease risk factor change - Healthy food intake measure: Change in resting energy expenditure 1 measure: Change in resting energy expenditure 2 measure: Change in resting energy expenditure 3 measure: Change in resting energy expenditure 4 measure: Change in respiratory quotient 1 measure: Change in respiratory quotient 2 measure: Change in respiratory quotient 3 measure: Change in respiratory quotient 4 measure: Change in health-related quality of life - Proportions of problems in five dimensions measure: Change in health-related quality of life - Index score measure: Change in health-related quality of life - Visual analog score of present health status measure: Change in health-related quality of life - Health status categories measure: Change in self-reported physical activity level measure: Change in exposure pattern to the food environment measure: Change in exposure pattern to the built environment measure: Process evaluation measure 1 - Extent to which intervention was implemented as planned measure: Process evaluation measure 2 - Number of sessions of each intervention component delivered measure: Process evaluation measure 3 - Number of sessions of each intervention component received measure: Process evaluation measure 4 - Satisfaction with individual lifestyle counselling measure: Process evaluation measure 5 - Satisfaction with the lifestyle school measure: Process evaluation measure 6A - Perceived facilitators measure: Process evaluation measure 6B - Perceived barriers measure: Process evaluation measure 7 - Reach sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for lifestyle intervention status: RECRUITING city: Gothenburg country: Sweden name: Mats Börjesson, Prof. role: CONTACT email: [email protected] name: Carina Persson, Ass. prof. role: CONTACT email: [email protected] lat: 57.70716 lon: 11.96679 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-12 uploadDate: 2024-04-12T10:31 filename: Prot_000.pdf size: 411005 hasResults: False |
<|newrecord|> nctId: NCT06379789 id: R131L1265-HEMB-2318 id: 2023-507260-40-00 type: REGISTRY domain: EU CTR Number briefTitle: A Trial to Learn if REGV131-LNP1265 is Safe and Works to Help the Body Make Clotting Factor in Pediatric, Adolescent and Adult Patients With Hemophilia B acronym: BEYOND-9 overallStatus: NOT_YET_RECRUITING date: 2024-07-25 date: 2032-07-03 date: 2032-07-03 date: 2024-04-23 date: 2024-04-23 name: Regeneron Pharmaceuticals class: INDUSTRY name: Intellia Therapeutics briefSummary: Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the "study drug". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy. |
The main aim of this study is to find a safe and well-tolerated dose of the study drug by checking the side effects that may happen from taking it. |
The study is looking at several other research questions including: |
* How much study drug is in the blood at different times |
* Whether the body makes antibodies against parts of the study drug, which could make the drug less effective or could lead to side effects. Antibodies are proteins produced by the body's immune system in response to a foreign substance |
* Whether the body makes antibodies against the clotting factor replacement therapy |
* How quality of life is affected by hemophilia B and if it changes after taking study drug |
* How joint health is affected by hemophilia B and if it changes after taking study drug |
* How often visits are required for the emergency room, urgent care center, physician's office, hospital, telephone or online are required as a result of bleeding events, and if the frequency changes after taking study drug |
* How often factor replacement therapy is needed, both on a regular basis for prevention of bleeding, and as needed to treat bleeding events (and it if changes after taking study drug) |
* Whether there is a difference in 2 different methods for measuring Factor 9 activity in the blood conditions: Hemophilia B studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: REGV131 name: LNP1265 measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Coagulation Factor IX (FIX) functional activity measured using the chromogenic substrate assay measure: Change in FIX functional activity in plasma, measured using the chromogenic substrate assay measure: Annualized bleeding rate (ABR) following sustained FIX functional activity among participants receiving the RDE measure: Change in FIX functional activity in plasma measured using the chromogenic substrate assay measure: ABR following sustained FIX functional activity among participants receiving the RDE measure: FIX functional activity in plasma over time during the study period using the chromogenic substrate assay measure: Annualized treated bleeding rate (tABR) following sustained FIX functional activity, among participants receiving the RDE measure: Annualized utilization (IU/kg/year) of FIX replacement therapy following sustained FIX functional activity among participants receiving the RDE measure: Remaining free of FIX replacement therapy among those receiving the RDE following sustained FIX expression measure: Remaining zero spontaneous bleeding events among those receiving the RDE over sustained FIX functional activity period measure: Concentrations of REGV131 components measure: Concentrations of LNP1265 components measure: Detection of antibodies to the F9 transgene product FIX protein measure: Detection of total binding antibodies (TAbs) to the adeno-associated virus 8 (AAV8) capsid proteins measure: Detection of neutralizing antibodies/transduction inhibitors (NAb/TI) to the adeno-associated virus 8 (AAV8) capsid proteins measure: Detection of antibodies to LNP1265 measure: Detection of antibodies to CRISPR-associated protein 9 (Cas9) protein measure: Detection of vector DNA in blood measure: Detection of vector DNA in saliva measure: Detection of vector DNA in nasal secretions measure: Detection of vector DNA in semen measure: Detection of vector DNA in urine measure: Detection of vector DNA in feces measure: Incidence of TEAEs measure: Severity of TEAEs measure: Detection of vector DNA in relevant matrices based on data analysis of Part 1 Dose Confirmation Cohort measure: Detection of vector DNA in relevant matrices over time based on data analysis from adult cohorts over time sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379776 id: LabForSIMS-LC1 briefTitle: 3D Model - Classification of Thoracic and Lumbar Spinal Fractures. overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2026-09-30 date: 2026-09-30 date: 2024-04-23 date: 2024-04-23 name: Université Paris-Sud class: OTHER briefSummary: The goal of this clinical trial is to evaluate and compare the effectiveness of a 3D interactive model versus traditional teaching methods in enhancing the teaching of thoracic and lumbar spine fractures classification (AO Spine) among orthopedic residents. |
The main questions this study aims to answer are: |
Does the use of a 3D interactive model improve residents' knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods? To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy, injury mechanisms, pathophysiology, and fracture diagnosis among surgical residents? |
Participants will be randomly assigned to either: |
Group A: Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification. They can explore fractures, access textual information, and anatomical annotations. |
Group B: Traditional teaching materials including slides, texts, and diagrams illustrating spine fractures according to the AO Spine classification. |
Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model. |
Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge, experience with 3D educational tools, confidence levels in managing spine fractures, and satisfaction with the teaching method. |
The study aims to ascertain if the use of the 3D model significantly enhances residents' comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum. conditions: Lumbar Spine Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Education through a 3D model name: Education through a traditional pedagogical support measure: Specific Questionnaire measure: Objective Structured Assessment of Technical Skills (OSATS) measure: Subjective questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379763 id: 170/2024 briefTitle: Effect of Diaphragmatic Breathing Exercise on Pain and Sleep Quality in Individuals With Non-specific Chronic Neck Pain overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-30 date: 2024-06-30 date: 2024-04-23 date: 2024-04-23 name: University of Jordan class: OTHER briefSummary: This research focuses on adding diaphragmatic breathing to conventional physiotherapy sessions, particularly for patients suffering from chronic neck pain aged between 20-40 years in Jordan. Chronic neck pain is recognized as one of the most prevalent musculoskeletal pain disorders, significantly impacting physical, social, and psychological aspects of life. This issue leads to a decline in functional performance and work productivity, negatively affecting both individual and societal levels. Several factors, such as poor posture and prolonged use of smartphones, contribute to the exacerbation of non-specific chronic neck pain. These problems also affect respiratory muscles, particularly the diaphragm responsible for primary respiration, resulting in a shift from abdominal to chest breathing. This alteration increases the use of neck muscles, subsequently intensifying neck pain and negatively impacting sleep quality in these individuals. The primary objective of this therapeutic study is to investigate the role of adding diaphragmatic breathing to physiotherapy sessions in alleviating pain and improving sleep quality. |
RCT study will investigate the effect of adding the diaphragmatic breathing to conventional physiotherapy treatment on pain and sleep quality over one month. conditions: Non-specific Chronic Neck Pain conditions: Diaphragmatic Breathing Exercise studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized clinical trial (RCT) Participants will be randomly allocated into two groups using the block randomization method. The following groups will be formed: experimental group A (diaphragmatic breathing plus conservative physiotherapy intervention, cervical neck ROM, neck stretching exercises), and group B, primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the participants will not know which of exercises that will be giving for them more better in experimental or control group whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: diaphragmatic breathing exercise name: conventional physiotherapy exercise measure: neck pain measure: neck pain measure: sleep quality sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: The university of Jordan status: RECRUITING city: Amman zip: 11942 country: Jordan name: ISLAM ALNAQEEB, master role: CONTACT phone: 00962797246713 email: [email protected] name: Musab Abu beidar, master role: CONTACT phone: 00962790319243 email: [email protected] lat: 31.95522 lon: 35.94503 hasResults: False |
<|newrecord|> nctId: NCT06379750 id: STOPNCD briefTitle: Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-03-01 date: 2028-03-01 date: 2024-04-23 date: 2024-04-23 name: Queen's University class: OTHER name: Kilimanjaro Clinical Research Institute name: Muhimbili University of Health and Allied Sciences briefSummary: The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. We will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. We will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, we will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which we evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which we use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. We will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change. conditions: Hypertension conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: OTHER masking: NONE count: 1320 type: ESTIMATED name: Nurse-delivered care using WelTel check-ins and BCC SMS name: Community-based peer-support model measure: Systolic blood pressure measure: Blood pressure control sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379737 id: 359n/AO/23 id: MASI_CARIVARI21_01 type: OTHER_GRANT domain: Fondazione Cariparo briefTitle: Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial acronym: MULTI-COVID overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-20 date: 2023-12-20 date: 2024-04-23 date: 2024-04-23 name: Padua University General Hospital class: OTHER briefSummary: Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings. |
Design: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week. |
Outcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction. conditions: Long COVID studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Multi-systemic Rehabilitation measure: Numerical Rating Scale (NRS) measure: Hand grip strength measure: Barthel Dyspnea Scale measure: Fatigue Assessment Scale measure: Beck's Depression Inventory (BDI measure: Beck Anxiety Inventory (BAI) measure: 12-Item Short Form Health Survey (SF-12) measure: Patients satisfaction sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universityof Padua city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 hasResults: False |
<|newrecord|> nctId: NCT06379724 id: 150349 briefTitle: Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2026-12 date: 2024-04-23 date: 2024-04-23 name: University of Kansas Medical Center class: OTHER briefSummary: Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system. conditions: Burns conditions: Skin Graft Complications studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, blinded, non-inferiority study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future. The research coordinator will have the code to the blind. The surgical team will not be blinded as the overall consistency of the topical agents will differ and may be apparent. whoMasked: PARTICIPANT count: 62 type: ESTIMATED name: Tranexamic acid name: Thrombin JMI name: skin graft measure: The number of participants with hematoma occurrence measure: The rate of percentage of graft take adherence amongst participants measure: Comparison of number of participants that require re-operation measure: Difference in cost between two hemostatic agents sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379711 id: H22-03727 briefTitle: Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2028-08-01 date: 2028-08-01 date: 2024-04-23 date: 2024-04-23 name: University of British Columbia class: OTHER briefSummary: The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters. conditions: Spinal Cord Injuries conditions: Cardiovascular Diseases conditions: Cardiopulmonary Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre-Post Study primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Transcutaneous Spinal Cord Stimulation (tSCS) measure: Circulating endothelial biomarkers in EMV/µL (Park et al., 2023) measure: Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008) measure: Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FVC measure: Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FEV1 sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Blusson Spinal Cord Centre city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada lat: 49.24966 lon: -123.11934 hasResults: False |
<|newrecord|> nctId: NCT06379698 id: CHUBX 2023/78 briefTitle: Rein 3D PRINT PERSONALIZE acronym: R3DP-P overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-06-15 date: 2027-06-15 date: 2024-04-23 date: 2024-04-23 name: University Hospital, Bordeaux class: OTHER briefSummary: The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers. conditions: Tumoral Kidney studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ESTIMATED name: personalized 3D model pré-opérative education name: generic 3D model pré-opérative education measure: Qualitative assessment of patient experience 1 measure: Qualitative assessment of patient experience 2 measure: Qualitative assessment of patient experience 3 measure: Description of interactions between carers and patients measure: Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care. measure: Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process measure: To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model) measure: Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire) measure: Description of the changes perceived by carers in patients management in both group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux country: France name: Gaëlle MARGUE, Docteur role: CONTACT lat: 44.84044 lon: -0.5805 hasResults: False |
<|newrecord|> nctId: NCT06379685 id: SOPH190-0923/I briefTitle: Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2025-04-30 date: 2025-04-30 date: 2024-04-23 date: 2024-04-23 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®. conditions: Dry Eye conditions: Dry Eyes Chronic conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, controlled, comparative. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: PRO-190 name: Systane Ultra® measure: Incidence Unexpected Related Adverse Reactions measure: Changes in the ocular comfort index (OCI) score in between interventions measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in tear film breakup time measure: Changes in intraocular pressure (IOP) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Changes in lissamine green staining sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379672 id: 2023[No.193] briefTitle: Resonance Breathing Training for Long Covid-related Myocardial Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2024-08-25 date: 2024-09-05 date: 2024-04-23 date: 2024-04-23 name: Chengdu Sport University class: OTHER briefSummary: An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury conditions: Long COVID conditions: Myocardial Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Resonance breathing measure: New YorkHeart Association (NYHA) measure: left ventricle global longitudinal strain, LVGLS measure: hypertension measure: Average heart rate sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06379659 id: IR.MUI.MED.REC.1402.449 id: IRCT20110908007513N18 type: REGISTRY domain: IRAN registry of clinical trials (IRCT) briefTitle: Effectiveness of Intrauterine Growth Hormone Administration as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer overallStatus: RECRUITING date: 2024-05 date: 2024-07 date: 2024-11 date: 2024-04-23 date: 2024-04-29 name: Isfahan University of Medical Sciences class: OTHER briefSummary: The purpose of this clinical trial is to see if intrauterine growth hormone infusions can help subjects reach a suitable endometrial thickness in patients who are resistant to routine hormonal therapy for embryo transfer in the In Vitro Fertilization (IVF) cycle. |
The primary aim of this study is to assess the effectiveness of injecting Growth hormone directly into the uterus to enhance endometrial thickness. Additionally, we aim to compare the likelihood of pregnancy between patients receiving the Growth hormone infusion and those receiving a placebo. conditions: Thin Endometrium conditions: Infertility Female conditions: Infertility studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was designed as a randomized controlled exploratory clinical trial, controlled with a parallel placebo group and random allocation using an online based system. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In this study, a double-blind methodology will be employed to minimize bias. Patients will be administered medication without knowing the study group and placebo or treatment intervention. To ensure uniformity between growth hormone and placebo, which has a similar appearance to the placebo, will be prepared by an individual informed of the enrolled patients in the study and will be provided to the administering physician. The evaluator assessing outcomes such as clinical pregnancy rate and endometrial thickness will not know which treatment each patient received. Laboratory staff will also be unaware of the treatment groups. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Growh hormone name: Placebo measure: Endometrial thickness measure: Clinical Pregnancy Rate measure: Response to treatment measure: Implantation rate measure: IVF cancellation rate measure: Early pregnancy complications sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center status: RECRUITING city: Isfahan zip: 8174673461 country: Iran, Islamic Republic of name: Nastaran Zamani Dehkordi role: CONTACT phoneExt: +989133842958 email: [email protected] name: Hatav Ghasemi Dehkordi role: CONTACT phoneExt: +989131134081 email: [email protected] name: Hatav Ghasemi Tehrani role: PRINCIPAL_INVESTIGATOR lat: 32.65246 lon: 51.67462 hasResults: False |
<|newrecord|> nctId: NCT06379646 id: YTS109-003 briefTitle: An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-21 date: 2026-04-21 date: 2024-04-23 date: 2024-04-23 name: China Immunotech (Beijing) Biotechnology Co., Ltd. class: INDUSTRY name: Shanghai Changzheng Hospital briefSummary: An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease conditions: Systemic Lupus Erythematosus conditions: Systemic Sclerosis conditions: Inflammatory Myopathy conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis conditions: Antiphospholipid Syndrome conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: YTS109 measure: Safety outcomes measure: Efficacy outcomes for SLE measure: Efficacy outcomes for Sjogren's Syndrome measure: Efficacy outcomes for Systemic Sclerosis measure: Efficacy outcomes for Inflammatory Myopathy measure: Efficacy outcomes for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis measure: Efficacy outcomes for Antiphospholipid Syndrome measure: Peak Plasma Concentration (Cmax) of YTS109 measure: Time to Peak (Tmax) of YTS109 measure: Area under the plasma concentration versus time curve (AUC) of YTS109 measure: PD parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379633 id: s67010 briefTitle: Virtual Reality Exposure for Socially Anxious Adolescents acronym: VIRTUS overallStatus: RECRUITING date: 2024-03-27 date: 2026-06 date: 2026-06 date: 2024-04-23 date: 2024-04-23 name: KU Leuven class: OTHER name: Utrecht University briefSummary: Overall in this project, the primary goal is to evaluate the efficacy of virtual reality exposure (VRE) for adolescents with elevated social anxiety using a three-arm randomized controlled trial: (1) virtual reality exposure (VRE); (2) in vivo exposure (IVE); and (3) waitlist (WL) - the control condition. |
It is predicted that both VRE and IVE will be more successful in decreasing social anxiety symptoms than the WL condition at post-assessment and that VRE will be as effective as in vivo in reducing social anxiety symptoms. Furthermore, it is expected that there will be no difference between the two active conditions in the long term (at 3- months \& 6-months follow up). Similar results are expected in the secondary outcome measures, intended to capture the participants' general well-being. |
Moreover, the study has the following (secondary) objectives: |
* To elucidate potential working mechanisms of VRE and IVE |
* To identify predictors of adolescents' response to VRE and IVE |
* To assess to what extent adolescents accept VRE and IVE and how they experience it conditions: Social Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to one of the three conditions and will remain in that condition throughout the training sessions. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: All pre-assessments and post-assessment will be conducted by researchers who will be blind to the participants' allocated condition. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: In vivo exposure name: (Virtual reality) exposure measure: Brief version of the Social Phobia and Anxiety Inventory (SPAI-18) measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale measure: Behavioral assessment task (BAT) - Peak anxiety measure: Brief Resilience Scale (BRS) measure: Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales measure: Revised Children's Anxiety and Depression Scale (RCADS) measure: Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale measure: Social Phobia Weekly Summary Scale (SPWSS) measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale measure: Adolescent Social Cognitions Questionnaire (ASCQ) measure: Behavioral assessment task (BAT) - Anticipatory anxiety measure: Behavioral assessment task (BAT) - Physiological assessment measure: Behavioral assessment task (BAT) - Physiological assessment measure: Behavioral assessment task (BAT) - Physiological assessment measure: Behavioral assessment task (BAT) - Task duration measure: Behavioral assessment task (BAT) - Confederate rating measure: Behavioral inhibition system / behavioral activation system scale (BIS/BAS) measure: Experiences in Close Relationship Scale - Relationship Structures (ECR-RS) measure: Immersive Tendency Questionnaire (ITQ) - Factor Involvement measure: Unified Theory of Acceptance and Use of Technology (UTAUT-A) - Attitudes subscale measure: Unified Theory of Acceptance and Use of Technology (UTAUT-EC) - Expectancy subscale measure: VR experience, motivation, need for connection/relatedness, openness to experiences measure: Preference for treatment question measure: Credibility and Expectancy Questionnaire (CEQ) measure: Working Alliance Inventory-Short Form (WAI-S) measure: Exposure log questions - expectancy violation & expectancy change measure: Exposure log open-ended questions - expectancy violation & expectancy change measure: Exposure log questions - within- & between- session habituation measure: Exposure log question- Self-efficacy measure: Exposure log question - Presence measure: Exposure log questions - Participant feedback measure: Acceptability interview sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: Psychological Institute (PSI) of KU Leuven status: RECRUITING city: Leuven zip: 3000 Leuven country: Belgium name: Jella De Lee, MSc role: CONTACT phone: +3216373075 email: [email protected] name: Elizabeth S. Uduwa-vidanalage, MSc role: CONTACT email: [email protected] name: Dirk Hermans, PhD role: PRINCIPAL_INVESTIGATOR name: Iris Engelhard, PhD role: SUB_INVESTIGATOR name: Katharina Meyerbröker, PhD role: SUB_INVESTIGATOR name: Sara Scheveneels, PhD role: SUB_INVESTIGATOR name: Jella De Lee, MSc role: SUB_INVESTIGATOR name: Elizabeth S Uduwa-vidanalage, MSc role: SUB_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06379620 id: 22-5544 briefTitle: Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction acronym: Hi-OXSR overallStatus: COMPLETED date: 2022-11-29 date: 2024-03-04 date: 2024-03-04 date: 2024-04-23 date: 2024-04-25 name: University Health Network, Toronto class: OTHER briefSummary: During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation. |
Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction. conditions: Post COVID-19 Condition studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open label, pilot treatment study. Screening data will be reviewed to determine subject eligibility. Upon successful completion of all screening procedures, subject will be considered eligible for enrollment. |
The subject will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask, twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days. Subjects will be asked to return to the clinic for additional evaluations on Days 15 and 45. primaryPurpose: TREATMENT masking: NONE count: 37 type: ACTUAL name: Hi-OxSR Sequential Rebreathing mask (oxygen concentrator) measure: Safety of use of Hi-OX sequential rebreathing device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06379607 id: HFNC2024 briefTitle: High Flow Nasal Cannula Rates in Pediatric Asthma overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-09-30 date: 2025-09-30 date: 2024-04-23 date: 2024-04-23 name: University of Rochester class: OTHER briefSummary: This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations. conditions: Pediatric Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 27 type: ESTIMATED name: "High Flow" High Flow Nasal Cannula name: "Low Flow" High Flow Nasal Cannula measure: Percent of participants enrolled measure: Mean Change in Pediatric Asthma Severity Score (PASS) measure: Mean Change in Respiratory Rate measure: Mean Total Duration of Continuous Albuterol measure: Percentage of Children with Escalation of Respiratory Support measure: Mean Total Duration of Respiratory Support measure: Percentage of Participants placed on Adjunct Asthma Therapies measure: Percentage of Participants who needed Sedation measure: Percentage of Participants on Antibiotics measure: Mean PICU Length of Stay (LOS) measure: Mean Hospital Length of Stay (LOS) sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06379594 id: 294633 briefTitle: UK Based Remote Brain Health Clinic (BHC) for Patients With Mild Cognitive Impairment (MCI) acronym: BHC overallStatus: ENROLLING_BY_INVITATION date: 2022-06-20 date: 2027-12 date: 2028-06 date: 2024-04-23 date: 2024-04-23 name: South London and Maudsley NHS Foundation Trust class: OTHER briefSummary: This project aims to understand the feasibility, acceptability and real-world evidence of a novel UK-based remote brain health clinic for patients with mild cognitive impairment (MCI). A timely and accurate diagnosis of dementia is a priority in the UK and MCI is indicative of future risk of cognitive decline. An accurate etiological diagnosis of MCI (MCI-subtyping - distinguishing those who are likely to go on to develop dementia and those who are not) is vital for treatment planning. Whilst the assessment of molecular biological markers (biomarkers) for etiological diagnosis of MCI and Alzheimer's disease (AD) is increasingly recommended and employed internationally, the uptake is low in UK memory clinics. The Brain Health Clinic (BHC) has been specifically designed as a state-of-the-art diagnostic centre for those with MCI. Procedures will include a range of clinical and biomarker assessments, with molecular biomarkers based on lumbar puncture and cerebrospinal fluid (CSF) analysis. Additionally, the clinic will employ remote neuropsychiatric assessments using digital and telephonic methods. This allows for regular contact, whilst adhering to changes in clinical practice and national guidance due to the COVID-19 pandemic. Our overarching objectives are to first establish the acceptability and feasibility of the remote Brain Health Clinic and its novel clinical and biomarker assessment programme. Then secondly establish the impact of care under the Brain Health Clinic on i) care management decisions (e.g. follow-up and treatment planning); ii) time to etiological diagnosis of MCI (MCI-subtyping); and iii) time to diagnosis of dementia and severity of dementia at the time of diagnosis. conditions: Mild Cognitive Impairment conditions: Mild Cognitive Impairment Due to Alzheimer's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI. measure: To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI. measure: To establish the acceptability and feasibility of the following procedures/ biomarker assessment in a Brain Health Clinic measure: 2. To establish the acceptability and feasibility of administering the following cognitive assessments remotely in a brain health clinic measure: To establish the validity of novel MRI analysis software tools measure: 5. To investigate the acceptability and feasibility of remote tablet-based cognitive training measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King's College London city: London state: Denmark Hill zip: SE5 8AF country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06379581 id: 2022-04900-02 briefTitle: Skin Cancer Diagnostics Using Photoacoustic Imaging overallStatus: RECRUITING date: 2023-01-01 date: 2025-10-01 date: 2025-10-01 date: 2024-04-23 date: 2024-04-24 name: Region Skane class: OTHER name: Lund University briefSummary: In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth. conditions: Skin Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Tumor thickness measure: Tumor size sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthamology, Lund, Skåne University Hospital status: RECRUITING city: Lund zip: 22185 country: Sweden name: Malin Malmsjö, Professor role: CONTACT phone: +46722335060 email: [email protected] lat: 55.70584 lon: 13.19321 hasResults: False |
<|newrecord|> nctId: NCT06379568 id: SichuanPPHLC01 briefTitle: Risk of Aspergillus Infection in Patients With Chronic Lung Disease overallStatus: COMPLETED date: 2022-07-01 date: 2024-01-31 date: 2024-01-31 date: 2024-04-23 date: 2024-04-23 name: Lin Chen class: OTHER briefSummary: Large doses of systemic corticosteroids ，severe lung tissue damage and longer COPD diagnosis may increase the risk of IPA in patients with chronic structural lung disease. By comparing the risk factors of aspergillus colonization group and aspergillus infection group, the main risk factors of aspergillus pneumonia were determined. conditions: Fungal Infection Lungs studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 209 type: ACTUAL name: No intervention measure: Descriptive statistical index measure: Independent risk factor for aspergillus pneumonia measure: The area under ROC curve of risk factors for aspergillus pneumonia measure: Threshold analysis of aspergillus pneumonia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China lat: 30.66667 lon: 104.06667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-31 uploadDate: 2024-04-17T04:01 filename: Prot_SAP_000.pdf size: 101446 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-31 uploadDate: 2024-04-14T12:03 filename: ICF_001.pdf size: 105933 hasResults: False |
<|newrecord|> nctId: NCT06379555 id: 2023-A02756-39 briefTitle: Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study acronym: WALANPOIGNE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: Wrist articular fractures are more difficult to treat and rehabilitation takes longer. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones. |
For these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and ligament rupture of carpal bones can be treated. |
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