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<|newrecord|> nctId: NCT06262503 id: P.T.REC/012/004810 briefTitle: the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-02 date: 2024-03 date: 2024-02-16 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: 1. To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
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2. To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.
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A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation . conditions: Phantom Pain Following Amputation of Lower Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group1:conventional physiotherapy for phantom Pain Group2:conventional physiotherapy and Virtual Reality for phantom Pain primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Virtual Reality name: Transcutaneous Electrical Nerve Stimulation (TENS) name: Mirroring Therapy name: Phantom Exercises measure: Pain Intensity Level measure: Lower Extremity Functional sex: ALL minimumAge: 18 Months maximumAge: 75 Months stdAges: CHILD facility: Faculty of Physical therapy, Cairo university city: Giza zip: 12613 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06262490 id: P.T.REC/012/004765 briefTitle: Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-09-01 date: 2024-02-16 date: 2024-02-16 name: Cairo University class: OTHER briefSummary: The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms . conditions: Chronic Perineal Pain conditions: Pelvic Floor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Traditional ultrasound therapy name: Pelvic floor rehabilitation measure: Assessment of osteomyoarticular symptoms measure: Assessment of perineal pain intensity measure: Assessment of pelvic floor muscle strength measure: Assessment of pelvic floor muscle tightness measure: Assessment of lumbar spine mobility sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt name: Aya T- Allah M. Nabil, PhD student role: CONTACT phone: 01063028038 email: drayanabil1993@gmail.com name: Salwa M. El Badry role: CONTACT name: Amel M. Yousef, Prof. role: PRINCIPAL_INVESTIGATOR name: Hazem S. Al-Ashmawy, Ass. Prof role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06262477 id: NL-TCZ-12280 briefTitle: A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants overallStatus: RECRUITING date: 2024-01-02 date: 2024-11-30 date: 2024-11-30 date: 2024-02-16 date: 2024-02-16 name: Biogen class: INDUSTRY briefSummary: The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: BIIB800 name: Actemra measure: Maximum Serum Concentration (Cmax) of Tocilizumab measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab measure: Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab measure: Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab measure: Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab measure: Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R) measure: Maximum Observed Effect (Emax) of sIL-6R measure: Time to Emax (tEmax) of sIL-6R measure: AUE of High Sensitive C-Reactive Protein (hsCRP) measure: Minimum Observed Effect Emin of hsCRP measure: Time to Emin (tEmin) of hsCRP measure: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs) measure: Number of Participants With ADA Titers sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit Inc. status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States role: CONTACT phone: 608-210-5574 email: sarah.russell@fortrea.com name: Sarah Russell, MD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06262464 id: 17.361/ 07.12.2023 briefTitle: An OCD Prevention Programme for at Risk Adults acronym: ØCD overallStatus: RECRUITING date: 2024-02-09 date: 2024-03-29 date: 2024-04-01 date: 2024-02-16 date: 2024-03-18 name: Babes-Bolyai University class: OTHER name: Romanian National Authority for Scientific Research briefSummary: The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Prevention measure: Change from baseline in OCD symptoms on the OCI-R after the intervention measure: Change from baseline in depressive symptoms on the PHQ-9 after the intervention measure: Change from baseline in anxiety symptoms on the GAD-7 after the intervention measure: Change from baseline in experiential avoidance on the EAQ after the intervention measure: Change from baseline in cognitive distortions on the OBQ-44 after the intervention measure: Change from baseline in uncertainty intolerance on the IUS after the intervention measure: Change from baseline in resilience on the RSA after the intervention measure: Change from baseline in life quality on the WHOQOL-BREF after the intervention measure: Change from baseline in irrationality on the ATQ after the intervention measure: Change from baseline in global health on the GHQ-12 after the intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy status: RECRUITING city: Cluj-Napoca zip: 400015 country: Romania name: Roxana AI Cardos, PhD Student role: CONTACT phone: 0040751477323 email: roxana.cardos@ubbcluj.ro lat: 46.76667 lon: 23.6 hasResults: False
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<|newrecord|> nctId: NCT06262451 id: 20-30182 id: 5R24AI118629 type: NIH link: https://reporter.nih.gov/quickSearch/5R24AI118629 briefTitle: Fecal Microbiota Transplant National Registry overallStatus: RECRUITING date: 2023-10-20 date: 2032-10 date: 2032-10 date: 2024-02-16 date: 2024-02-16 name: University of California, San Francisco class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits. conditions: Fecal Microbiota Transplant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: To assess short-term and long-term safety of FMT and other gut-related-microbiota products measure: To characterize effectiveness of FMT and other gut-related-microbiota products. measure: To gather information on FMT practice in North America measure: To promote scientific investigation. measure: To aid practitioners and sponsors in satisfying regulatory requirements sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94115 country: United States name: Rachael Leigh Delacruz role: CONTACT phone: 415-514-8087 email: rachaelleigh.delacruz@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False
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<|newrecord|> nctId: NCT06262438 id: MH22CAQ id: 2022-002886-14 type: EUDRACT_NUMBER id: 2023-505000-27 type: OTHER domain: EU CT Number briefTitle: CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients acronym: CHIP-AML22/Q overallStatus: RECRUITING date: 2024-02-06 date: 2028-06 date: 2032-06 date: 2024-02-16 date: 2024-02-16 name: Princess Maxima Center for Pediatric Oncology class: OTHER name: Daiichi Sankyo briefSummary: The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type. conditions: Acute Myeloid Leukemia in Children studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Given the rarity of pediatric subjects with newly diagnosed Acute Myeloid Leukemia (AML) with FLT3-ITD mutations and the slow enrollment in historical studies, it is not feasible to enroll a sufficient number of subjects for an adequately powered randomized study. Therefore, a standard oncology Phase 2 response-rate design has been chosen. One of the exploratory objectives planned is to compare the outcome of patients treated in this study to the outcome of patients treated in the NOPHO-DBH AML-2012 study as historical control. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Quizartinib name: Etoposide name: Dexrazoxane name: Mitoxantrone name: Cytarabine name: Methotrexate name: Daunorubicin name: Fludarabine name: allo-SCT measure: Primary objective (efficacy) measure: Primary objective (safety) measure: Secondary objectives (efficacy_1) measure: Secondary objectives (efficacy_2) measure: Secondary objectives (efficacy_3) measure: Secondary objectives (efficacy_4) measure: Secondary objectives (efficacy_5) measure: Secondary objectives (efficacy_6) measure: Secondary objectives (efficacy_7) measure: Secondary objectives (efficacy_8) measure: Secondary objectives (efficacy_9) measure: Secondary objectives (safety) - Adverse Events, Laboratory Abnormalities and cumulative incidence of non-relapse mortality measure: Pharmacokinetics (PK_1) measure: Pharmacokinetics (PK_2) measure: Pharmacokinetics (PK_3) measure: Pharmacokinetics (PK_4) measure: Palatability of quizartinib formulations sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Princess Máxima Center for pediatric oncology status: RECRUITING city: Utrecht zip: 3584 CS country: Netherlands name: Gertjan Kaspers, Prof. Dr. role: CONTACT name: Bianca Goemans, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06262425 id: ALC001NR004 briefTitle: rTMS Over S1 Enhance Motor Learning in Healthy People overallStatus: RECRUITING date: 2024-01-20 date: 2025-06-15 date: 2025-09-15 date: 2024-02-16 date: 2024-02-20 name: Neuron, Spain class: OTHER briefSummary: The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple. conditions: Transcranial Magnetic Stimulation conditions: Motor Learning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 95 type: ESTIMATED name: repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex name: repetitive Transcranial Magnetic Stimulation over primary motor cortex name: sham repetitive Transcranial Magnetic Stimulation measure: Change in accuracy measure: Change in reaction time speed measure: Change in pegs placed in 30 seconds sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neuron status: RECRUITING city: Madrid zip: 28045 country: Spain name: Alfredo Lerín Calvo, PhD Student role: CONTACT phone: +34620187457 email: alfre_lerin@hotmail.com lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06262412 id: 2023-02193-01 briefTitle: Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder overallStatus: RECRUITING date: 2024-02-19 date: 2026-04-30 date: 2026-10-31 date: 2024-02-16 date: 2024-02-26 name: Karolinska Institutet class: OTHER name: Region Stockholm name: Vastra Gotaland Region name: Region Skane briefSummary: The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the 6-month durability of a therapist-guided, Internet-delivered cognitive-behavior therapy programme for children and adolescents with body dysmorphic disorder. conditions: Body Dysmorphic Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multisite parallel-group randomised controlled superiority trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: All study personnel who can be blind to study aims/hypotheses and group allocation, will be blind. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blind to study aims/hypotheses and treatment allocation for the full duration of the trial (up to the 6-month follow-up). The assessors will not receive any information about the study design, objectives or treatment conditions in order to maximise the blinding integrity. At each follow-up assessment, participants will be reminded by their assessor to not reveal details about their treatment. whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: Internet-delivered cognitive-behaviour therapy (ICBT) name: Internet-delivered relaxation treatment (IRT) measure: Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A) measure: Treatment response and full or partial remission measure: Clinical Global Impression - Severity (CGI-S) measure: Clinical Global Impression - Improvement (CGI-I) measure: Children's Global Assessment Scale (CGAS) measure: Appearance Anxiety Index (AAI) measure: Short Mood and Feeling Questionnaire - child version and parent version (SMFQ) + additional suicide item (only child/adolescent) measure: Generalized Anxiety Disorder - 7 item scale (GAD-7) measure: Deliberate Self-Harm Inventory - Youth version (DSHI-Y-7) measure: CRAFFT (acronym for the key words Car, Relax, Alone, Forget, Friends and Trouble) measure: Work and Social Adjustment Scale - youth (WSAS-Y) and parent version (WSAS-P) measure: Child Health Utility 9D (CHU9D) measure: Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P) measure: Working Alliance Inventory - child (WAI-C) and parent version (WAI-P) measure: Client Satisfaction Questionnaire (CSQ-8) measure: Treatment Credibility and Expectancy Scale (TCES) measure: Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS) measure: Treatment preference measure: Areas of concern and cosmetic procedures measure: School absenteeism measure: Concurrent interventions measure: BASS platform usage data measure: Completed modules measure: Adverse events questionnaire sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: BUP OCD och relaterade tillstånd status: RECRUITING city: Stockholm zip: 113 30 country: Sweden name: Anita Birovecz, MSc role: CONTACT phone: +46 70 275 61 25 email: anita.birovecz@ki.se lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06262399 id: ITL-2002-CL-999 id: 2022-003778-22 type: EUDRACT_NUMBER briefTitle: Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2040-04 date: 2040-04 date: 2024-02-16 date: 2024-02-16 name: Intellia Therapeutics class: INDUSTRY briefSummary: This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy. conditions: Hereditary Angioedema studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol measure: To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects measure: Change from baseline in consumption of on-demand HAE medications for reported HAE attacks measure: Change from baseline in healthcare utilization for HAE attacks measure: Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument. measure: Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument. measure: Change from baseline in QoL parameters as measured by the WPAI:GH instrument. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre National de Reference - Grenoble city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Hôpital Claude Huriez city: Lille country: France lat: 50.63297 lon: 3.05858 facility: New Zealand Clinical Research city: Auckland country: New Zealand lat: -36.84853 lon: 174.76349 facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital city: Cambridge country: United Kingdom lat: 52.2 lon: 0.11667 hasResults: False
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<|newrecord|> nctId: NCT06262386 id: 202202172B0 briefTitle: Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial overallStatus: RECRUITING date: 2023-08-01 date: 2028-07-31 date: 2028-07-31 date: 2024-02-16 date: 2024-02-16 name: Chang Gung Memorial Hospital class: OTHER name: National Science and Technology Council briefSummary: For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.
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In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.
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The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases. conditions: Lung Cancer conditions: Relapse/Recurrence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 358 type: ESTIMATED name: Cisplatin based chemottherapy measure: Accuracy of proposed relapse prediction model measure: early relapse rate measure: Overall surveival sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ching-Yang Wu status: RECRUITING city: Taoyuan City zip: 333 country: Taiwan name: Ching-Yang Wu role: CONTACT phone: +886975368204 email: wu.chingyang@gmail.com name: Jason CH Hsieh role: CONTACT phone: +886975366137 email: wisdom5000@gmail.com name: Jui-Ying Fu role: SUB_INVESTIGATOR name: Ching-Feng Wu role: SUB_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06262373 id: 221321 briefTitle: Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes overallStatus: COMPLETED date: 2017-10-01 date: 2019-10-01 date: 2019-10-01 date: 2024-02-16 date: 2024-02-16 name: King's College Hospital NHS Trust class: OTHER briefSummary: The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery. conditions: Miscarriage in First Trimester studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 236 type: ACTUAL name: Ultrasound measure: Primary measure: Secondary measure: Secondary sex: FEMALE minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: King's College Hospital city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06262360 id: P2023457 briefTitle: Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia acronym: EIT_ped overallStatus: RECRUITING date: 2024-02-16 date: 2024-06-30 date: 2024-09-30 date: 2024-02-16 date: 2024-02-21 name: Queen Fabiola Children's University Hospital class: OTHER briefSummary: The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.
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Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).
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Patients will be allocated to three different group in a ration of 1:1:1.
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* Group 1: spontaneous mask ventilation (20 patients).
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* Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).
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* Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).
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* Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).
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Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).
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Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).
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Electrical impedance tomography measurements:
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The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.
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The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.
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A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.
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The EIT measurements will be taken of 4 different moments:
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T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).
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T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.
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T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.
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T4: Before the discharge of the PACU. conditions: Anesthesia, Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: General anesthesia with mask ventilation name: General anesthesia and spontaneous laryngeal mask ventilation name: General anesthesia with spontaneous laryngeal mask ventilation with pressure support measure: Variation of poorly ventilated pulmonary zones sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: denis.schmartz@hubruxelles.be lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06262347 id: 2024-0115 id: UG1DA013732 type: NIH link: https://reporter.nih.gov/quickSearch/UG1DA013732 briefTitle: Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD acronym: TOME overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-20 date: 2025-06-20 date: 2024-02-16 date: 2024-02-20 name: T. John Winhusen, PhD class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: National Institute on Drug Abuse (NIDA) briefSummary: The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons. conditions: Opioid Use Disorder conditions: Pregnancy Related conditions: Substance Use conditions: Drug Abuse conditions: Drug Abuse in Pregnancy conditions: Drug Addiction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an intent-to-treat, two-arm, open-label, randomized controlled trial. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) name: Control measure: Medication for Opioid Use Disorder (MOUD) knowledge score measure: Opioid Overdose knowledge score measure: Medication for Opioid Use Disorder (MOUD) Internalized Stigma measure: Drug Self-efficacy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262334 id: Pro00133917 id: K23MD016123 type: NIH link: https://reporter.nih.gov/quickSearch/K23MD016123 briefTitle: Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men overallStatus: RECRUITING date: 2024-03-20 date: 2024-06-15 date: 2024-06-15 date: 2024-02-16 date: 2024-03-26 name: University of South Carolina class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.
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It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.
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The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. conditions: Health Related Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: The Fade to Fitness Program measure: Number of men who are eligible/eligible. measure: Length of time needed to enroll 15 men measure: Facilitator-assessed attendance in intervention measure: Number of men who express interest in the study measure: Attrition in intervention measure: Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention measure: Change in weight measure: Change in body mass index measure: Change in moderate-to-vigorous physical activity measure: Global Health - Mental 2a measure: Global Health - Physical 2a measure: Perceived Stress Scale measure: Emotional Distress - Depression - Short Form 4a measure: Healthy Eating Subscale of the Health Promotion Lifestyle Profile II measure: Instrumental Support- Short Form 4a measure: Informational Support - Short Form 4a measure: Emotional Support - Short Form 4a measure: Companionship - Short Form 4a measure: Motivation and Attitudes Towards Changing Health (MATCH) measure: NIH Self-Efficacy Measure measure: Subjective Social Norms of Health Behavior measure: Valuing Questionnaire measure: Diet sex: MALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Carolina status: RECRUITING city: Columbia state: South Carolina zip: 29208 country: United States name: Guillermo M Wippold, PhD role: CONTACT phone: 803-216-1051 email: wippold@mailbox.sc.edu name: Guillermo M Wippold, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.00071 lon: -81.03481 hasResults: False
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<|newrecord|> nctId: NCT06262321 id: URLUN23099 briefTitle: Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax acronym: DRO2301 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-02-01 date: 2029-02-01 date: 2024-02-16 date: 2024-04-10 name: University of Rochester class: OTHER briefSummary: Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy. conditions: Stage 4 NSCLC conditions: Radiotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Prophylactic Palliative Radiotherapy measure: Freedom from symptomatic progression of irradiated thoracic target(s) measure: OS (Kaplan-Meier) (Kaplan-Meier) measure: Freedom from local recurrence of irradiated thoracic target lesion(s) measure: PFS (freedom from local and distant progression; Kaplan-Meier) measure: Duration of time that patient is maintenance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262308 id: 334235 briefTitle: Emotional Support for Women Experiencing PPROM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-16 date: 2024-02-16 name: King's College London class: OTHER briefSummary: Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women. conditions: Fetal Membranes, Premature Rupture conditions: Preterm Birth Complication studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a pilot study where a small cohort of women will give given personalised psychological intervention primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 8 type: ESTIMATED name: Psychological intervention along Cognitive Behavioural Therapy principles measure: Mood Score 1 measure: Mood Score 2 measure: Participant Feedback sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: St Thomas' Hospital, King's College London city: London state: Greater London zip: SE1 7EH country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06262295 id: 2023-A02475-40 briefTitle: National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS) overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2027-09 date: 2027-09 date: 2024-02-16 date: 2024-02-16 name: French Cardiology Society class: OTHER name: Abbott briefSummary: Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.
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The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe.
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The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use. conditions: Pacemaker studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: To confirm the safety of the AVEIR VR LP device measure: To confirm the effectiveness of the AVEIR VR LP device measure: To collect patient characteristics and indications in normal conditions of use of the AVEIR VR LP device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262282 id: NTM-OB-17 (PART C) briefTitle: Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria acronym: POSTSTAMP overallStatus: ENROLLING_BY_INVITATION date: 2024-02-05 date: 2026-12 date: 2028-12 date: 2024-02-16 date: 2024-02-16 name: National Jewish Health class: OTHER name: Cystic Fibrosis Foundation briefSummary: About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year. conditions: Cystic Fibrosis conditions: Nontuberculous Mycobacterial Lung Disease conditions: Nontuberculous Mycobacterium Infection conditions: Mycobacterium Infections conditions: Mycobacterium; Pulmonary studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: mycobacteriophage measure: Adherence to therapy measure: Phage susceptibility measure: Culture conversion measure: Tolerance of treatment measure: Clinical Response (pulmonary function testing) measure: Microbiologic response to phage measure: Clinical response (BMI) measure: Clinical response (CFQR) measure: Clinical Response (antibiotic courses for non- NTM exacerbations) sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama city: Birmingham state: Alabama zip: 35233 country: United States lat: 33.52066 lon: -86.80249 facility: Children's Hospital of Los Angeles city: Los Angeles state: California zip: 90027 country: United States lat: 34.05223 lon: -118.24368 facility: University of California city: San Diego state: California zip: 92103 country: United States lat: 32.71533 lon: -117.15726 facility: Childrens Hospital Colorado city: Denver state: Colorado zip: 80045 country: United States lat: 39.73915 lon: -104.9847 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: John Hopkins University city: Baltimore state: Maryland zip: 21218 country: United States lat: 39.29038 lon: -76.61219 facility: Boston Childrens Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Dartmouth Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States lat: 43.64229 lon: -72.25176 facility: Columbia University city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: Southwestern Medical Center at Dallas city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: University of Vermont city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 facility: University of Washington city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06262269 id: Sportscol id: 2022-A00021-42 type: OTHER domain: Number IDRCB briefTitle: Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents overallStatus: RECRUITING date: 2022-09-21 date: 2025-06 date: 2025-12 date: 2024-02-16 date: 2024-03-08 name: Association des Paralysees de France (APF) class: OTHER name: Fondation de France briefSummary: This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows:
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* Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS.
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* A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis. conditions: Adolescent Idiopathic Scoliosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Home-based adapted physical activity program supervised by an APA teacher via individual video conference. name: First period of the home-based adapted physical activity program with an exercise booklet. name: Second period of the home-based adapted physical activity program with an exercise booklet. measure: Evaluation to overall physical performance on an ergometer-rowing machine measure: Evaluation of overall physical performance on an ergometer-rowing machine measure: Evaluation of perivertebral muscle performance (Plank) measure: Evaluation of perivertebral muscle performance (Rowing) measure: Indirect assessment of VO2 max measure: The Ratings Perceveid Exertion for Children during exercise (RPE-C) measure: Assessment of motivation to change measure: Evaluation of attendance at adapted physical activity sessions measure: Anthropometric evaluation (Height) measure: Anthropometric evaluation (weight) measure: Anthropometric evaluation (BMI) measure: Anthropometric evaluation by bioimpedance measurement measure: Analysis of the static vertical posture on a force platform SATEL® measure: Evaluation of the EOS radiograph of the total spine in front (Type) measure: Evaluation of the EOS radiograph of the total spine in front and in profile (Angle) measure: Evaluation of the EOS radiograph of the total spine in front (Frontal deviation) measure: Evaluation of the EOS radiograph of the total spine in front (Risser) measure: Photogrammetric morphostatic evaluation by surface topography measure: Measurement of the main gibbosity measure: Assessment of quality of life by the Scoliosis Research Society (SRS) scale : SRS-18 measure: Satisfaction questionnaires sex: FEMALE minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: SSR Marc Sautelet status: RECRUITING city: Villeneuve-d'Ascq zip: 59650 country: France name: Jean-François Catanzariti, Médecin MPR role: CONTACT lat: 50.61669 lon: 3.16664 hasResults: False
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<|newrecord|> nctId: NCT06262256 id: HIIT-GLS-METS briefTitle: Effects of High-intensity Interval Training on Myocardial Strain in Metabolic Syndrome Patients overallStatus: COMPLETED date: 2022-09-01 date: 2023-05-30 date: 2023-12-22 date: 2024-02-15 date: 2024-02-15 name: University of Castilla-La Mancha class: OTHER name: Complejo Hospitalario de Toledo briefSummary: the effects of high-intensity interval training on myocardial function will be studied in a group of patients under medical treatment for the components of metabolic syndrome. conditions: High-Intensity Interval Training conditions: Metabolic Syndrome conditions: Myocardial Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial with control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Echocardiography evaluators will be masked about participant allocation. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: High-intensity interval training measure: Changes in global longitudinal strain measure: changes in cardiorespiratory fitness measure: changes in metabolic syndrome z-score measure: changes in visceral fat measure: changes in left ventricle passive filling (E wave) measure: changes in early diastolic mitral annulus velocity (e' wave) measure: changes in estimated left ventricle filling pressures (E/e') sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Castilla-La Mancha city: Toledo state: Castilla-La Mancha zip: 45071 country: Spain lat: 39.8581 lon: -4.02263 hasResults: False
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<|newrecord|> nctId: NCT06262243 id: ORDUU-HEM-TÇ-01 briefTitle: The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum overallStatus: RECRUITING date: 2024-01-15 date: 2024-08-30 date: 2024-09-01 date: 2024-02-15 date: 2024-02-15 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success. conditions: Cesarean Section studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research is a randomized controlled experimental design. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: In this randomized controlled study, 78 mothers, 39 in each group, will be included in the intervention and control groups that meet the criteria for participation in the study. The researcher will give general information about the research to the mothers in the intervention and control groups during hospitalization and nurse admission, and their written informed consent will be obtained. whoMasked: PARTICIPANT count: 78 type: ESTIMATED name: electric blankets measure: Postpartum comfort scale measure: A Tool to Evaluate the Amount of Breast Milk the Baby Receives measure: Bristol Breastfeeding Assessment Tool measure: Insufficient Milk Perception Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun Training and Research Hospital status: RECRUITING city: Samsun state: İ̇lkadim zip: 55080 country: Turkey name: TUBA ÇITAK role: CONTACT phone: 05349265496 email: tubadlkc@gmail.com name: Ebru ŞAHİN role: SUB_INVESTIGATOR name: Tuba ÇITAK role: PRINCIPAL_INVESTIGATOR lat: 41.27976 lon: 36.3361 hasResults: False
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<|newrecord|> nctId: NCT06262230 id: OPCI on ASD Children briefTitle: Feasibility and Effectiveness of OPCI on ASD Children overallStatus: COMPLETED date: 2022-11-20 date: 2023-10-31 date: 2023-10-31 date: 2024-02-15 date: 2024-02-15 name: Peking University class: OTHER briefSummary: The goal of this interventional study was to explore the feasibility and effectiveness of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are:
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1. What is the acceptability and adherence of OPCI;
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2. Whether OPCI is effective on the social abilities and mental health of ASD children;
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3. What impact does OPCI have on ordinary children and parents of both children? conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: In this study, ordinary children will be paired with ASD children according to age, hobbies and other conditions primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ACTUAL name: Online Inclusive Companionship Intervention measure: Social Behavior of ASD Children measure: Mental Health of ASD Children measure: Intervention Process Screen Recording Coding measure: Symptom Severity measure: Mental Health of Ordinary Children measure: Social Ability of Ordinary Children measure: Mental Health of Parents sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD facility: Peking University city: Beijing state: Beijing zip: 100871 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06262217 id: INGN21ST510 briefTitle: Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke acronym: MIRACLES overallStatus: RECRUITING date: 2023-11-11 date: 2024-05-31 date: 2024-08-01 date: 2024-02-15 date: 2024-02-15 name: NHS Greater Glasgow and Clyde class: OTHER name: University of Glasgow briefSummary: This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered. conditions: Stroke, Acute studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Mobile MRI scanner measure: Diagnostic sensitivity and specificity of mobile MRI scanner measure: Comparison of MRI abnormalities measure: Final Clinical Diagnosis measure: Final Clinical Diagnosis measure: Time from arrival at the Emergency Department to scan measure: Use of treatments measure: Patient Outcomes measure: Level of confidence in final diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Elizabeth University Hospital status: RECRUITING city: Glasgow country: United Kingdom name: Stewart Rodney role: CONTACT phone: 0141 451 6879 email: stewart.rodney@glasgow.ac.uk lat: 55.86515 lon: -4.25763 hasResults: False
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<|newrecord|> nctId: NCT06262204 id: Hallux Shark Screw(R) briefTitle: Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw). overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-02-28 date: 2026-02-28 date: 2024-02-15 date: 2024-04-05 name: Orthopedic Hospital Vienna Speising class: OTHER briefSummary: The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.
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The main questions it aims to answer are:
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Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized. conditions: Hallux Valgus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: does get the information only after 2 years at the end of teh study whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Hallux Valgus Treatment with Shark Screw® name: Hallux Valgus Treatment with metal screw measure: clinical result of Hallux Valgus treatment measure: radiological (bony union)result of Hallux Valgus treatment measure: change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS) measure: Hallux-Valgus angle (HVA) change measure: gait analysis measure: Intermetatarsal angle (IMA) change sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising city: Vienna zip: 1130 country: Austria name: Florian Wenzel-Schwarz, MD role: CONTACT phone: +43180182 phoneExt: 3081 email: florian.wenzel-schwarz@oss.at name: Florian Wenzel-Schwarz, MD role: PRINCIPAL_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False
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<|newrecord|> nctId: NCT06262191 id: 2137249 briefTitle: Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy overallStatus: RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-06-01 date: 2024-02-15 date: 2024-03-25 name: Northern Arizona University class: OTHER briefSummary: This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Differential and adjustable stiffness AFO (DAS-AFO) measure: Muscle activity measure: Metabolic cost of transport measure: Pictorial Children's Effort Rating Table (PCERT) measure: System Usability Score (SUS) questionnaire sex: ALL minimumAge: 8 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Northern Arizona University status: RECRUITING city: Flagstaff state: Arizona zip: 86011 country: United States name: Zach Lerner, PhD role: CONTACT phone: 928-523-1787 email: zachary.lerner@nau.edu lat: 35.19807 lon: -111.65127 hasResults: False
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<|newrecord|> nctId: NCT06262178 id: 23-1393 briefTitle: Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-02-15 date: 2024-02-15 name: New York University class: OTHER name: Cohen Veterans Network name: University of California, Davis briefSummary: The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy). conditions: PTSD conditions: Depression conditions: Parent-Child Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PSTAIR combines elements of two existing Evidence-Based Treatments (EBTs): Skills Training in Affective and Interpersonal Regulation (STAIR), targeting maternal trauma and emotion dysregulation, and dyadic Parent-Child Care (PC-CARE), targeting parenting. We will shorten PSTAIR into a 10-15 session modular intervention and individualize treatment using an adaptive decision rule and shared decision making. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Parenting-STAIR name: Treatment as Usual measure: Post-traumatic stress disorder (PTSD) Checklist 5 measure: Patient Health Questionnaire-9 (PHQ-9) measure: Parenting Sense of Competence Scale (PSOC) measure: Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Diagnosis measure: Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Symptom Severity measure: Structured Clinical Interview for DSM 5 (SCID) measure: Parenting Stress Index 4-Short Form (PSI4-SF) measure: Difficulties in Emotion Regulation Scale (DERS) measure: Brief Cope measure: Dyadic Parent-Child Interaction Coding System-IV (DPICS) measure: Treatment Acceptability and Expectations (TAE) measure: Strengths and Difficulties Questionnaire (SDQ) measure: Eyberg Child Behavior Inventory (ECBI) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262165 id: RC23_0497 briefTitle: Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis acronym: BILAN overallStatus: RECRUITING date: 2024-02-16 date: 2032-06-15 date: 2032-12-15 date: 2024-02-15 date: 2024-04-12 name: Nantes University Hospital class: OTHER briefSummary: The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Patients with Anorexia Nervosa measure: Identification of new blood biomarkers and hepatic cytolysis sex: ALL minimumAge: 15 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital status: RECRUITING city: Nantes state: Loire-Atlantique zip: 44093 country: France name: Sarra SMATI-GRANGEON, MCU-PH role: CONTACT phone: 33 2 53 48.27.01 email: sarra.grangeon@chu-nantes.fr lat: 47.21725 lon: -1.55336 hasResults: False
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<|newrecord|> nctId: NCT06262152 id: 49187/2023 briefTitle: Sleep Profile of Patients With Septo-optic Dysplasia overallStatus: RECRUITING date: 2023-12-20 date: 2024-01-20 date: 2025-05-20 date: 2024-02-15 date: 2024-02-15 name: IRCCS National Neurological Institute "C. Mondino" Foundation class: OTHER briefSummary: The aim of this study is to evaluate sleep of patients with septo-optic dysplasia compared to patients with an isolated disorder of peripheral visual system and patients with corpus callosum agenesis since both visus defict and agenesis of corpus callosum might be present SOD but associated to other features / structural and functional anomalies.
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Included patients and their caregivers will be asked to compile standardize sleep questionnaires and a sleep screening through an interview will be scheduled. Patients will be asked to wear an actigraph on their non-dominant hand wrist for 7 days. conditions: Septo-Optic Dysplasia conditions: Agenesis of Corpus Callosum conditions: Blindness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Actigraphy, blood and salivary sample, and sleep evaluation measure: Sleep profile ( Sleep quality, sleep efficiency) of patients with SOD measure: melatonin profile of patients with SOD measure: Sleep EEG description of patients with SOD sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Casimiro Mondino Foundation status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: Ludovica Pasca, MD role: CONTACT phone: 00393337201551 email: ludovica.pasca@mondino.it name: Valentina Franco, MD role: CONTACT lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06262139 id: MT218-002 briefTitle: Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-09 date: 2024-02-15 date: 2024-04-29 name: Molecular Theranostics LLC class: INDUSTRY name: Emory University briefSummary: This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy. conditions: MRI Scan studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: prostate cancer patients primaryPurpose: DIAGNOSTIC masking: NONE count: 12 type: ESTIMATED name: MT218 injection measure: Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT sex: MALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06262126 id: 23-012673 briefTitle: Virtual Reality for Non-cardiac Chest Pain overallStatus: RECRUITING date: 2024-02-14 date: 2024-12 date: 2025-01 date: 2024-02-15 date: 2024-04-17 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP). conditions: Gastrointestinal Diseases conditions: Chest Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 10 type: ESTIMATED name: Virtual Reality measure: Measure changes in GERD symptoms using the GERDQ questionnare measure: Measure changes in GERD quality of life using the GERD-HRQL questionnaire measure: Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire measure: Measure changes in GI symptom severity using the PAGI-SYM questionnaire measure: Measure changes in GI related patient assessment of quality of life using PAGI-QOL measure: Measure changes in anxiety and depression using the HADs scale measure: Measure changes in resilience using the brief resilience scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Wendi Lehman role: CONTACT phone: 904-953-8742 email: Lehman.Wendi@mayo.edu lat: 30.33218 lon: -81.65565 hasResults: False
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<|newrecord|> nctId: NCT06262113 id: 2024P000392 id: AD-2022C2-24790 type: OTHER_GRANT domain: PCORI briefTitle: A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1 overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-06 date: 2026-08 date: 2024-02-15 date: 2024-02-15 name: Massachusetts General Hospital class: OTHER name: Patient-Centered Outcomes Research Institute briefSummary: The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.
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Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits scheduled with a primary care provider (PCP) are eligible to enroll in the study. conditions: Neurofibromatosis 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 360 type: ESTIMATED name: Letters about NF1 Care (Content Type 1) name: Letters about NF1 Care (Content Type 2) measure: Receipt of Recommended NF1 Health Screenings measure: Patient Activation Measure® measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Rating of the Visit measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): How Well Providers Communicate With Patients Subscale measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Providers' Use of Information to Coordinate Patient Care Subscale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06262100 id: EYL_23_01 briefTitle: Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye overallStatus: RECRUITING date: 2024-01-15 date: 2024-07-30 date: 2024-12-15 date: 2024-02-15 date: 2024-02-15 name: Marinomed Biotech AG class: INDUSTRY briefSummary: Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Carragelose measure: Change in dry eye symptoms measure: Responder analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IOBA,Ocular Surface Research Group, University of Valladolid status: RECRUITING city: Valladolid zip: 47011 country: Spain name: Marta Balanco Vázquez, PhD role: CONTACT phone: C email: mblancov@ioba.med.uva.es name: Margarita Calogne, PhD role: CONTACT phone: V email: calogne@ioba.med.uva.es lat: 41.65518 lon: -4.72372 hasResults: False
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<|newrecord|> nctId: NCT06262087 id: MU-CIRB 2023/044.2203 briefTitle: The Combined FIFA 11+ and Change of Direction Training overallStatus: RECRUITING date: 2024-02-15 date: 2024-06 date: 2024-12 date: 2024-02-15 date: 2024-03-15 name: Mahidol University class: OTHER briefSummary: The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+. conditions: Rehabilitation conditions: Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Change of direction training name: FIFA 11+ program measure: Peak knee valgus angle sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: FFC league in Cambodia status: RECRUITING city: Phnom Penh country: Cambodia name: Komsak Sinsurin, Ph.D. role: CONTACT phone: +66 024415450 phoneExt: 20605 email: komsak.sin@mahidol.edu name: Chanteng Huoth, M.Sc. role: PRINCIPAL_INVESTIGATOR lat: 11.56245 lon: 104.91601 hasResults: False
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<|newrecord|> nctId: NCT06262074 id: IEC-2418 briefTitle: Effect of Structured Training Program in Diabetic Patients overallStatus: RECRUITING date: 2024-02-08 date: 2024-02-08 date: 2024-03-31 date: 2024-02-15 date: 2024-02-15 name: Maharishi Markendeswar University (Deemed to be University) class: OTHER briefSummary: Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals. conditions: Diabetic Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Structured Exercise Program name: Non structured exercise program measure: Michigan neuropathy screening instrument (MNSI) measure: Biothesiometer measure: NeuroQoL measure: NPRS sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MMIPR status: RECRUITING city: Ambala state: Haryana zip: 133207 country: India name: Subhashish Chatterjee, MPT(NEURO) role: CONTACT phone: +918950037407 email: subhasishphysio@gmail.com name: Subhashish Chatterjee, MPT role: PRINCIPAL_INVESTIGATOR lat: 30.36099 lon: 76.79782 hasResults: False
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<|newrecord|> nctId: NCT06262061 id: PRO-TBI-FS briefTitle: Propranolol for the Treatment of Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-09 date: 2024-02-15 date: 2024-02-15 name: London Health Sciences Centre class: OTHER briefSummary: Traumatic brain injury (TBI) is a leading cause of global disease and directly affects over 1.5 million Canadians, with 165 000 TBIs occurring yearly in Canada. Despite the burden of TBIs, there are limited treatment options available and current treatments generally focus on supportive care. The aim of TBI treatment is reduce inflammation and damage occurring after the TBI (secondary injury).
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Beta- blockers (BBs) are medications commonly used to block the actions of endogenous catecholamines- hormones that are thought to contribute to secondary injury within brain tissue. This reduces metabolic demand in the vulnerable, injured brain. BBs have been studied in several retrospective trials and one single-center, non- blinded randomized controlled study. These results point towards a benefit to the use of BBs in TBI but need to be confirmed in a rigorous manner before they are widely adopted.
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The current study aims to assess the feasibility of a single centre randomized controlled trial of BBs versus placebo to treat moderate to severe TBI. This feasibility trial will inform the planning of a large multi-center study powered to detect a difference in cognitive outcomes and mortality. It also will allow the investigators to gather biologic samples for measuring serum catecholamines and inflammatory mediators to better understand the basic science mechanisms of BBs in this patient population; and to assess the feasibility of using the Cambridge Battery to assess cognitive outcomes of trial participants. conditions: TBI (Traumatic Brain Injury) studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single- center double- blinded randomized control trial comparing placebo to propranolol for the treatment of moderate- severe traumatic brain injury. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Patients will be randomized in a 1:1 allocation to either the propranolol or control group. Our hospital pharmacy will control the randomization procedure. The propranolol group will receive over-encapsulated whole marketed tablets comprised of 20mg oral propranolol \[USP grade\] filled with lactose monohydrate powder \[NF grade\] encapsulated with opaque gelatin capsules twice daily for 14 days (or until hospital discharge or death). The control group will receive an oral placebo comprised of lactose monohydrate powder \[NF grade\] encapsulated with indistinguishable opaque gelatin capsules. The pharmacy will have access to the randomization key. Nursing staff will remove the gelatin capsule casing and dissolve the trial drug \& placebo in sterile water prior to administering it enterally via a feeding tube to the participants. Aside from the nursing staff, the participants, research team, and remainder of the clinical care teams will all remain blinded to treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Propranolol name: Placebo measure: Hospital Mortality measure: Cognitive function measure: Catecholamines/Inflammatory markers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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